Bacterial Vaginosis, Sexually Transmitted Disease, Urinary Tract Infections, Vaginal Candidiasis
Conditions
Keywords
Syndromic management, Point of care testing
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.
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).
Interventions
DIAGNOSTIC_TESTUrogenital 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).
Sponsors
Rinda Ubuzima, Rwanda
Institute of Tropical Medicine, Belgium
Janneke van de Wijgert
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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). |
| 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. |
Countries
Rwanda
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 705 |
| Total | 705 |
Baseline characteristics
| Characteristic | Women at Risk of Urogenital Infections. | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 705 Participants | — |
| Age, Continuous | 32.9 years | — |
| Bacterial vaginosis positive by gold standard test | 125 Participants | — |
| Chlamydia trachomatis positive by gold standard test | 60 Participants | — |
| Neisseria gonorrhoeae positive by gold standard test | 50 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Race/Ethnicity, Customized African (Rwandan) | 705 Participants | — |
| Region of Enrollment Rwanda | 705 participants | — |
| Sex: Female, Male Female | 705 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
| Trichomonas vaginalis positive by gold standard test | 111 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 705 |
| other Total, other adverse events | 2 / 705 |
| serious Total, serious adverse events | 0 / 705 |
Outcome results
Primary
Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys)
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.
Population: A random selection of 107 enrolled women.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Women at Risk of Urogenital Infections. | Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys) | Felt welcome at study clinic | 107 Participants |
| Women at Risk of Urogenital Infections. | Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys) | Thought medical services were of good quality | 107 Participants |
| Women at Risk of Urogenital Infections. | Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys) | Thought counselling was of good quality | 107 Participants |
| Women at Risk of Urogenital Infections. | Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys) | Thought visit duration was too long but worth it | 41 Participants |
| Women at Risk of Urogenital Infections. | Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys) | Thought visit duration was too long and not worth | 0 Participants |
| Women at Risk of Urogenital Infections. | Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys) | Willing to be tested in future even if asymptomati | 100 Participants |
| Women at Risk of Urogenital Infections. | Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys) | Willing to pay for services in future | 95 Participants |
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)
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Women at Risk of Urogenital Infections. | Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators) | Had a positive CT/NG risk score | 396 Participants |
| Women at Risk of Urogenital Infections. | Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators) | Had a positive syphilis risk score | 378 Participants |
| Women at Risk of Urogenital Infections. | Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators) | Underwent a pelvic examination | 399 Participants |
| Women at Risk of Urogenital Infections. | Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators) | Had any abnormality during the pelvic examination | 216 Participants |
| Women at Risk of Urogenital Infections. | Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators) | Had at least one positive POCT result | 541 Participants |
| Women at Risk of Urogenital Infections. | Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators) | Received all positive POCT results at main visit | 505 Participants |
| Women at Risk of Urogenital Infections. | Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators) | Received inadequate treatment | 0 Participants |
| Women at Risk of Urogenital Infections. | Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators) | Needed and received a referral | 79 Participants |
| Women at Risk of Urogenital Infections. | Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators) | Had at least one partner requiring notification | 201 Participants |
| Women at Risk of Urogenital Infections. | Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators) | Required at least one additional visit | 51 Participants |
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.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Chlamydia sensitivity | 58.3 % (sensitivity/specificity/PPV/NPV) |
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Chlamydia specificity | 44.7 % (sensitivity/specificity/PPV/NPV) |
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Chlamydia PPV | 8.9 % (sensitivity/specificity/PPV/NPV) |
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Chlamydia NPV | 92 % (sensitivity/specificity/PPV/NPV) |
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Gonorrhea sensitivity | 66.0 % (sensitivity/specificity/PPV/NPV) |
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Gonorrhea specificity | 45.2 % (sensitivity/specificity/PPV/NPV) |
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Gonorrhea PPV | 8.4 % (sensitivity/specificity/PPV/NPV) |
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Gonorrhea NPV | 94.6 % (sensitivity/specificity/PPV/NPV) |
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Trichomonas vaginalis sensitivity | 60.4 % (sensitivity/specificity/PPV/NPV) |
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Trichomonas vaginalis specificity | 45.6 % (sensitivity/specificity/PPV/NPV) |
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Trichomonas vaginalis PPV | 17.5 % (sensitivity/specificity/PPV/NPV) |
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Trichomonas vaginalis NPV | 85.7 % (sensitivity/specificity/PPV/NPV) |
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Bacterial vaginosis sensitivity | 61.6 % (sensitivity/specificity/PPV/NPV) |
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Bacterial vaginosis specificity | 46.0 % (sensitivity/specificity/PPV/NPV) |
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Bacterial vaginosis PPV | 20.2 % (sensitivity/specificity/PPV/NPV) |
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Bacterial vaginosis NPV | 84.4 % (sensitivity/specificity/PPV/NPV) |
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Vulvovaginal candidiasis sensitivity | 74.6 % (sensitivity/specificity/PPV/NPV) |
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Vulvovaginal candidiasis specificity | 50.6 % (sensitivity/specificity/PPV/NPV) |
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Vulvovaginal candidiasis PPV | 12.4 % (sensitivity/specificity/PPV/NPV) |
| Women at Risk of Urogenital Infections. | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Vulvovaginal candidiasis NPV | 95.5 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Vulvovaginal candidiasis specificity | 69.4 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Chlamydia sensitivity | 71.7 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Trichomonas vaginalis PPV | 83.5 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Chlamydia specificity | 100 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Bacterial vaginosis NPV | 97.5 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Chlamydia PPV | 100 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Trichomonas vaginalis NPV | 94.2 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Chlamydia NPV | 97.4 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Vulvovaginal candidiasis NPV | 95.4 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Gonorrhea sensitivity | 76.0 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Bacterial vaginosis sensitivity | 95.2 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Gonorrhea specificity | 100 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Vulvovaginal candidiasis sensitivity | 64.4 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Gonorrhea PPV | 100 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Bacterial vaginosis specificity | 41.2 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Gonorrhea NPV | 98.2 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Vulvovaginal candidiasis PPV | 16.5 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Trichomonas vaginalis sensitivity | 68.5 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Bacterial vaginosis PPV | 26.4 % (sensitivity/specificity/PPV/NPV) |
| WISH (Entire Study Population) | Performance of Syndromic Management With or Without Integration of Point-of-care Tests | Trichomonas vaginalis specificity | 97.4 % (sensitivity/specificity/PPV/NPV) |