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2 October 2017 1 Rwanda WISH Study Rwanda WISH Study (Women’s Improvement of Sexual and reproductive Health) Statistical Analysis Plan of Primary and Secondary Endpoints Author: Marinus Verwijs, Project Manager Supervisor: Janneke van de Wijgert, Professor and Chief Investigator Version date: 2 October 2017 Sponsor University of Liverpool Study site Rinda Ubuzima P.O. Box 4560, Kigali, Rwanda Tel: +250-788439009 Chief investigator (CI) Professor Janneke van de Wijgert, PhD MPH MD Institute of Infection and Global Health, University of Liverpool Ronald Ross Building, 8 West Derby Street, Liverpool L69 7BE Tel office: +44-151-795-9613; Tel mobile: +44-755-719-5108 Email: [email protected] Principal Investigator (PI) Stephen Agaba, MD Tel mobile: +250-788 357 866 Email: [email protected] Funder European and Developing Countries Clinical Trials Partnership (EDCTP) Funding period 1 Jan 2016 – 31 Dec 2017 Data collection period 5 Jul 2016 – 14 March 2017 Protocol version, date Version: 0.5; Date: 8 November 2016 Previous ap proved Version: 0.4; Date: 6 June 2016 versions, dates 2 October 2017 1 Table of Contents 1. Background ............................................................................................................................................. 3 1.1 WISH objectives and endpoints ............................................................................................................. 3 1.2 WISH study population .......................................................................................................................... 3 1.3 WISH study procedures ......................................................................................................................... 4 1.4 STI syndromic management: WHO and Rwandan guidelines ............................................................... 4 2. Participant disposition............................................................................................................................. 5 3. Description of the study population ........................................................................................................ 7 4. Primary objectives ................................................................................................................................... 9 4.1 Monitoring and evaluation indicators ................................................................................................... 9 4.2 Gold standard test results at Main Visits ............................................................................................ 24 4.3 Adverse events and social harms ........................................................................................................ 25 5. Secondary objectives ............................................................................................................................. 25 5.1 Definitions of gold standard in the WISH Study and diagnostic approaches made ............................ 25 5.2 Syndromic diagnoses based on spontaneously and structurally reported symptoms ......................... 27 5.3 Comparisons syndromic management vs. WISH procedures vs. gold standard testing ...................... 29 5.4 Overview syndromic management and WISH procedures vs. gold standard testing .......................... 35 5.5 Primary and secondary objective outcomes based on gold standard tests ........................................ 36 5.6 Mistakes made in clinic flow and diagnosis & care procedures .......................................................... 36 6. Additional laboratory results ................................................................................................................. 37 7. Feasibility endpoints ............................................................................................................................. 37 7.1 Infrastructure/training/procurement: requirements and challenges ................................................. 38 7.2 Recruitment challenges ....................................................................................................................... 39 7.3 Overall costs ....................................................................................................................................... 40 7.4 Timing of procedures ........................................................................................................................... 41 7.5 Procedure observations and clinic flow problems observed ............................................................... 43 7.6 Client satisfaction survey ..................................................................................................................... 43 7.7 Staff survey .......................................................................................................................................... 45 7.8 Electronic participant identification register data .............................................................................. 48 7.9 Potential alternative risk score for Chlamydia and Gonorrhea .......................................................... 49 8. Appendices ............................................................................................................................................ 50 8.1 WHO Syndromic Management Algorithms ......................................................................................... 50 8.2 Rwandan Syndromic Management Algorithms .................................................................................. 54 8.3 WISH Algorithms ................................................................................................................................. 59 2 October 2017 2 1. Background 1.1 WISH objectives and endpoints 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 (VDS) is known to be suboptimal. We conducted the WISH (Women’s Improvement of Sexual and reproductive Health) study to address this problem. Data collection took place at the Rinda Ubuzima (RU) research clinic in Kigali, Rwanda, from July 2016 to March 2017. The study was sponsored by the University of Liverpool (UoL). The primary objective of the WISH study is to evaluate whether it is feasible to improve urogenital infection care in high risk women in Kigali, Rwanda (see ‘study population’ below), 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 buboes, and lower abdominal pain (LAP) in women reporting relevant symptoms. The secondary objectives of the 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 stakeholders (clinicians, programme implementers and policymakers) about the potential improvement of urogenital infection care in Rwanda as well as 3b) the potential roll-out of novel vaginal microbicides and multipurpose prevention technologies for HIV and pregnancy prevention as soon as efficacious products become available. This statistical analysis plan (SAP) describes the statistical analyses to be undertaken to achieve the primary objective and the first secondary objective (POCT performance), as well as some related exploratory analyses. The other secondary objectives will be analysed separately. Primary objectives Primary endpoints 1. Implement improved • Monitoring and evaluation indicators, such as: urogenital infection care − Inputs: Procurement experiences/costs, infrastructure and services and monitor and training requirements; evaluate these services − Activities/outputs: Numbers of clients counselled and risk scored, diagnostic tests conducted, infections diagnosed and treated, and referrals made; staff time required for each activity; time spent at the clinic for each client trajectory; − Outcomes/impacts: Improvements of access to and quality of services (from client satisfaction survey, staff interviews). Secondary objectives Secondary endpoints 1. Compare perfo rmance of • Sensitivity, specificity, PPV, and NPV for: syndromic management, − TV, BV: Syndromic vs POCT of everyone vs gold standard POCT, and gold standard − Candidiasis: Syndromic vs gold standard molecular testing for the − NG, CT: Syndromic vs POCT after risk scoring vs POCT (= gold diagnosis of NG, CT, TV, standard) of everyone. The POCT test is a molecular test and BV, and candidiasis. is considered to be a gold standard in this SAP. 1.2 WISH study population We enrolled adult women (18 years or older) living in the city of Kigali who were at high risk of HIV/urogenital infections (defined as having had more than one sexual partner OR having been treated for a sexually transmitted infection (STI) in the 12 months prior to enrollment) regardless of 2 October 2017 3 the presence of current urogenital symptoms. Each woman could participate in the WISH study only once. Women were excluded when they were participating in another health intervention study or were unfit for participation as judged by the PI, but they were not excluded when they were known HIV-positive and/or pregnant. Unmarried women aged 18-20
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