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Completed

NCT Number: NCT03045809

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Rinda Ubuzima

Kigali, Rwanda

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Primary outcomes

  1. Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators)

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

    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)

  2. Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys)

    Time frame: Each client satisfaction survey was conducted at a main visit and lasted up to 30 min.

    Answers to questions about experiences with the procedures (client satisfaction survey).

  3. Performance of Syndromic Management With or Without Integration of Point-of-care Tests

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

    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.

Sponsors and collaborators

Lead sponsor

Janneke van de Wijgert

Other

Collaborators

  • Institute of Tropical Medicine, Belgium
  • Rinda Ubuzima, Rwanda

Registry information

Official study title

Improving HIV Prevention and Sexual and Reproductive Health Care in High Risk Women in Rwanda Using Lessons Learnt From Previous Rinda Ubuzima Projects

Acronym: WISH

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 8, 2017
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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