Women's Improvement of Sexual Health (WISH) Demonstration Project (WISH)
|ClinicalTrials.gov Identifier: NCT03045809|
Recruitment Status : Active, not recruiting
First Posted : February 8, 2017
Last Update Posted : May 18, 2017
|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|
|Estimated Study Completion Date :||April 30, 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: At main study visits and optional additional visits (scheduled only when clinically needed) over a total data collection period of one year. ]Clinical indicators: numbers of women counselled and risk scored, diagnostic tests conducted, infections diagnosed and treated, referrals made.
- Feasibility of integrating point-of-care testing (client satisfaction and staff surveys) [ Time Frame: At main study visits (client satisfaction survey) and at the end of the one year data collection period (staff survey). ]Answers to questions about experiences with the procedures to clients (client satisfaction survey) and study staff (staff survey)
- Performance of syndromic management with or without integration of point-of-care tests [ Time Frame: At main study visits over the total data collection period of one year. ]Sensitivity, specificity, positive predictive values (PPV), and negative predictive values (NPV) of 1) syndromic management, 2) risk scoring followed by POC testing (CT/NG), and 3) POC testing of everyone (CT/NG, TV and BV).
- Cost-effectiveness of integrating point-of-care testing [ Time Frame: At main and additional study visits in the last three months of the data collection period. ]Cost-effectiveness parameters (such as costs for each diagnostic algorithm and costs per correctly and incorrectly managed infection)
- Feasibility of integrating point-of-care testing (qualitative) [ Time Frame: One workshop just before and one immediately after the one year data collection period. ]Consensus, majority and minority opinions of stakeholders from transcripts of workshops.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045809
|Kigali City, Kigali, Rwanda|
|Principal Investigator:||Janneke van de Wijgert, MD PhD MPH||University of Liverpool|