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

Johns Hopkins Bloomberg School of Public Health

Status and phase: Completed; Phase 2

Conditions: Sexually Transmitted Diseases; HIV Infections

Treatments: Behavioral: Group cognitive behavioral therapy (CBT); Behavioral: Peer-oriented intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00183456

DAHBR 9A-ASI

R01MH066810 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 746 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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746 participants in 4 patient groups

Intervention Condition: CHAT

Experimental 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.

Treatment:

Behavioral: Peer-oriented intervention

Comparison Condition: Standard of Care

Active Comparator group

Description:

The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.

Treatment:

Behavioral: Group cognitive behavioral therapy (CBT)

Network Participants

No Intervention group

Description:

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.

Non-randomized Baseline index participants

No Intervention group

Description:

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.