Madagascar Female Condom Study

Sexually Transmitted Diseases Clinical Trial

Official title:

Measuring the Impact of Male and Female Condom Promotion Among Commercial Sex Workers in Madagascar

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272974
• Other study ID #: 9713
• Status: Completed
• Phase: Phase 3
• First received: January 4, 2006
• Last updated: January 4, 2006
• Start date: February 2001
• Est. completion date: August 2003

Study information

• Verified date: August 2003
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: August 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria: Adult female sex workers from the two sites

Exclusion Criteria: None specified

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Sexually Transmitted Diseases

Intervention

Behavioral:
• Clinic-based counseling

Locations

Country	Name	City	State
Madagascar	Isotry Health Center	Antananarivo
Madagascar	Dispensaire Kelly	Tamatave

Sponsors (4)

Lead Sponsor	Collaborator
FHI 360	Ministry of Health, Madagascar, National Reference Laboratory, Madagascar, University of North Carolina

Country where clinical trial is conducted

Madagascar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of protection (male and female condoms)
Primary	STIs

External Links

•   Link