Search

Abstract Background There is growing global concern about poor mental health among adolescents in sub-Saharan Africa. In particular, adolescent girls face multiple challenges in managing menstruation which can impact both their health and wellbeing. In this study we address an evidence gap on the association of a broad range of menstrual-related factors with mental health problems amongst secondary school female adolescents in Uganda. Methods We used baseline data from a cluster-randomised menstrual health intervention trial conducted in 60 secondary schools in two districts in Uganda. Baseline data were collected between March and July 2022, including socio-demographic characteristics, menstrual knowledge and attitudes, menstrual practices and self-efficacy, and mental health problems measured using the Strengths and Difficulties Questionnaire Total Difficulties score (SDQ-25). We used random-effects linear regression to estimate the adjusted mean difference (aMD) for the association between mental health problems (SDQ Total Difficulties Score) and menstrual-related factors, including the Menstrual Practice Needs Scale (MPNS) and the Self-Efficacy in Addressing Menstrual Needs scale (SAMNS)), accounting for school-level clustering and adjusting for prior confounders. Results Among the 3841 female participants, there was strong and consistent evidence of associations between mental health problems and menstrual-related factors. Mental health problems were associated with poor knowledge about menstruation (aMD = 1.17, 95%CI 0.50, 1.84

Abstract Violence, poor mental health, and harmful substance use are commonly experienced by female sex workers (FSWs) in sub-Saharan Africa, all of which are associated with increased HIV susceptibility. We aimed to investigate the associations between violence, poor mental health and harmful alcohol/substance use with hair cortisol concentration (HCC) levels as a potential biological pathway linking the experiences of these stressors and HIV vulnerability. We used the baseline data of the Maisha Fiti study of FSWs in Nairobi, Kenya. Participants reported recent violence, poor mental health, and harmful alcohol/substance use. Hair samples proximal to the scalp were collected to measure cortisol levels determined by ELISA. We analysed the data of 425 HIV-negative respondents who provided at least 2 cm of hair sample. The prevalence of recent violence was 89.3% (physical 54.6%; sexual 49.4%; emotional 77.0% and financial 66.5%), and 29.1% had been arrested due to sex work. 23.7% of participants reported moderate/severe depression, 11.6% moderate/severe anxiety, 13.5% PTSD and 10.8% recent suicidal thoughts and/or attempts. About half of the participants (48.8%) reported recent harmful alcohol and/or other substance use. In multivariable linear regression analyses, both physical and/or sexual violence (adjusted geometric mean ratio (aGMR) = 1.28; 95% CI 1.01–1.62) and harmful alcohol and/or other substance use (aGMR = 1.31; 95% CI 1.03–1.65) were positively and independently associated with increased HCC levels. Findings suggest a role of violence and substance use in elevated HCC levels, which could increase HIV risk due to cortisol-related T cell activation. However, longitudinal and mechanistic studies are needed to confirm this hypothesis.

Abstract Background Although depression is the leading cause of disability worldwide, treatment coverage for the condition is inadequate. Supply-side barriers (e.g. shortage of specialist mental health professionals) and demand-side barriers (e.g. lack of awareness about depression) lead to limited availability of evidence-based interventions, poor demand for care, and low levels of adherence to care. The aim of our study is to examine if the addition of a community intervention delivered by community volunteers enhances the population-level impact of an evidence based psychosocial intervention (Healthy Activity Program [HAP]) in routine primary care by increasing demand for HAP and improving HAP adherence and effectiveness. Methods A hybrid type 2 effectiveness implementation cluster randomised controlled trial will be implemented in the state of Goa, India. Twenty-eight clusters of villages and their associated public sector health centres will be randomly allocated through restricted randomisation. Clusters will be randomly allocated to the ‘Community Model’ or ‘Facility Model’ arms. All clusters will offer the HAP and clusters in the ‘Community Model’ arm will additionally receive activities delivered by community volunteers (“Sangathis”) to increase awareness about depression and support demand for and adherence to HAP. The primary outcomes are Contact Coverage (Patient Health Questionnaire [PHQ-9] score > 4 as a proportion of those screened) and Effectiveness Coverage (mean PHQ-9 score amongst those who score ≥ 15 at baseline, i.e. those who have moderately severe to severe depression) at 3 months post-recruitment. Additional outcomes at 3 and 6 months will assess sustained effectiveness, remission, response to treatment, depression awareness, social support, treatment completion, and activation levels. Economic and disability outcomes will be assessed to estimate incremental cost-effectiveness ratios. Implementation will be evaluated through process data and qualitative data informed by the RE-AIM framework. A minimum of 79488 primary care attenders will be screened for the Contact Coverage outcome, and 588 individuals with PHQ-9 ≥ 15 will be recruited for the Effectiveness Coverage outcome. Discussion If effective, our community intervention will have relevance to India’s Ayushman Bharat universal healthcare programme which is scaling up care for depression in primary care, and also to other low- and middle- income countries. Trial registration Registered on ClincalTrials.gov ( NCT05890222 .) on 12/05/2023.

Background There is a lack of empirical data on design effects (DEFF) for mortality rate for highly clustered data such as with Ebola virus disease (EVD), along with a lack of documentation of methodological limitations and operational utility of mortality estimated from cluster-sampled studies when the DEFF is high. Objectives The objectives of this paper are to report EVD mortality rate and DEFF estimates, and discuss the methodological limitations of cluster surveys when data are highly clustered such as during an EVD outbreak. Methods We analysed the outputs of two independent population-based surveys conducted at the end of the 2014–2016 EVD outbreak in Bo District, Sierra Leone, in urban and rural areas. In each area, 35 clusters of 14 households were selected with probability proportional to population size. We collected information on morbidity, mortality and changes in household composition during the recall period (May 2014 to April 2015). Rates were calculated for all-cause, all-age, under-5 and EVD-specific mortality, respectively, by areas and overall. Crude and adjusted mortality rates were estimated using Poisson regression, accounting for the surveys sample weights and the clustered design. Results Overall 980 households and 6,522 individuals participated in both surveys. A total of 64 deaths were reported, of which 20 were attributed to EVD. The crude and EVD-specific mortality rates were 0.35/10,000 person-days (95%CI: 0.23–0.52) and 0.12/10,000 person-days (95%CI: 0.05–0.32), respectively. The DEFF for EVD mortality was 5.53, and for non-EVD mortality, it was 1.53. DEFF for EVD-specific mortality was 6.18 in the rural area and 0.58 in the urban area. DEFF for non-EVD-specific mortality was 1.87 in the rural area and 0.44 in the urban area. Conclusion Our findings demonstrate a high degree of clustering; this contributed to imprecise mortality estimates, which have limited utility when assessing the impact of disease. We provide DEFF estimates that can inform future cluster surveys and discuss design improvements to mitigate the limitations of surveys for highly clustered data.

Abstract Background We sought to determine whether the Good School Toolkit-Primary violence prevention intervention was associated with reduced victimisation and perpetration of peer and intimate partner violence four years later, and if any associations were moderated by sex and early adolescent: family connectedness, socio-economic status, and experience of violence outside of school. Methods Drawing on schools involved in a randomised controlled trial of the intervention, we used a quasi-experimental design to compare violence outcomes between those who received the intervention during our trial (n = 1388), and those who did not receive the intervention during or after the trial (n = 522). Data were collected in 2014 (mean age 13.4, SD 1.5 years) from participants in 42 schools in Luwero District, Uganda, and 2018/19 from the same participants both in and out of school (mean age 18, SD: 1.77 years). We compared children who received the Good School Toolkit-Primary, a whole school violence prevention intervention, during a randomised controlled trial, to those who did not receive the intervention during or after the trial. Outcomes were measured using items adapted from the International Society for the Prevention of Child Abuse and Neglect Child Abuse Screening Tool-Child Institutional. We used mixed-effect multivariable logistic regression, with school fitted as a random-effect to account for clustering. Results 1910 adolescents aged about 16–19 years old were included in our analysis. We found no evidence of an average long-term intervention effect on our primary outcome, peer violence victimization at follow-up (aOR = 0.81, 95%CI = 0.59–1.11); or for any secondary outcome. However, exposure to the intervention was associated with: later reductions in peer violence, for adolescents with high family connectedness (aOR = 0.70, 95% CI 0.49 to 0.99), but not for those with low family connectedness (aOR = 1.07, 95% CI 0.69 to 1.6; p-interaction = 0.06); and reduced later intimate partner violence perpetration among males with high socio-economic status (aOR = 0.32, 95%CI 0.11 to 0.90), but not low socio-economic status (aOR = 1.01 95%CI 0.37 to 2.76, p-interaction = 0.05). Conclusions Young adolescents in connected families and with higher socio-economic status may be better equipped to transfer violence prevention skills from primary school to new relationships as they get older. Trial registration Clinicaltrials.gov, NCT01678846, registration date 24 August 2012. Protocol for this paper: https://www.researchprotocols.org/2020/12/e20940 .

Abstract 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

Abstract Background The war in South Sudan has displaced more than four million people, with Uganda hosting the largest number of South Sudanese refugees. Research in Uganda has shown elevated levels of alcohol misuse and psychological distress among these refugees. The World Health Organization (WHO) has developed a trans-diagnostic scalable psychological intervention called Problem Management Plus (PM +) to reduce psychological distress among populations exposed to adversities. Our study aims to evaluate the effectiveness and cost-effectiveness of the CHANGE intervention, which builds on PM + , to also address alcohol misuse through problem-solving therapy and selected behavioural strategies for dealing with alcohol use disorders. We hypothesise that the CHANGE intervention together with enhanced usual care (EUC) will be superior to EUC alone in increasing the percentage of days abstinent. Methods A parallel-arm individually randomised controlled trial will be conducted in the Rhino Camp and Imvepi settlements in Uganda. Five hundred adult male South Sudanese refugees with (i) elevated levels of alcohol use (between 8 and 20 on the Alcohol Use Disorder Identification Test [AUDIT]); and (ii) psychological distress (> 16 on the Kessler Psychological Distress Scale) will be randomly assigned 1:1 to EUC or CHANGE and EUC. CHANGE will be delivered by lay healthcare providers over 6 weeks. Outcomes will be assessed at 3 and 12 months post-randomisation. The primary outcome is the percentage of days abstinent, measured by the timeline follow-back measure at 3 months. Secondary outcomes include percentage of days abstinent at 12 months and alcohol misuse (measured by the AUDIT), psychological distress (i.e. depression, anxiety, posttraumatic stress disorder), functional disability, perpetration of intimate partner violence, and health economic indicators at 3 and 12 months. A mixed-methods process evaluation will investigate competency, dose, fidelity, feasibility, and acceptability. Primary analyses will be intention-to-treat. Discussion CHANGE aims to address alcohol misuse and psychological distress with male refugees in a humanitarian setting. If it is proven to be effective, it can help fill an important under-researched gap in humanitarian service delivery. Trial registration ISRCTN ISRCTN10360385. Registered on 30 January 2023.

Abstract 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

Abstract Background Children who initiate antiretroviral therapy (ART) before age 5 years can recover height and weight compared to uninfected peers, but growth outcomes are unknown for children initiating ART at older ages. We investigated factors associated with growth failure at ART initiation and modelled growth by age on ART. Methods We conducted secondary analysis of cohort of children aged 6–15 years late-diagnosed with HIV in Harare, Zimbabwe, with entry at ART initiation in 2013–2015. Factors associated with height-for-age (HAZ), weight-for-age (WAZ) and BMI-for-age (BAZ) z-scores

Abstract Background It is not known whether post-traumatic stress disorder (PTSD) increases HIV-risk behaviours among young people in sub-Saharan Africa. We assessed associations of PTSD symptoms with sexual behaviour, HIV risk perception, and attitudes towards PrEP among young people taking part in the CHAPS community survey. We hypothesised that PTSD symptoms would increase sexual behaviours associated with HIV risk, hinder PrEP uptake and influence preference for daily versus on-demand PrEP. Methods Young people without HIV, aged 13–24 years, were purposively recruited in Johannesburg and Cape Town in South Africa, Wakiso in Uganda, and Chitungwiza in Zimbabwe, and surveyed on socio-demographic characteristics, PrEP knowledge and attitudes, sexual behaviour, HIV perception and salience, and mental health. PTSD symptoms were measured using the Primary Care PTSD Screen for the Diagnostic and Statistical Manual of Mental Disorders 5 (PC-PTSD-5). Logistic and ordinal logistic regression was used to assess associations between PC-PTSD-5 score and socio-demographic characteristics, sexual behaviour, HIV risk perception, PrEP attitudes, and substance use, adjusting for age, sex, setting, depression and anxiety. Results Of 1330 young people (51% male, median age 19 years), 522 (39%) reported at least one PTSD symptom. There was strong evidence that having a higher PC-PTSD-5 score was associated with reported forced sex (OR 3.18, 95%CI: 2.05–4.93), self-perception as a person who takes risks (OR 1.12, 95%CI: 1.04–1.20), and increased frequency of thinking about risk of HIV acquisition (OR 1.16, 95%CI: 1.08–1.25). PTSD symptoms were not associated with willingness to take PrEP, preference for on-demand versus daily PrEP, or actual HIV risk behaviour such as condomless sex. Conclusions Symptoms consistent with probable PTSD were common among young people in South Africa, Uganda and Zimbabwe but did not impact PrEP attitudes or PrEP preferences. Evaluation for PTSD might form part of a general assessment in sexual and reproductive health services in these countries. More work is needed to understand the impact of PTSD on HIV-risk behaviour, forced sex and response to preventive strategies including PrEP.

Abstract 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.

Abstract Background Female sex workers (FSWs) are at high risk of mental health problems and suicide risk. Few longitudinal studies have examined risk factors for poor mental health among FSWs. Methods Maisha Fiti is a longitudinal study among FSWs randomly selected from Sex Worker Outreach Programme clinics across Nairobi. Behavioural-biological survey data were collected at baseline (n = 1003, June–December 2019), midline (n = 366) (Jan–March 2020) and endline (n = 877) (June 2020–Jan 2021). Women reporting mental health problems were offered counselling services. Multivariable mixed logistic regression models were used to examine factors associated with mental health problems and suicidal behaviours. Results There was a decline in the proportion of women reporting any mental health problem (depression and/or anxiety and/or PTSD) (baseline: 29.9%, midline: 13.3%, endline: 11.8%). There was strong evidence that any mental health problem was associated with recent hunger (aOR 1.99; 95% CI 1.37–2.88) and recent violence from non-intimate partners (2.23; 95% CI 1.55–3.19). Recent suicidal behaviour prevalence was similar across survey rounds (baseline: 10.2%; midline: 10.2%; endline: 10.4%), and was associated with recent violence from non-intimate partners (aOR 1.96; 95% CI 1.31–2.95), recent hunger (aOR 1.69; 95% CI 1.15–2.47) and having an additional employment to sex work (aOR 1.50; 95% CI 1.00–2.23). Conclusions Our study found a decline in mental health problems but high levels of persistent suicidal behaviours among FSWs. Syndemic risk factors including food insecurity and violence were longitudinally associated with mental health problems and recent suicidal behaviours. There is a need for accessible mental health services for FSWs, alongside structural interventions addressing poverty and violence.

We evaluated a digital learning programme for non-specialists to develop knowledge-based competencies in a problem-solving intervention for adolescents to examine the overall impact of training on knowledge-based competencies among learners; and to compare the effects of two training conditions (self-guided digital training with or without coaching) in a nested parallel, two-arm, individually randomised controlled trial. Eligible participants were 18 or older; fluent in Hindi or English; able to access digital training; and had no prior experience of delivering structured psychotherapies. 277 participants were enrolled from 31 March 2022 to 19 June 2022 of which 230 (83%) completed the study. There was a significant increase in competency score from pre-training (Mean = 7.01, SD = 3.29) to post-training (Mean = 8.88, SD = 3.80), 6 weeks after the pre-training assessment. Knowledge competency scores showed larger increase among participants randomised to the coaching arm (AMD = 1.09, 95% CI 0.26–1.92, p = 0.01) with an effect size (d) of 0.33 (95% CI 0.08–0.58). More participants completed training in the coaching arm (n = 96, 69.6%) compared to the self-guided training arm (n = 56, 40.3%). In conclusion, a coach-supported remote digital training intervention is associated with enhanced participation by learners and increased psychotherapeutic knowledge competencies.

We evaluated the effectiveness of community-based rehabilitation (CBR) in reducing depressive symptoms, alcohol use disorder, food insecurity and underweight in people with schizophrenia. This cluster-randomised controlled trial was conducted in a rural district of Ethiopia. Fifty-four sub-districts were allocated in a 1:1 ratio to the facility-based care [FBC] plus CBR arm and the FBC alone arm. Lay workers delivered CBR over 12 months. We assessed food insecurity (self-reported hunger), underweight (BMI< 18.5 kg/m2), depressive symptoms (PHQ-9) and alcohol use disorder (AUDIT ≥ 8) at 6 and 12 months. Seventy-nine participants with schizophrenia in 24 sub-districts were assigned to CBR plus FBC and 87 participants in 24 sub-districts were assigned to FBC only. There was no evidence of an intervention effect on food insecurity (aOR 0.52, 95% CI 0.16–1.67; p = 0.27), underweight (aOR 0.44, 95% CI 0.17–1.12; p = 0.08), alcohol use disorder (aOR 0.82, 95% CI 0.24–2.74; p = 0.74) or depressive symptoms (adjusted mean difference − 0.06, 95% CI −1.35, 1.22; p = 0.92). Psychosocial interventions in low-resource settings should support access to treatment amongst people with schizophrenia, and further research should explore how impacts on economic, physical and mental health outcomes can be achieved.

Abstract Background Mothers with perinatal depression can show different symptom trajectories and may spontaneously remit from depression, however, the latter is poorly understood. This is the first study which sought to investigate predictors of spontaneous remission and longer-term recovery among untreated women with perinatal depression. Methods We analysed data from two randomised controlled trials in women with perinatal depression in India and Pakistan. Analyses were restricted to women in the control groups who did not receive active treatment. Generalised estimating equations and logistic regressions were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs), adjusting for within-person correlation. Results In multivariable analyses, remission was associated with a husband who is not working (adjusted OR, aOR = 2.04, 95% CI 1.02–4.11), lower Patient Health Questionnaire-9 score at baseline (aOR = 0.43, 95% CI 0.20–0.90 for score of ≥20 vs. 10–14) and better social support at baseline (aOR = 2.37, 95% CI 1.32–4.27 for high vs. low social support). Conclusions Women with low baseline severity may remit from perinatal depression with adequate social support from family and friends. These factors are important contributors to the management of perinatal depression and the prevention of clinical worsening, and should be considered when designing low-threshold psychological interventions.

Background ‘POD Adventures’ is a gamified problem-solving intervention delivered via smartphone app, and supported by non-specialist counsellors for a target population of secondary school students in India during the COVID-19 pandemic. Aims To evaluate the feasibility and acceptability of undertaking a randomised controlled trial of POD Adventures when delivered online with telephone support from counsellors. Method We conducted a parallel, two-arm, individually randomised pilot-controlled trial with 11 secondary schools in Goa, India. Participants received either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes were assessed at two timepoints: baseline and 6 weeks post-randomisation. Results Seventy-nine classroom sensitisation sessions reaching a total of 1575 students were conducted. Ninety-two self-initiated study referrals (5.8%) were received, but only 11 participants enrolled in the study. No intervention arm participants completed the intervention. Outcomes at 6 weeks were not available for intervention arm participants (n = 5), and only four control arm participants completed outcomes. No qualitative interviews or participant satisfaction measures were completed because participants could not be reached by the study team. Conclusions Despite modifications to address barriers arising from COVID-19 restrictions, online delivery was not feasible in the study context. Low recruitment and missing feasibility and acceptability data make it difficult to draw conclusions about intervention engagement and indicative clinical outcomes. Prior findings showing high uptake, adherence and engagement with POD Adventures when delivered in a school-based context suggest that an online study and delivery posed the biggest barriers to study participation and engagement.

Abstract 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.

Abstract 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

Abstract Background Adverse childhood experiences (ACEs), poverty, violence and harmful alcohol/substance use are associated with poor mental health outcomes, but few studies have examined these risks among Female Sex Workers (FSWs). We examine the prevalence and correlates of common mental health problems including suicidal thoughts and behaviours among FSWs in Kenya. Methods Maisha Fiti is a longitudinal study among FSWs randomly selected from Sex Worker Outreach Programme (SWOP) clinics across Nairobi. Baseline behavioural-biological survey (n = 1003) data were collected June–December 2019. Mental health problems were assessed using the Patient Health Questionnaire (PHQ-9) for depression, the Generalised Anxiety Disorder tool (GAD-7) for anxiety, the Harvard Trauma Questionnaire (HTQ-17) for Post-Traumatic Stress Disorder (PTSD) and a two-item tool to measure recent suicidal thoughts/behaviours. Other measurement tools included the WHO Adverse Childhood Experiences (ACE) score, WHO Violence Against Women questionnaire, and the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). Descriptive statistics and multivariable logistic regression were conducted using a hierarchical modelling approach. Results Of 1039 eligible FSWs, 1003 FSWs participated in the study (response rate: 96%) with mean age 33.7 years. The prevalence of moderate/severe depression was 23.2%, moderate/severe anxiety 11.0%, PTSD 14.0% and recent suicidal thoughts/behaviours 10.2% (2.6% suicide attempt, 10.0% suicidal thoughts). Depression, anxiety, PTSD and recent suicidal thoughts/behaviours were all independently associated with higher ACE scores, recent hunger (missed a meal in last week due to financial difficulties), recent sexual/physical violence and increased harmful alcohol/substance. PTSD was additionally associated with increased chlamydia prevalence and recent suicidal thoughts/behaviours with low education and low socio-economic status. Mental health problems were less prevalent among women reporting social support. Conclusions The high burden of mental health problems indicates a need for accessible services tailored for FSWs alongside structural interventions addressing poverty, harmful alcohol/substance use and violence. Given the high rates of ACEs, early childhood and family interventions should be considered to prevent poor mental health outcomes.

Background There is evidence of an association between life events and psychosis in Europe, North America and Australasia, but few studies have examined this association in the rest of the world. Aims To test the association between exposure to life events and psychosis in catchment areas in India, Nigeria, and Trinidad and Tobago. Method We conducted a population-based, matched case–control study of 194 participants in India, Nigeria, and Trinidad and Tobago. Cases were recruited through comprehensive population-based, case-finding strategies. The Harvard Trauma Questionnaire was used to measure life events. The Screening Schedule for Psychosis was used to screen for psychotic symptoms. The association between psychosis and having experienced life events (experienced or witnessed) was estimated by conditional logistic regression. Results There was no overall evidence of an association between psychosis and having experienced or witnessed life events (adjusted odds ratio 1.19, 95% CI 0.62–2.28). We found evidence of effect modification by site (P = 0.002), with stronger evidence of an association in India (adjusted odds ratio 1.56, 95% CI 1.03–2.34), inconclusive evidence in Nigeria (adjusted odds ratio 1.17, 95% CI 0.95–1.45) and evidence of an inverse association in Trinidad and Tobago (adjusted odds ratio 0.66, 95% CI 0.44–0.97). Conclusions This study found no overall evidence of an association between witnessing or experiencing life events and psychotic disorder across three culturally and economically diverse countries. There was preliminary evidence that the association varies between settings.

Abstract Background An estimated 8–30 % of people living with HIV (PLWH) have depressive disorders (DD) in sub-Saharan Africa. Of these, the majority are untreated in most of HIV care services. There is evidence from low- and middle- income countries of the effectiveness of both psychological treatments and antidepressant medication for the treatment of DD among PLWH, but no evidence on how these can be integrated into routine HIV care. This protocol describes a cluster-randomised trial to evaluate the effectiveness and cost-effectiveness of the HIV + D model for the integration of a collaborative stepped care intervention for DD into routine HIV care, which we have developed and piloted in Uganda. Methods Forty public health care facilities that provide HIV care in Kalungu, Masaka and Wakiso Districts will be randomly selected to participate in the trial. Each facility will recruit 10–30 eligible PLWH with DD and the total sample size will be 1200. The clusters will be randomised 1:1 to receive Enhanced Usual Care alone (EUC, i.e. HIV clinicians trained in Mental Health Gap Action Programme including guidelines on when and where to refer patients for psychiatric care) or EUC plus HIV + D (psychoeducation, Behavioural Activation, antidepressant medication and referral to a supervising mental health worker, delivered in a collaborative care stepwise approach). Eligibility criteria are PLWH attending the clinic, aged ≥ 18 years who screen positive on a depression screening questionnaire (Patient Health Questionnaire, PHQ-9 ≥ 10). The primary outcome is the mean depressive disorder symptom severity scores (assessed using the PHQ-9) at 3 months’ post-randomisation, with secondary mental health, disability, HIV and economic outcomes measured at 3 and 12 months. The cost-effectiveness of EUC with HIV + D will be assessed from both the health system and the societal perspectives by collecting health system, patient and productivity costs and mean DD severity scores at 3 months, additional to health and non-health related quality of life measures (EQ-5D-5 L and OxCAP-MH). Discussion The study findings will inform policy makers and practitioners on the cost-effectiveness of a stepped care approach to integrate depression management in routine care for PLWH in low-resource settings. Trial registration: ISRCTN, ISRCTN86760765. Registered 07 September 2017, https://doi.org/10.1186/ISRCTN86760765 .

In order to respond more effectively to the health of young people in South Africa, in 2017 the National Department of Health of South Africa released the National Adolescent and Youth Health Policy. The Policy focused on a range of health problems and recommended interventions for delivery through multiple settings and government departments. It also included specific recommendations to empower and involve young people in policy and programme implementation. Adaptation of a short course on adolescent health in lowand middle-income countries, organized annually by the London School of Hygiene and Tropical Medicine and the World Health Organization, was piloted in 2017 as one means of contributing to the implementation of the Policy. The Adolescent and Youth Health Policy short course was subsequently offered in 2018 and 2019, attracting 96 participants working on adolescent health in various organizations at national and provincial levels throughout the country. Most participants (75%) successfully completed the course, as assessed by the completion criteria that had been defined. The range of topics for the assignments selected by the participants over the 3 years reflected both the content and intent of the Policy. The evaluations of the short course indicate that it helped to create legitimacy and strengthen the capacity of various constituencies, both of which are important prerequisites for policy implementation.

Abstract Introduction Index-linked HIV testing, targeted at sexual contacts or children of individuals with HIV, may improve yield and efficiency. The B-GAP study evaluated index-linked testing approaches in health facility and community-based settings. This paper reports on a qualitative study to understand factors that affect uptake of index-linked HIV testing for children and adolescents. Methods We conducted four focus group discussions (FGDs) with caregivers who had their children tested through B-GAP and one FGD with providers who offered index-linked HIV testing to indexes. We aimed to understand enabling and inhibiting factors in the decision-making process. Translated and transcribed transcripts were read for familiarisation. Following initial coding, analytical memos were written to identify emerging key themes across the data. Results Our findings showed there was inadequate emphasis on paediatric HIV in routine care which had a negative impact on subsequent uptake of testing for children. Once the decision to test had been made, access to facilities was sometimes challenging and alleviated by community-based testing. A key finding was that HIV testing is not a discrete event but a process that was influenced by relationships with other family members and children themselves. These relationships raised complex issues that could prevent or delay the testing process. Conclusion There is a need to improve messaging on the importance of HIV testing for children and adolescents and to provide support to caregivers and their families in order to improve testing uptake. Addressing access barriers through the provision of community-based testing and implementing a family-centred approach can optimise index-linked testing.

Abstract Background Poor menstrual health and hygiene (MHH) is a globally recognised public health challenge. A pilot study of an MHH intervention was conducted in two secondary schools in Entebbe, Uganda, over 9 months. The intervention included five components delivered by the implementing partner (WoMena Uganda) and the research team: (i) training teachers to implement government guidelines for puberty education, (ii) a drama skit to reduce stigma about menstruation, (iii) training in use of a menstrual kit (including re-usable pads), (iv) guidance on pain relief methods including provision of analgesics and (v) improvements to school water, sanitation and hygiene (WASH) facilities. The aim of the process evaluation was to examine implementation, context and possible causal pathways. Methods We collected information on fidelity, dose, reach, acceptability, context and mechanisms of impact using (i) quantitative survey data collected from female and male students in year 2 of secondary school (ages 13–21; 450 at the baseline and 369 at endline); (ii) qualitative data from 40 in-depth interviews with parents, teachers and female students, and four focus group discussions with students, stratified by gender; (iii) data from unannounced visits checking on WASH facilities throughout the study; and (iv) routine data collected as part of the implementation. Quantitative data were used primarily to assess fidelity, dose and reach. Qualitative data were used primarily to assess acceptability, context and possible mechanisms. Results Both schools received all intervention elements that were delivered by the research team and implementing partner. The drama skit, menstrual kit and pain management intervention components were delivered with fidelity. Intervention components that relied on school ownership (puberty education training and WASH improvements) were not fully delivered. Overall, the intervention was acceptable to participants. Multilevel contextual factors including schools’ social and physical environment, and family, cultural and social factors influenced the acceptability of the intervention in the school setting. The intervention components reinforced one another, as suggested in our theoretical framework. Conclusion The intervention was feasible to deliver and acceptable to the schools and students. We propose a full-scale cluster-randomised trial to evaluate the intervention, adding a school-based MHH leadership group to address issues with school ownership. Trial registration ClinicalTrials.gov NCT04064736 . Registered August 22, 2019, retrospectively registered.

Abstract Background Violence exposure in adolescence is associated with a range of poor health and social outcomes, including both the perpetration and experience of violence in later intimate relationships. However, there is little longitudinal evidence on how both individual and contextual characteristics encourage or interrupt these associations. We designed the Contexts of Violence in Adolescence Cohort study (CoVAC) to provide evidence on these pathways for Ugandan adolescents, with the aim of providing information to improve the design of violence prevention interventions for adolescents and young adults. Methods CoVAC is a mixed-methods prospective cohort study with three parallel strands. Between 2014 and 2022, the study comprises three waves of quantitative survey data collection; qualitative data from five time points; and a series of workshops to facilitate direct use of emerging findings by intervention developers at Uganda-based NGO Raising Voices in their ongoing work to prevent violence. 3431 adolescents participated in a survey in 2014 when the majority were aged 11–14 years, and agreed to be re-contacted for a Wave 2 survey in 2018 (aged about 15–18 years); and again in 2021 (aged 18–21 years). 36 young people from Wave 1 survey sample will be invited to participate in longitudinal qualitative data collection. Adolescents aged 18 years and over will provide informed consent; for those under age 18 years, adolescents will be invited to assent, except in cases where caregivers, following notification, have opted not to consent to their adolescent’s participation. Quantitative and qualitative data will be analysed iteratively, and triangulation will be used to confirm, clarify and deepen our interpretation of findings. We will hold regular structured meetings so that emerging findings can be integrated into intervention development. Discussion This will be the first longitudinal study on the aetiology of violence over adolescence in sub-Saharan Africa which will enable examination of pathways using mixed methods at multiple time points. Quantitative mediation analysis, and annual qualitative fieldwork will provide detailed insights into how adolescents’ violence-related experiences, perspectives and practices relate to their social contexts and how these change over time. Results will feed directly into intervention development to reduce violence and harmful sequelae. Trial registration This study is a long-term follow up of participants in the Good Schools Study (NCT01678846, clinicaltrials.gov). This protocol is for cohort follow-up only; we have a separate protocol paper describing an evaluation of the long-term effects of the Good School Toolkit (In preparation).

Background Adolescents living with HIV have poor virological suppression and high prevalence of common mental disorders (CMDs). In Zimbabwe, the Zvandiri adolescent peer support programme is effective at improving virological suppression. We assessed the effect of training Zvandiri peer counsellors known as Community Adolescent Treatment Supporters (CATS) in problem-solving therapy (PST) on virological suppression and mental health outcomes. Methods and findings Sixty clinics were randomised 1:1 to either normal Zvandiri peer counselling or a peer counsellor trained in PST. In January to March 2019, 842 adolescents aged 10 to 19 years and living with HIV who screened positive for CMDs were enrolled (375 (44.5%) male and 418 (49.6%) orphaned of at least one parent). The primary outcome was virological nonsuppression (viral load ≥1,000 copies/mL). Secondary outcomes were symptoms of CMDs measured with the Shona Symptom Questionnaire (SSQ ≥8) and depression measured with the Patient Health Questionnaire (PHQ-9 ≥10) and health utility score using the EQ-5D. The adjusted odds ratios (AORs) and 95% confidence intervals (CIs) were estimated using logistic regression adjusting for clinic-level clustering. Case reviews and focus group discussions were used to determine feasibility of intervention delivery. At baseline, 35.1% of participants had virological nonsuppression and 70.3% had SSQ≥8. After 48 weeks, follow-up was 89.5% for viral load data and 90.9% for other outcomes. Virological nonsuppression decreased in both arms, but there was no evidence of an intervention effect (prevalence of nonsuppression 14.7% in the Zvandiri-PST arm versus 11.9% in the Zvandiri arm; AOR = 1.29; 95% CI 0.68, 2.48; p = 0.44). There was strong evidence of an apparent effect on common mental health outcomes (SSQ ≥8: 2.4% versus 10.3% [AOR = 0.19; 95% CI 0.08, 0.46; p < 0.001]; PHQ-9 ≥10: 2.9% versus 8.8% [AOR = 0.32; 95% CI 0.14, 0.78; p = 0.01]). Prevalence of EQ-5D index score Conclusions PST training for CATS did not add to the benefit of peer support in reducing virological nonsuppression but led to improved symptoms of CMD and depression compared to standard Zvandiri care among adolescents living with HIV in Zimbabwe. Active involvement of caregivers and strengthened referral structures could increase feasibility and effectiveness. Trial registration Pan African Clinical Trials Registry PACTR201810756862405. Victoria Simms and co-workers report on a trial of problem discussion therapy for adolescents with HIV infection and common mental disorders in Zimbabwe. Author summary Why was this study done? Common mental disorders (CMDs) such as anxiety and depression are highly prevalent among adolescents living with HIV. It is important to identify strategies to treat CMDs in this population. The Friendship Bench is a proven effective mental health intervention based on problem-solving therapy (PST), which is delivered by trained lay counsellors. The Zvandiri programme is a proven effective intervention to improve HIV outcomes among adolescents, delivered by trained peer counsellors. It is not known whether PST could improve mental health, and HIV outcomes, among adolescents living with HIV, when delivered in addition to the Zvandiri programme. What did the researchers do and find? We conducted a trial among 842 adolescents living with HIV in Zimbabwe, who also had CMDs (depression and anxiety), and attended public health clinics for HIV care. We randomly allocated 30 clinics to provide Zvandiri peer counselling to adolescents living with HIV, and a further 30 clinics to provide Zvandiri counselling plus the Friendship Bench PST. After a year, there was no difference in the proportion with unsuppressed HIV viral load, and this was low in both groups. There was a substantial improvement in mental health (depression and anxiety) in both groups, with significantly better outcomes among those in the Friendship Bench group. The peer counsellors adapted their training and focused on problem discussion rather than problem-solving, because many adolescents identified problems that they did not have the resources to solve. What do these findings mean? To our knowledge, this is the first study to show that an intervention can improve mental health among adolescents living with HIV who have mental health disorders. The lack of an impact on HIV viral load, compared to the Zvandiri programme, might be because of the effectiveness of the Zvandiri counselling and the presence of resistance to HIV drugs in a small number of participants. Mental healthcare should be integrated in HIV care for adolescents. It should be age specific, with shorter sessions than for adults, creating a space for discussing and sharing problems, and involving caregivers as appropriate.

Abstract Background The 2014–2016 Ebola epidemic in West Africa was the largest Ebola epidemic to date. Contact tracing was a core surveillance activity. Challenges with paper-based contact tracing systems include incomplete identification of contacts, delays in communication and response, loss of contact lists, inadequate data collection and transcription errors. The aim of this study was to design and evaluate an electronic system for tracing contacts of Ebola cases in Port Loko District, Sierra Leone, and to compare this with the existing paper-based system. The electronic system featured data capture using a smartphone application, linked to an alert system to notify the District Ebola Response Centre of symptomatic contacts. Methods The intervention was a customised three-tier smartphone application developed using Dimagi’s CommCare platform known as the Ebola Contact Tracing application (ECT app). Eligible study participants were all 26 Contact Tracing Coordinators (CTCs) and 86 Contact Tracers (CTs) working in the 11 Chiefdoms of Port Loko District during the study period (April–August 2015). Case detection was from 13th April to 17th July 2015. The CTCs and their CTs were provided with smartphones installed with the ECT app which was used to conduct contact tracing activities. Completeness and timeliness of contact tracing using the app were compared with data from April 13th-June 7th 2015, when the standard paper-based system was used. Results For 25 laboratory-confirmed cases for whom paper-based contact tracing was conducted, data for only 39% of 408 contacts were returned to the District, and data were often incomplete. For 16 cases for whom app-based contact tracing was conducted, 63% of 556 contacts were recorded as having been visited on the app, and the median recorded duration from case confirmation to first contact visit was 70 h. Conclusion There were considerable challenges to conducting high-quality contact tracing in this setting using either the paper-based or the app-based system. However, the study demonstrated that it was possible to implement mobile health (mHealth) in this emergency setting. The app had the benefits of improved data completeness, storage and accuracy, but the challenges of using an app in this setting and epidemic context were substantial.

Abstract Background Conduct, anxiety, and depressive disorders account for over 75% of the adolescent mental health burden globally. The current protocol will test a low-intensity problem-solving intervention for school-going adolescents with common mental health problems in India. The protocol also tests the effects of a classroom-based sensitization intervention on the demand for counselling services in an embedded recruitment trial. Methods/design We will conduct a two-arm, individually randomized controlled trial in six Government-run secondary schools in New Delhi. The targeted sample is 240 adolescents in grades 9–12 with persistent, elevated mental health symptoms and associated distress/impairment. Participants will receive either a brief problem-solving intervention delivered over 3 weeks by lay counsellors (intervention) or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health symptoms and idiographic problems will be assessed at 6 weeks (co-primary outcomes) and again at 12 weeks post-randomization. In addition, adolescent-reported distress/impairment, perceived stress, mental wellbeing, and clinical remission, as well as parent-reported adolescent mental health symptoms and impact scores, will be assessed at 6 and 12 weeks post-randomization. We will also complete a parallel process evaluation, including estimations of the costs of delivering the interventions. An embedded recruitment trial will apply a stepped-wedge, cluster (class)-randomized controlled design in 70 classes across the six schools. This will evaluate the added effect of a classroom-based sensitization intervention over and above school-level sensitization activities on the primary outcome of referral rate into the host trial. Other outcomes will be the proportion of referrals eligible to participate in the host trial, proportion of self-generated referrals, and severity and pattern of symptoms among referred adolescents in each condition. Power calculations were undertaken separately for each trial. A detailed statistical analysis plan will be developed separately for each trial prior to unblinding. Discussion Both trials were initiated on 20 August 2018. A single research protocol for both trials offers a resource-efficient methodology for testing the effectiveness of linked procedures to enhance uptake and outcomes of a school-based psychological intervention for common adolescent mental health problems. Trial registration Both trials are registered prospectively with the National Institute of Health registry (www.clinicaltrials.gov), registration numbers NCT03633916 and NCT03630471, registered on 16th August, 2018 and 14th August, 2018 respectively).

Abstract Background HIV epidemiology among female sex workers (FSWs) and their clients in the Middle East and North Africa (MENA) region is poorly understood. We addressed this gap through a comprehensive epidemiological assessment. Methods A systematic review of population size estimation and HIV prevalence studies was conducted and reported following PRISMA guidelines. Risk of bias (ROB) assessments were conducted for all included studies using various quality domains, as informed by Cochrane Collaboration guidelines. The pooled mean HIV prevalence was estimated using random-effects meta-analyses. Sources of heterogeneity and temporal trends were identified through meta-regressions. Results We identified 270 size estimation studies in FSWs and 42 in clients, and 485 HIV prevalence studies in 287,719 FSWs and 69 in 29,531 clients/proxy populations. Most studies had low ROB in multiple quality domains. The median proportion of reproductive-age women reporting current/recent sex work was 0.6% (range = 0.2–2.4%) and of men reporting currently/recently buying sex was 5.7% (range = 0.3–13.8%). HIV prevalence ranged from 0 to 70% in FSWs (median = 0.1%) and 0–34.6% in clients (median = 0.4%). The regional pooled mean HIV prevalence was 1.4% (95% CI = 1.1–1.8%) in FSWs and 0.4% (95% CI = 0.1–0.7%) in clients. Country-specific pooled prevalence was < 1% in most countries, 1–5% in North Africa and Somalia, 17.3% in South Sudan, and 17.9% in Djibouti. Meta-regressions identified strong subregional variations in prevalence. Compared to Eastern MENA, the adjusted odds ratios (AORs) ranged from 0.2 (95% CI = 0.1–0.4) in the Fertile Crescent to 45.4 (95% CI = 24.7–83.7) in the Horn of Africa. There was strong evidence for increasing prevalence post-2003; the odds increased by 15% per year (AOR = 1.15, 95% CI = 1.09–1.21). There was also a large variability in sexual and injecting risk behaviors among FSWs within and across countries. Levels of HIV testing among FSWs were generally low. The median fraction of FSWs that tested for HIV in the past 12 months was 12.1% (range = 0.9–38.0%). Conclusions HIV epidemics among FSWs are emerging in MENA, and some have reached stable endemic levels, although still some countries have limited epidemic dynamics. The epidemic has been growing for over a decade, with strong regionalization and heterogeneity. HIV testing levels were far below the service coverage target of “UNAIDS 2016–2021 Strategy.”

Abstract Background Complex health interventions must incorporate user preferences to maximize their potential effectiveness. Discrete choice experiments (DCEs) quantify the strength of user preferences and identify preference heterogeneity across users. We present the process of using a DCE to supplement conventional qualitative formative research in the design of a demand creation intervention for voluntary medical male circumcision (VMMC) to prevent HIV in Tanzania. Methods The VMMC intervention was designed within a 3-month formative phase. In-depth interviews (n = 30) and participatory group discussions (n = 20) sought to identify broad setting-specific barriers to and facilitators of VMMC among adult men. Qualitative results informed the DCE development, identifying the role of female partners, service providers’ attitudes and social stigma. A DCE among 325 men in Njombe and Tabora, Tanzania, subsequently measured preferences for modifiable VMMC service characteristics. The final VMMC demand creation intervention design drew jointly on the qualitative and DCE findings. Results While the qualitative research informed the community mobilization intervention, the DCE guided the specific VMMC service configuration. The significant positive utilities (u) for availability of partner counselling (u = 0.43, p

Abstract Background Very little is known about the barriers and facilitators to antiretroviral therapy (ART) access and adherence among older Africans. Most studies on ART have focused on individuals who are 15–49 years of age. Methods We used in-depth interviews with 40 persons living with HIV, aged 50 to 96 years, who had either initiated ART (n = 26) or were waiting to initiate ART (n = 14), to explore barriers and facilitators to ART access and adherence in rural Uganda. Results Guided by the Andersen Behavior Model, thematic content analysis highlighted 21 primary factors related to environment, patient and health behavior. Nine of the factors were common to both access and adherence, the remaining 12 were evenly split between access and adherence. Transportation costs, food insecurity, and healthcare workers’ knowledge, attitudes and behaviors were key barriers. Conclusions These barriers were similar to those outlined for younger populations in other studies, but were compounded by age. Despite barriers, either due to the exceptional nature of HIV care or overreporting, both ART access and self-reported adherence were better than expected. Older persons living with HIV highlighted health care needs for non-HIV-related illnesses, suggesting while HIV care is adequate, care for the ailments of “old age” is lagging.

AbstractBackgroundAdolescents living with HIV (ALHIV) experience a high burden of mental health disorder which is a barrier to antiretroviral therapy adherence. In Zimbabwe, trained, mentored peer supporters living with HIV (Community Adolescent Treatment Supporters – CATS) have been found to improve adherence, viral suppression and psychosocial well-being among ALHIV. The Friendship Bench is the largest integrated mental health programme in Africa. We hypothesise that combining the CATS programme and Friendship Bench will improve mental health and virological suppression among ALHIV compared with the CATS programme alone.MethodsWe will conduct a cluster-randomised controlled trial in 60 clinics randomised 1:1 in five provinces. ALHIV attending the control arm clinics will receive standard CATS support and clinic support following the Ministry of Health guidelines. Those attending the intervention arm clinics will receive Friendship Bench problem-solving therapy, delivered by trained CATS. Participants with the signs of psychological distress will be referred to the clinic for further assessment and management. The primary outcome is HIV virological failure (≥1000 copies/ml) or death at 48 weeks. Secondary outcomes include the proportion of adolescents with common mental disorder symptoms (defined as Shona Symptom Questionnaire (SSQ-14) score ≥8), proportion with depression symptoms (defined as Patient Health Questionnaire (PHQ-9) score ≥11), symptom severity (mean SSQ-14 and PHQ-9 scores) and EQ-5D score for health-related quality of life.ConclusionsThis trial evaluates the effectiveness of peer-delivery of mental health care on mental health and HIV viral load among ALHIV. If effective this intervention has the potential to be scaled-up to improve these outcomes.Trial registration: PACTR201810756862405. 08 October 2018.

Abstract Background Knowledge of HIV status remains below target in sub-Saharan Africa, especially among men and adolescents. HIV self-testing (HIVST) is a novel approach that enables unique distribution strategies, with potential to be highly decentralised and to provide complementary coverage to facility-based testing approaches. However, substantial gaps in evidence remain on the effectiveness and cost-effectiveness of HIVST, particularly in rural settings, and on approaches to facilitate linkage to confirmatory HIV testing, prevention, and treatment services. This protocol describes two cluster-randomized trials (CRT) included within the UNITAID/PSI HIV Self-Testing Africa (STAR) project. Methods Two independent CRTs were designed around existing reproductive health programmes in rural Malawi and rural/peri-urban Zambia. Common features include use of constrained randomisation to allocate health clinic catchment areas to either standard HIV testing (SOC) or SOC plus community-based distribution of OraQuick HIV Self Tests (Bethlehem, PA USA, assembled in Thailand) by trained lay distributors selected by the community. Community-based distribution agents will be trained (3-day curriculum) to provide brief demonstration of kit use and interpretation, information and encouragement to access follow up services, and management of social harm. The primary outcome of both CRTs is the proportion of the population aged 16 years and older who tested for HIV within the 12-month intervention period. Secondary outcomes in both trials include lifetime HIV testing, antiretroviral therapy (ART) initiation and ART use. Circumcision status among males will be a secondary outcome in Zambia and clinic-level demand for ART will be a secondary outcome in Malawi. Outcomes will be measured using cross-sectional household surveys, and routine data extraction from participating clinics. Costing studies will be used to evaluate the cost-effectiveness of the intervention arm. Qualitative research will be used to guide distribution and explore reasons for testing and linkage to onward care. Discussion The STAR-Malawi and STAR-Zambia trials will provide rigorous evidence of whether community-based lay HIVST distribution is an effective and cost-effective approach to increasing coverage of HIV testing and demand for follow-on HIV services in rural and peri-urban communities in sub-Saharan Africa. Trial registration Clinicaltrials.gov, Malawi: NCT02718274, 18 March 2016; Zambia: NCT02793804, 3 June 2016. Protocol date: 21 February 2018.

Abstract Background Community-based rehabilitation (CBR), or community-based inclusive development, is an approach to address the complex health, social and economic needs of people with schizophrenia in low and middle-income countries. Formative work was undertaken previously to design a culturally appropriate CBR intervention for people with schizophrenia in Ethiopia. The current study explored the acceptability and feasibility of CBR in practice, as well as how CBR may improve functioning among people with schizophrenia. Methods This mixed methods pilot study took place in rural Ethiopia between December 2014 and December 2015. Ten people with schizophrenia who were unresponsive to treatment with medication alone, and their caregivers, participated in CBR. CBR was led by lay workers with five weeks training and involved home visits (education, family intervention and support returning to work) and community mobilisation. Theory of change was used to guide the pilot evaluation. Qualitative and quantitative data were collected at baseline, six months and 12 months. Forty in-depth interviews and two focus group discussions were conducted with 31 individuals comprising people with schizophrenia, caregivers, CBR workers, supervisors, health officers and community members. Results The RISE CBR intervention may have a positive impact on functioning through the pathways of enhanced family support, improved access to health care, increased income and improved self-esteem. CBR was acceptable to CBR workers, community leaders and health officers. Some CBR workers found it challenging to accept the choices of people with schizophrenia. These concerns were felt to be resolvable with supplementary training for CBR workers. The intervention was feasible but further evaluation is needed on a larger scale. Conclusion In low and middle-income countries, CBR may be an acceptable and feasible adjuvant approach to facility-based care for people with schizophrenia. However, contextual factors, including poverty and inaccessible anti-psychotic medication, remain substantial challenges. There were indications that CBR can impact on functioning but the RISE trial will determine effectiveness.

Abstract Background Suicidal ideation may lead to deliberate self-harm which increases the risk of death by suicide. Globally, the main cause of deliberate self-harm is depression. The aim of this study was to explore prevalence of, and risk factors for, suicidal ideation among men and women with common mental disorder (CMD) symptoms attending public clinics in Zimbabwe, and to determine whether problem solving therapy delivered by lay health workers can reduce common mental disorder symptoms among people with suicidal ideation, using secondary analysis of a randomised controlled trial. Methods At trial enrolment, the Shona Symptom Questionnaire (SSQ) was used to screen for CMD symptoms. In the intervention arm, participants received six problem-solving therapy sessions conducted by trained and supervised lay health workers, while those in the control arm received enhanced usual care. We used multivariate logistic regression to identify risk factors for suicidal ideation at enrolment, and cluster-level logistic regression to compare SSQ scores at endline (6 months follow-up) between trial arms, stratified by suicidal ideation at enrolment. Results There were 573 participants who screened positive for CMD symptoms and 75 (13.1%) reported suicidal ideation at baseline. At baseline, after adjusting for confounders, suicidal ideation was independently associated with being aged over 24, lack of household income (household income yes/no; adjusted odds ratio 0.52 (95% CI 0.29, 0.95); p = 0.03) and with having recently skipped a meal due to lack of food (adjusted odds ratio 3.06 (95% CI 1.81, 5.18); p

Abstract Background Little is understood of Ebola virus disease (EVD) transmission dynamics and community compliance with control measures over time. Understanding these interactions is essential if interventions are to be effective in future outbreaks. We conducted a mixed-methods study to explore these factors in a rural village that experienced sustained EVD transmission in Kailahun District, Sierra Leone. Methods We reconstructed transmission dynamics using a cross-sectional survey conducted in April 2015, and cross-referenced our results with surveillance, burial, and Ebola Management Centre (EMC) data. Factors associated with EVD transmission were assessed with Cox proportional hazards regression. Following the survey, qualitative semi-structured interviews explored views of community informants and households. Results All households (n = 240; 1161 individuals) participated in the survey. 29 of 31 EVD probable/confirmed cases died (93·5% case fatality rate); six deaths (20·6%) had been missed by other surveillance systems. Transmission over five generations lasted 16 weeks. Although most households had ≤5 members there was a significant increase in risk of Ebola in households with > 5 members. Risk of EVD was also associated with older age. Cases were spatially clustered; all occurred in 15 households. EVD transmission was better understood when the community experience started to concord with public health messages being given. Perceptions of contact tracing changed from invading privacy and selling people to ensuring community safety. Burials in plastic bags, without female attendants or prayer, were perceived as dishonourable. Further reasons for low compliance were low EMC survival rates, family perceptions of a moral duty to provide care to relatives, poor communication with the EMC, and loss of livelihoods due to quarantine. Compliance with response measures increased only after the second generation, coinciding with the implementation of restrictive by-laws, return of the first survivor, reduced contact with dead bodies, and admission of patients to the EMC. Conclusions Transmission occurred primarily in a few large households, with prolonged transmission and a high death toll. Return of a survivor to the village and more effective implementation of control strategies coincided with increased compliance to control measures, with few subsequent cases. We propose key recommendations for management of EVD outbreaks based on this experience.

Abstract Background Management of menstruation can present substantial challenges to girls in low-income settings. In preparation for a menstrual hygiene intervention to reduce school absenteeism in Uganda, this study aimed to investigate menstruation management practices, barriers and facilitators, and the influence of menstruation on school absenteeism among secondary school students in a peri-urban district of Uganda. Methods Qualitative and quantitative studies were conducted among consenting girls and boys aged 14–17 years in four secondary schools in Entebbe sub-District, Uganda. Methods included group and in-depth interviews with students, a quantitative cross-sectional questionnaire, a prospectively self-completed menstrual diary, key informant interviews with policy makers, and observations of school water, sanitation and hygiene facilities. Multiple logistic regression was used to assess factors associated with school absenteeism during the most recent menstrual period. Results Girls reported substantial embarrassment and fear of teasing related to menstruation in the qualitative interviews, and said that this, together with menstrual pain and lack of effective materials for menstrual hygiene management, led to school absenteeism. All policy makers interviewed reported poverty and menstruation as the key factors associated with school attendance. The 352 girls with questionnaire data had a median age of 16 (inter-quartile range (IQR) = 15,16) years, with median age at menarche of 13 (IQR = 13,14) years. Of these, 64 girls (18.7%) reported having stained their clothes and 69 (19.7%) reported missing at least 1 day of school, during their most recent period. Missing school during the most recent period was associated with physical symptoms (headache (odds ratio (OR) = 2.15, 95%CI:1.20, 3.86), stomach pain (OR = 1.89, 95%CI:0.89, 4.04), back pain (OR = 1.75, 95%CI:0.97, 3.14), and with changing protection 4 or more times per 24 h period (OR = 2.08, 95%CI:1.06, 4.10). In the diary sub-study among 40 girls, school absence was reported on 28% of period-days, compared with 7% of non-period days (adjusted odds ratio = 5.99, 95%CI:4.4, 8.2; p

Abstract Background World Health Organization (WHO) adolescent HIV-testing and treatment guidelines recommend community-based interventions to support antiretroviral therapy (ART) adherence and retention in care, while acknowledging that the evidence to support this recommendation is weak. This cluster randomized controlled trial aims to evaluate the effectiveness and cost-effectiveness of a psychosocial, community-based intervention on HIV-related and psychosocial outcomes. Methods/design We are conducting the trial in two districts. Sixteen clinics were randomized to either enhanced ART-adherence support or standard of care. Eligible individuals (HIV-positive adolescents aged 13–19 years and eligible for ART) in both arms receive ART and adherence support provided by adult counselors and nursing staff. Adolescents in the intervention arm additionally attend a monthly support group, are allocated to a designated community adolescent treatment supporter, and followed up through a short message service (SMS) and calls plus home visits. The type and frequency of contact is determined by whether the adolescent is “stable” or in need of enhanced support. Stable adolescents receive a monthly home visit plus a weekly, individualized SMS. An additional home visit is conducted if participants miss a scheduled clinic appointment or support-group meeting. Participants in need of further, enhanced, support receive bi-weekly home visits, weekly phone calls and daily SMS. Caregivers of adolescents in the intervention arm attend a caregiver support group. Trial outcomes are assessed through a clinical, behavioral and psychological assessment conducted at baseline and after 48 and 96 weeks. The primary outcome is the proportion who have died or have virological failure (viral load ≥1000 copies/ml) at 96 weeks. Secondary outcomes include virological failure at 48 weeks, retention in care (proportion of missed visits) and psychosocial outcomes at both time points. Statistical analyses will be conducted and reported in line with CONSORT guidelines for cluster randomized trials, including a flowchart. Discussion This study provides a unique opportunity to generate evidence of the impact of the on-going Zvandiri program, for adolescents living with HIV, on virological failure and psychosocial outcomes as delivered in a real-world setting. If found to reduce rates of treatment failure, this would strengthen support for further scale-up across Zimbabwe and likely the region more widely. Trial registration Pan African Clinical Trial Registry database, registration number PACTR201609001767322 (the Zvandiri trial). Retrospectively registered on 5 September 2016.

Abstract Background In Africa, accessing eye health services is a major challenge. Ocular surface squamous neoplasia (OSSN) is a substantial ocular health problem in Africa related to solar UV light exposure and HIV infection among other risk factors. The disease causes visual loss and even death in advanced cases. This study was conducted to assess referral pathway and treatment delay for patients with OSSN in Kenya. Methods Adults with conjunctival lesions presenting to four eye centres were asked about their occupations, when they noticed the growth, health facilities visited in seeking care, cost of consultation, surgery, medicines and histopathology and dates at each step. The time-to-presentation was divided into quartiles and correlates analysed using ordinal logistic regression. Results We evaluated 158 first-time presenters with OSSN. Most were women (102 [65%]), living with HIV (78/110 tested [71%]), with low to medium income (127 [80%]). Most of the HIV patients (49/78 [63%]) were in antiretroviral care programs. About half (88/158, [56%]) presented directly to the study centres while the rest were referred. Indirect presenters sought care earlier than direct presenters (median 2.0 months vs 5.5 months) and travelled a shorter distance to the first health facility (median 20 km vs 30 km) but had surgery later (median 12.5 months vs 5.5 months). Visits beyond the first health facility for indirect presenters markedly increased delay (median 7.3, 29.0, 37.9, and 32.0 months for 1–4 facilities, respectively). Delay was associated with number of health facilities visited (adjusted ordered OR = 9.12; 95%CI 2.83–29.4, p

Background: Validated tools for assessing alcohol use among young people in low-income countries are needed to estimate prevalence and evaluate alcohol-reduction interventions. We validated Alcohol Use Disorders Identification Test (AUDIT) against Timeline Follow Back (TLFB), Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and phosphatidylethanol (PEth); and the 30-day-AUDIT against the 12-months-AUDIT among young Ugandans. Methods: In 2018, we collected retrospective data on 30-day and 12-month AUDIT, TLFB and DSM-5 in a cross-sectional study of 15–24 year old residents of Ugandan fishing communities. AUDIT was administered by Audio Computer Assisted Self-Interviewing (ACASI) and DSM-5 and TLFB by psychiatric nurses. We determined PEth16:0/18:1 levels from dried blood spots using liquid chromatography tandem-mass spectrometry (heavy usage, ≥210 ng/mL) and calculated sensitivity and specificity of AUDIT against the other measures. Results: Among 1281 participants (52.7% male, mean age 20 years), half (n = 659; 51.4%) reported ever drinking alcohol, 19.4% had 12-month-AUDIT ≥ 8 (21.5% men; 17.0% women), and 24.2% had 30-day-AUDIT ≥ 8 (29.0% men; 18.9% women). Twenty percent of participants had detectable PEth with 55 (4.3%) classified as heavy drinkers; 50.7% reported ≥ 2 symptoms on DSM-5 and 6.3% reported binge drinking in the previous month based on TLFB (8.9% men, 3.5% women). The 30-day-AUDIT ≥ 8 had sensitivity 86.7%, 95%CI: 81.8%–90.7% and specificity 90.9%, 95%CI:89.0%–92.6% versus 12-month-AUDIT ≥ 8. Both 30-day and 12-month-AUDIT ≥ 8 were sensitive and specific markers of heavy drinking by PEth (12-month-AUDIT sensitivity = 80.0%; 95%CI:67.0%–89.6%; specificity = 83.3%; 95%CI:81.1%–85.3%). The 30-day-AUDIT was a sensitive and specific marker of binge drinking based on TLFB (sensitivity = 82.7%; 95%CI:72.7%–90.2%, specificity = 79.8%; 95%CI:77.4%–82.1%); 12-month-AUDIT had lower sensitivity. Both 30-day and 12-month AUDIT ≥ 8 were highly specific but insensitive markers of having DSM-5 ≥ 2 symptoms. Conclusion: Among young people in Uganda, ACASI-administered 30-day and 12-month-AUDIT have good diagnostic properties compared to PEth, DSM-5 and TLFB. Self-reported AUDIT provides a quick and valid means of assessing alcohol misuse in these communities.

Abstract Background Hepatitis C virus (HCV) and HIV are both transmitted through percutaneous exposures among people who inject drugs (PWID). Ecological analyses on global epidemiological data have identified a positive association between HCV and HIV prevalence among PWID. Our objective was to demonstrate how HCV prevalence can be used to predict HIV epidemic potential among PWID. Methods Two population-level models were constructed to simulate the evolution of HCV and HIV epidemics among PWID. The models described HCV and HIV parenteral transmission, and were solved both deterministically and stochastically. Results The modeling results provided a good fit to the epidemiological data describing the ecological HCV and HIV association among PWID. HCV was estimated to be eight times more transmissible per shared injection than HIV. A threshold HCV prevalence of 29.0% (95% uncertainty interval (UI): 20.7-39.8) and 46.5% (95% UI: 37.6-56.6) were identified for a sustainable HIV epidemic (HIV prevalence >1%) and concentrated HIV epidemic (HIV prevalence >5%), respectively. The association between HCV and HIV was further described with six dynamical regimes depicting the overlapping epidemiology of the two infections, and was quantified using defined and estimated measures of association. Modeling predictions across a wide range of HCV prevalence indicated overall acceptable precision in predicting HIV prevalence at endemic equilibrium. Modeling predictions were found to be robust with respect to stochasticity and behavioral and biological parameter uncertainty. In an illustrative application of the methodology, the modeling predictions of endemic HIV prevalence in Iran agreed with the scale and time course of the HIV epidemic in this country. Conclusions Our results show that HCV prevalence can be used as a proxy biomarker of HIV epidemic potential among PWID, and that the scale and evolution of HIV epidemic expansion can be predicted with sufficient precision to inform HIV policy, programming, and resource allocation.

Background: Trachomatous trichiasis (TT) may lead to disability, impeding productive activities, resulting in loss of income. This study was conducted to determine if trichiasis surgery improves participation in productive and leisure activities, and ability to perform activities without difficulty or assistance. Methods: We recruited 1000 adults with trichiasis (cases) and 200 comparison participants, matched to every fifth trichiasis case on age (+/- two years), sex and location. The ‘Stylised Activity List’ tool, developed for the World Bank Living Standard Measurement Survey, was adapted to collect data on activity in the last week (participation in activity, difficulty with activity, requirement of assistance for activity), at baseline and 12 months later. All trichiasis cases received trichiasis surgery at baseline. Random effect logistic regression was used to compare cases and comparison participants. Results: There was strong evidence that trichiasis surgery substantially improves the ability of trichiasis cases to perform all the productive and leisure activities investigated without difficulty, with large increases in processing agricultural products, 21.1% to 87.0% (p

To determine the presence of Kaposi sarcoma–associated herpesvirus (KSHV) and other serologic markers, we tested serum specimens of 339 Amerindians, 181 rural non-Amerindians, and 1,133 urban blood donors (13 Amerindians) in the Brazilian Amazon. High KSHV seroprevalence in children and inverse association with herpes simplex virus type 2 indicates predominant nonsexual transmission among Amerindians.