Trial Outcomes & Findings for Women's Improvement of Sexual Health (WISH) Demonstration Project (NCT NCT03045809)
NCT ID: NCT03045809
Last Updated: 2019-09-11
Results Overview
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)
Recruitment status
COMPLETED
Target enrollment
705 participants
Primary outcome timeframe
Each participant was assessed at one main study visit, which lasted up to 4 hours.
Results posted on
2019-09-11
Participant Flow
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.
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.
Participant milestones
| Measure |
Women at Risk of Urogenital Infections.
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 Study
STARTED
|
705
|
|
Overall Study
Attended an Additional Visit (if Needed)
|
51
|
|
Overall Study
COMPLETED
|
705
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Women at Risk of Urogenital Infections.
n=705 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=705 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
705 Participants
n=705 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=705 Participants
|
|
Age, Continuous
|
32.9 years
n=705 Participants
|
|
Sex: Female, Male
Female
|
705 Participants
n=705 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=705 Participants
|
|
Race/Ethnicity, Customized
African (Rwandan)
|
705 Participants
n=705 Participants
|
|
Region of Enrollment
Rwanda
|
705 participants
n=705 Participants
|
|
Chlamydia trachomatis positive by gold standard test
|
60 Participants
n=705 Participants
|
|
Neisseria gonorrhoeae positive by gold standard test
|
50 Participants
n=705 Participants
|
|
Trichomonas vaginalis positive by gold standard test
|
111 Participants
n=705 Participants
|
|
Bacterial vaginosis positive by gold standard test
|
125 Participants
n=705 Participants
|
PRIMARY outcome
Timeframe: Each participant was assessed at one main study visit, which lasted up to 4 hours.Population: 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.
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)
Outcome measures
| Measure |
Women at Risk of Urogenital Infections.
n=705 Participants
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.
|
WISH (Entire Study Population)
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.
|
|---|---|---|
|
Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators)
Had a positive CT/NG risk score
|
396 Participants
|
—
|
|
Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators)
Had a positive syphilis risk score
|
378 Participants
|
—
|
|
Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators)
Underwent a pelvic examination
|
399 Participants
|
—
|
|
Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators)
Had any abnormality during the pelvic examination
|
216 Participants
|
—
|
|
Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators)
Had at least one positive POCT result
|
541 Participants
|
—
|
|
Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators)
Received all positive POCT results at main visit
|
505 Participants
|
—
|
|
Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators)
Received inadequate treatment
|
0 Participants
|
—
|
|
Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators)
Needed and received a referral
|
79 Participants
|
—
|
|
Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators)
Had at least one partner requiring notification
|
201 Participants
|
—
|
|
Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators)
Required at least one additional visit
|
51 Participants
|
—
|
PRIMARY outcome
Timeframe: Each client satisfaction survey was conducted at a main visit and lasted up to 30 min.Population: A random selection of 107 enrolled women.
Answers to questions about experiences with the procedures (client satisfaction survey).
Outcome measures
| Measure |
Women at Risk of Urogenital Infections.
n=107 Participants
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.
|
WISH (Entire Study Population)
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.
|
|---|---|---|
|
Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys)
Felt welcome at study clinic
|
107 Participants
|
—
|
|
Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys)
Thought medical services were of good quality
|
107 Participants
|
—
|
|
Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys)
Thought counselling was of good quality
|
107 Participants
|
—
|
|
Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys)
Thought visit duration was too long but worth it
|
41 Participants
|
—
|
|
Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys)
Thought visit duration was too long and not worth
|
0 Participants
|
—
|
|
Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys)
Willing to be tested in future even if asymptomati
|
100 Participants
|
—
|
|
Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys)
Willing to pay for services in future
|
95 Participants
|
—
|
PRIMARY outcome
Timeframe: Each participant was assessed at one main study visit, which lasted up to 4 hours.Population: 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).
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.
Outcome measures
| Measure |
Women at Risk of Urogenital Infections.
n=705 Participants
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.
|
WISH (Entire Study Population)
n=705 Participants
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.
|
|---|---|---|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Bacterial vaginosis specificity
|
46.0 % (sensitivity/specificity/PPV/NPV)
Interval 41.9 to 50.2
|
41.2 % (sensitivity/specificity/PPV/NPV)
Interval 37.2 to 45.4
|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Bacterial vaginosis PPV
|
20.2 % (sensitivity/specificity/PPV/NPV)
Interval 16.4 to 24.5
|
26.4 % (sensitivity/specificity/PPV/NPV)
Interval 22.5 to 30.7
|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Bacterial vaginosis NPV
|
84.4 % (sensitivity/specificity/PPV/NPV)
Interval 79.9 to 88.1
|
97.5 % (sensitivity/specificity/PPV/NPV)
Interval 94.5 to 98.9
|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Vulvovaginal candidiasis sensitivity
|
74.6 % (sensitivity/specificity/PPV/NPV)
Interval 61.9 to 84.1
|
64.4 % (sensitivity/specificity/PPV/NPV)
Interval 51.4 to 75.6
|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Vulvovaginal candidiasis specificity
|
50.6 % (sensitivity/specificity/PPV/NPV)
Interval 46.6 to 54.5
|
69.4 % (sensitivity/specificity/PPV/NPV)
Interval 65.7 to 72.9
|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Vulvovaginal candidiasis PPV
|
12.4 % (sensitivity/specificity/PPV/NPV)
Interval 9.3 to 16.2
|
16.5 % (sensitivity/specificity/PPV/NPV)
Interval 12.2 to 21.8
|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Vulvovaginal candidiasis NPV
|
95.5 % (sensitivity/specificity/PPV/NPV)
Interval 92.7 to 97.3
|
95.4 % (sensitivity/specificity/PPV/NPV)
Interval 93.1 to 97.0
|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Chlamydia sensitivity
|
58.3 % (sensitivity/specificity/PPV/NPV)
Interval 45.5 to 70.2
|
71.7 % (sensitivity/specificity/PPV/NPV)
Interval 58.3 to 81.7
|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Chlamydia specificity
|
44.7 % (sensitivity/specificity/PPV/NPV)
Interval 40.8 to 48.5
|
100 % (sensitivity/specificity/PPV/NPV)
Interval 100.0 to 100.0
|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Chlamydia PPV
|
8.9 % (sensitivity/specificity/PPV/NPV)
Interval 6.5 to 12.1
|
100 % (sensitivity/specificity/PPV/NPV)
Interval 100.0 to 100.0
|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Chlamydia NPV
|
92 % (sensitivity/specificity/PPV/NPV)
Interval 88.4 to 94.6
|
97.4 % (sensitivity/specificity/PPV/NPV)
Interval 95.9 to 98.4
|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Gonorrhea sensitivity
|
66.0 % (sensitivity/specificity/PPV/NPV)
Interval 51.8 to 77.8
|
76.0 % (sensitivity/specificity/PPV/NPV)
Interval 62.2 to 85.9
|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Gonorrhea specificity
|
45.2 % (sensitivity/specificity/PPV/NPV)
Interval 41.4 to 49.0
|
100 % (sensitivity/specificity/PPV/NPV)
Interval 100.0 to 100.0
|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Gonorrhea PPV
|
8.4 % (sensitivity/specificity/PPV/NPV)
Interval 6.0 to 11.6
|
100 % (sensitivity/specificity/PPV/NPV)
Interval 100.0 to 100.0
|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Gonorrhea NPV
|
94.6 % (sensitivity/specificity/PPV/NPV)
Interval 91.4 to 96.6
|
98.2 % (sensitivity/specificity/PPV/NPV)
Interval 96.9 to 99.0
|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Trichomonas vaginalis sensitivity
|
60.4 % (sensitivity/specificity/PPV/NPV)
Interval 50.9 to 69.1
|
68.5 % (sensitivity/specificity/PPV/NPV)
Interval 59.2 to 76.5
|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Trichomonas vaginalis specificity
|
45.6 % (sensitivity/specificity/PPV/NPV)
Interval 41.6 to 49.7
|
97.4 % (sensitivity/specificity/PPV/NPV)
Interval 95.7 to 98.4
|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Trichomonas vaginalis PPV
|
17.5 % (sensitivity/specificity/PPV/NPV)
Interval 14.0 to 21.7
|
83.5 % (sensitivity/specificity/PPV/NPV)
Interval 74.4 to 89.8
|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Trichomonas vaginalis NPV
|
85.7 % (sensitivity/specificity/PPV/NPV)
Interval 81.3 to 89.2
|
94.2 % (sensitivity/specificity/PPV/NPV)
Interval 92.0 to 95.8
|
|
Performance of Syndromic Management With or Without Integration of Point-of-care Tests
Bacterial vaginosis sensitivity
|
61.6 % (sensitivity/specificity/PPV/NPV)
Interval 52.7 to 69.7
|
95.2 % (sensitivity/specificity/PPV/NPV)
Interval 89.7 to 97.8
|
Adverse Events
Women at Risk of Urogenital Infections.
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Women at Risk of Urogenital Infections.
n=705 participants at risk
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.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Allergic reaction to metronidazole
|
0.28%
2/705 • Number of events 2 • Each participant was assessed at one main study visit, which lasted up to 4 hours.
|
Additional Information
Prof. Janneke van de Wijgert, Chief Investigator
University of Liverpool
Phone: +447557195108
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place