Ignite Creation Date:
2024-05-06 @ 9:40 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03045809
Status:
COMPLETED
Last Update Posted:
2019-09-11
First Post:
2017-02-02
Brief Title:
Womens Improvement of Sexual Health WISH Demonstration Project
Sponsor:
Janneke van de Wijgert
Organization:
University of Liverpool
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WISH
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 ulcersinguinal 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 CTNG if pregnant or considered at risk by risk scoring questionnaire
6 Syndromic management of genital ulcersinguinal 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 CTNG 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 CTNG 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
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 CTNG if pregnant or considered at risk by risk scoring questionnaire
6 Syndromic management of genital ulcersinguinal 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 CTNG 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 CTNG 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None