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

Network HIV Prevention Intervention for Drug Users

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).

Study Overview

• Status: Completed
• Conditions: HIV Infections; Sexually Transmitted Diseases
• Intervention / Treatment: Behavioral: Peer-oriented intervention; Behavioral: Group cognitive behavioral therapy (CBT)

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 Type: Interventional
• Enrollment (Actual): 746
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • The Lighthouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria for CBT or Peer Intervention Participants:

1. Female
2. Age 18-55
3. Did not inject drugs in the past 6 months
4. Self-reported sex with at least 1 male partner in the past 6 months

5. Had at least 1 of the following sexual risk factors:

   1. More than 2 sex partners in the past 6 months
   2. STI diagnosis in the past 6 months
   3. 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:

1. 18 years old or older

2. One of the following:

   1. Injected drugs
   2. Sex partner of index
   3. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Carl A. Latkin, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): July 1, 2007
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): June 28, 2013
• Last Update Submitted That Met QC Criteria: June 24, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: HIV Seronegativity; Intervention; women; Social Networks; Sex Education; Peer Group; Peer Education; Social Identity Theory
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: R01MH066810 (U.S. NIH Grant/Contract); DAHBR 9A-ASI