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Introduction: Adherence counselling with point‐of‐care (POC) drug‐level feedback using a novel tenofovir assay may support pre‐exposure prophylaxis (PrEP) adherence; however, perceptions of urine testing and its impact on adherence are not well studied. We qualitatively examined how POC tenofovir testing was experienced by transgender women (TGW) in Uganda. Methods: Within a cluster randomized trial of peer‐delivered HIV self‐testing, self‐sampling for sexually transmitted infections and PrEP among HIV‐negative TGW showing overall low PrEP prevention‐effective adherence (NCT04328025), we conducted a nested qualitative sub‐study of the urine POC assay among a random sample of 30 TGW (August 2021−February 2022). TGW interviews explored: (1) experiences with POC urine tenofovir testing and (2) perceptions of PrEP adherence counselling with drug‐level feedback. We used an inductive content analytic approach for analysis. Results: Median age was 21 years (interquartile range 20–24), and 70% engaged in sex work. Four content categories describe how TGW experienced POC urine tenofovir testing: (1) Urine tenofovir testing was initially met with scepticism: Testing urine to detect PrEP initially induced anxiety, with some perceptions of being intrusive and unwarranted. With counselling, however, participants found POC testing acceptable and beneficial. (2) Alignment of urine test results and adherence behaviours: Drug‐level feedback aligned with what TGW knew about their adherence. Concurrence between pill taking and tenofovir detection in urine reinforced confidence in test accuracy. (3) Interpretation of urine tenofovir results: TGW familiar with the interpretation of oral‐fluid HIV self‐tests knew that two lines on the test device signified positivity (presence of HIV). However, two lines on the urine test strip indicated a positive result for non‐adherence (absence of tenofovir), causing confusion. Research nurses explained the difference in test interpretation to participants' satisfaction. (4) White coat dosing: Some TGW deliberately chose not to attend scheduled clinic appointments to avoid detecting their PrEP non‐adherence during urine testing. They restarted PrEP before returning to clinic, a behaviour called "white coat dosing." Conclusions: Incorporating POC urine testing into routine PrEP adherence counselling was acceptable and potentially beneficial for TGW but required attention to context. Additional research is needed to identify effective strategies for optimizing adherence monitoring and counselling for this population. [ABSTRACT FROM AUTHOR]

To determine the effect of a school traffic warden program on increasing driver yield and safe child pedestrian crossing behavior in Kampala, Uganda. We designed and implemented a school traffic warden program in specific school zones in Kampala, Uganda. We randomly assigned 34 primary schools in Kampala, in a 1:1 ratio, using a computer-generated randomization sequence, to control or intervention arms in a cluster randomized trial. Each school in the intervention group received one trained adult traffic warden stationed at roads adjacent to schools to help young children safely cross. The control schools continued with the standard of care. We extracted and coded outcome data from video recordings on driver yield and child crossing behavior (defined as waiting at the curb, looking both ways for oncoming vehicles, not running while crossing, and avoiding illegal crossing between vehicles) at baseline and after 6 months. Using a mixed effect modified Poisson regression model, we estimated the prevalence ratio to assess whether being in a school traffic warden program was associated with increased driver yield and safe crossing behavior. A higher proportion of drivers yielded to child pedestrians at crossings with a school traffic warden (aPR 7.2; 95% CI 4.42–11.82). Children were 70% more likely to demonstrate safe crossing behavior in the intervention clusters than in control clusters (aPR 1.7; 95% CI 1.04–2.85). A higher prevalence was recorded for walking while crossing (aPR 1.2; 95% CI 1.08–1.25) in the intervention clusters. The school traffic warden program is associated with increased driver yield and safe child pedestrian crossing behavior, i.e., stopping at the curb, walking while crossing, and not crossing between vehicles. Therefore, the school traffic warden program could be promoted to supplement other road safety measures, such as pedestrian safety road infrastructure, legislation, and enforcement that specifically protects children in school zones. [ABSTRACT FROM AUTHOR]

Objective: This study examined the effects of a peer-led integrated nutrition education intervention with maternal social support using Care Groups on infant growth among South Sudanese refugees in Uganda. Methods: A community-based cluster-randomized trial (RCT) was conducted among 390 pregnant women (third trimester). Two intervention study arms were Mothers-only(n = 131) and Parents-combined (n = 142) with a Control (n = 117). WHO infant growth standards defined length-for-age z-scores (LAZ) for stunting, weight-for-age z-scores (WAZ) for underweight and weight-for-length z-scores (WLZ) for wasting. The Medical Outcomes Study (MOS) social support index was a proxy measure for social support. A split-plot ANOVA tested the interaction effects of social support, intervention, and time on infant growth after adjusting for covariates. Further, pairwise comparisons explained mean differences in infant growth among the study arms. Results: The mean infant birth weight was 3.1 ± 0.5 kg. Over the study period, infant stunting was most prevalent in the Control (≥ 14%) compared to Mothers-only (< 9.5%) and Parents-combined (< 7.4%) arms. There were significant interaction effects of the Care Group intervention and social support by time on infant mean LAZ (F (6, 560) = 28.91, p < 0.001), WAZ (F (5.8, 539.4) = 12.70, p = < 0.001) and WLZ (F (5.3, 492.5) = 3.38, p = 0.004). Simple main effects by the end of the study showed that the intervention improved infant mean LAZ (Mothers-only vs. Control (mean difference, MD) = 2.05, p < 0.001; Parents-combined vs. Control, MD = 2.00, p < 0.001) and WAZ (Mothers-only vs. Control, MD = 1.27, p < 0.001; Parents-combined vs. Control, MD = 1.28, p < 0.001). Conclusion: Maternal social support with an integrated nutrition education intervention significantly improved infant stunting and underweight. Nutrition-sensitive approaches focused on reducing child undernutrition among post-emergency refugees may benefit from using Care Groups in programs. Trial registration: Clinicaltrials.gov, NCT05584969. [ABSTRACT FROM AUTHOR]

Background: Isoniazid preventive therapy (IPT) works to prevent tuberculosis (TB) among people living with HIV (PLHIV), but uptake remains low in Sub-Saharan Africa. In this analysis, we sought to identify barriers mid-level managers face in scaling IPT in Uganda and the mechanisms by which the SEARCH-IPT trial intervention influenced their abilities to increase IPT uptake. Methods: The SEARCH-IPT study was a cluster randomized trial conducted from 2017–2021. The SEARCH-IPT intervention created collaborative groups of district health managers, facilitated by local HIV and TB experts, and provided leadership and management training over 3-years to increase IPT uptake in Uganda. In this qualitative study we analyzed transcripts of annual Focus Group Discussions and Key Informant Interviews, from a subset of SEARCH-IPT participants from intervention and control groups, and participant observation field notes. We conducted the analysis using inductive and deductive coding (with a priori codes and those derived from analysis) and a framework approach for data synthesis. Results: When discussing factors that enabled positive outcomes, intervention managers described feeling ownership over interventions, supported by the leadership and management training they received in the SEARCH-IPT study, and the importance of collaboration between districts facilitated by the intervention. In contrast, when discussing factors that impeded their ability to make changes, intervention and control managers described external funders setting agendas, lack of collaboration in meetings that operated with more of a 'top-down' approach, inadequate supplies and staffing, and lack of motivation among frontline providers. Intervention group managers mentioned redistribution of available stock within districts as well as between districts, reflecting efforts of the SEARCH-IPT intervention to promote between-district collaboration, whereas control group managers mentioned redistribution within their districts to maximize the use of available IPT stock. Conclusions: In Uganda, mid-level managers' perceptions of barriers to scaling IPT included limited power to set agendas and control over funding, inadequate resources, lack of motivation of frontline providers, and lack of political prioritization. We found that the SEARCH-IPT intervention supported managers to design and implement strategies to improve IPT uptake and collaborate between districts. This may have contributed to the overall intervention effect in increasing the uptake of IPT among PLHIV compared to standard practice. Trial registration: ClinicalTrials.gov, NCT03315962, Registered 20 October 2017. [ABSTRACT FROM AUTHOR]

Introduction: Peer delivery is a client‐centred approach that could maximize the coverage and impact of HIV services for transgender women (TGW). We conducted qualitative interviews to examine how peer‐delivered HIV self‐testing (HIVST), sexually transmitted infection self‐sampling (STISS) and oral pre‐exposure prophylaxis (PrEP) influenced prevention choices among TGW and their intimate partners in Uganda. Methods: Within a cluster randomized trial of peer‐delivered HIVST, STISS and PrEP among HIV‐negative TGW (NCT04328025), we conducted 55 qualitative interviews with 30 TGW, 15 intimate partners and 10 TGW peers (August 2021–February 2022). TGW interviews explored: (1) HIV self‐test and PrEP experiences; (2) HIVST with intimate partners; and (3) descriptions of self‐sampling for STI testing. Partner interviews covered: (1) experiences with HIVST; (2) disclosure of HIV status to intimate partner; and (3) descriptions of sexual behaviours after testing. Peer interview topics included: (1) intervention delivery experiences; and (2) recommendations for peer‐delivered HIV prevention services to TGW, including psychological support and coping strategies. Qualitative data were analysed using an inductive content analytic approach. Results: Peer‐delivered combination prevention was valued by this group of TGW and their partners. (1) Peer services extended beyond delivering HIV/STI kits and PrEP refills to caring for individual health and wellbeing by providing stigma coping strategies. Peer psychosocial support empowered research participants to become "HIVST ambassadors," teach non‐study TGW about self‐testing and PrEP, and encourage linkage to care. (2) HIVST with intimate partners and mutual disclosure of HIV status strengthened partnered relationships. PrEP use after both partners tested HIV negative implied infidelity. (3) Self‐sampling enabled TGW to take control of their STI testing and avoid the embarrassment of exposing their bodies. Privacy and confidentiality motivated the uptake of STI testing and treatment. Conclusions: In this sample of TGW from Uganda, peer delivery of HIVST, STISS and PrEP refills benefitted individual prevention efforts and extended to a new linkage of TGW not engaged in care. Integrating peer services into differentiated PrEP delivery could increase HIV/STI test coverage and PrEP use in this vulnerable population. [ABSTRACT FROM AUTHOR]

Introduction: Optimizing HIV prevention may require structured approaches for providing client‐centred choices as well as community‐based entry points and delivery. We evaluated the effect of a dynamic choice model for HIV prevention, delivered by community health workers (CHWs) with clinician support, on the use of biomedical prevention among persons at risk of HIV in rural East Africa. Methods: We conducted a cluster randomized trial among persons (≥15 years) with current or anticipated HIV risk in 16 villages in Uganda and Kenya (SEARCH; NCT04810650). The intervention was a client‐centred HIV prevention model, including (1) structured client choice of product (pre‐exposure prophylaxis [PrEP] or post‐exposure prophylaxis [PEP]), service location (clinic or out‐of‐clinic) and HIV testing modality (self‐test or rapid test), with the ability to switch over time; (2) a structured assessment of patient barriers and development of a personalized support plan; and (3) phone access to a clinician 24/7. The intervention was delivered by CHWs and supported by clinicians who oversaw PrEP and PEP initiation and monitoring. Participants in control villages were referred to local health facilities for HIV prevention services, delivered by Ministry of Health staff. The primary outcome was biomedical prevention coverage: a proportion of 48‐week follow‐up with self‐reported PrEP or PEP use. Results: From May to July 2021, we enrolled 429 people (212 intervention; 217 control): 57% women and 35% aged 15–24 years. Among intervention participants, 58% chose PrEP and 58% chose PEP at least once over follow‐up; self‐testing increased from 52% (baseline) to 71% (week 48); ≥98% chose out‐of‐facility service delivery. Among 413 (96%) participants with the primary outcome ascertained, average biomedical prevention coverage was 28.0% in the intervention versus 0.5% in the control: a difference of 27.5% (95% CI: 23.0–31.9%, p<0.001). Impact was larger during periods of self‐reported HIV risk: 36.6% coverage in intervention versus 0.9% in control, a difference of 35.7% (95% CI: 27.5–43.9, p<0.001). Intervention effects were seen across subgroups defined by sex, age group and alcohol use. Conclusions: A client‐centred dynamic choice HIV prevention intervention, including the option to switch between products and CHW‐based delivery in the community, increased biomedical prevention coverage by 27.5%. However, substantial person‐time at risk of HIV remained uncovered. [ABSTRACT FROM AUTHOR]

Introduction: Poor asthma control in adolescents is partly attributed to inadequate asthma education for self-management. This study is set to determine the effectiveness of the "KmAsthma" self-management app in improving the control of asthma among adolescents in a low-resource setting.Methods: The two-arm 6-month cluster randomized controlled trial, will aim at enrolling 120 day scholars aged 12-19 years in secondary schools with a clinician's diagnosis and self-reported uncontrolled asthma in Kampala City Uganda. The primary endpoint of asthma control will be measured as a change in mean Asthma Control Test (ACT) scores. Asthma quality of life, adherence to medications, and self-efficacy will also be assessed. The iMprovIng the ContROl of aSthma (MICROS) study will employ the "KmAsthma" app for self-management education. The intervention group will receive the app on their smartphones and training on its eight sections: the profile, asthma history, goals, inspirations, reminders, connect, information about asthma, and emergency support. Participants will navigate these sections to set asthma control goals, schedule medication reminders, log daily symptoms, and receive guidance for attacks. All participants will be encouraged to seek routine care. A study nurse will follow up with each participant via the phone six weeks post-intervention. The MICROS study was approved by the Makerere University School of Medicine Research and Ethics Committee and the Uganda National Council of Science and Technology. This protocol is registered on Clinicaltrials.gov (NCT05850806).Conclusion: The MICROS study will provide comprehensive insights into how effective a mHealth intervention can be an aid for adolescents in a low-resource setting in managing their asthma. The findings of this study will contribute to filling the gap leading to unsatisfactory asthma control in adolescents. [ABSTRACT FROM AUTHOR]

Background: The burden of drowning among occupational boaters in low and middle-income countries is highest globally. In Uganda, over 95% of people who drowned from boating-related activities were not wearing lifejackets at the time of the incident. We implemented and evaluated a peer-led training program to improve lifejacket wear among occupational boaters on Lake Albert, Uganda. Methods: We conducted a two-arm cluster randomized controlled trial in which fourteen landing sites were randomized to the intervention and non-intervention arm with a 1:1 allocation ratio. In the intervention arm, a six-month peer-to-peer training program on lifejacket wear was implemented while the non-intervention arm continued to receive the routine Marine Police sensitizations on drowning prevention through its community policing program. The effect of the intervention was assessed on self-reported and observed lifejacket wear using a test of differences in proportions of wear following the intention to treat principle. The effect of contamination was assessed using mixed effect modified Poisson regression following the As Treated analysis principle at 95% CI. Results are reported according to the CONSORT statement–extension for cluster randomized trials. Results: Self-reported lifejacket wear increased markedly from 30.8% to 65.1% in the intervention arm compared to the non-intervention arm which rose from 29.9% to 43.2%. Observed wear increased from 1.0% to 26.8% in the intervention arm and from 0.6% to 8.8% in the non-intervention arm. The test of differences in proportions of self-reported lifejacket wear (65.1%– 43.2% = 21.9%, p-value <0.001) and observed wear (26.8%– 8.8% = 18%, p-value <0.001) showed statistically significant differences between the intervention and non-intervention arm. Self-reported lifejacket wear was higher among boaters who received peer training than those who did not (Adj. PR 1.78, 95% CI 1.38–2.30). Conclusion: This study demonstrated that peer-led training significantly improves lifejacket wear among occupational boaters. The government of Uganda through the relevant ministries, and the Landing Site Management Committees should embrace and scale up peer-led training programs on lifejacket wear to reduce drowning deaths. [ABSTRACT FROM AUTHOR]

Background: Decreasing or flattening funding for vertical HIV services means that new and innovative ways of providing care are necessary. This study aimed to assess the determinants of readiness for integration of Antiretroviral Therapy (ART) services at the departmental level among primary health care providers (PHCP) at selected health facilities in Lira District. Methods: A cross-sectional survey employing mixed methods approaches was conducted between January and February 2022 among 340 primary healthcare practitioners (PHCP) at selected health facilities in Lira district. An interviewer-administered questionnaire was used to collect quantitative data. Quantitative data was analyzed using Stata version 15. and presented as proportions, means, percentages, frequencies, and odds ratios. Logistic regression was used to determine associations of the factors with readiness for ART integration at a 95% level of significance. Thematic analysis was used to analyze qualitative data. Results: The majority 75.2% (95% CI; 0.703–0.795) of the respondents reported being ready for the integration of ART services. PHCPs who were aware of the integration of services and those who had worked in the same facility for at least 6 years had higher odds of readiness for integration of ART, compared with their counterparts [aOR = 7.36; 95% CI = 3.857–14.028, p-value <0.001] for knowledge and duration at the current facility [aOR = 2.92; 95% CI = 1.293–6.599, p-value < 0.05] respectively. From the qualitative data, the dominant view was that integration is a good thing that should be implemented immediately. However, several challenges were noted, key among which include limited staffing and drug supplies at the facilities, coupled with limited space. Conclusions: The study reveals a high level of readiness for the integration of ART services at departmental levels among Primary Healthcare Providers. Notably, PHCPs knowledgeable about integration and those who spent at least six years at the current health facility of work, were strong determinants for the integration of ART services in resource limited settings. In light of these findings, we recommend that policymakers prioritize the implementation of training programs aimed at upskilling healthcare workers. Furthermore, we advocate that a cluster randomized controlled trial be conducted, to evaluate the long-term effects of this integration on overall health outcomes. [ABSTRACT FROM AUTHOR]

Background: The World Health Organization recommends birth companionship for all women in labor. There is insufficient evidence on birth companionship in low-income settings and it is not clear if role orientation impacts effectiveness. The aim of this study was to assess the efficacy of midwife-led role orientation of birth companions of on maternal satisfaction and birth outcomes in a sub-region in Uganda. Methods: A stepped wedge cluster randomized trial conducted (control n = 240), intervention n = 235) from 4 clusters. Women who had a birth companion, in spontaneously established labor and, expecting a vaginal delivery were eligible. The intervention was "midwife-provided orientation of birth companions". The admitting midwife provided an orientation session for the birth companion on supportive labor techniques. The primary outcome was the chance of having a spontaneous vaginal delivery. Assessors were not blinded. Independent t-test and Chi-Square tests were used to assess the differences by study period. Results: Mean maternal satisfaction rate was significantly higher in the intervention period compared to the control period (P > 0.001). High maternal satisfaction levels were noted among the women who were; at the regional referral hospital, younger, first-time mothers, and unmarried (P < 0.001). Satisfaction with pain management was rated lowest across study periods. Satisfaction with humaneness was rated highest with a higher score in the intervention period (93%) than the control (79.5%). There were no statistically significant differences in the mode of delivery, need to augment labor, length of labor and Apgar scores. Conclusion: Midwife-led role orientation of birth companions increased maternal satisfaction. Nevertheless, no significant effect was noted in the mode of delivery, length of labor, Apgar score, and need to augment labor. Findings could inform the integration of birth companions in the admission process of the woman in labor in similar settings. Trial registration number: NCT04771325. [ABSTRACT FROM AUTHOR]

Introduction: Uganda's community health worker (CHW), or village health team (VHT), program faces significant challenges with poor retention and insufficient financial and program investment. Adequate compensation comprising financial and non-financial components is critical to retaining any workforce, including CHWs. This study evaluates the impact of a recognition-based non-financial incentives package on the motivation, performance, and retention of VHTs, as well as on the utilization of health services by the community. The incentive package and intervention were developed in collaboration with the district-level leadership and award VHTs who have met predetermined performance thresholds with a certificate and a government-branded jacket in a public ceremony. Methods: A two-armed cluster randomized controlled trial (RCT), conducted at the parish level in Uganda's Masindi District, will evaluate the effects of the 12-month intervention. The cluster-RCT will use a mixed-methods approach, which includes a baseline/endline VHT survey to assess the impact of the intervention on key outcomes, with an expected sample of 240 VHTs per study arm; our primary outcome is the total number of household visits per VHT and our multiple secondary outcomes include other performance indicators, motivation, and retention; VHT performance and retention data will be validated using monthly phone surveys tracking key performance indicators and through abstraction of VHT-submitted health facility reports; and focus group discussions will be conducted with VHTs and community members to understand how the intervention was received. Data collection activities will be administered in local languages. To assess the impact of the intervention, the study will conduct a regression analysis using Generalized Estimating Equations adjusting for cluster effect. Further, a difference-in-differences analysis will be conducted. Discussion: This study utilized a cluster-RCT design to assess the impact of a recognition-based incentives intervention on the motivation, performance, and retention of VHTs in Uganda's Masindi District. Utilizing a mixed-methods approach, the study will provide insights on the effectiveness and limitations of the intervention, VHT perspectives on perceived value, and critical insights on how non-financial incentives might support the strengthening of the community health workforce. Trial registration: ClinicalTrials.gov NCT05176106. Retrospectively registered on 4 January 2022. [ABSTRACT FROM AUTHOR]

This article reports on a post-test only cluster randomized controlled trial that assessed the impact of exposure to the Child-Optimized Financial Education (COFE) curriculum, delivered within Savings and Lending Communities (SILC) in Uganda, on caregivers' spending on school and healthcare expenses for children, and caregivers' financial self-efficacy. Participation in SILCs with COFE was significantly associated with caregivers paying for children's required school expenses compared to SILCs who were not exposed to COFE. Other outcomes were not significantly influenced by COFE. Child-centered household-level financial planning and saving may support the educational needs of Ugandan children and potentially Uganda's national-level education targets. [ABSTRACT FROM AUTHOR]

Objectives. Menstrual hygiene management is one of the main barriers to girls' education attainment in low-and middle-income countries. Poor access to sanitary products and lack of menstrual knowledge affect students' performance at school compared to the opposite sex. Limited evidence is available to provide solutions for schoolgirls. This study examines the effectiveness of menstrual health education programs on well-being and behavioral change among adolescent girls in rural Uganda. Methods. A cluster randomized controlled trial was conducted across 3 schools, including 66 girls aged 13-17 years, in a rural village in Mukono District, Uganda. Schools were randomly allocated to 2 groups: i) health education program intervention and ii) control group (no intervention). Results. After 5 weeks of the Health Education Program, the schoolgirls in experiment groups showed significantly less fear of sharing the menstruation-related concern with parents and pupils [Mean Difference (MD)=0.87, P=0.029) (MD=2.02, P=0.000), and the sense of shameful feelings during menstruation (MD=1.65, P= 0.004); conversely, the fear to go to school during menstruation did not differ between experiment and control groups (MD=-0.04, P=0.94). However, the changes in feeling comfortable having a period at school were significantly different between the experiment and control groups (P=0.001). Conclusions. The study demonstrated promising results of a low-cost intervention for enhancing girls' menstrual health education in a low-income context. Puberty education and reusable pad sewing provision were strongly associated with improving schoolgirls' psychosocial wellbeing related to menstrual management. [ABSTRACT FROM AUTHOR]

Objective: To examine the role of psychological flexibility as a potential mediator in the relationship between involvement in a guided self-help intervention, Self-Help Plus, and psychological distress in a sample of South Sudanese refugee women living in northern Uganda. Method: We conducted secondary analysis of data from a cluster randomized controlled trial conducted in 2018. We used multilevel mediation modeling to explore the relationship of psychological flexibility, as measured by the Acceptance and Action Questionnaire (AAQ-II), as a mediating factor in the relationship between Self-Help Plus involvement and general psychological distress as measured by the Kessler Psychological Distress Scale–6 (K6). Results: We found strong multilevel mediation of decreased K6 scores in the treatment group by AAQ-II scores (multilevel b = −3.28). A more pronounced mediation effect was discovered immediately post intervention (b = −1.09) compared to 3-month follow-up (b = −0.84). This is in line with the current literature that demonstrates the role of psychological flexibility as a primary mechanism of change in ACT-based interventions. Conclusions: Psychological flexibility is a contributing component in the theory of change for this ACT-based intervention. Identifying the core components of interventions allows for more effective adaptation and implementation of relevant services, especially in low-resource contexts. What is the public health significance of this article?: Public mental health in humanitarian settings demands interventions with flexibility in implementation, options for paraprofessional use, and low-resource demand. Accordingly, the purpose of this investigation is to contextualize a promising, low-intensity ACT-based intervention within existing literature and expand on its primary mechanism of change, increases in psychological flexibility. This article suggests that specific elements of this therapy are readily adapted for use in novel cultural settings and facilitate change in psychological flexibility while retaining the key components of an effective intervention. [ABSTRACT FROM AUTHOR]

Background: Uganda has one of the highest fertility rates globally, but only 30% of women report using an effective method of contraception. Community-based, multi-level interventions are needed to help couples in rural Uganda overcome barriers to contraceptive use. Methods: This study will pilot test the Family Health = Family Wealth intervention, a multi-level, community-based intervention employing transformative community dialogues, which use facilitated discussion to reshape community norms that influence family planning acceptance, to alter individual attitudes and the perception of community norms that discourage family planning. Community dialogues are delivered to groups of couples over 4 sessions (two gender-segregated and two gender-mixed). Sessions simultaneously address individual and interpersonal-level determinants of family planning and link couples to family planning services. At the health system level, a refresher training will be conducted with health workers in the intervention community's health center to address gaps in contraceptive knowledge and skills as identified from a needs assessment. The intervention will be evaluated through a pilot quasi-experimental trial paired with a mixed methods process evaluation. Participants include 70 couples (N=140) randomized by community to the Family Health = Family Wealth intervention (n=35 couples) or to an attention-matched water, sanitation, and hygiene (WASH) intervention (n=35 couples). Participants include sexually active, married couples who are age 18 (or an emancipated minor) to 40 for women and age 18 (or an emancipated minor) to 50 for men, not pregnant, at least one person in the couple reports wanting to avoid pregnancy for at least a year, and not currently using a method of contraception or using a low-efficacy or ineffective method of contraception. The primary aims of the study are to (1) assess the feasibility of the intervention trial procedures, (2) the acceptability and feasibility of the intervention content and structure, and (3) explore the intervention's preliminary effectiveness at increasing contraceptive use and affecting related outcomes among couples. Discussion: Filling the unmet need for family planning has important public health implications, including reductions in pregnancy-related health risks and deaths, and infant mortality. This pilot intervention trial will gather preliminary evidence on the acceptability, feasibility, and potential effect of a novel, multi-level, community-based intervention to increase contraceptive use among couples with an unmet need for family planning in rural Uganda. We aim to use the findings of this pilot study to refine the trial procedures and intervention content for a future, larger cluster randomized controlled trial to establish the intervention's efficacy. Trial registration: ClinicalTrials.gov NCT04262882; registered on February 10, 2020. [ABSTRACT FROM AUTHOR]

Background: Children in low-and-middle-income countries (LMICs) are facing tremendous mental health challenges. Numerous evidence-based interventions (EBIs) have been adapted to LMICs and shown effectiveness in addressing the needs, but most EBIs have not been adopted widely using scalable and sustainable implementation models that leverage and strengthen existing structures. There is a need to apply implementation science methodology to study strategies to effectively scale-up EBIs and sustain the practices in LMICs. Through a cross-sector collaboration, we are carrying out a second-generation investigation of implementation and effectiveness of a school-based mental health EBI, ParentCorps Professional Development (PD), to scale-up and sustain the EBI in Uganda to promote early childhood students' mental health. Our previous studies in Uganda supported that culturally adapted PD resulted in short-term benefits for classrooms, children, and families. However, our previous implementation of PD was relied on mental health professionals (MHPs) to provide PD to teachers. Because of the shortage of MHPs in Uganda, a new scalable implementation model is needed to provide PD at scale. Objectives: This study tests a new scalable and sustainable PD implementation model and simultaneously studies the effectiveness. This paper describes use of collaboration, task-shifting, and Train-the-Trainer strategies for scaling-up PD, and protocol for studying the effectiveness-implementation of ParentCorps-PD for teachers in urban and rural Ugandan schools. We will examine whether the new scale-up implementation approach will yield anticipated impacts and investigate the underlying effectiveness-implementation mechanisms that contribute to success. In addition, considering the effects of PD on teachers and students will influence by teacher wellness. This study also examines the added value (i.e. impact and costs) of a brief wellness intervention for teachers and students. Methods: Using a hybrid-type II effectiveness-implementation cluster randomized controlled trial (cRCT), we will randomize 36 schools (18 urban and 18 rural) with 540 teachers and nearly 2000 families to one of three conditions: PD + Teacher-Wellness (PDT), PD alone (PD), and Control. Primary effectiveness outcomes are teachers' use of mental health promoting strategies, teacher stress management, and child mental health. The implementation fidelity/quality for the scale-up model will be monitored. Mixed methods will be employed to examine underlying mechanisms of implementation and impact as well as cost-effectiveness. Discussion: This research will generate important knowledge regarding the value of an EBI in urban and rural communities in a LMIC, and efforts toward supporting teachers to prevent and manage early signs of children's mental health issues as a potentially cost-effective strategy to promote child population mental health in low resource settings. Trial Registration: This trial was registered with ClinicalTrials.gov (registration number: NCT04383327; https://clinicaltrials.gov/ct2/show/NCT04383327) on May13, 2020. [ABSTRACT FROM AUTHOR]

Background: Over 80% of the morbidity and mortality related to non-communicable diseases (NCDs) occurs in low-income and middle-income countries (LMICs). Community health workers (CHWs) may improve disease control and medication adherence among patients with NCDs in LMICs, particularly in sub-Saharan African settings. In Uganda, and the majority of LMICs, management of uncontrolled hypertension remains limited in constrained health systems. Intervening at the primary care level, using CHWs to improve medical treatment outcomes has not been well studied. We aim to determine the effectiveness of a CHW-led intervention in blood pressure control among confirmed hypertensive patients and patient-related factors associated with uncontrolled hypertension.Methods: We will conduct a stepped-wedge cluster randomized controlled trial study of 869 adult patients with hypertension attending two NCD clinics to test the effectiveness, acceptability, and fidelity of a CHW-led intervention. The multi-component intervention will be centered on monthly household visits by trained CHWs for a period of 1 year, consisting of the following: (1) blood pressure and sugar monitoring, (2) BMI monitoring, (3) cardiovascular disease risk assessment, (4) using checklists to guide monitoring and referral to clinics, and (5) healthy lifestyle counseling and education. During home visits, CHWs will remind patients of follow-up visits. We will measure blood pressure at baseline and 3-monthly for the entire cohort. We will conduct individual-level mixed effects analyses of study data, adjusting for time and clustering by patient and community.Conclusion: The results of this study will inform community delivered HTN management across a range of LMIC settings.Trial Registration: ClinicalTrials.gov NCT05068505 . Registered on October 6, 2021. [ABSTRACT FROM AUTHOR]

Background: Sub-Saharan Africa (SSA) is heavily burdened by HIV, with 85% of the global new infections among adolescents happening in the region. With advances in medication and national policies promoting antiretroviral therapy (ART), children < 15 years living with HIV (CLWH) continue to grow with a chronic, highly stigmatized disease. Unfortunately, the stigma they experience results in much lower quality of life, including poor mental health and treatment outcomes. Family members also experience stigma and shame by virtue of their association with an HIV-infected family member. Yet, stigma-reduction interventions targeting CLWH and their families are very limited. The goal of this study is to address HIV-associated stigma among CLWH and their caregivers in Uganda. Methods: This three-arm cluster randomized control trial, known as Suubi4Stigma, will evaluate the feasibility, acceptability, and preliminary impact of two evidence-based interventions: (1) group cognitive behavioral therapy (G-CBT) focused on cognitive restructuring and strengthening coping skills at the individual level and (2) a multiple family group (MFG) intervention that strengthens family relationships to address stigma among CLWH (N = 90, 10–14 years) and their families (dyads) in Uganda. Nine clinics will be randomized to one of three study arms (n = 3 clinics, 30 child-caregiver dyads each): (1) usual care; (2) G-CBT + usual care; and (3) MFG + usual care. Both treatment and control conditions will be delivered over a 3-month period. Data will be collected at baseline (pre-intervention) and at 3 months and 6 months post-intervention initiation. Conclusion: The primary aim of the proposed project is to address the urgent need for theoretically and empirically informed interventions that seek to reduce HIV-associated stigma and its negative impact on adolescent health and psychosocial well-being. As several countries in SSA grapple with care and support for CLWH, this study will lay the foundation for a larger intervention study investigating how HIV-associated stigma can be reduced to foster healthy child development—especially for CLWH as they transition through adolescence. Trial registration: ClinicalTrials.gov: NCT04528732; Registered August 27, 2020 [ABSTRACT FROM AUTHOR]

Background: Maintaining a motivated health workforce is critical to health system effectiveness and quality of care. Scant evidence exists on whether interventions aimed to strengthen health infrastructure in low-resource settings affect health workers. This study evaluated the impact of an intervention providing solar light and electricity to rural maternity facilities in Uganda on health workers' job satisfaction.Methods: We used a mixed-methods design embedded in a cluster randomized trial to evaluate whether and how the We Care Solar Suitcase intervention, a solar electric system providing lighting and power, affected health workers in rural Ugandan maternity facilities with unreliable light. Facilities were randomly assigned to receive the intervention or not without blinding in a cluster-randomized controlled trial. Outcomes were assessed through two rounds of surveys with health workers. We used regression analyses to examine the intervention's impact on job satisfaction. We used an inductive approach to analyze qualitative data to understand the study context and interpret quantitative findings.Results: We interviewed 85 health workers across 30 facilities, the majority of whom were midwives or nurses. Qualitative reports indicated that unreliable light made it difficult to provide care, worsened facility conditions, and harmed health workers and patients. Before the intervention, only 4% of health workers were satisfied with their access to light and electricity. After the installation, satisfaction with light increased by 76 percentage points [95% confidence interval (CI): 61-92 percentage points], although satisfaction with electricity did not change. Experience of negative impacts of lack of overhead light also significantly decreased and the intervention modestly increased job satisfaction. Qualitative evidence illustrated how the intervention may have strengthened health workers' sense of job security and confidence in providing high-quality care while pointing towards implementation challenges and other barriers health workers faced.Conclusions: Reliable access to light and electricity directly affects health workers' ability to provide maternal and neonatal care and modestly improves job satisfaction. Policy makers should invest in health infrastructure as part of multifaceted policy strategies to strengthen human resources for health and to improve maternal and newborn health services. Trial registration socialscienceregistry.org: AEARCTR-0003078. Registered June 12, 2018, https://www.socialscienceregistry.org/trials/3078 Additionally registered on: ClinicalTrials.gov: NCT03589625, Registered July 18, 2018, https://clinicaltrials.gov/ct2/show/NCT03589625 ). [ABSTRACT FROM AUTHOR]

Background: One of the main barriers of the management of household tuberculosis child contacts is the necessity for parents to bring healthy children to the facility. We assessed the feasibility of a community intervention for tuberculosis (TB) household child contact management and the conditions for its evaluation in a cluster randomized controlled trial in Cameroon and Uganda. Methods: We assessed three dimensions of feasibility using a mixed method approach: (1) recruitment capability using retrospective aggregated data from facility registers; (2) acceptability of the intervention using focus group discussions with TB patients and in-depth interviews with healthcare providers and community leaders; and (3) adaptation, integration, and resources of the intervention in existing TB services using a survey and discussions with stakeholders. Results: Reaching the sample size is feasible in all clusters in 15 months with the condition of regrouping 2 facilities in the same cluster in Uganda due to decentralization of TB services. Community health worker (CHW) selection and training and simplified tools for contact screening, tolerability, and adherence of preventive therapy were key elements for the implementation of the community intervention. Healthcare providers and patients found the intervention of child contact investigations and TB preventive treatment management in the household acceptable in both countries due to its benefits (competing priorities, transport cost) as compared to facility-based management. TB stigma was present, but not a barrier for the community intervention. Visit schedule and team conduct were identified as key facilitators for the intervention. Conclusions: This study shows that evaluating a community intervention for TB child contact management in a cluster randomized trial is feasible in Cameroon and Uganda. Trial registration: Clini calTr ials. gov NCT03832023. Registered on February 6th 2019. [ABSTRACT FROM AUTHOR]

Background: Long-lasting insecticidal nets (LLINs) are the main vector control tool for pregnant women, but their efficacy may be compromised, in part, due to pyrethroid resistance. In 2017, the Ugandan Ministry of Health embedded a cluster randomized controlled trial into the national LLIN campaign, where a random subset of health subdistricts (HSDs) received LLINs treated with piperonyl butoxide (PBO), a chemical synergist known to partially restore pyrethroid sensitivity. Using data from a small, non-randomly selected subset of HSDs, this secondary analysis used quasi-experimental methods to quantify the overall impact of the LLIN campaign on pregnancy outcomes. In an exploratory analysis, differences between PBO and conventional (non-PBO) LLINs on pregnancy outcomes were assessed. Methods: Birth registry data (n = 39,085) were retrospectively collected from 21 health facilities across 12 HSDs, 29 months before and 9 months after the LLIN campaign (from 2015 to 2018). Of the 12 HSDs, six received conventional LLINs, five received PBO LLINs, and one received a mix of conventional and PBO LLINs. Interrupted time-series analyses (ITSAs) were used to estimate changes in monthly incidence of stillbirth and low birthweight (LBW; <2500 g) before-and-after the campaign. Poisson regression with robust standard errors modeled campaign effects, adjusting for health facility-level differences, seasonal variation, and time-varying maternal characteristics. Comparisons between PBO and conventional LLINs were estimated using difference-in-differences estimators. Results: ITSAs estimated the campaign was associated with a 26% [95% CI: 7–41] reduction in stillbirth incidence (incidence rate ratio (IRR) = 0.74 [0.59–0.93]) and a 15% [-7, 33] reduction in LBW incidence (IRR=0.85 [0.67–1.07]) over a 9-month period. The effect on stillbirth incidence was greatest for women delivering 7–9 months after the campaign (IRR=0.60 [0.41–0.87]) for whom the LLINs would have covered most of their pregnancy. The IRRs estimated from difference-in-differences analyses comparing PBO to conventional LLINs was 0.78 [95% CI: 0.52, 1.16] for stillbirth incidence and 1.15 [95% CI: 0.87, 1.52] for LBW incidence. Conclusions: In this region of Uganda, where pyrethroid resistance is high, this study found that a mass LLIN campaign was associated with reduced stillbirth incidence. Effects of the campaign were greatest for women who would have received LLINs early in pregnancy, suggesting malaria protection early in pregnancy can have important benefits that are not necessarily realized through antenatal malaria services. Results from the exploratory analyses comparing PBO and conventional LLINs on pregnancy outcomes were inconclusive, largely due to the wide confidence intervals that crossed the null. Thus, future studies with larger sample sizes are needed. [ABSTRACT FROM AUTHOR]

Background: Hypertension treatment reduces morbidity and mortality yet has not been broadly implemented in many low-resource settings, including sub-Saharan Africa (SSA). We hypothesized that a patient-centered integrated chronic disease model that included hypertension treatment and leveraged the HIV care system would reduce mortality among adults with uncontrolled hypertension in rural Kenya and Uganda.Methods and Findings: This is a secondary analysis of the SEARCH trial (NCT:01864603), in which 32 communities underwent baseline population-based multidisease testing, including hypertension screening, and were randomized to standard country-guided treatment or to a patient-centered integrated chronic care model including treatment for hypertension, diabetes, and HIV. Patient-centered care included on-site introduction to clinic staff at screening, nursing triage to expedite visits, reduced visit frequency, flexible clinic hours, and a welcoming clinic environment. The analytic population included nonpregnant adults (≥18 years) with baseline uncontrolled hypertension (blood pressure ≥140/90 mm Hg). The primary outcome was 3-year all-cause mortality with comprehensive population-level assessment. Secondary outcomes included hypertension control assessed at a population level at year 3 (defined per country guidelines as at least 1 blood pressure measure <140/90 mm Hg on 3 repeated measures). Between-arm comparisons used cluster-level targeted maximum likelihood estimation. Among 86,078 adults screened at study baseline (June 2013 to July 2014), 10,928 (13%) had uncontrolled hypertension. Median age was 53 years (25th to 75th percentile 40 to 66); 6,058 (55%) were female; 677 (6%) were HIV infected; and 477 (4%) had diabetes mellitus. Overall, 174 participants (3.2%) in the intervention group and 225 participants (4.1%) in the control group died during 3 years of follow-up (adjusted relative risk (aRR) 0.79, 95% confidence interval (CI) 0.64 to 0.97, p = 0.028). Among those with baseline grade 3 hypertension (≥180/110 mm Hg), 22 (4.9%) in the intervention group and 42 (7.9%) in the control group died during 3 years of follow-up (aRR 0.62, 95% CI 0.39 to 0.97, p = 0.038). Estimated population-level hypertension control at year 3 was 53% in intervention and 44% in control communities (aRR 1.22, 95% CI 1.12 to 1.33, p < 0.001). Study limitations include inability to identify specific causes of death and control conditions that exceeded current standard hypertension care.Conclusions: In this cluster randomized comparison where both arms received population-level hypertension screening, implementation of a patient-centered hypertension care model was associated with a 21% reduction in all-cause mortality and a 22% improvement in hypertension control compared to standard care among adults with baseline uncontrolled hypertension. Patient-centered chronic care programs for HIV can be leveraged to reduce the overall burden of cardiovascular mortality in SSA.Trial Registration: ClinicalTrials.gov NCT01864603. [ABSTRACT FROM AUTHOR]

Background: Literature shows a high prevalence of psychological distress (PD) as well as common mental disorders (CMD) such as major depressive disorders (MDD), generalized anxiety disorders (GAD), post-traumatic stress disorders (PTSD), and substance misuse disorders (SUD) among people exposed to disasters and pandemics like the COVID-19. Moreover, CMD are associated with increased mortality (mainly through suicide) and morbidity (loss of productivity). A number of countries have made deliberate efforts to identify and manage CMD in light of COVID-19. However, low levels of mental health literacy (MHL) manifested by the individual's unawareness of CMD symptoms, limited human and mental health infrastructure resources, and high levels of mental illness stigma (MIS) are barriers to integration of mental health care in general health care during pandemics and epidemics such as the COVID-19.Objectives: For the proposed study, we will determine effectiveness of a psycho-education intervention delivered by village health team (VHT) members.Methods: We will employ a cluster randomized trial design in 24 villages in central Uganda. We will collect baseline data to and document the prevalence of MHL, PD, MDD, PTSD, GAD, and SUD. We will distribute information education and communication materials (IEC) aimed at improving MHL to 420 adult individuals in the intervention arm (n = 12 villages). In the control arm (n = 12 villages), VHTs will distribute ministry of health COVID-19 information leaflets to 420 participants. Within 7 days of distributing the materials, research assistants will conduct a follow-up interview and assess for the same parameters (MHL, PD, MDD, PTSD, GAD, and SUD). We will use an intention to treat analysis to estimate the effectiveness of the psycho-education intervention.Discussion: Findings from this research will guide policy and practice regarding the integration of mental health services in the community in the context of epidemic preparedness and response.Trial Registration: ClinicalTrials.gov NCT04616989 . Registered on 05 November 2020. [ABSTRACT FROM AUTHOR]

Introduction: Evidence from low‐resource settings indicates that economic insecurity is a major barrier to HIV treatment adherence. Economic empowerment (EE) interventions have the potential to improve adherence outcomes among adolescents living with HIV (ALWHIV) by mitigating the effects of poverty. This study aims to assess the efficacy and cost‐effectiveness of a savings‐led family‐based EE intervention, Suubi + Adherence, aimed at improving antiretroviral therapy (ART) adherence outcomes ALWHIV in Uganda. Methods: Adolescents (mean age 12 years at enrolment; 56% female) receiving ART for HIV at 39 health centres were randomized to Suubi + Adherence intervention (n = 358) or bolstered standard of care (BSOC; n = 344). A difference‐in‐differences analysis was employed to assess the change in the proportion of virally suppressed adolescents (HIV RNA viral load <40 copies/mL) over 24 months. The cost‐effectiveness analysis examined how much the intervention cost to virally suppress one additional adolescent relative to BSOC from the healthcare provider perspective. Results: At 24 months, the intervention was associated with an 8.85‐percentage point [95% confidence interval (CI) 0.80 to 16.90 percentage points] increase in the proportion of virally suppressed adolescents between the study arms (p = 0.032). Per‐participant costs were US$177 and US$263 for the BSOC and intervention groups respectively. The incremental cost of virally suppressing one additional adolescent was estimated at US$970 [95% CI, US$508 to 10,725] over two years. Conclusions: Our results support the integration of family‐based EE interventions into adherence‐support strategies as part of routine HIV care in low‐resource settings to address the underlying economic drivers of poor ART adherence among ALWHIV. Moreover, per‐participant costs to achieve viral suppression do not seem prohibitive compared to other community‐based adherence interventions targeted at ALWHIV in low‐resource settings. Further research on combination interventions at the nexus of economic security and HIV treatment and care is needed to inform the development of feasible and scalable HIV policies and programmes. [ABSTRACT FROM AUTHOR]

Background: Safer conception counseling (SCC) to promote the use of safer conception methods (SCM) is not yet part of routine family planning or HIV care. Guidelines for the use of SCM have been published, but to date there are no published controlled evaluations of SCC. Furthermore, it is unknown whether standard methods commonly used in resource constrained settings to integrate new services would be sufficient, or if enhanced training and supervision would result in a more efficacious approach to implementing SCC.Methods: In a hybrid, cluster randomized controlled trial, six HIV clinics were randomly assigned to implement the SCC intervention Our Choice using either a high (SCC1) or low intensity (SCC2) approach (differentiated by amount of training and supervision), or existing family planning services (usual care). Three hundred eighty-nine HIV clients considering childbearing with an HIV-negative partner enrolled. The primary outcome was self-reported use of appropriate reproductive method (SCM if trying to conceive; modern contraceptives if not) over 12 months or until pregnancy.Results: The combined intervention groups used appropriate reproductive methods more than usual care [20.8% vs. 6.9%; adjusted OR (95% CI)=10.63 (2.79, 40.49)], and SCC1 reported a higher rate than SCC2 [27.1% vs. 14.6%; OR (95% CI)=4.50 (1.44, 14.01)]. Among those trying to conceive, the intervention arms reported greater accurate use of SCM compared to usual care [24.1% vs. 0%; OR (95% CI)=91.84 (4.94, 1709.0)], and SCC1 performed better than SCC2 [34.6% vs. 11.5%; OR (95% CI)=6.43 (1.90, 21.73)]. The arms did not vary on modern contraception use among those not trying to conceive. A cost of $631 per person was estimated to obtain accurate use of SCM in SCC1, compared to $1014 in SCC2.Conclusions: More intensive provider training and more frequent supervision leads to greater adoption of complex SCM behaviors and is more cost-effective than the standard low intensity implementation approach.Trial Registration: Clinicaltrials.gov, NCT03167879 ; date registered May 23, 2017. [ABSTRACT FROM AUTHOR]

Background: There are major gaps in the management of pediatric tuberculosis (TB) contact investigation for rapid identification of active tuberculosis and initiation of preventive therapy. This study aims to evaluate the impact of a community-based intervention as compared to facility-based model for the management of children in contact with bacteriologically confirmed pulmonary TB adults in low-resource high-burden settings.Methods/design: This multicenter parallel open-label cluster randomized controlled trial is composed of three phases: I, baseline phase in which retrospective data are collected, quality of data recording in facility registers is checked, and expected acceptability and feasibility of the intervention is assessed; II, intervention phase with enrolment of index cases and contact cases in either facility- or community-based models; and III, explanatory phase including endpoint data analysis, cost-effectiveness analysis, and post-intervention acceptability assessment by healthcare providers and beneficiaries. The study uses both quantitative and qualitative analysis methods. The community-based intervention includes identification and screening of all household contacts, referral of contacts with TB-suggestive symptoms to the facility for investigation, and household initiation of preventive therapy with follow-up of eligible child contacts by community healthcare workers, i.e., all young (< 5 years) child contacts or older (5-14 years) child contacts living with HIV, and with no evidence of TB disease. Twenty clusters representing TB diagnostic and treatment facilities with their catchment areas are randomized in a 1:1 ratio to either the community-based intervention arm or the facility-based standard of care arm in Cameroon and Uganda. Randomization was stratified by country and constrained on the number of index cases per cluster. The primary endpoint is the proportion of eligible child contacts who initiate and complete the preventive therapy. The sample size is of 1500 child contacts to identify a 10% difference between the arms with the assumption that 60% of children will complete the preventive therapy in the standard of care arm.Discussion: This study will provide evidence of the impact of a community-based intervention on household child contact screening and management of TB preventive therapy in order to improve care and prevention of childhood TB in low-resource high-burden settings.Trial Registration: ClinicalTrials.gov NCT03832023 . Registered on 6 February 2019. [ABSTRACT FROM AUTHOR]

Background: Effective implementation strategies are needed to increase engagement in HIV services in hyperendemic settings. We conducted a pragmatic cluster-randomized trial in a high-risk, highly mobile fishing community (HIV prevalence: approximately 38%) in Rakai, Uganda, to assess the impact of a community health worker-delivered, theory-based (situated Information, Motivation, and Behavior Skills), motivational interviewing-informed, and mobile phone application-supported counseling strategy called "Health Scouts" to promote engagement in HIV treatment and prevention services.Methods and Findings: The study community was divided into 40 contiguous, randomly allocated clusters (20 intervention clusters, n = 1,054 participants at baseline; 20 control clusters, n = 1,094 participants at baseline). From September 2015 to December 2018, the Health Scouts were deployed in intervention clusters. Community-wide, cross-sectional surveys of consenting 15 to 49-year-old residents were conducted at approximately 15 months (mid-study) and at approximately 39 months (end-study) assessing the primary programmatic outcomes of self-reported linkage to HIV care, antiretroviral therapy (ART) use, and male circumcision, and the primary biologic outcome of HIV viral suppression (<400 copies/mL). Secondary outcomes included HIV testing coverage, HIV incidence, and consistent condom use. The primary intent-to-treat analysis used log-linear binomial regression with generalized estimating equation to estimate prevalence risk ratios (PRR) in the intervention versus control arm. A total of 2,533 (45% female, mean age: 31 years) and 1,903 (46% female; mean age 32 years) residents completed the mid-study and end-study surveys, respectively. At mid-study, there were no differences in outcomes between arms. At end-study, self-reported receipt of the Health Scouts intervention was 38% in the intervention arm and 23% in the control arm, suggesting moderate intervention uptake in the intervention arm and substantial contamination in the control arm. At end-study, intention-to-treat analysis found higher HIV care coverage (PRR: 1.06, 95% CI: 1.01 to 1.10, p = 0.011) and ART coverage (PRR: 1.05, 95% CI: 1.01 to 1.10, p = 0.028) among HIV-positive participants in the intervention compared with the control arm. Male circumcision coverage among all men (PRR: 1.05, 95% CI: 0.96 to 1.14, p = 0.31) and HIV viral suppression among HIV-positive participants (PRR: 1.04, 95% CI: 0.98 to 1.12, p = 0.20) were higher in the intervention arm, but differences were not statistically significant. No differences were seen in secondary outcomes. Study limitations include reliance on self-report for programmatic outcomes and substantial contamination which may have diluted estimates of effect.Conclusions: A novel community health worker intervention improved HIV care and ART coverage in an HIV hyperendemic setting but did not clearly improve male circumcision coverage or HIV viral suppression. This community-based, implementation strategy may be a useful component in some settings for HIV epidemic control.Trial Registration: ClinicalTrials.gov NCT02556957. [ABSTRACT FROM AUTHOR]

Background: Delays in diagnosis and treatment of tuberculosis (TB) remain common in high-burden countries. To improve case detection, substantial investments have been made to scale-up Xpert MTB/RIF (Xpert), a cartridge-based nucleic acid amplification test that can detect TB within 2 hours, as a replacement for sputum smear microscopy. However, the optimal strategy for implementation of Xpert testing remains unclear.Methods: The Xpert Performance Evaluation for Linkage to Tuberculosis Care (XPEL-TB) trial uses an ultra-pragmatic, hybrid type II effectiveness-implementation design to assess the effectiveness and implementation of a streamlined strategy for delivery of Xpert testing in real-world settings. Twenty health centers with TB microscopy units were selected to participate in the trial, with ten health centers randomized to the intervention strategy (onsite molecular testing using GeneXpert Edge, process redesign to facilitate same-day TB diagnosis and treatment, and performance feedback) or routine care (onsite sputum smear microscopy plus referral of sputum samples to Xpert testing sites). The primary outcome is the number of patients with microbiologically confirmed TB who were initiated on treatment within 14 days of presentation to the health center, which reflects successful completion of the TB diagnostic evaluation process. Secondary outcomes include health outcomes (6-month vital status), as well as measures of the reach, adoption, and implementation of the intervention strategy.Discussion: The design elements and implementation approach for the XPEL-TB trial were intentionally selected to minimize disruptions to routine care procedures, with the goal of limiting their influence on key primary and secondary outcomes. Trial findings may result in increased support and funding for rapid, onsite molecular testing as the standard-of-care for all patients being evaluated for TB.Trial Registration: US National Institutes of Health's ClinicalTrials.gov, NCT03044158. Registered 06 February 2017. Pan African Clinical Trials Registry, PACTR201610001763265. Registered 03 September 2016. [ABSTRACT FROM AUTHOR]

Background: The rapid scale-up of HIV therapy across Africa has failed to adequately engage adolescents living with HIV (ALWHIV). Retention and viral suppression for this group (ALWHIV) is 50% lower than for adults. Indeed, on the African continent, HIV remains the single leading cause of mortality among adolescents. Strategies tailored to the unqiue developmental and social vulnerabilities of this group are urgently needed to enhance successful treatment. Methods: We carried out a five-year longitudinal cluster randomized trial (ClinicalTrials.gov ID: NCT01790373) with adolescents living with HIV (ALWHIV) ages 10 to 16 years clustered at health care clinics to test the effect of a family economic empowerment (EE) intervention on viral suppression in five districuts in Uganda. In total, 39 accredited health care clinics from study districts with existing procedures tailored to adolescent adherence were eligible to participate in the trial. We used data from 288 youth with detectable HIV viral loads (VL) at baseline (158 –intervention group from 20 clinics, 130 –non-intervention group from 19 clinics). The primary end point was undetectable plasma HIV RNA levels, defined as < 40 copies/ml. We used Kaplan-Meier (KM) analysis and Cox proportional hazard models to estimate intervention effects. Findings: The Kaplan-Meier (KM) analysis indicated that an incidence of undetectable VL (0.254) was significantly higher in the intervention condition compared to 0.173 (in non-intervention arm) translated into incidence rate ratio of 1.468 (CI: 1.064–2.038), p = 0.008. Cox regression results showed that along with the family-based EE intervention (adj. HR = 1.446, CI: 1.073–1.949, p = 0.015), higher number of medications per day had significant positive effects on the viral suppression (adj.HR = 1.852, CI: 1.275–2.690, p = 0.001). Interpretation: A family economic empowerment intervention improved treatment success for ALWHIV in Uganda. Analyses of cost effectiveness and scalability are needed to advance incorporation of this intervention into routine practice in low and middle-income countries. [ABSTRACT FROM AUTHOR]

Background: Uptake of couples' HIV counseling and testing (couples' HCT) services remains largely low in most settings. We report the effect of a demand-creation intervention trial on couples' HCT uptake among married or cohabiting individuals who had never received couples' HCT.Methods: This was a cluster-randomized intervention trial implemented in three study regions with differing HIV prevalence levels (range: 9-43 %) in Rakai district, southwestern Uganda, between February and September 2014. We randomly assigned six clusters (1:1) to receive the intervention or serve as the comparison arm using computer-generated random numbers. In the intervention clusters, individuals attended small group, couple and male-focused interactive sessions, reinforced with testimonies from 'expert couples', and received invitation coupons to test together with their partners at designated health facilities. In the comparison clusters, participants attended general adult health education sessions but received no invitation coupons. The primary outcome was couples' HCT uptake, measured 12 months post-baseline. Baseline data were collected between November 2013 and February 2014 while follow-up data were collected between March and April 2015. We conducted intention-to-treat analysis using a mixed effects Poisson regression model to assess for differences in couples' HCT uptake between the intervention and comparison clusters. Data analysis was conducted using STATA statistical software, version 14.1.Results: Of 2135 married or cohabiting individuals interviewed at baseline, 42 % (n = 846) had ever received couples' HCT. Of those who had never received couples' HCT (n = 1,174), 697 were interviewed in the intervention clusters while 477 were interviewed in the comparison clusters. 73.6 % (n = 513) of those interviewed in the intervention and 82.6 % (n = 394) of those interviewed in the comparison cluster were interviewed at follow-up. Of those interviewed, 72.3 % (n = 371) in the intervention and 65.2 % (n = 257) in the comparison clusters received HCT. Couples' HCT uptake was higher in the intervention than in the comparison clusters (20.3 % versus 13.7 %; adjusted prevalence ratio (aPR) = 1.43, 95 % CI: 1.02, 2.01, P = 0.04).Conclusion: Our findings show that a small group, couple and male-focused, demand-creation intervention reinforced with testimonies from 'expert couples', improved uptake of couples' HCT in this rural setting.Trial Registration: ClinicalTrials.gov, NCT02492061 . Date of registration: June 14, 2015. [ABSTRACT FROM AUTHOR]

Background: The Integrated Infectious Disease Capacity-Building Evaluation (IDCAP) was designed to test the effects of two interventions, Integrated Management of Infectious Disease (IMID) training and on-site support (OSS), on clinical practice of mid-level practitioners. This article reports the effects of these interventions on clinical practice in management of common childhood illnesses. Methods: Two trainees from each of 36 health facilities participated in the IMID training. IMID was a three-week core course, two one-week boost courses, and distance learning over nine months. Eighteen of the 36 health facilities were then randomly assigned to arm A, and participated in OSS, while the other 18 health facilities assigned to arm B did not. Clinical faculty assessed trainee practice on clinical practice of six sets of tasks: patient history, physical examination, laboratory tests, diagnosis, treatment, and patient/caregiver education. The effects of IMID were measured by the post/pre adjusted relative risk (aRR) of appropriate practice in arm B. The incremental effects of OSS were measured by the adjusted ratio of relative risks (aRRR) in arm A compared to arm B. All hypotheses were tested at a 5% level of significance. Results: Patient samples were comparable across arms at baseline and endline. The majority of children were aged under five years; 84% at baseline and 97% at endline. The effects of IMID on patient history (aRR = 1.12; 95% CI = 1.04-1.21) and physical examination (aRR = 1.40; 95% CI = 1.16-1.68) tasks were statistically significant. OSS was associated with incremental improvement in patient history (aRRR = 1.18; 95% CI = 1.06-1.31), and physical examination (aRRR = 1.27; 95% CI = 1.02-1.59) tasks. Improvements in laboratory testing, diagnosis, treatment, and patient/caregiver education were not statistically significant. Conclusion: IMID training was associated with improved patient history taking and physical examination, and OSS further improved these clinical practices. On-site training and continuous quality improvement activities support transfer of learning to practice among mid-level practitioners. [ABSTRACT FROM AUTHOR]

Background: HIV is the leading cause of mortality among youth in sub-Saharan Africa. Uganda hosts over 1.43 million refugees, and more than 83,000 live in Kampala, largely in informal settlements. There is limited information about HIV testing uptake and preferences among urban refugee and displaced youth. HIV self-testing is a promising method for increasing testing uptake. Further, mobile health (mHealth) interventions have been effective in increasing HIV testing uptake and could be particularly useful among youth. Objective: This study aims to evaluate the feasibility and effectiveness of two HIV self-testing implementation strategies (HIV self-testing intervention alone and HIV self-testing combined with an mHealth intervention) in comparison with the HIV testing standard of care in terms of HIV testing outcomes among refugee/displaced youth aged 16 to 24 years in Kampala, Uganda. Methods: A three-arm cluster randomized controlled trial will be implemented across five informal settlements grouped into three sites, based on proximity, and randomization will be performed with a 1:1:1 method. Approximately 450 adolescents (150 per cluster) will be enrolled and followed for 12 months. Data will be collected at the following three time points: baseline enrollment, 8 months after enrollment, and 12 months after enrollment. Primary outcomes (HIV testing frequency, HIV status knowledge, linkage to confirmatory testing, and linkage to HIV care) and secondary outcomes (depression, condom use efficacy, consistent condom use, sexual relationship power, HIV stigma, and adolescent sexual and reproductive health stigma) will be evaluated. Results: The study has been conducted in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines. The study has received ethical approval from the University of Toronto (June 14, 2019), Mildmay Uganda (November 11, 2019), and the Uganda National Council for Science and Technology (August 3, 2020). The Tushirikiane trial launched in February 2020, recruiting a total of 452 participants. Data collection was paused for 8 months due to COVID-19. Data collection for wave 2 resumed in November 2020, and as of December 10, 2020, a total of 295 participants have been followed-up. The third, and final, wave of data collection will be conducted between February and March 2021. Conclusions: This study will contribute to the knowledge of differentiated HIV testing implementation strategies for urban refugee and displaced youth living in informal settlements. We will share the findings in peer-reviewed manuscripts and conference presentations. Trial Registration: ClinicalTrials.gov NCT04504097; https://clinicaltrials.gov/ct2/show/NCT04504097. International Registered Report Identifier (IRRID): DERR1-10.2196/26192 JMIR Res Protoc 2021;10(2):e26192 doi:10.2196/26192 [ABSTRACT FROM AUTHOR]

Background: Simulation-based training is a common strategy for improving the quality of facility-based maternity services and is often evaluated using Kirkpatrick's theoretical model. The results on the Kirkpatrick levels are closely related to the quality of the instructional design of a training program. The instructional design is generally defined as the "set of prescriptions for teaching methods to improve the quality of instruction with a goal of optimizing learning outcomes." Objective: The aim of this study is to evaluate the instructional design of a technology-enhanced simulation-based training in obstetrics, the reaction of participants, and the effect on knowledge, teamwork, and skills in a low-income country. Methods: A stepped-wedge cluster randomized trial was performed in a university hospital in Kampala, Uganda, with an annual delivery volume of over 31,000. In November 2014, a medical simulation center was installed with a full-body birthing simulator (Noelle S550, Gaumard Scientific), an interactive neonate (Simon S102 Newborn CPR Simulator, Gaumard Scientific), and an audio and video recording system. Twelve local obstetricians were trained and certified as medical simulation trainers. From 2014 to 2016, training was provided to 57 residents in groups of 6 to 9 students. Descriptive statistics were calculated for ten instructional design features of the training course measured by the 42-item ID-SIM (Instructional Design of a Simulation Improved by Monitoring). The Wilcoxon signed rank test was conducted to investigate the differences in scores on knowledge, the Clinical Teamwork Scale, and medical technical skills. Results: The mean scores on the ten instructional design features ranged from 54.9 (95% CI 48.5-61.3) to 84.3 (95% CI 80.9-87.6) out of 100. The highest mean score was given on the feature feedback and the lowest scores on repetitive practice and controlled environment. The overall score for the training day was 92.8 out of 100 (95% CI 89.5-96.1). Knowledge improved significantly, with a test score of 63.4% (95% CI 60.7-66.1) before and 78.9% (95% CI 76.8-81.1) after the training (P <.001). The overall score on the 10-point Clinical Teamwork Scale was 6.0 (95% CI 4.4-7.6) before and 5.9 (95% CI 4.5-7.2) after the training (P =.78). Medical technical skills were scored at 55.5% (95% CI 47.2-63.8) before and 65.6% (95% CI 56.5-74.7) after training (P =.08). Conclusions: Most instructional design features of a technology-enhanced simulation-based training in obstetrics in a low-income country were scored high, although intervals were large. The overall score for the training day was high, and knowledge did improve after the training program, but no changes in teamwork and (most) medical technical skills were found. The lowest-scored instructional design features may be improved to achieve further learning aims. Trial Registration: ISRCTN Registry ISRCTN98617255; http://www.isrctn.com/ISRCTN98617255 International Registered Report Identifier (IRRID): RR2-10.1186/s12884-020-03050-3 JMIR Med Educ 2021;7(1):e17277 doi:10.2196/17277 [ABSTRACT FROM AUTHOR]

Background: Neonatal hypoglycemia is the most common endocrine abnormality in children, which is associated with increased morbidity and mortality. The burden and risk factors of neonatal hypoglycemia in rural communities in sub-Saharan Africa are unknown. Objective: To determine the prevalence and risk factors for neonatal hypoglycemia in Lira District, Northern Uganda. Methods: This was a community-based cross-sectional study, nested in a cluster randomized controlled trial designed to promote health facility births and newborn care practices in Lira District, Northern Uganda. This study recruited neonates born to mothers in the parent study. Random blood glucose was measured using an On Call® Plus glucometer (ACON Laboratories, Inc., 10125 Mesa Road, San Diego, CA, USA). We defined hypoglycemia as a blood glucose of < 47 mg/dl. To determine the factors associated with neonatal hypoglycemia, a multivariable linear regression mixed-effects model was used. Results: We examined 1416 participants of mean age 3.1 days (standard deviation (SD) 2.1) and mean weight of 3.2 kg (SD 0.5). The mean neonatal blood glucose level was 81.6 mg/dl (SD 16.8). The prevalence of a blood glucose concentration of < 47 mg/dl was 2.2% (31/1416): 95% CI 1.2%, 3.9%. The risk factors for neonatal hypoglycemia were delayed breastfeeding initiation [adjusted mean difference, − 2.6; 95% CI, − 4.4, − 0.79] and child age of 3 days or less [adjusted mean, − 12.2; 95% CI, − 14.0, − 10.4]. Conclusion: The incidence of neonatal hypoglycemia was low in this community and was predicted by delay in initiating breastfeeding and a child age of 3 days or less. We therefore suggest targeted screening and management of neonatal hypoglycemia among neonates before 3 days of age and those who are delayed in the onset of breastfeeding. [ABSTRACT FROM AUTHOR]

Background: Sub-Saharan Africa (SSA) has the highest number of people living with HIV/AIDS, with Nigeria, South Africa, and Uganda accounting for 48% of new infections. A systematic review of the HIV burden among women engaged in sex work (WESW) in 50 low- and middle-income countries found that they had increased odds of HIV infection relative to the general female population. Social structural factors, such as the sex work environment, violence, stigma, cultural issues, and criminalization of sex work are critical in shaping sexually transmitted infection (STI)/HIV risks among WESW and their clients in Uganda. Poverty is the most commonly cited reason for involvement in sex work in SSA. Against this backdrop, this study protocol describes a randomized controlled trial (RCT) that tests the impact of adding economic empowerment to traditional HIV risk reduction (HIVRR) to reduce new incidence of STIs and HIV among WESW in Rakai and the greater Masaka regions in Uganda.Methods: This three-arm RCT will evaluate the efficacy of adding savings, financial literacy and vocational training/mentorship to traditional HIVRR on reducing new incidence of STI infections among 990 WESW across 33 hotspots. The three arms (n = 330 each) are: 1) Control group: only HIVRR versus 2) Treatment group 1: HIVRR plus Savings plus Financial Literacy (HIVRR + S + FL); and 3) Treatment group 2: HIVRR plus S plus FL plus Vocational Skills Training and Mentorship (V) (HIVRR + S + FL + V). Data will be collected at baseline (pre-test), 6, 12, 18 and 24-months post-intervention initiation. This study will use an embedded experimental mixed methods design where qualitative data will be collected post-intervention across all conditions to explore participant experiences.Discussion: When WESW have access to more capital and/or alternative forms of employment and start earning formal income outside of sex work, they may be better able to improve their skills and employability for professional advancement, thereby reducing their STI/HIV risk. The study findings may advance our understanding of how best to implement gender-specific HIV prevention globally, engaging women across the HIV treatment cascade. Further, results will provide evidence for the intervention's efficacy to reduce STIs and inform implementation sustainability, including costs and cost-effectiveness.Trial Registration: ClinicalTrials.gov , ID: NCT03583541 . [ABSTRACT FROM AUTHOR]