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© 2015 Elsevier Ltd. All rights reserved.BACKGROUND: Concerns have been raised about efavirenz reducing the effectiveness of contraceptive implants. We aimed to establish whether pregnancy rates differ between HIV-positive women who use various contracepti

The Mpumalanga Men's Study (MPMS) is the assessment of the Project Boithato HIV prevention intervention for South African MSM. Boithato aims to increase consistent condom use, regular testing for HIV-negative MSM, and linkage to care for HIV-positive MSM.

SettingAntiretroviral therapy (ART) reduces pulmonary tuberculosis (PTB) in human immunodeficiency virus (HIV) infected children. Recent ART recommendations have increased the number of children on ART.ObjectiveTo determine the prevalence and incidence of TB in HIV-infected children after the implementation of expanded ART guidelines.DesignA prospective cohort study including HIV-infected children aged 6 weeks to 14 years was conducted in Kenya. The primary outcome measure was clinically diagnosed TB. Study participants were screened for prevalent TB at enrollment using Kenya's national guidelines and followed at monthly intervals to detect incident TB. Predictors of TB were assessed using logistic regression and Cox proportional hazards regression.ResultsOf 689 participants (median age 6.4 years), 509 (73.9%) were on ART at baseline. There were 51 cases of prevalent TB (7.4%) and 10 incident cases, with over 720.3 child-years of observation (incidence 1.4 per 100 child-years). Months on ART (adjusted hazard ratio [aHR] 0.91, P = 0.003; aOR 0.91, P< 0.001) and months in care before ART (aHR 0.87, P= 0.001; aOR 0.92, P < 0.001) were protective against incident and prevalent TB.ConclusionsART was protective against TB in this cohort of HIV-infected children with high levels of ART use. Optimal TB prevention strategies should emphasize early ART in children.

Background: Despite strong evidence for the effectiveness of anti-retroviral therapy for improving the health of women living with HIV and for the prevention of mother-to-child transmission (PMTCT), HIV persists as a major maternal and child health problem

HIV-seropositive, active injection-drug users (IDUs), compared with other HIV populations, continue to have low rates of highly active antiretroviral therapy (HAART) use, contributing to disparities in their HIV health outcomes. We sought to identify individual-level, interpersonal, and structural factors associated with HAART use among active IDUs to inform comprehensive, contextually tailored intervention to improve the HAART use of IDUs. Prospective data from three semiannual assessments were combined, and logistic general estimating equations were used to identify variables associated with taking HAART 6 months later. Participants were a community sample of HIV-seropositive, active IDUs enrolled in the INSPIRE study, a U.S. multisite (Baltimore, Miami, New York, San Francisco) prevention intervention. The analytic sample included 1,225 observations, and comprised 62% males, 75% active drug users, 75% non-Hispanic blacks, and 55% with a CD4 count <350; 48% reported HAART use. Adjusted analyses indicated that the later HAART use of IDUs was independently predicted by patient-provider engagement, stable housing, medical coverage, and more HIV primary care visits. Significant individual factors included not currently using drugs and a positive attitude about HAART benefits even if using illicit drugs. Those who reported patient-centered interactions with their HIV primary care provider had a 45% greater odds of later HAART use, and those with stable housing had twofold greater odds. These findings suggest that interventions to improve the HIV treatment of IDUs and to reduce their HIV health disparities should be comprehensive, promoting better patient-provider engagement, stable housing, HAART education with regard to illicit drug use, and integration of drug-abuse treatment with HIV primary care. [ABSTRACT FROM AUTHOR]

OBJECTIVES: For HIV-positive injection drug users (IDUs), access to appropriate HIV care is crucial. Providing care for HIV-positive IDUs, however, is often demanding and can be problematic. The health care needs and experiences of IDUs have often been overlooked when efforts to improve HIV care are addressed. METHODS: This study examined health care experiences in a sample of HIV-positive IDUs. A qualitative study of 161 sexually active and currently injecting HIV-positive IDUs from two urban areas was conducted to understand how HIV had affected their lives. Interview data were analyzed using a content analysis approach. RESULTS: Participants' experiences included interactions with health care providers that were both negative and positive experiences. Some HIV-positive IDUs left care because of unfair and discriminatory treatment from providers. CONCLUSIONS: Increasing understanding among providers working with different populations of HIV-positive individuals may positively influence clinical practice and improve the quality of health care for HIV-positive IDU. [ABSTRACT FROM AUTHOR]

Background: Cannabinoid use could potentially alter HIV RNA levels by two mechanisms: immune modulation or cannabinoid-protease inhibitor interactions (because both share cytochrome P-450 metabolic pathways).Objective: To determine the short-term effects of smoked marijuana on the viral load in HIV-infected patients.Design: Randomized, placebo-controlled, 21-day intervention trial.Setting: The inpatient General Clinical Research Center at the San Francisco General Hospital, San Francisco, California.Participants: 67 patients with HIV-1 infection.Intervention: Participants were randomly assigned to a 3.95%-tetrahydrocannabinol marijuana cigarette, a 2.5-mg dronabinol (delta-9-tetrahydrocannabinol) capsule, or a placebo capsule three times daily before meals.Measurements: HIV RNA levels, CD4+ and CD8+ cell subsets, and pharmacokinetic analyses of the protease inhibitors.Results: 62 study participants were eligible for the primary end point (marijuana group, 20 patients; dronabinol group, 22 patients; and placebo group, 20 patients). Baseline HIV RNA level was less than 50 copies/mL for 36 participants (58%), and the median CD4+ cell count was 340 x 109 cells/L. When adjusted for baseline variables, the estimated average effect versus placebo on change in log10 viral load from baseline to day 21 was -0.07 (95% CI, -0.30 to 0.13) for marijuana and -0.04 (CI, -0.20 to 0.14) for dronabinol. The adjusted average changes in viral load in marijuana and dronabinol relative to placebo were -15% (CI, -50% to 34%) and -8% (CI, -37% to 37%), respectively. Neither CD4+ nor CD8+ cell counts appeared to be adversely affected by the cannabinoids.Conclusions: Smoked and oral cannabinoids did not seem to be unsafe in people with HIV infection with respect to HIV RNA levels, CD4+ and CD8+ cell counts, or protease inhibitor levels over a 21-day treatment. [ABSTRACT FROM AUTHOR]

Cannabinoids, including smoked marijuana and delta9-tetrahydrocannabinol (THC) (dronabinol, Marinol), have been used to treat human immunodeficiency virus-1 (HIV)-associated anorexia and weight loss. Concerns have been raised, however, that these compounds might have adverse effects on the immune system of subjects with HIV infection. To determine whether such effects occur, the authors designed a randomized, prospective, controlled trial comparing the use of marijuana cigarettes (3.95% THC), dronabinol (2.5 mg), and oral placebo in HIV-infected adults taking protease inhibitor-containing highly active antiretroviral therapy (HAART). Assays of immune phenotype (including flow cytometric quantitation of T cell subpopulations, B cells, and natural killer [NK] cells) and immunefunction (including assays for induced cytokine production, NK cell function, and lymphoproliferation) were performed at baseline and weekly thereafter. On the basis of these measurements and during this short 21-day study period, few statistically significant effects were noted on immune system phenotypes orfunctions in this patient population. [ABSTRACT FROM AUTHOR]

Background: Across sub-Saharan Africa, mid-level healthcare managers oversee implementation of national guidelines. It remains unclear whether leadership and management training can improve population health outcomes., Methods: We sought to evaluate leadership/management skills among district-level health managers in Uganda participating in the SEARCH-IPT randomised trial to promote isoniazid preventive therapy (IPT) for persons with HIV (PWH). The intervention, which led to higher IPT rates, included annual leadership/management training of managers. We conducted a cross-sectional survey assessing leadership/management skills among managers at trial completion. The survey evaluated self-reported use of leadership/management tools and general leadership/management. We conducted a survey among a sample of providers to understand the intervention's impact. Targeted minimum loss-based estimation (TMLE) was used to compare responses between trial arms., Results: Of 163 managers participating in the SEARCH-IPT trial, 119 (73%) completed the survey. Intervention managers reported more frequent use of leadership/management tools taught in the intervention curriculum than control managers (+3.64, 95% CI 1.98-5.30, P < 0.001). There were no significant differences in self-reported leadership skills in the intervention as compared to the control group. Among providers, the average reported quality of guidance and supervision was significantly higher in intervention vs control districts (+1.08, 95% CI 0.63-1.53, P = 0.001)., Conclusions: A leadership and management training intervention increased the use of leadership/management tools among mid-level managers and resulted in higher perceived quality of supervision among providers in intervention vs control districts in Uganda. These findings suggest improved leadership/management among managers contributed to increased IPT use among PWH in the intervention districts of the SEARCH-IPT trial., (© 2024 The Authors.)

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.)

Background: Isoniazid preventive therapy (IPT) works to prevent tuberculosis (TB) among people living with HIV (PLHIV), but uptake remains low in Sub-Saharan Africa. In this analysis, we sought to identify barriers mid-level managers face in scaling IPT in Uganda and the mechanisms by which the SEARCH-IPT trial intervention influenced their abilities to increase IPT uptake., Methods: The SEARCH-IPT study was a cluster randomized trial conducted from 2017-2021. The SEARCH-IPT intervention created collaborative groups of district health managers, facilitated by local HIV and TB experts, and provided leadership and management training over 3-years to increase IPT uptake in Uganda. In this qualitative study we analyzed transcripts of annual Focus Group Discussions and Key Informant Interviews, from a subset of SEARCH-IPT participants from intervention and control groups, and participant observation field notes. We conducted the analysis using inductive and deductive coding (with a priori codes and those derived from analysis) and a framework approach for data synthesis., Results: When discussing factors that enabled positive outcomes, intervention managers described feeling ownership over interventions, supported by the leadership and management training they received in the SEARCH-IPT study, and the importance of collaboration between districts facilitated by the intervention. In contrast, when discussing factors that impeded their ability to make changes, intervention and control managers described external funders setting agendas, lack of collaboration in meetings that operated with more of a 'top-down' approach, inadequate supplies and staffing, and lack of motivation among frontline providers. Intervention group managers mentioned redistribution of available stock within districts as well as between districts, reflecting efforts of the SEARCH-IPT intervention to promote between-district collaboration, whereas control group managers mentioned redistribution within their districts to maximize the use of available IPT stock., Conclusions: In Uganda, mid-level managers' perceptions of barriers to scaling IPT included limited power to set agendas and control over funding, inadequate resources, lack of motivation of frontline providers, and lack of political prioritization. We found that the SEARCH-IPT intervention supported managers to design and implement strategies to improve IPT uptake and collaborate between districts. This may have contributed to the overall intervention effect in increasing the uptake of IPT among PLHIV compared to standard practice., Trial Registration: ClinicalTrials.gov, NCT03315962 , Registered 20 October 2017., (© 2024. The Author(s).)

Background: 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., Objective: To determine if a positive urine drug test (UDT) for stimulants was associated with subsequent opioid-related harm or discontinuation of LTOT., Design: Retrospective cohort study., Patients: People living with and without HIV living in a major metropolitan area with public insurance, prescribed LTOT for chronic, non-cancer pain (n=600)., Main Measures: 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., Results: 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)., Conclusions: 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., Competing Interests: Declaration of Competing Interest None of the authors have conflicts of interest to declare related to this work., (Copyright © 2023. Published by Elsevier B.V.)

Objective: HIV prevention service delivery models that offer product choices, and the option to change preferences over time, may increase prevention coverage. Outpatient departments in sub-Saharan Africa diagnose a high proportion of new HIV infections, but are an understudied entry point to biomedical prevention., Design: Individually randomized trial of dynamic choice HIV prevention (DCP) intervention vs. standard-of-care (SOC) among individuals with current/anticipated HIV exposure risk at outpatient departments in rural Kenya and Uganda (SEARCH; NCT04810650)., Methods: Our DCP intervention included 1) product choice (oral preexposure prophylaxis [PrEP] or postexposure prophylaxis [PEP]) with an option to switch over time, 2) HIV provider- or self-testing, 3) service location choice (community vs. clinic-based), and 4) provider training on patient-centered care. Primary outcome was proportion of follow-up covered by PrEP/PEP over 48 weeks assessed via self-report., Results: We enrolled 403 participants (61% women; median 27 years, IQR 22-37). In the DCP arm, 86% ever chose PrEP, 15% ever chose PEP over 48 weeks; selection of HIV self-testing increased from 26 to 51% and of out-of-facility visits from 8 to 52%. Among 376 of 403 (93%) with outcomes ascertained, time covered by PrEP/PEP was higher in DCP (47.5%) vs. SOC (18.3%); difference = 29.2% (95% confidence interval: 22.7-35.7; P  < 0.001). Effects were similar among women and men (28.2 and 31.0% higher coverage in DCP, respectively) and larger during periods of self-reported HIV risk (DCP 64.9% vs. SOC 26.3%; difference = 38.6%; 95% confidence interval: 31.0-46.2; P  < 0.001)., Conclusion: A dynamic choice HIV prevention intervention resulted in two-fold greater time covered by biomedical prevention products compared to SOC in general outpatient departments in eastern Africa., (Copyright © 2023 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.)

Mobile crisis services for people experiencing distress related to mental health or substance use are expanding rapidly across the US, yet there is little evidence to support these specific models of care. These new programs present a unique opportunity to expand the literature by utilizing implementation science methods to inform the future design of crisis systems. This mixed methods study will examine the effectiveness and acceptability of the Street Crisis Response Team (SCRT), a new 911-dispatched multidisciplinary mobile crisis intervention piloted in San Francisco, California. First, using quantitative data from electronic health records, we will conduct an interrupted time series analysis to quantitatively examine the impacts of the SCRT on people experiencing homelessness who utilized public behavioral health crisis services in San Francisco between November 2019 and August 2022, across four main outcomes within 30 days of the crisis episode: routine care utilization, crisis care reutilization, assessment for housing services, and jail entry. Second, to understand its impact on health equity, we will analyze racial and ethnic disparities in these outcomes prior to and after implementation of the SCRT. For the qualitative component, we will conduct semi-structured interviews with recipients of the SCRT's services to understand their experiences of the intervention and to identify how the SCRT influenced their health-related trajectories after the crisis encounter. Once complete, the quantitative and qualitative findings will be further analyzed in tandem to assist with more nuanced understanding of the effectiveness of the SCRT program. This evaluation of a novel mobile crisis response program will advance the field, while also providing a model for how real-world program implementation can be achieved in crisis service settings., Competing Interests: Dr. Goldman is a paid research consultant for Vibrant Emotional Health, the National Council for Mental Wellbeing, Peg’s Foundation, the University of California, Davis, and the Research Foundation for Mental Hygiene, Inc. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Background: Economic inequity systematically affects Black emerging adults (BEA), aged 18-24, and their healthy trajectory into adulthood. Guaranteed income (GI)-temporary, unconditional cash payments-is gaining traction as a policy solution to address the inequitable distribution of resources sewn by decades of structural racism and disinvestment. GI provides recipients with security, time, and support to enable their transition into adulthood and shows promise for improving mental and physical health outcomes. To date, few GI pilots have targeted emerging adults. The BEEM trial seeks to determine whether providing GI to BEA improves financial wellbeing, mental and physical health as a means to address health disparities., Methods/design: Using a randomized controlled crossover trial design, 300 low-income BEA from San Francisco and Oakland, California, are randomized to receive a $500/month GI either during the first 12-months of follow-up (Phase I) or during the second 12-months of a total of 24-months follow-up (Phase II). All participants are offered enrollment in optional peer discussion groups and financial mentoring to bolster financial capability. Primary intention-to-treat analyzes will evaluate the impact of GI at 12 months among Phase I GI recipients compared to waitlist arm participants using Generalized Estimating Equations (GEE). Primary outcomes include: (a) financial well-being (investing in education/training); (b) mental health status (depressive symptoms); and (c) unmet need for mental health and sexual and reproductive health services. Secondary analyzes will examine effects of optional financial capability components using GEE with causal inference methods to adjust for differences across sub-strata. We will also explore the degree to which GI impacts dissipate after payments end. Study outcomes will be collected via surveys every 3 months throughout the study. A nested longitudinal qualitative cohort of 36 participants will further clarify how GI impacts these outcomes. We also discuss how anti-racism praxis guided the intervention design, evaluation design, and implementation., Discussion: Findings will provide the first experimental evidence of whether targeted GI paired with complementary financial programming improves the financial well-being, mental health, and unmet health service needs of urban BEA. Results will contribute timely evidence for utilizing GI as a policy tool to reduce health disparities., Clinical Trial Registration: https://clinicaltrials.gov, identifier NCT05609188., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Lippman, Libby, Nakphong, Arons, Balanoff, Mocello, Arnold, Shade, Qurashi, Downing, Moore, Dow and Lightfoot.)

Low-cost interventions are needed to reduce alcohol use among persons with HIV (PWH) in low-income settings. Brief alcohol interventions hold promise, and technology may efficiently deliver brief intervention components with high frequency. We conducted a costing study of the components of a randomized trial that compared a counselling-based intervention with two in-person one-on-one sessions supplemented by booster sessions to reinforce the intervention among PWH with unhealthy alcohol use in southwest Uganda. Booster sessions were delivered twice weekly by two-way short message service (SMS) or Interactive Voice Response (IVR), i.e. via technology, or approximately monthly via live calls from counsellors. We found no significant intervention effects compared to the control, however the cost of the types of booster sessions differed. Start up and recurring costs for the technology-delivered booster sessions were 2.5 to 3 times the cost per participant of the live-call delivered booster intervention for 1000 participants. These results suggest technology-based interventions for PWH are unlikely to be lower cost than person-delivered interventions unless they are at very large scale., (© 2023. The Author(s).)

Background: Social and cognitive developmental events can disrupt care and medication adherence among adolescents and young adults living with HIV in sub-Saharan Africa. We hypothesised that a dynamic multilevel health system intervention helping adolescents and young adults and their providers navigate life-stage related events would increase virological suppression compared with standard care., Methods: We did a cluster randomised, open-label trial of young individuals aged 15-24 years with HIV and receiving care in eligible clinics (operated by the government and with ≥25 young people receiving care) in rural Kenya and Uganda. After clinic randomisation stratified by region, patient population, and previous participation in the SEARCH trial, participants in intervention clinics received life-stage-based assessment at routine visits, flexible clinic access, and rapid viral load feedback. Providers had a secure mobile platform for interprovider consultation. The control clinics followed standard practice. The primary, prespecified endpoint was virological suppression (HIV RNA <400 copies per mL) at 2 years of follow-up among participants who enrolled before Dec 1, 2019, and received care at the study clinics. This trial is registered with ClinicalTrials.gov, NCT03848728, and is closed to recruitment., Findings: 28 clinics were enrolled and randomly assigned (14 control, 14 intervention) in January, 2019. Between March 14, 2019, and Nov 26, 2020, we recruited 1988 participants at the clinics, of whom 1549 were included in the analysis (785 at intervention clinics and 764 at control clinics). The median participant age was 21 years (IQR 19-23) and 1248 (80·6%) of 1549 participants were female. The mean proportion of participants with virological suppression at 2 years was 88% (95% CI 85-92) for participants in intervention clinics and 80% (77-84) for participants in control clinics, equivalent to a 10% beneficial effect of the intervention (risk ratio [RR] 1·10, 95% CI 1·03-1·16; p=0·0019). The intervention resulted in increased virological suppression within all subgroups of sex, age, and care status at baseline, with greatest improvement among those re-engaging in care (RR 1·60, 95% CI 1·00-2·55; p=0·025)., Interpretation: Routine and systematic life-stage-based assessment, prompt adherence support with rapid viral load testing, and patient-centred, flexible clinic access could help bring adolescents and young adults living with HIV closer towards a goal of universal virological suppression., Funding: Eunice Kennedy Shriver National Institute of Child Health and Human Development, US National Institutes of Health., Competing Interests: Declaration of interests DH has received research grants from the National Institutes of Health, and non-financial support from Gilead and AbbVie, all via her institution. EC has received payments for consultation on unrelated studies of HIV and hypertension from the Infectious Diseases Research Collaboration in Uganda. All other authors declare no competing interests., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: In 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., Method: The 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., Discussion: This 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., (© 2023. The Author(s).)

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.)

Background: Adolescents and young adults living with HIV (AYAH) aged 14-24 years in Africa experience substantially higher rates of virological failure and HIV-related mortality than adults. We propose to utilize developmentally appropriate interventions with high potential for effectiveness, tailored by AYAH pre-implementation, in a sequential multiple assignment randomized trial (SMART) aimed at improving viral suppression for AYAH in Kenya., Methods: Using a SMART design, we will randomize 880 AYAH in Kisumu, Kenya to either youth-centered education and counseling (standard of care) or electronic peer navigation in which a peer provides support, information, and counseling via phone and automated monthly text messages. Those with a lapse in engagement (defined as either a missed clinic visit by ≥14 days or HIV viral load ≥1000 copies/ml) will be randomized a second time to one of three higher-intensity re-engagement interventions: This study will evaluate which interventions and which dynamic sequence of interventions improve sustained viral suppression and HIV care engagement in AYAH at 24 months post-enrollment and assess the cost-effectiveness of successful strategies., Discussion: The study utilizes promising interventions tailored to AYAH while optimizing resources by intensifying services only for those AYAH who need more support. Findings from this innovative study will offer evidence for public health programming to end the HIV epidemic as a public health threat for AYAH in Africa., Trial Registration: Clinicaltrials.govNCT04432571, registered June 16, 2020., Competing Interests: Declaration of Competing Interest The authors declare that they have no competing interests., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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

Objective: We 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)., Design: I-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., Methods: Eighteen 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., Results: Overall, 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., Conclusion: Results 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 Registration: NCT02417233, registered 12 December 2014; closed to accrual 17 April 2015., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Introduction: Continuity of care is an attribute of high-quality health systems and a necessary component of chronic disease management. Assessment of health information systems for HIV care in South Africa has identified substantial rates of clinic transfer, much of it undocumented. Understanding the reasons for changing sources of care and the implications for patient outcomes is important in informing policy responses., Methods: In this secondary analysis of the 2014 - 2016 I-Care trial, we examined self-reported changes in source of HIV care among a cohort of individuals living with HIV and in care in North West Province, South Africa. Individuals were enrolled in the study within 1 year of diagnosis; participants completed surveys at 6 and 12 months including items on sources of care. Clinical data were extracted from records at participants' original clinic for 12 months following enrollment. We assessed frequency and reason for changing clinics and compared the demographics and care outcomes of those changing and not changing source of care., Results: Six hundred seventy-five (89.8%) of 752 study participants completed follow-up surveys with information on sources of HIV care; 101 (15%) reported receiving care at a different facility by month 12 of follow-up. The primary reason for changing was mobility (N=78, 77%). Those who changed clinics were more likely to be young adults, non-citizens, and pregnant at time of diagnosis. Self-reported clinic attendance and ART adherence did not differ based on changing clinics. Those on ART not changing clinics reported 0.66 visits more on average than were documented in clinic records., Conclusion: At least 1 in 6 participants in HIV care changed clinics within 2 years of diagnosis, mainly driven by mobility; while most appeared lost to follow-up based on records from the original clinic, self-reported visits and adherence were equivalent to those not changing clinics. Routine clinic visits could incorporate questions about care at other locations as well as potential relocation, particularly for younger, pregnant, and non-citizen patients, to support existing efforts to make HIV care records portable and facilitate continuity of care across clinics., Trial Registration: The original trial was registered with ClinicalTrials.gov , NCT02417233, on 12 December 2014., (© 2022. The Author(s).)

Introduction: There 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 Analysis: Integrated 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 Dissemination: Ethics 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 Number: NCT04624061., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Importance: Food insecurity and HIV health outcomes are linked through nutritional, mental health, and health behavior pathways., Objective: To examine the effects of a multisectoral agriculture and livelihood intervention on HIV viral suppression and nutritional, mental health, and behavioral outcomes among HIV-positive adults prescribed antiretroviral therapy (ART)., Design, Setting, and Participants: This cluster randomized clinical trial was performed in 8 pairs of health facilities in Kenya. Participants were 18 years or older, living with HIV, and receiving ART for longer than 6 months; had moderate to severe food insecurity; and had access to arable land and surface water and/or shallow aquifers. Participants were followed up every 6 months for 24 months. Data were collected from June 23, 2016, to June 13, 2017, with follow-up completed by December 16, 2019. Data were analyzed from June 25 to August 31, 2020, using intention-to-treat and per-protocol methods., Interventions: A loan to purchase a human-powered irrigation pump, fertilizer, seeds, and pesticides combined with the provision of training in sustainable agriculture and financial literacy., Main Outcomes and Measures: The primary outcome was the relative change from baseline to the end of follow-up in viral load suppression (≤200 copies/mL) compared between study groups using difference-in-differences analyses. Secondary outcomes included clinic attendance, ART adherence, food insecurity, depression, self-confidence, and social support., Results: A total of 720 participants were enrolled (396 women [55.0%]; mean [SD] age, 40.38 [9.12] years), including 366 in the intervention group and 354 in the control group. Retention included 677 (94.0%) at the 24-month visit. HIV viral suppression improved in both groups from baseline to end of follow-up from 314 of 366 (85.8%) to 327 of 344 (95.1%) in the intervention group and from 291 of 353 (82.4%) to 314 of 333 (94.3%) in the control group (P = .86). Food insecurity decreased more in the intervention than the control group (difference in linear trend, -3.54 [95% CI, -4.16 to -2.92]). Proportions of those with depression during the 24-month follow-up period declined more in the intervention group (from 169 of 365 [46.3%] to 36 of 344 [10.5%]) than the control group (106 of 354 [29.9%] to 41 of 333 [12.3%]; difference in trend, -0.83 [95% CI, -1.45 to -0.20]). Self-confidence improved more in the intervention than control group (difference in trend, -0.37 [95% CI, -0.59 to -0.15]; P = .001), as did social support (difference in trend, -3.63 [95% CI, -4.30 to -2.95]; P < .001)., Conclusions and Relevance: In this cluster randomized trial, the multisectoral agricultural intervention led to demonstrable health and other benefits; however, it was not possible to detect additional effects of the intervention on HIV clinical indicators. Agricultural interventions that improve productivity and livelihoods hold promise as a way of addressing food insecurity and the underpinnings of poor health among people living with HIV in resource-limited settings., Trial Registration: ClinicalTrials.gov Identifier: NCT02815579.

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&lt;0.05) greater odds were demonstrated at both 12 and 24 months for three outcomes: prescription of ART (ORs: 1.42 at 12 months, 1.49 at 24 months), VS among all participants (ORs: 1.49, 1.54) and VS among those with a clinic visit and viral load test (ORs: 1.53, 1.98). The outcomes of any HIV care visit and retention in HIV care had significantly greater odds (ORs: 1.38 and 1.58, respectively) only at 12 months compared to baseline., 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., (© 2022 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Background: Despite 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., Methods: We 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., Findings: Between 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)., Interpretation: Following 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., Funding: National Institute of Allergy and Infectious Diseases., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

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.

Background: Universal testing and treatment for HIV has shown promise as an approach to reduce mortality and lower HIV incidence. Evidence on the economic effects of this approach on individuals and households in low-resource settings is scarce. We aimed to examine the effect of universal HIV testing and treatment on a range of economic outcomes., Methods: We collected data in household surveys done over a 3-year period in a sample of HIV-positive and HIV-negative adults participating in a cluster-randomised trial of universal HIV testing and treatment in 32 rural communities in Kenya and Uganda. Communities of approximately 10 000 people were pair-matched on the basis of geographical and population characteristics, with the best-matching 16 pairs randomly assigned (1:1) to intervention or control groups. Participants in intervention communities received annual HIV and multidisease testing, universal antiretroviral therapy (ART) eligibility, and patient-centred care. Participants in control communities received baseline testing and medical care according to national guidelines. We analysed employment and health-care utilisation outcomes for working-age adults (age 18-65 years) and education outcomes for school-age children (6-17 years) using data from 3 years after the intervention. This trial is now complete, and is registered with ClinicalTrials.gov, NCT01864603., Findings: Between July 9, 2013, and June 15, 2017, we collected survey data on 8198 working-age adults and 6755 school-age children. Compared with adults living with HIV in control communities, adults living with HIV in intervention communities were more likely to be employed (difference 9·7% [95% CI 2·1 to 18·3]), less likely to seek health care (-10·3% [-22·0 to 0·1]), and less likely to spend money on health care (-12·7% [-22·4 to 0·6]) 3 years after the intervention. We found no significant differences in outcomes between HIV-negative adults in intervention and control communities. Among children in households with HIV-positive adults, the intervention led to a 7·3% (95% CI 1·0 to 15·1) increase in primary school completion after 3 years in intervention communities compared with control communities., Interpretation: Universal HIV testing and treatment improved employment outcomes and other indicators of socioeconomic wellbeing for HIV-positive adults and children in their households, but had no effect on HIV-negative adults. Our findings suggest that the considerable investments needed to expand ART access might have substantial short-term and long-term economic returns., Funding: National Institutes of Health., Competing Interests: Declaration of interests EDC reports grants from the European and Developing Countries Clinical Trials Partnership. CRC reports grants by the National Institutes of Health and Centers for Disease Control and Prevention, serves as Chair of the Scientific Advisory Board at Osel, and reports receiving fees for legal consultation from and has stock options at Osel and Evvy. All other authors declare no competing interests., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: A significant proportion (20-59%) of people living with HIV in sub-Saharan Africa desire childbearing, are of reproductive age, and are in sero-different relationships (~50%). Thus it is plausible that some portion of new HIV transmissions are due to attempts to become pregnant. Safer conception (SC) methods that effectively reduce the risk of HIV transmission exist and can be made available in resource-constrained settings. Few studies in the region, and none in Botswana, have quantitatively examined the correlates of information, motivation, and behavioral skills for SC uptake., Methods: We surveyed 356 women living with HIV from 6/2018 to 12/2018 at six public-sector health clinics in Gaborone, Botswana. Participants were 18-40 years old, not pregnant, and desired future children or were unsure about their childbearing plans. We examined correlates of SC information, motivation, and behavioral skills using nested linear regression models, adjusting for socio-demographic, interpersonal, and structural variables., Results: Knowledge of SC methods varied widely. While some SC methods were well known (medical male circumcision by 83%, antiretroviral therapy for viral suppression by 64%), most other methods were known by less than 40% of participants. Our final models reveal that stigma as well as relationship and partner factors affect SC information, motivation, and behavioral skills. Both internalized childbearing stigma (ß=-0.50, 95%CI:-0.17, -0.02) and perceived community childbearing stigma were negatively associated with SC information (ß=-0.09, 95%CI:-0.80, -0.21). Anticipated (ß=-0.06, 95%CI:-0.12, -0.003) and internalized stigma (ß=-0.27, 95%CI:-0.44; -0.10) were associated with decreased SC motivation, while perceived community childbearing stigma was associated with increased SC motivation (ß=0.07, 95%CI:0.02, 0.11). Finally, internalized childbearing stigma was associated with decreased SC behavioral skills (ß=-0.80, 95%CI: -1.12, -0.47) while SC information (ß=0.24, 95%CI:0.12, 0.36), motivation (ß=0.36, 95%CI:0.15, 0.58), and perceived partner willingness to use SC (ß=0.47, 95%CI:0.36, 0.57) were positively associated with behavioral skills CONCLUSIONS: Low SC method-specific information levels are concerning since almost half (47%) of the study participants reported they were in sero-different relationships and desired more children. Findings highlight the importance of addressing HIV stigma and partner dynamics in interventions to improve SC information, motivation, and behavioral skills., (© 2021. The Author(s).)

Introduction: Few interventions have demonstrated improved retention in care for people living with HIV (PLHIV) in sub-Saharan Africa. We tested the efficacy of two personal support interventions - one using text messaging (SMS-only) and the second pairing SMS with peer navigation (SMS+PN) - to improve HIV care retention over one year., Methods: In a cluster randomized control trial (NCT# 02417233) in North West Province, South Africa, we randomized 17 government clinics to three conditions: SMS-only (6), SMS+PN (7) or standard of care (SOC; 4). Participants at SMS-only clinics received appointment reminders, biweekly healthy living messages and twice monthly SMS check-ins. Participants at SMS+PN clinics received SMS appointment reminders and healthy living messages and spoke at least twice monthly with peer navigators (PLHIV receiving care) to address barriers to care. Outcomes were collected through biweekly clinical record extraction and surveys at baseline, six and 12 months. Retention in HIV care over one year was defined as clinic visits every three months for participants on antiretroviral therapy (ART) and CD4 screening every six months for pre-ART participants. We used generalized estimating equations, adjusting for clustering by clinic, to test for differences across conditions., Results: Between October 2014 and April 2015, we enrolled 752 adult clients recently diagnosed with HIV (SOC: 167; SMS-only: 289; SMS+PN: 296). Individuals in the SMS+PN arm had approximately two more clinic visits over a year than those in other arms (p < 0.01) and were more likely to be retained in care over one year than those in SOC clinics (54% vs. 38%; OR: 1.77, CI: 1.02, 3.10). Differences between SMS+PN and SOC conditions remained significant when restricting analyses to the 628 participants on ART (61% vs. 45% retained; OR: 1.78, CI: 1.08, 2.93). The SMS-only intervention did not improve retention relative to SOC (40% vs. 38%, OR: 1.12, CI: 0.63, 1.98)., Conclusions: A combination of SMS appointment reminders with personalized, peer-delivered support proved effective at enhancing retention in HIV care over one year. While some clients may only require appointment reminders, the SMS+PN approach offers increased flexibility and tailored, one-on-one support for patients struggling with more substantive challenges., (© 2021 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Transgender women of color are disproportionately impacted by HIV, poor health outcomes, and transgender-related discrimination (TD). We tested the Model of Gender Affirmation (GA) to identify intervention-amenable targets to enhance viral suppression (VS) using data from 858 transgender women of color living with HIV (49% Latina, 42% Black; 36% virally suppressed) in a serial mediation model. Global fit statistics demonstrated good model fit; statistically significant (p ≤ 0.05) direct pathways were between TD and GA, GA and healthcare empowerment (HCE), and HCE and VS. Significant indirect pathways were from TD to VS via GA and HCE (p = 0.036) and GA to VS via HCE (p = 0.028). Gender affirmation and healthcare empowerment significantly and fully mediated the total effect of transgender-related discrimination on viral suppression. These data provide empirical evidence for the Model of Gender Affirmation. Interventions that boost gender affirmation and healthcare empowerment may improve viral suppression among transgender women of color living with HIV.

Background: In the United States, patients with HIV face significant barriers to linkage to and retention in care which impede the necessary steps toward achieving the desired clinical outcome of viral suppression. Individual-level interventions, such as patient navigation, are evidence based, effective strategies for improving care engagement. In addition, use of surveillance and clinical data to identify patients who are not fully engaged in care may improve the effectiveness and cost-effectiveness of these programs., Methods and Findings: We employed a pre-post design to estimate the outcomes and costs, from the program perspective, of 5 state-level demonstration programs funded under the Health Resources and Services Administration's Special Projects of National Significance Program (HRSA/SPNS) Systems Linkages Initiative that employed existing surveillance and/or clinical data to identify individuals who had never entered HIV care, had fallen out of care, or were at risk of falling out of care and navigation strategies to engage patients in HIV care. Outcomes and costs were measured relative to standard of care during the first year of implementation of the interventions (2013 to 2014). We followed patients to estimate the number and proportion of additional patients linked, reengaged, retained, and virally suppressed by 12 months after enrollment in the interventions. We employed inverse probability weighting to adjust for differences in patient characteristics across programs, missing data, and loss to follow-up. We estimated the additional costs expended during the first year of each intervention and the cost per outcome of each intervention as the additional cost per HIV additional care continuum target achieved (cost per patient linked, reengaged, retained, and virally suppressed) 12 months after enrollment in each intervention. In this study, 3,443 patients were enrolled in Louisiana (LA), Massachusetts (MA), North Carolina (NC), Virginia (VA), and Wisconsin (WI) (147, 151, 2,491, 321, and 333, respectively). Patients were a mean of 40 years old, 75% male, and African American (69%) or Caucasian (22%). At baseline, 24% were newly diagnosed, 2% had never been in HIV care, 45% had fallen out of care, and 29% were at risk of falling out of care. All 5 interventions were associated with increases in the number and proportion of patients with viral suppression [percent increase: LA = 90.9%, 95% confidence interval (CI) = 88.4 to 93.4; MA = 78.1%, 95% CI = 72.4 to 83.8; NC = 47.5%, 95% CI = 45.2 to 49.8; VA = 54.6, 95% CI = 49.4 to 59.9; WI = 58.4, 95% CI = 53.4 to 63.4]. Overall, interventions cost an additional $4,415 (range = $3,746 to $5,619), $2,009 (range = $1,516 to $2,274), $920 (range = $627 to $941), $2,212 (range = $1,789 to $2,683), and $3,700 ($2,734 to $4,101), respectively per additional patient virally suppressed. The results of this study are limited in that we did not have contemporaneous controls for each intervention; thus, we are only able to assess patients against themselves at baseline and not against standard of care during the same time period., Conclusions: Patient navigation programs were associated with improvements in engagement of patients in HIV care and viral suppression. Cost per outcome was minimized in states that utilized surveillance data to identify individuals who were out of care and/or those that were able to identify a larger number of patients in need of improvement at baseline. These results have the potential to inform the targeting and design of future navigation-type interventions., Competing Interests: The authors have declared that no competing interests exist.

Objective: Sub-Saharan Africa faces twin epidemics of HIV and noncommunicable diseases including hypertension. Integrating hypertension care into chronic HIV care is a global priority, but cost estimates are lacking. In the SEARCH Study, we performed population-level HIV/hypertension testing, and offered integrated streamlined chronic care. Here, we estimate costs for integrated hypertension/HIV care for HIV-positive individuals, and costs for hypertension care for HIV-negative individuals in the same clinics., Design: Microcosting analysis of healthcare expenditures within Ugandan HIV clinics., Methods: SEARCH (NCT: 01864603) conducted community health campaigns for diagnosis and linkage to care for both HIV and hypertension. HIV-positive patients received hypertension/HIV care jointly including blood pressure monitoring and medications; HIV-negative patients received hypertension care at the same clinics. Within 10 Ugandan study communities during 2015-2016, we estimated incremental annual per-patient hypertension care costs using micro-costing techniques, time-and-motion personnel studies, and administrative/clinical records review., Results: Overall, 70 HIV-positive and 2355 HIV-negative participants received hypertension care. For HIV-positive participants, average incremental cost of hypertension care was $6.29 per person per year, a 2.1% marginal increase over prior estimates for HIV care alone. For HIV-negative participants, hypertension care cost $11.39 per person per year, a 3.8% marginal increase over HIV care costs. Key costs for HIV-positive patients included hypertension medications ($6.19 per patient per year; 98% of total) and laboratory testing ($0.10 per patient per year; 2%). Key costs for HIV-negative patients included medications ($5.09 per patient per year; 45%) and clinic staff salaries ($3.66 per patient per year; 32%)., Conclusion: For only 2-4% estimated additional costs, hypertension care was added to HIV care, and also expanded to all HIV-negative patients in prototypic Ugandan clinics, demonstrating substantial synergy. Our results should encourage accelerated scale-up of hypertension care into existing clinics., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The US National HIV/AIDS Strategy (NHAS) emphasizes the use of technology to facilitate coordination of comprehensive care for people with HIV. We examined cost-effectiveness from the health system perspective of 6 health information technology (HIT) interventions implemented during 2008 to 2012 in a Ryan White HIV/AIDS Program (RWHAP) Special Projects of National Significance (SPNS) Program demonstration project., Methods/findings: HIT interventions were implemented at 6 sites: Bronx, New York; Durham, North Carolina; Long Beach, California; New Orleans, Louisiana; New York, New York (2 sites); and Paterson, New Jersey. These interventions included: (1) use of HIV surveillance data to identify out-of-care individuals; (2) extension of access to electronic health records (EHRs) to support service providers; (3) use of electronic laboratory ordering and prescribing; and (4) development of a patient portal. We employed standard microcosting techniques to estimate costs (in 2018 US dollars) associated with intervention implementation. Data from a sample of electronic patient records from each demonstration site were analyzed to compare prescription of antiretroviral therapy (ART), CD4 cell counts, and suppression of viral load, before and after implementation of interventions. Markov models were used to estimate additional healthcare costs and quality-adjusted life-years saved as a result of each intervention. Overall, demonstration site interventions cost $3,913,313 (range = $287,682 to $998,201) among 3,110 individuals (range = 258 to 1,181) over 3 years. Changes in the proportion of patients prescribed ART ranged from a decrease from 87.0% to 72.7% at Site 4 to an increase from 74.6% to 94.2% at Site 6; changes in the proportion of patients with 0 to 200 CD4 cells/mm3 ranged from a decrease from 20.2% to 11.0% in Site 6 to an increase from 16.7% to 30.2% in Site 2; and changes in the proportion of patients with undetectable viral load ranged from a decrease from 84.6% to 46.0% in Site 1 to an increase from 67.0% to 69.9% in Site 5. Four of the 6 interventions-including use of HIV surveillance data to identify out-of-care individuals, use of electronic laboratory ordering and prescribing, and development of a patient portal-were not only cost-effective but also cost saving ($6.87 to $14.91 saved per dollar invested). In contrast, the 2 interventions that extended access to EHRs to support service providers were not effective and, therefore, not cost-effective. Most interventions remained either cost-saving or not cost-effective under all sensitivity analysis scenarios. The intervention that used HIV surveillance data to identify out-of-care individuals was no longer cost-saving when the effect of HIV on an individual's health status was reduced and when the natural progression of HIV was increased. The results of this study are limited in that we did not have contemporaneous controls for each intervention; thus, we are only able to assess sites against themselves at baseline and not against standard of care during the same time period., Conclusions: These results provide additional support for the use of HIT as a tool to enhance rapid and effective treatment of HIV to achieve sustained viral suppression. HIT has the potential to increase utilization of services, improve health outcomes, and reduce subsequent transmission of HIV., Competing Interests: The authors have declared that no competing interests exist.

Background: The United States HIV care workforce is shrinking, which could complicate service delivery to people living with HIV (PLWH). In this study, we examined the impact of practice transformations, defined as efficiencies in structures and delivery of care, on demonstration project sites within the Workforce Capacity Building Initiative, a Health Resources and Services Administration (HRSA) Ryan White HIV/AIDS Program Special Projects of National Significance (SPNS)., Methods and Findings: Data were collected at 14 demonstration project sites in 7 states and the District of Columbia. Organizational assessments were completed at sites once before and 4 times after implementation. They captured 3 transformation approaches: maximizing the HIV care workforce (efforts to increase the number of existing healthcare workforce members involved in the care of PLWH), share-the-care (team-based care giving more responsibility to midlevel providers and staff), and enhancing client engagement in primary HIV care to reduce emergency and inpatient care (e.g., care coordination). We also obtained Ryan White HIV/AIDS Program Services Reports (RSRs) from sites for calendar years (CYs) 2014-2016, corresponding to before, during, and after transformation. The RSR include data on client retention in HIV care, prescription of antiretroviral therapy (ART), and viral suppression. We used generalized estimating equation (GEE) models to analyze changes among sites implementing each practice transformation approach. The demonstration projects had a mean of 18.5 prescribing providers (SD = 23.5). They reported data on more than 13,500 clients per year (mean = 969/site, SD = 1,351). Demographic characteristics remained similar over time. In 2014, a majority of clients were male (71% versus 28% female and 0.2% transgender), with a mean age of 47 (interquartile range [IQR] 37-54). Racial/ethnic characteristics (48% African American, 31% Hispanic/Latino, 14% white) and HIV risk varied (31% men who have sex with men; 31% heterosexual men and women; 7% injection drug use). A substantial minority was on Medicaid (41%). Across sites, there was significant uptake in practices consistent with maximizing the HIV care workforce (18% increase, p < 0.001), share-the-care (25% increase, p < 0.001), and facilitating patient engagement in HIV primary care (13% increase, p < 0.001). There were also significant improvements over time in retention in HIV care (adjusted odds ratio [aOR] = 1.03; 95% confidence interval [CI] 1.02-1.04; p < 0.001), ART prescription levels (aOR = 1.01; 95% CI 1.00-1.01; p < 0.001), and viral suppression (aOR = 1.03; 95% CI 1.02-1.04; p < 0.001). All outcomes improved at sites that implemented transformations to maximize the HIV care workforce or improve client engagement. At sites that implemented share-the-care practices, only retention in care and viral suppression outcomes improved. Study limitations included use of demonstration project sites funded by the Ryan White HIV/AIDS Program (RWHAP), which tend to have better HIV outcomes than other US clinics; varying practice transformation designs; lack of a true control condition; and a potential Hawthorne effect because site teams were aware of the evaluation., Conclusions: In this study, we found that practice transformations are a potential strategy for addressing anticipated workforce challenges among those providing care to PLWH. They hold the promise of optimizing the use of personnel and ensuring the delivery of care to all in need while potentially enhancing HIV care continuum outcomes., Competing Interests: The authors have declared that no competing interests exist.

Background: Universal antiretroviral therapy (ART) with annual population testing and a multidisease, patient-centered strategy could reduce new human immunodeficiency virus (HIV) infections and improve community health., Methods: We randomly assigned 32 rural communities in Uganda and Kenya to baseline HIV and multidisease testing and national guideline-restricted ART (control group) or to baseline testing plus annual testing, eligibility for universal ART, and patient-centered care (intervention group). The primary end point was the cumulative incidence of HIV infection at 3 years. Secondary end points included viral suppression, death, tuberculosis, hypertension control, and the change in the annual incidence of HIV infection (which was evaluated in the intervention group only)., Results: A total of 150,395 persons were included in the analyses. Population-level viral suppression among 15,399 HIV-infected persons was 42% at baseline and was higher in the intervention group than in the control group at 3 years (79% vs. 68%; relative prevalence, 1.15; 95% confidence interval [CI], 1.11 to 1.20). The annual incidence of HIV infection in the intervention group decreased by 32% over 3 years (from 0.43 to 0.31 cases per 100 person-years; relative rate, 0.68; 95% CI, 0.56 to 0.84). However, the 3-year cumulative incidence (704 incident HIV infections) did not differ significantly between the intervention group and the control group (0.77% and 0.81%, respectively; relative risk, 0.95; 95% CI, 0.77 to 1.17). Among HIV-infected persons, the risk of death by year 3 was 3% in the intervention group and 4% in the control group (0.99 vs. 1.29 deaths per 100 person-years; relative risk, 0.77; 95% CI, 0.64 to 0.93). The risk of HIV-associated tuberculosis or death by year 3 among HIV-infected persons was 4% in the intervention group and 5% in the control group (1.19 vs. 1.50 events per 100 person-years; relative risk, 0.79; 95% CI, 0.67 to 0.94). At 3 years, 47% of adults with hypertension in the intervention group and 37% in the control group had hypertension control (relative prevalence, 1.26; 95% CI, 1.15 to 1.39)., Conclusions: Universal HIV treatment did not result in a significantly lower incidence of HIV infection than standard care, probably owing to the availability of comprehensive baseline HIV testing and the rapid expansion of ART eligibility in the control group. (Funded by the National Institutes of Health and others; SEARCH ClinicalTrials.gov number, NCT01864603.)., (Copyright © 2019 Massachusetts Medical Society.)

Introduction: To achieve epidemic control of HIV by 2030, countries aim to meet 90-90-90 targets to increase knowledge of HIV-positive status, initiation of antiretroviral therapy (ART) and viral suppression by 2020. We assessed the progress towards these targets from 2014 to 2016 in South Africa as expanded treatment policies were introduced using population-representative surveys., Methods: Data were collected in January to March 2014 and August to November 2016 in Dr. Ruth Segomotsi Mompati District, North West Province. Each multi-stage cluster sample included 46 enumeration areas (EA), a target of 36 dwelling units (DU) per EA, and a single resident aged 18 to 49 per DU. Data collection included behavioural surveys, rapid HIV antibody testing and dried blood spot collection. We used weighted general linear regression to evaluate differences in the HIV care continuum over time., Results: Overall, 1044 and 971 participants enrolled in 2014 and 2016 respectively with approximately 77% undergoing HIV testing. Despite increases in reported testing, known status among people living with HIV (PLHIV) remained similar at 68.7% (95% Confidence Interval (CI) = 60.9-75.6) in 2014 and 72.8% (95% CI = 63.6-80.4) in 2016. Men were consistently less likely than women to know their status. Among those with known status, PLHIV on ART increased significantly from 80.9% (95% CI = 71.9-87.4) to 91.5% (95% CI = 84.4-95.5). Viral suppression (<5000 copies/mL using DBS) among those on ART increased significantly from 55.0% (95% CI = 39.6-70.4) in 2014 to 81.4% (95% CI = 72.0-90.8) in 2016. Among all PLHIV an estimated 72.0% (95% CI = 63.8-80.1) of women and 45.8% (95% CI = 27.0-64.7) of men achieved viral suppression by 2016., Conclusions: Over a period during which fixed-dose combination was introduced, ART eligibility expanded, and efforts to streamline treatment were implemented, major improvements in the second and third 90-90-90 targets were achieved. Achieving the first 90 target will require targeted and improved testing models for men., (© 2019 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Background: Female positive/male negative HIV-serodiscordant couples express a desire for children and may engage in condomless sex to become pregnant. Current guidelines recommend antiretroviral treatment in HIV-serodiscordant couples, yet HIV RNA viral suppression may not be routinely assessed or guaranteed and pre-exposure prophylaxis may not be readily available. Therefore, options for becoming pregnant while limiting HIV transmission should be offered and accessible to HIV-affected couples desiring children., Methods: A prospective pilot study of female positive/male negative HIV-serodiscordant couples desiring children was conducted to evaluate the acceptability, feasibility, and effectiveness of timed vaginal insemination. Eligible women were 18-34 years with regular menses. Prior to timed vaginal insemination, couples were observed for two months, and tested and treated for sexually transmitted infections. Timed vaginal insemination was performed for up to six menstrual cycles. A fertility evaluation and HIV RNA viral load assessment was offered to couples who did not become pregnant., Findings: Forty female positive/male negative HIV-serodiscordant couples were enrolled; 17 (42.5%) exited prior to timed vaginal insemination. Twenty-three couples (57.5%) were introduced to timed vaginal insemination; eight (34.8%) achieved pregnancy, and six live births resulted without a case of HIV transmission. Seven couples completed a fertility evaluation. Four women had no demonstrable tubal patency bilaterally; one male partner had decreased sperm motility. Five women had unilateral/bilateral tubal patency; and seven women had an HIV RNA viral load (≥ 400 copies/mL)., Conclusion: Timed vaginal insemination is an acceptable, feasible, and effective method for attempting pregnancy. Given the desire for children and inadequate viral suppression, interventions to support safely becoming pregnant should be integrated into HIV prevention programs., Competing Interests: The authors have declared that no competing interests exist.

Objectives/design: As antiretroviral therapy (ART) rapidly expands in sub-Saharan Africa using new efficient care models, data on costs of these approaches are lacking. We examined costs of a streamlined HIV care delivery model within a large HIV test-and-treat study in Uganda and Kenya., Methods: We calculated observed per-person-per-year (ppy) costs of streamlined care in 17 health facilities in SEARCH Study intervention communities (NCT: 01864603) via micro-costing techniques, time-and-motion studies, staff interviews, and administrative records. Cost categories included salaries, ART, viral load testing, recurring goods/services, and fixed capital/facility costs. We then modeled costs under three increasingly efficient scale-up scenarios: lowest-cost ART, centralized viral load testing, and governmental healthcare worker salaries. We assessed the relationship between community-specific ART delivery costs, retention in care, and viral suppression., Results: Estimated streamlined HIV care delivery costs were $291/ppy. ART ($117/ppy for TDF/3TC/EFV [40%]) and viral load testing ($110/ppy for 2 tests/year [39%]) dominated costs versus salaries ($51/ppy), recurring costs ($5/ppy), and fixed costs ($7/ppy). Optimized ART scale-up with lowest-cost ART ($100/ppy), annual viral load testing ($24/ppy), and governmental healthcare salaries ($27/ppy), lowered streamlined care cost to $163/ppy. We found clinic-to-clinic heterogeneity in retention and viral suppression levels versus streamlined care delivery costs, but no correlation between cost and either retention or viral suppression., Conclusions: In the SEARCH Study, streamlined HIV care delivery costs were similar to or lower than prior estimates despite including viral load testing; further optimizations could substantially reduce costs further. These data can inform global strategies for financing ART expansion to achieve UNAIDS 90-90-90 targets.

This mixed-methods study used qualitative interviews to explore discrepancies between self-reported HIV care and treatment-related behaviors and the presence of antiretroviral medications (ARVs) in a population-based survey in South Africa. ARV analytes were identified among 18% of those reporting HIV-negative status and 18% of those reporting not being on ART. Among participants reporting diagnosis over a year prior, 19% reported multiple HIV tests in the past year. Qualitative results indicated that participant misunderstandings about their care and treatment played a substantial role in reporting inaccuracies. Participants conflated the term HIV test with CD4 and viral load testing, and confusion with terminology was compounded by recall difficulties. Data entry errors likely also played a role. Frequent discrepancies between biomarkers and self-reported data were more likely due to poor understanding of care and treatment and biomedical terminology than intentional misreporting. Results indicate a need for improving patient-provider communication, in addition to incorporating objective measures of treatment and care behaviors such as ARV analytes, to reduce inaccuracies.

Background: Alcohol use has been shown to accelerate disease progression in experimental studies of simian immunodeficiency virus in macaques, but the results in observational studies of HIV have been conflicting., Methods: We conducted a prospective cohort study of the impact of unhealthy alcohol use on CD4 cell count among HIV-infected persons in southwestern Uganda not yet eligible for antiretroviral treatment (ART). Unhealthy alcohol consumption was 3-month Alcohol Use Disorders Identification Test-Consumption positive (≥3 for women, ≥4 for men) and/or phosphatidylethanol (PEth-an alcohol biomarker) ≥50 ng/mL, modeled as a time-dependent variable in a linear mixed effects model of CD4 count., Results: At baseline, 43% of the 446 participants were drinking at unhealthy levels and the median CD4 cell count was 550 cells/mm (interquartile range 416-685). The estimated CD4 cell count decline per year was -14.5 cells/mm (95% confidence interval: -38.6 to 9.5) for unhealthy drinking vs. -24.0 cells/mm (95% confidence interval: -43.6 to -4.5) for refraining from unhealthy drinking, with no significant difference in decline by unhealthy alcohol use (P value 0.54), adjusting for age, sex, religion, time since HIV diagnosis, and HIV viral load. Additional analyses exploring alternative alcohol measures, participant subgroups, and time-dependent confounding yielded similar findings., Conclusion: Unhealthy alcohol use had no apparent impact on the short-term rate of CD4 count decline among HIV-infected ART naive individuals in Uganda, using biological markers to augment self-report and examining disease progression before ART initiation to avoid unmeasured confounding because of misclassification of ART adherence.