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

April 18, 2018 updated by: Johns Hopkins Bloomberg School of Public Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1521

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Dar es Salaam, Tanzania
        • Muhimbili University College of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HIV Testing and receiving results
Time Frame: within one month of initial visit to ANC
within one month of initial visit to ANC

Secondary Outcome Measures

Outcome Measure
Time Frame
use of nevirapine
Time Frame: 3 months after testing
3 months after testing
use of protection at time of sexual intercourse
Time Frame: 3 months after HIV test
3 months after HIV test
domestic violence
Time Frame: 3 months after HIV test
3 months after HIV test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Actual)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H.32.02.05.29

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.

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