- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03045809
Women's Improvement of Sexual Health (WISH) Demonstration Project (WISH)
Improving HIV Prevention and Sexual and Reproductive Health Care in High Risk Women in Rwanda Using Lessons Learnt From Previous Rinda Ubuzima Projects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a cross-sectional study. The improved urogenital infection care services will be advertised to women in Kigali, Rwanda, targeting women with urogenital complaints as well as women without urogenital complaints who have had high risk behavior. The services will be available for free at the research clinic for the duration of the project. All consenting women who attend the research clinic during the study period will be offered:
- Voluntary counselling and testing for HIV.
- Urine pregnancy test if indicated and contraception counselling.
- POC testing for UTI if UTI symptoms are present.
- POC testing for TV and BV regardless of symptoms, and management of vaginal candidiasis based on symptom-reporting.
- POC testing for syphilis and CT/NG if pregnant or considered at risk by risk scoring questionnaire.
- Syndromic management of genital ulcers/inguinal bubos and lower abdominal pain.
- Treatment and partner notification and treatment as appropriate, and referrals to antenatal, family planning, HIV and cervical cancer screening care.
Information about sociodemographics, risk behavior, sexual and reproductive health history and current urogenital symptoms will be collected during the clinic visit. Women can opt out of each service offered. Services will be delivered within one half day. However, women can choose to leave before all results are available, and be contacted by study staff when results are available, which is particularly relevant for women undergoing CT/NG POC testing (which takes about 90 minutes).
Vaginal swabs for storage will be taken from all consenting women (women can choose between self- or clinician-sampling) for additional research testing at the end of the study to allow for performance evaluation of the CT/NG, TV and BV POC tests.
Opinions of stakeholders will be gathered during workshops (one before and one after completion of the study) and in-depth interviews (IDIs).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kigali, Rwanda
- Rinda Ubuzima
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female, at least 18 years old (no upper age limit)
- At high risk of HIV/STIs, defined as having had more than one sexual partner in the last 12 months OR having been treated for an STI in the last 12 months
- Willing and able to provide written informed consent.
Exclusion Criteria:
- Already participated in this study before (each woman can only participate once)
- Participating in another health intervention study
- For any other reason as judged by the Principal Investigator (these reasons will be recorded)
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Women at risk of urogenital infections
Adult women living in the city of Kigali who are at high risk of HIV/urogenital infections (defined as having had more than one sexual partner in the last 12 months OR having been treated for a sexually transmitted infection (STI) in the last 12 months) regardless of the presence of current urogenital symptoms.
Women who are known to be HIV-positive and/or pregnant are not excluded.
All eligible women will be offered urogenital infection point-of-care tests.
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Instead of syndromic management of symptomatic women, the study offers screening of high risk women regardless of symptoms using point-of-care tests for HIV, TV, and BV (all women), syphilis, NG, and CT (when risk score positive), and UTI (when symptomatic).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators)
Time Frame: Each participant was assessed at one main study visit, which lasted up to 4 hours.
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Clinical monitoring and evaluation indicators: numbers of women with positive CT/NG or syphilis risk scores, number of pelvic exams done, etc (see row titles in the table)
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Each participant was assessed at one main study visit, which lasted up to 4 hours.
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Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys)
Time Frame: Each client satisfaction survey was conducted at a main visit and lasted up to 30 min.
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Answers to questions about experiences with the procedures (client satisfaction survey).
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Each client satisfaction survey was conducted at a main visit and lasted up to 30 min.
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Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Time Frame: Each participant was assessed at one main study visit, which lasted up to 4 hours.
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With performance we mean sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
We determined the number of women who would have received treatment for BV, VVC, TV, NG, and/or CT in the following situations: 1) if we would have followed the WHO syndromic management algorithms for vaginal discharge and lower abdominal pain; and 2) based on the POCT-based WISH algorithms (this is what we did in real life during the study), and compared each of these with gold standard infection-specific diagnoses.
The results of the first comparison are reported in the first column and results of the second comparison in the second column.
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Each participant was assessed at one main study visit, which lasted up to 4 hours.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Janneke van de Wijgert, MD PhD MPH, University of Liverpool
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Communicable Diseases
- Urologic Diseases
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Mycoses
- Vaginal Diseases
- Vulvar Diseases
- Vaginitis
- Vulvitis
- Vulvovaginitis
- Candidiasis
- Urinary Tract Infections
- Vaginosis, Bacterial
- Sexually Transmitted Diseases
- Candidiasis, Vulvovaginal
Other Study ID Numbers
- UoL001208
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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