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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00325585 |
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.
Condition | Intervention | Phase |
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Acquired Immunodeficiency Syndrome |
Behavioral: Couples HIV counseling and testing Behavioral: Women's relationship-focused HIV counseling and testing |
Phase II |
Study Type: | Interventional |
Official Title: | Couples HIV Intervention Randomized Controlled Trial |
Estimated Enrollment: | 780 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | January 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For women:
For men:
Contact: James M McMahon, Ph.D. | 212-845-4553 | mcmahon@ndri.org |
United States, New York | |
NDRI South Bronx Field Office | Recruiting |
Bronx, New York, United States, 10455 | |
Contact: Leilani Torres, B.A. 718-742-9133 torres@ndri.org | |
Principal Investigator: James M McMahon, Ph.D. |
Principal Investigator: | James M McMahon, Ph.D. | National Development and Research Institutes, Inc. |
Study ID Numbers: | R01-DA015641 |
Study First Received: | May 11, 2006 |
Last Updated: | May 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00325585 History of Changes |
Health Authority: | United States: Federal Government |
Human Immunodeficiency Viruses Acquired Immunodeficiency Syndrome Substance Abuse |
Sexually Transmitted Disease, Viral Intervention Studies Women's Health |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Acquired Immunodeficiency Syndrome |
Sexually Transmitted Diseases Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Disease Immune System Diseases Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes |
Virus Diseases Pathologic Processes HIV Infections Syndrome Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |