Clinical trial NCT03045809: Women's Improvement of Sexual Health (WISH) Demonstration Project
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexually Transmitted Disease
Bacterial Vaginosis
Vaginal Candidiasis
Urinary Tract Infections
Keywords: Syndromic management
Point of care testing
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: Rinda Ubuzima, Rwanda
name: Institute of Tropical Medicine, Belgium
First posted: 2017-02-08
Enrollment: 705
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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).

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)

Primary outcomes:
measure: Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators)
timeFrame: Each participant was assessed at one main study visit, which lasted up to 4 hours.
measure: Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys)
timeFrame: Each client satisfaction survey was conducted at a main visit and lasted up to 30 min.
measure: Performance of Syndromic Management With or Without Integration of Point-of-care Tests
timeFrame: Each participant was assessed at one main study visit, which lasted up to 4 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: Rinda Ubuzima
Study officials:
affiliation: University of Liverpool
name: Janneke van de Wijgert, MD PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: