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Completed

NCT Number: NCT00183456

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for CBT or Peer Intervention Participants:

  • Female
  • Age 18-55
  • Did not inject drugs in the past 6 months
  • Self-reported sex with at least 1 male partner in the past 6 months
  • Had at least 1 of the following sexual risk factors:
  • More than 2 sex partners in the past 6 months
  • STI diagnosis in the past 6 months
  • 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:

  • 18 years old or older
  • One of the following:
  • Injected drugs
  • Sex partner of index
  • 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

Treatment and study plan

Peer-oriented intervention

Behavioral

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.

Group Cognitive Behavioral Therapy (CBT)

Behavioral

Group CBT will focus on teaching ways to modify thoughts and behaviors associated with risky sexual behaviors.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Network HIV Prevention Intervention for Drug Users

Important dates

Study start
2005
Primary completion
2007
Study completion
2009
First posted
Sep 16, 2005
Registry last updated
Jun 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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