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

NCT00183456 | Completed Phase 2 Results

• 2 other identifiers: R01MH066810DAHBR 9A-ASI
• Study Type: interventional
• Target: 746
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV Infections; Sexually Transmitted Diseases

Keywords

Sex Education; Peer Group; Social Identity Theory; HIV Seronegativity; Intervention; women; Social Networks; Peer Education

Outcome Measures

Primary Outcomes (7)

• 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

• Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)

  12 months

• Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)

  18 month

• Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)

  18 months

• Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)

  18 months

• Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)

  18 months

• Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)

  18 months

Secondary Outcomes (3)

• HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)

  6 months

• HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)

  12 months

• HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)

  18 months

Study Arms (4)

Intervention Condition: CHAT

EXPERIMENTAL

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

Comparison Condition: Standard of Care

ACTIVE COMPARATOR

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)

Network Participants

NO INTERVENTION

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.

Non-randomized Baseline index participants

NO INTERVENTION

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.

Interventions

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.

Intervention Condition: CHAT

Group cognitive behavioral therapy (CBT) BEHAVIORAL

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

Comparison Condition: Standard of Care

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• Currently enrolled in another HIV prevention intervention

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

The Lighthouse

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Carl Latkin, PhD
• Organization: Johns Hopkins Bloomberg School of Public Health

clatkin@jhsph.edu

Study Officials

• Carl A. Latkin, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: September 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: December 1, 2009
• Last Updated: June 28, 2013
• Results First Posted: October 18, 2012

Record last verified: 2013-06

Locations

US (1)