Sexually Transmitted DiseasesPhase 3NCT00272974
Madagascar Female Condom Study
A Phase 3 study testing Clinic-based counseling in people with Sexually Transmitted Diseases, run by FHI 360 at 2 sites in Madagascar.
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. Read more about this study
- Who is it for?
- Ages 0 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases
- What is being tested?
- Clinic-based counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 2 sitesMadagascar
- Study dates
- Feb 2001to Aug 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Inclusion Criteria: Adult female sex workers from the two sites
Exclusion Criteria: None specified
Trial locations and contacts
2 sites in 1 country.
Madagascar2 sites
Isotry Health Center
Antananarivo
Dispensaire Kelly
Toamasina
About this study
Official title: Measuring the Impact of Male and Female Condom Promotion Among Commercial Sex Workers in Madagascar
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:
- 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:
- 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.
- To examine short-term and medium-term changes in STI prevalence when the female condom is added to the male condom distribution system.
- To measure the incremental cost-effectiveness of adding female condom promotion to existing male condom distribution systems
Read the 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.
- Conditions
- Sexually Transmitted Diseases
- Being tested
- Clinic-based counseling
- Keywords
- AE adverse event, DCF data collection forms, IRB Institutional Review Board, SAE serious adverse event
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic-based counselingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of protection (male and female condoms)
STIs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startFeb 2001
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Madagascar, National Reference Laboratory, Madagascar, University of North Carolina
- Investigators
- Theresa Hatzell, PhD, MPH, Study chair, FHI 360Paul Feldblum, PhD, Study director, FHI 360Kathleen Van Damme, MD, Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272974
- Sponsor's protocol ID
- 9713
- Status last verified
- Aug 2003
- First submitted
- 4 Jan 2006
- Last updated
- 9 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Impact of Male and Female Condom Promotion Among Commercial Sex Workers in Madagascar
- ClinicalTrials.gov ID
- NCT00272974
- Acronym / sponsor ID
- 9713
- Conditions
- Sexually Transmitted Diseases
- Keywords
- AE adverse event, DCF data collection forms, IRB Institutional Review Board, SAE serious adverse event
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Ministry of Health, Madagascar, National Reference Laboratory, Madagascar, University of North Carolina
- Study start
- Feb 2001
- Study completion
- Aug 2003
- First posted
- 9 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
- To examine short-term and medium-term changes in STI prevalence when the female condom is added to the male condom distribution system.
- To measure the incremental cost-effectiveness of adding female condom promotion to existing male condom distribution systems
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.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinic-based counseling | Behavioural | – |
Primary outcome
Use of protection (male and female condoms)
STIs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2006.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa Hatzell, PhD, MPH study chair
FHI 360
Paul Feldblum, PhD study director
FHI 360
Kathleen Van Damme, MD principal investigator
FHI 360
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clinic-based counseling in people with Sexually Transmitted Diseases, run by FHI 360 at 2 sites in Madagascar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Madagascar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of protection (male and female condoms). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2006.