Bareng Aletta Sanny Nonyane

Background: Tuberculosis-preventive treatment (TPT) is recommended for those at risk of tuberculosis, but despite encouraging trial data, evidence of its effectiveness from routine settings with diverse TPT regimens is limited. We describe routine TPT implementation outcomes in people living with human immunodeficiency virus (HIV; PLWH) to identify bottlenecks and opportunities for improvement along the cascade of care. Methods: From 2021–2023, we conducted a 24-month prospective cohort study of PLWH facilities in Ethiopia, South Africa and Zimbabwe. Sociodemographic and clinical data were collected at enrollment. During follow-up, we collected TPT initiation, TPT-related adverse effects, and completion data. A subgroup was allocated digital boxes as a proxy measure for assessing treatment completion. Tuberculosis diagnoses were confirmed from clinic records or symptom agnostic sputum testing using Xpert MTB/RIF assay and mycobacteria growth indicator tube (MGIT) culture at 12- and 24 months after enrollment. Results: We enrolled 2095 participants, mostly female (n = 1489 [71.1%]), with a median age of 42 years (interquartile range, 35–50 years). Approximately 60% (n = 1312) were considered eligible for TPT, and 1110 (84.6%) initiated TPT within 60 days of antiretroviral therapy initiation or refill during follow-up (rifapentine and isoniazid [3HP] in 625 and 6 or 12 months of isoniazid [6H/12H] in 487). TPT was completed in 55.4% (406 of 733). Mild symptoms compatible with TPT adverse effects were commonly reported in 3HP versus 6H/12H (190 [31.0%] vs 51 [11.0%], respectively; P < .001]. The tuberculosis incidence rate was 1.27/100 person-years (95% confidence interval, .95–1.69) during study follow-up in a mostly long-term antiretroviral therapy population and was lower for PLWH who completed TPT (adjusted incidence rate ratio, 0.39 [.20–.78]; P = .01). Conclusions: There were losses along the cascade, particularly at completion. In programmatic settings, we observed more potential mild symptoms from 3HP compared to 6H/12H use. Interventions to support TPT completion are needed.

Background: Tuberculosis preventive therapy (TPT) reduces tuberculosis incidence among people living with HIV (PLHIV), yet uptake has been sub-optimal. We evaluated trends of TPT prescribing among people initiated on antiretroviral therapy (ART). Setting: Thirty-six public sector clinics in South Africa. Methods: We retrospectively analyzed individual-level clinical data abstracted from clinics in the Free State and North West provinces, South Africa. We included PLHIV who initiated ART 2005-2022 and had ≥1 HIV-related clinic visits on or after 15 September 2021. The timing of TPT prescribing was defined by the earliest recorded TPT prescription date as: (1) TPT prescription within ≤6 months, (2) TPT prescription >6 months, or (3) no recorded TPT prescription on or after ART initiation. Results: Among 48,718 ART initiators, 23,168 (47.6%) were prescribed TPT on or after ART initiation; 15,510 (31.8%) were prescribed TPT ≤6 months and 7,658 (15.7%) were prescribed TPT >6 months after ART initiation. Early TPT prescribing increased from 0.7% in the 2005-2010 cohort to 71.3% in 2022 ART initiators, while TPT prescribing >6 months after ART initiation declined from 28.5% in the 2005-2010 cohort to 1.3% among those who initiated ART in 2022. Cumulative TPT prescribing was 29.2% in the 2005-2010 cohort, 34.2% in the 2011-2015 cohort, and 72.6% in the 2022 cohort. Conclusions: Over 2005-2022, TPT prescribing shifted markedly toward initiation near the time of ART initiation, with early prescribing exceeding 70% by 2022. Cumulative prescribing remained low among people from earlier ART cohorts, underscoring the need for targeted catch-up strategies.

Background: The burden of children with lower respiratory infections and low blood oxygen levels (hypoxemia) is high, and outcomes are poor in low- and middle-income countries (LMICs). Pulse oximeters noninvasively measure the capillary oxyhemoglobin saturation (SpO ₂ ) to identify hypoxemia, but high-quality devices designed for the unique needs of children are rarely available in primary health care clinics (PHCs) in LMICs, where children initially access care. Objective: This study aims to evaluate whether 2 pediatric pulse oximeters co-designed with health care workers (HCWs) in LMICs improve the correct SpO ₂ management of children in PHCs compared to a standard pulse oximeter. Methods: We are conducting a pragmatic 3-arm cluster randomized controlled trial in the Eastern Khayelitsha, Northern, and Tygerberg areas of Cape Town, South Africa, over 18 months between 2024 and 2026. We plan to enroll 1200 children aged younger than 2 years with an acute respiratory infection from 18 PHCs randomized to implement one of 3 pulse oximeters, either 1 standard-of-care device or 2 intervention devices. HCWs in selected PHCs will administer the intervention. Our primary outcome will be “correct SpO ₂ management,” an intermediate clinical end point between device implementation and hypoxemia outcome, defined by the following three elements necessary to reduce inappropriately treated hypoxemia: (1) device adoption—HCW use of the device as evidenced by a HCW-documented SpO ₂ and pulse rate; (2) quality SpO ₂ measurement—SpO ₂ confirmed by reference device measurement within 2% SpO ₂ above or below the HCW-measured SpO ₂ ; and (3) correct SpO ₂ decision-making—an appropriate referral recommendation by the HCW. A concurrent mixed methods process evaluation will explore how, why, for whom, and to what extent these devices impact the clinical management of hypoxemic children. The primary analysis will be intention-to-treat. For all primary and secondary outcomes, we will conduct pairwise comparisons between the 2 intervention arms and the control arm. Results: Data collection commenced in 2024, and results are expected from 2026 to 2027. As of December 2025, enrollment has been completed in 12 clinics. Conclusions: While there are notable challenges inherent in designing a trial to evaluate whether pulse oximeters improve HCW SpO ₂ management of children at PHCs, our protocol development process attempted to address all potential limitations and sources of bias to maximize the trial’s future impact.

Introduction: Women who use drugs in Tanzania face a disproportionately high burden of HIV and mental health disorders. Despite the availability of pre-exposure prophylaxis (PrEP), uptake remains low, highlighting the need for integrated, scalable interventions that address co-occurring substance use and mental health challenges. Motivational interviewing (MI) and cognitive-behavioural approaches, such as the Common Elements Treatment Approach (CETA), show promise for enhancing HIV prevention outcomes in this population. This study presents the protocol for a pilot feasibility trial assessing the acceptability, feasibility and preliminary efficacy of MI for PrEP (MI-PrEP) and a combined CETA and MI-PrEP intervention (CETA + MI-PrEP) to improve PrEP engagement among women who use drugs in Tanzania. Methods and analysis: This individually randomised, parallel-group pilot trial will be conducted in Dar es Salaam, Tanzania, guided by the situated Information, Motivation and Behavioral Skills model. Eligible participants are adult women who use heroin, report recent drug-related or sex-related HIV risk behaviours, are HIV-negative and exhibit symptoms of depression, anxiety or post-traumatic stress disorder. Participants are randomised to one of three arms: MI-PrEP, CETA + MI-PrEP or enhanced treatment as usual. Interventions are delivered face-to-face by trained counsellors. Feasibility and acceptability will be assessed using recruitment and retention data, surveys and qualitative interviews. Preliminary effects will be measured for PrEP initiation, symptoms of common mental disorders and substance use. Ethics and dissemination: Ethical approval has been obtained from the Johns Hopkins Bloomberg School of Public Health Institutional Review Board (25580), the Muhimbili University of Health and Allied Sciences Ethics Review Committee (MUHAS-REC-12-2023-1994) and the National Health Research Ethics Committee at the National Institute for Medical Research in Tanzania (NIMR/HQ/R.8a/Vol.IX/4830). Results will be disseminated through ClinicalTrials.gov, peer-reviewed publications, conferences, presentations and research briefings to community stakeholders. Trial registration: ClinicalTrials.gov ID: NCT06835751 . Initially registered 14 February 2025, https://clinicaltrials.gov/study/NCT06835751 , last updated 5 December 2025.

Background/Objectives. Associations between stunting and dietary practices have been understudied among HIV-exposed and HIV-free children. We investigated associations between birthweight, socio-demographics, and dietary and feeding practices with stunting at 9 and 18 months among children in eSwatini. Methods. We used generalized linear mixed models (GLMs) with a logit link to characterize associations between stunting and birthweight quartiles, socio-demographics, maternal characteristics, and infant dietary diversity scores. We examined the moderating effects of dietary factors on relations between birthweight and stunting. Generalized structural equation models characterized direct and indirect associations between exposures and stunting at 18 months, mediated through stunting at 9 months. Results. We included 367 HIV-exposed and HIV-free children. Infants in the third and fourth birthweight quartiles had reduced odds of stunting at 9 months [adjusted odds ratio (adj OR) 0.24 (IQR 0.11, 0.55), p < 0.001; 0.10 (0.03, 0.33), p < 0.001, respectively]. Moderation by dietary diversity was limited to a relative decline in the second birthweight quartile. Stunting prevalence significantly increased from 9 months (21%) to 18 months (37%). Mediated by stunting at 9 months, there were significant direct and indirect effects of birthweight and dietary diversity on stunting at 18 months. Conclusions. Among HIV-exposed and HIV-free children, stunting prevalence increased with age and was associated with lower birthweight. Dietary diversity attenuated stunting risk among children in the second birthweight quartile. Prenatal strategies to reduce low birth weight (LBW) and additional attention to the social determinants of health, particularly dietary diversity, are warranted in programs and policies to reduce stunting.

Background: Photographic imagery holds profound power in shaping narratives, identities, and perceptions in global health education. Historically, visual representation used in global health has perpetuated colonial hierarchies, reinforcing inequities and marginalizing the voices and lived realities of the communities they depict. These images can inadvertently sustain harmful stereotypes and distort the complexity of global health challenges.

BACKGROUND Disparities in HIV care persist and there is a need to evaluate scalable approaches to improving HIV care engagement and viral suppression in real-world settings. OBJECTIVE To compare standard of care HIV linkage, adherence, and retention (LAR) clinic-based support services to a mobile health (mHealth)-enhanced linkage, adherence, and retention (mLAR) intervention and assess mLAR implementation. METHODS Participants were enrolled from six Baltimore HIV clinics in an individual-level randomized controlled trial. Eligibility criteria included adults living with HIV who had a new HIV diagnosis, were out of care, or were deemed by clinic staff as someone who could benefit from LAR services. Participants in the control group received the referring clinic’s standard LAR services. Participants randomized to the intervention additionally received mHealth-supported patient navigation including an app platform that integrated HIV surveillance data from throughout Maryland. The primary outcome was HIV virologic suppression at 12 months. Participants with non-suppressed viral load or missing viral loads at 12 months (inclusive of a +/- 3-month window) were considered virologic failures. Secondary outcomes included loss to follow-up and mortality at 12 months. Implementation outcomes were assessed via in-depth interviews with participants and patient support staff. This study was implemented in collaboration with patients and stakeholders, including members of the Baltimore City Health Department, the Maryland Department of Health, patient navigators, HIV healthcare providers, and people living with HIV. Members of the Steering Committee provided guidance on the study design and implementation, app development, interpretation of results, and dissemination of findings. RESULTS A total of 451 participants (226 LAR control group and 225 mLAR intervention group) were randomized and 3 (1 LAR and 2 mLAR) withdrew consent before the study endpoint. Virologic suppression was 56.9% (95% CI 50.4%-63.4%, LAR) and 50.3% (95% CI 44.%-57.7%, mLAR) in the two arms [difference 5.8% (-3.4%-14.9%), p-value=0.22]. Sixty-six participants (29.3%) in the LAR arm and 71 (31.8%) in the mLAR arm were missing a viral load test at 12 months and were assumed to be not virologically suppressed. These results were similar when stratified by race, ethnicity and clinic site. In the LAR and mLAR arms, respectively, 28.9% (95% CI 22.9%-34.8%) and 31.8% (95% CI 25.7%-37.9%) of participants were lost to follow-up [difference -2.9% (-11.5%-5.6%), p-value=0.49] while all-cause mortality was 4.9% versus 4.0% [Pearson's chi-squared p<0.662]. In-depth interviews revealed mixed perceptions of the app; some participants and patient navigators valued its usability, while others found it redundant with existing tools like electronic medical record portals and phone communication. CONCLUSIONS An app-based mobile health intervention for patients and patient supporters had no impact on virologic suppression, engagement in care, or mortality. In populations with complex socio-structural determinants of health, additional strategies are needed to improve HIV care outcomes. CLINICALTRIAL ClinicalTrials.gov NCT03934437

Introduction: While highly effective for reducing the risk of tuberculosis (TB) disease, TB preventive treatment (TPT) is underused among people living with HIV (PWH). We evaluated the effectiveness of a behavioural economics-based choice architecture approach to increase facility-level TPT prescribing to PWH in Malawi, Mozambique and Zimbabwe.Methods: We conducted a cluster-randomised trial within the IMPAACT4TB 3HP rollout, in which 57 healthcare facilities were randomly assigned 1:1 to choice architecture (intervention) or standard TPT prescribing (control). The aim was to link TPT to antiretroviral therapy (ART) prescribing and to make TPT prescribing the default. The intervention was supported by clinician training and a default prescribing module built into the point-of-care HIV electronic medical record in Malawi and stickers placed in clients’ clinical stationery in Mozambique and Zimbabwe. Data were collected in aggregate, and the primary outcome was the facility-level percentage of clients initiating ART who initiated TPT. The CAT study was registered with clinicaltrials.gov where it is listed as completed.Results: Implementation occurred from October 2021 to September 2022 in Mozambique (20 facilities), April 2021 to March 2022 in Malawi (19 facilities) and June 2021 to May 2022 in Zimbabwe (18 facilities), for a total of 29 control arm and 28 choice architecture intervention arm facilities, respectively. Comparing control to intervention facilities, mean TPT prescribing to clients initiating ART was 70.9% vs 86.9% in Mozambique (difference: −16.0%; 95% CI: −38.3%, 6.3%; p=0.15), 56.5% vs 55.5% in Malawi (difference: 1.0%; 95% CI: −14.0%, 16.9%; p=0.89) and 56.2% vs 55.9% in Zimbabwe (difference: 0.2%; 95% CI: −25.2%, 25.8%; p=0.98).Conclusion: The choice architecture intervention did not overcome barriers to TPT prescribing. While the intervention may have led to an improvement in TPT prescribing in Mozambique, no differences were observed in the other countries. Further innovation is needed to ensure that all clients initiating ART are either prescribed TPT or started on anti-TB treatment, as appropriate.Trial registration number: NCT04466293.

Background: Tuberculosis preventive treatment (TPT) is highly effective at preventing tuberculosis (TB) disease but is poorly implemented. We aimed to determine whether home-based contact management improves TPT uptake among close child contacts compared to the facility-based standard of care. Methods: We conducted a pragmatic cluster-randomized trial among close contacts of TB clients aged <15 years in 18 primary health facilities in Oromia, Ethiopia. Facilities were randomized 1:1 to home-based or facility-based contact management. The intervention was conducted by community health workers (CHWs) and task-shared with TB focal persons. The primary endpoint was the cluster-level ratio of the number of contacts aged <15 years initiated on TPT per TB client. Results: The cluster-level mean number of child contacts initiated on TPT per TB client was 40% higher in the home-based (1.7 contacts per TB client) versus facility-based arm (1.3 contacts per TB client; rate ratio 1.4, 95% confidence interval [CI]: .7–2.7). In the care continuum, assuming 2.1 children <15 years per household, 73% and 63% of children completed TPT in the 2 arms, respectively. One child failed TPT and 2 children discontinued TPT due to drug-related adverse reactions in the home-based and facility-based arms, respectively. Conclusions: Home-based contact management by CHWs increased the number of children initiated on TPT by 40% without negative effects on treatment outcomes. Though not statistically significant, on a larger scale, the increased number of children identified and initiated on TPT has the potential to substantially reduce the burden of pediatric TB in Ethiopia and elsewhere. Clinical Trials Registration: NCT04369326.