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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
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
History of Changes
  Purpose

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).


Condition Intervention Phase
HIV Infections
Sexually Transmitted Diseases
 Behavioral: Peer-oriented intervention
Behavioral: Group cognitive behavioral therapy (CBT)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Network HIV Prevention Intervention for Drug Users

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
Enrollment: 746
Study Start Date: September 2005
Study Completion Date: December 2009
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183456

Locations
United States, Maryland
The Lighthouse
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Carl A. Latkin, PhD Johns Hopkins Bloomberg School of Public Health
  More Information

No publications provided

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00183456     History of Changes
Other Study ID Numbers: R01 MH066810, R01MH066810, DAHBR 9A-ASI
Study First Received: September 13, 2005
Results First Received: September 14, 2012
Last Updated: June 24, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Sex Education
Peer Group
Social Identity Theory
HIV Seronegativity
 Intervention
women
Social Networks
Peer Education

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Genital Diseases, Female
Genital Diseases, Male
Infection
Virus Diseases

ClinicalTrials.gov processed this record on March 01, 2015