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Trial record 49 of 175 for:    chlamydia infection | "Sexually Transmitted Diseases"

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

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ClinicalTrials.gov Identifier: NCT03045809
Recruitment Status : Active, not recruiting
First Posted : February 8, 2017
Last Update Posted : May 18, 2017
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) cost effectiveness of the POC tests for CT/NG, TV and BV; and 3) 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).


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
Estimated Study Completion Date : April 30, 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: At main study visits and optional additional visits (scheduled only when clinically needed) over a total data collection period of one year. ]
    Clinical indicators: numbers of women counselled and risk scored, diagnostic tests conducted, infections diagnosed and treated, referrals made.

  2. Feasibility of integrating point-of-care testing (client satisfaction and staff surveys) [ Time Frame: At main study visits (client satisfaction survey) and at the end of the one year data collection period (staff survey). ]
    Answers to questions about experiences with the procedures to clients (client satisfaction survey) and study staff (staff survey)


Secondary Outcome Measures :
  1. Performance of syndromic management with or without integration of point-of-care tests [ Time Frame: At main study visits over the total data collection period of one year. ]
    Sensitivity, specificity, positive predictive values (PPV), and negative predictive values (NPV) of 1) syndromic management, 2) risk scoring followed by POC testing (CT/NG), and 3) POC testing of everyone (CT/NG, TV and BV).

  2. Cost-effectiveness of integrating point-of-care testing [ Time Frame: At main and additional study visits in the last three months of the data collection period. ]
    Cost-effectiveness parameters (such as costs for each diagnostic algorithm and costs per correctly and incorrectly managed infection)

  3. Feasibility of integrating point-of-care testing (qualitative) [ Time Frame: One workshop just before and one immediately after the one year data collection period. ]
    Consensus, majority and minority opinions of stakeholders from transcripts of workshops.


Biospecimen Retention:   Samples With DNA
The only samples to be retained are two vaginal swabs per participant. If funding permits, DNA will be extracted for qPCR testing of select urogenital organisms.


Information from the National Library of Medicine

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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
Rwanda
Rinda Ubuzima
Kigali City, Kigali, Rwanda
Sponsors and Collaborators
Janneke van de Wijgert
Rinda Ubuzima, Rwanda
Institute of Tropical Medicine, Belgium
Investigators
Principal Investigator: Janneke van de Wijgert, MD PhD MPH University of Liverpool

Responsible Party: Janneke van de Wijgert, Professor, University of Liverpool
ClinicalTrials.gov Identifier: NCT03045809     History of Changes
Other Study ID Numbers: UoL001208
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
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.

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:
Urinary Tract Infections
Sexually Transmitted Diseases
Infection
Bacterial Infections
Candidiasis
Vaginosis, Bacterial
Candidiasis, Vulvovaginal
Urologic Diseases
Mycoses
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Virus Diseases
Genital Diseases, Male
Vulvovaginitis
Vulvitis
Vulvar Diseases