N/A
N=705
Women's Improvement of Sexual Health (WISH) Demonstration Project
Sexually Transmitted Disease · Bacterial Vaginosis · Vaginal Candidiasis · Urinary Tract Infections
Bottom Line
View on ClinicalTrials.gov: NCT03045809 ↗Enrolled (actual)
705
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators) — 396; 378; 399; 216 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Urogenital infection point-of-care tests (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Janneke van de Wijgert
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators) |
396; 378; 399; 216; 541; 505 | — |
| PRIMARY Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys) |
107; 107; 107; 41; 0; 100 | — |
| PRIMARY Performance of Syndromic Management With or Without Integration of Point-of-care Tests |
58.3; 71.7; 44.7; 100; 8.9; 100 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Female, at least 18 years old (no upper age limit)
- At high risk of HIV/STIs, defined as having had more than one sexual partner in the last 12 months OR having been treated for an STI in the last 12 months
- Willing and able to provide written informed consent.
Exclusion Criteria
- Already participated in this study before (each woman can only participate once)
- Participating in another health intervention study
- For any other reason as judged by the Principal Investigator (these reasons will be recorded)
Data sourced from ClinicalTrials.gov (NCT03045809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.