Search

ObjectiveWe examine the efficacy of short message service (SMS) and SMS with peer navigation (SMS + PN) in improving linkage to HIV care and initiation of antiretroviral therapy (ART).DesignI-Care was a cluster randomized trial conducted in primary care facilities in North West Province, South Africa. The primary study outcome was retention in HIV care; this analysis includes secondary outcomes: linkage to care and ART initiation.MethodsEighteen primary care clinics were randomized to automated SMS ( n  = 7), automated and tailored SMS + PN ( n  = 7), or standard of care (SOC; n  = 4). Recently HIV diagnosed adults ( n  = 752) were recruited from October 2014 to April 2015. Those not previously linked to care ( n  = 352) contributed data to this analysis. Data extracted from clinical records were used to assess the days that elapsed between diagnosis and linkage to care and ART initiation. Cox proportional hazards models and generalized estimating equations were employed to compare outcomes between trial arms, overall and stratified by sex and pregnancy status.ResultsOverall, SMS ( n  = 132) and SMS + PN ( n  = 133) participants linked at 1.28 [95% confidence interval (CI): 1.01-1.61] and 1.60 (95% CI: 1.29-1.99) times the rate of SOC participants ( n  = 87), respectively. SMS + PN significantly improved time to ART initiation among non-pregnant women (hazards ratio: 1.68; 95% CI: 1.25-2.25) and men (hazards ratio: 1.83; 95% CI: 1.03-3.26) as compared with SOC.ConclusionResults suggest SMS and peer navigation services significantly reduce time to linkage to HIV care in sub-Saharan Africa and that SMS + PN reduced time to ART initiation among men and non-pregnant women. Both should be considered candidates for integration into national programs.Trial registrationNCT02417233, registered 12 December 2014; closed to accrual 17 April 2015.

BackgroundIn 2020, the Health Resources and Services Administration's HIV/AIDS Bureau funded an initiative to promote implementation of rapid antiretroviral therapy initiation in 14 HIV treatment settings across the U.S. The goal of this initiative is to accelerate uptake of this evidence-based strategy and provide an implementation blueprint for other HIV care settings to reduce the time from HIV diagnosis to entry into care, for re-engagement in care for those out of care, initiation of treatment, and viral suppression. As part of the effort, an evaluation and technical assistance provider (ETAP) was funded to study implementation of the model in the 14 implementation sites.MethodThe ETAP has used implementation science methods framed by the Dynamic Capabilities Model integrated with the Conceptual Model of Implementation Research to develop a Hybrid Type II, multi-site mixed-methods evaluation, described in this paper. The results of the evaluation will describe strategies associated with uptake, implementation outcomes, and HIV-related health outcomes for patients.DiscussionThis approach will allow us to understand in detail the processes that sites to implement and integrate rapid initiation of antiretroviral therapy as standard of care as a means of achieving equity in HIV care.

Voluntary male medical circumcision (VMMC) reduces HIV acquisition by up to 60%. Kenya has successfully scaled up VMMC to an estimated 91% of eligible men and boys in certain regions in combination due to VMMC and cultural circumcisions. VMMC as a program is implemented regionally in traditionally non-circumcising counties where the prevalence is still below 91%, ranging from 56.4% to 66.7%. Given that funding toward VMMC is expected to decline in the coming years, it is important to identify what models of service delivery are most appropriate and efficient to sustainably meet the VMMC needs of new cohorts' eligible men. To this end, we compared the costs of facility-based VMMC and one within a rapid results initiative (RRI), a public health service scheduled during school holidays to perform many procedures over a short period. We employed activity-based micro-costing to estimate the costs, from the implementer perspective, of facility-based VMMC and RRI-based VMMC conducted between October 2017 and September 2018 at 41 sites in Kisumu County, Kenya supported by the Family AIDS care & Education Services (FACES). We conducted site visits and reviewed financial ledger and programmatic data to identify and quantify resources consumed and the number of VMMC procedures performed during routine care and RRIs. Ledger data were used to estimate fixed costs, recurring costs, and cost per circumcision (CPC) in United States dollar (USD). A sensitivity analysis was done to estimate CPC where we allocated 6 months of the ledger to facility-based and 6 months to RRI. Overall, FACES spent $3,092,891 toward VMMC services and performed 42,139 procedures during the funding year. This included $2,644,910 in stable programmatic costs, $139,786 procedure costs, and $308,195 for RRI-specific activities. Over the year, 49% (n = 20,625) of procedures were performed as part of routine care and 51% (n = 21,514) were performed during the RRIs. Procedures conducted during facility-based cost $99.35 per circumcision, those conducted during the RRIs cost $48.51 per circumcision, and according to our sensitivity analysis, CPC for facility-based ranges from $99.35 to $287.24 and for RRI costs ranged from $29.81 to $48.51. The cost of VMMC during the RRI was substantially lower than unit costs reported in previous costing studies. We conclude that circumcision campaigns, such as the RRI, offer an efficient and sustainable approach to VMMC.

IntroductionThere is a high burden of hypertension (HTN) among HIV-infected people in Uganda. However, capacity to prevent, diagnose and treat HTN is suboptimal. This study seeks to leverage the existing HIV-related infrastructure in primary care health facilities (HFs) using the integrated HIV/HTN care model to improve health outcomes of patients with HIV and HTN.Methods and analysisIntegrated HIV/HTN study a type-1 effectiveness/implementation cluster randomised trial, will evaluate the effectiveness of a multicomponent model intervention in 13 districts randomised to the intervention arm compared with 13 districts randomised to control. Two randomly selected HFs per district and their patients will be eligible to participate. The intervention will comprise training of primary healthcare (PHC) providers followed by regular supervision, integration of HTN care into HIV clinics, improvement of the health management information system, IT-based messaging to improve communication among frontline PHCs and district-level managers. HTN care guidelines, sphygmomanometers, patient registers and a buffer stock of essential drugs will be provided to HFs in both study arms. We will perform cross-sectional surveys at baseline, 12 and 24 months, on a random sample of patients attending HFs to measure effectiveness of the integrated care model between 2021 and 2024. We will perform in-depth interviews of providers, patients and healthcare managers to assess barriers and facilitators of integrated care. We will measure the cost of the intervention through microcosting and time-and-motion studies. The outcomes will be analysed taking the clustered structure of the data set into account.Ethics and disseminationEthics approval has been obtained from the Research Ethics Committees at London School of Hygiene and Tropical Medicine, and Makerere University School of Medicine. All participants will provide informed consent prior to study inclusion. Strict confidentiality will be applied throughout. Findings will be disseminated to public through meetings, and publications.Trial registration numberNCT04624061.

BackgroundDespite longstanding guidelines endorsing isoniazid preventive therapy (IPT) for people with HIV, uptake is low across sub-Saharan Africa. Mid-level health managers oversee IPT programmes nationally; interventions aimed at this group have not been tested. We aimed to establish whether providing structured leadership and management training and facilitating subregional collaboration and routine data feedback to mid-level managers could increase IPT initiation among people with HIV compared with standard practice.MethodsWe conducted a cluster randomised trial in Uganda among district-level health managers. We randomly assigned clusters of between four and seven managers in a 1:1 ratio to intervention or control groups. Our intervention convened managers into mini-collaboratives facilitated by Ugandan experts in tuberculosis and HIV, and provided business leadership and management training, SMS platform access, and data feedback. The control was standard practice. Participants were not masked to trial group, but study statisticians were masked until trial completion. The primary outcome was IPT initiation rates among adults with HIV in facilities overseen by participants over a period of 2 years (2019-21). We conducted prespecified analyses that excluded the third quarter of 2019 (Q3-2019) to understand intervention effects independent of a national 100-day IPT push tied to a financial contingency during Q3-2019. This trial is registered with ClinicalTrials.gov (NCT03315962), and is ongoing.FindingsBetween Nov 15, 2017, and March 14, 2018, managers from 82 of 82 eligible districts (61% of Uganda's 135 districts) were enrolled and randomised: 43 districts to intervention, 39 to control. Intervention delivery took place between Dec 6, 2017, and Feb 2, 2022. Over 2 years, IPT initiation rates were 0·74 versus 0·65 starts per person-year in intervention versus control groups (incidence rate ratio [IRR] 1·14, 95% CI 0·88-1·46; p=0·16). Excluding Q3-2019, IPT initiation was higher in the intervention group versus the control group: 0·32 versus 0·25 starts per person-year (IRR 1·27, 95% CI 1·00-1·61; p=0·026).InterpretationFollowing an intervention targeting managers in more than 60% of Uganda's districts, IPT initiation rates were not significantly higher in intervention than control groups. After accounting for large increases in IPT from a 100-day push in both groups, the intervention led to significantly increased IPT rates, sustained after the push and during the COVID-19 pandemic. Our findings suggest that interventions centred on mid-level health managers can improve IPT implementation on a large, subnational scale, and merit further exploration to address key public health challenges for which strong evidence exists but implementation remains suboptimal.FundingNational Institute of Allergy and Infectious Diseases.

Background: Cardiovascular disease (CVD) morbidity and mortality is increasing in Africa, largely due to undiagnosed and untreated hypertension. Approaches that leverage existing primary health systems could improve hypertension treatment and reduce CVD, but cost-effectiveness is unknown. We evaluated the cost-effectiveness of population-level hypertension screening and implementation of chronic care clinics across eastern, southern, central, and western Africa. Methods and findings: We conducted a modeling study to simulate hypertension and CVD across 3,000 scenarios representing a range of settings across eastern, southern, central, and western Africa. We evaluated 2 policies compared to current hypertension treatment: (1) expansion of HIV primary care clinics into chronic care clinics that provide hypertension treatment for all persons regardless of HIV status (chronic care clinic or CCC policy); and (2) CCC plus population-level hypertension screening of adults ≥40 years of age by community health workers (CHW policy). For our primary analysis, we used a cost-effectiveness threshold of US $500 per disability-adjusted life-year (DALY) averted, a 3% annual discount rate, and a 50-year time horizon. A strategy was considered cost-effective if it led to the lowest net DALYs, which is a measure of DALY burden that takes account of the DALY implications of the cost for a given cost-effectiveness threshold. Among adults 45 to 64 years, CCC implementation would improve population-level hypertension control (the proportion of people with hypertension whose blood pressure is controlled) from mean 4% (90% range 1% to 7%) to 14% (6% to 26%); additional CHW screening would improve control to 44% (35% to 54%). Among all adults, CCC implementation would reduce ischemic heart disease (IHD) incidence by 10% (3% to 17%), strokes by 13% (5% to 23%), and CVD mortality by 9% (3% to 15%). CCC plus CHW screening would reduce IHD by 28% (19% to 36%), strokes by 36% (25% to 47%), and CVD mortality by 25% (17% to 34%). CHW screening was cost-effective in 62% of scenarios, CCC in 31%, and neither policy was cost-effective in 7% of scenarios. Pooling across setting-scenarios, incremental cost-effectiveness ratios were $69/DALY averted for CCC and $389/DALY averted adding CHW screening to CCC. Conclusions: Leveraging existing healthcare infrastructure to implement population-level hypertension screening by CHWs and hypertension treatment through integrated chronic care clinics is expected to reduce CVD morbidity and mortality and is likely to be cost-effective in most settings across Africa. Matthew Hickey and colleagues report the results of a modelling study that indicates that leveraging existing healthcare infrastructure to implement population-level hypertension assessment and treatment could be cost effective. Author summary: Why was this study done?: Cardiovascular disease (CVD), such as heart attacks and strokes, are increasingly causing illness and death in Africa, mainly due to undiagnosed and untreated hypertension. Hypertension is currently treated primarily in specialized clinics; existing primary health systems, particularly those developed for HIV care, could potentially be used to treat hypertension more effectively. Prior research also demonstrates that community health workers can successfully conduct hypertension screening in the community, improving both diagnosis and linkage to care. This research aimed to determine whether integration of hypertension care within existing primary health systems with or without community health worker screening of all adults aged 40 or greater in the community for hypertension would be a worthwhile investment in Africa. What did the researchers do and find?: We incorporated hypertension and CVD into an existing individual-level HIV model and simulated hypertension and CVD outcomes across 3,000 scenarios in eastern, southern, central, and western Africa. We evaluated 2 policies compared to current standard hypertension care: expanding primary care clinics to include HIV and hypertension (chronic care clinic or CCC policy) and adding community health worker (CHW) screening for all adults over 40 years of age. For all adults, CCC would reduce heart attacks by 10%, strokes by 13%, and cardiovascular deaths by 9%, while adding CHW screening would reduce these by 28%, 36%, and 25%, respectively. CHW screening was cost-effective in 62% of scenarios, CCC in 31%, and neither policy was considered cost-effective in 7% of scenarios. What do these findings mean?: Using existing primary health care and community health worker infrastructure to screen and treat hypertension can significantly reduce illness and death from CVD in Africa. Implementing chronic care clinics and community health worker screenings for hypertension is likely to be cost-effective in most settings. These findings support policy changes to integrate hypertension management into existing primary health services to improve CVD prevention. Though we considered numerous factors in our model, findings are limited by uncertainty in model parameters, inability to include all potential policy alternatives, and uncertainty around how the current state of hypertension care will evolve in the future. [ABSTRACT FROM AUTHOR]

INTRODUCTION Transgender women (TW) are highly impacted by HIV worldwide and in the United States. Global HIV prevalence estimates among TW range from 19.9% to 40% [1, 2]. In the [...], : Introduction: Transgender women (TW) worldwide have a high prevalence of HIV, and TW with HIV encounter numerous healthcare barriers. It is critical to develop evidence‐informed interventions to improve their engagement in healthcare to achieve durable viral suppression (VS). We evaluated whether participation in one of nine interventions designed specifically for TW was associated with improved engagement in HIV care among transgender women of colour (TWC). Methods: Between 2013 and 2017, nine US organizations implemented nine distinct and innovative HIV care engagement interventions with diverse strategies, including: individual and group sessions, case management and navigation, outreach, drop‐in spaces, peer support and/or incentives to engage TWC with HIV in care. The organizations enrolled 858 TWC, conducted surveys, captured intervention exposure data and extracted medical record data. Our evaluation of the interventions employed a pre‐post design and examined four outcomes—any HIV care visit, antiretroviral therapy (ART) prescription, retention in HIV care and VS (both overall and among those with a clinic visit and viral load test), at baseline and every 6 months for 24 months. We employed logistic generalized estimating equations to assess the relative odds of each outcome at 12 and 24 months compared to baseline. Results: Overall, 79% of participants were exposed to at least one intervention activity. Over 24 months of follow‐up, participants received services for a median of over 6 hours (range: 3–69 hours/participant). Compared to baseline, significantly (p Conclusions: These evaluation results illustrate promising approaches to improve engagement in HIV care and VS among TWC with HIV. Continued development, adaptation and scale‐up of culturally tailored HIV care interventions for this key population are necessary to meet the UNAIDS 95‐95‐95 goals.

This article discusses the implementation of a diversity, equity, and inclusion (DEI) curriculum for health research professionals at a large academic research institution. The curriculum consisted of four workshops aimed at increasing knowledge of core DEI concepts and improving skills for inclusive behaviors. Attendees showed increased DEI knowledge and perceived skills throughout the sessions. The curriculum was developed based on a needs assessment survey and feedback from department members. The workshops focused on topics such as unconscious bias, cultural humility, microaggressions, and allyship. The article emphasizes the importance of diversity and inclusion in the fields of public health and health sciences. [Extracted from the article]

Pediatric HIV remains a significant global concern, with 160,000 new infections annually. Accelerating Children's HIV/AIDS Treatment (ACT) provided a strategic response to the "treatment gap" for children. We examined whether activities under ACT increased testing and identification of youth living with HIV (YLWH). Family AIDS Care & Education Services implemented ACT across 130 health facilities in western Kenya between October 2015 and September 2016, providing: HIV-testing counselors and space; training on the Family Information Table (FIT) and chart audits; community outreach testing; and text message reminders for pregnant women. We analyzed the number of youths tested and identified with HIV over time and between intervention and control sites using interrupted time series analysis. We tested 268,312 youths (7,183 infants <18 months; 145,833 children 18 months to 9 years; and 115,296 adolescents 10–14 years). Mean monthly number tested per health facility increased from 2.8 to 7.2 (p < 0.0001) in infants, 44.8–142.0 (p < 0.0001) in children, and 30.1–123.3 (p < 0.0001) in adolescents. Mean monthly number identified with HIV per facility increased from 0.06 to 0.37 (p < 0.0001) in infants; 0.34–0.62 (p = 0.008) in children; and 0.17–0.26 (p = 0.04) in adolescents, resulting in 1,328 diagnoses. Among infants, FIT training was associated with increased HIV testing over time, incidence rate ratio (IRR) = 3.85 (95% confidence interval [CI] 2.16-6.84; p < 0.0001). Text messaging increased testing, IRR = 2.10 (95% CI 1.57-2.80; p < 0.0001) and identification of HIV in infants, IRR = 1.83 (95% CI 1.06-3.18; p = 0.0381) and older children, IRR = 2.25 (95% CI 1.62, 3.13; p < 0.0001). Chart audits increased testing over time among adolescents (IRR = 2.11; 95% CI 1.21-3.66; p = 0.0082). Outreach was associated with identification of adolescents with HIV, IRR = 1.58 (95% CI 1.22-2.06; p = 0.0005). In lower-income settings, targeted interventions effective at reaching YLWH can help optimize resource allocation to address gaps in testing and identification to further reduce HIV-related morbidity and mortality. [ABSTRACT FROM AUTHOR]

There is lack of clarity regarding the impact of and optimal clinical response to stimulant use among people prescribed long-term opioid therapy (LTOT) for pain. To determine if a positive urine drug test (UDT) for stimulants was associated with subsequent opioid-related harm or discontinuation of LTOT. Retrospective cohort study. People living with and without HIV living in a major metropolitan area with public insurance, prescribed LTOT for chronic, non-cancer pain (n=600). UDT results from January 2012 to June 2019 were evaluated against 1) opioid-related emergency department (ED) visits (oversedation, constipation, infections associated with injecting opioids, and opioid seeking) or death in each 90-day period following a UDT, using logistic regression, and 2) LTOT discontinuation. There were no opioid overdose deaths within 90 days following a stimulant-positive UDT. A stimulant-positive UDT was not statistically significantly associated with opioid-related ED visits within 90 days (adjusted odds ratio [aOR] 1.39; 95% CI=0.88–2.21). Stimulant-positive UDT was independently associated with subsequent discontinuation of LTOT within 90 days (aOR 2.96; 95% CI=2.13 – 4.12). Living with HIV was independently associated with decreased odds of LTOT discontinuation (aOR 0.65; 95% CI 0.43 – 0.99). Despite no association between a stimulant-positive UDT and subsequent opioid-related harm, there was an association with subsequent LTOT discontinuation, with heterogeneity across clinical groups. Detection of stimulant use should result in a discussion of substance use and risk, rather than reflex LTOT discontinuation. • Odds of opioid-related harm among those with stimulant-positive urine tests while on long-term opioid therapy is unknown. • Stimulant-positive UDT was not statistically significantly associated with opioid-related ED visits or death within 90 days. • Results suggest that stimulant-positive UDT should trigger an LTOT discussion, not reflex discontinuation as was observed. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular disease (CVD) morbidity and mortality is increasing in Africa, largely due to undiagnosed and untreated hypertension. Approaches that leverage existing primary health systems could improve hypertension treatment and reduce CVD, but cost-effectiveness is unknown. We evaluated the cost-effectiveness of population-level hypertension screening and implementation of chronic care clinics across eastern, southern, central, and western Africa., Methods and Findings: We conducted a modelling study to simulate hypertension and CVD across 3000 scenarios representing a range of settings across eastern, southern, central, and western Africa. We evaluated two policies compared to current hypertension treatment: 1) expansion of HIV primary care clinics into chronic care clinics that provide hypertension treatment for all persons regardless of HIV status (chronic care clinic or CCC policy), and 2) CCC plus population-level hypertension screening of adults ≥40 years by community health workers (CHW policy). For our primary analysis, we used a cost-effectiveness threshold of US $500 per disability-adjusted life-year (DALY) averted, a 3% annual discount rate, and a 50-year time horizon. A strategy was considered cost-effective if it led to the lowest net DALYs, which is a measure of DALY burden that takes account of the DALY implications of the cost for a given cost-effectiveness threshold.Among adults 45-64 years, CCC implementation would improve population-level hypertension control (the proportion of people with hypertension whose blood pressure is controlled) from mean 4% (90% range 1-7%) to 14% (6-26%); additional CHW screening would improve control to 44% (35-54%). Among all adults, CCC implementation would reduce ischemic heart disease (IHD) incidence by 10% (3-17%), strokes by 13% (5-23%), and CVD mortality by 9% (3-15%). CCC plus CHW screening would reduce IHD by 28% (19-36%), strokes by 36% (25-47%), and CVD mortality by 25% (17-34%). CHW screening was cost-effective in 62% of scenarios, CCC in 31%, and neither policy was cost-effective in 7% of scenarios. Pooling across setting-scenarios, incremental cost-effectiveness ratios were $69/DALY averted for CCC and $389/DALY averted adding CHW screening to CCC., Conclusions: Leveraging existing healthcare infrastructure to implement population-level hypertension screening by CHWs and hypertension treatment through integrated chronic care clinics is expected to reduce CVD morbidity and mortality and is likely to be cost-effective in most settings across Africa., Funding: National Institutes of Health (K23HL162578, U01-AI150510).

Introduction: Large proportions of people living with HIV (PLHIV) in sub-Saharan Africa are not linked to or retained in HIV care. There is a critical need for cost-effective interventions to improve engagement and retention in care and inform optimal allocation of resources., Methods: We estimated costs associated with a short message service (SMS) plus peer navigation (SMS+PN) intervention; an SMS-only intervention; and standard of care (SOC), within the I-Care cluster-randomized trial to improve HIV care engagement for recently diagnosed PLHIV. We employed a uniform cost data-collection protocol to quantify resources used and associated costs for each intervention., Results: Compared with SOC, the SMS+PN intervention cost $1284 ($828-$2859) more per additional patient linked to care within 30 days and $1904 ($1158-$5343) more per additional patient retained in care at 12 months, while improving linkage by 24% (95% CI: 11 to 36) and retention by 16% (95% CI: 6 to 26). By contrast, the SMS-only intervention cost $198 ($93-dominated) more per additional patient linked to care and $697 ($171-dominated) more per additional patient retained in care but was not significantly associated with improvements in linkage (12%; 95% CI: -1 to 25) or retention (3%; 95% CI: -7 to 14) compared with SOC. The efficiency of the SMS+PN intervention could be improved by 46%, to $690 more per additional patient linked and $1023 more per additional patient retained in care, if implemented within the Department of Health using more efficient distribution of staff resources., Discussion: Findings suggest that scale-up of the SMS+PN intervention could benefit patients, improving care and health outcomes while being cost-effective., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Despite advances in incorporating diversity and structural competency into medical education curriculum, there is limited curriculum for public health research professionals. We developed and implemented a four-part diversity, equity, and inclusion (DEI) training series tailored for academic health research professionals to increase foundational knowledge of core diversity concepts and improve skills., Methods: We analyzed close- and open-ended attendee survey data to evaluate within- and between-session changes in DEI knowledge and perceived skills., Results: Over the four sessions, workshop attendance ranged from 45 to 82 attendees from our 250-person academic department and represented a mix of staff (64%), faculty (25%), and trainees (11%). Most identified as female (74%), 28% as a member of an underrepresented racial and ethnic minority (URM) group, and 17% as LGBTQI. During all four sessions, attendees increased their level of DEI knowledge, and within sessions two through four, attendees' perception of DEI skills increased. We observed increased situational DEI awareness as higher proportions of attendees noted disparities in mentoring and opportunities for advancement/promotion. An increase in a perceived lack of DEI in the workplace as a problem was observed; but only statistically significant among URM attendees., Discussion: Developing applied curricula yielded measurable improvements in knowledge and skills for a diverse health research department of faculty, staff, and students. Nesting this training within a more extensive program of departmental activities to improve climate and address systematic exclusion likely contributed to the series' success. Additional research is underway to understand the series' longer-term impact on applying skills for behavior change., Competing Interests: The authors have nothing to declare., (© The Author(s) 2024.)

Background: Long-acting injectable cabotegravir (CAB-LA) for preexposure prophylaxis (PrEP) has proven efficacious in randomized controlled trials. Further research is critical to evaluate its effectiveness in real-world settings and identify effective implementation approaches, especially among young sexual and gender minorities (SGMs)., Objective: ImPrEP CAB Brasil is an implementation study aiming to generate critical evidence on the feasibility, acceptability, and effectiveness of incorporating CAB-LA into the existing public health oral PrEP services in 6 Brazilian cities. It will also evaluate a mobile health (mHealth) education and decision support tool, digital injection appointment reminders, and the facilitators of and barriers to integrating CAB-LA into the existing services., Methods: This type-2 hybrid implementation-effectiveness study includes formative work, qualitative assessments, and clinical steps 1 to 4. For formative work, we will use participatory design methods to develop an initial CAB-LA implementation package and process mapping at each site to facilitate optimal client flow. SGMs aged 18 to 30 years arriving at a study clinic interested in PrEP (naive) will be invited for step 1. Individuals who tested HIV negative will receive mHealth intervention and standard of care (SOC) counseling or SOC for PrEP choice (oral or CAB-LA). Participants interested in CAB-LA will be invited for step 2, and those with undetectable HIV viral load will receive same-day CAB-LA injection and will be randomized to receive digital appointment reminders or SOC. Clinical appointments and CAB-LA injection are scheduled after 1 month and every 2 months thereafter (25-month follow-up). Participants will be invited to a 1-year follow-up to step 3 if they decide to change to oral PrEP or discontinue CAB-LA and to step 4 if diagnosed with HIV during the study. Outcomes of interest include PrEP acceptability, choice, effectiveness, implementation, and feasibility. HIV incidence in the CAB-LA cohort (n=1200) will be compared with that in a similar oral PrEP cohort from the public health system. The effectiveness of the mHealth and digital interventions will be assessed using interrupted time series analysis and logistic mixed models, respectively., Results: During the third and fourth quarters of 2022, we obtained regulatory approvals; programmed data entry and management systems; trained sites; and performed community consultancy and formative work. Study enrollment is programmed for the second quarter of 2023., Conclusions: ImPrEP CAB Brasil is the first study to evaluate CAB-LA PrEP implementation in Latin America, one of the regions where PrEP scale-up is most needed. This study will be fundamental to designing programmatic strategies for implementing and scaling up feasible, equitable, cost-effective, sustainable, and comprehensive alternatives for PrEP programs. It will also contribute to maximizing the impact of a public health approach to reducing HIV incidence among SGMs in Brazil and other countries in the Global South., Trial Registration: Clinicaltrials.gov NCT05515770; https://clinicaltrials.gov/ct2/show/NCT05515770., International Registered Report Identifier (irrid): PRR1-10.2196/44961., (©Beatriz Grinsztejn, Thiago Silva Torres, Brenda Hoagland, Emilia Moreira Jalil, Ronaldo Ismerio Moreira, Gabrielle O'Malley, Starley B Shade, Marcos R Benedetti, Julio Moreira, Keila Simpson, Maria Cristina Pimenta, Valdiléa Gonçalves Veloso, The ImPrEP CAB-Brasil Study Team. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 19.04.2023.)