A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs
|ClinicalTrials.gov Identifier: NCT00183456|
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : October 18, 2012
Last Update Posted : June 28, 2013
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Sexually Transmitted Diseases||Behavioral: Peer-oriented intervention Behavioral: Group cognitive behavioral therapy (CBT)||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||746 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Network HIV Prevention Intervention for Drug Users|
|Study Start Date :||September 2005|
|Primary Completion Date :||July 2007|
|Study Completion Date :||December 2009|
Experimental: Intervention Condition: CHAT
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
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.
Active Comparator: Comparison Condition: Standard of Care
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)
Group CBT will focus on teaching ways to modify thoughts and behaviors associated with risky sexual behaviors.
No Intervention: Network Participants
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
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.
- Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners) [ Time Frame: 6 months ]Number of participants that had 2 or more sex partners in the past 90 days.
- Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days) [ Time Frame: 12 months ]
- Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days) [ Time Frame: 18 month ]
- Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days) [ Time Frame: 18 months ]
- Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days) [ Time Frame: 18 months ]
- Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days) [ Time Frame: 18 months ]
- Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days) [ Time Frame: 18 months ]
- HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) [ Time Frame: 6 months ]
- HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) [ Time Frame: 12 months ]
- HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183456
|United States, Maryland|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Carl A. Latkin, PhD||Johns Hopkins Bloomberg School of Public Health|