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Madagascar Female Condom Study

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, Madagascar
National Reference Laboratory, Madagascar
University of North Carolina
Information provided by:
FHI 360
ClinicalTrials.gov Identifier:
NCT00272974
First received: January 4, 2006
Last updated: NA
Last verified: August 2003
History: No changes posted
  Purpose

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

Condition Intervention Phase
Sexually Transmitted Diseases
Behavioral: Clinic-based counseling
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Measuring the Impact of Male and Female Condom Promotion Among Commercial Sex Workers in Madagascar

Resource links provided by NLM:


Further study details as provided by FHI 360:

Primary Outcome Measures:
  • Use of protection (male and female condoms)
  • STIs

Estimated Enrollment: 1000
Study Start Date: February 2001
Estimated Study Completion Date: August 2003
Detailed Description:

This three-phased study examined ways to improve services for the prevention of STIs among commercial sex workers. This study was conducted in identical fashion in two sites (Tamatave and Antananarivo) in Madagascar. It tested whether condom promotion through community-based counseling or clinic based counseling leads to an increased level of protection among high-risk sex acts and a subsequent decrease in STI infection rates.

In Phase I, women at each site were randomly assigned to a study arm receiving a community-based male condom promotion intervention, or a study arm receiving community-based male condom promotion supplemented with clinic-based counseling. Randomization was accomplished by the use of sequentially-numbered sealed, opaque envelopes containing the group assignment. The randomization list was stratified by study site. Phase I began with baseline measurement of male condom use and STI prevalence. Participants returned three times, at two month intervals, for follow-up. At each visit, face-to-face interviews were conducted to estimate the proportion of protected sex acts. At the third visit only, participants were tested for gonococcal, chlamydial, and trichomonal infections. This reliance on a combination of biologic and behavioral outcomes helped to reduce any bias brought on by the inherent limitations of either of these measures on its own.

Half the women completing Phase I at each site were then randomized to a Phase II study arm receiving a community-based male and female condom promotion intervention, while the other half entered Phase II receiving the same community-based male and female condom promotion supplemented with clinic-based counseling. This sequential randomization scheme allowed measurement of the short-term (within 6 months) effect of clinic-based counseling on male condom use and STI prevalence, and the short-term effect of clinic-based counseling on male condom + female condom use and STI prevalence. A similar data collection process was used, with measurement of male and female condom use in all three visits, and STI testing in the third visit only.

In Phase III, participants were followed for an additional 6 months, in the same intervention group to which they were assigned at the beginning of Phase II, to assess the medium-term impacts of the female condom, after participants had a chance to become accustomed to the female condom.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Adult female sex workers from the two sites

Exclusion Criteria: None specified

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272974

Locations
Madagascar
Isotry Health Center
Antananarivo, Madagascar
Dispensaire Kelly
Tamatave, Madagascar
Sponsors and Collaborators
FHI 360
Ministry of Health, Madagascar
National Reference Laboratory, Madagascar
University of North Carolina
Investigators
Study Chair: Theresa Hatzell, PhD, MPH FHI 360
Study Director: Paul Feldblum, PhD FHI 360
Principal Investigator: Kathleen Van Damme, MD FHI 360
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00272974     History of Changes
Other Study ID Numbers: 9713
Study First Received: January 4, 2006
Last Updated: January 4, 2006
Health Authority: United States: Federal Government

Keywords provided by FHI 360:
AE adverse event
DCF data collection forms
IRB Institutional Review Board
SAE serious adverse event

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Genital Diseases, Female
Genital Diseases, Male
Infection
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014