HIV Prevention Intervention for Couples
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|ClinicalTrials.gov Identifier: NCT00325585|
Recruitment Status : Completed
First Posted : May 15, 2006
Last Update Posted : April 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Acquired Immunodeficiency Syndrome||Behavioral: Couples HIV counseling and testing Behavioral: Women's relationship-focused HIV counseling and testing||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||780 participants|
|Official Title:||Couples HIV Intervention Randomized Controlled Trial|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||June 2008|
- risk behaviors
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325585
|United States, New York|
|NDRI South Bronx Field Office|
|Bronx, New York, United States, 10455|
|Principal Investigator:||James M McMahon, Ph.D.||National Development and Research Institutes, Inc.|