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

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ClinicalTrials.gov Identifier: NCT00183456
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : October 18, 2012
Last Update Posted : June 28, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 746 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Network HIV Prevention Intervention for Drug Users
Study Start Date : September 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : December 2009

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U.S. FDA Resources

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners) [ Time Frame: 6 months ]
    Number of participants that had 2 or more sex partners in the past 90 days.

  2. Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days) [ Time Frame: 12 months ]
  3. Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days) [ Time Frame: 18 month ]
  4. Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days) [ Time Frame: 18 months ]
  5. Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days) [ Time Frame: 18 months ]
  6. Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days) [ Time Frame: 18 months ]
  7. Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days) [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) [ Time Frame: 6 months ]
  2. HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) [ Time Frame: 12 months ]
  3. HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) [ Time Frame: 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00183456     History of Changes
Other Study ID Numbers: R01MH066810 ( U.S. NIH Grant/Contract )
DAHBR 9A-ASI
First Posted: September 16, 2005    Key Record Dates
Results First Posted: October 18, 2012
Last Update Posted: June 28, 2013
Last Verified: June 2013

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:
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female