MedTrace Logo

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

NCT03045809 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 705

Last updated 2019-09-11

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Rinda Ubuzima, Rwanda

    collaborator UNKNOWN

  • Institute of Tropical Medicine, Belgium

    collaborator OTHER

  • Janneke van de Wijgert

    lead OTHER

Principal Investigators

  • Janneke van de Wijgert, MD PhD MPH · University of Liverpool

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-05
Primary Completion
2017-03-14
Completion
2018-08-06

Countries

  • Rwanda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03045809 on ClinicalTrials.gov