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A Key Link for Transmission Prevention (MP3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William (Bill) C. Miller, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01450189
First received: September 18, 2011
Last updated: May 10, 2016
Last verified: May 2016
Results First Received: January 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited through screening in two sexually transmitted disease clinics and two HIV testing sites in Lilongwe, Malawi.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Standard Counseling Arm

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.

Behavioral Intervention Arm

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.

Behavioral Intervention Plus Antiretrovirals (BIA)

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.


Participant Flow:   Overall Study
    Standard Counseling Arm   Behavioral Intervention Arm   Behavioral Intervention Plus Antiretrovirals (BIA)
STARTED   9   18   19 
COMPLETED   9   18   19 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard Counseling Arm

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.

Behavioral Intervention Arm

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.

Behavioral Intervention Plus Antiretrovirals (BIA)

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 Total of all reporting groups

Baseline Measures
   Standard Counseling Arm   Behavioral Intervention Arm   Behavioral Intervention Plus Antiretrovirals (BIA)   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   18   19   46 
Age 
[Units: Years]
Mean (Standard Deviation)
 31.6  (8.1)   26.7  (5.1)   27.1  (7.9)   27.7  (7.0) 
Gender 
[Units: Participants]
       
Female   4   7   7   18 
Male   5   11   12   28 
Region of Enrollment 
[Units: Participants]
       
Malawi   9   18   19   46 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening   [ Time Frame: 1 year ]

2.  Primary:   Prevalence of AHI Among Persons Screened   [ Time Frame: 1 year ]

3.  Primary:   Proportion of Persons With AHI Successfully Recruited Into the Study   [ Time Frame: 1 year ]

4.  Primary:   Proportion of Participants Completing Full Course of ARVs in Arm BIA   [ Time Frame: 1 year ]

5.  Primary:   Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment.   [ Time Frame: 1 year ]

6.  Primary:   Proportion of Persons Completing All Scheduled Visits in Each Study Arm   [ Time Frame: 1 year ]

7.  Primary:   Number of Adverse Events   [ Time Frame: one year ]

8.  Secondary:   Unprotected Sex Acts in Previous One Week - 12 Weeks   [ Time Frame: 12 weeks ]

9.  Secondary:   Unprotected Sex Acts in Previous One Week - 26 Weeks   [ Time Frame: 26 weeks ]

10.  Secondary:   Unprotected Sex Acts in Previous One Week - 52 Weeks   [ Time Frame: 52 weeks ]

11.  Secondary:   Unprotected Sex Acts in Previous One Month - 12 Weeks   [ Time Frame: 12 weeks ]

12.  Secondary:   Unprotected Sex Acts in Previous One Month - 26 Weeks   [ Time Frame: 26 weeks ]

13.  Secondary:   Unprotected Sex Acts in Previous One Month - 52 Weeks   [ Time Frame: 52 weeks ]

14.  Secondary:   Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)   [ Time Frame: 26 weeks ]

15.  Secondary:   Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)   [ Time Frame: 52 weeks ]

16.  Secondary:   Cumulative Incidence Herpes Simplex Virus Type 2   [ Time Frame: 26 weeks ]

17.  Secondary:   Cumulative Incidence Herpes Simplex Virus Type 2   [ Time Frame: 52 weeks ]

18.  Secondary:   Number of Partners Reporting for HIV Testing   [ Time Frame: 52 weeks ]

19.  Secondary:   Proportion of Partners Reporting for HIV Testing   [ Time Frame: 52 weeks ]

20.  Secondary:   Suppression of HIV RNA to <1000c/ml at 12 Weeks   [ Time Frame: 12 weeks ]

21.  Secondary:   Time to HIV RNA Suppression <1000 c/ml   [ Time Frame: From date of randomization until viral load suppression, up to 52 weeks ]

22.  Secondary:   Blood HIV RNA Concentration at Week 12   [ Time Frame: 12 weeks ]

23.  Secondary:   Blood HIV RNA Concentration at Week 26   [ Time Frame: 26 weeks ]

24.  Secondary:   Blood HIV RNA Concentration at Week 52   [ Time Frame: 52 weeks ]

25.  Secondary:   Genital HIV RNA Concentration - Week 12, Women   [ Time Frame: 12 weeks ]

26.  Secondary:   Genital HIV RNA Concentration - Week 26, Women   [ Time Frame: 26 weeks ]

27.  Secondary:   Genital HIV RNA Concentration - Week 52, Women   [ Time Frame: 52 weeks ]

28.  Secondary:   Genital HIV RNA Concentration - Week 12, Men   [ Time Frame: 12 weeks ]

29.  Secondary:   Genital HIV RNA Concentration - Week 26, Men   [ Time Frame: 26 weeks ]

30.  Secondary:   Genital HIV RNA Concentration - Week 52, Men   [ Time Frame: 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Please note that this trial was a pilot study.


  More Information
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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
e-mail: bill_miller@unc.edu



Responsible Party: William (Bill) C. Miller, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01450189     History of Changes
Other Study ID Numbers: 11-0815
CID 1002 ( Other Identifier: UNC at Chapel Hill )
Study First Received: September 18, 2011
Results First Received: January 13, 2016
Last Updated: May 10, 2016
Health Authority: United States: Institutional Review Board
Malawi: National Health Sciences Research Committee