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

Study Overview
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Brief Summary
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This study will determine the effectiveness of a peer outreach intervention in preventing HIV infection in adults at high risk for contracting HIV and other sexually transmitted diseases (STDs).

Detailed Description
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The persistence of HIV and STD epidemics indicates that more effective, sustainable preventive interventions are needed, particularly for low-income, inner-city populations. This study will determine the effectiveness of a theoretically based peer outreach program in preventing HIV and STD transmission among adults in the Baltimore, Maryland area. Participants will be randomly assigned to receive either a network-oriented peer program emphasizing one's social identity and the goals of protecting one's family and community or group cognitive behavioral therapy (CBT). The peer program will also train participants to provide HIV/STD education to their peers. Participants will be assessed at study entry and during several subsequent follow-up visits. At these study visits, participants will complete questionnaires about their sexual health knowledge and sexual behaviors. Participants and members of their peer network will have follow-up visits at Months 6, 12, and 18.

Official Title
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Network HIV Prevention Intervention for Drug Users

Conditions
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HIV Infections, Sexually Transmitted Diseases

Intervention / Treatment
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* Behavioral: Peer-oriented intervention
* Behavioral: Group cognitive behavioral therapy (CBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for CBT or Peer Intervention Participants: Female Age 18-55 Did not inject drugs in the past 6 months Self-reported sex with at least 1 male partner in the past 6 months Had at least 1 of the following sexual risk factors: More than 2 sex partners in the past 6 months STI diagnosis in the past 6 months Had a high risk sex partner in the past 90 days (i.e. a sex partner that injected drugs, smoked crack, was HIV+, or MSM) Inclusion Criteria for Peer Network Participants: 18 years old or older One of the following: Injected drugs Sex partner of index Social network member that the index felt comfortable talking to about HIV/STIs Exclusion Criteria for All Participants: Currently enrolled in another HIV prevention intervention

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Condition: CHAT<br>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. | Behavioral: Peer-oriented intervention<br>* The peer-oriented intervention program emphasized social identity and the goals of protecting family and community. The peer program also trained participants to provide HIV/STD education to their peers.<br>|
| Active Comparator: Comparison Condition: Standard of Care<br>The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information. | Behavioral: Group cognitive behavioral therapy (CBT)<br>* Group CBT will focus on teaching ways to modify thoughts and behaviors associated with risky sexual behaviors.<br>|
| No Intervention: Network Participants<br>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. | |
| No Intervention: Non-randomized Baseline index participants<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners) | Number of participants that had 2 or more sex partners in the past 90 days. | 6 months | 
| Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days) |  | 12 months | 
| Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days) |  | 18 month | 
| Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days) |  | 18 months | 
| Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days) |  | 18 months | 
| Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days) |  | 18 months | 
| Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days) |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) |  | 6 months | 
| HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) |  | 12 months | 
| HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sex Education, Peer Group, Social Identity Theory, HIV Seronegativity, Intervention, women, Social Networks, Peer Education