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

Tracking Information
First Received Date ^ICMJE	February 28, 2008
Last Updated Date	March 6, 2008
Start Date ^ICMJE	March 2003
Primary Completion Date	September 2004 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 6, 2008)	HIV Testing and receiving results [ Time Frame: within one month of initial visit to ANC ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00631384 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 6, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Experimental Design of Couple Counseling and Testing in Antenatal Clinics in Dar es Salaam, Tanzania
Official Title ^ICMJE	Experimental Design of Couple Counseling and Testing in Antenatal Clinics in Dar es Salaam, Tanzania
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Behavioral: Couples VCT Offer women coming to antenatal clinics to have their husbands come with them for couples VCT Behavioral: Individual VCT Women to receive individual VCT
Study Arm (s)	Experimental: 1 Women to be asked to bring husbands for couple VCT Intervention: Behavioral: Couples VCT Active Comparator: 2 Women to receive individual VCT Intervention: Behavioral: Individual VCT
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1521
Completion Date	September 2004
Primary Completion Date	September 2004 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Tanzania

Administrative Information
NCT Number ^ICMJE	NCT00631384
Other Study ID Numbers ^ICMJE	H.32.02.05.29
Has Data Monitoring Committee	Yes
Responsible Party	Stan Becker, Johns Hopkins University
Study Sponsor ^ICMJE	Johns Hopkins Bloomberg School of Public Health
Collaborators ^ICMJE	Johns Hopkins University
Investigators ^ICMJE	Not Provided
Information Provided By	Johns Hopkins Bloomberg School of Public Health
Verification Date	February 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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