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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Network HIV Prevention Intervention for Drug Users

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Sexually Transmitted Diseases

U.S. FDA Resources

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

Primary Outcome Measures:

Changes from Baseline in Sexual Risk Behavior at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Sexual Risk behavior was measured by number of sex partners and condom use
Changes from Baseline in Sexual Risk Behavior at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Sexual Risk behavior was measured by number of sex partners and condom use
Changes from Baseline in Sexual Risk Behavior at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Sexual Risk behavior was measured by number of sex partners and condom use

Secondary Outcome Measures:

Changes from Baseline in Drug Behaviors at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Drug behavior was measured by the use of cocaine or heroin (regardless of route).
Changes from Baseline in Drug Behaviors at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Drug behavior was measured by the use of cocaine or heroin (regardless of route).
Changes from Baseline in Drug Behaviors at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Drug behavior was measured by the use of cocaine or heroin (regardless of route).
Changes from Baseline in Communication about HIV/STIs at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
This was assessed by asking the participant how often they talk with network members about HIV and/or STIs and it was measured on a scale from ''never'' to ''more than once a day.''
Changes from Baseline in Communication about HIV/STIs at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
This was assessed by asking the participant how often they talk with network members about HIV and/or STIs and it was measured on a scale from ''never'' to ''more than once a day.''
Changes from Baseline in Communication about HIV/STIs at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
This was assessed by asking the participant how often they talk with network members about HIV and/or STIs and it was measured on a scale from ''never'' to ''more than once a day.''

Enrollment:	746
Study Start Date:	September 2005
Study Completion Date:	December 2009
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Intervention Condition: CHAT 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 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.
Active Comparator: Comparison Condition: Standard of Care 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) 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. 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.

Eligibility

Ages Eligible for Study:	18 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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:
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:

18 years old or older
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

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:	Carl Latkin, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00183456 History of Changes
Other Study ID Numbers:	R01 MH066810, DAHBR 9A-ASI
Study First Received:	September 13, 2005
Last Updated:	August 9, 2011
Health Authority:	United States: Federal Government

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

Sex Education
Peer Group
Social Identity Theory
HIV Seronegativity

Intervention
women
Social Networks
Peer Education

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on February 09, 2012