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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00183456
First received: September 13, 2005
Last updated: June 24, 2013
Last verified: June 2013

September 13, 2005
June 24, 2013
September 2005
July 2007   (final data collection date for primary outcome measure)
  • Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days) [ Time Frame: 18 month ] [ Designated as safety issue: No ]
  • Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
HIV risk behaviors; measured 3, 6, 12, and 18 months post-intervention
Complete list of historical versions of study NCT00183456 on ClinicalTrials.gov Archive Site
  • HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Overdose risk behaviors; measured 3, 6, 12, and 18 months post-intervention
Not Provided
Not Provided
 
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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
  • HIV Infections
  • Sexually Transmitted Diseases
  • 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.
  • Behavioral: Group cognitive behavioral therapy (CBT)
    Group CBT will focus on teaching ways to modify thoughts and behaviors associated with risky sexual behaviors.
  • 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.
    Intervention: Behavioral: Peer-oriented intervention
  • 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.
    Intervention: Behavioral: Group cognitive behavioral therapy (CBT)
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
746
December 2009
July 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 74 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00183456
R01 MH066810, R01MH066810, DAHBR 9A-ASI
Not Provided
Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
National Institute of Mental Health (NIMH)
Principal Investigator: Carl A. Latkin, PhD Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP