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Madagascar Female Condom Study

NCT00272974 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2006-01-09

No results posted yet for this study

Summary

The study was designed to measure the effects of male and female condom promotion on STI prevalence and reported condom use by sex workers and their partners. It also examined whether the intensity of the education and support given to intended users affected adoption and sustained use of these methods.

The primary objective of the study was:

1. To test the effect of supplementing community-based male and female condom promotion with clinic-based counseling, measured in terms of the level of protection in high-risk sex acts and STI prevalence.

Secondary objectives of the study included:
2. To monitor short- and medium terms changes in the proportion of protected sex acts among commercial sex workers after the female condom is added to a male condom distribution system.
3. To examine short-term and medium-term changes in STI prevalence when the female condom is added to the male condom distribution system.
4. To measure the incremental cost-effectiveness of adding female condom promotion to existing male condom distribution systems

Conditions

  • Sexually Transmitted Diseases

Interventions

BEHAVIORAL

Clinic-based counseling

Sponsors & Collaborators

  • Ministry of Health, Madagascar

    collaborator OTHER_GOV

  • National Reference Laboratory, Madagascar

    collaborator OTHER

  • University of North Carolina

    collaborator OTHER

  • FHI 360

    lead OTHER

Principal Investigators

  • Theresa Hatzell, PhD, MPH · FHI 360

  • Paul Feldblum, PhD · FHI 360

  • Kathleen Van Damme, MD · FHI 360

Study Design

Allocation
RANDOMIZED
Purpose
ECT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-02-28
Completion
2003-08-31

Countries

  • Madagascar

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00272974 on ClinicalTrials.gov