Women's Improvement of Sexual Health (WISH) Demonstration Project (WISH)
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|ClinicalTrials.gov Identifier: NCT03045809|
Recruitment Status : Completed
First Posted : February 8, 2017
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
|Condition or disease||Intervention/treatment|
|Sexually Transmitted Disease Bacterial Vaginosis Vaginal Candidiasis Urinary Tract Infections||Diagnostic Test: Urogenital infection point-of-care tests|
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 :||Observational|
|Actual Enrollment :||705 participants|
|Official Title:||Improving HIV Prevention and Sexual and Reproductive Health Care in High Risk Women in Rwanda Using Lessons Learnt From Previous Rinda Ubuzima Projects|
|Actual Study Start Date :||July 5, 2016|
|Actual Primary Completion Date :||March 14, 2017|
|Actual Study Completion Date :||August 6, 2018|
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.
Diagnostic Test: Urogenital infection point-of-care tests
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).
- 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. ]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)
- 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. ]Answers to questions about experiences with the procedures (client satisfaction survey).
- 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. ]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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045809
|Principal Investigator:||Janneke van de Wijgert, MD PhD MPH||University of Liverpool|