Sexually Transmitted DiseaseWISHNCT03045809
Women's Improvement of Sexual Health (WISH) Demonstration Project
An observational study of Sexually Transmitted Disease and Bacterial Vaginosis, run by Janneke van de Wijgert at 1 site in Rwanda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Disease, Bacterial Vaginosis, Vaginal Candidiasis
- What is being tested?
- Urogenital infection point-of-care tests
- How many people
- 705 participants
- Where
- 1 siteRwanda
- Study dates
- 5 Jul 2016to 6 Aug 2018
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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 will not be excluded.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- 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).
- Conditions
- Sexually Transmitted Disease, Bacterial Vaginosis, Vaginal Candidiasis, Urinary Tract Infections
- Being tested
- Urogenital infection point-of-care tests
- Keywords
- Syndromic management, Point of care testing
- Medical subject headings
- Sexually Transmitted Diseases, Vaginosis, Bacterial, Candidiasis, Vulvovaginal, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urogenital infection point-of-care testsDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Urogenital infection point-of-care tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators)
Clinical monitoring and evaluation indicators: numbers of women with positive CT/NG or syphilis risk scores, number of pelvic exams done, etc (see row titles in the table)
Measured: Each participant was assessed at one main study visit, which lasted up to 4 hours.
Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys)
Answers to questions about experiences with the procedures (client satisfaction survey).
Measured: Each client satisfaction survey was conducted at a main visit and lasted up to 30 min.
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
With performance we mean sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). We determined the number of women who would have received treatment for BV, VVC, TV, NG, and/or CT in the following situations: 1) if we would have followed the WHO syndromic management algorithms for vaginal discharge and lower abdominal pain; and 2) based on the POCT-based WISH algorithms (this is what we did in real life during the study), and compared each of these with gold standard infection-specific diagnoses. The results of the first comparison are reported in the first column and results of the second comparison in the second column.
Measured: Each participant was assessed at one main study visit, which lasted up to 4 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start5 Jul 2016
- Primary completion14 Mar 2017
- Study completion6 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sexually Transmitted DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 705 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janneke van de Wijgert
- Sponsor type
- University, hospital or other
- Collaborators
- Rinda Ubuzima, Rwanda, Institute of Tropical Medicine, Belgium
- Responsible party
- Sponsor-investigator, Janneke van de Wijgert, University of Liverpool
- Investigators
- Janneke van de Wijgert, MD PhD MPH, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045809
- Sponsor's protocol ID
- UoL001208
- Acronym
- WISH
- Status last verified
- Jul 2019
- First submitted
- 2 Feb 2017
- Last updated
- 11 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The University of Liverpool and project investigators support open access but university-wide systems are not yet accessible and open access has not yet been negotiated with the Rwandan authorities.