A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other Sexually Transmitted Diseases - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

April 21, 2009

Start Date ^ICMJE

September 2004

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

HIV risk behaviors [ Time Frame: Measured at Months 3, 6, 12, and 18 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

HIV risk behaviors; measured 3, 6, 12, and 18 months post-intervention

Change History

Complete list of historical versions of study NCT00183456 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Overdose risk behaviors; measured 3, 6, 12, and 18 months post-intervention

Descriptive Information

Brief Title ^ICMJE

A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other Sexually Transmitted Diseases

Official Title ^ICMJE

Network HIV Prevention Intervention for Drug Users

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).

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. Each intervention will last 6 months. Participants will be assessed at study entry and at the end of the study. 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 3, 6, 12, and 18 after the end of the study. Participants and peers will also complete the sexual health and behavior questionnaires at each follow-up visit.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

HIV Infections
Sexually Transmitted Diseases

Intervention ^ICMJE

Behavioral: Peer-oriented intervention
Behavioral: Group cognitive behavioral therapy (CBT)

Study Arms / Comparison Groups

Experimental: Participants will receive a network-oriented peer program for 6 months
Active Comparator: Participants will receive group cognitive behavioral therapy for 6 months

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

800

Estimated Completion Date

July 2009

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria for CBT or Peer Intervention Participants:

Infected with an STD within 6 months prior to study entry
Has had 3 or more sexual partners within 90 days prior to study entry
Live in the Baltimore, Maryland area
Had heterosexual sex in the past 6 months
Had a sexual partner who engaged in risky behavior within 90 days of study entry
Has not injected drugs
Female
Age between 18 and 55 years old

Inclusion Criteria for Peer Network Participants:

Referred by intervention participant
18 years old or older
Male or female
Engaged in HIV risk behavior, defined as injecting drugs in the past 6 months or having sex with an intervention participant in the past 90 days
Intervention participant felt comfortable talking to network member about HIV and STDs
Interacts with intervention participant at least a few times a month

Exclusion Criteria for All Participants:

Currently enrolled in another HIV prevention intervention

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00183456

Responsible Party

Carl Latkin, Johns Hopkins University

Study ID Numbers ^ICMJE

R01 MH066810, DAHBR 9A-ASI

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Carl A. Latkin, PhD

Johns Hopkins Bloomberg School of Public Health

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP