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Background: This study tests behavioral economics incentives to improve adherence to antiretroviral treatment (ART), with 1 approach being low cost., Setting: Three hundred twenty-nine adults at Mildmay Hospital in Kampala, Uganda, on ART for at least 2 years and showing adherence problems received the intervention for about 15 months until the study was interrupted by a nation-wide COVID-19 lockdown., Methods: We randomized participants into 1 of 3 (1:1:1) groups: usual care ("control" group; n = 109) or 1 of 2 intervention groups where eligibility for nonmonetary prizes was based on showing at least 90% electronically measured ART adherence ("adherence-linked" group, n = 111) or keeping clinic appointments as scheduled ("clinic-linked"; n = 109). After 12 months, participants could win a larger prize for consistently high adherence or viral suppression. Primary outcomes were mean adherence and viral suppression. Analysis was by intention-to-treat using linear regression. This trial is registered with ClinicalTrials.gov, NCT03494777 ., Results: Neither incentive arm increased adherence compared with the control; we estimate a 3.9 percentage point increase in "adherence-linked" arm [95% confidence interval (CI): -0.70 to 8.60 ( P = 0.10)] and 0.024 in the "clinic-linked" arm [95% CI: -0.02 to 0.07 ( P = 0.28)]. For the prespecified subgroup of those with initial low adherence, incentives increased adherence by 7.60 percentage points (95% CI: 0.01, 0.15; P = 0.04, "adherence-linked") and 5.60 percentage points (95% CI: -0.01, 0.12; P = 0.10, "clinic-linked"). We find no effects on clinic attendance or viral suppression., Conclusions: Incentives did not improve viral suppression or ART adherence overall but worked for the prespecified subgroup of those with initial low adherence. More effectively identifying those in need of adherence support will allow better targeting of this and other incentive interventions., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Spatial repellents (SRs) have been widely used for the prevention of mosquito bites, and preliminary findings suggest efficacy against both malaria (1) and Aedes-borne viruses (2) but their effectiveness in reducing mosquito-borne diseases under operational use has never been evaluated. SRs have the potential of being critical tools in the prevention of mosquito-borne diseases in contexts where typical vector control strategies, such as insecticide-treated nets (ITNs) and indoor residual spraying, are inaccessible or underutilized such as among displaced persons or in emergency relief settings., Methods: Children will be enrolled in 3 separate cohorts to establish the effectiveness of SRs in reducing malaria infection in different distribution channels. One cohort will estimate the direct effect of the SR distributed through a reference channel (study personnel distribution). The two remaining cohorts will estimate the protection of the SR distributed through a voucher channel and the Village Health Team channel. Cohorts will be followed twice a month (approximately every 15 days): during the first scheduled household visit in the month, a blood sample will be taken for malaria rapid diagnostic test (Monthly Visit #1); and, during the second scheduled household visit, a blood sample will only be taken if the participant has a recent history of fever (Monthly Visit #2). The incidence of malaria in each cohort will be estimated and compared to the reference cohort to determine the benefit of using a SR in an area with high, year-round transmission of malaria., Discussion: This study will address the knowledge gap of whether or not SRs are effective in reducing human malaria disease in humanitarian assistance and emergency response settings in sub-Saharan Africa where underlying transmission rates are historically high and ITNs may or may not be widely deployed. This research will inform policy makers on whether to recommend SRs as a means to further reduce malaria transmission for such operational programs., Trial Registration: ClinicalTrials.gov NCT06122142. Registered on November 8, 2023., (© 2024. The Author(s).)

Introduction: Habits are a common strategy for successfully countering medication non-adherence, yet existing interventions do not support participants during the long habit formation period, resulting in high attrition. We test a novel intervention combining text messages and incentives with anchoring to support antiretroviral therapy (ART) pill-taking habits., Methods: In a randomized, parallel controlled trial, a sample of 155 participants 18 years and older who initiated ART within 3 months were recruited at Mildmay Uganda between October 2021 and April 2022. All participants were educated on the anchoring strategy and chose an anchor, that is existing routines, to pair with pill-taking. Participants were randomized to either usual care (C = 49), daily text message reminders to follow their anchoring plan (Messages group; T1 = 49) or messages and incentives conditional on pill-taking in line with their anchor (Incentives group; T2 = 57). Assessments occurred at baseline, month 3 (end of intervention) and month 9 (end of observation period). The primary outcomes are electronically measured mean adherence and pill-taking consistent with participants' anchor time., Results: The primary outcome of pill-taking in line with the anchoring plan was higher in the Incentives group during the 3-month intervention (12.2 p.p. [95% CI: 2.2 22.2; p = .02]), and remained significantly higher after the incentives were withdrawn (months 4-6 (14.2 p.p. [95% CI 1.1 27.2; p = .03]); months 7-9 (14.1 p.p. [95% CI -0.2 28.5; p = .05])). Mean adherence was higher in both treatment groups relative to the control group during the intervention (T1 vs. C, p = .06; T2 vs. C, p = .06) but not post-intervention., Conclusions: The promising approach of using incentives to support habit formation among ART treatment initiators needs to be evaluated in a fully powered study to further our understanding of the habit formation process and to evaluate its cost-effectiveness., (© 2024 RAND Corporation and The Author(s). Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Background: Smallholder farmers receive educational interventions on safe pesticide handling by governmental agencies, industries, or nongovernmental organizations to reduce exposure risks. However, existing educational interventions have limited effects on changing behaviors. Targeting psychosocial determinants of behavior change in educational interventions through theory- and evidence-based approaches may enhance their effectiveness., Objective: We aim at describing the intervention development and study design of a 3-arm cluster-randomized controlled trial to assess the effects in improving safe pesticide handling and reducing pesticide exposure of (1) an existing educational intervention and (2) a newly developed SMS text messaging intervention based on the Risks, Attitudes, Norms, Abilities, and Self-regulation (RANAS) behavior change approach., Methods: We enrolled 539 Ugandan smallholder farmers in 12 clusters (subcounties). The clusters, each with 45 farmers, were randomly allocated to one of the three arms: (1) educational intervention, (2) educational intervention+RANAS-based SMS text messages, or (3) control group. The educational intervention comprised a 2-day workshop that targeted multiple aspects of safe pesticide handling, whereas the SMS text messages targeted the use of personal protective equipment (PPE) and were based on the RANAS approach. For intervention development in this study, this approach includes identifying psychosocial determinants of PPE use at baseline and selecting behavior change techniques to target them in SMS text messages. The primary outcomes of the study are (1) pesticide knowledge, attitude, and practice scores indicating performance throughout the educational intervention; and (2) frequency of PPE use. Secondary outcomes are the RANAS-based behavioral determinants of PPE use, the frequency of glove use, algorithm-based pesticide exposure intensity scores, and signs and symptoms of pesticide poisoning. The outcomes were assessed in structured interviews before the intervention (baseline) and at the 12-month follow-up. The effect of the interventions among the arms will be analyzed using the intervention arms and baseline measures as predictors and the follow-up measures as outcomes in linear multivariable mixed models including the clusters as random effects. The mediating psychosocial determinants of the interventions will be assessed in multiple mediation models., Results: The study was conducted from 2020 to 2021-baseline interviews were conducted in October 2020, and the educational intervention was delivered in November 2020. The RANAS-based SMS text messages were developed based on the baseline data for relevant behavioral determinants of PPE use and sent between February 2021 and September 2021. Follow-up interviews were conducted in October 2021. Overall, 539 farmers were enrolled in the study at baseline; 8.3% (45/539) were lost to follow-up by the end of the study., Conclusions: This study will contribute to a better understanding of the effectiveness and behavior change mechanisms of educational interventions by using an experimental, cluster-randomized study design to improve pesticide handling among smallholder farmers., Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN) 18237656; https://doi.org/10.1186/ISRCTN18237656., International Registered Report Identifier (irrid): DERR1-10.2196/55238., (©Peter Ssekkadde, Vica Marie Jelena Tomberge, Curdin Brugger, Aggrey Atuhaire, Mohamed Aqiel Dalvie, Hanna-Andrea Rother, Martin Röösli, Jennifer Inauen, Samuel Fuhrimann. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 08.05.2024.)

Background: Injury is a global health concern, and injury-related mortality disproportionately impacts low- and middle-income countries (LMICs). Compelling evidence from observational studies in high-income countries shows that trauma education programs, such as the Rural Trauma Team Development Course (RTTDC), increase clinician knowledge of injury care. There is a dearth of such evidence from controlled clinical trials to demonstrate the effect of the RTTDC on process and patient outcomes in LMICs., Objective: This multicenter cluster randomized controlled clinical trial aims to examine the impact of the RTTDC on process and patient outcomes associated with motorcycle accident-related injuries in an African low-resource setting., Methods: This is a 2-arm, parallel, multi-period, cluster randomized, controlled, clinical trial in Uganda, where rural trauma team development training is not routinely conducted. We will recruit regional referral hospitals and include patients with motorcycle accident-related injuries, interns, medical trainees, and road traffic law enforcement professionals. The intervention group (RTTDC) and control group (standard care) will include 3 hospitals each. The primary outcomes will be the interval from the accident to hospital admission and the interval from the referral decision to hospital discharge. The secondary outcomes will be all-cause mortality and morbidity associated with neurological and orthopedic injuries at 90 days after injury. All outcomes will be measured as final values. We will compare baseline characteristics and outcomes at both individual and cluster levels between the intervention and control groups. We will use mixed effects regression models to report any absolute or relative differences along with 95% CIs. We will perform subgroup analyses to evaluate and control confounding due to injury mechanisms and injury severity. We will establish a motorcycle trauma outcome (MOTOR) registry in consultation with community traffic police., Results: The trial was approved on August 27, 2019. The actual recruitment of the first patient participant began on September 01, 2019. The last follow-up was on August 27, 2023. Posttrial care, including linkage to clinical, social support, and referral services, is to be completed by November 27, 2023. Data analyses will be performed in Spring 2024, and the results are expected to be published in Autumn 2024., Conclusions: This trial will unveil how a locally contextualized rural trauma team development program impacts organizational efficiency in a continent challenged with limited infrastructure and human resources. Moreover, this trial will uncover how rural trauma team coordination impacts clinical outcomes, such as mortality and morbidity associated with neurological and orthopedic injuries, which are the key targets for strengthening trauma systems in LMICs where prehospital care is in the early stage. Our results could inform the design, implementation, and scalability of future rural trauma teams and trauma education programs in LMICs., Trial Registration: Pan African Clinical Trials Registry (PACTR202308851460352); https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25763., International Registered Report Identifier (irrid): DERR1-10.2196/55297., (©Herman Lule, Micheal Mugerwa, Robinson Ssebuufu, Patrick Kyamanywa, Till Bärnighausen, Jussi P Posti, Michael Lowery Wilson. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 07.05.2024.)

We examined the impact of an economic empowerment intervention on ART adherence among ALHIV. We used data from 455 ALHIV, randomized into intervention, n = 111, and control n = 344. ALHIV were aged 12-16 and recruited from 39 clinics in Uganda between January 2013 and December 2015. The intervention comprised a long-term child development account (CDA), micro-enterprise workshops, and educational sessions. Adherence was measured using unannounced pill counts. We used mixed-effects logistic regression analysis to examine the effect of the intervention on ART adherence. The mean age was 12.6 years. Despite observing non-significant group main effects, we found significant group-by-time interaction effects χ 2 (5) = 45.41, p < 0.001. Pairwise comparisons showed that compared to the control group, participants who received the intervention had significantly higher adherence at visit four, OR = 1.52 (95% CI: 1.07-2.18), p = 0.020; visit five, OR = 1.59 (95% CI: 1.06-2.38), p = 0.026; and visit six, OR = 1.94 (95% CI: 1.24-3.04), p = 0.004. Efforts to support ALHIV to live longer and healthier lives should incorporate components addressing poverty. However, declining adherence raises concerns over ALHIV's long-term well-being. The trial was registered at ClinicalTrials.gov, registration number NCT01790373, with a primary outcome of adherence to HIV treatment., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction: Despite the scale-up of Option B+, long-term retention of women in HIV care during pregnancy and the postpartum period remains an important challenge. We compared adherence to clinic appointments and antiretroviral therapy (ART) at 6 weeks, 6, and and 24 months postpartum among pregnant women living with HIV and initiating Option B+. Women were randomized to a peer group support, community-based drug distribution and income-generating intervention called "Friends for Life Circles" (FLCs) versus the standard of care (SOC). Our secondary outcome was infant HIV status and HIV-free survival at 6 weeks and 18 months postpartum., Methods: Between 16 May 2016 and 12 September 2017, 540 ART-naïve pregnant women living with HIV at urban and rural health facilities in Uganda were enrolled in the study at any gestational age. Participants were randomized 1:1 to the unblinded FLC intervention or SOC at enrolment and assessed for adherence to the prevention of mother-to-child HIV transmission (PMTCT) clinic appointments at 6 weeks, 12, and 24 months postpartum, self-reported adherence to ART at 6 weeks, 6 and 24 months postpartum and supported by plasma HIV-1 RNA viral load (VL) measured at the same time points, retention in care through the end of study, and HIV status and HIV-free survival of infants at 18 months postpartum. The FLC groups were formed during pregnancy within 4 months of enrollment and held monthly meetings in their communites, and were followed up until the last group participant reached 24 months post delivery. We used Log-rank and Chi-Square p-values to test the equality of Kaplan-Meier survival probabilities and hazard rates (HR) for failure to retain in care for any reason by study arm., Results: There was no significant difference in adherence to PMTCT clinic visits or to ART or in median viral loads between FLC and SOC arms at any follow-up time points. Retention in care through the end of study was high in both arms but significantly higher among participants randomized to FLC (86.7%) compared to SOC (79.3%), p = 0.022. The adjusted HR of visit dropout was 2.4 times greater among participants randomized to SOC compared to FLC (aHR = 2.363, 95% CI: 1.199-4.656, p = 0.013). Median VL remained < 400 copies/ml in both arms at 6 weeks, 6, and 24 months postpartum. Eight of the 431 infants tested at 18 months were HIV positive (1.9%), however, this was not statistically different among mothers enrolled in the FLC arm compared to those in the SOC arm. At 18 months, HIV-free survival of children born to mothers in the FLC arm was significantly higher than that of children born to mothers in the SOC arm., Conclusions: Our findings suggest that programmatic interventions that provide group support, community-based ART distribution, and income-generation activities may contribute to retention in PMTCT care, HIV-free survival of children born to women living with HIV, and ultimately, to the elimination of mother-to-child HIV transmission (EMTCT)., Trial Registration: NCT02515370 (04/08/2015) on ClinicalTrials.gov., Competing Interests: PM received funding from NIH/Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) grant # IR01HD080476-01., (Copyright: © 2024 Amone 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.)

Perinatal depression has been shown to have deleterious effects on maternal postpartum functioning as well as early child development. However, few studies have documented whether depression care helps to mitigate these effects. We examined the effects of the M-DEPTH (Maternal Depression Treatment in HIV) depression care model (including antidepressants and individual problem solving therapy) on maternal functioning and infant development in the first 6 months post-delivery in an ongoing cluster randomized controlled trial of 391 HIV-infected women with at least mild depressive symptoms enrolled across eight antenatal care clinics in Uganda. A subsample of 354 (177 in each of the intervention and control groups) had a live birth delivery and composed the analytic sample, of whom 69% had clinical depression at enrollment; 70% of women in the intervention group (including 96% of those with clinical depression) received depression treatment. Repeated-measures multivariable regression models found that the intervention group reported better infant care, lower parental burden, and greater perceived adequacy of parental support, compared to the control group. These findings suggest that depression care for pregnant women living with HIV is important not only for maternal mental health but also because it helps women to better manage parenting and care for their infant. [ABSTRACT FROM AUTHOR]

Background: Micronutrient deficiencies and anemia are widespread among children with stunting., Objectives: We assessed the effects of lipid-based nutrient supplements (LNS) containing milk protein (MP) and/or whey permeate (WP) on micronutrient status and hemoglobin (Hb) among children with stunting., Methods: This was a secondary analysis of a randomized controlled trial. Children aged 12-59 mo with stunting were randomly assigned to LNS (100 g/d) with milk or soy protein and WP or maltodextrin for 12 wk, or no supplement. Hb, serum ferritin (S-FE), serum soluble transferrin receptor (S-TfR), plasma cobalamin (P-Cob), plasma methylmalonic acid (P-MMA), plasma folate (P-Fol), and serum retinol-binding protein (S-RBP) were measured at inclusion and at 12 wk. Data were analyzed using linear and logistic mixed-effects models., Results: Among 750 children, with mean age ± SD of 32 ± 11.7 mo, 45% (n = 338) were female and 98% (n = 736) completed follow-up. LNS, compared with no supplementation, resulted in 43% [95% confidence interval (CI): 28, 60] greater increase in S-FE corrected for inflammation (S-FEci), 2.4 (95% CI: 1.2, 3.5) mg/L greater decline in S-TfR, 138 (95% CI: 111, 164) pmol/L greater increase in P-Cob, 33% (95% CI: 27, 39) reduction in P-MMA, and 8.5 (95% CI: 6.6, 10.3) nmol/L greater increase in P-Fol. There was no effect of LNS on S-RBP. Lactation modified the effect of LNS on markers of cobalamin status, reflecting improved status among nonbreastfed and no effects among breastfed children. LNS increased Hb by 3.8 (95% CI: 1.7, 6.0) g/L and reduced the odds of anemia by 55% (odds ratio: 0.45, 95% CI: 0.29, 0.70). MP compared with soy protein increased S-FEci by 14% (95% CI: 3, 26)., Conclusions: LNS supplementation increases Hb and improves iron, cobalamin, and folate status, but not vitamin A status among children with stunting. LNS should be considered for children with stunting. This trial was registered at ISRCTN as 13093195., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Nicotine replacement therapy (NRT) and short messaging service (SMS)-based tobacco cessation interventions have demonstrated effectiveness in reducing tobacco use in many populations, but evidence is needed on which tailored treatments are most efficacious in meeting the complex medical and psychosocial factors confronting people living with HIV (PLWH) in sub-Saharan Africa (SSA). This paper describes the protocol of a study to test the efficacy of both NRT and a tailored SMS-based tobacco use cessation intervention among PLWH in Uganda and Zambia., Methods: In a randomized controlled trial, 800 adult PLWH who use tobacco will be recruited by health care professionals at HIV treatment centers where they are receiving care. Participants will be randomized to one of the four study arms: (1) standard of care [SOC; brief clinician advice to quit combined with HIV education and information aimed at encouraging HIV treatment adherence (with no mention of tobacco) delivered via text messages]; (2) SOC + 12 weeks of NRT; (3) SOC + 6 weeks of SMS text messages to support quitting tobacco use (SMS); or (4) SOC + NRT + SMS. Participants will receive a cell phone and solar panel with power bank for charging the phone. The main outcome is cessation of tobacco use by study participants verified by urinary cotinine (< 15 ng/mL) at 6 months post-enrollment. As a secondary tobacco use outcome, we will measure 7-day point-prevalence abstinence (7 consecutive days of no tobacco use) measured by self-report and biochemically-verified at 4 weeks, 8 weeks, and 3 months post enrollment., Discussion: Our study will provide insight into the efficacy, feasibility and applicability of delivering tobacco cessation interventions through health care professionals combined with tailored tobacco cessation SMS text messaging in two countries with different tobacco use patterns, policy environments, and health care resources and provide needed information to providers and policymakers looking for cost-effective tobacco cessation interventions. The previously tested SMS-platform to be used in our study is uniquely positioned to be scaled in low- and middle-income countries worldwide, in which case evidence of even modest success in reducing the prevalence of tobacco consumption among PLWH could confer enormous health and economic benefits., Trial Registration: ClinicalTrials.gov Identifier NCT05487807. Registered August 4, 2022, https://clinicaltrials.gov/ct2/show/record/NCT05487807., (© 2024. The Author(s).)

Introduction: Unhealthy alcohol use significantly contributes to viral non-suppression among persons with HIV (PWH). It is unknown whether brief behavioural interventions to reduce alcohol use can improve viral suppression among PWH with unhealthy alcohol use in sub-Saharan Africa (SSA)., Methods: As part of the SEARCH study (NCT04810650), we conducted an individually randomized trial in Kenya and Uganda of a brief, skills-based alcohol intervention among PWH with self-reported unhealthy alcohol use (Alcohol Use Disorders Identification Test-Consumption [AUDIT-C], prior 3 months, ≥3/female; ≥4/male) and at risk of viral non-suppression, defined as either recent HIV viral non-suppression (≥400 copies/ml), missed visits, out of care or new diagnosis. The intervention included baseline and 3-month in-person counselling sessions with interim booster phone calls every 3 weeks. The primary outcome was HIV viral suppression (<400 copies/ml) at 24 weeks, and the secondary outcome was unhealthy alcohol use, defined by AUDIT-C or phosphatidylethanol (PEth), an alcohol biomarker, ≥50 ng/ml at 24 weeks., Results: Between April and September 2021, 401 persons (198 intervention, 203 control) were enrolled from HIV clinics in Uganda (58%) and Kenya (27%) and alcohol-serving venues in Kenya (15%). At baseline, 60% were virally suppressed. Viral suppression did not differ between arms at 24 weeks: suppression was 83% in intervention and 82% in control arms (RR: 1.01, 95% CI: 0.93-1.1). Among PWH with baseline viral non-suppression, 24-week suppression was 73% in intervention and 64% in control arms (RR 1.15, 95% CI: 0.93-1.43). Unhealthy alcohol use declined from 98% at baseline to 73% in intervention and 84% in control arms at 24 weeks (RR: 0.86, 95% CI: 0.79-0.94). Effects on unhealthy alcohol use were stronger among women (RR 0.70, 95% CI: 0.56-0.88) than men (RR 0.93, 95% CI: 0.85-1.01) and among participants with a baseline PEth⩽200 ng/ml (RR 0.68, 95% CI: 0.53-0.87) versus >200 ng/ml (RR 0.97, 95% CI: 0.92-1.02)., Conclusions: In a randomized trial of 401 PWH with unhealthy alcohol use and risk for viral non-suppression, a brief alcohol intervention reduced unhealthy alcohol use but did not affect viral suppression at 24 weeks. Brief alcohol interventions have the potential to improve the health of PWH in SSA by reducing alcohol use, a significant driver of HIV-associated co-morbidities., (© 2023 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Background: Treatment outcomes of HIV-positive individuals are threatened by low antiretroviral therapy (ART) adherence, a problem that is particularly acute among youth. Incentives are a promising tool to support ART adherence, but traditional incentive designs rewarding uniformly high levels of the desired health behavior may demotivate those with low levels of the behavior. In this study, we investigate the effectiveness of alternative approaches to target-setting for incentive eligibility using subgoals (i.e., individual-specific, interim targets leading up to the optimal target)., Methods / Design: We will enroll 628 HIV-positive youth between ages 15 and 30 into a 3-year randomized controlled trial. Participants will be randomized 1:1:1:1 to a control arm or one of three intervention arms (n = 157 each) that allow them to enter a prize drawing for small incentives if their ART adherence meets the given goal. In the first arm (T1, assigned subgoal), goals will be externally assigned and adapted to their initial adherence level. In the second arm (T2, participatory subgoal), participants can set their own interim goals. In the third arm (T3, fixed goal), all participants must reach the same target goal of 90% adherence. T1 and T2 participants are required to reach 90% adherence by month 12 to participate in a larger prize drawing. The control group receives the usual standard of care. All four groups will receive weekly motivational messages; the three treatment groups will additionally receive reminders of their upcoming prize drawing. Adherence will be measured continuously throughout the intervention period using electronic devices and for 12 months post-intervention. Surveys will be conducted at baseline and every 6 months. Viral loads will be measured annually. The primary outcome is Wisepill-measured adherence and a binary measure for whether the person took at least 90% of their pills. The secondary outcome is the log-transformed viral load as a continuous measure., Discussion: Our study is one of the first to apply insights about the psychology and behavioral economics of goal-setting to the design of incentives, by testing whether conditioning the eligibility threshold for incentives on subgoals (interim goals leading up to the ultimate, high goal) improves motivation and adherence more than setting a uniformly highly goal, and a comparison group., Trial Registration: ClinicalTrials.gov NCT05378607. Date of registration: May 18, 2022., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Cervical cancer (CC) is the most common cancer among women in Uganda, yet lifetime CC screening is as low as 5%. Training women who have screened for CC to engage in peer advocacy could increase uptake of CC screening in social networks. We conducted a randomized controlled trial of a peer-facilitated, manualized, 7-session group intervention to train women to engage in CC prevention advocacy. Forty women recently screened for CC (index participants) enrolled and were assigned to receive the intervention (n = 20) or wait-list control (n = 20). Each index was asked to recruit up to three female social network members (alters) who had not been screened for CC (n = 103 enrolled alters). All index and alter participants were assessed at baseline and month-6 follow-up. All but one (n = 39; 98%) index and 98 (95%) alter participants completed the month 6 assessment. In multivariate regression models controlling for baseline outcome measures and demographic covariates, intervention alters were more likely to have been screened for CC at month 6 [67% vs. 16%; adjusted OR (95% CI) = 12.13 (4.07, 36.16)], compared to control alters. Data also revealed significant increased engagement in CC prevention advocacy, among both index and alter participants in the intervention group at month 6, compared to the control group. The intervention was highly effective in increasing CC screening uptake among social network members, and engagement in CC prevention advocacy among not only intervention recipients, but also targets of advocacy, suggesting the potential for wide dissemination of CC knowledge.Trial Registration. NIH Clinical Trial Registry NCT04960748 ( clinicaltrials.gov )., (© 2023. The Author(s).)

Fifty-six Ugandan mothers/caregivers received Mediational Intervention for Sensitizing Caregivers (MISC) biweekly for one year; 46 mothers received treatment-as-usual. Preschool PHIV child attention was measured by proportion of time viewing a 7-min animation (early childhood vigilance test or ECVT) at enrollment, 6 and 12 months. Analysis of covariance compared ECVT outcomes for the two intervention groups, controlling for baseline ECVT performance, age and weight-for-age z scores. Differences by trial arm were not significant at any of the three time points. MISC trial-arm children on combination ART during the study period displayed more stable ECVT scores across time points compared to controls.

Objective: We examine the preliminary impact of group-cognitive behavioral therapy (G-CBT) versus a family-strengthening intervention delivered via multiple family group (MFG) in improving ART adherence among adolescents living with HIV (ALHIV) in Uganda., Methods: We analyzed data from a pilot cluster-randomized trial (2020-2022) conducted in 9 clinics in Uganda among 89 participants, who were eligible out of the 147 ALHIV screened. Participants were eligible if they were aged 10-14 years, HIV positive, taking ART, and living with a family. Adolescents were randomized, at the clinic level, to receive the usual care (n = 29), MFG (n = 34), or G-CBT (n = 26). The interventions were delivered over 3 months. Overall, the mean percentage attendance for the 10 G-CBT and MFG sessions was 87.7% and 90.2%, respectively. Three ALHIV were lost to follow-up, while 1 child died. Adherence was assessed using pharmacy records collected at baseline and 4 additional pharmacy visits. We used mixed-effects logistic regression analysis to examine the effect of the interventions on ART adherence., Results: We found statistically significant main effects for the intervention, χ2(2) = 7.76, p = .021, time, χ2(2) = 39.67, p < .001, and intervention-time interaction effect χ2(6)= 27.65, p < .001. Pairwise comparisons showed increasing adherence in the MFG group compared to usual care at visit 3 (odds ratio [OR] = 4.52 [1.01-20.11], p = .047) and visit 5 (OR = 3.56 [1.42-8.91], p = .007). Also, compared to usual care, participants who received G-CBT showed higher adherence at visit 4 (OR = 2.69 [1.32-5.50], p = .007)., Conclusions: Our study showed preliminary evidence that G-CBT and MFG might have contributed to improved ART adherence among ALHIV. Moreover, G-CBT is a low-cost alternative to expensive individual therapy, especially in low-resource settings. The results warrant the need for more extensive studies to better understand the role of these interventions in the routine care of ALHIV. The trial is registered at ClinicalTrials.Gov (#NCT04528732)., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

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., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Oporia 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: 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]

Perinatal depression has been shown to impede adherence to antiretroviral therapy (ART) and the prevention of mother-to-child transmission (PMTCT) care continuum; therefore, treating perinatal depression may result in increased viral suppression and PMTCT adherence. We examined the effects of the M-DEPTH (Maternal Depression Treatment in HIV) depression care model (including antidepressants and individual Problem Solving Therapy) on depression, maternal viral suppression and adherence to PMTCT care processes in an ongoing cluster-randomized controlled trial of 391 HIV-infected pregnant women (200 usual care; 191 intervention) with at least mild depressive symptoms enrolled across 8 antenatal care clinics in Uganda. At baseline, 68.3% had clinical depression and 41.7% had detectable HIV viral load. Adjusted repeated-measures multivariable regression models found that the intervention group was nearly 80% less likely to be clinically depressed [Adjusted OR (95% CI) 0.22 (0.05, 0.89)] at the 2-month post-pregnancy assessment, compared to the control group. However, the intervention and control groups did not differ meaningfully on maternal viral suppression, ART adherence, and other PMTCT care processes and outcomes. In this sample of women who were mostly virally suppressed and ART adherent at baseline, the depression care model had a strong effect on depression alleviation, but no downstream effects on viral suppression or other PMTCT care processes.Trial Registration NIH Clinical Trial Registry NCT03892915 (clinicaltrials.gov)., (© 2023. The Author(s).)

Background: Increasing trends of antimicrobial resistance are observed around the world, driven in part by excessive use of antimicrobials. Limited access to diagnostics, particularly in low- and middle-income countries, contributes to diagnostic uncertainty, which may promote unnecessary antibiotic use. We investigated whether introducing a package of diagnostic tools, clinical algorithm, and training-and-communication messages could safely reduce antibiotic prescribing compared with current standard-of-care for febrile patients presenting to outpatient clinics in Uganda., Methods: This was an open-label, multicenter, 2-arm randomized controlled trial conducted at 3 public health facilities (Aduku, Nagongera, and Kihihi health center IVs) comparing the proportions of antibiotic prescriptions and clinical outcomes for febrile outpatients aged ≥1 year. The intervention arm included a package of point-of-care tests, a diagnostic and treatment algorithm, and training-and-communication messages. Standard-of-care was provided to patients in the control arm., Results: A total of 2400 patients were enrolled, with 49.5% in the intervention arm. Overall, there was no significant difference in antibiotic prescriptions between the study arms (relative risk [RR]: 1.03; 95% CI: .96-1.11). In the intervention arm, patients with positive malaria test results (313/500 [62.6%] vs 170/473 [35.9%]) had a higher RR of being prescribed antibiotics (1.74; 1.52-2.00), while those with negative malaria results (348/688 [50.6%] vs 376/508 [74.0%]) had a lower RR (.68; .63-.75). There was no significant difference in clinical outcomes., Conclusions: This study found that a diagnostic intervention for management of febrile outpatients did not achieve the desired impact on antibiotic prescribing at 3 diverse and representative health facility sites in Uganda., Competing Interests: Potential conflicts of interest. S. D., O. S., P. O., and J. N. were employees of FIND. P. H. reports research funding from FIND and an honoraria payment from Oxford International Biomedical Centre (OIBC). H. H. is a salaried employee of the London School of Hygiene and Tropical Medicine and received separate financial support from the study sponsors for some work on the project reported in this supplement. They receive salary support from the UK Foreign Commonwealth and Development Office. They receive royalties from UpToDate, a clinical decision support tool from Wolters Kluwer for authoring and maintaining the chapter on “Laboratory tools for diagnosis of malaria.” During the study period, they received honoraria for lecturing for the University of Virginia and for a doctoral thesis review for the University of Otago in New Zealand. They also hold index-linked mutual fund and retirement account investments. S. W. reports grant funding from FIND for statistical analysis and services from Agentur für Computeranwendungen in der Medizin (ACOMED). T. K. reports statistical design and analysis grant funding and consultation fees from FIND. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Background: The effects of conflict and displacement on adolescent mental health and protection are profound and can have lasting consequences. We aimed to investigate the effectiveness of two group-based psychosocial interventions on mental health and protection of South Sudanese refugee adolescents., Methods: A randomized controlled trial was done in four villages within the Omugo extension of Rhino Camp refugee settlement in the West Nile region of Uganda. Male and female adolescents (aged 9-14 years) were randomly assigned to attend 12 weeks of either a Standard psychosocial intervention delivered in a child-friendly space (CFS) or a more structured sequential delivery of psychosocial sessions guided by a newly developed Toolkit for Child-Friendly Spaces in Humanitarian Settings. The primary outcomes were psychological distress and resilience 12 months after baseline assessment. The trial is registered with ClinicalTrials.gov, NCT03897894., Results: Between May 28, 2019, and February 20, 2020, 1,280 eligible adolescents were recruited. With 70.2% retention at follow-up, 214 assigned to the Standard, 211 assigned to the Toolkit, and 370 assigned to the waitlist control were included in the intention-to-treat and as-treated analysis. Both the Toolkit and Standard approaches were more effective in reducing psychological distress and perceived protection risks reported by adolescents compared to no intervention. Differential intervention impacts are indicated in subgroup analyses., Conclusions: The trial found that both psychosocial interventions when implemented in a CFS are well suited as a first-line mental health and violence prevention intervention for adolescent populations exposed to conflict and forced displacement. Where feasible, CFS should be implemented as a primary response strategy soon after displacement to improve psychological health and reduce the risk environment for adolescents., (© 2022 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.)

Purpose: Economic empowerment and family strengthening interventions have shown promise for improving psychosocial well-being in a range of populations. This study investigates the effect of a combination economic and family strengthening intervention on psychosocial well-being among Ugandan adolescent girls and young women (AGYW)., Methods: We harnessed data from a three-arm cluster randomized controlled trial among AGYW aged 14-17 years in 47 Ugandan secondary schools. Schools were randomized to either a youth development account intervention (YDA) [N = 16 schools], YDA plus a multiple family group intervention (YDA + MFG) [N = 15 schools], or bolstered standard of care (BSOC) [N = 16 schools]. We estimated the effect of each intervention (BSOC = referent) on three measures of psychosocial well-being: hopelessness (Beck's Hopelessness Scale), self-concept (Tennessee Self-Concept Scale), and self-esteem (Rosenberg Self-Esteem Scale) at 12 months following enrollment using multi-level linear mixed models for each outcome., Results: A total of 1,260 AGYW (mean age, 15.4) were enrolled-471 assigned to YDA (37%), 381 to YDA + MFG (30%), and 408 to usual care (32%). Over the 12-month follow-up, participants assigned to the YDA + MFG group had significantly greater reductions in hopelessness and improvements in self-esteem outcomes compared to BSOC participants. Those enrolled in the YDA arm alone also had significantly greater reductions in hopelessness compared to BSOC participants., Discussion: Combination interventions, combining economic empowerment (represented here by YDA), and family-strengthening (represented by MFG) can improve the psychosocial well-being of AGYW. The long-term effects of these interventions should be further tested for potential scale-up in an effort to address the persistent mental health treatment gap in resource-constrained settings., (Copyright © 2023. Published by Elsevier Inc.)

Background: In high resource settings, lactate and pH levels measured from fetal scalp and umbilical cord blood are widely used as predictors of perinatal mortality. However, the same is not true in low resource settings, where much of perinatal mortality occurs. The scalability of this practice has been hindered by difficulty in collecting fetal scalp and umbilical blood sample. Little is known about the use of alternatives such as maternal blood, which is easier and safer to obtain. Therefore, we aimed to compare maternal and umbilical cord blood lactate levels for predicting perinatal deaths., Methods: This was secondary analysis of data from a randomized controlled trial assessing the effect of sodium bicarbonate on maternal and perinatal outcomes among women with obstructed labour at Mbale regional referral hospital in Eastern Uganda. Lactate concentration in maternal capillary, myometrial, umbilical venous and arterial blood was measured at the bedside using a lactate Pro 2 device (Akray, Japan Shiga) upon diagnosis of obstructed labour. We constructed Receiver Operating Characteristic curves to compare the predictive ability of maternal and umbilical cord lactate and the optimal cutoffs calculated basing on the maximal Youden and Liu indices., Results: Perinatal mortality risk was: 102.2 deaths per 1,000 live births: 95% CI (78.1-130.6). The areas under the ROC curves were 0.86 for umbilical arterial lactate, 0.71 for umbilical venous lactate, and 0.65 for myometrial lactate, 0.59 for maternal lactate baseline, and 0.65 at1hr after administration of bicarbonate. The optimal cutoffs for predicting perinatal death were 15 0.85 mmol/L for umbilical arterial lactate, 10.15mmol/L for umbilical venous lactate, 8.75mmol/L for myometrial lactate, and 3.95mmol/L for maternal lactate at recruitment and 7.35mmol/L after 1 h., Conclusion: Maternal lactate was a poor predictor of perinatal death, but umbilical artery lactate has a high predictive value. There is need for future studies on the utility of amniotic fluid in predicting intrapartum perinatal deaths., (© 2023. The Author(s).)

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., (© 2023. The Author(s).)

Objectives. To investigate the long-term (12- and 24-month) impact of an economic empowerment intervention on HIV risk behaviors and mental health among school-going adolescent girls in Uganda. Methods. A total of 1260 girls aged 14 to 17 years were randomized at the school level to (1) standard health and sex education (controls; n = 408 students; n = 16 schools), (2) 1-to-1 matched savings youth development account (YDA; n = 471 students; n = 16 schools), or (3) combination intervention (YDA and multiple family group [YDA+MFG]; n = 15 schools; n = 381 students). Mixed-effects models were fitted. Results. YDA and YDA+MFG girls had significantly lower depressive symptoms and better self-concept than controls at 24 months. Only YDA+MFG girls had significantly lower hopelessness levels than controls. There were no significant study group differences at 12 and 24 months for sexual risk-taking behavior and attitudes. There was no significant difference between YDA and YDA+MFG groups for all outcomes. Conclusions. Providing YDA and MFG can positively improve adolescent girls' mental health, but our analyses showed no significant differences across groups on sexual risk-taking behaviors. Future studies may consider replicating these interventions and analyses in older populations, including those transitioning into young adults. Trial Registration. ClinicalTrials.gov Identifier: NCT03307226. ( Am J Public Health . 2023;113(3):306-315. https://doi.org/10.2105/10.2105/AJPH.2022.307169).

Purpose: To test the efficacy of two interventions to reduce alcohol use and increase viral suppression compared to a control in persons with HIV (PWH)., Methods: In a three-arm (1:1:1) randomized controlled trial (N = 269), we compared in-person counselling (45-70 minutes, two sessions over three months) with interim monthly booster phone calls (live call arm) or twice-weekly automated booster sessions (technology arm) to a brief advice control arm. We enrolled PWH self-reporting unhealthy alcohol use (Alcohol Use Disorders Identification Test - Consumption, prior three months, women ≥3, men ≥4). Primary outcomes were number of self-reported drinking days (NDD) in the prior 21 and biomarker phosphatidylethanol (PEth) at six and nine months and viral suppression (<40 copies/mL) at nine months; we adjusted for sex and baseline outcomes., Results: At baseline, mean 21-day NDDs were 9.4 (95 % CI: 9.1-9.8), mean PEth was 407.8 ng/mL (95 % CI: 340.7-474.8), and 89.2 % were virally suppressed. At follow-up, there were significant reductions in mean NDDs for the live call versus control arm (3.5, 95 % CI:2.1-4.9, p < 0.001) and for the technology versus control arm (3.6, 95 % CI: 2.2-5.1, p < 0.001). The mean PEth differences compared to the control arm were not significant, i.e. 36.4 ng/mL (95 % CI: -117.5 to 190.3, p = 0.643) for the live call and -30.9 ng/mL (95 % CI: -194.8 to 132.9, p = 0.711) for the technology arm. Nine-month viral suppression compared to the control was similar in the live call and in the technology arm., Conclusion: Intervention effects were found on self-reported NDD but not PEth or viral suppression, suggesting no treatment effect. (NCT #03928418)., Competing Interests: Conflict of interest Dr. Hahn received consulting fees from Pear Therapeutics in 2022., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Artemether-lumefantrine (AL) is the most widely used artemisinin-based combination therapy in Sub-Saharan Africa and is threatened by the emergence of artemisinin resistance. Dosing is suboptimal in young children. We hypothesized that extending AL duration will improve exposure and reduce reinfection risks., Methods: We conducted a prospective, randomized, open-label pharmacokinetic/pharmacodynamic study of extended duration AL in children with malaria in high-transmission rural Uganda. Children received 3-day (standard 6-dose) or 5-day (10-dose) AL with sampling for artemether, dihydroartemisinin, and lumefantrine over 42-day clinical follow-up. Primary outcomes were (1) comparative pharmacokinetic parameters between regimens and (2) recurrent parasitemia analyzed as intention-to-treat., Results: A total of 177 children aged 16 months to 16 years were randomized, contributing 227 total episodes. Terminal median lumefantrine concentrations were significantly increased in the 5-day versus 3-day regimen on days 7, 14, and 21 (P < .001). A predefined day 7 lumefantrine threshold of 280 ng/mL was strongly predictive of recurrence risk at 28 and 42 days (P < .001). Kaplan-Meier estimated 28-day (51% vs 40%) and 42-day risk (75% vs 68%) did not significantly differ between 3- and 5-day regimens. No significant toxicity was seen with the extended regimen., Conclusions: Extending the duration of AL was safe and significantly enhanced overall drug exposure in young children but did not lead to significant reductions in recurrent parasitemia risk in our high-transmission setting. However, day 7 levels were strongly predictive of recurrent parasitemia risk, and those in the lowest weight-band were at higher risk of underdosing with the standard 3-day regimen., Clinical Trial Registration: ClinicalTrials.gov number NCT03453840., Competing Interests: Potential conflicts of interest. The authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest., (© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Background: The metabolic health of urban Ugandans, mostly females, is increasingly becoming sub-optimal., Objectives: We assessed the effect of a complex lifestyle intervention, based on a small change approach, on metabolic health among females of reproductive age in urban Uganda., Methods: A cluster randomized controlled two-arm trial with a 1:1 allocation involving church communities in Kampala (Uganda) was undertaken. The intervention arm received infographics and face-to-face group sessions, whereas the comparison arm received infographics only. Eligible participants were aged 18 to 45 years with a waist circumference of ≥80 cm and without cardiometabolic diseases. The study included a 3-month intervention and a 3-month postintervention follow-up. The primary outcome was a reduction in waist circumference. Secondary outcomes included optimization of cardiometabolic health, physical activity, and fruit and vegetable intake. Intention to treat analyses were performed using linear mixed models. This trial was registered at clinicaltrials.gov as NCT04635332., Results: The study was conducted between 21 November 2020 and 8 May 2021. Six church communities were randomly selected, 3 (n = 66) per study arm. At 3 months and postintervention follow-up, 118 and 100 participants were analyzed, respectively. At 3 months, waist circumference tended to be lower in the intervention arm (-1.48 cm (95% CI: -3.05, 0.10) P = 0.06). The intervention showed an effect on fasting blood glucose concentrations (-6.95 mg/dL (95% CI: -13.37, -0.53) P = 0.034). Participants in the intervention arm consumed more fruits (62.6 g (95% CI: 1.9, 123.3) P = 0.046) and vegetables (66.2 g (95% CI: 25.5, 106.8) P = 0.002), whereas physical activity increased with no notable differences across the study arms. At 6 months, we found an intervention effect on waist circumference (-1.87 cm (95% CI: -3.32, -0.44) P = 0.011), fasting blood glucose concentration (-6.48 mg/dL (95% CI: -12.76, -0.21) P = 0.043), fruit consumption (29.7 g (95% CI: 5.8, 53.7) P = 0.015), and physical activity (2675.1 MET-mins/wk (95% CI: 1045.7, 4304.4) P = 0.001)., Conclusions: The intervention improved and sustained physical activity and fruit and vegetable intake, but these changes were accompanied by minimal cardiometabolic health improvements. If maintained over time, the attained lifestyle improvements may result in substantial cardiometabolic health improvements., (Copyright © 2022 American Society for Nutrition. Published by Elsevier Inc. All rights reserved.)

Background: Adherence is key to the treatment success of multi-drug resistant tuberculosis (MDR-TB) and prevention of community transmission. Directly observed therapy (DOT) is the recommended approach for the management of patients with MDR-TB. Uganda implements a health facility-based DOT approach where all patients diagnosed with MDR-TB report to the nearest private or public health facility for daily observation of ingesting their medicines by a health care provider. Directly observed therapy is very costly for both the patient and health care system. It follows the assumption that MDR TB patients have a history of poor adherence to TB treatment. But only 21% of MDR-TB patients notified globally and 1.4–12% notified in Uganda had been previously treated for TB. The shift to all oral treatment regimen for MDR-TB provides an opportunity for the exploration of self-administered therapy for this group of patients even with use of remotely operated adherence technology. We are conducting a non-inferiority open-label randomized controlled trial to compare adherence to MDR-TB treatment among patients on self-administered therapy (measured by Medication Events Monitoring System (MEMS) technology) with a control group on DOT. Methods: We plan to enrol 164 newly diagnosed MDR-TB patients aged ≥ 8 years from three regional hospitals based in rural and urban Uganda. Patients with conditions that affect their dexterity and ability to operate the MEMS-operated medicine equipment will not be eligible to participate in the trial. Patients are randomized to either of the two study arms: self-administered therapy with adherence being monitored using MEMS technology (intervention arm) or health facility-based DOT (control arm) and will be followed up monthly. Adherence is measured by the number of days the medicine bottle is open to access medication as recorded by the MEMS software in the intervention arm and treatment complaint days as recorded in the TB treatment card in the control arm. The primary outcome is the comparison of adherence rates between the two study arms. Discussion: The evaluation of self-administered therapy for patients with MDR-TB is important to inform cost-effective management strategies for these patients. The approval of all oral regimens for the treatment of MDR-TB provides an opportunity for innovations such as MEMS technology to support sustainable options for MDR-TB treatment adherence support in low-resource settings. Trial registration: Pan African Clinical Trials Registry, Cochrane #PACTR202205876377808. Retrospectively registered on 13 May 2022 [ABSTRACT FROM AUTHOR]

We assessed an intervention aimed at improving adherence to antiretroviral therapy (ART) among pregnant and postpartum women living with HIV (PPWLH). We randomized 133 pregnant women initiating ART in Uganda to receive text reminders generated by real time-enabled electronic monitors and data-informed counseling through 3 months postpartum (PPM3) or standard care. Intention-to-treat analyses found low adherence levels and no intervention impact. Proportions achieving ≥95% adherence in PPM3 were 16.4% vs. 9.1% (t = -1.14, p = 0.26) in intervention vs. comparison groups, respectively; 30.9% vs. 29.1% achieved ≥80% adherence. Additional analyses found significant adherence declines after delivery, and no effect on disease progression (CD4-cell count, viral load), though treatment interruptions were significantly fewer in intervention participants. Per-protocol analyses encompassing participants who used adherence monitors as designed experienced better outcomes, suggesting potential benefit for some PPWLH. The study was registered on ClinicalTrials.Gov (NCT02396394)., (© 2022. The Author(s).)

150/150 words.We examined the 5-year impact of an economic empowerment (EE) intervention on: adherence, viral suppression, sexual risk-taking intentions (primary); and physical health, educational and economic (secondary) outcomes among adolescents living with HIV in Uganda. The Suubi + Adherence study (2012-2018) randomized clinics to: (1) Control group, n = 19 clinics, n = 344 participants; (2) intervention group which received matched savings accounts, mentorship, financial management and, business development training, n = 20 clinics, n = 358 participants. Participants completed post-baseline assessments at 12-, 24-, 36-, and 48-months. No significant differences in viral load, sexual risk-intentions and physical health perception were observed. The intervention group had better adherence (at 24-months) (Contrast=-0.28; 95% CI: -0.55, -0.004), higher school enrolment (OR = 2.18; 95% CI:1.30, 3.66); reported savings OR = 2.03 (1.29, 3.18) and higher savings (Contrast = 0.40; 95% CI:0.10, 0.70) than controls at 48-months. The EE intervention was efficacious in improving adherence, school enrolment, and economic outcomes creating opportunities for improved overall health among adolescents living with HIV., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Until recently, due to widespread prevalence of molecular markers associated with sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) resistance in east and southern Africa, seasonal malaria chemoprevention (SMC) has not been used at scale in this region. This study assessed the protective effectiveness of monthly administration of SP + AQ (SPAQ) to children aged 3-59 months in Karamoja sub-region, Uganda, where parasite resistance is assumed to be high and malaria transmission is seasonal., Methods: A two-arm quasi-experimental, open-label prospective non-randomized control trial (nRCT) was conducted in three districts. In two intervention districts, 85,000 children aged 3-59 months were targeted to receive monthly courses of SMC using SPAQ during the peak transmission season (May to September) 2021. A third district served as a control, where SMC was not implemented. Communities with comparable malaria attack rates were selected from the three districts, and households with at least one SMC-eligible child were purposively selected. A total cohort of 600 children (200 children per district) were selected and followed using passive surveillance for breakthrough confirmed malaria episodes during the five-month peak transmission season. Malaria incidence rate per person-months and number of malaria episodes among children in the two arms were compared. Kaplan-Meier failure estimates were used to compare the probability of a positive malaria test. Other factors that may influence malaria transmission and infection among children in the two arms were also assessed using multivariable cox proportional hazards regression model., Results: The malaria incidence rate was 3.0 and 38.8 per 100 person-months in the intervention and control groups, respectively. In the intervention areas 90.0% (361/400) of children did not experience any malaria episodes during the study period, compared to 15% (29/200) in the control area. The incidence rate ratio was 0.078 (95% CI 0.063-0.096), which corresponds to a protective effectiveness of 92% (95% CI 90.0-94.0) among children in the intervention area., Conclusion: SMC using SPAQ provided high protective effect against malaria during the peak transmission season in children aged 3-59 months in the Karamoja sub-region of Uganda., (© 2023. The Author(s).)

Background: In Sub-Saharan Africa, 41 to 58% of the caregivers of children with disabilities experience psychological distress and have poor mental well-being. Cognitive behavioural therapy (CBT) has a moderate effect on improving mental well-being. However, no study has examined its effects among caregivers of children with disabilities at home and in schools. This study evaluated the effectiveness of CBT in improving mental well-being among caregivers of children with disabilities in urban Uganda., Methods: We conducted a two-arm cluster-randomized controlled trial in 11 schools across the Kampala district of Uganda. The intervention was a multi-modal CBT training program conducted for six months among 392 home and school caregivers of children with disabilities. In the first three months, caregivers received group-based CBT, and in the next three months, they received phone-based CBT. We used generalized linear mixed-effects regression to examine the differences in the mental well-being of caregivers in the control group vs those in the intervention group., Results: Home caregivers' mental well-being was significantly higher after phone-based CBT (unstandardized coefficient of the estimate (B) = 4.31, 95% CI = 1.18-6.82; P < 0.001, Cohen's D (d) = 0.27). School caregivers' mental well-being was significantly higher after group-based CBT (B = 3.98, 95% CI = 0.22-7.47; P = 0.038, d = 0.25)., Conclusions: Group-based CBT improved mental well-being among school caregivers, and phone-based CBT improved mental well-being among home caregivers. Interventions targeting school caregivers of children with disabilities should employ group settings and those targeting home caregivers should utilize peer-to-peer networks to enhance the caregivers' mental well-being., Registration: The study protocol was registered with UMIN Clinical Trials Registry (UMIN-CTR). Trial ID: UMIN000040912., Competing Interests: Disclosure of interest: The authors completed the ICMJE Disclosure of Interest Form (available upon request from the corresponding author) and disclose no relevant interests., (Copyright © 2022 by the Journal of Global Health. All rights reserved.)

Background: Fewer than 10% of people with hypertension in sub-Saharan Africa are diagnosed, linked to care, and achieve hypertension control. We hypothesized that a one-time financial incentive and phone call reminder for missed appointments would increase linkage to hypertension care following community-based screening in rural Uganda and Kenya., Methods: In a randomized controlled trial, we conducted community-based hypertension screening and enrolled adults ≥25 years with blood pressure ≥140/90 mmHg on three measures; we excluded participants with known hypertension or hypertensive emergency. The intervention was transportation reimbursement upon linkage (~$5 USD) and up to three reminder phone calls for those not linking within seven days. Control participants received a clinic referral only. Outcomes were linkage to hypertension care within 30 days (primary) and hypertension control &lt;140/90 mmHg measured in all participants at 90 days (secondary). We used targeted minimum loss-based estimation to compute adjusted risk ratios (aRR)., Results: We screened 1,998 participants, identifying 370 (18.5%) with uncontrolled hypertension and enrolling 199 (100 control, 99 intervention). Reasons for non-enrollment included prior hypertension diagnosis (n = 108) and hypertensive emergency (n = 32). Participants were 60% female, median age 56 (range 27-99); 10% were HIV-positive and 42% had baseline blood pressure ≥160/100 mmHg. Linkage to care within 30 days was 96% in intervention and 66% in control (aRR 1.45, 95%CI 1.25-1.68). Hypertension control at 90 days was 51% intervention and 41% control (aRR 1.22, 95%CI 0.92-1.66)., Conclusion: A one-time financial incentive and reminder call for missed visits resulted in a 30% absolute increase in linkage to hypertension care following community-based screening. Financial incentives can improve the critical step of linkage to care for people newly diagnosed with hypertension in the community., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Hickey 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: Increased mobile phone penetration allows the interviewing of respondents using interactive voice response surveys in low- and middle-income countries. However, there has been little investigation of the best type of incentive to obtain data from a representative sample in these countries., Objective: We assessed the effect of different airtime incentives options on cooperation and response rates of an interactive voice response survey in Bangladesh and Uganda., Methods: The open-label randomized controlled trial had three arms: (1) no incentive (control), (2) promised airtime incentive of 50 Bangladeshi Taka (US $0.60; 1 BDT is approximately equivalent to US $0.012) or 5000 Ugandan Shilling (US $1.35; 1 UGX is approximately equivalent to US $0.00028), and (3) lottery incentive (500 BDT and 100,000 UGX), in which the odds of winning were 1:20. Fully automated random-digit dialing was used to sample eligible participants aged ≥18 years. The risk ratios (RRs) with 95% confidence intervals for primary outcomes of response and cooperation rates were obtained using log-binomial regression., Results: Between June 14 and July 14, 2017, a total of 546,746 phone calls were made in Bangladesh, with 1165 complete interviews being conducted. Between March 26 and April 22, 2017, a total of 178,572 phone calls were made in Uganda, with 1248 complete interviews being conducted. Cooperation rates were significantly higher for the promised incentive (Bangladesh: 39.3%; RR 1.38, 95% CI 1.24-1.55, P<.001; Uganda: 59.9%; RR 1.47, 95% CI 1.33-1.62, P<.001) and the lottery incentive arms (Bangladesh: 36.6%; RR 1.28, 95% CI 1.15-1.45, P<.001; Uganda: 54.6%; RR 1.34, 95% CI 1.21-1.48, P<.001) than those for the control arm (Bangladesh: 28.4%; Uganda: 40.9%). Similarly, response rates were significantly higher for the promised incentive (Bangladesh: 26.5%%; RR 1.26, 95% CI 1.14-1.39, P<.001; Uganda: 41.2%; RR 1.27, 95% CI 1.16-1.39, P<.001) and lottery incentive arms (Bangladesh: 24.5%%; RR 1.17, 95% CI 1.06-1.29, P=.002; Uganda: 37.9%%; RR 1.17, 95% CI 1.06-1.29, P=.001) than those for the control arm (Bangladesh: 21.0%; Uganda: 32.4%)., Conclusions: Promised or lottery airtime incentives improved survey participation and facilitated a large sample within a short period in 2 countries., Trial Registration: ClinicalTrials.gov NCT03773146; http://clinicaltrials.gov/ct2/show/NCT03773146., (©Dustin Garrett Gibson, Gulam Muhammed Al Kibria, George William Pariyo, Saifuddin Ahmed, Joseph Ali, Alain Bernard Labrique, Iqbal Ansary Khan, Elizeus Rutebemberwa, Meerjady Sabrina Flora, Adnan Ali Hyder. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 09.05.2022.)

Valid, reliable behavioral data and contextually meaningful interventions are necessary for improved health outcomes. Ecological Momentary Assessment and Intervention (EMAI), which collects data as behaviors occur to deliver real-time interventions, may be more accurate and reliable than retrospective methods. The rapid expansion of mobile technologies in low-and-middle-income countries allows for unprecedented remote data collection and intervention opportunities. However, no previous studies have trialed EMAI in sub-Saharan Africa. We assessed EMAI acceptability and feasibility, including participant retention and response rate, in a prospective, parallel group, randomized pilot trial in Rakai, Uganda comparing behavioral outcomes among adults submitting ecological momentary assessments (EMA) versus EMAI. After training, participants submitted EMA data on five nutrition and health risk behaviors over a 90-day period using a smartphone-based application utilizing prompt-based, participant-initiated, and geospatial coordinate data collection, with study coordinator support and incentives for >50% completion. Included behaviors and associated EMAI-arm intervention messages were selected to pilot a range of EMAI applications. Acceptability was measured on questionnaires. We estimated the association between high response rate and participant characteristics and conducted thematic analysis characterizing participant experiences. Study completion was 48/50 participants. Median prompt response rate was 66.5% (IQR: 60.0%-78.6%). Prior smartphone app use at baseline (aPR 3.76, 95%CI: 1.16-12.17, p = 0.03) and being in the intervention arm (aPR 2.55, 95% CI: 1.01-6.44, p = 0.05) were significantly associated with the top response rate quartile (response to >78.6% of prompts). All participants submitted self-initiated reports, covering all behaviors of interest, including potentially sensitive behaviors. Inconsistent phone charging was the most reported feasibility challenge. In this pilot, EMAI was acceptable and feasible. Response rates were good; additional strategies to improve compliance should be investigated. EMAI using mobile technologies may support improved behavioral data collection and intervention approaches in low and middle-income settings. This approach should be tested in larger studies., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: emocha Mobile Health Inc. developed the application used in this study. LC is entitled to royalties on certain non-research revenue generated by this company and owns company equity. Specific to this study, LC received no royalties or compensation from emocha Mobile Health Inc. This arrangement has been reviewed and approved by the Johns Hopkins University in accordance with its conflict of interest policies. All other study team members have declared that no competing interests exist. This competing interest does not alter our adherence to PLOS ONE policies on sharing data and materials.

Objective: Uganda is HIV-endemic with a prevalence of 5.7%. Lack of epidemic control has been attributed to low engagement with HIV testing. Collaborating with informal healthcare providers, such as traditional healers, has been proposed as a strategy to increase testing uptake. We explored acceptability and implementation of an HIV testing program where traditional healers delivered point-of-care testing and counseling to adults of unknown serostatus (clinicaltrials.gov NCT#03718871)., Methods: This study was conducted in rural, southwestern Uganda. We interviewed participating traditional healers ( N  = 17) and a purposive sample of trial participants ( N  = 107). Healers were practicing within 10 km of Mbarara township, and 18+ years old. Participants were 18+ years old; sexually active; had received care from participating healers; self-reported not receiving an HIV test in prior 12 months; and not previously diagnosed with HIV infection. Interviews explored perceptions of a healer-delivered HIV testing model and were analyzed following a content-analysis approach., Results: Most participants were female individuals ( N  = 68, 55%). Healer-delivered HIV testing overcame structural barriers, such as underlying poverty and rural locations that limited use, as transportation was costly and often prohibitive. Additionally, healers were located in villages and communities, which made services more accessible compared with facility-based testing. Participants also considered healers trustworthy and 'confidential'. These qualities explain some preference for healer-delivered HIV testing, in contrast to 'stigmatizing' biomedical settings., Conclusion: Traditional healer-delivered HIV testing was considered more confidential and easily accessible compared with clinic-based testing. Offering services through traditional healers may improve uptake of HIV testing services in rural, medically pluralistic communities., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: People living with HIV (PLHIV) have an increased risk of developing active tuberculosis (TB). To reduce the burden of TB among PLHIV, the World Health Organization (WHO) recommends systematic TB screening followed by (1) confirmatory TB testing for all who screen positive and (2) TB preventive therapy (TPT) for all TPT-eligible PLHIV who screen negative. Symptom-based screening remains the standard of care in most high TB burden settings, including Uganda. Despite having high sensitivity for active TB among antiretroviral-naïve PLHIV, symptom screening has poor specificity; as such, many high-risk PLHIV without active TB are not referred for TPT. C-reactive protein (CRP) is a promising alternative strategy for TB screening that has comparable sensitivity and higher specificity than symptom screening, and was endorsed by WHO in 2021. However, the impact of CRP-based TB screening on TB burden for PLHIV remains unclear., Methods: TB SCRIPT (TB Screening Improves Preventive Therapy Uptake) is a phase 3, multi-center, single-blinded, individual (1:1) randomized controlled trial evaluating the effectiveness of CRP-based TB screening on clinical outcomes of PLHIV. The trial aims to compare the effectiveness of a TB screening strategy based on CRP levels using a point-of-care (POC) assay on 2-year TB incidence and all-cause mortality (composite primary trial endpoint) and prevalent TB case detection and uptake of TPT (intermediate outcomes), relative to symptom-based TB screening (current practice)., Discussion: This study will be critical to improving selection of eligible PLHIV for TPT and helping guide the scale-up and integration of TB screening and TPT activities. This work will enable the field to improve TB screening by removing barriers to TPT initiation among eligible PLHIV, and provide randomized evidence to inform and strengthen WHO guidelines., Trial Registration: ClinicalTrials.gov NCT04557176. Registered on September 21, 2020., (© 2022. The Author(s).)

Introduction: Family planning knowledge is poor and use is low in Ugandan fishing communities. We compared the effectiveness of enhanced family planning (FP) education with routine counselling on FP knowledge and use., Methods: Individuals aged 15-49 years were randomly assigned to intervention or control arm. The intervention constituted enhanced FP education based on a simplified handout extracted from the WHO FP guidance tool called, "Family planning: A global handbook for FP providers" which participants took home for additional reading. The control arm constituted FP counselling following Uganda Ministry of Health guidelines. FP knowledge score and contraceptive prevalence rate (CPR) were compared between trial arms at baseline and at 12 months. Negative binomial regression models were used to estimate the effect of the intervention on FP knowledge and use., Results: Overall, 1410 participants were screened to enrol 1004 (502 per study arm, 48.5% women). Subsequently, 384 (76.5%) and 383 (76.3%) completed the 12 months' follow-up in the intervention and control arms respectively. At baseline, a median FP knowledge score of 8 and a < 70% FP knowledge score was observed for all participants with a CPR of 36.8%. At month-12, the median FP knowledge score improved in both arms, higher in the intervention arm than the control arm (46 vs 30; p < 0.001). In the intervention arm, 304 (79.2%) had a score of ≥70 compared with 21 (5.5%) in the control arm (p < 0.001). In the negative binomial regression model, the change in FP knowledge score was 47% higher in the intervention arm than in the control arm (score ratio: 1.47, 95%CI: 1. 43-1.51, p < 0.001). The change in CPR was 16% higher in the intervention arm than in the control arm (Prevalence ratio: 1.16, 95%CI: 1.01-1.34, p < 0.040)., Interpretation: Enhanced FP education using a simplified FP education handout was more effective in increasing FP knowledge and use compared to routine FP counselling for people living in fishing communities. Innovative FP education interventions are recommended for improving FP knowledge and optimizing uptake in remote-rural settings where literacy levels are low., Trial Registration: The study was registered by the Pan African Clinical Trial Registry on 03 July 2021 with a Trial Registration Number PACTR202107891858045 . "Retrospectively registered"., (© 2022. The Author(s).)

Background: Lack of financial preparedness for pregnancy can lead to adverse outcomes during childbirth. Behavioral science interventions have been shown to influence savings behavior. Financial savings interventions can be adapted for the purpose of encouraging individuals to save towards maternal healthcare costs. This article describes a protocol to assess the effectiveness of an intervention formulated with a behavioral science approach for encouraging use of maternal health services through increased financial savings for birth preparedness and maternal healthcare costs among pregnant women or their partners in Uganda., Methods: A randomized controlled trial will be conducted to assess the effectiveness of the intervention among pregnant women or their partners in Uganda's central region, including the capital of Kampala. Seven hundred pregnant women (12-35 gestational weeks) or their partners will be recruited. All participants will receive access to a committed mobile money health savings account provided by a local organization that also offers savings targets and reminders for antenatal care appointments and health tips as part of a "Mamas Program" offered to expectant mothers. The time period in the intervention is from the day of enrollment until two weeks after the delivery date. The control group will receive the standard Mama Program offering. The intervention group will receive the standard Mama Program offering plus behavioral designs encouraging savings behavior through short-message service (SMS) text messages. The primary outcome is usage of maternal health services measured by level of birth preparedness and delivery at a health facility. Secondary outcomes include male involvement in maternal healthcare, measured by financial support, as well as total savings for healthcare, assessed using the validated amount of savings accrued in participants' clinicPesa accounts from the day of enrollment plus any withdrawals for healthcare expenditures during the intervention period., Discussion: The study will contribute to a better understanding of the effectiveness of behavioral designs encouraging financial savings during pregnancy into committed mobile money health savings accounts. The study could contribute to demonstrating the effectiveness of savings on birth preparedness, usage of maternal health services, and male involvement in maternal healthcare., Trial Registration: UMIN-CTR Clinical Trial, UMIN000046472. Registered on 19 January 2022. https://center6.umin.ac.jp/cgi-open-bin/icdr&#95;e/ctr&#95;view.cgi?recptno=R000053008., (© 2022. The Author(s).)

Background: Unmet need for family planning and unintended pregnancies are high in developing countries. Home pregnancy tests help women determine their pregnancy status earlier and the confirmation of a negative pregnancy status can facilitate the adoption of family planning. This study provides the first experimental evidence of the effect of access to pregnancy tests on women's demand for modern family planning., Methods: A randomized controlled trial was conducted among 810 women of reproductive age in northern Uganda. During a baseline survey, women were randomly allocated to either: (1) an offer to take a hCG urine pregnancy test during the survey (on-the-spot pregnancy test) (N = 170), (2) an offer of a home pregnancy test kit to be used at any time in the future (future-use pregnancy test) (N = 163), (3) offers of both on-the-spot and future-use pregnancy tests (N = 153), or (4) a control group (N = 324). Future-use pregnancy tests were offered either for free, or randomly assigned prices. Approximately 4 weeks after the baseline survey, a follow-up survey was conducted; modern contraception methods were made available at no charge at local community outreach centers., Results: When offered a free, on-the-spot pregnancy test, 62 percent of women accepted (N = 200). Almost all, 97 percent (N = 69), of women offered a free future-use pregnancy test strip, accepted it. Purchases of future-use pregnancy tests declined with price. The offer of either on-the-spot, future-use tests, or both, have no overall large or statistically significant effects on the take-up of modern family planning., Conclusion: Demand for pregnancy tests is high and access to pregnancy tests has the potential to facilitate the demand for family planning. At the same time, more research is needed to understand underlying beliefs about pregnancy status and risk that guide behaviors ultimately important for maternal and neonatal health. Trial registration The study was pre-registered in July 2018 for AEA RCT registry (AEARCTR-0003187) and clinicaltrials.gov (NCT03975933). Registered 05 June 2019, https://clinicaltrials.gov/ct2/show/record/NCT03975933., (© 2021. The Author(s).)

Introduction: Innovative strategies are needed to disseminate HIV prevention messages across communities efficiently, as well as reduce HIV stigma while promoting HIV prevention. This randomized controlled trial will evaluate the efficacy of a social network-based group intervention, Game Changers, which trains persons living with HIV (PLWH) to encourage members of their social network to use HIV protective behaviors METHODS: PLWH in HIV care for at least 1 year will be randomly assigned to receive the 8-session group advocacy training intervention or no-intervention control group. Each enrolled PLWH (index participant) will be asked to recruit up to four social network members (alter participant). Assessments will be administered at baseline and months 6, 12, and 18 to both index and alter participants. The primary outcomes are HIV testing and condom use among alter participants; secondary outcomes are engagement in HIV prevention advocacy and internalized HIV stigma among index participants. Repeated-measures multivariable regression analyses will be conducted to compare outcomes between the intervention and control arms, in addition to a cost-effectiveness evaluation., Discussion: This social network-based approach to HIV prevention is particularly timely in the era of biomedical interventions, which require widespread penetration of effective HIV prevention and care messaging into communities. Positioning PLWH as central to the solution for controlling (vs. causing) the HIV epidemic has the potential to reduce HIV stigma and improve prevention outcomes at the individual and network levels., Trial Registration: ClinicalTrials.gov NIH Clinical Trial Registry NCT05098015. Registered on October 18, 2021., (© 2022. The Author(s).)

Introduction: Surgical Site Infections (SSIs) constitute 15%-45% of hospital acquired infections in sub-Saharan Africa. Cesarean section (CS) increases the risk of developing sepsis by 5-20 times and is highest when the operation is emergency. Therefore, the purpose of this study was to measure the effect of chloroxylenol in reducing the incidence of post cesarean SSIs at Mbarara Regional Referral Hospital (MRRH)., Methods: a randomized controlled trial was conducted at MRRH maternity ward and mothers were randomized into either control or intervention arms. The intervention was a complete body bath with chloroxylenol antiseptic soap before the operation, while the control arm participants received a standard ward pre-operative preparation procedures. All participants were followed up for 30 days and assessed using an SSI screening tool., Results: ninety-six women were randomized, and 48 were assigned to each arm. The overall incidence of SSI was 30.21%. The incidence of SSI was significantly lower in the intervention compared to the control arm (6.25% in the intervention arm versus 54.17% in the control arm) (p-value <0.001). Chloroxylenol bath was protective of SSI with a 90% risk reduction for SSI (95% confidence interval of 67%-97%)., Conclusion: a preoperative bath with chloroxylenol for pregnant mothers is associated with a significantly lower risk of post cesarean section surgical site infections. Health facilities with a high burden of post SSI should consider adding this simple and effective intervention to the existing infection prevention measures. Clinical Trials.gov registration (NCT03544710)., Competing Interests: The authors declare no competing interests., (Copyright: Henry Lukabwe et al.)

Solar lighting is an alternative to polluting kerosene and other fuel-based lighting devices relied upon by millions of families in resource-limited settings. Whether solar lighting provides sustained displacement of fuel-based lighting sources and reductions in personal exposure to fine particulate matter (PM 2 . 5 ) and black carbon (BC) has not been examined in randomized controlled trials. Eighty adult women living in rural Uganda who utilized fuel-based (candles and kerosene lamps) and/or clean (solar, grid, and battery-powered devices) lighting were randomized in a 1:1 ratio to receive a home solar lighting system at no cost to study participants (ClinicalTrials.gov NCT03351504). Among intervention group participants, kerosene lamps were completely displaced in 92% of households using them. The intervention led to an average exposure reduction of 36.1 μg/m 3 (95% CI -70.3 to -2.0) in PM 2 . 5 and 10.8 μg/m 3 (95% CI -17.6 to -4.1) in BC, corresponding to a reduction from baseline of 37% and 91%, respectively. Reductions were greatest among participants using kerosene lamps. Displacement of kerosene lamps and personal exposure reductions were sustained over 12 months of follow-up. Solar lighting presents an immediate opportunity for achieving sustained reductions in personal exposure to PM 2.5 and BC and should be considered in household air pollution intervention packages., (© 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Introduction: Cervical cancer (CC) is the most common cancer and accounts for one quarter of all cancer-related deaths among women in Uganda, where lifetime CC screening is estimated to be as low as 5%. This study will evaluate the feasibility, acceptability, and preliminary efficacy of a social network-based group intervention designed to empower women who have received CC screening to encourage women in their social network to also screen. Methods: Forty adult women (index participants) who have recently screened for CC will be recruited, 20 of whom will be randomly assigned to take part in the intervention and 20 to the wait-list control. Each index participant will be asked to recruit up to three female social network members (i.e., alters; maximum total = 120 alters) who have not screened for CC to participate in the study. Assessments (survey and chart abstraction) will be administered at baseline and month 6 to index and alter participants. The primary outcome is CC screening among participating alters, with a secondary outcome being engagement in CC prevention advocacy among index participants. Repeated-measure multivariable regression analyses will be conducted to compare outcomes between the intervention and control arms. Discussion: If successful, this intervention model has the potential not only to impact uptake of CC screening and treatment but also to establish a paradigm that can be applied to other health conditions. Trial registration: NIH Clinical Trial Registry NCT04960748 (clinicaltrials.gov). [ABSTRACT FROM AUTHOR]

Traumatic stress due to conflict and war causes major mental health problems in many resource-poor countries. The objective of this study was to examine whether trained lay counselors can carry out effective treatment of posttraumatic stress disorder (PTSD) in a refugee settlement. In a randomized controlled dissemination trial in Uganda with 277 Rwandan and Somalian refugees who were diagnosed with PTSD the authors investigated the effectiveness of psychotherapy administered by lay counselors. Strictly manualized narrative exposure therapy (NET) was compared with more flexible trauma counseling (TC) and a no-treatment monitoring group (MG). Fewer participants (4%) dropped out of NET treatment than TC (21%). Both active treatment groups were statistically and clinically superior to MG on PTSD symptoms and physical health but did not differ from each other. At follow-up, a PTSD diagnosis could not be established anymore in 70% of NET and 65% TC participants, whereas only 37% in MG did not meet PTSD criteria anymore. Short-term psychotherapy carried out by lay counselors with limited training can be effective to treat war-related PTSD in a refugee settlement. (Contains 2 tables and 3 figures.)

Background: Virologic failure in HIV predicts the development of drug resistance and mortality. Genotypic resistance testing (GRT), which is the standard of care after virologic failure in high-income settings, is rarely implemented in sub-Saharan Africa., Objective: To estimate the effectiveness of GRT for improving virologic suppression rates among people with HIV in sub-Saharan Africa for whom first-line therapy fails., Design: Pragmatic, unblinded, randomized controlled trial. (ClinicalTrials.gov: NCT02787499)., Setting: Ambulatory HIV clinics in the public sector in Uganda and South Africa., Patients: Adults receiving first-line antiretroviral therapy with a recent HIV RNA viral load of 1000 copies/mL or higher., Intervention: Participants were randomly assigned to receive standard of care (SOC), including adherence counseling sessions and repeated viral load testing, or immediate GRT., Measurements: The primary outcome of interest was achievement of an HIV RNA viral load below 200 copies/mL 9 months after enrollment., Results: The trial enrolled 840 persons, divided equally between countries. Approximately half (51%) were women. Most (72%) were receiving a regimen of tenofovir, emtricitabine, and efavirenz at enrollment. The rate of virologic suppression did not differ 9 months after enrollment between the GRT group (63% [263 of 417]) and SOC group (61% [256 of 423]; odds ratio [OR], 1.11 [95% CI, 0.83 to 1.49]; P = 0.46). Among participants with persistent failure (HIV RNA viral load ≥1000 copies/mL) at 9 months, the prevalence of drug resistance was higher in the SOC group (76% [78 of 103] vs. 59% [48 of 82]; OR, 2.30 [CI, 1.22 to 4.35]; P = 0.014). Other secondary outcomes, including 9-month survival and retention in care, were similar between groups., Limitation: Participants were receiving nonnucleoside reverse transcriptase inhibitor-based therapy at enrollment, limiting the generalizability of the findings., Conclusion: The addition of GRT to routine care after first-line virologic failure in Uganda and South Africa did not improve rates of resuppression., Primary Funding Source: The President's Emergency Plan for AIDS Relief and the National Institute of Allergy and Infectious Diseases.

Objective: To evaluate the impact of a peer-referral and clinic welcome programme for reducing barriers to adolescents' uptake of family planning services in Uganda., Methods: We developed an intervention using behavioural design and carried out a stratified, randomized controlled evaluation of the intervention in girls aged 15-19 years. Sexual and reproductive health clinics were randomized into control (56 clinics) and intervention groups (60 clinics). All intervention clinics received the core intervention (materials to create an adolescent-friendly environment and referral cards to give to friends), while a subset of clinics additionally received training in youth-friendly service provision. We collected clinics' routine data on monthly numbers of visits by adults and adolescents over a 15-month baseline and 6-month intervention period, 2018-2020., Findings: In multivariate regression analysis we found significant effects of the intervention on primary outcomes in the pooled intervention group compared with control. Mean monthly visits by adolescents increased by 45% (incidence rate ratio, IRR: 1.45; 95% confidence interval, CI: 1.14-1.85), or over five additional adolescent clients per clinic per month. The mean adolescent proportion of total clients improved by 5.3 percentage points (95% CI: 0.02-0.09). Within treatment arms, clinics receiving the training in youth-friendly service provision showed the strongest effects: a 62% increase (IRR: 1.62; 95% CI: 1.21-2.17) in adolescent clients, or over seven additional adolescents per clinic per month, relative to the control group., Conclusion: A behavioural change intervention designed to target identified barriers can increase adolescents' uptake of family planning counselling and services., ((c) 2021 The authors; licensee World Health Organization.)

Childhood undernutrition is a major health burden worldwide that increases childhood morbidity and mortality and causes impairment in infant growth and developmental delays that can persist into adulthood. The first weeks and months after birth are critical to the establishment of healthy growth and development during childhood. The World Health Organization recommends immediate and exclusive breastfeeding (EBF). In infants for whom EBF may not meet nutritional and caloric demands, early, daily, small-volume formula supplementation along with breastfeeding may more effectively avoid underweight wasting and stunting in early infancy than breastfeeding alone. The primary objective of this randomized controlled trial is to evaluate the efficacy of formula for 30 days among low birth weight (LBW) infants <6 hours of age and those not LBW with weights <2600 grams at 4 days of age. We will compare breastfeeding and formula (up to 59 milliliters administered daily) through 30 days of infant age vs recommendations for frequent EBF without supplementation, and test the hypothesis that formula increases weight-for-age z-score at 30 days of infant age. The trial will enroll and randomize 324 mother-infant pairs in Guinea-Bissau and Uganda, and follow them for 6 months for outcomes including growth, intestinal microbiota, breastfeeding duration, infant dietary intake, and adverse events. Conservatively estimating 20% loss to follow up, this sample size provides ≥80% power per weight stratum for intervention group comparison to detect a difference of 0.20 with respect to the outcome of WAZ at day 30. This trial was approved by the University of California, San Francisco Institutional Review Board (19-29405); the Guinea-Bissau National Committee on Ethics in Health (Comite Nacional de Etica na Saude, 075/CNES/INASA/2020); the Higher Degrees, Research and Ethics Committee of Makerere University (871); and the Uganda National Council of Science and Technology (HS1226ES). We plan to disseminate study results in peer-reviewed journals and international conferences. Trial registration number: NCT04704076., Competing Interests: Dr. Roberts declares receipt of research funding from Danone International for development of a questionnaire assessing food culture in an adult population. All other authors have declared that no competing interests exist. The study product will be purchased retail; Abbott Nutrition has no role in the study other than manufacturing the formula for commercial sale.

We tested an intervention that aimed to increase retention in antiretroviral therapy (ART) among HIV-positive pregnant and postpartum women, a population shown to be vulnerable to poor ART outcomes. 133 pregnant women initiating ART at 2 hospitals in Uganda used real time-enabled wireless pill monitors (WPM) for 1 month, and were then randomized to receive text message reminders (triggered by late dose-taking) and data-informed counseling through 3 months postpartum or standard care. We assessed "full retention" (proportion attending all monthly clinic visits and delivering at a study facility; "visit retention" (proportion of clinic visits attended); and "postpartum retention" (proportion retained at 3 months postpartum). Intention-to-treat and per protocol analyses found that retention was relatively low and similar between groups, with no significant differences. Retention declined significantly post-delivery. The intervention was unsuccessful in this population, which experiences suboptimal ART retention and is in urgent need of effective interventions.

Background: High-dose rifampicin may improve outcomes of tuberculous meningitis (TBM). Little safety or pharmacokinetic (PK) data exist on high-dose rifampicin in human immunodeficiency virus (HIV) coinfection, and no cerebrospinal fluid (CSF) PK data exist from Africa. We hypothesized that high-dose rifampicin would increase serum and CSF concentrations without excess toxicity., Methods: In this phase II open-label trial, Ugandan adults with suspected TBM were randomized to standard-of-care control (PO-10, rifampicin 10 mg/kg/day), intravenous rifampicin (IV-20, 20 mg/kg/day), or high-dose oral rifampicin (PO-35, 35 mg/kg/day). We performed PK sampling on days 2 and 14. The primary outcomes were total exposure (AUC0-24), maximum concentration (Cmax), CSF concentration, and grade 3-5 adverse events., Results: We enrolled 61 adults, 92% were living with HIV, median CD4 count was 50 cells/µL (interquartile range [IQR] 46-56). On day 2, geometric mean plasma AUC0-24hr was 42.9·h mg/L with standard-of-care 10 mg/kg dosing, 249·h mg/L for IV-20 and 327·h mg/L for PO-35 (P < .001). In CSF, standard of care achieved undetectable rifampicin concentration in 56% of participants and geometric mean AUC0-24hr 0.27 mg/L, compared with 1.74 mg/L (95% confidence interval [CI] 1.2-2.5) for IV-20 and 2.17 mg/L (1.6-2.9) for PO-35 regimens (P < .001). Achieving CSF concentrations above rifampicin minimal inhibitory concentration (MIC) occurred in 11% (2/18) of standard-of-care, 93% (14/15) of IV-20, and 95% (18/19) of PO-35 participants. Higher serum and CSF levels were sustained at day 14. Adverse events did not differ by dose (P = .34)., Conclusions: Current international guidelines result in sub-therapeutic CSF rifampicin concentration for 89% of Ugandan TBM patients. High-dose intravenous and oral rifampicin were safe and respectively resulted in exposures ~6- and ~8-fold higher than standard of care, and CSF levels above the MIC., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America.)