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 (Adult)
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

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

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


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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 29, 2016

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