Experimental Design of Couple Counseling and Testing in Antenatal Clinics in Dar es Salaam, Tanzania (CVCT)
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Couples VCT
Individual VCT
Sponsored by
About this trial
This is an interventional health services research trial for HIV Infections focused on measuring Voluntary Counseling and Testing, HIV, HIV seronegativity
Eligibility 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
Sites / Locations
- Muhimbili University College of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Women to be asked to bring husbands for couple VCT
Women to receive individual VCT
Outcomes
Primary Outcome Measures
HIV Testing and receiving results
Secondary Outcome Measures
use of nevirapine
use of protection at time of sexual intercourse
domestic violence
Full Information
NCT ID
NCT00631384
First Posted
February 28, 2008
Last Updated
April 18, 2018
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT00631384
Brief Title
Experimental Design of Couple Counseling and Testing in Antenatal Clinics in Dar es Salaam, Tanzania
Acronym
CVCT
Official Title
Experimental Design of Couple Counseling and Testing in Antenatal Clinics in Dar es Salaam, Tanzania
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Johns Hopkins University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Voluntary Counseling and Testing, HIV, HIV seronegativity
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1521 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Women to be asked to bring husbands for couple VCT
Arm Title
2
Arm Type
Active Comparator
Arm Description
Women to receive individual VCT
Intervention Type
Behavioral
Intervention Name(s)
Couples VCT
Intervention Description
Offer women coming to antenatal clinics to have their husbands come with them for couples VCT
Intervention Type
Behavioral
Intervention Name(s)
Individual VCT
Intervention Description
Women to receive individual VCT
Primary Outcome Measure Information:
Title
HIV Testing and receiving results
Time Frame
within one month of initial visit to ANC
Secondary Outcome Measure Information:
Title
use of nevirapine
Time Frame
3 months after testing
Title
use of protection at time of sexual intercourse
Time Frame
3 months after HIV test
Title
domestic violence
Time Frame
3 months after HIV test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Muhimbili University College of Health Sciences
City
Dar es Salaam
Country
Tanzania
12. IPD Sharing Statement
Learn more about this trial
Experimental Design of Couple Counseling and Testing in Antenatal Clinics in Dar es Salaam, Tanzania
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