Clinical trial NCT00183456: A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs
Official title: Network HIV Prevention Intervention for Drug Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Sexually Transmitted Diseases
Keywords: Sex Education
Peer Group
Social Identity Theory
HIV Seronegativity
Intervention
women
Social Networks
Peer Education
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-16
Enrollment: 746
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)
timeFrame: 6 months
measure: Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)
timeFrame: 12 months
measure: Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)
timeFrame: 18 month
measure: Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)
timeFrame: 18 months
measure: Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)
timeFrame: 18 months
measure: Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)
timeFrame: 18 months
measure: Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)
timeFrame: 18 months
Secondary outcomes:
measure: HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
timeFrame: 6 months
measure: HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
timeFrame: 12 months
measure: HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
timeFrame: 18 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Lighthouse
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Carl A. Latkin, PhD
role: PRINCIPAL_INVESTIGATOR
References: