ArticlesTargeted point-of-care testing compared with syndromic management of urogenital infections in women (WISH): a cross-sectional screening and diagnostic accuracy study
Introduction
Sexually transmitted infections and other urogenital infections cause a major burden of disease worldwide.1 WHO estimated that 357 million new curable infections caused by Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Treponema pallidum occurred in 2012.2 In women, bacterial vaginosis, vulvovaginal candidiasis, and urinary tract infections are also common.3, 4 Long-term sequelae include increased risk of HIV acquisition and transmission, pelvic inflammatory disease, pregnancy complications, and invasive neonatal infections.4, 5, 6
Most resource-poor countries diagnose genital infections syndromically, using local guidelines that are based on WHO guidelines for the management of sexually transmitted infections.7, 8 Each patient-reported symptom, potentially augmented by clinician-observed signs during a physical examination, is treated for all organisms that might cause that symptom.7 In women, the four main syndromes on which the WHO algorithms are based are vaginal discharge without lower abdominal pain, lower abdominal pain with or without vaginal discharge, genital ulcers with or without inguinal buboes, and inguinal buboes without genital ulcers.7
The vaginal discharge syndrome is the most common.8, 9 WHO recommends that women with vaginal discharge should always be treated for bacterial vaginosis and trichomoniasis, and for chlamydia and gonorrhoea if local prevalence is high or if locally designed risk assessments are positive. WHO recommends additional treatment for vulvovaginal candidiasis if the discharge is curd-like or is accompanied by vulval oedema, erythema, or excoriations. In Europe, most sexually transmitted infections and urogenital infections in women are treated presumptively by primary care physicians.
By definition, syndromic and presumptive approaches miss all asymptomatic infections. Asymptomatic infections in women are common and are associated with the complications outlined above.4, 10 Furthermore, many studies in different countries have shown that the performance of algorithms for vaginal discharge and lower abdominal pain in symptomatic women are suboptimal, leading to undertreatment, overtreatment, or inadequate treatment of patients.9, 11, 12, 13
The women's improvement of sexual and reproductive health (WISH) study in Kigali, Rwanda, sought to improve case-finding and infection management in women by introducing point-of-care tests (POCTs).14 Our aim was to use POCTs that comply with WHO ASSURED criteria (affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free, and deliverable to end users) as much as possible.15, 16 Participants were first asked about urogenital symptoms as if we were to provide them with syndromic care, but were then offered the POCT-based WISH algorithms. Stored clinical samples from all women were also tested by gold standard nucleic acid amplification tests (NAATs). This study design allowed us to compare the performance of the WISH algorithms and the WHO vaginal discharge and lower abdominal pain algorithms with gold standard results, to evaluate the feasibility and acceptability of the WISH algorithms, recommend optimal algorithms given currently available POCTs, and identify POCT development gaps.
Section snippets
Study design and participants
This cross-sectional screening and diagnostic accuracy study was done at the Rinda Ubuzima research clinic and laboratory in Kigali, Rwanda. Study staff had extensive experience in sexual and reproductive health care. Our aim was to recruit women at risk of acquiring HIV and sexually transmitted infections, who were at varying degrees of risk and not exclusively sex workers.
Recruitment activities were implemented by study staff with the help of community mobilisers. Two mobilisers were women
Results
Participants were recruited between July 5, 2016, and March 14, 2017. All 705 enrolled participants completed a study visit, and 51 attended 53 additional visits. 40 of 51 participants attended additional visits because they received results or additional treatment, 11 had persistent or new symptoms, two had a mild allergic reaction to metronidazole, one patient returned for a speculum examination, and one to obtain information. No other adverse events or social harms were reported apart from
Discussion
The WISH study showed that POCT integration in first-line urogenital care is feasible and improves case-finding and infection management in Rwandan women. Vaginal discharge (including genital itching and burning) and lower abdominal pain (including pain during sex) were by far the most common symptoms reported. Most women reporting these symptoms did not require immediate treatment because they either had no infection or had mild vaginal dysbiosis (defined as above-normal vaginal concentrations
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