New long-acting HIV prevention product choices, including lenacapavir, cabotegravir, and investigational monthly oral MK‑8527, usher in promise for ending HIV as a public health threat. Decisions taken at a product's launch determine who will access it and shape its population-level impact. We argue that targeted universalism should be used to organise the roll‑out of pre-exposure prophylaxis (PrEP) choices. Targeted universalism means setting the goal of universal access for anyone who wants effective prevention and then tailoring functional supports, such as convenient delivery points and improved provider capacity for supportive interactions, to: 1) guide distribution of limited supply, and 2) help groups facing the steepest barriers to engage with prevention on an equal footing. As a policy framework, targeted universalism thus seeks to avoid mistakes that have restricted the population-level impact of oral PrEP by eliminating epidemiologically driven risk targeting, reckoning with the social resistance associated with stigmatised interventions and populations, and facilitating equitable coverage through systems strengthening.

There has been limited research reporting approaches used in the adaptation of implementation strategies for integrating HIV and NCD services that involve healthcare providers in low- and middle-income country (LMIC) settings. This paper describes how human-centered design (HCD) was used to 1) adapt a multifaceted implementation strategy for integrating HIV and NCD services through end-user engagement and 2) share insights from the specific suggestions made through the HCD process with healthcare providers. As part of the TASKPEN an implementation science-driven intervention aimed at task shifting and integrating the evidence-based WHO Package of Essential NCDs Interventions (WHO-PEN) approach into routine healthcare settings for PLHIV, we co-designed implementation strategy components (i.e., "sub-components") to strengthen HIV/NCD integration in four HIV clinics in Lusaka, Zambia. The HCD process involved qualitative approaches with healthcare providers, namely lay and non-physician healthcare workers (NPHWs) such as nurses and community healthcare workers (CHWs). A four-phased approach of exploration through formative qualitative work, ideation with intervention deliverers, analysis, and refinement was used to develop strategy sub-components. Rapid thematic data analysis was used to synthesise the data. Applying HCD to a locally-informed intervention for screening and managing cardio-metabolic co-morbidities for Zambian PLHIV informed the addition of sub-components to the multi-faceted implementation strategy to improve adoption, appropriateness, and feasibility. Through co-design workshops, healthcare providers suggested specific sub-components be added to enhance the intervention. Specifically, four sub-component strategy ideas were produced: introducing NCD/HIV champions, circulating a weekly facility NCD medication bulletin, dashboard reporting of HIV/NCD cases, and community sensitization. The use of HCD in implementation science is a promising approach to refining implementation strategies that are likely to result in the success of HIV/NCD integration in Zambia and similar LMIC settings.

Globally, an estimated 56.8 million people require palliative care each year, with half in their final year of life. However, access appears to be scarce in the most impoverished settings, like rural sub-Saharan Africa. Africa is expected to experience a sharp rise in severe health-related suffering, underscoring the need to increase access to palliative care. A convergent parallel mixed-methods design was conducted to assess factors affecting palliative care access and utilisation in rural Malawi. Interviews using a question guide were conducted with patients, caregivers, and service providers to examine experiences in palliative care access and service utilisation, and the analysis used thematic content analysis. Electronic medical data were extracted, de-identified, and analysed using STATA software version 18.0 from nine palliative care implementing facilities using descriptive statistics. Electronic medical records were analysed with 204 patients enrolled in the program. The mean age was 58.6 years, and 47

Introduction: Integrating HIV and non-communicable disease (NCD) services is an essential strategy for improving health outcomes for people living with HIV (PLHIV) and NCDs, and may optimize resource utilization, use of patient time, and healthcare costs. This paper examines the determinants that motivate and shape the implementation process of NCD integration into HIV services, as well as the factors that influence successful integration. Methods: Nested in a pilot implementation trial, this study employed a qualitative case study design to collect data following the introduction of an integrated HIV/NCD intervention based on the WHO Package of Essential Non-communicable Disease (WHO PEN) interventions in two health facilities in Lusaka, Zambia. Data collection included four focus group discussions (two with professional non-physician healthcare workers (NPHWs) such as nurses and two with lay NPHWs, such as community healthcare workers, (CHWs)), eight in-depth interviews with PLHIV with comorbid cardiometabolic NCDs like hypertension, and one key informant interview with a clinician. The data were analysed using a thematic approach guided by the Consolidated Framework for Implementation Research (CFIR). Results: The integration of NCD into HIV services improved patient satisfaction, increased NCD medication availability, and enhanced documentation of vital signs. However, limited staffing and facility space, pill burden, treatment prioritisation, work overload, and fear of mismanagement by CHWs hindered integration. These barriers could affect the sustainability of HIV/NCD service integration. Empowering NPHWs through training and providing NCD guidelines and job aids enabled task shifting and built confidence among healthcare providers. Task-sharing also increased coordination among NPHWs, especially nurses and CHWs. Strong local leadership, driven by facility-appointed champions, and regular monitoring and supervision by study mentors, facilitated integration. Conclusion: Effective HIV/NCD integration requires a multifaceted strategy that addresses human resource capacity development, basic NCD resources such as diagnostic testing equipment and medications, facility-level leadership and coordination among healthcare providers, and reorganisation of clinical workflows. Addressing these factors is crucial for optimising health outcomes for PLHIV with NCDs in Zambia and other similar settings.

BACKGROUND:Zambia established a recent infection testing algorithm (RITA) incorporating a novel point-of-care (POC) rapid test-the Asanté™ HIV-1 Rapid Recency® Assay (RTRI)-plus a HIV-1 viral load (VL) test to distinguish recent (≤12 months) from long-term (>12 months) HIV acquisition. This study evaluated the field performance of RTRI when implemented by healthcare workers at the POC. METHODS:We enrolled individuals newly diagnosed with HIV between 20 May 2021 and 10 March 2022 at two Ministry of Health facilities in Lusaka, Zambia. Participants received on-site RTRI testing and provided an additional sample for repeat RTRI and VL testing at a central laboratory. Final recent infection testing algorithm (RITA) results were returned to the study sites and were made available to clients at their study follow-up visit. Agreement between POC- and laboratory-RTRI was assessed using Cohen's Kappa. We compared recent versus long-term HIV classification across testing locations using the national RITA as the reference standard. Four focus group discussions (FGDs) with health staff explored perceptions surrounding POC-RTRI implementation. RESULTS:Agreement between POC and laboratory RTRI was 96.5%, with a Kappa of 0.812 (95% CI: 0.704-0.920). The POC-RTRI results indicated numerically more recent infections than laboratory-RTRI (30 vs 27), with three POC-RTRI false positives resulting in reduced sensitivity 85.0% for the POC-RTRI compared to 100.0% sensitivity for the laboratory-RTRI against the RITA reference standard. FGD participants (n = 28) agreed that POC RTRI was feasible and acceptable with adequate training, human resources, client counselling, and quality assurance measures. CONCLUSION:There was strong concordance between POC- and laboratory-RTRI results. The findings support the feasibility of implementing RTRI at POC by non-laboratory health workers, provided adequate training and health system resources are in place.

Background: Access to safe drinking water is a considerable problem in Malawi. Contaminated water plays a major role in diarrheal disease, particularly for people living with HIV and their families. Water, sanitation, and hygiene (WASH) interventions can reduce the risk of diarrhea among children by up to 50%. However, few published reports describe WASH integration in routine HIV care programming in Africa. Objective: To evaluate a WASH program integrated within the prevention of vertical transmission of HIV (PVTH) care in Lilongwe, Malawi. Methods: The University of North Carolina's Project Malawi, the Proctor & Gamble Company (P&G), and the Malawi Ministry of Health implemented a safe drinking water program from 2008 to 2023, integrated within the national PVTH program in Lilongwe, Malawi. We provided a point-of-use WASH package to pregnant and breastfeeding women (PBFW) with HIV and their families that included soap, sieves, closed-water containers, and P&G water purification packets. We examine program impact by describing trends in childhood diarrhea and retention in care at 33 program facilities and 29 non-program facilities from 2018 to 2022. Findings: Over the program's final 5 years, an estimated 2 million water purification packets were distributed annually. From 2018 to 2022 in program facilities, non-bloody diarrhea rates among children under 5 years remained constant, while bloody-diarrhea rates fell at both program and non-program facilities. A small association was found between facility participation in the program and retention in care among PBFW living with HIV (incidence rate ratio: 1.05, 95% CI: 0.99-1.12), but of borderline statistical significance. Conclusions: In an environment where access to clean water is not assured, we demonstrated the feasibility of delivering a WASH package in HIV care settings over 15 consecutive years. The collaboration between government, academic, and industry partners provides an example for how to integrate WASH within PVTH programming.

The rapid reduction in foreign development assistance from the United States and other countries in 2025 has disrupted essential global health programming. Countries that previously received development assistance, such as Zambia, may experience weakening of health system capacity due to program cancellations. This study aimed to describe the perceived impacts of USAID program defunding on healthcare delivery in Zambia. We conducted a cross-sectional survey at 34 purposively selected healthcare facilities in three districts of Zambia in April and May 2025. Through facility-level assessments and individual-level surveys with 330 healthcare workers, we identified changes in health system building blocks that may have arisen from program defunding. The facility-level assessment found that 71% of healthcare facilities (n = 24) experienced changes related to funding cuts within the previous three to four months. In open-ended surveys, healthcare workers reported impacts on the health system, including stock-outs of essential medicines, diagnostic tests, and infection control supplies; layoffs of US-supported healthcare workers; and reduced ability to work with electronic medical records. Workers described how these changes affected workplace morale, patient satisfaction, and their ability to deliver essential services. This study reveals the immediate consequences of defunding foreign assistance, which, if left unaddressed, may weaken health systems and worsen health outcomes. National governments and partner organizations should prioritize interventions and investments that build health system resilience, such as expanding healthcare revenue streams and improving workforce capacity. In the wake of funding cuts, health system strengthening can reduce reliance on foreign assistance and improve population health.

BACKGROUND:People with HIV experience conventional and HIV-specific risk factors for increased blood pressure and may have different trajectories than people without HIV. Using data from the Multicenter AIDS Cohort Study (MACS) and Women's Interagency HIV Study (WIHS), we describe longitudinal patterns in blood pressure, hypertension, and vital status for people with HIV and without HIV. METHODS:We estimated longitudinal trajectories of systolic and diastolic blood pressure, pulse pressure, and mean arterial pressure using generalized estimating equations. Using multinomial logistic regression and Kaplan-Meier curves, we estimated the proportion of participants in four states corresponding to vital and hypertensive status. RESULTS:We included men and women with HIV who reported antiretroviral therapy use (MACS: n  = 1555; WIHS: n  = 2765) and men and women without HIV (MACS: n  = 1671; WIHS: n  = 1145) between ages 20 and 70 from 1998 to 2019. Trajectory shapes were similar between people with and without HIV within cohorts. Men with and without HIV had similar blood pressure across ages. Women with HIV had lower blood pressure than those without HIV (average systolic difference -4.7 mmHg; 95% CI: -5.6, -3.8). Despite comparable average time alive without hypertension, people with HIV experienced higher mortality than those without HIV (risk at age 50, MACS: 13.1% vs. 8.1%; WIHS 33.3% vs. 9.6%). CONCLUSION:Blood pressure trajectories were similar between people with and without HIV, although blood pressure was slightly lower for women with HIV. High mortality among people with HIV (vs. without) may have resulted in a lower proportion of people with hypertension at older ages.

BACKGROUND:Elimination of vertical transmission of HIV remains a major global public health priority. In Malawi, more than one-third of pediatric HIV acquisitions are attributed to perinatal HIV acquisition during breastfeeding. HIV pre-exposure prophylaxis (PrEP) is a crucial biomedical tool to keep women free of HIV and eliminate vertical transmission, but effectiveness has been hampered by poor uptake and premature discontinuation. Implementation science approaches are needed to improve uptake, persistence, and adherence to PrEP among postpartum women at risk of HIV. METHODS:LINK is a type I hybrid effectiveness implementation cluster-randomized trial conducted at 12 service delivery sites within Lilongwe district, Malawi. The LINK model is a novel postpartum HIV prevention package that uses implementation strategies of integration and task-shifting/sharing and includes the following evidence-based practices: (1) maternal HIV testing integrated with Expanded Programme for Immunization (EPI) sites for infant immunizations [integration], (2) PrEP screening and referral for mothers who test HIV-negative, (3) engagement of male partner(s), and (4) community-facility linkage (CFL) peer mother model for PrEP (re)engagement [integration and task shift/share]. Clinics are randomized 1:1 to intervention or control conditions. Effectiveness outcomes include PrEP uptake, adherence, and 6-month persistence among breastfeeding women at intervention compared to control sites. Implementation outcomes assessed at intervention sites include reach, adoption, acceptability, fidelity, scalability, sustainability and cost-effectiveness. We will analyze effectiveness outcomes with routine medical records, surveys, and PrEP drug metabolites via dried blood spots which will provide additional insights into HIV risk and PrEP usage and will facilitate a "constructed cohort" of PrEP eligible postpartum women. Implementation outcomes rely on in-depth interviews, surveys, site assessments, structured observations, and other tools. Human centered design workshops prior to implementation will further inform site-specific procedures for LINK model integration and launch. DISCUSSION:The study establishes a simple, scalable model, building on existing HIV and maternal and child health service delivery platforms, to accelerate efforts toward eliminating vertical transmission. If the LINK model is successful at improving PrEP usage among postpartum women, feasible, and cost-effective, we will have the knowledge to support quickly sustaining and scaling the intervention in Malawi and beyond. TRIAL REGISTRATION:Clinicaltrials.gov NCT06506188 (registered: 2024/07/17).

Misclassification between causes of death can produce bias in estimated cumulative incidence functions. When estimating causal quantities, such as comparing the cumulative incidence of death due to specific causes under interventions, such bias can lead to suboptimal decision making. Here, a consistent semiparametric estimator of the cumulative incidence function under interventions in settings with misclassification between two event types is presented. The measurement parameters for this estimator can be informed by validation data or expert knowledge. Moreover, a modified bootstrap approach to variance estimation is proposed for confidence interval construction. The proposed estimator was applied to estimate the cumulative incidence of AIDS-related mortality in the Multicenter AIDS Cohort Study under single- versus combination-drug antiretroviral therapy regimens that may be subject to confounding. The proposed estimator is shown to be consistent and performed well in finite samples via a series of simulation experiments.

ImportanceLittle is known about the factors affecting viral suppression among people living with HIV returning to the community after incarceration (ie, reentrants) in Africa. ObjectiveTo describe changes in viral suppression among reentrants living with HIV in Zambia and estimate the association between postrelease alcohol use and viral suppression. Design, Setting, and ParticipantsThis cohort study enrolled incarcerated people living with HIV from 5 prisons and surrounding communities in Zambia and conducted study visits before and after prison release to assess HIV-associated health behaviors and changes in clinical outcomes between March 2017 and November 2019. Eligible participants were incarcerated people aged at least 18 years, living with HIV, with release planned fewer than 30 days from screening, enrolled in the national HIV program, planning on living in Lusaka postrelease, and providing voluntary informed consent. Data were analyzed from April 20, 2024, to October 2, 2025. ExposurePostrelease unhealthy alcohol use (UAU), per the World Health Organization Alcohol Use Disorders Identification Test. Main Outcomes and MeasuresThe primary outcome was HIV-1 viral load (VL) suppression (<1000 copies/mL) before and after release. Mixed-effects Poisson regression was used to estimate the association between postrelease UAU and loss of viral suppression, using a directed acyclic graph to identify confounders. ResultsOf 396 individuals screened, a total of 295 incarcerated people living with HIV (74.7%; median [IQR] age, 34 [29-41] years; 237 [80.3%] male) were included, with median (IQR) baseline CD4+ of 378 (244.5-506.5) cells/mL. At release, participants had been incarcerated a median (IQR) of 7.4 (3.5-15.4) months and receiving antiretroviral therapy for 13.2 (4.3-62.5) months. Documented viral suppression decreased from 237 individuals (80.3%) before release to 211 individuals (71.5%) after release. A total of 251 participants (85.1%) completed follow-up at a median (IQR) of 7.8 (5.4-11.6) months after release. UAU (prevalence ratio [PR], 3.35; 95% CI, 1.82-6.15) and unhealthy drug use (PR, 2.82; 95% CI, 1.39-5.71) were associated with postrelease unsuppressed VL. Among 205 participants (69.5%) with prerelease viral suppression, postrelease UAU was significantly associated with loss of viral suppression (adjusted risk ratio, 4.07; 95% CI, 1.97-8.42). Conclusions and RelevanceThis cohort study of reentrants living with HIV in Zambia found that postrelease UAU was significantly associated with loss of viral suppression after community reentry. These findings suggest that new care models are needed to support HIV care continuity and address comorbid substance use in this population.

In Malawi and elsewhere in Africa, many children living with HIV are unaware of their status, often because of missed services for the prevention of vertical transmission of HIV (PVTH). Pregnant and breastfeeding women (PBFW) living with HIV frequently go without viral load (VL) monitoring and their infants miss key HIV testing milestones for early infant HIV diagnosis (EID). In Malawi, the current standard of care (SOC) involves mostly passive approaches to pediatric HIV diagnosis, relying on mothers presenting to health facilities with their infants. To reach PBFW living with HIV and their infants who miss critical HIV services and who are at higher risk for adverse HIV outcomes, including vertical transmission, we developed the “Point-of-care Active Case finding Management” or “PAC-Man” model. PAC-Man uses a multifaceted implementation strategy involving task-shifted mobile teams to reach these mother-infant pairs (MIPs) with evidence-based point-of-care (POC) technology for EID and maternal VL testing in the community, linked to back-to-care and antiretroviral therapy (ART) services. We will conduct a hybrid type III effectiveness-implementation incomplete stepped-wedge cluster-randomized trial in 12 clinics in Malawi over a 3-year period to test our strategy. Control periods will reflect SOC. Intervention periods will add PAC-Man to SOC. The primary outcome is reach of infant EID testing by age 6 months in the clinic population. Secondary outcomes include the proportion of infants newly diagnosed with HIV initiating ART and maternal VL testing reach. These outcomes will be assessed using routinely collected clinic data augmented with field surveys enrolling a sample of MIPs randomly selected from each clinic. Implementation outcomes of acceptability, adoption, fidelity, implementation, sustainability, cost, and scalability will be assessed using convergent mixed methods. Study findings will offer new insights into the effects of differentiated, community-based services for reaching infants unaware of their HIV-positive status and their mothers and characterize the fit of the PAC-Man strategy with the national PVTH program. The study holds promise for improving access to EID and VL testing, and ART, for MIPs currently being missed by traditional facility-based approaches and could suggest a novel approach for use in real-world PVTH programs across Africa. This study is registered at ClinicalTrials.gov, NCT06493357.

Introduction An estimated 800 000 children (<15 years) globally living with HIV remain undiagnosed. To reach these children with timely HIV testing services during infancy, we implemented a community-based differentiated care model using mobile point-of-care (POC) technology for early infant diagnosis (EID) of HIV, and assessed its effects on EID positivity, antiretroviral therapy (ART) initiation and 3-month retention in care.Methods Between 1 June 2019 and 31 May 2020 at six health facilities in Lusaka, Zambia, we enrolled mother-infant pairs (MIPs) at high risk for vertical transmission of HIV based on missing or late infant EID testing or other maternal risk factors. We offered these MIPs community POC EID testing (post-intervention), and compared their outcomes to historical high-risk controls at the same sites (1 June 2017–31 May 2018; pre-intervention). We used propensity score matched weighting and mixed effects regression modelling to estimate outcome differences pre-intervention and post-intervention, and to identify MIP characteristics predictive of vertical transmission of HIV.Results 2577 MIPs were included in the analysis: 1763 and 814 high-risk MIPs from the pre-intervention and post-intervention periods, respectively. Infant HIV positivity was significantly higher in the post-intervention (2.2%) vs pre-intervention (1.1%) period (p=0.038), however this difference was attenuated (0.83%, 95% CI: −0.50%, 2.15%) after adjusting for differences in maternal age, maternal antenatal care visits, infant birth month and facility. During the post-intervention period, MIPs where the mother disengaged from care were 12.97 (95% CI: 2.41, 69.98) times as likely to have an infant diagnosed with HIV vs those in which the infant received late EID testing without maternal care disengagement. Among 18 infants diagnosed with HIV by the intervention, 16 (88.9%) initiated same-day ART and all continued ART at 3-month follow-up.Conclusion Community-based differentiated care employing POC EID technology increased testing positivity in unadjusted analyses, and resulted in high ART initiation and early care retention, suggesting it may be a promising approach for reaching infants and young children living with HIV being missed by current facility-based approaches.Trial registration number This trial is registered under the following Clinicaltrials.gov Identifier: NCT03133728

INTRODUCTION:Despite being at high risk of HIV acquisition, access to pre-exposure prophylaxis (PrEP) among adolescent girls and young women (AGYW) is low in Zambia because PrEP is traditionally delivered in clinical settings. We describe the effects of community centres supported by the Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe (DREAMS) initiative on PrEP outcomes in Zambia and examine factors associated with PrEP continuation. METHODS:We collected individual-level PrEP data for AGYW aged 15-24 years at risk of HIV acquisition and enrolled in DREAMS in seven districts of Zambia between August 2022 and August 2024. We used Pearson's Chi-squared test to examine differences in beneficiary characteristics between clients with a PrEP initiation visit and ≥ 2 PrEP visits (i.e. an initiation plus ≥ 1 return visit), and mixed effects Poisson regression modelling to estimate the association between DREAMS enrolment criteria and PrEP continuation (defined as ≥ 1 PrEP visit within 180 days of initiation). We also estimated the marginal probability of PrEP continuation by number of DREAMS enrolment criteria and used Kaplan-Meier methods to estimate the time to the first PrEP return visit by client age band. RESULTS:Between 11 August 2022 and 23 August 2024, 15,502 AGYW aged 15-24 years were screened for PrEP eligibility, of whom 15,072 (97.2%) initiated PrEP per national guidelines. Of those initiating PrEP, 9807 (65.1%) had sufficient follow-up time to allow for observation of a PrEP return visit. The proportion of AGYW who had ≥ 1 PrEP return visit within 180 days of initiation was 59.0% (n/N = 5706/9675). Across age bands, the percent probability of having a PrEP return visit within 180 days of initiation was highest among clients who reported ≥ 4 DREAMS enrolment criteria at 91.7% (95% CI: 70.7, 112.7%) for clients aged 15-19 years and 83.6% (95% CI: 61.1, 106.2%) for clients aged 20-24 years. Overall, 41.5% of clients had a first PrEP return visit between 21 and 42 days of PrEP initiation. CONCLUSIONS:The high number and proportion of AGYW initiated on PrEP suggests that decentralising PrEP services to DREAMS community centres has the potential to improve PrEP access among AGYW. Increasing HIV risk perception among AGYW may improve PrEP continuation.

Objective Malawi’s prisons are overcrowded, contributing to tuberculosis (TB) and Human Immunodeficiency Virus (HIV) transmission and service delivery gaps for both conditions. We applied an empirically supported three-stage model of HIV/TB care to guide the improvement of TB/HIV service delivery in select Malawian prisons.Design We conducted a pilot implementation research study using multimethods from May 2022 to April 2023.Setting Two semi-urban prisons in Malawi.Participants We purposively sampled participants detained at the study sites during the study period.Methods and intervention We collected data on sociodemographics, medical history and screening results for sexually transmitted infections (STIs), HIV and TB results. We conducted in-depth interviews with prison professional staff and used content analysis to explore the feasibility of implementing the three-stage model of HIV and TB care in Malawian prisons.Results Mean participant age was 35 years (SD 12.2 years). We screened 100 out of 647 (15%) incarcerated people for TB/HIV according to the three-stage model and identified the following: five cases of TB disease; two cases of HIV-associated TB; seven persons living with HIV; eight persons diagnosed and treated for STIs, including genital ulcer disease and syphilis. For those tested for HIV at entry, midpoint and exit screening, there was no documented case of seroconversion during the incarceration period. There was evidence of potential STI transmission during incarceration, as suggested by a 4% rate of new urethral discharge among participants. Qualitative data suggest that it is feasible to implement the three-stage model of HIV/TB in the Malawi prison setting.Conclusions We found evidence of HIV, TB and STIs among incarcerated people in two semi-urban prisons in Malawi, with low HIV status awareness on prison entry. It is feasible to implement the three-stage model of HIV/TB in prison settings, although with material support to overcome implementation challenges. Coordination with Ministry of Health officials could facilitate model feasibility and sustainability in Malawi’s prisons.

INTRODUCTION:"Programme science" deploys scientific methods to address questions that are a priority to support the impact of public health programmes. As such, programme science responds to the challenges of making such studies: (1) feasible to undertake, (2) useful, (3) rigorous, (4) real-world-relevant, (5) informative, and undertaken by (6) equitable partnerships. The acronym "FURRIE" is proposed to describe this set of six challenges. This paper discusses selected HIV/STI (sexually transmitted infection) programme science case studies to illustrate how programme science rises to the FURRIE challenges. DISCUSSION:One way in which programme science is made more feasible is through the analysis and interpretation of data collected through service delivery. For some questions, these data can be augmented through methods that reach potential clients of services who have not accessed services or been lost to follow-up. Process evaluation can enhance the usefulness of programme science by studying implementation processes, programme-client interactions and contextual factors. Ensuring rigour by limiting bias and confounding in the real-world context of programme science studies requires methodological innovation. Striving for scientific rigour can also have the unintended consequence of creating a gap between what happens in a study, and what happens in the "real-world." Community-led monitoring is one approach to grounding data collection in the real-world experience of clients. Evaluating complex, context-specific strategies to strengthen health outcomes in a way that is informative for other settings requires clear specification of the intervention packages that are planned and delivered in practice. Programme science provides a model for equitable partnership through co-leadership between programmes, researchers and the communities they serve. CONCLUSIONS:Programme science addresses the FURRIE challenges, thereby improving programme impact and ultimately health outcomes and health equity. The adoption and adaptation of the types of novel programme science approaches showcased here should be promoted within and beyond the HIV/STI field.

BACKGROUND:Despite increasing morbidity and mortality from non-communicable diseases (NCD) globally, health systems in low- and middle-income countries (LMICs) have limited capacity to address these chronic conditions, particularly in sub-Saharan Africa (SSA). There is an urgent need, therefore, to respond to NCDs in SSA, beginning by applying lessons learned from the first global response to any chronic disease-HIV-to tackle the leading cardiometabolic killers of people living with HIV (PLHIV). We have developed a feasible and acceptable package of evidence-based interventions and a multi-faceted implementation strategy, known as "TASKPEN," that has been adapted to the Zambian setting to address hypertension, diabetes, and dyslipidemia. The TASKPEN multifaceted implementation strategy focuses on reorganizing service delivery for integrated HIV-NCD care and features task-shifting, practice facilitation, and leveraging HIV platforms for NCD care. We propose a hybrid type II effectiveness-implementation stepped-wedge cluster randomized trial to evaluate the effects of TASKPEN on clinical and implementation outcomes, including dual control of HIV and cardiometabolic NCDs, as well as quality of life, intervention reach, and cost-effectiveness.METHODS:The trial will be conducted in 12 urban health facilities in Lusaka, Zambia over a 30-month period. Clinical outcomes will be assessed via surveys with PLHIV accessing routine HIV services, and a prospective cohort of PLHIV with cardiometabolic comorbidities nested within the larger trial. We will also collect data using mixed methods, including in-depth interviews, questionnaires, focus group discussions, and structured observations, and estimate cost-effectiveness through time-and-motion studies and other costing methods, to understand implementation outcomes according to Proctor's Outcomes for Implementation Research, the Consolidated Framework for Implementation Research, and selected dimensions of RE-AIM.DISCUSSION:Findings from this study will be used to make discrete, actionable, and context-specific recommendations in Zambia and the region for integrating cardiometabolic NCD care into national HIV treatment programs. While the TASKPEN study focuses on cardiometabolic NCDs in PLHIV, the multifaceted implementation strategy studied will be relevant to other NCDs and to people without HIV. It is expected that the trial will generate new insights that enable delivery of high-quality integrated HIV-NCD care, which may improve cardiovascular morbidity and viral suppression for PLHIV in SSA. This study was registered at ClinicalTrials.gov (NCT05950919).

BACKGROUND:People in correctional settings are a key population for HIV epidemic control. We sought to demonstrate scale-up of universal test and treat in correctional facilities in South Africa and Zambia through a virtual cross-sectional analysis. METHODS:We used routine data on 2 dates: At the start of universal test and treat implementation (time 1, T1) and 1 year later (time 2, T2). We obtained correctional facility census lists for the selected dates and matched HIV testing and treatment data to generate virtual cross-sections of HIV care continuum indicators. RESULTS:In the South African site, there were 4193 and 3868 people in the facility at times T1 and T2; 43% and 36% were matched with HIV testing or treatment data, respectively. At T1 and T2, respectively, 1803 (43%) and 1386 (36%) had known HIV status, 804 (19%) and 845 (21%) were known to be living with HIV, and 60% and 56% of those with known HIV were receiving antiretroviral therapy (ART). In the Zambian site, there were 1467 and 1366 people in the facility at times T1 and T2; 58% and 92% were matched with HIV testing or treatment data, respectively. At T1 and T2, respectively, 857 (59%) and 1263 (92%) had known HIV status, 277 (19%) and 647 (47%) were known to be living with HIV, and 68% and 68% of those with known HIV were receiving ART. CONCLUSIONS:This virtual cross-sectional analysis identified gaps in HIV testing coverage, and ART initiation that was not clearly demonstrated by prior cohort-based studies.

AbstractIntroductionOptimizing uptake of pre‐exposure prophylaxis (PrEP) for individuals at risk of HIV acquisition has been challenging despite clear scientific evidence and normative guidelines, particularly for key populations (KPs) such as men who have sex with men (MSM), female sex workers (FSWs), transgender (TG) people and persons who inject drugs (PWID). Applying an iterative Programme Science cycle, building on the effective programme coverage framework, we describe the approach used by the Centre for Infectious Disease Research in Zambia (CIDRZ) to scale up PrEP delivery and address inequities in PrEP access for KP in Lusaka, Zambia.MethodsIn 2019, CIDRZ partnered with 10 local KP civil society organizations (CSOs) and the Ministry of Health (MOH) to offer HIV services within KP‐designated community safe spaces. KP CSO partners led KP mobilization, managed safe spaces and delivered peer support; MOH organized clinicians and clinical commodities; and CIDRZ provided technical oversight. In December 2021, we introduced a community‐based intervention focused on PrEP delivery in venues where KP socialize. We collected routine programme data from September 2019 to June 2023 using programme‐specific tools and the national electronic health record. We estimated the before‐after effects of our intervention on PrEP uptake, continuation and equity for KP using descriptive statistics and interrupted time series regression, and used mixed‐effects regression to estimate marginal probabilities of PrEP continuity.ResultsMost (25,658) of the 38,307 (67.0%) Key Population Investment Fund beneficiaries were reached with HIV prevention services at community‐based venues. In total, 23,527 (61.4%) received HIV testing services, with 15,508 (65.9%) testing HIV negative and found PrEP eligible, and 15,241 (98.3%) initiating PrEP. Across all programme quarters and KP types, PrEP uptake was >90%. After introducing venue‐based PrEP delivery, PrEP uptake (98.7% after vs. 96.5% before, p < 0.001) and the number of initiations (p = 0.014) increased significantly. The proportion of KP with ≥1 PrEP continuation visit within 6 months of initiation was unchanged post‐intervention (46.7%, 95% confidence interval [CI]: 45.7%, 47.6%) versus pre‐intervention (47.2%, 95% CI: 45.4%, 49.1%).ConclusionsApplying Programme Science principles, we demonstrate how decentralizing HIV prevention services to KP venues and safe spaces in partnership with KP CSOs enabled successful community‐based PrEP delivery beyond the reach of traditional facility‐based services.