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Trial record 34 of 110 for:    test | ( Map: Malawi )

A Key Link for Transmission Prevention (MP3)

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ClinicalTrials.gov Identifier: NCT01450189
Recruitment Status : Completed
First Posted : October 12, 2011
Results First Posted : May 12, 2016
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition HIV
Interventions Behavioral: Standard HIV prevention messages
Behavioral: BI: Information-Motivation-Behavioral Skills Model
Drug: Raltegravir
Drug: emtricitabine/tenofovir disoproxil fumarate
Enrollment 46
Recruitment Details Participants were recruited through screening in two sexually transmitted disease clinics and two HIV testing sites in Lilongwe, Malawi.
Pre-assignment Details Participants were evaluated in two stages: screening for acute HIV infection (AHI) and enrollment of persons with AHI for follow-up. As this is a pilot study, some outcomes refer to screening only. The original protocol called for 115 persons with AHI; only 46 persons were enrolled as the study period ended and funding expired.
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Behavioral Intervention Plus Antiretrovirals (BIA)
Hide Arm/Group Description

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.

ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.

Period Title: Overall Study
Started 9 18 19
Completed 9 18 19
Not Completed 0 0 0
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Behavioral Intervention Plus Antiretrovirals (BIA) Total
Hide Arm/Group Description

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.

ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 9 18 19 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 18 participants 19 participants 46 participants
31.6  (8.1) 26.7  (5.1) 27.1  (7.9) 27.7  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 18 participants 19 participants 46 participants
Female
4
  44.4%
7
  38.9%
7
  36.8%
18
  39.1%
Male
5
  55.6%
11
  61.1%
12
  63.2%
28
  60.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Malawi Number Analyzed 9 participants 18 participants 19 participants 46 participants
9 18 19 46
1.Primary Outcome
Title Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All persons screened
Arm/Group Title Overall
Hide Arm/Group Description:
All arms combined
Overall Number of Participants Analyzed 14755
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants screened
0.622
(0.614 to 0.630)
2.Primary Outcome
Title Prevalence of AHI Among Persons Screened
Hide Description Prevalence of AHI among all persons screened. This measure is among all persons screened, prior to randomization.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 9171
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.0073
(0.0057 to 0.0093)
3.Primary Outcome
Title Proportion of Persons With AHI Successfully Recruited Into the Study
Hide Description This outcome reflects the ability to recruit persons with AHI into a study. The outcome is based on the population prior to randomization.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 67
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of persons with AHI recruited
0.69
(0.56 to 0.79)
4.Primary Outcome
Title Proportion of Participants Completing Full Course of ARVs in Arm BIA
Hide Description Proportion of participants in the BIA arm receiving full course of ARVs. This outcome is calculated among the BIA arm only, as that
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Number of persons in BIA arm eligible for study-provided ARVs
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Behavioral Intervention Plus Antiretrovirals (BIA)
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.

ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.

Overall Number of Participants Analyzed 0 0 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of BIA participants
0.917
(0.615 to 0.998)
5.Primary Outcome
Title Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment.
Hide Description In this pilot study, we addressed our ability to complete the behavioral intervention quickly. As two arms received the behavioral intervention, this outcome is combined across those two arms.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All persons in the two behavioral intervention arms
Arm/Group Title Combined Behavioral Intervention Arms
Hide Arm/Group Description:
Both the behavioral intervention and behavioral intervention plus antiretroviral arms are combined in this outcome
Overall Number of Participants Analyzed 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.216
(0.098 to 0.382)
6.Primary Outcome
Title Proportion of Persons Completing All Scheduled Visits in Each Study Arm
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Behavioral Intervention Plus Antiretrovirals (BIA)
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.

ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.

Overall Number of Participants Analyzed 9 18 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.44
(0.14 to 0.79)
0.44
(0.22 to 0.69)
0.37
(0.16 to 0.62)
7.Primary Outcome
Title Number of Adverse Events
Hide Description Mean number of adverse events per group
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 9 18 19
Mean (95% Confidence Interval)
Unit of Measure: number of events
0.78
(0.31 to 1.6)
1.3
(0.81 to 1.9)
1.3
(0.85 to 1.9)
8.Secondary Outcome
Title Unprotected Sex Acts in Previous One Week - 12 Weeks
Hide Description The mean number of unprotected sex acts in previous one week, assessed at 12 weeks
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number includes enrolled persons who completed the ACASI interview within the window for this visit
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 6 16 15
Mean (95% Confidence Interval)
Unit of Measure: unprotected sex acts/week
0
(0 to 0.6)
0.5
(0.2 to 1.0)
1.2
(0.7 to 1.9)
9.Secondary Outcome
Title Unprotected Sex Acts in Previous One Week - 26 Weeks
Hide Description The mean number of unprotected sex acts in previous one week, assessed at 26 weeks
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number includes enrolled persons who completed the ACASI interview within the window for this visit
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 8 14 15
Mean (95% Confidence Interval)
Unit of Measure: unprotected sex acts/week
0.25
(0.03 to 0.9)
0.1
(0.02 to 0.5)
0.5
(0.2 to 1.0)
10.Secondary Outcome
Title Unprotected Sex Acts in Previous One Week - 52 Weeks
Hide Description The mean number of unprotected sex acts in previous one week, assessed at 52 weeks
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number includes enrolled persons who completed the ACASI interview within the window for this visit
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 6 10 13
Mean (95% Confidence Interval)
Unit of Measure: unprotected sex acts/week
0.8
(0.3 to 1.9)
0.2
(0.02 to 0.7)
0
(0 to 0.3)
11.Secondary Outcome
Title Unprotected Sex Acts in Previous One Month - 12 Weeks
Hide Description The mean number of unprotected sex acts in previous one month, assessed at 12 weeks
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number includes enrolled persons who completed the ACASI interview within the window for this visit
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 6 16 15
Mean (95% Confidence Interval)
Unit of Measure: unprotected sex acts/month
0
(0 to 0.6)
0.8
(0.4 to 1.4)
0
(0 to 0.3)
12.Secondary Outcome
Title Unprotected Sex Acts in Previous One Month - 26 Weeks
Hide Description The mean number of unprotected sex acts in previous one month, assessed at 26 weeks
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number includes enrolled persons who completed the ACASI interview within the window for this visit
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 8 14 15
Mean (95% Confidence Interval)
Unit of Measure: unprotected sex acts/month
0.25
(0.03 to 0.9)
0.2
(0.04 to 0.6)
0.4
(0.1 to 0.9)
13.Secondary Outcome
Title Unprotected Sex Acts in Previous One Month - 52 Weeks
Hide Description The mean number of unprotected sex acts in previous one month, assessed at 52 weeks
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number includes enrolled persons who completed the ACASI interview within the window for this visit
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 6 10 13
Mean (95% Confidence Interval)
Unit of Measure: unprotected sex acts/month
0.8
(0.3 to 1.9)
0.5
(0.2 to 1.2)
0
(0 to 0.3)
14.Secondary Outcome
Title Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)
Hide Description Cumulative incidence, definied as at least one incident infection with either gonorrhea, chlamydia or trichomoniasis
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number includes all persons with gonorrhea, chlamydia, and trichomoniasis results who had not withdrawn from the study by the first scheduled STI tests
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 7 15 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.14
(0.004 to 0.58)
0.33
(0.12 to 0.62)
0.12
(0.015 to 0.36)
15.Secondary Outcome
Title Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)
Hide Description At least one incident infection with either gonorrhea, chlamydia or trichomoniasis
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number includes all persons with gonorrhea, chlamydia, and trichomoniasis results and who had at least one visit after Week 26
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 7 12 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.14
(0.004 to 0.58)
0.42
(0.15 to 0.72)
0.15
(0.019 to 0.45)
16.Secondary Outcome
Title Cumulative Incidence Herpes Simplex Virus Type 2
Hide Description cumulative incidence of herpes simplex virus type 2, assessed at 26 weeks. Persons with baseline positivity were excluded.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number includes all persons who were confirmed HSV-2 negative at baseline and who had an informative test on or before Week 26
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 2 4 4
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.5
(0.01 to 1)
0.5
(0.07 to 0.9)
0.25
(0.006 to 0.8)
17.Secondary Outcome
Title Cumulative Incidence Herpes Simplex Virus Type 2
Hide Description cumulative incidence of herpes simplex virus type 2, assessed at 52 weeks. Persons with baseline positivity were excluded.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number includes all persons who were confirmed HSV-2 negative at baseline and who had an informative test on or before Week 52
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 2 3 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.5
(0.01 to 1)
1.0
(0.3 to 1.0)
0.3
(0.008 to 0.9)
18.Secondary Outcome
Title Number of Partners Reporting for HIV Testing
Hide Description Number of partners per index reporting for HIV testing at any time during follow-up
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 9 18 19
Mean (95% Confidence Interval)
Unit of Measure: partners per index participant
0.4
(0.1 to 1.1)
0.4
(0.2 to 0.9)
0.4
(0.1 to 0.8)
19.Secondary Outcome
Title Proportion of Partners Reporting for HIV Testing
Hide Description Proportion of sexual partners reporting for HIV testing among all sexual partners named by the index participants
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of sexual partners named by the index participants is the denominator. For example, the 9 index participants in the standard arm named 35 partners. 4 partners presented, giving a proportion of 0.1 (4/35)
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 9 18 19
Overall Number of Units Analyzed
Type of Units Analyzed: Sexual partners
35 78 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of sex partners
0.1
(0.03 to 0.3)
0.1
(0.04 to 0.2)
0.1
(0.01 to 0.3)
20.Secondary Outcome
Title Suppression of HIV RNA to <1000c/ml at 12 Weeks
Hide Description Proportion of persons in each arm with viral load <1000copies/ml at 12 weeks
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 9 18 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.5
(0.16 to 0.84)
0.25
(0.07 to 0.52)
0.72
(0.47 to 0.90)
21.Secondary Outcome
Title Time to HIV RNA Suppression <1000 c/ml
Hide Description median time to viral load suppression (<1000 c/ml)
Time Frame From date of randomization until viral load suppression, up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 9 18 19
Median (95% Confidence Interval)
Unit of Measure: weeks
39
(26 to 52)
26
(26 to 39)
16
(14 to 19)
22.Secondary Outcome
Title Blood HIV RNA Concentration at Week 12
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 6 16 15
Median (Full Range)
Unit of Measure: copies/ml
19411
(0 to 351974)
22734
(20 to 741360)
20
(0 to 2313294)
23.Secondary Outcome
Title Blood HIV RNA Concentration at Week 26
Hide Description [Not Specified]
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 8 14 15
Median (Full Range)
Unit of Measure: copies/ml
8661
(0 to 208087)
58504
(20 to 438579)
6788
(0 to 196903)
24.Secondary Outcome
Title Blood HIV RNA Concentration at Week 52
Hide Description [Not Specified]
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 6 10 11
Median (Full Range)
Unit of Measure: copies/ml
3248.5
(0 to 35668)
6467.5
(0 to 432656)
10876
(0 to 101615)
25.Secondary Outcome
Title Genital HIV RNA Concentration - Week 12, Women
Hide Description median HIV RNA concentration in cervical lavage fluid
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 2 5 4
Median (Full Range)
Unit of Measure: copies/ml
82.5
(0 to 165)
0
(0 to 6501)
38.5
(0 to 90)
26.Secondary Outcome
Title Genital HIV RNA Concentration - Week 26, Women
Hide Description median HIV RNA concentration in cervical lavage fluid
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 4 4 3
Median (Full Range)
Unit of Measure: copies/ml
11.5
(0 to 564)
0
(0 to 92)
164
(0 to 2500)
27.Secondary Outcome
Title Genital HIV RNA Concentration - Week 52, Women
Hide Description median HIV RNA concentration in cervical lavage fluid
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 3 2 2
Median (Full Range)
Unit of Measure: copies/ml
0
(0 to 124)
219
(0 to 438)
2111
(350 to 3872)
28.Secondary Outcome
Title Genital HIV RNA Concentration - Week 12, Men
Hide Description median HIV RNA concentration as measured in semen
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 2 5 7
Median (Full Range)
Unit of Measure: copies/ml
25364
(1636 to 49092)
446
(0 to 23798)
0
(0 to 782)
29.Secondary Outcome
Title Genital HIV RNA Concentration - Week 26, Men
Hide Description median HIV RNA concentration as measured in semen
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 2 3 4
Median (Full Range)
Unit of Measure: copies/ml
9456
(788 to 18124)
292
(0 to 2024)
0
(0 to 0)
30.Secondary Outcome
Title Genital HIV RNA Concentration - Week 52, Men
Hide Description median HIV RNA concentration as measured in semen
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Only Behavioral Intervention Plus ARV
Hide Arm/Group Description:

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm:

Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Overall Number of Participants Analyzed 1 2 5
Median (Full Range)
Unit of Measure: copies/ml
13088
(13088 to 13088)
66
(0 to 132)
0
(0 to 826)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Counseling Arm Behavioral Intervention Arm Behavioral Intervention Plus Antiretrovirals (BIA)
Hide Arm/Group Description

The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.

The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.

The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.

ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.

All-Cause Mortality
Standard Counseling Arm Behavioral Intervention Arm Behavioral Intervention Plus Antiretrovirals (BIA)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Standard Counseling Arm Behavioral Intervention Arm Behavioral Intervention Plus Antiretrovirals (BIA)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/18 (0.00%)      0/19 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Counseling Arm Behavioral Intervention Arm Behavioral Intervention Plus Antiretrovirals (BIA)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/9 (44.44%)      11/18 (61.11%)      13/19 (68.42%)    
Gastrointestinal disorders       
nausea/vomiting/diarrhea/abdominal pain *  2/9 (22.22%)  2 4/18 (22.22%)  5 6/19 (31.58%)  10
toothache *  0/9 (0.00%)  0/18 (0.00%)  1/19 (5.26%)  1
General disorders       
fever/chills *  2/9 (22.22%)  2 1/18 (5.56%)  1 2/19 (10.53%)  2
headache *  0/9 (0.00%)  2/18 (11.11%)  2 1/19 (5.26%)  1
weakness *  0/9 (0.00%)  1/18 (5.56%)  0/19 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia *  0/9 (0.00%)  0/18 (0.00%)  1/19 (5.26%)  1
Nervous system disorders       
Dizziness *  0/9 (0.00%)  0 2/18 (11.11%)  2 0/19 (0.00%) 
Numbness (feet) *  0/9 (0.00%)  0/18 (0.00%)  1/19 (5.26%)  2
Reproductive system and breast disorders       
genital discharge/sores *  0/9 (0.00%)  0 3/18 (16.67%)  4 4/19 (21.05%)  4
Respiratory, thoracic and mediastinal disorders       
Chest pain *  0/9 (0.00%)  0/18 (0.00%)  1/19 (5.26%)  1
Cough *  2/9 (22.22%)  2 0/18 (0.00%)  1/19 (5.26%)  1
Skin and subcutaneous tissue disorders       
finger nail changes *  0/9 (0.00%)  1/18 (5.56%)  1 0/19 (0.00%) 
Skin rash/skin sores/itching *  1/9 (11.11%)  1 5/18 (27.78%)  7 3/19 (15.79%)  3
*
Indicates events were collected by non-systematic assessment
Please note that this trial was a pilot study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: William C Miller
Organization: University of North Carolina at Chapel Hill
Phone: 9199669407
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01450189     History of Changes
Other Study ID Numbers: 11-0815
CID 1002 ( Other Identifier: UNC Chapel Hill )
First Submitted: September 18, 2011
First Posted: October 12, 2011
Results First Submitted: January 13, 2016
Results First Posted: May 12, 2016
Last Update Posted: April 19, 2018