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

NCT ID: NCT00631384

Last Updated: 2018-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1521 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Women to be asked to bring husbands for couple VCT

Group Type EXPERIMENTAL

Couples VCT

Intervention Type BEHAVIORAL

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

2

Women to receive individual VCT

Group Type ACTIVE_COMPARATOR

Individual VCT

Intervention Type BEHAVIORAL

Women to receive individual VCT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Couples VCT

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

Intervention Type BEHAVIORAL

Individual VCT

Women to receive individual VCT

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Johns Hopkins University

OTHER

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Muhimbili University College of Health Sciences

Dar es Salaam, , Tanzania

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Tanzania

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H.32.02.05.29

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.