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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045809
Recruitment Status : Completed
First Posted : February 8, 2017
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborators:
Rinda Ubuzima, Rwanda
Institute of Tropical Medicine, Belgium
Information provided by (Responsible Party):
Janneke van de Wijgert, University of Liverpool

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.

Condition or disease Intervention/treatment
Sexually Transmitted Disease Bacterial Vaginosis Vaginal Candidiasis Urinary Tract Infections Diagnostic Test: Urogenital infection point-of-care tests

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).

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Study Type : Observational
Actual Enrollment : 705 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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
Actual Study Start Date : July 5, 2016
Actual Primary Completion Date : March 14, 2017
Actual Study Completion Date : August 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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
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 Outcome Measures :
  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.


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045809


Locations
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Rwanda
Rinda Ubuzima
Kigali, Rwanda
Sponsors and Collaborators
Janneke van de Wijgert
Rinda Ubuzima, Rwanda
Institute of Tropical Medicine, Belgium
Investigators
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Principal Investigator: Janneke van de Wijgert, MD PhD MPH University of Liverpool
  Study Documents (Full-Text)

Documents provided by Janneke van de Wijgert, University of Liverpool:
Study Protocol  [PDF] June 6, 2016
Statistical Analysis Plan  [PDF] October 2, 2017


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Responsible Party: Janneke van de Wijgert, Professor, University of Liverpool
ClinicalTrials.gov Identifier: NCT03045809    
Other Study ID Numbers: UoL001208
First Posted: February 8, 2017    Key Record Dates
Results First Posted: September 11, 2019
Last Update Posted: September 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janneke van de Wijgert, University of Liverpool:
Syndromic management
Point of care testing
Additional relevant MeSH terms:
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Urinary Tract Infections
Candidiasis
Vaginosis, Bacterial
Sexually Transmitted Diseases
Candidiasis, Vulvovaginal
Infection
Urologic Diseases
Mycoses
Vaginal Diseases
Genital Diseases, Female
Bacterial Infections
Vaginitis
Virus Diseases
Genital Diseases, Male
Vulvovaginitis
Vulvitis
Vulvar Diseases