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

• Sponsor: Janneke van de Wijgert (Other)
• Overall Status: Completed
• CT.gov ID: NCT03045809
• Collaborator: Rinda Ubuzima, Rwanda (Other), Institute of Tropical Medicine, Belgium (Other)
• Enrollment: 705
• Location: 1
• Actual Duration (Months): 25
• Patients Per Site Per Month: 28.2

Study Details

Study Description

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	Phase
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 Design

• 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: Jul 5, 2016
• Actual Primary Completion Date: Mar 14, 2017
• Actual Study Completion Date: Aug 6, 2018

Arms and Interventions

Arm

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).

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rinda Ubuzima	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

Study Documents (Full-Text)

• Study Protocol - Jun 6, 2016
• Statistical Analysis Plan - Oct 2, 2017

More Information

Publications

None provided.

• Responsible Party: Janneke van de Wijgert, Professor, University of Liverpool
• ClinicalTrials.gov Identifier: NCT03045809
• Other Study ID Numbers: UoL001208
• First Posted: Feb 8, 2017
• Last Update Posted: Sep 11, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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, Professor, University of Liverpool: Syndromic management; Point of care testing
• Additional relevant MeSH terms: Urinary Tract Infections; Candidiasis; Vaginosis, Bacterial; Sexually Transmitted Diseases; Candidiasis, Vulvovaginal

Study Results

Participant Flow

Recruitment Details	At risk women regardless of symptoms were enrolled between 7-2016 and 3-2017. Recruitment activities were implemented by study staff with the help of community mobilizers. They organized recruitment meetings, and distributed flyers. Women were encouraged to refer their friends.
Pre-assignment Detail	Women were eligible if aged 18 or older, and at risk of sexually transmitted infections (more than one sex partner and/or having been treated for at least one STI in the past year), with or without urogenital symptoms. HIV-positive and pregnant women were not excluded. Women were screened free of charge but did not receive a monetary reimbursement.

Arm/Group Title	Women at Risk of Urogenital Infections.
Arm/Group Description	All enrolled women attended one main study visit and underwent the same procedures. At the main study visit, participants underwent a face-to-face interview that included questions about current (incl. past two weeks) urogenital symptoms. This information was used to reconstruct WHO syndromic management diagnoses. Next, the WISH algorithms that incorporated point-of-care (POC) testing were implemented. All women were offered HIV, pregnancy, Trichomonas vaginalis (TV OSOM), and bacterial vaginosis (BV; vaginal pH; pH≥5.0 considered BV) POC testing. We only offered chlamydia/gonorrhea (CT/NG) GeneXpert testing to women who had a positive CT/NG risk score, and Determine syphilis POC testing to women who had a positive syphilis risk score. Vulvovaginal candidiasis (VVC) was treated presumptively. Treatment, partner notification, and/or referral procedures were offered as needed. Gold standard diagnoses were determined by testing samples from all women for BV, VVC, TV, NG, and CT by PCR.
Period Title: Overall Study
STARTED	705
Attended an Additional Visit (if Needed)	51
COMPLETED	705
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Women at Risk of Urogenital Infections.
Arm/Group Description	All enrolled women attended one main study visit and underwent the same procedures. At the main study visit, participants underwent a face-to-face interview that included questions about current (incl. past two weeks) urogenital symptoms. This information was used to reconstruct WHO syndromic management diagnoses. Next, the WISH algorithms that incorporated point-of-care (POC) testing were implemented. All women were offered HIV, pregnancy, Trichomonas vaginalis (TV OSOM), and bacterial vaginosis (BV; vaginal pH; pH≥5.0 considered BV) POC testing. We only offered chlamydia/gonorrhea (CT/NG) GeneXpert testing to women who had a positive CT/NG risk score, and Determine syphilis POC testing to women who had a positive syphilis risk score. Vulvovaginal candidiasis (VVC) was treated presumptively. Treatment, partner notification, and/or referral procedures were offered as needed. Gold standard diagnoses were determined by testing samples from all women for BV, VVC, TV, NG, and CT by PCR.
Overall Participants	705
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	705 100%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	32.9
Sex: Female, Male (Count of Participants)
Female	705 100%
Male	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Race/Ethnicity, Customized (Count of Participants)
African (Rwandan)	705 100%
Region of Enrollment (participants) [Number]
Rwanda	705 100%
Chlamydia trachomatis positive by gold standard test (Count of Participants)
Count of Participants [Participants]	60 8.5%
Neisseria gonorrhoeae positive by gold standard test (Count of Participants)
Count of Participants [Participants]	50 7.1%
Trichomonas vaginalis positive by gold standard test (Count of Participants)
Count of Participants [Participants]	111 15.7%
Bacterial vaginosis positive by gold standard test (Count of Participants)
Count of Participants [Participants]	125 17.7%

Outcome Measures

1. Primary Outcome

Title	Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators)
Description	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)
Time Frame	Each participant was assessed at one main study visit, which lasted up to 4 hours.

Outcome Measure Data

Analysis Population Description

All 705 women who attended a main visit. Women were aged 18 or older, and at risk of sexually transmitted infections (more than one sex partner and/or having been treated for at least one STI in the past year), with or without urogenital symptoms. HIV-positive and pregnant women were not excluded.

Arm/Group Title	Women at Risk of Urogenital Infections.
Arm/Group Description	All enrolled women attended one main study visit and underwent the same procedures. At the main study visit, participants underwent a face-to-face interview that included questions about current (incl. past two weeks) urogenital symptoms. This information was used to reconstruct WHO syndromic management diagnoses. Next, the WISH algorithms that incorporated point-of-care (POC) testing were implemented. All women were offered HIV, pregnancy, Trichomonas vaginalis (TV OSOM), and bacterial vaginosis (BV; vaginal pH; pH≥5.0 considered BV) POC testing. We only offered chlamydia/gonorrhea (CT/NG) GeneXpert testing to women who had a positive CT/NG risk score, and Determine syphilis POC testing to women who had a positive syphilis risk score. Vulvovaginal candidiasis (VVC) was treated presumptively. Treatment, partner notification, and/or referral procedures were offered as needed. Gold standard diagnoses were determined by testing samples from all women for BV, VVC, TV, NG, and CT by PCR.
Measure Participants	705
Had a positive CT/NG risk score	396 56.2%
Had a positive syphilis risk score	378 53.6%
Underwent a pelvic examination	399 56.6%
Had any abnormality during the pelvic examination	216 30.6%
Had at least one positive POCT result	541 76.7%
Received all positive POCT results at main visit	505 71.6%
Received inadequate treatment	0 0%
Needed and received a referral	79 11.2%
Had at least one partner requiring notification	201 28.5%
Required at least one additional visit	51 7.2%

2. Primary Outcome

Title	Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys)
Description	Answers to questions about experiences with the procedures (client satisfaction survey).
Time Frame	Each client satisfaction survey was conducted at a main visit and lasted up to 30 min.

Outcome Measure Data

Analysis Population Description

A random selection of 107 enrolled women.

Arm/Group Title	Women at Risk of Urogenital Infections.
Arm/Group Description	All enrolled women attended one main study visit and underwent the same procedures. At the main study visit, participants underwent a face-to-face interview that included questions about current (incl. past two weeks) urogenital symptoms. This information was used to reconstruct WHO syndromic management diagnoses. Next, the WISH algorithms that incorporated point-of-care (POC) testing were implemented. All women were offered HIV, pregnancy, Trichomonas vaginalis (TV OSOM), and bacterial vaginosis (BV; vaginal pH; pH≥5.0 considered BV) POC testing. We only offered chlamydia/gonorrhea (CT/NG) GeneXpert testing to women who had a positive CT/NG risk score, and Determine syphilis POC testing to women who had a positive syphilis risk score. Vulvovaginal candidiasis (VVC) was treated presumptively. Treatment, partner notification, and/or referral procedures were offered as needed. Gold standard diagnoses were determined by testing samples from all women for BV, VVC, TV, NG, and CT by PCR.
Measure Participants	107
Felt welcome at study clinic	107 15.2%
Thought medical services were of good quality	107 15.2%
Thought counselling was of good quality	107 15.2%
Thought visit duration was too long but worth it	41 5.8%
Thought visit duration was too long and not worth	0 0%
Willing to be tested in future even if asymptomati	100 14.2%
Willing to pay for services in future	95 13.5%

3. Primary Outcome

Title	Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Description	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.
Time Frame	Each participant was assessed at one main study visit, which lasted up to 4 hours.

Outcome Measure Data

Analysis Population Description

Gold standard results availability ranged between 690 to 705 per separate outcome. For CT and NG, results were available for all 705 participants. For BV, VVC, and TV, 690 results were available (15 PCR results were invalid).

Arm/Group Title	WHO Syndromic Management (Entire Study Population)	WISH (Entire Study Population)
Arm/Group Description	Syndromic management vs gold standard. With performance we mean sensitivity, specificity, positive predictive value, and negative predictive value. We determined the number of women who would have received treatment for BV, VVC, TV, NG, and/or CT if we would have followed the WHO syndromic management algorithms for vaginal discharge and lower abdominal pain; and compared this with gold standard infection-specific diagnoses.	WISH POCT vs gold standard With performance we mean sensitivity, specificity, positive predictive value, and negative predictive value. We determined the number of women who had received treatment for BV, VVC, TV, NG, and/or CT based on the POCT-based WISH algorithms (this is what we did in real life during the study), and compared this with gold standard infection-specific diagnoses.
Measure Participants	705	705
Chlamydia sensitivity	58.3	71.7
Chlamydia specificity	44.7	100
Chlamydia PPV	8.9	100
Chlamydia NPV	92	97.4
Gonorrhea sensitivity	66.0	76.0
Gonorrhea specificity	45.2	100
Gonorrhea PPV	8.4	100
Gonorrhea NPV	94.6	98.2
Trichomonas vaginalis sensitivity	60.4	68.5
Trichomonas vaginalis specificity	45.6	97.4
Trichomonas vaginalis PPV	17.5	83.5
Trichomonas vaginalis NPV	85.7	94.2
Bacterial vaginosis sensitivity	61.6	95.2
Bacterial vaginosis specificity	46.0	41.2
Bacterial vaginosis PPV	20.2	26.4
Bacterial vaginosis NPV	84.4	97.5
Vulvovaginal candidiasis sensitivity	74.6	64.4
Vulvovaginal candidiasis specificity	50.6	69.4
Vulvovaginal candidiasis PPV	12.4	16.5
Vulvovaginal candidiasis NPV	95.5	95.4

Adverse Events

Time Frame	Each participant was assessed at one main study visit, which lasted up to 4 hours.
Arm/Group Title	Women at Risk of Urogenital Infections.
Arm/Group Description	All enrolled women attended one main study visit and underwent the same procedures. At the main study visit, participants underwent a face-to-face interview that included questions about current (incl. past two weeks) urogenital symptoms. This information was used to reconstruct WHO syndromic management diagnoses. Next, the WISH algorithms that incorporated point-of-care (POC) testing were implemented. All women were offered HIV, pregnancy, Trichomonas vaginalis (TV OSOM), and bacterial vaginosis (BV; vaginal pH; pH≥5.0 considered BV) POC testing. We only offered chlamydia/gonorrhea (CT/NG) GeneXpert testing to women who had a positive CT/NG risk score, and Determine syphilis POC testing to women who had a positive syphilis risk score. Vulvovaginal candidiasis (VVC) was treated presumptively. Treatment, partner notification, and/or referral procedures were offered as needed. Gold standard diagnoses were determined by testing samples from all women for BV, VVC, TV, NG, and CT by PCR.
All Cause Mortality
	Women at Risk of Urogenital Infections.
	Affected / at Risk (%)	# Events
Total	0/705 (0%)
Serious Adverse Events
	Women at Risk of Urogenital Infections.
	Affected / at Risk (%)	# Events
Total	0/705 (0%)
Other (Not Including Serious) Adverse Events
	Women at Risk of Urogenital Infections.
	Affected / at Risk (%)	# Events
Total	2/705 (0.3%)
Skin and subcutaneous tissue disorders
Allergic reaction to metronidazole	2/705 (0.3%)	2

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.