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HIV Prevention Intervention for Couples

Primary Purpose

Acquired Immunodeficiency Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Couples HIV counseling and testing
Women's relationship-focused HIV counseling and testing
Sponsored by
National Development and Research Institutes, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Acquired Immunodeficiency Syndrome focused on measuring Human Immunodeficiency Viruses, Acquired Immunodeficiency Syndrome, Substance Abuse, Sexually Transmitted Disease, Viral, Intervention Studies, Women's Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: For women: 18 years of age or older self-reported use of crack, cocaine or heroin in prior 30 days has male sex partner identified as primary partner for at least one year had unprotected vaginal or anal sex with current partner in prior 30 days able to enlist partner in study enrollment would not feel threatened participating in the study with primary partner must not have participated in HIV/AIDS related study or attended HIV counseling and testing session in six months self-reported HIV negative or sero-unaware For men: 18 years of age or older

Sites / Locations

  • NDRI South Bronx Field Office

Outcomes

Primary Outcome Measures

risk behaviors

Secondary Outcome Measures

Full Information

First Posted
May 11, 2006
Last Updated
April 5, 2013
Sponsor
National Development and Research Institutes, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00325585
Brief Title
HIV Prevention Intervention for Couples
Official Title
Couples HIV Intervention Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Development and Research Institutes, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

Brief Summary
Recent studies have shown that many drug-using minority women are vulnerable to HIV infection from their husbands or other intimate male partners. The goal of this study is to develop and evaluate two new HIV counseling and testing programs designed for drug-using women at risk for HIV from a primary male partner. It is predicted that HIV counseling and testing programs administered to couples rather than to women only, and programs that focus on intimate relationships in the context of HIV risk, will result in a reduction of risky sexual and drug-related behavior among drug-using women and their primary male partners. This four-year study employs a randomized clinical trial (RCT) design to test the effectiveness of two new HIV counseling and testing programs for women drug-users in Harlem and the South Bronx in New York City.
Detailed Description
The broad, long-term objective of this research is to establish primary preventive interventions to reduce human immunodeficiency virus (HIV) risk behavior among drug-using minority women. Recent studies indicate that high rates of sexual risk behavior occur within drug-using minority women's primary heterosexual relationships. Based on an integrated theory of HIV risk behavior, it is predicted that (a) interventions administered to couples rather than to women only, and (b) interventions that focus on relationship dynamics in the context of HIV risk, will result in a reduction of sexual and drug-related risk behavior among drug-using women and their primary partners. This four-year study employs a randomized clinical trial (RCT) 3-group design to test the efficacy of HIV intervention modality (couples versus women-only) and intervention content (relationship-focused versus standard HIV counseling and testing) on crack, cocaine and heroin (injected and noninjected) using women's sexual risk with primary partners. A total of 390 women drug-users and their partners are recruited from the streets of Harlem and the South Bronx in New York City. Participants are randomly assigned to one of three HIV counseling and testing intervention conditions: (a) couples, relationship-focused; (b) women-only, relationship-focused; or, (c) NIDA women-only standard HIV-CT (control). All subjects are administered baseline, 3-month, and 9-month follow-up assessments using a combination of computer-assisted personal interview (CAPI) and computer-assisted self interview (CASI) techniques. In addition to sociodemographic characteristics, the interview will measure drug-use patterns, HIV risk behavior, and dyadic- and individual-level variables operationalized to test specific hypotheses of women's HIV risk behavior and behavior change. In addition to testing the effectiveness of the experimental interventions, data analyses will determine the theory-driven psychosocial mechanisms that act to mediate and moderate any observed association between intervention treatment and subsequent risk reduction. Incremental cost-effectiveness analyses will also be performed. Results from this study will allow researchers to determine whether couple-based HIV counseling and testing is a more effective (and cost-effective) approach to HIV prevention than individual HIV counseling and testing. Analyses will further provide information on the specific components of couple-based interventions that were most effective in reducing HIV risk behavior, thereby contributing to theory development regarding intimate couples' HIV risk.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Immunodeficiency Syndrome
Keywords
Human Immunodeficiency Viruses, Acquired Immunodeficiency Syndrome, Substance Abuse, Sexually Transmitted Disease, Viral, Intervention Studies, Women's Health

7. Study Design

Study Phase
Phase 2
Enrollment
780 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Couples HIV counseling and testing
Intervention Type
Behavioral
Intervention Name(s)
Women's relationship-focused HIV counseling and testing
Primary Outcome Measure Information:
Title
risk behaviors

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For women: 18 years of age or older self-reported use of crack, cocaine or heroin in prior 30 days has male sex partner identified as primary partner for at least one year had unprotected vaginal or anal sex with current partner in prior 30 days able to enlist partner in study enrollment would not feel threatened participating in the study with primary partner must not have participated in HIV/AIDS related study or attended HIV counseling and testing session in six months self-reported HIV negative or sero-unaware For men: 18 years of age or older
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James M McMahon, Ph.D.
Organizational Affiliation
National Development and Research Institutes, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
NDRI South Bronx Field Office
City
Bronx
State/Province
New York
ZIP/Postal Code
10455
Country
United States

12. IPD Sharing Statement

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HIV Prevention Intervention for Couples

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