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| Name | Class |
|---|---|
| Rinda Ubuzima, Rwanda | UNKNOWN |
| Institute of Tropical Medicine, Belgium | OTHER |
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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urogenital infection point-of-care tests | Diagnostic Test | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators) | 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) | Each participant was assessed at one main study visit, which lasted up to 4 hours. |
| Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys) | Answers to questions about experiences with the procedures (client satisfaction survey). | Each client satisfaction survey was conducted at a main visit and lasted up to 30 min. |
| Performance of Syndromic Management With or Without Integration of Point-of-care Tests | 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. | Each participant was assessed at one main study visit, which lasted up to 4 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Janneke van de Wijgert, MD PhD MPH | University of Liverpool | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rinda Ubuzima | Kigali | Rwanda |
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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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators) | 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) | 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. | Posted | Count of Participants | Participants | Each participant was assessed at one main study visit, which lasted up to 4 hours. |
|
Each participant was assessed at one main study visit, which lasted up to 4 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction to metronidazole | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment | Allergic reaction to metronidazole; also included nausea, vomiting. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Janneke van de Wijgert, Chief Investigator | University of Liverpool | +447557195108 | j.vandewijgert@liverpool.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 6, 2016 | Jul 31, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 2, 2017 | Jul 31, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| D016585 | Vaginosis, Bacterial |
| D002181 | Candidiasis, Vulvovaginal |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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The only samples to be retained are two vaginal swabs per participant. DNA will be extracted for qPCR testing of select urogenital organisms.
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Chlamydia trachomatis positive by gold standard test | Count of Participants | Participants |
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| Neisseria gonorrhoeae positive by gold standard test | Count of Participants | Participants |
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| Trichomonas vaginalis positive by gold standard test | Count of Participants | Participants |
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| Bacterial vaginosis positive by gold standard test | Count of Participants | Participants |
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| Primary | Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys) | Answers to questions about experiences with the procedures (client satisfaction survey). | A random selection of 107 enrolled women. | Posted | Count of Participants | Participants | Each client satisfaction survey was conducted at a main visit and lasted up to 30 min. |
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| Primary | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | 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. | 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). | Posted | Number | 95% Confidence Interval | % (sensitivity/specificity/PPV/NPV) | Each participant was assessed at one main study visit, which lasted up to 4 hours. |
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| 0 |
| 705 |
| 0 |
| 705 |
| 2 |
| 705 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D014848 | Vulvovaginitis |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| Thought counselling was of good quality |
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| Thought visit duration was too long but worth it |
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| Thought visit duration was too long and not worth |
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| Willing to be tested in future even if asymptomati |
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| Willing to pay for services in future |
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| Chlamydia specificity |
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| Chlamydia PPV |
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| Chlamydia NPV |
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| Gonorrhea sensitivity |
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| Gonorrhea specificity |
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| Gonorrhea NPV |
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| Trichomonas vaginalis sensitivity |
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| Trichomonas vaginalis specificity |
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| Trichomonas vaginalis PPV |
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| Trichomonas vaginalis NPV |
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| Bacterial vaginosis sensitivity |
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| Bacterial vaginosis specificity |
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| Bacterial vaginosis PPV |
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| Bacterial vaginosis NPV |
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| Vulvovaginal candidiasis sensitivity |
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| Vulvovaginal candidiasis specificity |
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| Vulvovaginal candidiasis PPV |
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| Vulvovaginal candidiasis NPV |
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