Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1000 participants
INTERVENTIONAL
2001-02-28
2003-08-31
Brief Summary
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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
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
ECT
NONE
Interventions
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Clinic-based counseling
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria: None specified
0 Years
FEMALE
Yes
Sponsors
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Ministry of Health, Madagascar
OTHER_GOV
National Reference Laboratory, Madagascar
OTHER
University of North Carolina
OTHER
FHI 360
OTHER
Principal Investigators
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Theresa Hatzell, PhD, MPH
Role: STUDY_CHAIR
FHI 360
Paul Feldblum, PhD
Role: STUDY_DIRECTOR
FHI 360
Kathleen Van Damme, MD
Role: PRINCIPAL_INVESTIGATOR
FHI 360
Locations
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Isotry Health Center
Antananarivo, , Madagascar
Dispensaire Kelly
Toamasina, , Madagascar
Countries
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Related Links
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Related Info
Other Identifiers
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9713
Identifier Type: -
Identifier Source: org_study_id