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Acceptability and feasibility of genital self-sampling for the diagnosis of female genital schistosomiasis: a cross-sectional study in Zambia.

ABSTRACT: Background: Female genital schistosomiasis (FGS) is a neglected and disabling gynaecological disorder that is difficult to diagnose and is part of the wider spectrum of urogenital disease caused by the waterborne parasite Schistosoma haematobium. Over 90% of human schistosomiasis cases are found in sub-Saharan Africa with 3.8 million people infected with schistosomes in Zambia. Reported FGS prevalence ranges from 33-75% of those with urinary schistosomiasis in endemic areas, suggesting a potentially high FGS burden in Zambia alone. The Bilharzia and HIV (BILHIV) study evaluated home self-sampling genital collection methods for the diagnosis of FGS. Methods: Eligible participants included non-pregnant, sexually active women aged 18-31 who were previously recruited for the HPTN 071 (PopART) trial in Livingstone, Zambia. Household demographic and symptom questionnaires were administered by community workers. Participants were offered vaginal and cervical self-swabs and a urine cup. Cervicovaginal lavage (CVL) was performed in clinic by midwives. Information was collected from participants on the acceptability and feasibility of genital self-sampling. Results: From January-August 2018, 603 women were enrolled, and 87.3% (527/603) completed clinic follow up. A high proportion of participants indicated that self-collection of specimens was "easy" or "very easy" on a 5-point Likert scale. A high proportion of women would be willing to self-collect all three specimens again in future: vaginal swab 96.7% (583/603), cervical swab 96.5% (582/603), and urine 96.2% (580/603). Overall, 90.0% (543/603) preferred to self-collect samples at home, compared with sampling in the clinic Home-based self-sampling was preferred over provider-based sampling in the clinic due to greater privacy 65.0% (353/543), convenience 51.4% (279/543) and lack of needed transportation 17.7% (96/543). Conclusions: Home based genital self-sampling for FGS diagnosis is highly acceptable. This scalable method may inform future efforts for community-based diagnosis of FGS.

SUBMITTER: Rutty Phiri C

PROVIDER: S-EPMC7610177 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundWomen's health in resource-limited settings can benefit from the integrated management of high-burden diseases, such as female genital schistosomiasis (FGS) and human papilloma virus (HPV)-related cervical cancer. In schistosomiasis-endemic countries such as Madagascar, data on FGS and HPV prevalence are lacking as well as preventive measures for both conditions. This study aims to estimate the prevalence of FGS and HPV in rural Madagascar, and to examine associated risk factors to identify opportunities for improving women's health.MethodsAfter initial community outreach activities, interested women aged 18-49 years were recruited consecutively in 2021 at three primary health care centers in the district of Marovoay. FGS was detected by colposcopy. Colposcopy images were double-blind reviewed by two independent specialists. A Luminex bead-based assay was performed on cervical vaginal lavage specimens for HPV typing. Crude (CPR) and adjusted prevalence ratios (APR) of associations between selected factors and FGS and HPV positivity were estimated using univariable and multivariable binary Poisson regression with 95% confidence intervals (CIs).ResultsAmong 500 women enrolled, 302 had complete information on FGS and HPV diagnosis, and were thus eligible for analysis. Within the sample, 189 (62.6%, 95% CI: 56.9-68.1) cases of FGS were detected. A total of 129 women (42.7%, 95% CI: 37.1-48.5) tested positive for HPV. In total, 80 women (26.5%, 95% CI: 21.6-31.8]) tested positive for both conditions. No association was observed between FGS and HPV positivity, while previous pregnancy (APR = 0.65, 95% CI: 0.43-0.78) and older age (APR = 0.59, 95% CI: 0.42-0.81) are showing a negative association with HPV infection compared to no previous pregnancy and younger age groups.ConclusionsThe results of the study show that FGS and HPV are highly prevalent in rural Madagascar. The concurrent prevalence of these two conditions requires urgent adaptations of public health strategies to improve women's health, such as integrated services at primary level of care.

Project description:Female genital schistosomiasis (FGS) can occur in S. haematobium infection and is caused by parasite egg deposition in the genital tract. Confirming a diagnosis of FGS is challenging due to the lack of a diagnostic reference standard. A 2010 expert-led consensus meeting proposed visual inspection of the cervicovaginal mucosa as an adequate reference standard for FGS diagnosis. The agreement of expert human reviewers for visual-FGS has not been previously described. Methods: In two Zambian communities, non-menstruating, non-pregnant, sexually-active women aged 18-31 years participating in the HPTN 071 (PopART) Population-Cohort were enrolled in a cross-sectional study. Self-collected genital swabs and a urine specimen were collected at a home visit; trained midwives performed CVL and hand-held colposcopy at a clinic visit. S. haematobium eggs and circulating anodic antigen (CAA) were detected from urine. Two expert reviewers independently diagnosed visual-FGS as the presence of sandy patches, rubbery papules or abnormal blood vessels in digital cervicovaginal images obtained by hand-held colposcopy. PCR-FGS was defined as Schistosoma DNA detected by real-time PCR in any genital specimen (CVL or genital swab). Results: Of 527 women with cervicovaginal colposcopic images, 468/527 (88.8%) were deemed interpretable by Reviewer 1 and 417/527 (79.1%) by Reviewer 2. Visual-FGS was detected in 35.3% (165/468) of participants by expert review of colposcopic images by Reviewer 1 and in 63.6% (265/417) by Reviewer 2. Cohen's kappa statistic for agreement between the two expert reviewers was 0.16, corresponding to "slight" agreement. The reviewers made concordant diagnoses in 38.7% (204/527) participants (100 negative, 104 positive) and discordant diagnoses in 31.8% (168/527) participants. Conclusions: The unexpectedly low level of correlation between expert reviewers highlights the imperfect nature of visual diagnosis for FGS based on cervicovaginal images obtained with a hand-held colposcope. This finding is a call to action for improved point-of-care diagnostics for female genital schistosomiasis.

Project description:INTRODUCTION:Cervical cancer disproportionately burdens low-income and middle-income countries (LMICs) such as Guatemala. Self-collection testing for human papillomavirus (HPV) has been suggested as a form of cervical cancer screening to facilitate access in LMICs. This study assessed and compared the acceptability of self-collection HPV testing in two rural, indigenous and ethnically distinct communities in Guatemala: Santiago Atitlán, Sololá and Livingston, Izabal. METHODS:All participants, women between the ages of 18 and 60, completed a questionnaire. Eligible participants were also asked to self-collect a vaginal sample and complete a questionnaire regarding comfort and acceptability. Self-collected samples were tested for high-risk HPV using the real-time PCR Hybribio kit. RESULTS:In the indigenous community of Santiago Atitlán, of 438 age-eligible participants, 94% completed self-collection. Of those, 81% found it comfortable and 98% were willing to use it as a form of screening. In the multiethnic (Afro-Caribbean, indigenous) community of Livingston, of 322 age-eligible participants, 53% chose to self-collect. Among those who took the test, 83% found it comfortable and 95% were willing to use it as a form of screening. In Livingston, literacy (can read and/or write vs cannot read or write) was higher in women who chose to self-collect (prevalence ratio 2.25; 95% CI 1.38 to 3.68). Ethnicity, history of screening and reproductive history were not associated with willingness to self-collect in Livingston. Women in Santiago reported less prior use of healthcare than women in Livingston. Overall, 19% (106/549) of samples tested positive for high-risk HPV. CONCLUSION:Among women willing to self-collect in rural and indigenous communities in Guatemala, self-collection for HPV testing is highly acceptable. However, willingness to try self-collection might vary across communities and settings. Women from a community that used less healthcare were more likely to choose self-collection. Further research is necessary to determine what factors influence a woman's choice to self-collect.

Project description:BackgroundFemale Genital Schistosomiasis (FGS) is a neglected disease of the genital tract due to the inflammatory response to the presence of Schistosoma haematobium eggs in the genital tract. The WHO has prioritized the improvement of diagnostics for FGS and previous studies have explored the PCR-based detection of Schistosoma DNA on genital specimens, with encouraging results. This study aimed to determine the prevalence of FGS among women living in an endemic district in North-western Tanzania, using PCR on samples collected though cervical-vaginal swabs, and to compare the performance of self-collected and healthcare worker-collected (operator-collected) samples, and the acceptability of the different sampling methods.Methods/principal findingsA cross-sectional study was conducted involving 211 women living in 2 villages in the Maswa district of North-western Tanzania. Urine, self-collected and operator-collected cervical-vaginal swabs were obtained from participants. A questionnaire was administered, focusing on the comfortability in undergoing different diagnostic procedures. Prevalence of urinary schistosomiasis, as assessed by eggs in urine, was 8.5% (95%CI 5.1-13.1). DNA was pre-isolated from genital swabs and transported at room temperature to Italy for molecular analysis. Prevalence of active schistosomiasis, urinary schistosomiasis, and FGS were 10.0% (95% CI 6.3-14.8), 8.5% (95%CI 5.1-13.1), and 4.7% (95%CI 2.3-8.5), respectively. When real-time PCR was performed after a pre-amplification step, the prevalence of active schistosomiasis increased to 10.4% (95%CI 6.7-15.4), and FGS to 5.2% (95%CI 2.6-9.1). Of note, more cases were detected by self-collected than operator-collected swabs. The vast majority of participants (95.3%) declared that they were comfortable/very comfortable about genital self-sampling, which was indicated as the preferred sampling method by 40.3% of participants.Conclusions/significanceThe results of this study show that genital self-sampling followed by pre-amplified PCR on room temperature-stored DNA is a useful method from both technical and acceptability point of views. This encourages further studies to optimize samples processing, and identify the best operational flow to allow integration of FGS screening into women health programmes, such as HPV screening.

Project description:BackgroundEarly infant diagnosis is important for timely identification of HIV-infected infants and linkage to care. Testing at birth has been implemented to facilitate earlier diagnosis of HIV infection but may present new challenges. This study was conducted to understand the acceptability and feasibility of birth testing in urban and rural settings in southern Zambia.MethodsThis cross-sectional study was conducted at 11 hospitals and clinics in Livingstone, Choma, and Macha in Southern Province, Zambia from 2016 to 2018. Infants born to pregnant women living with HIV at the sites were eligible for enrollment. After enrollment, a questionnaire was administered to the mother and a dried blood spot card was collected from infants for testing at a central laboratory. When results were available, mothers were notified to return to the clinic. Acceptability of birth testing was evaluated based on the proportion of women who agreed to participate and the reasons for non-participation among women who declined. Feasibility of testing at birth was evaluated using turnaround times for returning results, the proportion of women receiving results, and linkage to care for infants testing positive.ResultsOne thousand four hundred three women were approached for the study. A small proportion declined due to refusal of birth testing (0 to 8.2% across sites). One thousand two hundred ninety women agreed to have their infants tested. The proportion of mothers receiving results ranged from 51.6 to 92.1%, and was significantly lower at the hospital than clinics in Livingstone (51.6% vs. 69.8%; p < 0.0001) and Macha (69.5% vs. 85.7%; p < 0.0001) but not Choma (85.7% vs. 92.1%; p = 0.34). For mothers who received test results, the median turnaround time from sample collection was 67 days in Livingstone and 53 days in Macha and Choma. Overall, 23 (1.8%) infants tested positive for HIV but only 8 (34.8%) were linked to care a median of 68 days (range: 29, 784) after sample collection.ConclusionsWhile testing at birth was acceptable, this study highlights the operational challenges under a centralized laboratory testing system. Point-of-care platforms are needed for rapid testing and return of results so HIV-infected children can be identified, linked to care, and treated as early as possible.

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Acceptability and feasibility of genital self-sampling for the diagnosis of female genital schistosomiasis: a cross-sectional study in Zambia.

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