Novel point-of-care cytokine biomarker lateral flow test for the screening for sexually transmitted infections and bacterial vaginosis: study protocol of a multicentre multidisciplinary prospective observational clinical study to evaluate the performance and feasibility of the Genital InFlammation Test (GIFT).

INTRODUCTION: A prototype lateral flow device detecting cytokine biomarkers interleukin (IL)-1α and IL-1ß has been developed as a point-of-care test-called the Genital InFlammation Test (GIFT)-for detecting genital inflammation associated with sexually transmitted infections (STIs) and/or bacterial vaginosis (BV) in women. In this paper, we describe the rationale and design for studies that will be conducted in South Africa, Zimbabwe and Madagascar to evaluate the performance of GIFT and how it could be integrated into routine care. METHODS AND ANALYSIS: We will conduct a prospective, multidisciplinary, multicentre, cross-sectional and observational clinical study comprising two distinct components: a biomedical ('diagnostic study') and a qualitative, modelling and economic ('an integration into care study') part. The diagnostic study aims to evaluate GIFT's performance in identifying asymptomatic women with discharge-causing STIs (Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG)) and BV. Study participants will be recruited from women attending research sites and family planning services. Several vaginal swabs will be collected for the evaluation of cytokine concentrations (ELISA), STIs (nucleic acid amplification tests), BV (Nugent score) and vaginal microbiome characteristics (16S rRNA gene sequencing). The first collected vaginal swab will be used for the GIFT assay which will be performed in parallel by a healthcare worker in the clinic near the participant, and by a technician in the laboratory. The integration into care study aims to explore how GIFT could be integrated into routine care. Four activities will be conducted: user experiences and/or perceptions of the GIFT device involving qualitative focus group discussions and in-depth interviews with key stakeholders; discrete choice experiments; development of a decision tree classification algorithm; and economic evaluation of defined management algorithms. ETHICS AND DISSEMINATION: Findings will be reported to participants, collaborators and local government for the three sites, presented at national and international conferences, and disseminated in peer-reviewed publications.The protocol and all study documents such as informed consent forms were reviewed and approved by the University of Cape Town Human Research Ethics Committee (HREC reference 366/2022), Medical Research Council of Zimbabwe (MRCZ/A/2966), Comité d'Ethique pour la Recherche Biomédicale de Madagascar (N° 143 MNSAP/SG/AMM/CERBM) and the London School of Hygiene and Tropical Medicine ethics committee (LSHTM reference 28046).Before the start, this study was submitted to the Clinicaltrials.gov public registry (NCT05723484). TRIAL REGISTRATION NUMBER: NCT05723484.

High uptake of menstrual health information, products and analgesics within an integrated sexual reproductive health service for young people in Zimbabwe.

BACKGROUND: Despite being integral to women's well-being, achieving good menstrual health (MH) remains a challenge. This study examined MH services uptake (including information, analgesics, and a choice of MH products - the menstrual cup and reusable pads) and sustained use of MH products within an integrated sexual and reproductive health intervention for young people in Zimbabwe. METHODS: This mixed-methods study was nested within a cluster randomised trial of integrated sexual and reproductive health services (CHIEDZA) for youth in three provinces (Harare, Mashonaland East, and Bulawayo). The study collected qualitative and quantitative data from 27,725 female clients aged 16-24 years, who accessed CHIEDZA from April 2019 - March 2022. Using a biometric (fingerprint recognition) identification system, known as SIMPRINTS, uptake of MH information, products, and analgesics and other services was tracked for each client. Descriptive statistics and logistic regression were used to investigate MH service uptake and product choice and use over time, and the factors associated with these outcomes. Thematic analysis of focus group discussions and interviews were used to further explore providers' and participants' experiences of the MH service and CHIEDZA intervention. RESULTS: Overall, 36,991 clients accessed CHIEDZA of whom 27,725 (75%) were female. Almost all (n = 26,448; 95.4%) took up the MH service at least once: 25433 took up an MH product with the majority (23,346; 92.8%) choosing reusable pads. The uptake of cups varied across province with Bulawayo province having the highest uptake (13.4%). Clients aged 20-24 years old were more likely to choose cups than reusable pads compared with those aged 16-19 years (9.4% vs 6.0%; p < 0.001). Over the implementation period, 300/1819 (16.5%) of clients swapped from the menstrual cup to reusable pads and 83/23346 (0.4%) swapped from reusable pads to the menstrual cup. Provision of the MH service encouraged uptake of other important SRH services. Qualitative findings highlighted the provision of free integrated SRH and MH services that included a choice of MH products and analgesics in a youth-friendly environment were key to high uptake and overall female engagement with SRH services. CONCLUSIONS: High uptake demonstrates how the MH service provided much needed access to MH products and information. Integration of MH within an SRH intervention proved central to young women accessing other SRH services.

Evaluation of a community-based aetiological approach for sexually transmitted infections management for youth in Zimbabwe: intervention findings from the STICH cluster randomised trial.

Background: Young people are at high risk of sexually transmitted infections (STIs). We report STI testing uptake, prevalence and incidence within a community-based integrated HIV and sexual and reproductive health service for youth, being evaluated in a cluster randomised trial in Zimbabwe. Methods: This paper reports the intervention findings of the cluster randomised trial whereby STI testing was offered to all service attendees (16-24 years) in 12 intervention clusters over 12 months between October 5, 2020, and December 17, 2021, in Zimbabwe. Testing for Chlamydia trachomatis [CT] and Neisseria gonorrhoeae [NG] was offered to males and females with results available in one week and follow-up of test-positive clients by telephone. Trichomonas vaginalis [TV] testing was offered to females only with same day results and treatment. Youth testing positive for any STI were offered partner notification slips and free treatment for partners. This trial was registered with ISRCTN Registry, ISRCTN15013425. Findings: Overall, 8549/9891 (86.1%) eligible youth accepted CT/NG testing. Prevalence of CT and NG was 14.7% (95% CI 13.6-15.8) and 2.8% (95% CI 2.2-3.6) respectively. Combined prevalence of CT, NG or TV in women was 23.2% (95% CI 21.5-25.0). After adjusting for cluster, age and sex, the odds of NG were increased in those living with HIV (aOR 3.14, 95% CI 2.21-4.47). The incidence rate among those who initially tested negative for CT or NG was 25.6/100PY (95% CI 20.6-31.8). CT/NG treatment uptake was 924/1526 (60.6%). TV treatment uptake was 483/489 (98.8%). A partner returned for treatment for 103/1807 clients (5.7%). Interpretation: Our findings show high acceptability of STI testing among youth. STI prevalence was high particularly among females and youth with HIV, underscoring the need for integration of HIV and STI services. Funding: MRC/ESRC/DFID/NIHR (MR/T040327/1) and Wellcome Trust (206316/Z/17/Z).

"It's not safe for me and what would it achieve?" Acceptability of patient-referral partner notification for sexually transmitted infections to young people, a mixed methods study from Zimbabwe.

Partner notification (PN) is considered integral to the management of sexually transmitted infections (STI). Patient-referral is a common PN strategy and relies on index cases notifying and encouraging their partners to access treatment; however, it has shown limited efficacy. We conducted a mixed methods study to understand young people's experiences of PN, particularly the risks and challenges encountered during patient-referral. All young people (16-24 years) attending a community-based sexual and reproductive health service in Zimbabwe who were diagnosed with an STI were counselled and offered PN slips, which enabled their partners to access free treatment at the service. PN slip uptake and partner treatment were recorded. Among 1807 young people (85.0% female) offered PN slips, 745 (41.2%) took up ≥1 PN slip and 103 partners (5.7%) returned for treatment. Most participants described feeling ill-equipped to counsel and persuade their partners to seek treatment. Between June and August 2021, youth researchers conducted in-depth interviews with 41 purposively selected young people diagnosed with an STI to explore their experiences of PN. PN posed considerable social risks, threatening their emotional and physical safety. Except for a minority in long-term, publicly acknowledged relationships, participants did not expect PN would achieve successful outcomes. Public health discourse, which constructs PN as "the right thing to do", influenced participants to adopt narratives that concealed the difficulties of PN and their unmet needs. Urgent interrogation is needed of whether PN is a suitable or constructive strategy to continue pursuing with young people. To improve the outcomes of preventing reinfection and onward transmission of STIs, we must consider developing alternative strategies that better align with young people's lived experiences.Plain language summary Partner notification is a public health strategy used to trace the sexual partners of people who have received a sexually transmitted infection (STI) diagnosis. It aims to interrupt the chains of STI transmission and prevent reinfection by treating both the person diagnosed and their sexual partners. The least effective but most common partner notification strategy used in many resource-limited settings is called "patient referral". This involves a sexual healthcare provider encouraging the person diagnosed to give a "partner notification slip" to their potentially exposed sexual partner/s and persuading them to access treatment. This research sought to better understand young people's experiences of partner notification, particularly the risks and challenges they faced during patient-referral.All young people (16-24 years) attending a community-based sexual and reproductive health service in Zimbabwe who were diagnosed with an STI were counselled and offered PN slips, which enabled their partners to access free treatment at the service. Young people trained as researchers interviewed 41 young people who had received a STI diagnosis to explore their experiences of partner notification.Only a small number (5.7%) of the partners of those who took a slip attended the service for treatment. Most participants felt they did not have the preparation, skills, or resources to persuade their partners to seek treatment. Many described negative experiences during and after partner notification, including relationship breakdown, reputation damage, and physical violence.These findings suggest that we should reconsider if partner notification is suitable or effective for use with young people. We should explore alternative approaches that do not present risks to young people's social, emotional, and physical safety and well-being.

High uptake of menstrual health information, products and analgesics within an integrated sexual reproductive health service for young people in Zimbabwe.

Background: Achieving good menstrual health (MH), integral to women's well-being, remains a challenge. This study examined MH services uptake (including information, analgesics, and a choice of MH products - the menstrual cup and reusable pads) and sustained use of MH products within an integrated sexual and reproductive health intervention for young people in Zimbabwe. Methods: This study was embedded within a cluster randomised trial of integrated sexual and reproductive health services (CHIEDZA) in three provinces (Harare, Mashonaland East, and Bulawayo). The study collected qualitative and quantitative data from female clients aged 16-24 years, who accessed CHIEDZA from April 2019 - March 2022. Uptake of MH information, products, and analgesics and other services was tracked for each client. Descriptive statistics and logistic regression were used to investigate MH service uptake and product choice and use over time, and the factors associated with these outcomes. Thematic analysis of focus group discussions and interviews were used to further explore providers' and participants' experiences of the MH service and CHIEDZA intervention. Results: Overall, 36991 clients accessed CHIEDZA of whom 27725 (75%) were female. Almost all (n = 26448; 95.4%) took up the MH service at least once: 25433 took up an MH product with the majority (23346; 92.8%) choosing reusable pads. The uptake of cups varied across province with Bulawayo province having the highest uptake (13.4%). Clients aged 20-24 years old were more likely to choose cups than reusable pads compared with those aged 16-19 years (9.4% vs 6.0%; p < 0.001). Over the implementation period, 300/1819 (16.5%) of clients swapped from the menstrual cup to reusable pads and 83/23346 (0.4%) swapped from reusable pads to the menstrual cup. Provision of the MH service encouraged uptake of other important SRH services. Qualitative findings highlighted the provision of free integrated SRH and MH services that included a choice of MH products and analgesics in a youth-friendly environment were key to high uptake and overall female engagement with SRH services. Conclusions: High uptake demonstrates how the MH service provided much needed access to MH products and information. Integration of MH within an SRH intervention proved central to young women accessing other SRH services.

Working from home and intimate partner violence among cis-women during the COVID-19 pandemic: evidence from a global, cross-sectional study.

BACKGROUND: Intimate partner violence (IPV) may have been exacerbated during the COVID-19 pandemic. This analysis aimed to determine how employment disruption during COVID-19, including working from home, was associated with IPV experience among cis-gendered women. METHODS: The International Sexual Health and Reproductive health (I-SHARE) study is a cross-sectional online survey implemented in 30 countries during the pandemic. Samples used convenience, online panel, and population-representative methods. IPV was a pre-specified primary outcome, measured using questions from a validated World Health Organisation instrument. Conditional logistic regression modelling was used to quantify the associations between IPV and changes to employment during COVID-19, adjusted for confounding. RESULTS: 13,416 cis-gender women, aged 18-97, were analysed. One third were from low and middle income countries, and two thirds from high income countries. The majority were heterosexual (82.7%), educated beyond secondary-level (72.4%) and childless (62.7%). During COVID-19 33.9% women worked from home, 14.6% lost employment, and 33.1% continued to work on-site. 15.5% experienced some form of IPV. Women working from home experienced greater odds of IPV than those working on-site (adjusted OR 1.40, 95% CI 1.12-1.74, p = 0.003). This finding was robust independent of sampling strategy and country income. The association was primarily driven by an increase in psychological violence, which was more prevalent than sexual or physical violence. The association was stronger in countries with high gender inequality. CONCLUSIONS: Working from home may increase IPV risk globally. Workplaces offering working from home should collaborate with support services and research interventions to strengthen resiliency against IPV.

A mixed-methods study measuring the effectiveness of a menstrual health intervention on menstrual health knowledge, perceptions and practices among young women in Zimbabwe.

OBJECTIVES: While integral to women's physical and mental well-being, achieving good menstrual health (MH) remains a challenge for many women. This study investigated the effectiveness of a comprehensive MH intervention on menstrual knowledge, perceptions and practices among women aged 16-24 years in Harare, Zimbabwe. DESIGN: A mixed-methods prospective cohort study with pre-post evaluation of an MH intervention. SETTING: Two intervention clusters in Harare, Zimbabwe. PARTICIPANTS: Overall, 303 female participants were recruited, of whom 189 (62.4%) were seen at midline (median follow-up 7.0; IQR 5.8-7.7 months) and 184 (60.7%) were seen at endline (median follow-up 12.4; IQR 11.9-13.8 months). Cohort follow-up was greatly affected by COVID-19 pandemic and associated restrictions. INTERVENTION: The MH intervention provided MH education and support, analgesics, and a choice of menstrual products in a community-based setting to improve MH outcomes among young women in Zimbabwe. PRIMARY AND SECONDARY OUTCOMES: Effectiveness of a comprehensive MH intervention on improving MH knowledge, perceptions, and practices among young women over time. Quantitative questionnaire data were collected at baseline, midline, and endline. At endline, thematic analysis of four focus group discussions was used to further explore participants' menstrual product use and experiences of the intervention. RESULTS: At midline, more participants had correct/positive responses for MH knowledge (adjusted OR (aOR)=12.14; 95% CI: 6.8 to 21.8), perceptions (aOR=2.85; 95% CI: 1.6 to 5.1) and practices for reusable pads (aOR=4.68; 95% CI: 2.3 to 9.6) than at baseline. Results were similar comparing endline with baseline for all MH outcomes. Qualitative findings showed that sociocultural norms, stigma and taboos around menstruation, and environmental factors such as limited access to water, sanitation and hygiene facilities affected the effect of the intervention on MH outcomes. CONCLUSIONS: The intervention improved MH knowledge, perceptions and practices among young women in Zimbabwe, and the comprehensive nature of the intervention was key to this. MH interventions should address interpersonal, environmental and societal factors. TRIAL REGISTRATION NUMBER: NCT03719521.

Acceptability of self-collected vaginal swabs for sexually transmitted infection testing among youth in a community-based setting in Zimbabwe.

BACKGROUND: Youth are a high-risk group for sexually transmitted infections (STIs). To increase access to STI testing, convenient approaches for sampling and testing are needed. We assessed the acceptability of self-collected vaginal swabs (SCVS) for STI testing among young women (16-24 years) attending a community-based sexual and reproductive health service in Zimbabwe. METHODS: A SCVS was used for point-of-care testing for Trichomonas vaginalis and a urine sample for testing for Chlamydia trachomatis and Neisseria gonorrhoeae. A questionnaire was administered to investigate the acceptability of SCVS versus self-collected urine samples. In-depth interviews (IDIs) explored the experience of SCVS and reasons for sample collection preference. Qualitative analysis was predominantly deductive. RESULTS: We recruited 129 women who took up STI testing (median age 20 years, IQR 18-22 years) and conducted 12 IDIs. Most participants reported that they understood the instructions (93.0%) and found SCVS easy (90.7%). Many participants felt relaxed (93.0%), in control (88.4%) and that they had enough privacy (90.7%). Pain or discomfort were reported by 16.3% and embarrassment by 15.5%. Among the 92 (71.3%) participants who provided both a SCVS and urine sample, 60.9% preferred SCVS. Sample collection method preferences were similar between 16-19 and 20-24year-olds. In IDIs, clear instructions, privacy, trust in the service and same-day results were perceived as important facilitators to taking up SCVS. Participants frequently described feeling relaxed and confident whilst taking a SCVS. Pain and discomfort were uncommon experiences. CONCLUSIONS: SCVS for STI testing are acceptable to young women and a feasible method of sample collection in community-based settings.

Heterosexual Oral and Anal Sex: Perceptions, Terminologies, and Attitudes of Younger and Older Adults in Ibadan, Nigeria.

Although heterosexual oral and anal sexual behaviors have been reported in sub-Saharan Africa, little is known about how they are understood and perceived, particularly, in West Africa. We undertook a qualitative exploration of local terminologies and sexual scripts associated with heterosexual oral and anal sex in preparation for a quantitative survey. We held focus group discussions (18) and interviews (44) with younger and middle-aged men and women from the general population and female sex workers (FSWs) in selected communities in Ibadan. Most participants had heard of oral and anal sex. Younger adults aged 18-25 years, particularly male participants and FSWs, appeared more informed than older adults in the general population. Sexually explicit movies were the most cited source of information. Oral and anal sexual behaviors were considered sensitive, with different local names, meanings, and interpretations. Participants advised against the use of slang terms in research. We identified six different scripts employed by participants in discussing oral and anal sex practices: protecting sexual relationship, financial reward, an alternative to vaginal sex, pleasure, male dominance and control, and risk, stigma, and disgust.

The Presence of Hemoglobin in Cervicovaginal Lavage Is Not Associated With Genital Schistosomiasis in Zambian Women From the BILHIV Study.

Background: Female genital schistosomiasis (FGS) occurs when Schistosoma haematobium eggs are deposited in reproductive tissue. Female genital schistosomiasis in the cervical mucosa is associated with increased vascularity. If FGS is associated with the presence of hemoglobin in cervicovaginal lavage (CVL), the use of urinary reagent strips to detect hemoglobin in CVL could supplement FGS diagnosis. Methods: Nonmenstruating, nonpregnant, sexually active women aged 18-31 participating in the HPTN 071 (PopART) Population-Cohort were invited in 2 Zambian communities. Genital self-swabs and a urine specimen were collected at a home visit, and CVL and hand-held colposcopy were performed at a midwife led clinic visit. Urinary reagent strips were used to identify hemoglobin in CVL. Eggs and circulating anodic antigen (CAA) were detected from urine. Visual-FGS was defined as the presence of sandy patches, rubbery papules, or abnormal blood vessels. Polymerase chain reaction (PCR)-FGS was defined as Schistosoma deoxyribonucleic acid detected by real-time PCR on CVL or cervical or vaginal swab. Results: Of 209 women with home genital swabs and companion CVL specimens, 66% (138 of 209) had detectable CVL hemoglobin, 13.4% (28 of 209) had PCR-defined FGS, and 17.2% (36 of 209) had visual-FGS. Active Schistosoma infection, diagnosed by CAA or urine microscopy, was present in 21.0% (44 of 209) participants. Active Schistosoma infection (P = .4), PCR-FGS (P = 0.7), and visual-FGS (P = 0.3) were not associated with CVL hemoglobin presence. Results did not differ in subgroups with high infection burden (cycle threshold < 35 or 2-3 positive genital PCR). Conclusions: Polymerase chain reaction-FGS, visual-FGS, and active Schistosoma infection were not associated with the presence of CVL hemoglobin. Further research is needed to establish accessible community-based FGS diagnostics.

Changes in concentrations of cervicovaginal immune mediators across the menstrual cycle: a systematic review and meta-analysis of individual patient data.

BACKGROUND: Hormonal changes during the menstrual cycle play a key role in shaping immunity in the cervicovaginal tract. Cervicovaginal fluid contains cytokines, chemokines, immunoglobulins, and other immune mediators. Many studies have shown that the concentrations of these immune mediators change throughout the menstrual cycle, but the studies have often shown inconsistent results. Our understanding of immunological correlates of the menstrual cycle remains limited and could be improved by meta-analysis of the available evidence. METHODS: We performed a systematic review and meta-analysis of cervicovaginal immune mediator concentrations throughout the menstrual cycle using individual participant data. Study eligibility included strict definitions of the cycle phase (by progesterone or days since the last menstrual period) and no use of hormonal contraception or intrauterine devices. We performed random-effects meta-analyses using inverse-variance pooling to estimate concentration differences between the follicular and luteal phases. In addition, we performed a new laboratory study, measuring select immune mediators in cervicovaginal lavage samples. RESULTS: We screened 1570 abstracts and identified 71 eligible studies. We analyzed data from 31 studies, encompassing 39,589 concentration measurements of 77 immune mediators made on 2112 samples from 871 participants. Meta-analyses were performed on 53 immune mediators. Antibodies, CC-type chemokines, MMPs, IL-6, IL-16, IL-1RA, G-CSF, GNLY, and ICAM1 were lower in the luteal phase than the follicular phase. Only IL-1α, HBD-2, and HBD-3 were elevated in the luteal phase. There was minimal change between the phases for CXCL8, 9, and 10, interferons, TNF, SLPI, elafin, lysozyme, lactoferrin, and interleukins 1ß, 2, 10, 12, 13, and 17A. The GRADE strength of evidence was moderate to high for all immune mediators listed here. CONCLUSIONS: Despite the variability of cervicovaginal immune mediator measurements, our meta-analyses show clear and consistent changes during the menstrual cycle. Many immune mediators were lower in the luteal phase, including chemokines, antibodies, matrix metalloproteinases, and several interleukins. Only interleukin-1α and beta-defensins were higher in the luteal phase. These cyclical differences may have consequences for immunity, susceptibility to infection, and fertility. Our study emphasizes the need to control for the effect of the menstrual cycle on immune mediators in future studies.

Menstrual health interventions, schooling, and mental health problems among Ugandan students (MENISCUS): study protocol for a school-based cluster-randomised trial.

BACKGROUND: Menstrual health is an increasingly recognised public health issue, defined as complete physical, mental, and social well-being in relation to the menstrual cycle. The MENISCUS trial aims to assess whether a multi-component intervention addressing physical and emotional aspects of menstrual health improves educational attainment, mental health problems, menstrual management, self-efficacy, and quality of life among girls in secondary school in Uganda. METHODS: The study is a parallel-arm cluster-randomised controlled trial with 60 schools (clusters) in Wakiso and Kalungu districts, with a mixed-methods process evaluation to assess intervention fidelity and acceptability and economic and policy analyses. The schools will be randomised 1:1 to immediate intervention or to optimised usual care with delayed intervention delivery. The intervention includes creation of a Menstrual Health Action Group at schools and NGO-led training of trainers on puberty education, development of a drama skit, delivery of a menstrual health kit including reusable pads and menstrual cups, access to pain management strategies including analgesics, and basic improvements to school water, sanitation, and hygiene facilities. Baseline data will be collected from secondary 2 students in 2022 (median age ~15.5 years), with endline after 1 year of intervention delivery (~3600 females and a random sample of ~900 males). The primary outcomes assessed in girls are (i) examination performance based on the Mathematics, English, and Biology curriculum taught during the intervention delivery (independently assessed by the Uganda National Examinations Board) and (ii) mental health problems using the Total Difficulties Scale of the Strengths and Difficulties 25-item questionnaire. Secondary outcomes are menstrual knowledge and attitudes in girls and boys and, in girls only, menstrual practices, self-efficacy in managing menstruation, quality of life and happiness, prevalence of urogenital infections, school and class attendance using a self-completed menstrual daily diary, and confidence in maths and science. DISCUSSION: The trial is innovative in evaluating a multi-component school-based menstrual health intervention addressing both physical and emotional aspects of menstrual health and using a "training of trainers" model designed to be sustainable within schools. If found to be cost-effective and acceptable, the intervention will have the potential for national and regional scale-up. TRIAL REGISTRATION: ISRCTN 45461276 . Registered on 16 September 2021.

Integration of a menstrual health intervention in a community-based sexual and reproductive health service for young people in Zimbabwe: a qualitative acceptability study.

BACKGROUND: Despite being fundamental to the health and well-being of women, menstrual health is often overlooked as a health priority and access to menstrual health education, products, and support is limited. Consequently, many young women are unprepared for menarche and face challenges in accessing menstrual health products and support and in managing menstruation in a healthy and dignified way. In this paper, we examine the acceptability of a comprehensive menstrual health and hygiene (MHH) intervention integrated within a community-based sexual and reproductive health (SRH) service for young people aged 16-24 years in Zimbabwe called CHIEDZA. METHODS: We conducted focus group discussions, that included participatory drawings, with CHIEDZA healthcare service providers (N = 3) and with young women who had attended CHIEDZA (N = 6) between June to August 2020. Translated transcripts were read for familiarisation and thematic analysis was used to explore acceptability. We applied Sekhon's thematic framework of acceptability that looks at seven key constructs (affective attitudes, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy). Data from FGDs and meeting minutes taken during the study time period were used to triangulate a comprehensive understanding of MHH intervention acceptability. RESULTS: The MHH intervention was acceptable to participants as it addressed the severe prevailing lack of access to menstrual health education, products, and support in the communities, and facilitated access to other SRH services on site. In addition to the constructs defined by Sekhon's thematic framework, acceptability was also informed by external contextual factors such as sociocultural norms and the economic environment. Providers highlighted the increased burden in their workload due to demand for MHH products, and how sociocultural beliefs around insertable menstrual products compromising virginity can negatively affect acceptability among young people and community members. CONCLUSIONS: MHH interventions are acceptable to young women in community-based settings in Zimbabwe as there is great unmet need for comprehensive MHH support. The integration of MHH in SRH services can serve as a facilitator to female engagement with SRH services. However, it is important to note that contextual external factors can affect the implementation and acceptability of integrated SRH and MHH services within communities. TRIAL REGISTRATION: Registry: Clinicaltrials.gov, Registration Number: NCT03719521 , Registration Date: October 25, 2018.

Oral, genital and anal human papillomavirus infections among female sex workers in Ibadan, Nigeria.

BACKGROUND: There are limited data on the epidemiology of HPV in different anatomical sites of female sex workers (FSW). We investigated the prevalence and concordance of cervical, vulval, oral and anal HPV among FSW in Ibadan, Nigeria. METHODS: FSWs aged 18-45 years were enrolled in a cross-sectional survey. After interview and clinical examination, samples were collected from mouth, cervix, vulva and anus. HPV genotyping was done with Anyplex II 28HPV assay. Multivariable analyses were performed to explore associated risk factors and concordance of HPV infections across sites. RESULTS: In total, 315 FSWs participated in the study with a mean age of 30-6.5 years. The prevalence of any HPV infection was 88% in the vulva, 84% in the cervix, 75% in the anus and 24% in the oral cavity. HPV 35 was the most prevalent and concordant high-risk type in the four sites. The risk factors for HPV infection by anatomic site varied. CONCLUSION: This large study showed a high prevalence and concordance of HPV infections of cervical, vulval, oral and anal HPV among FSWs in Nigeria. The potential to acquire and transmit HPV is high in this population, and we highlighted the urgency to protect young women through HPV vaccination.

"It was difficult to offer same day results": evaluation of community-based point-of-care testing for sexually transmitted infections among youth using the GeneXpert platform in Zimbabwe.

BACKGROUND: Point-of-care testing for sexually transmitted infections (STIs) may improve diagnosis and treatment of STIs in low- and middle-income counties. We explored the facilitators and barriers to point-of-care testing for Chlamydia trachomatis (CT) and Neisseria gonorrhoea (NG) for youth in community-based settings in Zimbabwe. METHODS: This study was nested within a cluster randomised trial of community-based delivery of integrated HIV and sexual and reproductive health services for youth aged 16 to 24 years. On-site CT/NG testing on urine samples using the Xpert® CT/NG test was piloted in four intervention clusters, with testing performed by service providers. On-site testing was defined as sample processing on the same day and site as sample collection. Outcomes included proportion of tests processed on-site, time between sample collection and collection of results, and proportion of clients receiving treatment. In-depth interviews were conducted with nine service providers and three staff members providing study co-ordination or laboratory support to explore facilitators and barriers to providing on-site CT/NG testing. RESULTS: Of 847 Xpert tests, 296 (35.0%) were performed on-site. Of these, 61 (20.6%) were positive for CT/NG; one (1.6%) received same day aetiological treatment; 33 (54.1%) presented later for treatment; and 5 (8.2%) were treated as a part of syndromic management. There was no difference in the proportion of clients who were treated whether their sample was processed on or off-site (64% (39/61) vs 60% (66/110); p = 0.61). The median (IQR) number of days between sample collection and collection of positive results was 14 (7-35) and 14 (7-52.5) for samples processed on and off-site, respectively, The interviews revealed four themes related to the provision of on-site testing associated with the i) diagnostic device ii) environment, iii) provider, and iv) clients. Some of the specific barriers identified included insufficient testing capacity, inadequate space, as well as reluctance of clients to wait for their results. CONCLUSIONS: In addition to research to optimise the implementation of point-of-care tests for STIs in resource-limited settings, the development of new platforms to reduce analytic time will be necessary to scale up STI testing and reduce the attrition between testing and treatment. TRIAL REGISTRATION: Registered in clinical trials.gov ( NCT03719521 ).

Effect of a combined household-level piped water and sanitation intervention on reported menstrual hygiene practices and symptoms of urogenital infections in rural Odisha, India.

Adequate menstrual hygiene management (MHM) requires access to water and sanitation and can be challenging for many women and girls living in resource-poor settings. Inadequate MHM has been associated with urogenital infections. The aim of this study is to assess the impact of a combined household-level piped water and sanitation intervention on MHM practices and urogenital infection symptoms (UGS) among women living in rural communities of Odisha (India). This study was nested within a pair-matched cohort study designed to assess impact of the Gram Vikas MANTRA program, which provided household-level piped water, bathing areas and latrine to all households in intervention villages, on diarrheal disease (primary outcome). The program did not specifically promote menstrual hygiene practices. Forty-five intervention villages were randomly selected from a list of those where implementation was previously completed at least five years before and matched to 45 control villages. Data for the main study was collected in four rounds from June 2015 to October 2016. For the MHM sub study, household surveys were administered in round four to randomly selected women aged 18 or older among study households from the 90 villages, to assess self-reported MHM practicesand urogenital infections symptoms. MHM practices were deemed adequate if they met some of the criteria developed on the basis of international monitoring that the GV program could modify (adequate frequency of absorbent change, washing the body with soap and privacy for managing menstruation). Multilevel mixed-effects logistic regression with a random effect distribution at the level of the pair and village was used to estimate the effect of the intervention on adequate MHM practices (primary outcome) and reported UGS (secondary outcome). A total of 1045 women (517 from intervention and 528 from control) were included in the study. Women who lived in the villages receiving the intervention, were more likely to report adequate MHM practices than those in control villages (Adjusted OR (AOR) 3.54, 95% Confidence Interval (CI): 1.86-6.78). 14.51% and 15.53% of women living in the control and intervention villages reported having at least one UGS. There was no evidence of an intervention effect on reported UGS (AOR = 0.97, 95%CI: 0.64-1.46). While household latrines or bathing areas with access to piped water improve the environment that enable MHM practices related to privacy, the provision of such facilities alone had only a moderate impact in adequate MHM and did not have an effect on self-reported UGS. More targeted inventions that include behavior change strategies and that address other barriers may be necessary to improve MHM practices.

Menstrual characteristics, menstrual anxiety and school attendance among adolescents in Uganda: a longitudinal study.

BACKGROUND: Qualitative data show negative impacts of menstruation on health and education in many settings, but there are few longitudinal quantitative studies of the impact of menstruation. We analyse associations with menstrual anxiety and school attendance in a study of Ugandan secondary school students. METHODS: Data were from a longitudinal pilot study of a menstrual health intervention (MENISCUS), conducted in two secondary schools in Entebbe sub-district, Uganda. Self-completed menstrual-related data, including menstrual anxiety, were collected from 232 participants pre- and post-intervention. A sub-cohort of 100 randomly-selected post-menarcheal girls were asked to self-complete daily diaries during 10 months of follow-up, with data on menstrual flow, pain, and school attendance. We used multivariable logistic regression to estimate associations with menstrual anxiety among all girls at baseline, and random-effects logistic regression to estimate associations of menstrual characteristics with school non-attendance for 3 months pre-intervention in the sub-cohort, adjusting for within-girl clustering. RESULTS: Overall, 130/222 (58.6%) of menstruating girls reported being anxious about their next period. Menstrual anxiety was higher in those not living with their mother (adjusted odds ratio (OR) = 1.91; 95% confidence interval (CI) 1.01-3.60), believing menstrual myths (aOR = 1.83; 0.95-3.50 for not agreeing that it is healthy for a girl to run, dance or cycle during her period; aOR = 1.97; 1.04-3.73 for agreeing that when a girl has her period she is unclean), lower menstrual confidence (aOR = 2.49; 1.33-4.65 for avoiding physical activity during her period; aOR = 1.68; 0.89-3.17 for not feeling comfortable to talk to other girls about her period; aOR = 2.89; 1.28-6.54 for agreeing that boys/girls tease them about their periods; and aOR = 2.27; 1.21-4.27 for worrying about being teased during her period). Those with lower knowledge about menstruation were less likely to report anxiety (aOR = 0.44; 0.23-0.84). During the pre-intervention period of the sub-cohort, school non-attendance was associated with menstrual pain, with 21.7% of girls missing school on days when they reported pain vs. 8.3% on days when no pain was reported (aOR = 3.82; 1.66-8.77). CONCLUSIONS: Menstruation causes substantial anxiety in Ugandan schoolgirls, and menstrual pain is associated with missing school on period-days. Menstrual health interventions should address socio-cultural aspects of menstruation to reduce anxiety, and provide education on pain management strategies to support school attendance.

Identifying youth at high risk for sexually transmitted infections in community-based settings using a risk prediction tool: a validation study.

BACKGROUND : Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the most common bacterial sexually transmitted infections (STIs) worldwide. In the absence of affordable point-of-care STI tests, WHO recommends STI testing based on risk factors. This study aimed to develop a prediction tool with a sensitivity of > 90% and efficiency (defined as the percentage of individuals that are eligible for diagnostic testing) of < 60%. METHODS: This study offered CT/NG testing as part of a cluster-randomised trial of community-based delivery of sexual and reproductive health services to youth aged 16-24 years in Zimbabwe. All individuals accepting STI testing completed an STI risk factor questionnaire. The outcome was positivity for either CT or NG. Backwards-stepwise logistic regression was performed with p ≥ 0.05 as criteria for exclusion. Coefficients of variables included in the final multivariable model were multiplied by 10 to generate weights for a STI risk prediction tool. A maximum likelihood Receiver Operating Characteristics (ROC) model was fitted, with the continuous variable score divided into 15 categories of equal size. Sensitivity, efficiency and number needed to screen were calculated for different cut-points. RESULTS: From 3 December 2019 to 5 February 2020, 1007 individuals opted for STI testing, of whom 1003 (99.6%) completed the questionnaire. CT/NG prevalence was 17.5% (95% CI 15.1, 19.8) (n = 175). CT/NG positivity was independently associated with being female, number of lifetime sexual partners, relationship status, HIV status, self-assessed STI risk and past or current pregnancy. The STI risk prediction score including those variables ranged from 2 to 46 with an area under the ROC curve of 0.72 (95% CI 0.68, 0.76). Two cut-points were chosen: (i) 23 for optimised sensitivity (75.9%) and specificity (59.3%) and (ii) 19 to maximise sensitivity (82.4%) while keeping efficiency at < 60% (59.4%). CONCLUSIONS: The high prevalence of STIs among youth, even in those with no or one reported risk factor, may preclude the use of risk prediction tools for selective STI testing. At a cut-point of 19 one in six young people with STIs would be missed.

Prevalence and genotype specific concordance of oro-genital and anal human papillomavirus infections among sexually active Nigerian women.

BACKGROUND: Human papillomavirus (HPV) associated cancers are increasingly reported globally, including in sub-Saharan Africa (SSA). However, with the exception of cervical HPV infection, data from SSA on the epidemiology of oral and genital HPV infections are limited. This study assessed the prevalence and concordance of oro-genital and anal HPV genotype specific infections among women in the general population. METHODS: We conducted a cross-sectional study in sexually active women aged 18-45 years in Ibadan, Nigeria. After a face-to-face interview and clinical examination, oral, cervical, vulvar, and anal samples were collected from participants and tested by the Anyplex II 28 HPV assay. Descriptive and multivariable analyses were used to report prevalence and risk factors associated with HPV infections. RESULTS: The prevalence of any vulva, cervical, anal, and oral HPV infections was 68.0% (210/309), 59.7% (182/305), 56.8% (172/303), and 16.1% (14/286), respectively. There was an inverse relationship between age-group and HPV prevalence of HPV in all anatomic sites except for the oral HPV infections. HPV 35 was the most prevalent high-risk HPV genotype in the vulva, cervix and oral cavity. Associated risk factors for HPV infection in each of the anatomic sites were reported. Overall, 10.0% (31/310) women had concordance of any HPV type in the four anatomic sites. CONCLUSION: There was a high prevalence of oro-genital and anal HPV infections among sexually active Nigerian women, with concordance of HPV types in the cervix, vulva, anus and oral cavity. We advocate large longitudinal studies that will involve sampling of multiple anatomic sites and inclusion of other women in the community for better understanding of HPV epidemiology in this region.