NCT03045809

Women's Improvement of Sexual Health (WISH) Demonstration Project

Improving HIV Prevention and Sexual and Reproductive Health Care in High Risk Women in Rwanda Using Lessons Learnt From Previous Rinda Ubuzima Projects

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 705 (actual)
• Sponsor: Janneke van de Wijgert · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The current standard of care for urogenital infections in Rwanda is syndromic management. Many urogenital infections are asymptomatic and therefore completely missed, and the management of vaginal discharge syndrome is known to be suboptimal. The primary objective of this study is to evaluate whether it is feasible to improve urogenital infection care in high risk women in Kigali, Rwanda, using point of care (POC) diagnostic testing for HIV, Trichomonas vaginalis (TV), and bacterial vaginosis (BV) in all women; POC testing for Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), and syphilis in pregnant women and women assessed to be at high risk for these infections using a risk scoring questionnaire; and management of vaginal candidiasis, urinary tract infection (UTI), genital ulcers/inguinal bubos, and lower abdominal pain in women reporting relevant symptoms. The secondary objectives of this study are 1) to evaluate the performance and 2) to obtain the opinions of Rwandan stakeholders.

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: 1. Voluntary counselling and testing for HIV. 2. Urine pregnancy test if indicated and contraception counselling. 3. POC testing for UTI if UTI symptoms are present. 4. POC testing for TV and BV regardless of symptoms, and management of vaginal candidiasis based on symptom-reporting. 5. POC testing for syphilis and CT/NG if pregnant or considered at risk by risk scoring questionnaire. 6. Syndromic management of genital ulcers/inguinal bubos and lower abdominal pain. 7. 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).

Conditions

• Sexually Transmitted Disease
• Bacterial Vaginosis
• Vaginal Candidiasis
• Urinary Tract Infections

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2016-07-05
• Primary completion: 2017-03-14
• Completion: 2018-08-06
• First posted: 2017-02-08
• Last updated: 2019-09-11
• Results posted: 2019-09-11

Locations

1 site across 1 country: Rwanda