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

NCT ID: NCT03045809

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 705 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-05
• Study Completion Date: 2018-08-06

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).

Conditions

Sexually Transmitted Disease; Bacterial Vaginosis; Vaginal Candidiasis; Urinary Tract Infections

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Urogenital infection point-of-care tests

Intervention Type: DIAGNOSTIC_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).

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rinda Ubuzima, Rwanda

UNKNOWN

Sponsor Role: collaborator

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: collaborator

Janneke van de Wijgert

OTHER

Sponsor Role: lead

Responsible Party

Janneke van de Wijgert

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Janneke van de Wijgert, MD PhD MPH

Role: PRINCIPAL_INVESTIGATOR

University of Liverpool

Locations

Rinda Ubuzima

Kigali, , Rwanda

Countries

Rwanda

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

UoL001208

Identifier Type: -

Identifier Source: org_study_id