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

NCT03045809 | Completed Results

• 1 other identifier: UoL001208
• Study Type: observational
• Target: 705
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Syndromic management; Point of care testing

Outcome Measures

Primary Outcomes (3)

• 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)

  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).

  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.

  Each participant was assessed at one main study visit, which lasted up to 4 hours.

Study Arms (1)

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.

Diagnostic Test: Urogenital infection point-of-care tests

Interventions

Urogenital infection point-of-care tests 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).

Women at risk of urogenital infections

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janneke van de Wijgert: lead
• Rinda Ubuzima, Rwanda: collaborator
• Institute of Tropical Medicine, Belgium: collaborator

Study Sites (1)

Rinda Ubuzima

Kigali, Rwanda

Location

Biospecimen

Retention: SAMPLES WITH DNA

The only samples to be retained are two vaginal swabs per participant. DNA will be extracted for qPCR testing of select urogenital organisms.

MeSH Terms

Conditions

Sexually Transmitted Diseases; Vaginosis, Bacterial; Candidiasis, Vulvovaginal; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Candidiasis; Mycoses; Vulvovaginitis; Vulvitis; Vulvar Diseases; Urologic Diseases; Male Urogenital Diseases

Limitations and Caveats

The study was implemented in a high prevalence population by experienced staff. Additional studies are required in low prevalence settings and in public primary care clinics. Our recruitment strategies mostly attracted women with symptoms.

Results Point of Contact

• Title: Prof. Janneke van de Wijgert, Chief Investigator
• Organization: University of Liverpool

j.vandewijgert@liverpool.ac.uk

+447557195108

Study Officials

• Janneke van de Wijgert, MD PhD MPH

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 8, 2017
• Study Start: July 5, 2016
• Primary Completion: March 14, 2017
• Study Completion: August 6, 2018
• Last Updated: September 11, 2019
• Results First Posted: September 11, 2019

Record last verified: 2019-07

Locations

RW (1)