BACKGROUND:Oral pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) provision via online pharmacies (henceforth online PrEP and PEP) offers promise in increasing biomedical HIV prevention coverage. In this study, we aimed to estimate the cost-effectiveness of online PrEP and PEP scale-up in western Kenya. METHODS:We adapted a network-based model, EMOD-HIV, to simulate online PrEP and PEP implementation from 2026 to 2036; costs and use of online PrEP and PEP and client characteristics were informed by the ePrEP Kenya pilot study, which evaluated online PrEP and PEP provision in Nairobi and Mombasa, Kenya. Other parameters were obtained from surveillance data and published literature. Eligible clients were aged 15-49 years reporting condomless sex with non-marital partners. We assumed online PrEP and PEP provision was implemented through public-private partnership, with the Kenya Ministry of Health providing PrEP and PEP drugs and service delivery costs paid by the online pharmacy (and charged to clients). We estimated HIV infections, HIV-related deaths, and disability-adjusted life-years (DALYs) averted compared with the baseline scenario of background oral PrEP only. We calculated incremental cost-effectiveness ratios (ICERs) assessing only costs incurred by the Kenya Ministry of Health over 35 years and used a supply-side threshold of US$500 per DALY averted. We calculated 95% uncertainty intervals (UIs) across 100 parameter sets. FINDINGS:Online PrEP and PEP was projected to reach population coverage of 0·7% (95% UI 0·7-0·8) for PEP and 0·3% (0·2-0·3) for PrEP and avert 13·9% (10·1-17·1) of HIV infections over 10 years. HIV-related deaths were reduced by 4·3% (95% UI 2·0-6·9) over the 35-year time horizon. The intervention was cost-effective from the Kenya Ministry of Health perspective (ICER $212 [95% UI 15-1409] per DALY averted). In a scenario assuming only online PEP availability (to isolate the effect of PEP), 11·6% (95% UI 8·6-15·2) of HIV infections were averted (ICER $210 [95% UI 41-3798] per DALY averted). The intervention remained cost-effective when varying PrEP and PEP effectiveness and assuming HIV testing and treatment disruptions. INTERPRETATION:Online PrEP and PEP can avert substantial HIV infections, even with low population coverage. PEP was responsible for most intervention health benefits, likely due to high observed demand for PEP compared with PrEP in the pilot study. Leveraging private retailers can be efficient for scaling up HIV prevention in an era of shrinking donor funding. FUNDING:Gates Foundation.

BACKGROUND:To our knowledge, there are no evidence-based implementation strategies for care cascade optimisation of mental, neurological, and substance use (MNS) disorder treatment in low-income and middle-income countries. This trial evaluated the effectiveness of the Systems Analysis and Improvement Approach for Mental Health (SAIA-MH) implementation strategy to improve MNS disorder care cascade outcomes in Mozambique. METHODS:We conducted a 3-year, cluster-randomised trial comparing an 8-month baseline period with a 2-year implementation period. All patients diagnosed with MNS disorders across government facilities in Mozambique were eligible. Eligible facilities were required to be naive to the SAIA-MH implementation strategy; currently providing MNS disorder services including prescribing medication; within a 3-h one-way drive from Chimoio City, Manica or Beira City, Sofala; have at least one psychiatric technician and one psychologist currently practising; and have at least 100 annual outpatient MNS disorder visits during 2020-21. Facilities were allocated to the SAIA-MH intervention or attentional placebo control (1:1) using constrained randomisation. Statistical analysts were masked during initial primary outcome assessment. The SAIA-MH strategy combines external facilitation, clinical consultation, and provider team meetings with system-engineering tools in a continuous quality improvement framework. The primary outcome was a combination of low functional impairment or functional improvement measured using the WHODAS 2.0. Secondary outcomes were medication adherence and appointment attendance. We involved people with related lived experience in all elements of the research and writing process. The study was registered at Clinicaltrials.gov, NCT05103033, and is completed. FINDINGS:Between Feb 4, 2022, and Oct 14, 2024, 3837 patients with MNS disorders (2153 in the intervention group and 1684 in the control group) attended 33 055 outpatient visits across 16 government facilities in Mozambique (eight intervention; eight attentional placebo control). The mean age was 26·0 years (SD 15·4; range 0-103), 2038 (53·1%) were male and 1800 (46·9%) were female, and 2581 (67·3%) were diagnosed with epilepsy. Ethnicity data were not collected. 966 patients in the intervention group (with 7697 visits) and 785 in the control group (with 3804 visits) who had their first visit during the study period, who completed the WHODAS 2.0 measurement at that visit, and who were aged 15 years or older, were included in the primary analysis of patient-visit-level functional improvement or low functional impairment to allow for examination of change from baseline. The SAIA-MH group showed 46·0 percentage points (95% CI 34·0 to 58·0; p<0·0001) higher functional improvement or low functional impairment, 18·1 percentage points (15·4 to 20·7; p<0·0001) higher medication adherence, and 18·4 percentage points (15·1 to 21·7; p<0·0001) higher appointment attendance than observed in the control group. Among non-adherent patient visits, the intervention group had 11·9 fewer non-adherent days than controls (95% CI -17·6 to -6·2; p<0·0001). WHODAS 2.0 scores decreased by 5·9 points more in the intervention group than the control group (95% CI -6·5 to -5·2; p<0·0001). One adverse event was reported during study implementation in the attentional placebo control group and was determined to be unrelated to study participation. INTERPRETATION:The SAIA-MH implementation strategy shows evidence of effectiveness in increasing patient functioning, appointment attendance, and medication adherence for patients with MNS disorders treated in outpatient primary care. Our findings warrant further research across implementation contexts to determine how differences in diagnostic and comorbidity case mix might influence the ability of SAIA-MH to reduce gaps in task-shared MNS care. FUNDING:National Institute of Mental Health TRANSLATION: For the Portuguese translation of the abstract see Supplementary Materials section.

Background Men who have sex with men (MSM) are at high risk for bacterial sexually transmitted infections (STIs), including gonorrhea, chlamydia, and syphilis, in Kenya. Because nucleic acid amplification testing (NAAT) is not widely accessible, most gonorrhea and chlamydia infections go undiagnosed and are treated only if symptomatic. World Health Organization (WHO)–recommended periodic presumptive treatment (PPT) and doxycycline post-exposure prophylaxis (doxyPEP) are both potential interventions to reduce the burden of bacterial STIs in this population. Neither has been rigorously tested among MSM in Africa. Objective This study aims to evaluate the effectiveness of WHO-recommended PPT versus doxyPEP, compared with standard syndromic treatment, in reducing the prevalence of bacterial STIs, including gonorrhea, chlamydia, and syphilis, among MSM in Kenya. Methods We are conducting an open-label randomized controlled trial with 2900 participants assigned in a 2:2:1 ratio to WHO-recommended PPT given every 3 months, doxyPEP taken 24-72 hours after condomless sex, or standard treatment. Sociodemographic, psychosocial, and behavioral data are collected by audio computer-assisted self-interview. Syphilis testing and treatment are provided as part of standard care. Throat and rectal swabs and urine are collected, pooled, and batch tested for gonorrhea and chlamydia by NAAT; these results are not used to guide treatment. The primary trial outcome is the combined prevalence of laboratory-diagnosed gonorrhea, chlamydia, and early syphilis after baseline; secondary outcomes include the prevalence of each pathogen individually and antimicrobial resistance in Neisseria gonorrhoeae. Primary and secondary outcomes will be compared between each intervention and the common control arm by estimating relative risks over follow-up (months 3-18) using a modified Poisson model fitted with generalized estimating equations. We will also assess implementation outcomes, including acceptability, feasibility, and safety of each intervention compared to standard care among providers and patients using a mixed methods approach. Finally, we will evaluate the potential health and economic impact of scaling up WHO-recommended PPT and doxyPEP compared to standard of care on STI control among MSM and their partners in Kenya using a stochastic, network-based model and cost-effectiveness analysis on trial data. Results Enrollment commenced on October 29, 2025. As of November 25, 2025, a total of 357 participants (12.3% of target) have been enrolled, including 133 in Kisumu, 122 in Nairobi, and 102 in Mombasa. Full enrollment is expected to take 6 months, with follow-up occurring over 18 months per participant. Results will be published in 2028. Conclusions Results of this trial will provide critical data needed to inform guidelines to improve STI control among MSM in sub-Saharan Africa and other resource-limited settings where NAAT is not routinely available. Modeled estimates of the health and economic impact of scaling up these two interventions on STI control among MSM and their partners in Kenya will provide critical information to guide policymakers considering adoption of either intervention. Trial Registration ClinicalTrials.gov NCT06468462; https://clinicaltrials.gov/ct2/show/NCT06468462 International Registered Report Identifier (IRRID) PRR1-10.2196/81113

ABSTRACT Introduction Monthly oral HIV pre-exposure prophylaxis (PrEP) such as MK-8527 offer promise as low-cost, self-administered options that are easily delivered through community-based platforms. Economic evaluations of MK-8527 either alone or alongside other long-acting (LA) PrEP products like lenacapavir are needed for informing HIV prevention strategies. Methods We adapted an agent-based network model, EMOD-HIV, to simulate LA-PrEP scale-up in South Africa and western Kenya from 2026-2035; scenarios evaluated MK-8527 alone, lenacapavir alone and combined strategies, with varying uptake among female sex workers, their male clients, and individuals with >1 partner. We assumed 95% effectiveness of MK-8527 for 2 months (assuming individuals took 2 of 3 pills dispensed) and 95% lenacapavir effectiveness for 6 months. Scenarios were compared to a baseline of daily oral PrEP only. Results Assuming the same uptake rates, MK-8527 alone achieved lower health impacts than lenacapavir alone in both settings (6-14% vs. 11-18% of HIV infections averted) but had substantially lower costs; provision costs of MK-8527 were 58-59% lower than lenacapavir assuming $1.00/pill and 40–43% lower at $2.50/pill. In western Kenya, ICERs for MK-8527 alone were $467/DALY averted and $799/DALY averted assuming pill prices of $1.00 and $2.50 respectively, compared to $1,306/DALY averted for lenacapavir. In South Africa, all LA-PrEP strategies were cost-saving over the 35-year horizon, although near-term budget impacts were substantial ($169–348 million over five years). Service delivery accounted for the majority of MK-8527 costs (73% at $1.00 per pill). Combined strategies of lenacapavir and MK-8527 increased health benefits (13-23% infections averted) but had higher provision costs than either strategy alone. Conclusion MK-8527 can reduce HIV incidence at lower costs than lenacapavir. However, high service delivery costs limit its cost-effectiveness to scenarios in which pill prices are low (US$1.00 per pill) and provision is targeted to populations at substantial HIV risk.

ABSTRACT Introduction Online delivery of HIV pre‐ and post‐exposure prophylaxis (PrEP and PEP) could address persistent access barriers, yet implementation across Africa remains limited. The ePrEP Kenya Pilot (NCT05377138) integrated PrEP and PEP services into an existing e‐pharmacy platform and identified client‐ and provider‐level barriers and facilitators to use. Methods In the pilot, clinicians screened adults (age 18+) in Nairobi and Mombasa Counties for PrEP and PEP eligibility via telehealth; pharmaceutical technologists courier‐delivered HIV testing services (including self‐testing) and dispensed PrEP or PEP to eligible clients who paid 150–250 KES (∼$1–2 USD) for HIV testing, ≤149 KES (∼$1 USD) for courier delivery and nothing for telehealth consultation or PrEP/PEP drugs. We conducted monthly check‐in calls with providers and, near study endline, in‐depth interviews (IDIs) with purposively sampled clients and all providers. We analysed verbatim call transcripts and IDIs inductively, then mapped identified barriers and facilitators to the Consolidated Framework for Implementation Research (CFIR). Results From February to November 2023, we conducted 10 check‐in calls and interviewed 30 clients (10 PEP, 10 PrEP with 1+ refill, 10 PrEP with no refills) and 10 providers (4 clinicians, 6 pharm techs). Clients had a median age of 27 years (IQR 25–30) and providers 28 years (IQR 27–31); 53% (16/30) of clients and 30% (3/10) of providers were female. In the Outer Setting CFIR domain, providers identified motorcycle manoeuvrability as a delivery facilitator but noted that traffic, poor road infrastructure, bad weather and personal safety concerns posed challenges. In the Inner Setting domain, providers identified information‐sharing practices and collegiality as facilitators. In the Individuals domain, clients’ capability, opportunity and motivation to use online PrEP/PEP services was reportedly facilitated by app‐guided HIV self‐testing, broad delivery zones and enhanced privacy, but hindered by low awareness of these services, limited access to internet‐enabled devices, data security concerns and uncertainties around couriers’ pharmacy credentials. Recommendations included reducing client costs, expanding delivery coverage and hours, and offering alternative delivery options (e.g. medication pick‐up lockers). Conclusions Online PrEP and PEP delivery is a promising differentiated service model, especially if partially subsidized by third‐party payers. Implementation success will require model adaptations that address logistical, infrastructural and awareness barriers.

Private pharmacies are ubiquitous yet underutilized for HIV pre- and post-exposure prophylaxis (PrEP and PEP) delivery. In a cluster-randomized trial in Kenya ( NCT05842122 ), we randomized 60 pharmacies 1:1:1:1 to: client-sustained delivery (∼$2/visit user fee); implementor-sustained delivery (∼$2/visit reimbursement); counselor-supported delivery (task shifting; ∼$1/visit reimbursement); or clinic referral (control; ∼$1/referral reimbursement). Commodities were supplied free to pharmacies from government stock. Primary outcomes were PrEP initiation and one-month continuation (any dispensing or refilling, respectively), self-reported by clients 60 days post-enrollment (multiple-comparisons threshold: p=0.017). From June 2023-April 2025, 5,808 clients enrolled; 64% were PEP candidates. Compared to referral, the counselor-supported arm had significantly higher PrEP initiation (RR=6.5, 95% CI [2.6, 16], p<0.001) and continuation rates (RR=5.1, 95% CI [1.4, 19], p=0.016); all intervention arms had significantly higher PEP initiation rates. One seroconversion, one social harm, and two provider needlestick injuries occurred. Pharmacy PrEP/PEP delivery outperformed clinic referral, particularly when fully subsidized and counselor-supported.

Most assisted partner services (APS) programs elicit partners at the time of HIV diagnosis when index clients may be reluctant to name all partners. Little is known about the benefits of ongoing partner elicitation after the initial visit. We utilized data collected in an APS implementation study across 31 facilities in western Kenya from August 2019 to June 2022. HIV testing service providers offered APS to consenting female index clients and asked them to name their male partners both at initial diagnosis and during follow-up clinic visits for 12 months. Partners were traced and offered HIV testing. Using multivariable Poisson Generalized Estimated Equation models, we compared characteristics of index clients who did and did not name additional partners and assessed HIV diagnoses and characteristics of partners named during initial versus follow-up visits. The 872 female index clients who accepted APS named 3461 male partners, of whom 2920 (84%) were successfully contacted and HIV tested. Of 1819 male partners named at the initial visit, 430 (23.6%) were previously diagnosed and 90 (4.9%) were newly diagnosed with HIV. Of 1101 male partners named at follow-up visits, 335 (30.4%) were previously diagnosed and 193 (17.5%) were newly diagnosed with HIV. Among partners tested, those named at follow-up visits were 3.9 times more likely to be newly diagnosed with HIV than those named at the initial visit (Relative Risk = 3.88, 95%CI = 3.00-4.98) and were more likely to report behaviors associated with HIV transmission, including having sex with >1 partner (p < 0.001) and with a partner at risk of HIV or with unknown HIV status (p = 0.01). Continuing partner elicitation for APS for 12 months after the initial visit was associated with a higher likelihood of identifying male partners at increased HIV risk compared to those initially named and increased the number of new HIV diagnoses.

BACKGROUND:Until recently, community-based antiretroviral therapy (ART) delivery was only available for people living with HIV on ART for ≥6 months with a suppressed viral load. However, early attrition from HIV care is common, particularly in refugee settlements where structural and psychosocial barriers to care are pronounced, and reducing barriers to life-saving ART sooner (e.g., at ART initiation) through community-based ART delivery may improve treatment outcomes. The Head StART study will evaluate the effectiveness, implementation, and health system costs of community ART delivery for individuals newly diagnosed with HIV in refugee settlements in Uganda. METHODS:In a cluster randomized trial, twelve health centers in five refugee settlements in Uganda were randomized (1:1) to intervention or standard of care (SoC), with stratification to balance site characteristics. Individuals testing positive for HIV are screened for study eligibility (inclusion criteria: diagnosed with HIV < 6 months, on ART ≤ 42 days, ≥ 18 years of age or emancipated minor or mature minor; exclusion criteria: pregnant/breastfeeding, medical reason for requiring facility-based care, concurrent trial participation) aiming to recruit up to 1,560 participants per arm (N = 3,120 total). Eligible individuals are enrolled and monitored longitudinally through abstraction of routinely collected data on HIV care outcomes. At intervention sites, participants are offered community ART delivery (Head StART intervention); at SoC sites, participants receive facility-based care. The primary outcome compares the proportion of participants virally suppressed 12 months post-ART initiation by arm in an intention-to-treat analysis. Qualitative interviews and direct observations will augment quantitative data to evaluate intervention implementation across sites. Micro-costing, time and motion observations, and costing interviews will assess intervention costs, which will inform a budget impact analysis. DISCUSSION:This trial will generate critical effectiveness, implementation, and budget impact data on community ART delivery for individuals newly diagnosed with HIV in refugee settlements needed to optimize HIV care for humanitarian populations. TRIAL REGISTRATION:ClinicalTrials.gov: NCT06126913. Registered 27 September 2023. https://clinicaltrials.gov/study/NCT06126913.

Background Long-acting injectable HIV pre-exposure prophylaxis (PrEP), including Lenacapavir, has the potential to accelerate HIV incidence declines in eastern and southern Africa (ESA). However, high product and delivery costs and constrained budgets necessitate efficient prioritization strategies to maximize impact and achieve cost-effectiveness. Methods We used district-level HIV incidence estimates published by UNAIDS to estimate the direct health and economic impact of prioritizing Lenacapavir delivery according to geography, age, and sex across 837 districts in 11 high-burden ESA countries. Infections and disability-adjusted life years (DALY) averted, number needed to treat (NNT), cost per DALY averted, and price thresholds to achieve cost-effectiveness were estimated across geographic prioritization scenarios. Cost-effectiveness was assessed against a $500 per DALY averted threshold, assuming $5,000 discounted lifetime HIV treatment costs and 10 DALYs per HIV infection. Sensitivity analyses varied Lenacapavir costs (commodities + delivery) per person per year (pppy) ($125 versus $55), DALYs per HIV infection (7.5), and the risk differentiation among those who uptake long-acting PrEP. Results HIV incidence varied substantially across ESA, with 50% of new infections in districts containing less than 20% of at-risk adults. Lenacapavir cost-effectiveness varied accordingly, with high-incidence districts exhibiting substantially lower NNT and higher price thresholds for cost-effective delivery. In high-incidence districts, [>5/1,000 person-years (py)], of South Africa, Mozambique, Lesotho, and eSwatini, Lenacapavir would be cost-effective at $50-100 pppy. In South Africa, at annual cost $55 pppy, Lenacapavir was cost-effective in all 52 districts when provided to women aged 15-24 years with incidence exceeding twice the district average and could reach approximately 18-20% of new infections while covering 4% of the full HIV-negative adult population aged 15-49 years. Geographically optimized prioritization in South Africa with minimal age and risk-group stratification achieved efficiency comparable to country-level prioritization to high-risk groups and key populations (~20% incidence reduction with 3-5% coverage). Impact and cost-effectiveness were sensitive to assumptions about risk heterogeneity. Conclusions Lenacapavir impact and cost-effectiveness varies substantially across geographic settings, driven primarily by variation in HIV incidence. Simple incidence-based models can identify where universal provision to certain demographic groups is both impactful and cost-effective, particularly in high-incidence districts and age groups. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This publication based on research funded in part by the Gates Foundation, including models and data analysis performed by the Institute for Disease Modeling. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript beyond the involvement of these authors. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced are available online at https://naomi-spectrum.unaids.org. Scripts used to generate datasets, run country simulations and models, and reproduce all tables and figures in the manuscript can be found at https://github.com/aakullian/LenOptim/tree/master/R/Manuscript

INTRODUCTION:HIV-self testing (HIVST) can increase men's HIV testing in Eastern and Southern Africa (ESA). While secondary HIVST distribution from pregnant women to male partners is standard of care in ESA, little is known about men's preferences for HIVST distribution strategies. METHODS:We administered a Discrete Choice Experiment (DCE) to men from Kampala and Wakiso, Uganda. DCE Attributes were: HIVST distributor (counselor, community health worker, partner, pharmacy staff), distributor sex, HIVST type (oral, blood-based), counseling/support (toll-free hotline, in-person, SMS) and HIVST distribution location (facility, home, mobile clinic, workplace, pharmacy, booth). We used conditional logit regression and latent class analysis. RESULTS:Among respondents (N=396, mean: 30 years old, 90% in a relationship), HIVST distribution was highly acceptable (a large negative opt-out preference weight); participants preferred oral HIVST with in-person or phone counseling/support and had a negative preference for receiving an HIVST at home from female partners. We identified three subgroups: 1) "Prefer HIVST distribution" (71.5% of sample) whose preferences aligned with the main analysis aside from only preferring in-person counseling and support, 2)"Prefer oral HIVST with real-time support" (21.2% of sample), whose preferences also aligned with the main analysis except for positive opt-out (indicating they would only uptake the intervention if it aligned with their preferences), and 3) "Prefer blood-based HIVST in pharmacy with real-time support (7.3%)", which preferred blood-based HIVST from pharmacies with in-person support. CONCLUSIONS:HIVST distribution was highly acceptable; overall men preferred oral HIVST with in-person support and did not prefer receiving HIVST at home from female partners.

Background: Human papillomavirus bivalent (2vHPV) and nonavalent (9vHPV) vaccines protect against HPV types causing 70% and 90% of cervical cancers, respectively. South African guidelines recommend vaccinating girls ages 9-14 with one dose of 2vHPV. Switching recommendations to 9vHPV could avert more cervical cancer burden, but the cost-effectiveness and cost-threshold of 9vHPV in South Africa is unknown. Methods: Using a validated compartmental HPV and HIV transmission model parameterized to KwaZulu-Natal, South Africa, we simulated scenarios of 2vHPV and 9vHPV implementation over 100 years with two doses (72% coverage) and one dose (80% and 90% coverage) with lifelong or waning single-dose vaccine efficacy. We evaluated cervical cancer cases and deaths averted. We also estimated the maximum cost/dose for 9vHPV to be cost-effective using willingness-to-pay thresholds from $500/DALY averted to $3,015/DALY averted (2023 USD). We also assessed the incremental cost-effectiveness ratios (ICERs) of 9vHPV at current costs ($110/dose) compared to 2vHPV ($9.23/dose). Results: Single-dose 9vHPV at 80% coverage could avert 7.9% more cervical cancer cases and 6.4% more deaths than 2vHPV (lifelong efficacy). The maximum 9vHPV price to be cost-effective (lifelong efficacy, 80% coverage) ranged from $15 ($500/DALY averted threshold) to $45/dose ($3,015/DALY averted threshold). At current market costs, single-dose 9vHPV at 90% coverage exceeds commonly used cost-effective thresholds with ICERs of $10,480/DALY averted (lifelong efficacy) and $8,806/DALY averted (waning efficacy). Conclusion: Implementing 9vHPV can result in a greater reduction in cervical cancer burden than 2vHPV, but vaccine costs need to be reduced for 9vHPV to be cost-effective in KwaZulu-Natal.

INTRODUCTION:Point-of-care (POC) urine tenofovir (TFV) tests can provide timely information regarding antiretroviral therapy (ART) adherence to support management of HIV treatment in clinics. However, there are limited data on the costs and feasibility of integrating POC testing into HIV clinics in sub-Saharan Africa. We characterized clinic flow and implementation costs of POC adherence testing for persons initiating ART in HIV care clinics in South Africa. METHODS:We conducted a microcosting within a randomized controlled implementation trial of POC TFV test in government clinics in Durban, South Africa (STREAM HIV). Time-and-motion observation was conducted between 1st March and 31st December 2022, to assess staff and client time needed for POC TFV testing and counselling. We estimated both financial and economic costs for capital, clinic consumables and personnel using a provider (national government) perspective. RESULTS:The estimated cost of POC TFV was USD $13 per client, assuming a clinic volume of 20 individuals initiating ART per month. The largest component costs of POC TFV testing were the test strip consumables, which accounted for 53% of the test cost. The median total time of a clinic visit with a POC TFV test, starting from client registration, was 49:19 (minutes: seconds) (IQR: 29:19-89:35). TFV testing took 9:22 (IQR: 7:35-14:11), taking up 19% of the total clinic visit time, including sample collection, sample loading, TFV test processing and counselling provision based on test results. Overall, 29% of the clinic visit time included direct clinical care and assessment with a provider, with clients spending a median 14:09 (IQR: 10:35-21:22) getting vitals checked, receiving adherence monitoring via POC TFV testing, and collecting their ART refill. Waiting in line for ART took most (48%) of the clinic visit time. CONCLUSIONS:POC TFV testing can be administered at reasonable costs, requires less than 10 minutes of healthcare provider time, and, therefore, may be feasible to implement in South African clinics. Findings can inform policy and budgetary planning for ART monitoring in South Africa and future cost-effectiveness analyses of POC TFV testing. CLINICAL TRIAL NUMBER:NCT04341779.

Brain magnetic resonance imaging (MRI) has been investigated as a neuroprognostication (NP) test after out-of-hospital cardiac arrest (OHCA); however, most studies have focused on predicting poor neurologic outcomes or death. We examined the ability of a composite brain MRI score (“NP score”) to predict neurologic outcomes in an OHCA cohort (2017–2023) who underwent brain MRI within 2–7 days post arrest and survived to hospital discharge. NP scores (range 0–214) were calculated from diffusion weighted imaging and fluid attenuated inversion recovery signals in prespecified neuroanatomical regions. We categorized neurologic outcomes as “independent” (Cerebral Performance Categories [CPC] 1–2), “dependent” (CPC 3), and “vegetative state” (CPC 4). We conducted correlation analyses and used computational modeling for probabilities to identify transition points between the outcome categories. Forty-two OHCA survivors were included (median age 47 years; 74

Up to 98% of adult voluntary medical male circumcision (VMMC) clients heal without adverse events (AEs) in South Africa and in the sub-Saharan Africa region. Yet, all clients in South Africa are required to attend in-person reviews, creating added effort for providers and clients. A randomized controlled trial (RCT) using our fee-free, open-source, two-way texting (2wT) approach showed that males could independently monitor their healing with nurse-led telehealth support. 2wT was more cost-effective than routine visits for quality post-operative monitoring. The objectives of this study were:1) assess the additive cost of 2wT vs. standard of care (SoC) during a stepped wedge design (SWD) expansion trial; 2) determine the cost of augmenting 2wT implementation with dedicated personnel during peak VMMC periods; and 3) estimate the cost savings of 2wT from the payer perspective if scaled in routine settings. Data were collected from routine financial reports and complemented by previous RCT time-motion estimates. We conducted activity-based costing of SWD and peak season periods. Sensitivity analysis to estimates 2wT costs at scale. Data included 6,842 males; 2,586 (38%) opted for 2wT. 2wT participants attended an average of zero in-person visits; SoC males had an average of 2 in-person visits. Under 2wT, quality care improved: AE ascertainment increased while loss to follow-up decreased. Given a VMMC population of 10,000 adults, scenario analysis suggests that: 1) 2wT becomes cost neutral with 45% 2wT enrollment; 2) 2wT saves $0.29/client with 60% 2wT enrollment; and 3) 2wT saves $0.46/client with 80% 2wT enrollment. When scaled, 2wT appears to significantly reduce healthcare system costs while improving the quality of post-operative care without additional client costs. Further scale-up of 2wT for eligible males across VMMC and other post-operative contexts in South Africa would likely increase cost savings while dramatically reducing the burden of in-person visits on patients and clinics.

Introduction: COVID-19 surveillance in congregate settings is important to mitigating disease, but the health and economic impact of testing remains unclear. Methods: The authors developed a Markov model to project the cost-utility of COVID-19 testing strategies in homeless shelters from the healthcare payer and societal perspective over 1 year. Model inputs utilized data from residents aged ≥18 years across 23 Seattle shelters from January 1, 2020, to May 31, 2021. No in-shelter surveillance was compared with scenarios of 2 COVID-19 testing strategies implemented monthly: polymerase chain reaction (PCR) testing and rapid antigen testing; scenarios in which only PCR testing was available were also evaluated. The primary health outcome was quality-adjusted life years. Interventions were considered cost-effective if the incremental cost-effectiveness ratio was ≤$150,000 per quality-adjusted life year and dominant if they saved costs and provided health effects. Results: When assuming the availability of both antigen and PCR tests, most rapid antigen testing strategies were cost-effective, whereas PCR testing was dominated by antigen testing. Compared with no in-shelter surveillance, antigen testing increased mean quality-adjusted life years by 0.0009 (0.03% infections averted) at an incremental cost of $97/resident from the healthcare perspective (incremental cost-effectiveness ratio=$112,352/quality-adjusted life year gained) and $8/resident from the societal perspective (incremental cost-effectiveness ratio=$9,627/quality-adjusted life year gained) at 75% vaccination coverage. PCR testing was not cost-effective when antigen testing was available but was cost-effective compared with no surveillance at low vaccination coverage levels (<30% coverage from the healthcare perspective and ≤48% coverage from the societal perspective). Probabilistic sensitivity analysis showed that antigen testing was cost-effective in 62% and 86% of simulations from the healthcare and societal perspectives, respectively. Conclusions: Modeled findings show that COVID-19 testing in shelters can be a cost-effective pandemic response. Antigen testing remained cost-effective at high vaccination levels, whereas PCR testing was most effective at low vaccination levels if antigen testing was not available.

BACKGROUND:Online pharmacy HIV pre- and post-exposure prophylaxis (PrEP/PEP) provision is a novel strategy to expand HIV prevention coverage. In the ePrEP pilot study, we found online pharmacy PrEP/PEP was feasible and reached populations at HIV risk in Kenya. However, program costs data are lacking. METHODS:We conducted a costing within the ePrEP pilot study in Nairobi from 11/01/2022-12/29/2023. We obtained costs from expense reports and conducted time-and-motion observations and staff interviews. We estimated total and unit costs in the first year of implementation, cost per client and per PrEP client-month (2023 US Dollars (USD)). RESULTS:Overall, 229 clients initiated PrEP (507 months of PrEP coverage) and 1320 initiated PEP. Based on observed program volume, annual financial cost was $109,945 USD (PrEP: $19,456; PEP: $90,489). Cost per client was higher for PrEP than PEP ($85 vs $68.6), and cost per PrEP client-month was $38 (mean duration: 2.2 months). Main drivers of financial costs were courier-delivery of HIV testing kits and drugs (PrEP: 50.6%; PEP: 40.5%), demand generation (PrEP: 25.9%; PEP: 32.1%), and equipment, system development, and utilities (PrEP: 9.3%; PEP: 9.8%). Assuming a scaled-up client volume of 2500 (PrEP: 370; PEP: 2130) reduced per-client financial costs for PrEP ($65.5) and PEP ($56) and cost per PrEP client-month ($29.6). CONCLUSIONS:Costs of online PrEP/PEP provision is likely higher than clinic-based PrEP. Implementing cost sharing models including charging clients for HIV testing and optimizing courier delivery routes can increase program efficiencies. Our cost estimates can inform economic evaluations of online PrEP/PEP delivery.