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

HIV Infections Clinical Trial

Official title:

Network HIV Prevention Intervention for Drug Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183456
• Other study ID #: R01MH066810
• Secondary ID: R01MH066810DAHBR
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: June 24, 2013
• Start date: September 2005
• Est. completion date: December 2009

Study information

• Verified date: June 2013
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 746
• Est. completion date: December 2009
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• Sexually Transmitted Diseases

Intervention

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.
• Group cognitive behavioral therapy (CBT)
Group CBT will focus on teaching ways to modify thoughts and behaviors associated with risky sexual behaviors.

Locations

Country	Name	City	State
United States	The Lighthouse	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)	Number of participants that had 2 or more sex partners in the past 90 days.	6 months	No
Primary	Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)		12 months	No
Primary	Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)		18 month	No
Primary	Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)		18 months	No
Primary	Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)		18 months	No
Primary	Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)		18 months	No
Primary	Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)		18 months	No
Secondary	HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)		6 months	No
Secondary	HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)		12 months	No
Secondary	HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)		18 months	No