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

Phase 2

Completed

• Conditions: HIV Infections; Sexually Transmitted Diseases
• Interventions: Behavioral: Group cognitive behavioral therapy (CBT); Behavioral: Peer-oriented intervention

• Registration Number: NCT00183456
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2007-07
• Study Completion: 2009-12
• Results First Submitted: 2012-09-14
• Results First Submitted QC: 2012-09-14
• Results First Posted: 2012-10-18
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-24
• Last Update Posted: 2013-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 746

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparison Condition: Standard of Care	Group cognitive behavioral therapy (CBT)	The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
Intervention Condition: CHAT	Peer-oriented intervention	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.

Primary Outcome Measures

Name	Time	Method
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
Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)	12 months
Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)	6 months	Number of participants that had 2 or more sex partners in the past 90 days.
Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)	18 months
Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)	18 month

Secondary Outcome Measures

Name	Time	Method
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)	18 months

Trial Locations

Locations (1)

The Lighthouse; 🇺🇸 Baltimore, Maryland, United States