HIV Prevention Intervention for Couples

NCT00325585 | Completed Phase 2

• 1 other identifier: R01DA015641
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Immunodeficiency Syndrome

Keywords

Human Immunodeficiency Viruses; Acquired Immunodeficiency Syndrome; Substance Abuse; Sexually Transmitted Disease, Viral; Intervention Studies; Women's Health

Outcome Measures

Primary Outcomes (1)

• risk behaviors

Interventions

Couples HIV counseling and testing BEHAVIORAL

Women's relationship-focused HIV counseling and testing BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For women:
• 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:
• years of age or older

Sponsors & Collaborators

• National Development and Research Institutes, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

NDRI South Bronx Field Office

The Bronx, New York, 10455, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Substance-Related Disorders; Sexually Transmitted Diseases, Viral

Condition Hierarchy (Ancestors)

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

Study Officials

• James M McMahon, Ph.D.

  National Development and Research Institutes, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2006
• First Posted: May 15, 2006
• Study Start: April 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: June 1, 2008
• Last Updated: April 9, 2013

Record last verified: 2013-04

Locations

US (1)