NCT00631384

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,521

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Mar 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

1.5 years

First QC Date

February 28, 2008

Last Update Submit

April 18, 2018

Conditions

HIV Infections

Keywords

Voluntary Counseling and TestingHIVHIV seronegativity

Outcome Measures

Primary Outcomes (1)

  • HIV Testing and receiving results

    within one month of initial visit to ANC

Secondary Outcomes (3)

  • use of nevirapine

    3 months after testing

  • use of protection at time of sexual intercourse

    3 months after HIV test

  • domestic violence

    3 months after HIV test

Study Arms (2)

1

EXPERIMENTAL

Women to be asked to bring husbands for couple VCT

Behavioral: Couples VCT

2

ACTIVE COMPARATOR

Women to receive individual VCT

Behavioral: Individual VCT

Interventions

Couples VCTBEHAVIORAL

Offer women coming to antenatal clinics to have their husbands come with them for couples VCT

1
Individual VCTBEHAVIORAL

Women to receive individual VCT

2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Up to 6 months of pregnancy
  • Currently married or in cohabiting union for 2+ years and co-resident with husband

You may not qualify if:

  • In polygamous marriage
  • or more months pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhimbili University College of Health Sciences

Dar es Salaam, Tanzania

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2008

First Posted

March 7, 2008

Study Start

March 1, 2003

Primary Completion

September 1, 2004

Study Completion

September 1, 2004

Last Updated

April 20, 2018

Record last verified: 2018-04

Locations

TA(1)