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

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

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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631384

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

Responsible Party: Stan Becker, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00631384     History of Changes
Other Study ID Numbers: H. 
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 seronegativity

ClinicalTrials.gov processed this record on May 24, 2016