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

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ClinicalTrials.gov Identifier: NCT00631384
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Couples VCT Behavioral: Individual VCT Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1521 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Experimental Design of Couple Counseling and Testing in Antenatal Clinics in Dar es Salaam, Tanzania
Study Start Date : March 2003
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. HIV Testing and receiving results [ Time Frame: within one month of initial visit to ANC ]

Secondary Outcome Measures :
  1. use of nevirapine [ Time Frame: 3 months after testing ]
  2. use of protection at time of sexual intercourse [ Time Frame: 3 months after HIV test ]
  3. domestic violence [ Time Frame: 3 months after HIV test ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00631384     History of Changes
Other Study ID Numbers: H.32.02.05.29
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

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