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Summary: Background: Clinical severity scores can identify patients at risk of severe disease and death, and improve patient management. The modified early warning score (MEWS), the quick Sequential (Sepsis-Related) Organ Failure Assessment (qSOFA), and the Universal Vital Assessment (UVA) were developed as risk-stratification tools, but they have not been fully validated in low-resource settings where fever and infectious diseases are frequent reasons for health care seeking. We assessed the performance of MEWS, qSOFA, and UVA in predicting mortality among febrile patients in the Lao PDR, Malawi, Mozambique, and Zimbabwe. Methods: We prospectively enrolled in- and outpatients aged ≥ 15 years who presented with fever (≥37.5 °C) from June 2018–March 2021. We collected clinical data to calculate each severity score. The primary outcome was mortality 28 days after enrolment. The predictive performance of each score was determined using area under the receiver operating curve (AUC). Findings: A total of 2797 participants were included in this analysis. The median (IQR) age was 32 (24–43) years, 38% were inpatients, and 60% (1684/2797) were female. By the time of follow-up, 7% (185/2797) had died. The AUC (95% CI) for MEWS, qSOFA and UVA were 0.67 (0.63–0.71), 0.68 (0.64–0.72), and 0.82 (0.79–0.85), respectively. The AUC comparison found UVA outperformed both MEWS (p

Abstract Background Chronic lung disease (CLD) is common among children with HIV (CWH) including in those taking antiretroviral therapy (ART). Azithromycin has both antimicrobial and anti-inflammatory effects and has been effective in improving lung function in a variety of lung diseases. We investigated lung function trajectories among CWH with CLD on ART enrolled in a randomized controlled trial of adjuvant azithromycin. We also investigated factors that modified the effect of azithromycin on lung function. Methods The study used data from a double-blinded placebo-controlled trial conducted in Malawi and Zimbabwe of 48 weeks on azithromycin (BREATHE: ClinicalTrials.gov NCT02426112) among CWH aged 6 to 19 years taking ART for at least six months who had a forced expiratory volume in one second (FEV1) z-score

Abstract Introduction Chronic lung disease is a major cause of morbidity in African children with HIV infection; however, the microbial determinants of HIV-associated chronic lung disease (HCLD) remain poorly understood. We conducted a case–control study to investigate the prevalence and densities of respiratory microbes among pneumococcal conjugate vaccine (PCV)-naive children with (HCLD +) and without HCLD (HCLD-) established on antiretroviral treatment (ART). Methods Nasopharyngeal swabs collected from HCLD + (defined as forced-expiratory-volume/second

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

AbstractPartner 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.

Background Youth have poorer HIV-related outcomes when compared to other age-groups. We describe the protocol for a cluster randomised trial (CRT) to evaluate the effectiveness of community-based, integrated HIV and sexual and reproductive health services for youth on HIV outcomes. Protocol The CHIEDZA trial is being conducted in three provinces in Zimbabwe, each with eight geographically demarcated areas (clusters) (total 24 clusters) randomised 1:1 to standard of care (existing health services) or to the intervention. The intervention comprises community-based delivery of HIV services including testing, antiretroviral therapy, treatment monitoring and adherence support as well as family planning, syndromic management of sexually transmitted infections (STIs), menstrual health management, condoms and HIV prevention and general health counselling. Youth aged 16–24 years living within intervention clusters are eligible to access CHIEDZA services. A CRT of STI screening (chlamydia, gonorrhoea and trichomoniasis) is nested in two provinces (16 of 24 clusters). The intervention is delivered over a 30-month period by a multidisciplinary team trained and configured to provide high-quality, youth friendly services. Outcomes will be ascertained through a population-based survey of 18–24-year-olds. The primary outcome is HIV viral load

Abstract Background Index-linked HIV testing for children, whereby HIV testing is offered to children of individuals living with HIV, has the potential to identify children living with undiagnosed HIV. The “Bridging the Gap in HIV Testing and Care for Children in Zimbabwe” (B-GAP) study implemented and evaluated the provision of index-linked HIV testing for children aged 2–18 years in Zimbabwe. We conducted a process evaluation to understand the considerations for programmatic delivery and scale-up of this strategy. Methods We used implementation documentation to explore experiences of the field teams and project manager who delivered the index-linked testing program, and to describe barriers and facilitators to index-linked testing from their perspectives. Qualitative data were drawn from weekly logs maintained by the field teams, monthly project meeting minutes, the project coordinator’s incident reports and WhatsApp group chats between the study team and the coordinator. Data from each of the sources was analysed thematically and synthesised to inform the scale-up of this intervention. Results Five main themes were identified related to the implementation of the intervention: (1) there was reduced clinic attendance of potentially eligible indexes due to community-based differentiated HIV care delivery and collection of HIV treatment by proxy individuals; (2) some indexes reported that they did not live in the same household as their children, reflecting the high levels of community mobility; (3) there were also thought to be some instances of ‘soft refusal’; (4) further, delivery of HIV testing was limited by difficulties faced by indexes in attending health facilities with their children for clinic-based testing, stigma around community-based testing, and the lack of familiarity of indexes with caregiver provided oral HIV testing; (5) and finally, test kit stockouts and inadequate staffing also constrained delivery of index-linked HIV testing. Conclusions There was attrition along the index-linked HIV testing cascade of children. While challenges remain at all levels of implementation, programmatic adaptations of index-linked HIV testing approaches to suit patterns of clinic attendance and household structures may strengthen implementation of this strategy. Our findings highlight the need to tailor index-linked HIV testing to subpopulations and contexts to maximise its effectiveness.

Abstract Background Long-term azithromycin (AZM) treatment reduces the frequency of acute respiratory exacerbation in children and adolescents with HIV-associated chronic lung disease (HCLD). However, the impact of this treatment on the respiratory bacteriome is unknown. Method African children with HCLD (defined as forced expiratory volume in 1 s z-score (FEV1z) less than − 1.0 with no reversibility) were enrolled in a placebo-controlled trial of once-weekly AZM given for 48-weeks (BREATHE trial). Sputum samples were collected at baseline, 48 weeks (end of treatment) and 72 weeks (6 months post-intervention in participants who reached this timepoint before trial conclusion). Sputum bacterial load and bacteriome profiles were determined using 16S rRNA gene qPCR and V4 region amplicon sequencing, respectively. The primary outcomes were within-participant and within-arm (AZM vs placebo) changes in the sputum bacteriome measured across baseline, 48 weeks and 72 weeks. Associations between clinical or socio-demographic factors and bacteriome profiles were also assessed using linear regression. Results In total, 347 participants (median age: 15.3 years, interquartile range [12.7–17.7]) were enrolled and randomised to AZM (173) or placebo (174). After 48 weeks, participants in the AZM arm had reduced sputum bacterial load vs placebo arm (16S rRNA copies/µl in log10, mean difference and 95% confidence interval [CI] of AZM vs placebo − 0.54 [− 0.71; − 0.36]). Shannon alpha diversity remained stable in the AZM arm but declined in the placebo arm between baseline and 48 weeks (3.03 vs. 2.80, p = 0.04, Wilcoxon paired test). Bacterial community structure changed in the AZM arm at 48 weeks compared with baseline (PERMANOVA test p = 0.003) but resolved at 72 weeks. The relative abundances of genera previously associated with HCLD decreased in the AZM arm at 48 weeks compared with baseline, including Haemophilus (17.9% vs. 25.8%, p

Introduction Sexually transmitted infections (STIs) such as chlamydia, gonorrhoea, trichomoniasis, and syphilis, are associated with adverse birth outcomes. Treatment should be accompanied by partner services to prevent re-infection and break cycles of transmission. Partner services include the processes of partner notification (PN) as well as arranging for their attendance for testing and/or treatment. However, due to a complex mix of cultural, socio-economic, and health access factors, uptake of partner services is often very low, in many settings globally. Alternative strategies to facilitate partner services are therefore needed. The aim of this study is to assess the impact of a small financial incentive on uptake of partner services for STIs as part of antenatal care (ANC) services in Zimbabwe. Methods and analysis This trial will be embedded within a prospective interventional study in Harare, aiming to evaluate integration of point-of-care diagnostics for STIs into ANC settings. One thousand pregnant women will be screened for chlamydia, gonorrhoea, trichomoniasis, and syphilis. All individuals with STIs will be offered treatment, risk reduction counselling, and client PN. Each clinic day will be randomised 1:1 to be an incentive or non-incentive day. On incentive days, participants diagnosed with a curable STI will be offered a PN slip, that when returned will entitle their partners to $3 (USD) in compensation. On non-incentive days, regular PN slips with no incentive are provided. The primary outcome measure is the proportion of individuals with at least one partner who returns for partner services based on administrative records. Secondary outcomes will include the number of days between index case diagnosis and the partner attending for partner services, uptake of PN slips by pregnant women, adverse birth outcomes in index cases, partners who receive treatment, and intervention cost. Registration Pan African Clinical Trials Registry: PACTR202302702036850 (Approval date 18th February 2022).

Summary: 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).

Background: The population of older adults is growing in sub-Saharan Africa. Ageing exponentially increases fragility fracture risk. Of all global regions, Africa is projected to observe the greatest increase in fragility fractures. Fractures cause pain, disability and sometimes death, and management is expensive, often requiring complex healthcare delivery. For countries to plan future healthcare services, understanding is needed of fracture epidemiology, associated health service costs and the currently available healthcare resources. Methods: The Fractures-E3 5-year mixed-methods research programme will investigate the epidemiology, economic impact, and treatment provision for fracture and wider musculoskeletal health in The Gambia, South Africa and Zimbabwe. These three countries are diverse in their geography, degree of urbanisation, maturity of health service infrastructure, and health profiles. The programme comprises five study types: (i) population-based cross-sectional studies to determine vertebral fracture prevalence. Secondary outcomes will include osteoarthritis and sarcopenia. Age- and sex-stratified household sampling will recruit 5030 adults aged 40 years and older; (ii) prospective cohort studies in adults aged 40 years and older will determine hip fracture incidence, associated risk factors, and outcomes over one year (e.g. mortality, disability, health-related quality of life); (iii) economic studies of direct health costs of hip fracture with projection modelling of future national health costs and cost-effectiveness analyses of different hip fracture care pathways; (iv) national surveys of hip fracture services (including traditional bonesetters in The Gambia); and (v) ethnographic studies of hip fracture care provision and experiences will understand fracture service pathways. Conclusions: Greater understanding of current and expected fracture burdens, fracture risk factors, and existing fracture care provision, is intended to inform national clinical guidelines, health service policy and planning and future health service development in sub-Saharan Africa.

Introduction: Sexually transmitted infections (STIs) such as chlamydia, gonorrhoea, trichomoniasis, and syphilis, are associated with adverse birth outcomes. Treatment should be accompanied by partner services to prevent re-infection and break cycles of transmission. Partner services include the processes of partner notification (PN) as well as arranging for their attendance for testing and/or treatment. However, due to a complex mix of cultural, socio-economic, and health access factors, uptake of partner services is often very low, in many settings globally. Alternative strategies to facilitate partner services are therefore needed. The aim of this study is to assess the effect of a small financial incentive on improving uptake of partner services for STIs as part of antenatal care (ANC) services in Zimbabwe. Methods and analysis: This trial will be embedded within a prospective interventional study in Harare, aiming to evaluate integration of point-of-care diagnostics for STIs into ANC settings. One thousand pregnant women will be screened for chlamydia, gonorrhoea, trichomoniasis, and syphilis. All individuals with STIs will be offered treatment, risk reduction counselling, and client PN. Each clinic day will be randomised 1:1 to be an incentive or non-incentive day. On incentive days, participants diagnosed with a curable STI will be offered a PN slip, that when returned will entitle their partners to $3 (USD) in compensation. On non-incentive days, regular PN slips with no incentive are provided. The primary outcome measure is the proportion of individuals with at least one partner who returns for partner services based on administrative records. Secondary outcomes will include the number of days between index case diagnosis and the partner attending for partner services, uptake of PN slips by pregnant women, adverse birth outcomes in index cases, partners who receive treatment, and intervention cost. Registration: Pan African Clinical Trials Registry: PACTR202302702036850 (Approval date 18th February 2022).

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 We investigated risk factors for sustained virological non-suppression (viral load ≥ 1000 copies/ml on two tests 48 weeks apart) among children and adolescents accessing HIV care in public sector clinics in Harare, Zimbabwe and Blantyre, Malawi. Methods Participants were enrolled between 2016 and 2019, were aged 6–19 years, living with HIV, had chronic lung disease (FEV z-score

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 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 ).

COVID-19 threatens hard-won gains in sexual and reproductive health (SRH) through compromising the ability of services to meet needs. Youth are particularly threatened due to existing barriers to their access to services. CHIEDZA is a community-based integrated SRH intervention for youth being trialled in Zimbabwe. CHIEDZA closed in March 2020, in response to national lockdown, and reopened in May 2020, categorised as an essential service. We aimed to understand the impact of CHIEDZA’s closure and its reopening, with adaptations to reduce COVID-19 transmission, on provider and youth experiences. Qualitative methods included interviews with service providers (n = 22) and youth (n = 26), and observations of CHIEDZA sites (n = 10) and intervention team meetings (n = 7). Analysis was iterative and inductive. The sudden closure of CHIEDZA impeded youth access to SRH services. The reopening of CHIEDZA was welcomed, but the necessary adaptations impacted the intervention and engagement with it. Adaptations restricted time with healthcare providers, heightening the tension between numbers of youths accessing the service and quality of service provision. The removal of social activities, which had particularly appealed to young men, impacted youth engagement and access to services, particularly for males. This paper demonstrates how a community-based youth-centred SRH intervention has been affected by and adapted to COVID-19. We demonstrate how critical ongoing service provision is, but how adaptations negatively impact service provision and youth engagement. The impact of adaptations additionally emphasises how time with non-judgemental providers, social activities, and integrated services are core components of youth-friendly services, not added extras.

Abstract Background By testing children and adolescents of HIV positive caretakers, index-linked HIV testing, a targeted HIV testing strategy, has the ability to identify high risk children and adolescents earlier and more efficiently, compared to blanket testing. We evaluated the incremental cost of integrating index-linked HIV testing via three modalities into HIV services in Zimbabwe. Methods A mixture of bottom-up and top-down costing was employed to estimate the provider cost per test and per HIV diagnosis for 2–18 year olds, through standard of care testing, and the incremental cost of index-linked HIV testing via three modalities: facility-based testing, home-based testing by a healthcare worker, and testing at home by the caregiver using an oral mucosal transudate test. In addition to interviews, direct observation and study process data, facility registries were abstracted to extract outcome data and resource use. Costs were converted to 2019 constant US$. Results The average cost per standard of care test in urban facilities was US$5.91 and US$7.15 at the rural facility. Incremental cost of an index-linked HIV test was driven by the uptake and number of participants tested. The lowest cost approach in the urban setting was home-based testing (US$6.69) and facility-based testing at the rural clinic (US$5.36). Testing by caregivers was almost always the most expensive option (rural US$62.49, urban US$17.49). Conclusions This is the first costing analysis of index-linked HIV testing strategies. Unit costs varied across sites and with uptake. When scaling up, alternative testing solutions that increase efficiency such as index-linked HIV testing of the entire household, as opposed to solely targeting children/adolescents, need to be explored.

Abstract Background Youth have disproportionately poor HIV outcomes. We aimed to co-design a community-based intervention with youth to improve HIV outcomes among 16-24 year-olds, to be trialled in Zimbabwe. Methods We conducted 90 in-depth interviews with youth, family members, community gatekeepers and healthcare providers to understand the barriers to uptake of existing HIV services. The interviews informed an outline intervention, which was refined through two participatory workshops with youth, and subsequent pilot-testing. Results Participants considered existing services inaccessible and unappealing: health facilities were perceived to be for ‘sick people’, centred around HIV and served by judgemental providers. Proposed features of an intervention to overcome these barriers included: i) delivery in a youth-only community space; ii) integration of HIV services with broader health services; iii) non-judgemental skilled healthcare providers; iv) entertainment to encourage attendance; and v) tailored timings and outreach. The intervention framework stands on three core pillars, based on optimising access (community-based youth-friendly settings); uptake and acceptability (service branding, confidentiality, and social activities); and content and quality (integrated HIV care cascade, high quality products, and trained providers). Conclusions Ongoing meaningful youth engagement is critical to designing HIV interventions if access, uptake, and coverage is to be achieved.

Background: Treatment for urinary tract infections (UTIs) is usually empiric and is based on local antimicrobial resistance data. These data, however, are scarce in low-resource settings. The aim of this study is to determine the impact of antibiotic treatment on clinical and bacteriological outcomes in patients presenting with UTI symptoms to primary care in Harare. Methods: This cohort study enrolled participants presenting with UTI symptoms to 10 primary healthcare clinics in Harare between July 2019 and July 2020. A questionnaire was administered and a urine sample was collected for culture. If the urine culture showed growth of ≥105 colony forming units/mL of a uropathogen, a follow up visit at 7-21 days was conducted. Results: The analysis included 168 participants with a median age of 33.6 years (IQR 25.1-51.4) and of whom 131/168 (78.0%) were female. Effective treatment was taken by 54/168 (32.1%) participants. The urine culture was negative at follow up in 41/54 (75.9%) of participants who took appropriate treatment and in 33/114 (28.9%, p

Abstract Background HIV-associated chronic lung disease (CLD) is common among children living with HIV (CLWH) in sub-Saharan Africa, including those on antiretroviral therapy (ART). However, the pathogenesis of CLD and its possible association with microbial determinants remain poorly understood. We investigated the prevalence, and antibiotic susceptibility of Streptococcus pneumoniae (SP), Staphylococcus aureus (SA), Haemophilus influenzae (HI), and Moraxella catarrhalis (MC) among CLWH (established on ART) who had CLD (CLD+), or not (CLD-) in Zimbabwe and Malawi. Methods Nasopharyngeal swabs (NP) and sputa were collected from CLD+ CLWH (defined as forced-expiratory volume per second z-score

Bronchiectasis (BE) is a chronic condition affecting the bronchial tree. It is characterized by the dilatation of large and medium-sized airways, secondary to damage of the underlying bronchial wall structural elements and accompanied by the clinical picture of recurrent or persistent cough. Despite an increased awareness of childhood BE, there is still a paucity of data on the epidemiology, pathophysiological phenotypes, diagnosis, management, and outcomes in Africa where the prevalence is mostly unmeasured, and likely to be higher than high-income countries. Diagnostic pathways and management principles have largely been extrapolated from approaches in adults and children in high-income countries or from data in children with cystic fibrosis. Here we provide an overview of pediatric BE in Africa, highlighting risk factors, diagnostic and management challenges, need for a global approach to addressing key research gaps, and recommendations for practitioners working in Africa.

Background: Healthcare workers (HCWs) have experienced anxiety and psychological distress during the COVID-19 pandemic. We established and report findings from an occupational health programme for HCWs in Zimbabwe that offered screening for SARS-CoV-2 with integrated screening for comorbidities including common mental disorder (CMD) and referral for counselling. Methods: Quantitative outcomes were fearfulness about COVID-19, the Shona Symptom Questionnaire (SSQ-14) score (cutpoint 8/14) and the number and proportion of HCWs offered referral for counselling, accepting referral and counselled. We used chi square tests to identify factors associated with fearfulness, and logistic regression was used to model the association of fearfulness with wave, adjusting for variables identified using a DAG. Qualitative data included 18 in-depth interviews, two workshops conducted with HCWs and written feedback from counsellors, analysed concurrently with data collection using thematic analysis. Results: Between 27 July 2020–31 July 2021, spanning three SARS-CoV-2 waves, the occupational health programme was accessed by 3577 HCWs from 22 facilities. The median age was 37 (IQR 30–43) years, 81.9% were women, 41.7% said they felt fearful about COVID-19 and 12.1% had an SSQ-14 score ≥ 8. A total of 501 HCWs were offered referral for counselling, 78.4% accepted and 68.9% had ≥1 counselling session. Adjusting for setting and role, wave 2 was associated with increased fearfulness over wave 1 (OR = 1.26, 95% CI 1.00–1.60). Qualitative data showed high levels of anxiety, psychosomatic symptoms and burnout related to the pandemic. Mental wellbeing was affected by financial insecurity, unmet physical health needs and inability to provide quality care within a fragile health system. Conclusions: HCWs in Zimbabwe experience a high burden of mental health symptoms, intensified by the COVID-19 pandemic. Sustainable mental health interventions must be multisectoral addressing mental, physical and financial wellbeing.

BackgroundPeople living with HIV have higher unmet family planning needs compared to those without HIV. This is heightened for young people. However, the provision of family planning for young people within HIV programmes is uncommon. We investigated family planning uptake, acceptability of, and engagement with a service offering integrated HIV and sexual and reproductive health services for youth in a community-based setting in Zimbabwe.MethodsCHIEDZA, a community-based intervention offering integrated HIV and sexual and reproductive health services to young people aged 16–24 years, is being trialed in Zimbabwe. This exploratory qualitative study was nested within an ongoing study process evaluation. Data was collected between March-May 2021 with two sets of interviews conducted: I) twelve semi-structured interviews with young women living with HIV aged 17–25 years and II) fifteen interviews conducted with young women without HIV aged between 20 and 25 years who used a contraceptive method. A thematic analysis approach was used.ResultsBefore engaging with CHIEDZA, young women had experienced judgmental providers, on account of their age, and received misinformation about contraceptive use and inadequate information about ART-contraceptive interactions. These presented as barriers to uptake and engagement. Upon attending CHIEDZA, all the young women reported receiving non-judgmental care. For those living with HIV, they were able to access integrated HIV and family planning services that supported them having broader sexual and reproductive needs beyond their HIV diagnosis. The family planning preference of young women living with HIV included medium to long-acting contraceptives to minimize adherence challenges, and desired partner involvement in dual protection to prevent HIV transmission. CHIEDZA's ability to meet these preferences shaped uptake, acceptability, and engagement with integrated HIV and family services.ConclusionsRecommendations for an HIV and family planning integrated service for young people living with HIV include: offering a range of services (including method-mix contraceptives) to choose from; supporting their agency to engage with the services which are most acceptable to them; and providing trained, supportive, knowledgeable, and non-judgmental health providers who can provide accurate information and counsel. We recommend youth-friendly, differentiated, person-centered care that recognize the multiple and intersecting needs of young people living with HIV.

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 Chronic lung disease (CLD) is a common co-morbidity for HIV-positive children and adolescents on antiretroviral therapy (ART) in sub-Saharan Africa. In this population, distinct airway microbiota may differentially confer risk of CLD. In a cross-sectional study of 202 HIV-infected children aged 6–16 years in Harare, Zimbabwe, we determined the association of sputum microbiota composition (using 16S ribosomal RNA V4 gene region sequencing) with CLD defined using clinical, spirometric, or radiographic criteria. Forty-two percent of children were determined to have CLD according to our definition. Dirichlet multinomial mixtures identified four compositionally distinct sputum microbiota structures. Patients whose sputum microbiota was dominated by Haemophilus, Moraxella or Neisseria (HMN) were at 1.5 times higher risk of CLD than those with Streptococcus or Prevotella (SP)-dominated microbiota (RR = 1.48, p = 0.035). Cell-free products of HMN sputum microbiota induced features of epithelial disruption and inflammatory gene expression in vitro, indicating enhanced pathogenic potential of these CLD-associated microbiota. Thus, HIV-positive children harbor distinct sputum microbiota, with those dominated by Haemophilus, Moraxella or Neisseria associated with enhanced pathogenesis in vitro and clinical CLD.

Abstract Background The 2012 Global Lung Function Initiative (GLI2012) provide multi-ethnic spirometric reference equations (SRE) for the 3–95 year-old age range, but Sub-Saharan African populations are not represented. This study aimed to evaluate the fit of the African-American GLI2012 SRE to a population of healthy urban and peri-urban Zimbabwean school-going children (7–13 years). Methods Spirometry and anthropometry were performed on black-Zimbabwean children recruited from three primary schools in urban and peri-urban Harare, with informed consent and assent. Individuals with a history or current symptoms of respiratory disease or with a body mass index-z score (BMI)

Background Overuse of antibiotics is one of the main drivers for antimicrobial resistance (AMR). Globally, most antibiotics are prescribed in the outpatient setting. This survey aimed to explore attitudes and practices with regards to microbiology tests, AMR and antibiotic prescribing among healthcare providers at public primary health clinics in Harare, Zimbabwe. Methods This cross-sectional survey was conducted in nine primary health clinics located in low-income suburbs of Harare between October and December 2020. In Zimbabwe, primary health clinics provide nurse-led outpatient care for acute and chronic illnesses. Healthcare providers who independently prescribe antibiotics and order diagnostic tests were invited to participate. The survey used self-administered questionnaires. A five-point Likert scale was used to determine attitudes and beliefs. Results A total of 91 healthcare providers agreed to participate in the survey. The majority of participants (62/91, 68%) had more than 10 years of work experience. Most participants reported that they consider AMR as a global (75/91, 82%) and/or national (81/91, 89%) problem, while 52/91 (57%) considered AMR to be a problem in their healthcare facilities. A fifth of participants (20/91, 22%) were unsure if AMR was a problem in their clinics. Participants felt that availability of national guidelines (89/89, 100%), training sessions on antibiotic prescribing (89/89, 100%) and regular audit and feedback on prescribing (82/88, 93%) were helpful interventions to improve prescribing. Conclusions These findings support the need for increased availability of data on AMR and antibiotic use in primary care. Educational interventions, regular audit and feedback, and access to practice guidelines may be useful to limit overuse of antibiotics.

There is substantial unmet need for family planning (FP) among women living with HIV (WLHIV), leading to unintended pregnancies and may contribute indirectly to increasing the risk of transmission of HIV. This review aims to determine whether integration of FP into HIV testing and care results in increased use of contraception, a reduction in unmet need for FP, improved use of safer conception methods and a reduction in unintended pregnancies in low and middle-income countries. A systematic review was undertaken incorporating studies from PubMed, EMBASE, CINAHL, Web of Science and Global Health, the International AIDS Society Abstract Archive, the World STI & HIV Congress Abstract Archive and the Conference on Retroviruses and Opportunistic Infections Abstract Archive published between 2016 and 2021, updating previous systematic reviews. After screening, 13 studies were included, 11 conducted in sub-Saharan Africa and 2 in India. The primary outcome of the review was contraceptive uptake and secondary outcomes included unmet need for FP, safer conception and unintended pregnancy. Integrated FP-HIV facilities were found to increase dual contraceptive use by at least 8% in five studies and modern contraceptive use by at least 8% in four studies. Findings from two studies suggested integration decreased the unmet need for contraception. Limited data prevented a conclusion from being drawn regarding whether integration increases safer conception. There was no evidence of integration reducing unintended pregnancies. The median quality score of studies was 3/9. Overall, integrated facilities have the potential of improving reproductive health of women accessing HIV services in LMICs. FP may be enhanced by including a safer conception component for WLHIV.Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021251008, identifier: CRD42021251008.

Background Management of co-morbidities among persons living with HIV is an emerging priority, which may require additional medication over and above life-long antiretroviral therapy (ART). We explored factors associated with adherence to the trial drug among children and adolescents with perinatally acquired HIV taking antiretroviral therapy (ART) in the Bronchopulmonary Function in Response to Azithromycin Treatment for Chronic Lung Disease in HIV-Infected Children (BREATHE) trial. Methods The BREATHE trial recruited 6–19 year olds with perinatally acquired HIV and co-morbid chronic lung disease as measured by FEV1. This two-site trial was individually randomised (1:1), double-blind and placebo-controlled. Participants received a once-weekly weight-based dose of 1–5 tablets of azithromycin (AZM: 250mg) or placebo, taken orally. We used pharmacy dispensing records and count of returned pills to measure adherence to study medication. Logistic regression was used to explore factors associated with adherence coverage. Poisson regression with Lexis expansion for time was used to explore whether adherence modified the effect of azithromycin on the incidence of acute respiratory exacerbation, a secondary outcome of the trial. Trial registration: ClinicalTrials.gov NCT02426112. Results The 347 participants (median age 15.3, 51% male) consumed 14,622 doses of study medication over 16,220 person-weeks under study. Adherence was higher for those randomised to AZM (73.4%) than placebo (68.4%) and declined over the 48 weeks of the study (Score test for trend Conclusion The majority of children and adolescents tolerated the addition of a once-weekly dose of medication to their pill burden. Barriers in adhering to treatment for co-morbid conditions are likely common to barriers in adhering to ART. Control of co-morbidities will therefore present additional challenges in HIV care.

The End TB strategy recommends social protection to mitigate socio-economic impacts of tuberculosis. Zimbabwe started implementing a conditional cash transfer (CCT) programme for people on drug resistant tuberculosis (DR-TB) treatment in 2013. We aimed to determine the proportion of people receiving CCT and effectiveness of CCT in improving treatment outcomes, explore their experiences with registering for CCT and understand the impact of CCT from the perspective of beneficiaries. Data from 2014–2021 were extracted from TB registers and CCT payment records within the National TB Programme. Sixteen in-depth interviews were conducted with people who were completing treatment or had completed treatment within two months. Poisson regression, adjusted for province, year of treatment, age and sex was used to investigate associations between receiving CCT and successful treatment outcomes among people who were in DR-TB care for ≥3 months after treatment initiation. Qualitative data were analyzed using thematic analysis. A total of 481 people were included in the quantitative study. Of these, 53% (254/481) received CCT at some point during treatment. People who exited DR-TB care within three months were 73% less likely to receive CCT than those who did not (prevalence ratio (PR) = 0.27 [95%CI: 0.18–0.41]). Among those who were alive and in care three months after treatment initiation, CCT recipients were 32% more likely to have successful outcomes than those who did not (adjusted PR = 1.32, [95%CI: 1.00–1.75]). Qualitative results revealed lack of knowledge about availability of CCT among people with DR-TB and missed opportunities by healthcare providers to provide information about availability of CCT. Delays and inconsistencies in disbursements of CCT were frequent themes. CCT were associated with successful treatment outcomes. Improvements in coverage, timeliness and predictability of disbursements are recommended.

Background: Right heart abnormalities and pulmonary hypertension (PH) may be secondary to chronic lung disease. Chronic lung disease is common in children with HIV. In the BREATHE trial (Trial registration: NCT02426112), azithromycin (AZM) reduced the risk of acute respiratory exacerbations in children aged 6–19 years with HIV-associated chronic lung disease (HCLD) taking antiretroviral therapy. We assessed the possible effect of AZM on right heart dysfunction and/or PH in the trial. Methods: A standardised transthoracic echocardiogram using M-mode, two-dimensional and Doppler was performed, at baseline and at completion of weight-based AZM given weekly for 48 weeks. Linear regression was used to compare trial arms. Results: A total of 169 participants (82 AZM arm; 87 placebo arm) were included. Participants in the placebo arm were older, median age 16.2 (13.0–18.2) vs 15.3 (12.9–17.4) years, p = 0.184 in the AZM arm. At baseline, right heart abnormalities (right ventricular systolic dysfunction (RVSD), dilatation, or PH) were observed in 7(4%). Following treatment, there was no difference in prevalence of RVSD between arms (p = 0.761). There was one incident case of suspected PH, and overall, no difference in pulmonary pressures. Conclusion: In children with HCLD, there was evidence of secondary cardiac effects, but AZM had no effect on right heart function. Long-term follow-up in children with HIV should be part of future research to understand the clinical implications of right heart abnormalities.

Abstract Background Many countries are facing overlapping epidemics of tuberculosis (TB) and diabetes mellitus (DM). Diabetes increases the overall risk of developing Tuberculosis (TB) and contributes to adverse treatment outcomes. Active screening for both diseases can reduce TB transmission and prevent the development of complications of DM. We investigated bi-directional TB-DM screening in Karachi, Pakistan, a country that ranks fifth among high TB burden countries, and has the seventh highest country burden for DM. Methods Between February to November 2014, community-based screeners identified presumptive TB and DM through verbal screening at private health clinics. Individuals with presumptive TB were referred for a chest X-ray and Xpert MTB/RIF. Presumptive DM cases had random blood glucose (RBS) tested. All individuals with bacteriologically positive TB were referred for diabetes testing (RBS). All pre-diabetics and diabetics were referred for a chest X-ray and Xpert MTB/RIF test. The primary outcomes of this study were uptake of TB and DM testing. Results A total of 450,385 individuals were screened, of whom 18,109 had presumptive DM and 90,137 had presumptive TB. 14,550 of these individuals were presumptive for both DM and TB. The uptake of DM testing among those with presumptive diabetes was 26.1% while the uptake of TB testing among presumptive TB cases was 5.9%. Despite efforts to promote bi-directional screening of TB and DM, the uptake of TB testing among pre-diabetes and diabetes cases was only 4.7%, while the uptake of DM testing among MTB positive cases was 21.8%. Conclusion While a high yield for TB was identified among pre-diabetics and diabetics along with a high yield of DM among individuals diagnosed with TB, there was a low uptake of TB testing amongst presumptive TB patients who were recorded as pre-diabetic or diabetic. Bi-directional screening for TB and DM which includes the integration of TB diagnostics, DM screening and TB-DM treatment within existing health care programs will need to address the operational challenges identified before implementing this as a strategy in public health programs.

Selection for resistance to azithromycin (AZM) and other antibiotics such as tetracyclines and lincosamides remains a concern with long-term AZM use for treatment of chronic lung diseases (CLD). We investigated the impact of 48 weeks of AZM on the carriage and antibiotic resistance of common respiratory bacteria among children with HIV-associated CLD. Nasopharyngeal (NP) swabs and sputa were collected at baseline, 48 and 72 weeks from participants with HIV-associated CLD randomised to receive weekly AZM or placebo for 48 weeks and followed post-intervention until 72 weeks. The primary outcomes were prevalence and antibiotic resistance of Streptococcus pneumoniae (SP), Staphylococcus aureus (SA), Haemophilus influenzae (HI) and Moraxella catarrhalis (MC) at these timepoints. Mixed-effects logistic regression and Fisher's exact test were used to compare carriage and resistance, respectively. Of 347 (174 AZM, 173 placebo) participants (median age 15 years (IQR 13–18), female 49%), NP carriage was significantly lower in the AZM (n=159) compared to placebo (n=153) arm for SP (18% versus 41%, p

Background: Assessment of the effectiveness of tuberculosis control strategies requires the periodic measurement of M. tuberculosis transmission in populations, which is notoriously difficult. One well-established method is to measure the prevalence of infectious pulmonary tuberculosis in the population which is then repeated at a second time point after a period of ‘intervention’, such as scale up of the Search-Treat-Prevent strategy of the Zero TB Cities initiative, allowing for a ‘before and after’ comparison. Protocol: The concurrent adult pulmonary tuberculosis prevalence survey (using digital radiography and Xpert MTB/RIF Ultra) and child M. tuberculosis infection survey (using QuantiFERON-TB® Gold Plus) will primarily provide a baseline measure of the burden of adult infectious tuberculosis in Karachi and assess whether a large-scale interferon gamma release assay survey in children aged 2 to 4 years is feasible. The target population for the prevalence survey is comprised of a stratified random sample of all adults aged 15 years and above and all children aged 2 to 4 years resident in four districts in Karachi. The survey procedures and analyses to estimate pulmonary tuberculosis prevalence are based on the World Health Organization methodology for tuberculosis prevalence surveys. Ethics and dissemination: The study protocol has been approved by the Interactive Research Development / The Indus Hospital Research Centre Research Ethics Committee in Karachi, Pakistan and the London School of Hygiene & Tropical Medicine Research Ethics Committee. Due to non-representative sampling in this setting, where a large proportion of the population are illiterate and are reluctant to provide fingerprints due to concerns about personal security, verbal informed consent will be obtained from each eligible participant or guardian. Results will be submitted to international peer-reviewed journals, presented at international conferences and shared with participating communities and with the Provincial and National TB programme.

Antimicrobial resistance (AMR) is compromising our ability to successfully treat infections. There are few data on gram-negative AMR prevalence in sub-Saharan Africa especially from the outpatient setting. This study aims to investigate the prevalence of and underlying molecular mechanisms for AMR in gram-negative bacilli causing urinary tract infections (UTIs) in Zimbabwe. Risk factors for AMR and how AMR impacts on clinical outcomes will also be investigated. Adults presenting with UTI symptoms at primary health clinics in Harare will be included. A questionnaire will be administered, and urine samples will be collected for culture. Participants with positive urine cultures will be followed up at 7-14 days post-enrolment. All participants will also be followed by telephone at 28 days to determine clinical outcomes. Bacterial identification and antibiotic susceptibility testing will be performed on positive cultures. The results from this study will be used to inform policy and development of treatment recommendations. Whole genome sequencing results will provide a better understanding of the prevalent resistance genes in Zimbabwe, of the spread of successful clones, and potentially will contribute to developing strategies to tackle AMR.

Objective: To investigate the incidence and predictors of viraemia among individuals on antiretroviral therapy (ART) in Harare, Zimbabwe. Methods: Children (0–19 years) and adults (>19 years) starting ART between 2013 and 2015 were followed for a median of 2.8 and 2.7 years, respectively. The incidence rates of virological failure (VF), low-level viraemia (LLV), and viral blips were assessed and the predictors of viraemia were determined using logistic and parametric survival regression analyses. Results: A total of 630 individuals initiated ART, and 19.7% of children and 5.6% of adults did not achieve viral suppression by 12 months. Younger age and CD4 count ≤200 cells/mm3 at baseline were associated with not being virally suppressed at 12 months in adults. Among those who achieved viral suppression during the follow-up period, the incidence of VF was higher in children (4.0/100 person-years vs. 0.4/100 person-years in adults; p

Women in sub-Saharan Africa report multiple impacts of menopause on daily life and have requested further information to support themselves. This study co-produced contextually relevant resources—booklets and poster—about menopause with women in Zimbabwe and South Africa. The study was conducted in four stages: interviews with women about the menopause; the development of prototype information resources; workshops with women to discuss country-specific resources; and the refinement of resources. During the interviews, women explained that they had not received or accessed much information about the menopause and thought the physical and psychological issues associated with the menopause had to be “endured”. Prototype information resources comprised booklets and a poster with contextually relevant images and information. Workshop participants suggested several changes, including the addition of more diverse images and further information about treatments. The resources were refined, translated into several African languages, and endorsed by the Ministry of Health in Zimbabwe and the South African Menopause Society in South Africa. Women will be able to access resources through healthcare clinics, community groups and churches. Working with women and other stakeholders enabled a development that was cognisant of experiences and needs. Work is now needed to improve access to treatments and support for menopause to reduce health inequities.

Abstract Background Community Health Worker (CHW) programmes are increasingly important in HIV service delivery. CHWs’ familiarity with the local context can improve intervention acceptability and sustainability but concerns have been raised about potential exploitation and “burnout” of CHWs as they become emotionally involved in clients’ lives. Little attention has been paid to what happens at the end of time-limited CHW interventions. This study aimed to examine the experience of CHWs’ withdrawal from clients and their families. Methods We conducted a qualitative study of CHWs’ experiences of “exiting” from households during the ZENITH (Zimbabwe Study for Enhancing Testing and Improving Treatment of HIV in Children) intervention, which provided 12 structured home visits over 72 weeks to families with children recently diagnosed with HIV. We conducted semi-structured interviews at 12 and 18 months with all 19 CHWs delivering the intervention and 36 purposively selected caregivers who received home visits. Analysis focused on perceptions of the end of the trial, when CHWs completed the scheduled home-based visits and there was no guarantee of programme continuation beyond the study. Results Termination of scheduled home visits caused significant distress to both CHWs and the households they visited. We identify 3 thematic “lessons learned” for CHW programmes. First, CHWs derived pride and self-worth from emotional labour as they became integral to families’ improved ability to cope, motivating them to go beyond formal job requirements. Second, clients’ growing dependence on CHWs led to “exit” being interpreted as abandonment by both CHWs and households, causing distress on both sides. Finally, in response to anxiety about “abandoning” families, CHWs maintained contact with families long after scheduled withdrawal of services. Conclusions CHWs can forge genuine bonds with households, creating expectations of long-term engagement. On the positive side, CHW derive pride from their work, attach social responsibility to their roles, and feel personal fulfilment in supporting families. If CHWs do not disengage from interventions as planned, or become demoralised by “exits”, interventions will prove less sustainable. CHWs are often lauded for their ability to develop trust with peers, yet this willingness and ability to create enduring emotional bonds could threaten programme delivery.

Abstract Background Community health worker (CHW)-delivered support visits to children living with HIV and their caregivers significantly reduced odds of virological failure among the children in the ZENITH trial conducted in Zimbabwe. We conducted a process evaluation to assess fidelity, acceptability, and feasibility of this intervention to identify lessons that could inform replication and scale-up of this approach. Methods Field manuals kept by each CHW, records from monthly supervisory meetings, and participant data collected throughout the trial were used to assess the intervention’s implementation. Data extracted from field manuals included visit type, content, and duration. Minutes from monthly supervisory meetings were used to capture CHW attendance. Results The trial enrolled 172 participants in the intervention arm of whom 5 subsequently refused all visits, 1 died before the intervention could be delivered, and 1 could not be located. Manuals for 8 participants were not returned, 3 were incorrectly entered, and 1 manual was lost. We had 154 manuals available for analysis. A total of 1553 visits were successfully conducted (median 11 per participant, range 1–20). Additionally, CHWs made 85 visits where they were unable to make contact with the family. Thirteen (8.4%) participants received 5 or fewer visits, 10 moved out of the study area, and 3 died. CHWs discussed disclosure with the child/family for over 89% of participants and assisted clients with developing and reviewing their personal treatment plan with over 85% of participants. Of the 20 CHWs (3 male, 17 female) selected to implement the intervention, 19 were retained at the end of the trial. Conclusions The intervention was acceptable to participants with most receiving and accepting the required number of visits. Key strenghts were high staff retention and fidelity to the intervention. This community-based intervention was an acceptable and feasible approach to reduce virological failure among children living with HIV. Trial registration The ZENITH trial was registered on 25 October 2012 in the Pan African Clinical Trials Registry under the trial registration number PACTR201212000442288. It can be found at http://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?dar=true&tNo=PACTR201212000442288.

Abstract Background Human immunodeficiency virus (HIV)-related chronic lung disease (CLD) among children is associated with substantial morbidity, despite antiretroviral therapy. This may be a consequence of repeated respiratory tract infections and/or dysregulated immune activation that accompanies HIV infection. Macrolides have anti-inflammatory and antimicrobial properties, and we hypothesised that azithromycin would reduce decline in lung function and morbidity through preventing respiratory tract infections and controlling systemic inflammation. Methods/design We are conducting a multicentre (Malawi and Zimbabwe), double-blind, randomised controlled trial of a 12-month course of weekly azithromycin versus placebo. The primary outcome is the mean change in forced expiratory volume in 1 second (FEV1) z-score at 12 months. Participants are followed up to 18 months to explore the durability of effect. Secondary outcomes are FEV1 z-score at 18 months, time to death, time to first acute respiratory exacerbation, number of exacerbations, number of hospitalisations, weight for age z-score at 12 and 18 months, number of adverse events, number of malaria episodes, number of bloodstream Salmonella typhi infections and number of gastroenteritis episodes. Participants will be followed up 3-monthly, and lung function will be assessed every 6 months. Laboratory substudies will be done to investigate the impact of azithromycin on systemic inflammation and on development of antimicrobial resistance as well as impact on the nasopharyngeal, lung and gut microbiome. Discussion The results of this trial will be of clinical relevance because there are no established guidelines on the treatment and management of HIV-associated CLD in children in sub-Saharan Africa, where 80% of the world’s HIV-infected children live and where HIV-associated CLD is highly prevalent. Trial registration ClinicalTrials.gov, NCT02426112 . Registered on 21 April 2015.