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Experimental Design of Couple Counseling and Testing in Antenatal Clinics in Dar es Salaam, Tanzania (CVCT)

This study has been completed.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00631384
First received: February 28, 2008
Last updated: March 6, 2008
Last verified: February 2008
History of Changes
  Purpose

The objective of this research is to evaluate the effectiveness of couples Voluntary Counseling and Testing for HIV (CVCT) compared to individual VCT (IVCT) in preventing MTCT, and in increasing preventive behaviors and minimizing spousal abuse among HIV positive women. We hypothesize that offering CVCT will not decrease uptake of VCT among women. This research will be carried out in 3 antenatal clinics in Dar es Salaam, Tanzania.


Condition Intervention
HIV Infections
 Behavioral: Couples VCT
Behavioral: Individual VCT

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Experimental Design of Couple Counseling and Testing in Antenatal Clinics in Dar es Salaam, Tanzania

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • HIV Testing and receiving results [ Time Frame: within one month of initial visit to ANC ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • use of nevirapine [ Time Frame: 3 months after testing ] [ Designated as safety issue: No ]
  • use of protection at time of sexual intercourse [ Time Frame: 3 months after HIV test ] [ Designated as safety issue: No ]
  • domestic violence [ Time Frame: 3 months after HIV test ] [ Designated as safety issue: No ]

Enrollment: 1521
Study Start Date: March 2003
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Women to be asked to bring husbands for couple VCT
 Behavioral: Couples VCT
Offer women coming to antenatal clinics to have their husbands come with them for couples VCT
Active Comparator: 2
Women to receive individual VCT
 Behavioral: Individual VCT
Women to receive individual VCT

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Up to 6 months of pregnancy
  • Currently married or in cohabiting union for 2+ years and co-resident with husband

Exclusion Criteria:

  • In polygamous marriage
  • 7 or more months pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631384

Locations
Tanzania
Muhimbili University College of Health Sciences
Dar es Salaam, Tanzania
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Johns Hopkins University
  More Information

No publications provided

Responsible Party: Stan Becker, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00631384     History of Changes
Other Study ID Numbers: H.32.02.05.29
Study First Received: February 28, 2008
Last Updated: March 6, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Voluntary Counseling and Testing
HIV
HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on March 14, 2013