- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00325585
HIV Prevention Intervention for Couples
Couples HIV Intervention Randomized Controlled Trial
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States, 10455
- NDRI South Bronx Field Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
risk behaviors
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: James M McMahon, Ph.D., National Development and Research Institutes, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
Other Study ID Numbers
- R01DA015641 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acquired Immunodeficiency Syndrome
-
VA Eastern Colorado Health Care SystemPublic Health Grant Program, Veterans Health Administration Office of Public...CompletedHuman Immunodeficiency Virus Infection(HIV)/Acquired Immunodeficiency Syndrome (AIDS) | Self-Directed ViolenceUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedHuman Immunodeficiency Virus | Acquired Immune Deficiency Syndrome Virus | Acquired Immunodeficiency Syndrome Virus | AIDS Virus | Human Immunodeficiency VirusesUnited States
-
Columbia UniversityNational Institute of Mental Health (NIMH); Ministry of Health and Social Welfare...CompletedHIV (Human Immunodeficiency Virus) | AIDS (Acquired Immunodeficiency Syndrome)Tanzania
-
Janssen-Cilag International NVCompletedHIV Infections | Human Immunodeficiency Virus | Acquired Immunodeficiency Syndrome Virus | AIDS VirusUnited Kingdom, Belgium, Germany, Spain, Portugal, Israel, Denmark, Russian Federation, Austria, Hungary, Switzerland
-
Emory UniversityGrady Health SystemCompleted
-
Columbia UniversityNational Institute of Nursing Research (NINR)CompletedHIV (Human Immunodeficiency Virus) | AIDS (Acquired Immunodeficiency Syndrome)United States
-
St. Jude Children's Research HospitalCompletedHuman Immunodeficiency Virus (HIV) | Acquired Immunodeficiency Syndrome (AIDS)United States
-
Janssen-Cilag International NVCompletedHuman Immunodeficiency Virus (HIV) Infections | Acquired Immunodeficiency Syndrome (AIDS) VirusFrance, United Kingdom, Belgium, Germany, Spain, Switzerland, Denmark, Israel, Austria, Poland, Hungary, Sweden, Ireland
-
Columbia UniversityNational Institute of Mental Health (NIMH)CompletedHuman Immunodeficiency Virus (HIV) | Acquired Immune Deficiency Syndrome (AIDS)Ethiopia
-
Columbia UniversityCompletedHuman Immunodeficiency Virus (HIV) | Acquired Immune Deficiency Syndrome (AIDS)Lesotho
Clinical Trials on Couples HIV counseling and testing
-
Emory UniversityNational Institute of Mental Health (NIMH)Completed
-
Hunter College of City University of New YorkNational Institute on Drug Abuse (NIDA); University of MichiganEnrolling by invitationHIV InfectionsUnited States
-
University of MichiganUniversity of Miami; University of RochesterCompleted
-
Hunter College of City University of New YorkNational Institute on Drug Abuse (NIDA)Completed
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedHIV InfectionsSouth Africa
-
University of California, Los AngelesEmory University; BroadReach Healthcare; USAID, South Africa; South African Department...CompletedHIV Infections | HIV Seropositivity | ARTSouth Africa
-
University of WashingtonCompletedPregnancy | HIV Counseling and Testing | Home Based | Male PartnerKenya
-
Emory UniversityCompletedHIVUnited States, South Africa
-
Virginia Commonwealth UniversityDepartment of Health and Human ServicesCompletedTraumatic Brain Injury | Acquired Brain InjuryUnited States