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

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00183456

Purpose

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	Intervention	Phase
HIV Infections Sexually Transmitted Diseases	Behavioral: Peer-oriented intervention Behavioral: Group cognitive behavioral therapy (CBT)	Phase II

MedlinePlus related topics: AIDS Sexually Transmitted Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Network HIV Prevention Intervention for Drug Users

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

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

Estimated Enrollment:	800
Study Start Date:	September 2004
Estimated Study Completion Date:	July 2009
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive a network-oriented peer program for 6 months	Behavioral: Peer-oriented intervention The peer-oriented intervention program will emphasize social identity and the goals of protecting family and community. The peer program will also train participants to provide HIV/STD education to their peers.
2: Active Comparator Participants will receive group cognitive behavioral therapy for 6 months	Behavioral: Group cognitive behavioral therapy (CBT) Group CBT will focus on teaching ways to modify thoughts and behaviors associated with risky sexual behaviors.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183456

Locations

United States, Maryland
The Lighthouse
Baltimore, Maryland, United States, 21231

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Carl A. Latkin, PhD

Johns Hopkins Bloomberg School of Public Health

More Information

No publications provided

Responsible Party:	Johns Hopkins University ( Carl Latkin )
Study ID Numbers:	R01 MH066810, DAHBR 9A-ASI
Study First Received:	September 13, 2005
Last Updated:	April 21, 2009
ClinicalTrials.gov Identifier:	NCT00183456 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Sex Education
Peer Group
Social Identity Theory
HIV Seronegativity

Study placed in the following topic categories:

Genital Diseases, Female
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Acquired Immunodeficiency Syndrome

Sexually Transmitted Diseases
Genital Diseases, Male
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Genital Diseases, Male

Immunologic Deficiency Syndromes
Genital Diseases, Female
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009