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Elizabeth Pleasants,1 Tekou B Koffi,2 Karen Weidert,1 Sandra I McCoy,1 Ndola Prata1 1School of Public Health, University of California at Berkeley, Berkeley, CA, USA; 2Cabinet De Recherche Et D’évaluation (CERA), Lomé, TogoCorrespondence: Ndola PrataSchool of Public Health, University of California at Berkeley, 2121 Berkeley Way West, #6142, Berkeley, CA 94720, USATel +1 510-642-6915Email Ndola@berkeley.eduBackground: Despite improvements in contraception availability, women face persistent barriers that compromise reproductive autonomy and informed choice. Provider bias is one way in which access to contraception can be restricted within clinical encounters and has been established as common in sub-Saharan Africa. This analysis assessed the prevalence of provider restrictions and the potential impact on women’s method uptake in Lomé, Togo.Methods: This sub-analysis used survey data from provider and client interviews collected to assess the impacts of the Agir pour la Planification Familiale (AgirPF) program in Togo. The relationships between provider restrictiveness and women’s receipt of their desired method of contraception were modelled using mixed effects logistic regressions looking at all women and among subgroups hypothesized to be at potentially higher risk of bias.Results: Around 84% of providers reported a restriction in contraceptive provision for the five contraceptive methods explored (pill, male condom, injectable, IUD, and implant). Around 53% of providers reported restricting at least four of the five methods based on age, parity, partner consent, or marital status. Among all women, there were no significant associations between provider restrictiveness and women’s receipt of desired method, including among those who desired long-acting methods. In adjusted modeling, marital status was a covariate significantly associated with desired method, with married women more likely to receive their desired method than unmarried women (aOR 2.73, 95% CI 1.45–5.13).Conclusion: Provider reports of high levels of restrictions in this population are concerning and should be further explored, especially its effects on unmarried women. However, restrictions reported by providers in this study did not appear to statistically significantly influence contraceptive method received.Keywords: provider bias, provider restrictions, contraception, Togo

Abstract Background Asthma is a major cause of pediatric morbidity and mortality. In acute exacerbations of asthma, corticosteroids reduce relapses, subsequent hospital admission and the need for ß2-agonist therapy. Prednisolone is relatively short-acting with a half-life of 12 to 36 hours, thereby requiring daily dosing. Prolonged treatment course, vomiting and a bitter taste may reduce patient compliance with prednisolone. Dexamethasone is a long-acting corticosteroid with a half-life of 36 to 72 hours. It is used frequently in children with croup and bacterial meningitis, and is well absorbed orally. The purpose of this trial is to examine whether a single dose of oral dexamethasone (0.3 mg/kg) is clinically non-inferior to prednisolone (1 mg/kg/day for three days) in the treatment of exacerbations of asthma in children who attend the Emergency Department. Methods/design This is a randomized, non-inferiority, open-label clinical trial. After informed consent with or without assent, patients will be randomized to either oral dexamethasone 0.3 mg/kg stat or prednisolone 1 mg/kg/day for three days. The primary outcome measure is the comparison between the Pediatric Respiratory Assessment Measure (PRAM) across both groups on Day 4. The PRAM score, a validated, responsive and reliable tool to determine asthma severity in children aged 2 to 16 years, will be performed by a clinician blinded to treatment allocation. Secondary outcomes include relapse, hospital admission and requirement for further steroid therapy. Data will be analyzed on an intention-to-treat and a per protocol basis. With a sample size of 232 subjects (105 in each group with an estimated 10% loss to follow-up), we will be able to reject the null hypothesis - that the population means of the experimental and control groups are equal with a probability (power) of 0.9. The Type I error probability associated with this test (of the null hypothesis) is 0.05. Discussion This clinical trial may provide evidence that a shorter steroid course using dexamethasone can be used in the treatment of acute pediatric asthma, thus eliminating the issue of compliance to treatment. Registration ISRCTN26944158 and EudraCT Number 2010-022001-18

Abstract Background Children with sickle cell disease (SCD) frequently and unpredictably present to the emergency department (ED) with pain. The painful event is the hallmark acute clinical manifestation of SCD, characterised by sudden onset and is usually bony in origin. This study aims to establish if 1.5mcg/kg of intranasal fentanyl (INF; administered via a Mucosal Atomiser Device, MAD™) is non-inferior to intravenous morphine 0.1 mg/kg in severe SCD-associated pain. Methods/design This study is a randomised,double-blind, double-dummy active control trial of children (weighing more than 10 kg) between 1 year and 21 years of age with severe painful sickle cell crisis. Severe pain is defined as rated seven or greater on a 0 to 10 age-appropriate numeric pain scale or equivalent. The trial will be conducted in a single tertiary urban paediatric ED in Dublin, Ireland. Each patient will receive a single active agent and a single placebo via the intravenous and intranasal routes. All clinical and research staff, patients and parents will be blinded to the treatment allocation. The primary endpoint is severity of pain scored at 10 min from administration of the study medications. Secondary endpoints include pain severity measured at 0, 5, 15, 20, 30, 60 and 120 min after the administration of analgesia, proportion of patients requiring rescue analgesia and incidence of adverse events. The trial ends at 120 min after the administration of the study drugs. A clinically meaningful difference in validated pain scores has been defined as 13 mm. Setting the permitted threshold to 50% of this limit (6 mm) and assuming both treatments are on average equal, a sample size of 30 patients (15 per group) will provide at least 80% power to demonstrate that INF is non-inferior to IV morphine with a level of significance of 0.05. Discussion This clinical trial will inform of the role of INF 1.5mcg/kg via MAD in the acute treatment of severe painful sickle cell crisis in children in the ED setting. Trial registration Current Controlled Trials ISRCTN67469672 and EudraCT no. 2011-005161-20

Objectives: This study aimed to develop a machine learning (ML) model to predict disengagement from HIV care, high viral load or death among people living with HIV (PLHIV) with the goal of enabling proactive support interventions in Tanzania. The algorithm addressed common challenges when applying ML to electronic medical record (EMR) data: (1) imbalanced outcome distribution; (2) heterogeneity across multisite EMR data and (3) evolving virological suppression thresholds., Design: Observational study using a national EMR database., Setting: Conducted in two regions in Tanzania, using data from the National HIV Care database., Participants: The study included over 6 million HIV care visit records from 295 961 PLHIV in two regions in Tanzania's National HIV Care database from January 2015 to May 2023., Results: Our ML model effectively identified PLHIV at increased risk of adverse outcomes. Key predictors included past disengagement from care, antiretroviral therapy (ART) status (which tracks a patient's engagement with ART across visits), age and time on ART. The downsampling approach we implemented effectively managed imbalanced data to reduce prediction bias. Site-specific algorithms performed better compared with a universal approach, highlighting the importance of tailoring ML models to local contexts. A sensitivity analysis confirmed the model's robustness to changes in viral load suppression thresholds., Conclusions: ML models leveraging large-scale databases of patient data offer significant potential to identify PLHIV for interventions to enhance engagement in HIV care in resource-limited settings. Tailoring algorithms to local contexts and flexibility towards evolving clinical guidelines are essential for maximising their impact., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

We conducted a cluster-randomized hybrid effectiveness-implementation study of CyberRwanda, a digital family planning and reproductive health intervention for Rwandan adolescents. Sixty schools were randomized 1:1:1 to control or to one of two implementation models-self-service (self-guided access on tablets) or facilitated (peer-led clubs plus tablet access) with no masking. Eligible participants were aged 12-19 years, in secondary school levels 1 or 2, and willing to provide consent or assent/parental consent and contact information for follow-up. In 2021, 6,078 randomly selected adolescents were enrolled. At 24 months, 91.3% of participants were retained and included in the primary intention-to-treat analyses (control, n = 1,845; self-service, n = 1,849 and facilitated, n = 1,858). There were no adverse events related to the study. CyberRwanda did not affect the primary outcomes of modern contraceptive use (prevalence ratio (PR) = 1.04; 95% confidence interval (CI) = 0.76, 1.42), childbearing (PR = 1.33; 95% CI = 0.71, 2.50) and HIV testing (PR = 1.00; 95% CI = 0.91, 1.11) in the full sample. Significantly higher modern contraceptive use observed in the CyberRwanda facilitated arm in a prespecified analysis of sexually active participants suggests that longer-term evaluation is needed to examine effects as more of the study population becomes sexually active and has increased demand for contraception. ClinicalTrials.gov registration: NCT04198272 ., (© 2024. The Author(s), under exclusive licence to Springer Nature America, Inc.)

Introduction: Little is known regarding health care seeking behaviors of women in sub-Saharan Africa, specifically Cameroon, who experience violence. The proportion of women who experienced violence enrolled in the Cameroon Trauma Registry (CTR) is lower than expected., Methods: We concatenated the databases from the October 2017-December 2020 CTR and 2018 Cameroon Demographic and Health Survey (DHS) into a singular database for cross-sectional study. Continuous and categorical variables were compared with Wilcoxon rank-sum and Fisher's exact test. Multivariable logistic regression examined associations between demographic factors and women belonging to the DHS or CTR cohort. We performed additional classification tree and random forest variable importance analyses., Results: 276 women (13%) in the CTR and 197 (13.1%) of women in the DHS endorsed violence from any perpetrator. A larger percentage of women in the DHS reported violence from an intimate partner (71.6% vs. 42.7%, p<0.001). CTR women who experienced IPV demonstrated greater university-level education (13.6% vs. 5.0%, p<0.001) and use of liquid petroleum gas (LPG) cooking fuel (64.4% vs. 41.1%, p<0.001). DHS women who experienced IPV reported greater ownership of agricultural land (29.8% vs. 9.3%, p<0.001). On regression, women who experienced IPV using LPG cooking fuel (aOR 2.55, p = 0.002) had greater odds of belonging to the CTR cohort while women who owned agricultural land (aOR 0.34, p = 0.007) had lower odds of presenting to hospital care. Classification tree variable observation demonstrated that LPG cooking fuel predicted a CTR woman who experienced IPV while ownership of agricultural land predicted a DHS woman who experienced IPV., Conclusion: Women who experienced violence presenting for hospital care have characteristics associated with higher SES and are less likely to demonstrate factors associated with residence in a rural setting compared to the general population of women experiencing violence., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Yost et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: Adverse sexual and reproductive health (SRH) outcomes, such as unplanned pregnancies and HIV infection, disproportionately affect adolescent girls and young women (AGYW; aged 15-24 years) in east Africa. Increasing uptake of preventive SRH services via innovative, youth-centred interventions is imperative to addressing disparities in SRH outcomes., Methods and Analysis: From 2018 to 2019, we used human-centred design to co-develop a theoretically driven HIV and pregnancy prevention intervention for AGYW at private drug shops called Accredited Drug Dispensing Outlets (ADDOs) in Tanzania. The result, Malkia Klabu (Queen Club), was a customer loyalty programme designed to strengthen ADDOs' role as SRH providers while encouraging uptake of critical SRH prevention products among AGYW. Malkia Klabu members had access to free contraceptives and oral HIV self-test (HIVST) kits and earned punches on a loyalty card for other shop purchases; punches were redeemable for small prizes. Our pilot among 40 shops showed that intervention ADDOs had higher AGYW patronage and distributed more HIVST kits and contraceptives to AGYW relative to business-as-usual (ie, client purchasing) comparison shops. We will conduct a cluster-randomised controlled trial (c-RCT) among 120-140 ADDOs in 40 health catchment areas in Shinyanga and Mwanza Regions (Lake Zone), Tanzania. ADDO shop recruitment includes a 1-month run-in with a tablet-based electronic inventory management system for tracking shop transactions, followed by enrolment, randomisation and a 24-month trial period. Our c-RCT evaluating the human-centred design-derived intervention will assess population impact on the primary outcomes of HIV diagnoses and antenatal care registrations, measured with routine health facility data. We will also assess secondary outcomes focusing on mechanisms of action, evaluate programme exposure and AGYW behaviour change in interviews with AGYW, and assess shop-level implementation strategies and fidelity., Ethics and Dissemination: Ethical approval was granted from both the University of California, San Francisco and the Tanzanian National Institute for Medical Research. Study progress and final outcomes will be posted annually to the National Clinical Trials website; study dissemination will occur at conferences, peer-reviewed manuscripts and local convenings of stakeholders., Trial Registration Number: NCT05357144., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Importance: Nearly half of US states have restricted abortion access. Policy makers are exploring pathways to increase access to abortion and reproductive health care more broadly. Since 2016, California pharmacists could prescribe hormonal birth control, providing an opportunity to learn about the implementation of pharmacist-provided reproductive health care., Objective: To explore the feasibility of broadening pharmacist scope of practice to include prescribing medication abortion., Design, Setting, and Participants: A cross-sectional online survey was conducted from October 11 to December 20, 2022, among a convenience sample of California licensed community pharmacists to examine their attitudes toward, knowledge of, and confidence in prescribing hormonal birth control and reports of pharmacy-level practices., Main Outcomes and Measures: Descriptive analyses and log-binomial regression models were used to compare medication abortion and contraceptive provision attitudes by pharmacist and pharmacy characteristics., Results: Among the 316 pharmacists included in the analysis who worked at community pharmacies across California (mean [SD] age, 40.9 [12.0] years; 169 of 285 [59.3%] cisgender women; and 159 of 272 [58.5%] non-Hispanic Asian individuals), most (193 of 280 [68.9%]) indicated willingness to prescribe medication abortion to pharmacy clients if allowed by law. However, less than half were confident in their knowledge of medication abortion (139 of 288 [48.3%]) or their ability to prescribe it (115 of 285 [40.4%]). Pharmacists who indicated that providing access to hormonal birth control as a prescribing provider was important (263 of 289 [91.0%]) and were confident in their ability to prescribe it (207 of 290 [71.4%]) were 3.96 (95% CI, 1.80-8.73) times and 2.44 (95% CI, 1.56-3.82) times more likely to be willing to prescribe medication abortion and to express confidence in doing so, respectively. Although most pharmacists held favorable attitudes toward hormonal birth control, less than half (144 of 308 [46.8%]) worked in a pharmacy that provided prescriptions for hormonal birth control, and 149 who did not reported barriers such as lack of knowledge or training (65 [43.6%]), insufficient staff or time to add new services (58 [38.9%]), and lack of coverage for services (50 [33.6%])., Conclusions and Relevance: The findings of this cross-sectional survey study of California pharmacists suggest that most pharmacists were willing to prescribe medication abortion. However, future efforts to expand pharmacists' scope of practice should include training to increase knowledge and confidence in prescribing medication abortion. Pharmacy-level barriers to hormonal birth control prescription, such as insurance coverage for pharmacist effort, should also be addressed, as they may serve as barriers to medication abortion access.

Despite the commendable progress made in addressing global health challenges and threats such as child mortality, HIV/AIDS, and Tuberculosis, many global health organizations still exhibit a Global North supremacy attitude, evidenced by their choice of leaders and executors of global health initiatives in low- and middle-income countries (LMICs). While efforts by the Global North to support global health practice in LMICs have led to economic development and advancement in locally led research, current global health practices tend to focus solely on intervention outcomes, often neglecting important systemic factors such as intellectual property ownership, sustainability, diversification of leadership roles, and national capacity development. This has resulted in the implementation of practices and systems informed by high-income countries (HICs) to the detriment of knowledge systems in LMICs, as they are deprived of the opportunity to generate local solutions for local problems. From their unique position as international global health fellows located in different African countries and receiving graduate education from a HIC institution, the authors of this viewpoint article assess how HIC institutions can better support LMICs. The authors propose several strategies for achieving equitable global health practices; 1) allocating funding to improve academic and research infrastructures in LMICs; 2) encouraging effective partnerships and collaborations with Global South scientists who have lived experiences in LMICs; 3) reviewing the trade-related aspects of intellectual property Rights (TRIPS) agreement; and 4) achieving equity in global health funding and education resources., Competing Interests: AWW, BEN, JJ, and MK, are current Gilead Global Health fellows in the University of California, Berkeley’s Online/On-campus MPH program and are receiving sponsorship for their graduate studies through the global health program. ENS is a graduate of the University of California, Berkeley School of Public Health. SM is a professor in Epidemiology at the University of California, Berkeley School of Public Health. The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright: © 2024 The Author(s).)

Background: Age-disparate relationships (ADR) place adolescent girls and young women (AGYW) at higher risk of unprotected sex and HIV infection; few studies have investigated ADR at first sex in sub-Saharan Africa. This study investigates ADR at first sex and its association with reproductive autonomy, reproductive empowerment, contraception coercion, and consent at first sex among female Rwandan youth., Methods: Cross-sectional data from a randomized trial (n = 5768) of in-school youth ages 12-19 at enrollment were analyzed with focus on those who reported sexual activity (n = 1319). General estimating equation linear models and Poisson models were used to estimate linear coefficients and prevalence ratios (PR), with 95% confidence intervals (CIs) estimated using robust standard errors., Results: Females reported a significantly higher average partner age gap than males by 2.43 years (2.90 years vs. 0.46 years, 95% CI: 2.01, 2.86). Overall, 23.4% (n = 102) of sexually active AGYW engaged in an ADR at first sex. The prevalence of non-consensual first sex was 60% higher among AGYW reporting ADR at first sex compared to AGYW reporting similar-aged partners (adjusted PR = 1.59, 95% CI: 1.25, 2.02). No association was found between ADR at first sex and reproductive autonomy, reproductive empowerment, or contraception coercion., Conclusions: Our results suggest a high prevalence of sexual violence among AGYW engaging in first sex with an age-disparate partner. However, we did not find evidence that ADR at first sex affects reproductive autonomy or empowerment within the first few years of sexual initiation. Further research is needed to explore the impact of ADR at first sex and longer-term trajectories of sexual behavior, empowerment and autonomy., Competing Interests: None., (© 2024 The Authors.)

Background: Economic incentives can improve clinical outcomes among in-care people living with HIV (PLHIV), but evidence is limited for their effectiveness among out-of-care PLHIV or those at risk of disengagement. We propose a type 1 hybrid effectiveness-implementation study to advance global knowledge about the use of economic incentives to strengthen the continuity of HIV care and accelerate global goals for HIV epidemic control., Methods: The Rudi Kundini, Pamoja Kundini study will evaluate two implementation models of an economic incentive strategy for supporting two groups of PLHIV in Tanzania. Phase 1 of the study consists of a two-arm, cluster randomized trial across 32 health facilities to assess the effectiveness of a home visit plus one-time economic incentive on the proportion of out-of-care PLHIV with viral load suppression (< 1000 copies/ml) 6 months after enrollment (n = 640). Phase 2 is an individual 1:1 randomized controlled trial designed to determine the effectiveness of a short-term counseling and economic incentive program offered to in-care PLHIV who are predicted through machine learning to be at risk of disengaging from care on the outcome of viral load suppression at 12 months (n = 692). The program includes up to three incentives conditional upon visit attendance coupled with adapted counselling sessions for this population of PLHIV. Consistent with a hybrid effectiveness-implementation study design, phase 3 is a mixed methods evaluation to explore barriers and facilitators to strategy implementation in phases 1 and 2. Results will be used to guide optimization and scale-up of the incentive strategies, if effective, to the larger population of Tanzanian PLHIV who struggle with continuity of HIV care., Discussion: Innovative strategies that recognize the dynamic process of lifelong retention in HIV care are urgently needed. Strategies such as conditional economic incentives are a simple and effective method for improving many health outcomes, including those on the HIV continuum. If coupled with other supportive services such as home visits (phase 1) or with tailored counselling (phase 2), economic incentives have the potential to strengthen engagement among the subpopulation of PLHIV who struggle with retention in care and could help to close the gap towards reaching global "95-95-95" goals for ending the AIDS epidemic., Trial Registration: Phase 1: ClinicalTrials.gov, NCT05248100 , registered 2/21/2022. Phase 2: ClinicalTrials.gov, NCT05373095 , registered 5/13/2022., (© 2024. The Author(s).)

Background: Adolescent girls and young woman (AGYW) comprise a significant proportion of new HIV infections and unintended pregnancies in sub-Saharan Africa yet face many barriers to accessing family planning and reproductive health (FPRH) information and services. Developed via human-centered design, the Malkia Klabu ("Queen Club") program aimed to facilitate access to HIV self-testing (HIVST) and FPRH information and products at privately-owned drug shops. We sought to understand barriers and facilitators to program implementation in a 4-month pilot in Tanzania., Methods: Forty semi-structured interviews were conducted with participants in a cluster randomized trial of the Malkia Klabu program from November 2019 through March 2020, including 11 with AGYW, 26 with drug shopkeepers, and three with counselors at health facilities to whom AGYW were referred. Interviews were audio-recorded, transcribed, coded, and analyzed to identify key themes. The Consolidated Framework for Implementation Research (CFIR) was used to assess barriers and facilitators to program implementation at multiple levels. CFIR considers the outer setting (e.g., culture and systemic conditions), the inner setting where the intervention is implemented (e.g., incentives, relationships, and available resources), the individuals involved, the innovation as it relates to stakeholder needs, and the implementation process., Results: The Malkia Klabu program reshaped and directed the role of drug shopkeepers as providers of information and resources rather than FPRH gatekeepers. Key implementation facilitators included the program's adaptability to a wide range of needs and stages of readiness among AGYW, ability to capitalize on AGYW social networks for driving membership, responsiveness to AGYW's need for privacy, and positive contributions to the income and community standing of drug shopkeepers. Components such as HIVST were highly acceptable to both AGYW and shopkeepers, and the introduction of the loyalty program and HIVST kits in shops opened doors to the provision of FPRH products and information, which was further facilitated by program tools such as videos, product displays, and symbol cards. Although some shopkeepers maintained beliefs that certain contraceptive methods were inappropriate for AGYW, most appeared to provide the products as part of the program., Conclusions: The Malkia Klabu intervention's success was due in part to its ability to address key motivations of both AGYW and drug shopkeepers, such as maintaining privacy and increasing access to FPRH products for AGYW and increasing business for shops. Better understanding these implementation barriers and facilitators can inform the program's future adaptation and scale-up., Trial Registration: clinicaltrials.gov #NCT04045912., (© 2024. The Author(s).)

Background: Pharmacies are a promising setting through which to expand access to human immunodeficiency virus (HIV) prevention, including pre-exposure and post-exposure prophylaxis (PrEP and PEP, respectively). We aimed to evaluate and inform the implementation of California's Senate Bill 159 (2019), allowing pharmacists to independently prescribe PrEP and PEP., Methods: From October through December 2022, we conducted a cross-sectional study of 919 California pharmacists and pharmacy students, primarily recruited via the email listservs of professional organizations. Participants completed an online survey assessing the implementation of pharmacist-initiated PrEP/PEP, including knowledge, attitudes, practices, perceived barriers, and implementation preferences elicited through a discrete choice experiment., Results: Among 919 participants (84% practicing pharmacists, 43% in community pharmacies), 11% and 13% reported that pharmacists at their pharmacy initiate PrEP and PEP, respectively. Most believed that pharmacist-initiated PrEP/PEP is important (96%) and were willing to provide PrEP (81%); fewer (27%) had PrEP/PEP training. Common implementation barriers were lack of staff/time and payment for pharmacist services. Participants preferred PrEP implementation models with in-pharmacy rapid oral HIV testing and pharmacists specifically hired to provide PrEP services., Conclusions: Despite pharmacists' supportive attitudes, Senate Bill 159 implementation in California pharmacies remains limited, in part due to policy-level and organizational-level barriers. Ensuring PrEP/PEP-related payment for services and sufficient workforce capacity is key to leveraging pharmacists' role in HIV prevention., Competing Interests: Potential conflicts of interest. All authors: No reported conflicts., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Objectives: To examine how sales of sexual and reproductive health (SRH) products varied among pharmacies in Kenya using administrative data, leveraging natural variation in the COVID-19 pandemic and accompanying policy restrictions between 2019 and 2021., Design and Setting: Ecological study of pharmacies in Kenya., Participants: 761 pharmacies using the Maisha Meds product inventory management system (capturing 572 916 products sold)., Outcomes: Sales quantity, price and revenue of SRH products sold per pharmacy per week., Results: COVID-19 deaths were associated with a -2.97% (95% CI -3.82%, -2.11%) decrease in sales quantity, a 1.09% (95% CI 0.44%, 1.72%) increase in sales price and a -1.89% (-1.00%, -2.79%) decrease in revenues per pharmacy per week. Results were similar when considering new COVID-19 cases (per 1000) and the Average Policy Stringency Index. Results differed substantially between individual SRH products-a large decrease in sales quantity in pregnancy tests, injectables and emergency contraception, a modest decrease in condoms and no change in oral contraception. Sales price increases were similarly varied; four of the five most sold products were revenue neutral., Conclusions: We found a robust negative association between SRH sales at pharmacies in Kenya and COVID-19 reported cases, deaths and policy restriction. Although our data cannot definitively point to reduced access, existing evidence from Kenya regarding unchanged fertility intentions, increases in unintended pregnancies and reported reasons for non-use of contraceptives during COVID-19 suggests a prominent role of reduced access. While policymakers may have a role in sustaining access, their role may be limited by broader macroeconomic problems, such as global supply chain disruptions and inflation, during supply shocks., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The field of violence prevention research is unequivocal that interventions must target contextual factors, like social norms, to reduce gender-based violence. Limited research, however, on the social norms contributing to intimate partner violence or reproductive coercion exists. One of the driving factors is lack of measurement tools to accurately assess social norms., Methods: Using an item response modelling approach, this study psychometrically assesses the reliability and validity of a social norms measure of the acceptability of intimate partner violence to exert control over wife agency, sexuality, and reproductive autonomy with data from a population-based sample of married adolescent girls (ages 13-18) and their husbands in rural Niger (n = 559 husband-wife dyads) collected in 2019., Results: A two-dimensional Partial Credit Model for polytomous items was fit, showing evidence of reliability and validity. Higher scores on the "challenging husband authority" dimension were statistically associated with husband perpetration of intimate partner violence., Conclusions: This brief scale is a short (5 items), practical measure with strong reliability and validity evidence. This scale can help identify populations with high-need for social norms-focused IPV prevention and to help measure the impact of such efforts., (© 2023. The Author(s).)

Background: Concerns about the interconnected relationship between HIV and mental health were heightened during the COVID-19 pandemic. This study assessed whether there were temporal changes in the mental health status of people living with HIV presenting for care in Shinyanga region, Tanzania. Specifically, we compared the prevalence of depression and anxiety before and during COVID-19, with the goal of describing the changing needs, if any, to person-centered HIV services., Methods: We analyzed baseline data from two randomized controlled trials of adults initiating ART in Shinyanga region, Tanzania between April-December 2018 (pre-COVID-19 period, n = 530) and May 2021-March 2022 (COVID-19 period, n = 542), respectively. We compared three mental health indicators that were similarly measured in both surveys: loss of interest in things, hopelessness about the future, and uncontrolled worrying. We also examined depression and anxiety which were measured using the Hopkins Symptom Checklist-25 in the pre-COVID-19 period and the Patient Health Questionnaire-4 in the COVID-19 period, respectively, and classified as binary indicators per each scale's threshold. We estimated prevalence differences (PD) in adverse mental health status before and during the COVID-19 pandemic, using stabilized inverse probability of treatment weighting to adjust for underlying differences in the two study populations., Results: We found significant temporal increases in the prevalence of feeling 'a lot' and 'extreme' loss of interest in things ['a lot' PD: 38, CI 34,41; 'extreme' PD: 9, CI 8,12)], hopelessness about the future [' a lot' PD: 46, CI 43,49; 'extreme' PD: 4, CI 3,6], and uncontrolled worrying [' a lot' PD: 34, CI 31,37; 'extreme' PD: 2, CI 0,4] during the COVID-19 pandemic. We also found substantially higher prevalence of depression [PD: 38, CI 34,42] and anxiety [PD: 41, CI 37,45]., Conclusions: After applying a quasi-experimental weighting approach, the prevalence of depression and anxiety symptoms among those starting ART during COVID-19 was much higher than before the pandemic. Although depression and anxiety were measured using different, validated scales, the concurrent increases in similarly measured mental health indicators lends confidence to these findings and warrants further research to assess the possible influence of COVID-19 on mental health among adults living with HIV. Trial Registration NCT03351556, registered November 24, 2017; NCT04201353, registered December 17, 2019., (© 2023. The Author(s).)

Machine learning methods for health care delivery optimization have the potential to improve retention in HIV care, a critical target of global efforts to end the epidemic. However, these methods have not been widely applied to medical record data in low- and middle-income countries. We used an ensemble decision tree approach to predict risk of disengagement from HIV care (missing an appointment by ≥28 days) in Tanzania. Our approach used routine electronic medical records (EMR) from the time of antiretroviral therapy (ART) initiation through 24 months of follow-up for 178 adults (63% female). We compared prediction accuracy when using EMR-based predictors alone and in combination with sociodemographic survey data collected by a research study. Models that included only EMR-based indicators and incorporated changes across past clinical visits achieved a mean accuracy of 75.2% for predicting risk of disengagement in the next 6 months, with a mean sensitivity of 54.7% for targeting the 30% highest-risk individuals. Additionally including survey-based predictors only modestly improved model performance. The most important variables for prediction were time-varying EMR indicators including changes in treatment status, body weight, and WHO clinical stage. Machine learning methods applied to existing EMR data in resource-constrained settings can predict individuals' future risk of disengagement from HIV care, potentially enabling better targeting and efficiency of interventions to promote retention in care., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Fahey et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: People incarcerated in US prisons have been disproportionately harmed by the COVID-19 pandemic. That prisons are such efficient superspreading environments can be attributed to several known factors: small, communal facilities where people are confined for prolonged periods of time; poor ventilation; a lack of non-punitive areas for quarantine/medical isolation; and staggeringly high numbers of people experiencing incarceration, among others. While health organizations have issued guidance on preventing and mitigating COVID-19 infection in carceral settings, little is known about if, when, and how recommendations have been implemented. We examined factors contributing to containment of one of the first California prison COVID-19 outbreaks and remaining vulnerabilities using an adapted multi-level determinants framework to systematically assess infectious disease risk in carceral settings., Methods: Case study employing administrative data; observation; and informal discussions with: people incarcerated at the prison, staff, and county public health officials., Results: Outbreak mitigation efforts were characterized by pre-planning (e.g., designation of ventilated, single-occupancy quarantine) and a quickly mobilized inter-institutional response that facilitated systematic, voluntary rapid testing. However, several systemic- and institutional-level vulnerabilities were unaddressed hindering efforts and posing significant risk for future outbreaks, including insufficient decarceration, continued inter-facility transfers, incomplete staff cohorting, and incompatibility between built environment features (e.g., dense living conditions) and public health recommendations., Conclusions: Our adapted framework facilitates systematically assessing prison-based infectious disease outbreaks and multi-level interventions. We find implementing some recommended public health strategies may have contributed to outbreak containment. However, even with a rapidly mobilized, inter-institutional response, failure to decarcerate created an overreliance on chance conditions. This left the facility vulnerable to future catastrophic outbreaks and may render standard public health strategies - including the introduction of effective vaccines - insufficient to prevent or contain those outbreaks., (© 2022. The Author(s).)

Adolescents experience significant barriers, including stigma and discrimination, to accessing voluntary family planning and reproductive health (FP/RH) services in Rwanda. Self-care interventions have been shown to reduce social barriers to FP/RH care, but little is known about the effectiveness of digital self-care for adolescents, particularly in low-resource settings. This paper presents findings from a pilot study of CyberRwanda, a digital self-care intervention providing comprehensive sexuality education and confidential online ordering of contraceptives for school-aged youth in Rwanda through a rights-based approach. A mixed-methods pilot study was conducted from November 2019 to February 2020 to assess feasibility, acceptability, and engagement and to inform a future impact evaluation. Surveys were administered to a random sample of 158 students aged 12-19 years in three secondary schools. In-depth interviews were conducted with students, parents, teachers, pharmacists, district-level administrators, and youth centre staff. Descriptive statistics were calculated and qualitative data were analyzed using a thematic coding approach. One hundred and fifty-eight surveys and 28 interviews were conducted. Results revealed high demand for CyberRwanda in schools. Students were interested in engaging with the program and found the FP/RH content relevant to their needs. However, few purchased contraceptive products through the online ordering system. There are preliminary indications that CyberRwanda may improve access to FP/RH information. An extended implementation period and further research are needed to measure the long-term impacts of the program and evaluate whether this digital self-care intervention can increase uptake of contraceptive methods and reduce adolescent pregnancy among school-aged youth.

Introduction: Conditional economic incentives are shown to promote medication adherence across a range of health conditions and settings; however, any long-term harms or benefits from these time-limited interventions remain largely unevaluated. We assessed 2-3 years outcomes from a 6-month incentive programme in Tanzania that originally improved short-term retention in HIV care and medication possession., Methods: We traced former participants in a 2013-2016 trial, which randomised 800 food-insecure adults starting HIV treatment at three clinics to receive either usual care (control) or up to 6 months of cash or food transfers (~US$11/month) contingent on timely attendance at monthly clinic appointments. The primary intention-to-treat analysis estimated 24-month and 36-month marginal risk differences (RD) between incentive and control groups for retention in care and all-cause mortality, using multiple imputation for a minority of missing outcomes. We also estimated mortality HRs from time-stratified Cox regression., Results: From 3 March 2018 to 19 September 2019, we determined 36-month retention and mortality statuses for 737 (92%) and 700 (88%) participants, respectively. Overall, approximately 660 (83%) participants were in care at 36 months while 43 (5%) had died. There were no differences between groups in retention at 24 months (86.5% intervention vs 84.4% control, RD 2.1, 95% CI -5.2 to 9.3) or 36 months (83.3% vs 77.8%, RD 5.6, -2.7 to 13.8), nor in mortality at either time point. The intervention group had a lower rate of death during the first 18 months (HR 0.27, 95% CI 0.10 to 0.74); mortality was similar thereafter (HR 1.13, 95% CI 0.33 to 3.79)., Conclusion: These findings confirm that incentives are a safe and effective tool to promote short-term adherence and potentially avert early deaths at the critical time of HIV treatment initiation. Complementary strategies are recommended to sustain lifelong retention in HIV care., Trial Registration Number: NCT01957917., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Adolescent and young adult women in sub-Saharan Africa experience barriers to sexual and reproductive health (SRH) services that elevate their risk of human immunodeficiency virus (HIV) acquisition and unintended pregnancy. Community drug shops may be effective distribution points to connect young women with SRH products. Thus, we used human-centred design (HCD) to create drug shops where young women could access HIV self-testing and contraception in Shinyanga, Tanzania. Enhancing the HCD process with behavioural science, we collected diverse data (i.e. 18 in-depth interviews, 9 'shadowing' interviews, 6 shop observations, 6 focus groups) to understand the latent needs and motivations of young women and drug shopkeepers, brainstormed creative solutions and iteratively refined and tested solutions for acceptability, feasibility and cultural fit. We found a widespread moral imperative to control young women's behaviour via misinformation about SRH, community gossip and financial control. Young women often engaged in mundane shopping at the behest of others. At drug shops, few SRH products were deemed appropriate for unmarried women, and many reactively sought SRH products only after engaging in higher risk behaviours. In response to these insights, we designed the 'Malkia Klabu' ('Queen Club') loyalty programme through which young women could earn mystery prizes by shopping at drug shops and discreetly request free SRH products, including HIV self-test kits, by pointing at symbols on loyalty cards. Our HCD approach increases the likelihood that the intervention will address the specific needs and preferences of both drug shopkeepers and young women. We will evaluate its effectiveness in a randomized trial., (© The Author(s) 2021. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine.)

Background: Viral suppression is key to ending the HIV epidemic, yet only 58% of people living with HIV (PLHIV) in sub-Saharan Africa are suppressed. Cash transfers are an effective strategy to improve retention in care, but little is known about optimization of implementation; for example, designing effective programs that integrate into existing clinic workflows. We studied implementation of an mHealth system to deliver cash transfers to support retention., Methods: We conducted a mixed-methods study assessing implementation of an mHealth cash transfer study. This was part of a larger, hybrid implementation-effectiveness randomized controlled trial evaluating cash transfers conditional on visit attendance for viral suppression among Tanzanian PLHIV initiating ART. An mHealth system using fingerprint identification and mobile payments was used to automatically disburse mobile money to eligible PLHIV. We used Proctor's framework, assessing implementation of the mHealth system from the perspectives of PLHIV and clinicians. We analyzed mHealth system data and conducted surveys (n = 530) and in-depth interviews (n = 25) with PLHIV, clinic and pharmacy staff (n = 10), and structured clinic observations (n = 2293 visits)., Results: One thousand six hundred fifty-one cash transfers were delivered to 346 PLHIV in the cash arms, 78% through mobile money. Among those in the cash arms, 81% registered their mobile money account with the mHealth system by study end, signaling high adoption. While acceptability for fingerprinting and mobile payments was high among PLHIV, interviews revealed mixed views: some had privacy concerns while others felt the system was secure and accurate, and provided some legitimacy to the clinical visits. Pharmacists praised system efficiency, but concerns about duplicative recordkeeping and added work arose. Clinic staff voiced excitement for the system's potential to bring the cash program to all patients and simplify workflows; yet concerns about multiple systems, staffing, and intermittent connectivity tempered enthusiasm, highlighting structural issues beyond program scope. Structured observations revealed a steep learning curve; repeat fingerprint scans and manual entry declined as the system improved., Conclusions: Biometric identification and mobile payments were acceptable to most patients and staff. Fingerprinting encountered some feasibility limitations in the first months of testing; however, mobile payments were highly successful. Biometric identification and mobile payments may provide a scalable mechanism to improve patient tracking and efficiently implement financial incentives in low-resource settings., Trial Registration: Name of the registry: clinicaltrials.gov Trial registration number: NCT03351556 Date of registration: 11/24/2017 Checklists: StaRI (included with submission). Note CONSORT for cluster-randomized trials was used for the main trial but is not directly applicable to this manuscript., (© 2021. The Author(s).)

Background: Public health initiatives must look for ways to cost-effectively scale critical interventions to achieve high coverage. Private sector distribution channels, can potentially distribute preventive healthcare products to hard-to-reach populations, decongest public healthcare systems, and increase the sustainability of programs by getting customers to share costs. However, little is known about how sellers set prices for new products. By introducing a new product, HIV self-test kits, to local drug shops, we observed whether shops experimented with pricing, charged different buyers different prices, and whether prices converged within the local market over our study period., Methods: From August to December 2019, we provided free HIV self-test kits, a new product, to 26 drug shops in Shinyanga, Tanzania to sell to the local community. We measured sales volume, price, customer age and sex using shop records. Using a multiple linear regression model, we conducted F-tests to determine whether shop, age, sex, and time (week) respectively were associated with price. We measured willingness-to-pay to restock test kits at the end of the study., Results: 514 test kits were sold over 18 weeks; 69% of buyers were male, 40% were aged 25-34 and 32% aged 35-44. Purchase prices ranged from 1000 to 6000 Tsh (median 3000 Tsh; ~$1.30 USD). Within shops, prices were 11.3% higher for 25-34 and 12.7% higher for 45+ year olds relative to 15-19-year olds (p = 0.029) and 13.5% lower for men (p = 0.023) on average. Although prices varied between shops, prices varied little within shops over time, and did not converge over the study period or cluster geospatially. Mean maximum willingness-to-pay to restock was 2000 Tsh per kit., Conclusions: Shopkeepers charged buyers different prices depending on buyers' age and sex. There was limited variation in prices within shops over time and low demand among shopkeepers to restock at the end of the study. Given the subsidized global wholesale price ($2 USD or ~ 4600 Tsh), further demand creation and/or cost-reduction is required before HIV self-test kits can become commercially viable in drug shops in this setting. Careful consideration is needed to align the motivations of retailers with public health priorities while meeting their private for-profit needs.

Background: HIV risk remains high among adolescent girls and young women (AGYW, ages 15-24) in Tanzania. Many AGYW experience stigma and provider bias at health facilities, deterring their use of HIV prevention services. Privately-owned drug shops, ubiquitous in many communities, may be an effective and accessible channel to deliver HIV prevention products to AGYW, including oral pre-exposure prophylaxis (PrEP) and the dapivirine vaginal ring., Methods: In July-August 2019, we enrolled 26 drug shops in Shinyanga, Tanzania in an ongoing study to create "girl-friendly" drug shops where AGYW can access HIV self-testing and contraception. At baseline, all shop dispensers were given basic information about oral PrEP and the dapivirine ring and were asked about their interest in stocking each. During the next 3-5 months, we surveyed AGYW (n = 56) customers about their interest in oral PrEP and the ring., Results: Among dispensers, the median age was 42 years and 77% were female. Overall, 42% of dispensers had heard of a medication for HIV prevention. Almost all dispensers reported some interest in stocking oral PrEP (92%) and the dapivirine ring (96%). Most (85%) reported they would provide oral PrEP to AGYW who requested it. Among AGYW customers, the median age was 17 years; 29% of AGYW were married or had a steady partner and 18% had children. Only 20% of AGYW had heard of a medication to prevent HIV, yet 64% and 43% expressed some interest in using oral PrEP and the dapivirine ring, respectively, after receiving information about the products. PrEP interest was higher among AGYW who were partnered and had children., Conclusions: Despite low prior awareness of PrEP among shop dispensers and AGYW, we found high levels of interest in oral PrEP and the dapivirine ring in both groups. Community-based drug shops represent a promising strategy to make HIV prevention more accessible to AGYW.

Heavy load carrying of water, firewood, and sand/stones is a ubiquitous activity for women living in developing countries. Although the intra-abdominal pressure associated with heavy load carrying is hypothesized to increase the risk of pelvic organ prolapse (POP) among women, relevant epidemiologic data are lacking. We conducted a comparative study involving two exploratory cross-sectional studies among convenience samples of women carrying heavy loads, with different characteristics: (1) as part of their activities for daily living, in Shinyanga region, Tanzania; and (2) working as sand miners in Pokhara, Nepal. Women were categorized has having "low" or "high" load-carrying exposures based on the measured weights of the loads being carried at the time of the survey, as well as on self-reported duration and frequency of load carrying. A summary score for lower abdominal discomfort suggestive of POP was generated using questions from the Pelvic Organ Prolapse Distress Inventory (POPDI-6). Women with higher load carrying exposures had on average higher discomfort scores in both Tanzania (adjusted prevalence difference (PD a ) = 3.7; 95% CI: -3.8-11.3; p = 0.33) and Nepal (PD a = 9.3; 95% CI: -4.9-23.6; p = 0.18). We identified trends suggestive of an association between increasing heavy load carrying exposures and symptoms of lower abdominal discomfort. Our findings underscore the need for larger epidemiologic studies of the potential adverse reproductive health effects of heavy load carrying activities on women in developing countries.

Introduction: Despite improvements in prevention of mother-to-child transmission (PMTCT) of HIV outcomes, there remain unacceptably high numbers of mother-to-child transmissions (MTCT) of HIV. Programmes and research collect multiple sources of PMTCT data, yet this data is rarely integrated in a systematic way. We conducted a data integration exercise to evaluate the Zimbabwe national PMTCT programme and derive lessons for strengthening implementation and documentation., Methods: We used data from four sources: research, Ministry of Health and Child Care (MOHCC) programme, Implementer - Organization for Public Health Interventions and Development, and modelling. Research data came from serial population representative cross-sectional surveys that evaluated the national PMTCT programme in 2012, 2014 and 2017/2018. MOHCC and Organization for Public Health Interventions and Development collected data with similar indicators for the period 2018 to 2019. Modelling data from 2017/18 UNAIDS Spectrum was used. We systematically integrated data from the different sources to explore PMTCT programme performance at each step of the cascade. We also conducted spatial analysis to identify hotspots of MTCT., Results: We developed cascades for HIV-positive and negative-mothers, and HIV exposed and infected infants to 24 months post-partum. Most data were available on HIV positive mothers. Few data were available 6-8 weeks post-delivery for HIV exposed/infected infants and none were available post-delivery for HIV-negative mothers. The different data sources largely concurred. Antenatal care (ANC) registration was high, although women often presented late. There was variable implementation of PMTCT services, MTCT hotspots were identified. Factors positively associated with MTCT included delayed ANC registration and mobility (use of more than one health facility) during pregnancy/breastfeeding. There was reduced MTCT among women whose partners accompanied them to ANC, and infants receiving antiretroviral prophylaxis. Notably, the largest contribution to MTCT was from postnatal women who had previously tested negative (12/25 in survey data, 17.6% estimated by Spectrum modelling). Data integration enabled formulation of interventions to improve programmes., Conclusions: Data integration was feasible and identified gaps in programme implementation/documentation leading to corrective interventions. Incident infections among mothers are the largest contributors to MTCT: there is need to strengthen the prevention cascade among HIV-negative women., (© 2020 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Background: Despite a growing body of literature on HIV service costs in sub-Saharan Africa, only a few studies have estimated the facility-level cost of prevention of Mother-to-Child Transmission (PMTCT) services, and even fewer provide insights into the variation of PMTCT costs across facilities. In this study, we present the first empirical costs estimation of the accelerated program for the prevention of mother-to-child transmission of HIV in Zimbabwe and investigate the determinants of heterogeneity of the facility-level average cost per service. To understand such variation, we explored the association between average costs per service and supply-and demand-side characteristics, and quality of services. One aspect of the supply-side we explore carefully is the scale of production-which we define as the annual number of women tested or the yearly number of HIV-positive women on prophylaxis., Methods: We collected rich data on the costs and PMTCT services provided by 157 health facilities out of 699 catchment areas in five provinces in Zimbabwe for 2013. In each health facility, we measured total costs and the number of women covered with PMTCT services and estimated the average cost per woman tested and the average cost per woman on either ARV prophylaxis or ART. We refer to these facility-level average costs per service as unitary costs. We also collected information on potential determinants of the variation of unitary costs. On the supply-side, we gathered data on the scale of production, staff composition and on the types of antenatal and family planning services provided. On the demand side, we measured the total population at the catchment area and surveyed eligible pairs of mothers and infants about previous use of HIV testing and prenatal care, and on the HIV status of both mothers and infants. We explored the determinants of unitary cost variation using a two-stage linear regression strategy., Results: The average annual total cost of the PMTCT program per facility was US$16,821 (median US$8,920). The average cost per pregnant woman tested was US$80 (median US$47), and the average cost per HIV-positive pregnant woman initiated on ARV prophylaxis or treatment was US$786 annually (median US$420). We found substantial heterogeneity of unitary costs across facilities regardless of facility type. The scale of production was a strong predictor of unitary costs variation across facilities, with a negative and statistically significant correlation between the two variables (p<0.01)., Conclusions: These findings are the first empirical estimations of PMTCT costs in Zimbabwe. Unitary costs were found to be heterogeneous across health facilities, with evidence consistent with economies of scale., Competing Interests: The authors have declared that no competing interests exist.

Objectives: Diarrhoeal illness is a leading cause of childhood morbidity and mortality and has long-term negative impacts on child development. Although flooring, water and sanitation have been identified as important routes of transmission of diarrhoeal pathogens, research examining variability in the association between flooring and diarrhoeal illness by water and sanitation is limited., Methods: We utilised cross-sectional data collected for the evaluation of Zimbabwe's Prevention of Mother-to-Child HIV transmission programme in 2014 and 2017-18. Mothers of infants 9-18 months of age self-reported the household's source of drinking water and type of sanitation facility, as well as infant diarrhoeal illness in the four weeks prior to the survey. Household flooring was assessed using interviewer observation, and households in which the main material of flooring was dirt/earthen were classified as having unimproved flooring, and those with solid flooring (e.g. cement) were classified as having improved flooring., Results: Mothers of infants living in households with improved flooring were less likely to report diarrhoeal illness in the last four weeks (PD a  = -4.8%, 95% CI: -8.6, -1.0). The association between flooring and diarrhoeal illness did not vary by the presence of improved/unimproved water (p RERI  = 0.91) or sanitation (p RERI  = 0.76)., Conclusions: Our findings support the hypothesis that household flooring is an important pathway for the transmission of diarrhoeal pathogens, even in settings where other aspects of sanitation are sub-optimal. Improvements to household flooring do not require behaviour change and may be an effective and expeditious strategy for reducing childhood diarrhoeal illness irrespective of household access to improved water and sanitation., (© 2020 John Wiley & Sons Ltd.)

Background: Heavy load carrying has been associated with musculoskeletal discomfort (MSD) and disability. However, there is a lack of research investigating this association in resource-constrained settings where heavy load carrying by women is common., Objectives: We assessed the impact of heavy load carrying on musculoskeletal pain and disability among women in Shinyanga Region, Tanzania, in an exploratory cross-sectional study., Methods: Eligible participants were a convenience sample of women, at least 18 years of age, who passed a study recruitment site carrying a load. We collected information on load-carrying practices, including frequency and time spent carrying water, wood, agricultural products, coal, sand, or rocks, and measured the weight of the load carried at the time. Outcomes included self-reported MSDs, defined as experiencing pain lasting >3 days in the neck, head, back, knees, feet and/or ankles within the last 1 year, and related disability. Using multivariable logistic regression we assessed for associations between load carrying exposures and MSDs and disability., Findings: Results showed a high prevalence of MSDs across the body regions assessed and evidence to suggest a relationship of back pain and related disability with several measures of load-carrying, including duration, frequency, and weight. Multivariable analyses revealed associations of increased load carrying exposures with low back pain (LBP) and related disability, including statistically significant increases in odds of LBP with increasing weight, total duration of load carrying/week and cumulative loads/week., Conclusions: Findings indicate a substantial burden of MSDs and disability in this population of women who carry heavy loads daily. The extent of discomfort and disability increased with increasing exposure to various load-carrying measures, especially for LBP. Larger epidemiologic studies that definitively assess relationships of load carrying with MSDs and disability are warranted., Competing Interests: The authors have no competing interests to declare., (Copyright: © 2020 The Author(s).)

Background: Ambitious targets have been set to end the HIV epidemic by 2030. Such targets assume that tools to end HIV exist and are successfully being deployed across populations, albeit unequally. Implementation science approaches are needed to understand the drivers of disparities and how to bring effective interventions to those most in need. We describe a hybrid implementation science approach, adapting a strategy to facilitate retention and viral suppression (VS) among people living with HIV/AIDS in Tanzania., Methods/design: We used Proctor framework and the multiphase optimization strategy to optimize a cash transfer to improve antiretroviral therapy adherence and VS among people living with HIV/AIDS in Tanzania. This involved 3 trials. The first trial tested the efficacy of cash and food assistance compared with the standard of care in improving antiretroviral therapy adherence among treatment initiators. Cash transfers were superior to the standard of care and noninferior, less expensive, and logistically simpler to implement compared with food. The second trial is dose-finding: identifying the optimal amount of cash for a 20% improvement in VS at 6 months. Before this, components were simplified to maximize reach, align with local policies, and reduce staff time. We assessed implementation science constructs to understand barriers to uptake and sustainability. Trial 3 is a cluster randomized controlled trial, testing the effectiveness of the optimized intervention in multiple settings., Discussion/implications: Our process illustrates the utility of applying multiple implementation science frameworks to arrive at an optimal implementation strategy to bridge the know-do gap with data to show efficacy and maximum potential for scalability and sustainability.

Objective: Food insecurity impedes antiretroviral therapy (ART) adherence. We previously demonstrated that short-term cash and food incentives increased ART possession and retention in HIV services in Tanzania. To elucidate potential pathways that led to these achievements, we examined whether incentives also improved food insecurity., Design: Three-arm randomized controlled trial., Methods: From 2013 to 2015, 805 food-insecure adult ART initiates (≤90 days) at three clinics were randomized to receive cash or food transfers (∼$11 per month for ≤6 months, conditional on visit attendance) or standard-of-care (SOC) services. We assessed changes from baseline to 6 and 12 months in: food insecurity (severe; access; dietary diversity), nutritional status (body weight; BMI), and work status. Difference-in-differences average treatment effects were estimated using inverse-probability-of-censoring-weighted longitudinal regression models., Results: The modified intention-to-treat analysis included 777 nonpregnant participants with 41.6% severe food insecurity. All three study groups experienced improvements from baseline in food insecurity, nutritional status, and work status. After 6 months, severe food insecurity declined within the cash (-31.4% points to 11.5%) and food (-30.3 to 10.4%) groups, but not within the SOC. Relative to the SOC, severe food insecurity decreased by an additional 24.3% points for cash (95% CI -45.0 to -3.5) and 23.3% percent points for food (95% CI -43.8 to -2.7). Neither intervention augmented improvements in severe food insecurity at 12 months, nor food access, dietary diversity, nutritional status, or work status at 6 or 12 months., Conclusion: Small cash and food transfers provided at treatment initiation may mitigate severe food insecurity. These effects may have facilitated previously observed improvements in ART adherence.

Background: WHO recommends that HIV infected women receive antiretroviral therapy (ART) minimally during pregnancy and breastfeeding ("Option B"), or ideally throughout their lives regardless of clinical stage ("Option B+") (Coovadia et al., Lancet 379:221-228, 2012). Although these recommendations were based on clinical trials demonstrating the efficacy of ART during pregnancy and breastfeeding, the population-level effectiveness of Option B+ is unknown, as are retention on ART beyond the immediate post-partum period, and the relative impact and cost-effectiveness of Option B+ compared to Option A (Centers for Disease Control and Prevention, Morb Mortal Wkly Rep 62:148-151, 2013; Ahmed et al., Curr Opin HIV AIDS 8:473-488, 2013). To address these issues, we conducted an impact evaluation of Zimbabwe's prevention of mother to child transmission programme conducted between 2011 and 2018 using serial, community-based cross-sectional serosurveys, which spanned changes in WHO recommendations. Here we describe the rationale for the design and analysis., Methods/design: Our method is to survey mother-infant pairs residing in the catchment areas of 157 health facilities randomly selected from 5 of 10 provinces in Zimbabwe. We collect questionnaires, blood samples from mothers and babies for HIV antibody and viral load testing, and verbal autopsies for deceased mothers/babies. Using this approach, we collected data from two previous time points: 2012 (pre-Option A standard of care), 2014 (post-Option A / pre-Option B+) and will collect a third round of data in 2017-18 (post Option B+ implementation) to monitor population-level trends in mother-to-child transmission of HIV (MTCT) and HIV-free infant survival. In addition, we will collect detailed information on facility level factors that may influence service delivery and costs., Discussion: Although the efficacy of antiretroviral therapy (ART) during pregnancy and breastfeeding for prevention of mother-to-child transmission of HIV (PMTCT) has been well-documented in randomized trials, little evidence exists on the population-level impact and cost-effectiveness of Option B+ or the influence of the facility on implementation (Siegfried et al., Cochrane Libr 7:CD003510, 2017). This study will provide essential data on these gaps and will provide estimates on retention in care among Option B+ clients after the breastfeeding period., Trial Registration: NCT03388398 Retrospectively registered January 3, 2018.

Background: The postpartum period is an opportune time for contraception adoption, as women have extended interaction with the reproductive healthcare system and therefore more opportunity to learn about and adopt contraceptive methods. This may be especially true for women who experience unintended pregnancy, a key target population for contraceptive programs and programs to eliminate mother-to-child HIV transmission. Among women in Zimbabwe surveyed in 2014, we examined the relationship between pregnancy intention associated with a woman's most recent pregnancy, and her subsequent postpartum contraceptive use., Methods: In our analysis we utilized a dataset from a random selection of catchment areas in Zimbabwe to examine the association between pregnancy intention of most recent pregnancy and subsequent postpartum contraceptive use using multinomial logistic regression models. We also explored whether this association differed by women's HIV status. Finally, we examined the association between pregnancy intention and changes in contraception from the pre- to postpartum periods., Results: Findings suggest that women who reported that their pregnancy was unintended adopted less modern (all non-traditional) contraceptive methods overall, but adopted long-acting reversible contraception (LARC) more frequently than women reporting an intended pregnancy (OR 1.41; CI 1.18, 1.68). Among HIV-positive women, this relationship was particularly strong (OR 3.12; CI 1.96, 4.97). However, when examining changes in contraceptive use from the pre-pregnancy to the postpartum period, women who had an unintended pregnancy had lower odds of changing to a more effective method postpartum overall (OR 0.71; CI 0.64, 0.79)., Conclusions: We did not find evidence of higher modern method adoption in the postpartum period among women with an unintended pregnancy. However, women who were already on a method in the pre-pregnancy period were catalyzed to move to more effective methods (such as LARC) postpartum. This study provides evidence of low modern (non-traditional) method adoption in general in the postpartum period among a vulnerable sub-population in Zimbabwe (women who experience unintended pregnancy). Simultaneously, however, it shows a relatively greater portion specifically of LARC use among women with an unintended pregnancy. Further research is needed to more closely examine the motivations behind these contraceptive decisions in order to better inform distribution and counseling programs.

Background: In the United States, young men who have sex with men (YMSM) experience a disproportionate burden of HIV and sexually transmitted infections (STIs). Mobile health (mHealth) interventions, including those that incorporate elements of games ("gamification"), have the potential to improve YMSM engagement in desirable sexual health services and behaviors. Gamification leverages theory and tools from behavioral science to motivate people to engage in a behavior in a context of fun. The objective of the study was to determine whether an intervention using gamification is acceptable to YMSM in California and potentially increases repeat HIV screening., Methods: Eligible YMSM were: (I) 18-26 years, (II) born as and/or self-identified as male, (III) reported male sexual partners, and (IV) lived in a zip code adjacent to one of the two study clinics in Oakland and Hollywood, California. The gamification intervention, Stick To It , had four components: (I) recruitment (clinic-based and online), (II) online enrollment, (III) online activities, and (IV) 'real-world' activities at the clinic. Participants earned points through online activities that could be redeemed for a chance to win prizes during HIV/STI screening and care visits. The primary outcome was intervention acceptability measured with participant engagement data and in-depth interviews. The secondary outcome was the intervention's preliminary effectiveness on repeat HIV screening within 6 months, restricted to the subset of men who provided consent for review of medical records and who had ≥6 months of follow-up. Outcomes were compared to a historical control group of similar YMSM who attended study clinics in the 12 months prior to intervention implementation., Results: Overall, 166 of 313 (53%) eligible YMSM registered. After registration, 93 (56%) participants completed enrollment and 31 (19%) completed ≥1 online activity in the subsequent 6 months. Points were redeemed in clinic by 11% of the 166 users (27% and 5% of those who enrolled in the clinic and online, respectively). Despite moderate engagement, participants provided a positive assessment of the program in interviews, reporting that the inclusion of game elements was motivating. The analysis of repeat HIV testing was assessed among 31 YMSM who consented to medical record review and who had ≥6 months of follow-up. During follow-up, 15 (48%) received ≥2 HIV tests compared to 157 (30%) of a historical comparison group of 517 similar YMSM who lived in the same zip codes and who received care at the same clinics before the intervention (OR =2.15, 95% CI: 1.03-4.47, P=0.04)., Conclusions: Engagement in the intervention was modest, with YMSM who enrolled in a clinic more actively engaged than YMSM who enrolled online. Among the subset of participants recruited in the clinic, repeat HIV screening was higher than a comparison group of similar YMSM attending the same clinic in the prior year., Competing Interests: Conflicts of Interest: The authors have no conflicts of interest to declare.

Background: Cash and in-kind incentives can improve health outcomes in various settings; however, there is concern that incentives may 'crowd out' intrinsic motivation to engage in beneficial behaviors. We examined this hypothesis in a randomized trial of food and cash incentives for people living with HIV infection in Tanzania., Methods: We analyzed data from 469 individuals randomized to one of three study arms: standard of care, short-term cash transfers, or short-term food assistance. Eligible participants were: 1) ≥18 years old; 2) HIV-infected; 3) food insecure; and 4) initiated antiretroviral therapy (ART) ≤90 days before the study. Food or cash transfers, valued at ~$11 per month and conditional on attending clinic visits, were provided for ≤6 months. Intrinsic motivation was measured at baseline, 6, and 12 months using the autonomous motivation section of the Treatment Self-Regulation Questionnaire (TSRQ). We compared the change in TSRQ score from baseline to 6 and 12 months and the change within study arms., Results: The mean intrinsic motivation score was 2.79 at baseline (range: 1-3), 2.91 at 6 months (range: 1-3), and 2.95 at 12 months (range: 2-3), which was 6 months after the incentives had ended. Among all patients, the intrinsic motivation score increased by 0.13 points at 6 months (95% CI (0.09, 0.17), Cohen's d = 0.29) and 0.19 points at 12 months (95% CI (0.14, 0.24), Cohen's d = 0.49). Intrinsic motivation also increased within each study group at 6 months: 0.15 points in the food arm (95% CI (0.09, 0.21), Cohen's d = 0.37), 0.11 points in the cash arm (95% CI (0.05, 0.18), Cohen's d = 0.25), and 0.08 points in the comparison arm (95% CI (-0.03, 0.19), Cohen's d = 0.21); findings were similar at 12 months. Increases in motivation were statistically similar between arms at 6 and 12 months., Conclusion: Intrinsic motivation for ART adherence increased significantly both overall and within the food and cash incentive arms, even after the incentive period was over. Increases in motivation did not differ by study group. These results suggest that incentive interventions for treatment adherence should not be withheld due to concerns of crowding out intrinsic motivation., Competing Interests: The authors have declared that no competing interests exist.

Background: Couples' HIV testing and counselling (CHTC) is associated with greater engagement with HIV prevention and care than individual testing and is cost-effective, but uptake remains suboptimal. Initiating discussion of CHTC might result in distrust between partners. Offering incentives for CHTC could change the focus of the pre-test discussion. We aimed to determine the impact of incentives for CHTC on uptake of couples testing and HIV case diagnosis in rural Zimbabwe., Methods: In this cluster-randomised trial, 68 rural communities (the clusters) in four districts receiving mobile HIV testing services were randomly assigned (1:1) to incentives for CHTC or not. Allocation was not masked to participants and researchers. Randomisation was stratified by district and proximity to a health facility. Within each stratum random permutation was done to allocate clusters to the study groups. In intervention communities, residents were informed that couples who tested together could select one of three grocery items worth US$1·50. Standard mobilisation for testing was done in comparison communities. The primary outcome was the proportion of individuals testing with a partner. Analysis was by intention to treat. 3 months after CHTC, couple-testers from four communities per group individually completed a telephone survey to evaluate any social harms resulting from incentives or CHTC. The effect of incentives on CHTC was estimated using logistic regression with random effects adjusting for clustering. The trial was registered with the Pan African Clinical Trial Registry, number PACTR201606001630356., Findings: From May 26, 2015, to Jan 29, 2016, of 24 679 participants counselled with data recorded, 14 099 (57·1%) were in the intervention group and 10 580 (42·9%) in the comparison group. 7852 (55·7%) testers in the intervention group versus 1062 (10·0%) in the comparison group tested with a partner (adjusted odds ratio 13·5 [95% CI 10·5-17·4]). Among 427 (83·7%) of 510 eligible participants who completed the telephone survey, 11 (2·6%) reported that they were pressured or themselves pressured their partner to test together; none regretted couples' testing. Relationship unrest was reported by eight individuals (1·9%), although none attributed this to incentives., Interpretation: Small non-monetary incentives, which are potentially scalable, were associated with significantly increased CHTC and HIV case diagnosis. Incentives did not increase social harms beyond the few typically encountered with CHTC without incentives. The intervention could help achieve UNAIDS 90-90-90 targets., Funding: The study was funded by the UK Department for International Development, Irish AID, and Swedish SIDA, through Population Services International Zimbabwe under the Integrated Support Program., (Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Introduction: Community health workers (CHWs) are lay workers who have the potential to enhance services to prevent mother-to-child HIV transmission (PMTCT) and improve the health of women living with HIV infection. We conducted a cluster-randomized trial of an intervention to integrate CHWs with 'Option B+' PMTCT services in Shinyanga Region, Tanzania., Methods: The intervention was implemented for 11 months and included four integrated components: 1) formal linkage of CHWs to health facilities; 2) CHW-led antiretroviral therapy (ART) adherence counseling; 3) loss to follow-up tracing by CHWs; and 4) distribution of Action Birth Cards (ABCs), a birth planning tool. We cluster-randomized 32 facilities offering PMTCT services, within strata of size, to the intervention (n = 15) or comparison (standard of care, n = 17) groups. Intervention effectiveness was determined with a difference-in-differences strategy based on clinical and pharmacy data from HIV-infected postpartum women at baseline (births in 2014) and endline (births April-Oct 2015). The primary outcome was retention in care between 60 and 120 days postpartum. Secondary outcomes included ART initiation, timing of ART initiation (as measured by week of gestation), and ART adherence 90 days postpartum, measured using the medication possession ratio (MPR≥95%)., Results: Intervention and comparison facilities were similar at baseline. Data were collected from 1,152 and 678 mother-infant pairs at baseline and endline, respectively. There were no significant differences in retention in care, ART initiation, or timing of ART initiation between the intervention and control groups. Adherence (MPR≥95%) at 90 days postpartum was 11.3 percentage points higher in the intervention group in ITT analyses (95% CI: -0.7, 23.3, p = 0.06), though this effect was attenuated after adjusting for baseline imbalance (9.5 percentage points, 95% CI: -2.9, 22.0, p = 0.13). Among only sites that had the greatest fidelity to the intervention, however, we found a stronger effect on adherence (13.6 percentage points, 95% CI: 2.5, 24.6)., Conclusions: Despite being feasible and acceptable, the CHW-based intervention did not have strong effects on most PMTCT indicators. CHW involvement in PMTCT programs may improve ART adherence among HIV-infected postpartum women, however, and success appears heavily dependent on program implementation., Trial Registration: Registry for International Development Impact Evaluations (RIDIE, ID 552553838b402) and ClinicalTrials.gov (NCT03058484).

Background: In the United States, young men who have sex with men (YMSM) remain disproportionately affected by human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs). Although routine HIV/STI screening is pivotal to the timely diagnosis of HIV and STIs, initiation of appropriate treatment, and reduced onward disease transmission, repeat screening is underused. Novel interventions that incorporate elements of games, an approach known as gamification, have the potential to increase routinization of HIV/STI screening among YMSM., Objective: The study aims to test the hypothesis that an incentive-based intervention that incorporates elements of gamification can increase routine HIV/STI screening among YMSM in California., Methods: The study consists of a formative research phase to develop the intervention and an implementation phase where the intervention is piloted in a controlled research setting. In the formative research phase, we use an iterative development process to design the intervention, including gathering information about the feasibility, acceptability, and expected effectiveness of potential game elements (eg, points, leaderboards, rewards). These activities include staff interviews, focus group discussions with members of the target population, and team meetings to strategize and develop the intervention. The final intervention is called Stick To It and consists of 3 components: (1) online enrollment, (2) Web-based activities consisting primarily of quizzes and a countdown "timer" to facilitate screening reminders, and (3) in-person activities that occur at 2 sexual health clinics. Participants earn points through the Web-based activities that are then redeemed for chances to win various prizes during clinic visits. The pilot study is a quasi-experimental study with a minimum of 60 intervention group participants recruited at the clinics, at community-based events, and online. We will compare outcomes in the intervention group with a historical control group consisting of individuals meeting the inclusion criteria who attended study clinics in the 12 months prior to intervention implementation. Eligible participants in the pilot study (1) are 18 to 26 years old, (2) were born or identify as male, 3) report male sexual partners, and 4) have a zip code of residence within defined areas in the vicinity of 1 of the 2 implementation sites. The primary outcome is repeat HIV/STI screening within 6 months., Results: This is an ongoing research study with initial results expected in the fourth quarter of 2017., Conclusions: We will develop and pilot test a gamification intervention to encourage YMSM to be regularly screened for HIV/STIs. The results from this research will provide preliminary evidence about the potential effectiveness of using gamification to amplify health-related behavioral change interventions. Further, the research aims to determine the processes that are essential to developing and implementing future health-related gamification interventions., Trial Registration: Clinicaltrials.gov NCT02946164; https://clinicaltrials.gov/ct2/show/NCT02946164 (Archived by WebCite at http://www.webcitation.org/6ri3G4HwD)., (©Christopher M Mejia, Daniel Acland, Raluca Buzdugan, Reva Grimball, Lauren Natoli, Mark R McGrath, Jeffrey D Klausner, Sandra I McCoy. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 17.07.2017.)

Background: Interventions incorporating constructs from behavioral economics and psychology have the potential to enhance HIV 'treatment as prevention' (TasP) strategies. To test this hypothesis, we evaluated an intervention to improve antiretroviral therapy (ART) adherence based on the concepts of social norms and priming., Methods: We used tools from marketing research and patient-centered design to develop a combination intervention that included visual feedback about clinic-level retention in care, a self-relevant prime, and useful take-home items with the priming image. The intervention was implemented at two HIV primary clinics in Shinyanga, Tanzania in 2-week intervals for six months. We conducted a quasi-experimental pilot study with a random sample of exposed and unexposed adult patients living with HIV infection (PLHIV) to compare retention and the proportion of patients with medication possession ratio (MPR) ≥95% after six months. Intervention acceptability was determined with a convenience sample of 405 PLHIV at baseline (n = 189) and endline (n = 216)., Results: Medical records were reviewed for 438 PLHIV (320 intervention, 118 standard of care). In adjusted analyses, PLHIV exposed to the intervention were significantly more likely to be in care after 6 months (87% vs. 79%, adjusted odds ratio (ORa) = 1.73, 95% CI: 1.08, 2.78, p<0.05) and were more likely to achieve MPR≥95% (70% vs. 59%, OR = 1.51, 95% CI: 0.96, 2.37, p = 0.07). The intervention was associated with increases in staff support of treatment goals (100% vs. 95%, p = 0.01) and life goals (66% vs. 50%, p<0.01), the perceived likelihood of other patients' adherence (54% vs. 32%, p<0.01), support from other patients (71% vs. 60%, p = 0.03), and being very satisfied with care (53% vs. 35%, p<0.01)., Conclusions: This novel intervention has the potential to improve the clinic experience, short-term retention in care, and ART adherence. Future studies are needed to expand the generalizability of the approach and evaluate effectiveness on clinical outcomes., Trial Registration: Clinicaltrials.gov NCT02938533.

Objective: We evaluated the effectiveness of short-term cash and food assistance to improve adherence to antiretroviral therapy (ART) and retention in care among people living with HIV in Tanzania., Methods: At three clinics, 805 participants were randomized to three groups in a 3 : 3 : 1 ratio, stratified by site : nutrition assessment and counseling (NAC) and cash transfers (∼$11/month, n = 347), NAC and food baskets (n = 345), and NAC-only (comparison group, n = 113, clinicaltrials.gov NCT01957917). Eligible people living with HIV were at least 18 years, initiated ART 90 days or less prior, and food insecure. Cash or food was provided for 6 or less consecutive months, conditional on visit attendance. The primary outcome was medication possession ratio (MPR ≥ 95%) at 6 months. Secondary outcomes were appointment attendance and loss to follow-up (LTFU) at 6 and 12 months., Results: The primary intent-to-treat analysis included 800 participants. Achievement of MPR ≥ 95% at 6 months was higher in the NAC + cash group compared with NAC-only (85.0 vs. 63.4%), a 21.6 percentage point difference [95% confidence interval (CI): 9.8, 33.4, P < 0.01]. MPR ≥ 95% was also significantly higher in the NAC + food group vs. NAC-only (difference = 15.8, 95% CI: 3.8, 27.9, P < 0.01). When directly compared, MPR ≥ 95% was similar in the NAC + cash and NAC + food groups (difference = 5.7, 95% CI: -1.2, 12.7, P = 0.15). Compared with NAC-only, appointment attendance and LTFU were significantly higher in both the NAC + cash and NAC + food groups at 6 months. At 12 months, the effect of NAC + cash, but not NAC + food, on MPR ≥ 95% and retention was sustained., Conclusion: Short-term conditional cash and food assistance improves ART possession and appointment attendance and reduces LTFU among food-insecure ART initiates in Tanzania.

Background: We assessed Zimbabwe's progress toward elimination of mother-to-child HIV transmission (MTCT) under Option A., Methods: We analyzed 2012 and 2014 cross-sectional serosurvey data from mother-infant pairs residing in the same 157 health facility catchment areas randomly sampled from five provinces. Eligible women were at least 16 years and mothers/caregivers of infants born 9-18 months prior. We aggregated individual-level questionnaire and HIV serostatus within catchment areas or district to estimate MTCT and the number of HIV-infected infants; these data were mapped using facility global positioning system coordinates., Results: A weighted population of 8800 and 10 404 mother-infant pairs was included from 2012 and 2014, respectively. In 2014, MTCT among HIV-exposed infants was 6.7% (95% confidence interval: 5.2, 8.6), not significantly different from 2012 (8.8%, 95% confidence interval: 6.9, 11.1, P = 0.13). From 2012 to 2014, self-reported antiretroviral therapy or prophylaxis among HIV-infected women increased from 59 to 65% (P = 0.05), as did self-reported infant antiretroviral prophylaxis (63 vs. 67%, P = 0.08). In 2014, 65 (41%), 55 (35%), and 37 (24%) catchment areas had the same, lower, and higher MTCT rate as in 2012, respectively. MTCT in 2014 varied by catchment areas (median = 0%, mean = 4.9%, interquartile range = 0-10%) as did the estimated number of HIV-infected infants (median = 0, mean = 1.1, interquartile range = 0-1.0). Also in 2014, 106 (68%) catchment areas had MTCT = 0%. Geovisualization revealed clustering of catchment areas where both MTCT and the estimated number of HIV-infected infants were relatively high., Conclusion: Although MTCT is declining in Zimbabwe, geospatial analysis indicates facility-level variability. Catchment areas with high MTCT rates and a high burden of HIV-infected infants should be the highest priority for service intensification.

Objective: We evaluated the impact of Option A on HIV-free infant survival and mother-to-child transmission (MTCT) in Zimbabwe., Design: Serial cross-sectional community-based serosurveys., Methods: We analyzed serosurvey data collected in 2012 and 2014 among mother-infant pairs from catchment areas of 132 health facilities from five of 10 provinces in Zimbabwe. Eligible infants (alive or deceased) were born 9-18 months before each survey to mothers at least 16 years old. We randomly selected mother-infant pairs and conducted questionnaires, verbal autopsies, and collected blood samples. We estimated the HIV-free infant survival and MTCT rate within each catchment area and compared the 2012 and 2014 estimates using a paired t test and number of HIV infections averted because of the intervention., Results: We analyzed 7249 mother-infant pairs with viable maternal specimens collected in 2012 and 8551 in 2014. The mean difference in the catchment area level MTCT between 2014 and 2012 was -5.2 percentage points (95% confidence interval = -8.1, -2.3, P < 0.001). The mean difference in the catchment area level HIV-free survival was 5.5 percentage points (95% confidence interval = 2.6, 8.5, P < 0.001). Between 2012 and 2014, 1779 infant infections were averted compared with the pre-Option A regimen. The association between HIV-free infant survival and duration of Option A implementation was NS at the multivariate level (P = 0.093)., Conclusion: We found a substantial and statistically significant increase in HIV-free survival and decrease in MTCT among infants aged 9-18 months following Option A rollout in Zimbabwe. This is the only evaluation of Option A and shows the effectiveness of Option A and Zimbabwe's remarkable progress toward eMTCT.

Background: In developing countries, facility-based delivery is recommended for maternal and neonatal health, and for prevention of mother-to-child HIV transmission (PMTCT). However, little is known about whether or not learning one's HIV status affects one's decision to deliver in a health facility. We examined this association in Zimbabwe., Methods: We analyzed data from a 2012 cross-sectional community-based serosurvey conducted to evaluate Zimbabwe's accelerated national PMTCT program. Eligible women (≥16 years old and mothers of infants born 9-18 months before the survey) were randomly sampled from the catchment areas of 157 health facilities in five of ten provinces. Participants were interviewed about where they delivered and provided blood samples for HIV testing., Results: Overall 8796 (77 %) mothers reported facility-based delivery; uptake varied by community (30-100%). The likelihood of facility-based delivery was not associated with maternal HIV status. Women who self-reported being HIV-positive before delivery were as likely to deliver in a health facility as women who were HIV-negative, irrespective of when they learned their status - before (adjusted prevalence ratio (PRa) = 1.04, 95% confidence interval (CI) = 1.00-1.09) or during pregnancy (PRa = 1.05, 95% CI = 1.01-1.09). Mothers who had not accessed antenatal care or tested for HIV were most likely to deliver outside a health facility (69%). Overall, however 77% of home deliveries occurred among women who had accessed antenatal care and were HIV-tested., Conclusions: Uptake of facility-based delivery was similar among HIV-infected and HIV-uninfected mothers, which was somewhat unexpected given the substantial technical and financial investment aimed at retaining HIV-positive women in care in Zimbabwe.

Background: Food insecurity is an important barrier to retention in care and adherence to antiretroviral therapy (ART) among people living with HIV infection (PLHIV). However, there is a lack of rigorous evidence about how to improve food security and HIV-related clinical outcomes. To address this gap, this randomized trial will evaluate three delivery models for short-term food and nutrition support for food insecure PLHIV in Shinyanga, Tanzania: nutrition assessment and counseling (NAC) alone, NAC plus food assistance, and NAC plus cash transfers., Methods/design: At three HIV care and treatment sites, 788 participants will be randomized into one of three study arms in a 3:3:1 ratio, stratified by site: NAC plus food assistance, NAC plus cash transfer, and NAC only. Eligible participants are: 1) at least 18 years of age; 2) living with HIV infection; 3) initiated ART in the past 90 days; and 4) food insecure, as measured with the Household Hunger Scale. PLHIV who are severely malnourished (body mass index (BMI) < 16 kg/m(2)) will be excluded. Participants randomized to receive food or cash transfers are eligible to receive assistance for up to six months, conditional on attending regularly scheduled visits with their HIV care provider. Participants will be followed for 12 months: the initial 6-month intervention period and then for another 6 months post-intervention. The primary outcome is ART adherence measured with the medication possession ratio. Secondary outcomes include 1) retention in care; 2) nutritional indicators including changes in food security, BMI, and weight gain; 3) viral suppression and self-reported ART adherence; and 4) participation in the labor force., Discussion: This rigorously designed trial will inform policy decisions regarding supportive strategies for food insecure PLHIV in the early stages of treatment. The study will measure outcomes immediately after the period of support ends as well as 6 months later, providing information on the duration of the interventions' effect. The comparison of food to cash transfers will better inform policies favoring cash assistance or will provide rationale for the continued investment in food and nutrition interventions for PLHIV., Trial Registration: ClinicalTrials.gov: NCT01957917.

Objective: We estimated HIV-free infant survival and mother-to-child HIV transmission (MTCT) rates in Zimbabwe, some of the first community-based estimates from a UNAIDS priority country., Methods: In 2012 we surveyed mother-infant pairs residing in the catchment areas of 157 health facilities randomly selected from 5 of 10 provinces in Zimbabwe. Enrolled infants were born 9-18 months before the survey. We collected questionnaires, blood samples for HIV testing, and verbal autopsies for deceased mothers/infants. Estimates were assessed among i) all HIV-exposed infants, as part of an impact evaluation of Option A of the 2010 WHO guidelines (rolled out in Zimbabwe in 2011), and ii) the subgroup of infants unexposed to Option A. We compared province-level MTCT rates measured among women in the community with MTCT rates measured using program monitoring data from facilities serving those communities., Findings: Among 8568 women with known HIV serostatus, 1107 (12.9%) were HIV-infected. Among all HIV-exposed infants, HIV-free infant survival was 90.9% (95% confidence interval (CI): 88.7-92.7) and MTCT was 8.8% (95% CI: 6.9-11.1). Sixty-six percent of HIV-exposed infants were still breastfeeding. Among the 762 infants born before Option A was implemented, 90.5% (95% CI: 88.1-92.5) were alive and HIV-uninfected at 9-18 months of age, and 9.1% (95%CI: 7.1-11.7) were HIV-infected. In four provinces, the community-based MTCT rate was higher than the facility-based MTCT rate. In Harare, the community and facility-based rates were 6.0% and 9.1%, respectively., Conclusion: By 2012 Zimbabwe had made substantial progress towards the elimination of MTCT. Our HIV-free infant survival and MTCT estimates capture HIV transmissions during pregnancy, delivery and breastfeeding regardless of whether or not mothers accessed health services. These estimates also provide a baseline against which to measure the impact of Option A guidelines (and subsequently Option B+).

Objective: To examine the uptake of services and behaviors in the prevention of mother-to-child HIV transmission (PMTCT) cascade in Zimbabwe and to determine factors associated with MTCT and maternal antiretroviral therapy (ART) or antiretroviral (ARV) prophylaxis., Design: Analysis of cross-sectional data from mother-infant pairs., Methods: We analyzed baseline data collected in 2012 as part of the impact evaluation of Zimbabwe's Accelerated National PMTCT Program. Using multistage cluster sampling, eligible mother-infant pairs were randomly sampled from the catchment areas of 157 facilities in 5 provinces, tested for HIV infection, and interviewed about PMTCT service utilization., Results: Of 8800 women, 94% attended ≥ 1 antenatal care visit, 92% knew their HIV serostatus during pregnancy, 77% delivered in a health facility, and 92% attended the 6-8 week postnatal visit. Among 1075 (12%) HIV-infected women, 59% reported ART/ARV prophylaxis and 63% of their HIV-exposed infants received ARV prophylaxis. Among HIV-exposed infants, maternal receipt of ART/ARV prophylaxis was protective against MTCT [adjusted prevalence ratio (PR(a)): 0.41, 95% confidence interval (CI): 0.23 to 0.74]. Factors associated with receipt of maternal ART/ARV prophylaxis included ≥ 4 antenatal care visits (PR(a): 1.18, 95% CI: 1.01 to 1.38), institutional delivery (PR(a): 1.31, 95% CI: 1.13 to 1.52), and disclosure of serostatus (PRa: 1.30, 95% CI: 1.12 to 1.49)., Conclusions: These data from women in the community indicate gaps in the PMTCT cascade before the accelerated program, which may have been missed by examination of health facility data alone. These gaps were especially noteworthy for services targeted specifically to HIV-infected women and their infants, such as maternal and infant ART/ARV prophylaxis.