NCT00272974

Brief 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. 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.
  2. 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. 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. 4.To measure the incremental cost-effectiveness of adding female condom promotion to existing male condom distribution systems

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2001

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
Last Updated

January 9, 2006

Status Verified

August 1, 2003

First QC Date

January 4, 2006

Last Update Submit

January 4, 2006

Conditions

Sexually Transmitted Diseases

Keywords

AE adverse eventDCF data collection formsIRB Institutional Review BoardSAE serious adverse event

Outcome Measures

Primary Outcomes (2)

  • Use of protection (male and female condoms)

  • STIs

Interventions

Clinic-based counselingBEHAVIORAL

Eligibility Criteria

Age0 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Isotry Health Center

Antananarivo, Madagascar

Location

Dispensaire Kelly

Toamasina, Madagascar

Location

Related Links

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Theresa Hatzell, PhD, MPH

    FHI 360

    STUDY CHAIR

  • Paul Feldblum, PhD

    FHI 360

    STUDY DIRECTOR

  • Kathleen Van Damme, MD

    FHI 360

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2006

First Posted

January 9, 2006

Study Start

February 1, 2001

Study Completion

August 1, 2003

Last Updated

January 9, 2006

Record last verified: 2003-08

Locations

MA(2)