CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 705 enrolled
Drug / intervention
Urogenital infection point-of-care testsother
Likely dose
Not stated in record
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Search/NCT03045809
NCT03045809N/ACompleted

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

Janneke van de Wijgert·observational·Posted Feb 8, 2017·Updated Sep 11, 2019

In Brief

An observational study evaluating Urogenital infection point-of-care tests for Sexually Transmitted Disease and 3 related conditions. Completed, enrolled 705 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesRwanda

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 8, 2017
Enrollment StartJul 5, 2016
Primary CompletionMar 14, 2017
Study CompletionAug 6, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.4 years ago

Interventions

Urogenital infection point-of-care testsother

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).