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A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00183456
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : October 18, 2012
Last Update Posted : June 28, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Conditions HIV Infections
Sexually Transmitted Diseases
Interventions Behavioral: Peer-oriented intervention
Behavioral: Group cognitive behavioral therapy (CBT)
Enrollment 746
Recruitment Details The sample consisted of women and their social network members. Index participants were recruited through street outreach as well as at health clinics, and other local community agencies. Social network members were recruited by index participants after completion of the index's baseline visit. Recruitment took place from September 2005-July 2007
Pre-assignment Details Those index participants that did not recruit a network member or did not show up to be randomized into a study condition were not assigned to a study condition. Network participants completed study interviews but were not assigned to a study condition and did not participate in the intervention.
Arm/Group Title Intervention Condition: CHAT Comparison Condition: Standard of Care Network Participants Non-randomized Baseline Index Participants
Hide Arm/Group Description Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options. The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information. Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention. This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
Period Title: Overall Study
Started 85 84 329 248
6 Month Follow-up 74 77 278 175
12 Month Follow-up 76 74 267 186
18 Month Follow-up 80 81 303 207
Completed 82 [1] 83 [2] 313 [3] 220 [4]
Not Completed 3 1 16 28
[1]
total # of intervention participants that completed any follow-up (6, 12, or 18 month Follow-up)
[2]
total # of comparison condition participants that completed any follow-up
[3]
total # of network participants that completed any follow-up
[4]
total # of non-randomized index participants that completed any follow-up
Arm/Group Title Intervention Condition: CHAT Comparison Condition: Standard of Care Network Participants Non-randomized Baseline Index Participants Total
Hide Arm/Group Description Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options. The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information. Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention. This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition. Total of all reporting groups
Overall Number of Baseline Participants 85 84 329 248 746
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 84 participants 329 participants 248 participants 746 participants
<=18 years
0
   0.0%
0
   0.0%
2
   0.6%
1
   0.4%
3
   0.4%
Between 18 and 65 years
85
 100.0%
84
 100.0%
323
  98.2%
247
  99.6%
739
  99.1%
>=65 years
0
   0.0%
0
   0.0%
4
   1.2%
0
   0.0%
4
   0.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 85 participants 84 participants 329 participants 248 participants 746 participants
42.1  (7) 43.3  (7) 42.9  (10) 40.6  (8) 42  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 84 participants 329 participants 248 participants 746 participants
Female
85
 100.0%
84
 100.0%
150
  45.6%
248
 100.0%
567
  76.0%
Male
0
   0.0%
0
   0.0%
179
  54.4%
0
   0.0%
179
  24.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 85 participants 84 participants 329 participants 248 participants 746 participants
85 84 329 248 746
1.Primary Outcome
Title Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)
Hide Description Number of participants that had 2 or more sex partners in the past 90 days.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Condition: CHAT Comparison Condition: Standard of Care Network Participants Non-randomized Baseline Index Participants
Hide Arm/Group Description:
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
Overall Number of Participants Analyzed 73 75 277 174
Measure Type: Number
Unit of Measure: participants
17 29 50 53
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Condition: CHAT, Comparison Condition: Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Generalized Estimating Equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
0.13 to 0.63
Estimation Comments [Not Specified]
2.Primary Outcome
Title Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Condition: CHAT Comparison Condition: Standard of Care Network Participants Non-randomized Baseline Index Participants
Hide Arm/Group Description:
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
Overall Number of Participants Analyzed 76 74 264 185
Measure Type: Number
Unit of Measure: participants
10 22 47 58
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Condition: CHAT, Comparison Condition: Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Generalized Estimating Equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
0.16 to 0.84
Estimation Comments [Not Specified]
3.Primary Outcome
Title Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)
Hide Description [Not Specified]
Time Frame 18 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Condition: CHAT Comparison Condition: Standard of Care Network Participants Non-randomized Baseline Index Participants
Hide Arm/Group Description:
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
Overall Number of Participants Analyzed 80 81 299 205
Measure Type: Number
Unit of Measure: participants
5 18 43 35
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Condition: CHAT, Comparison Condition: Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Generalized Estimating Equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
0.09 to 0.68
Estimation Comments [Not Specified]
4.Primary Outcome
Title Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)
Hide Description [Not Specified]
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Condition: CHAT Comparison Condition: Standard of Care Network Participants Non-randomized Baseline Index Participants
Hide Arm/Group Description:
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
Overall Number of Participants Analyzed 80 81 299 205
Measure Type: Number
Unit of Measure: participants
32 49 123 119
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Condition: CHAT, Comparison Condition: Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Generalized Estimating Equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.47
Confidence Interval (2-Sided) 95%
0.25 to 0.87
Estimation Comments [Not Specified]
5.Primary Outcome
Title Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)
Hide Description [Not Specified]
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Condition: CHAT Comparison Condition: Standard of Care Network Participants Non-randomized Baseline Index Participants
Hide Arm/Group Description:
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
Overall Number of Participants Analyzed 80 81 299 205
Measure Type: Number
Unit of Measure: participants
30 50 127 113
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Condition: CHAT, Comparison Condition: Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Generalized Estimating Equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.41
Confidence Interval (2-Sided) 95%
0.21 to 0.77
Estimation Comments [Not Specified]
6.Primary Outcome
Title Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)
Hide Description [Not Specified]
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Condition: CHAT Comparison Condition: Standard of Care Network Participants Non-randomized Baseline Index Participants
Hide Arm/Group Description:
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
Overall Number of Participants Analyzed 80 81 299 205
Measure Type: Number
Unit of Measure: participants
8 21 47 51
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Condition: CHAT, Comparison Condition: Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Generalized Estimating Equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
0.14 to 0.79
Estimation Comments [Not Specified]
7.Primary Outcome
Title Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)
Hide Description [Not Specified]
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Condition: CHAT Comparison Condition: Standard of Care Network Participants Non-randomized Baseline Index Participants
Hide Arm/Group Description:
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
Overall Number of Participants Analyzed 80 81 299 205
Measure Type: Number
Unit of Measure: participants
51 69 172 151
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Condition: CHAT, Comparison Condition: Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Generalized Estimating Equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
0.14 to 0.64
Estimation Comments [Not Specified]
8.Secondary Outcome
Title HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Condition: CHAT Comparison Condition: Standard of Care Network Participants Non-randomized Baseline Index Participants
Hide Arm/Group Description:
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
Overall Number of Participants Analyzed 73 77 277 173
Measure Type: Number
Unit of Measure: participants
61 52 155 117
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Condition: CHAT, Comparison Condition: Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Generalized Estimating Equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.68
Confidence Interval (2-Sided) 95%
1.22 to 5.89
Estimation Comments [Not Specified]
9.Secondary Outcome
Title HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Condition: CHAT Comparison Condition: Standard of Care Network Participants Non-randomized Baseline Index Participants
Hide Arm/Group Description:
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
Overall Number of Participants Analyzed 76 74 264 184
Measure Type: Number
Unit of Measure: participants
58 39 124 104
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Condition: CHAT, Comparison Condition: Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Generalized Estimating Equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.82
Confidence Interval (2-Sided) 95%
1.41 to 5.64
Estimation Comments [Not Specified]
10.Secondary Outcome
Title HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Hide Description [Not Specified]
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Condition: CHAT Comparison Condition: Standard of Care Network Participants Non-randomized Baseline Index Participants
Hide Arm/Group Description:
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
Overall Number of Participants Analyzed 78 81 291 202
Measure Type: Number
Unit of Measure: participants
56 42 141 113
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Condition: CHAT, Comparison Condition: Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Generalized Estimating Equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.41
Confidence Interval (2-Sided) 95%
1.25 to 4.65
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Condition: CHAT Comparison Condition: Standard of Care Network Participants Non-randomized Baseline Index Participants
Hide Arm/Group Description Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options. The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information. Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention. This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
All-Cause Mortality
Intervention Condition: CHAT Comparison Condition: Standard of Care Network Participants Non-randomized Baseline Index Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Condition: CHAT Comparison Condition: Standard of Care Network Participants Non-randomized Baseline Index Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/85 (0.00%)   0/84 (0.00%)   0/329 (0.00%)   0/248 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intervention Condition: CHAT Comparison Condition: Standard of Care Network Participants Non-randomized Baseline Index Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/85 (0.00%)   0/84 (0.00%)   0/329 (0.00%)   0/248 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Carl Latkin, PhD
Organization: Johns Hopkins Bloomberg School of Public Health
EMail: clatkin@jhsph.edu
Layout table for additonal information
Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00183456     History of Changes
Other Study ID Numbers: R01MH066810 ( U.S. NIH Grant/Contract )
R01MH066810 ( U.S. NIH Grant/Contract )
DAHBR 9A-ASI
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: September 14, 2012
Results First Posted: October 18, 2012
Last Update Posted: June 28, 2013