Faculty Bibliography

BACKGROUND:The Bridging Income Generation with Group Integrated Care (BIGPIC) trial in rural Kenya showed that integrating usual care with group medical visits or microfinance interventions reduced systolic blood pressure and cardiovascular risk in participants. We aimed to estimate the incremental cost-effectiveness of three BIGPIC interventions for a modelled cohort and by sex, as well as the cost of implementing these interventions. METHODS:For this analysis, we used data collected during the BIGPIC trial, a four-group, cluster-randomised trial conducted in the western Kenyan catchment area of the Academic Model Providing Access to Healthcare. BIGPIC enrolled participants from 24 rural health facilities in rural western Kenya aged 35 years or older with either increased blood pressure or diabetes. Participants were assigned to receive either usual care, group medical visits, microfinance, or a combination of group medical visits and microfinance (GMV-MF). Our model estimated the incremental cost-effectiveness of the three BIGPIC interventions via seven health states (ie, a hypertensive state, five chronic cardiovascular-disease states, and a death state) by simulating transitions between health states for a hypothetical cohort of individuals with hypertension on the basis of QRISK3 scores. In every cycle, participants accrued costs and disability-adjusted life-years (DALYs) associated with their health state. Incremental cost-effectiveness ratios (ICERs) were calculated for the entire modelled cohort and by sex by dividing the incremental cost by the incremental effectiveness of the next most expensive intervention. The main outcome of this analysis was ICERs for each intervention evaluated. This analysis is registered at ClinicalTrials.gov (NCT02501746). FINDINGS/RESULTS:Between Feb 6, 2017, and Dec 29, 2019, 2890 people were recruited to the BIGPIC trial. 2020 (69·9%) of 2890 participants were female and 870 (30·1%) were male. At baseline, mean QRISK3 score was 11·5 (95% CI 11·1-11·9) for the trial population, 11·9 (11·5-12·2) for male participants, and 11·3 (11·0-11·6) for female participants. For the population of Kenya, group medical visits were estimated to cost US$7 more per individual than usual care and result in 0·005 more DALYs averted (ICER $1455 per DALY averted). Microfinance was estimated to cost $19 more than group medical visits but was only estimated to avert 0·001 more DALYs. Relative to group medical visits, GMV-MF was estimated to cost $29 more and avert 0·009 more DALYs ($3235 per DALY averted). Relative to usual care, GMV-MF was estimated to cost $37 more and avert 0·014 more DALYs ($2601 per DALY averted). In the first year of the intervention, usual care was estimated to be the least expensive intervention to implement ($87 per participant; $10 238 per health-facility catchment area [HFCA]), then group medical visits ($99 per participant; $12 268 per HFCA), then microfinance ($120 per participant; $14 172 per HFCA), with GMV-MF estimated to be the most expensive intervention to implement ($139 per participant; $16 913 per HFCA). INTERPRETATION/CONCLUSIONS:Group medical visits and GMV-MF were estimated to be cost-effective strategies to improve blood-pressure control in rural Kenya. However, which intervention to pursue depends on resource availability. Policy makers should consider these factors, in addition to sex differences in programme effectiveness, when selecting optimal implementation strategies. FUNDING/BACKGROUND:US National Institutes of Health.

INTRODUCTION/BACKGROUND:Adolescent girls and young women (AGYW) in India face additional health inequities compared to their male peers, as gender norms constrain agency for prevention and self-care. The onset of the COVID-19 pandemic and associated lockdowns deepened health inequities and often worsened mental health, but the impacts on agency are unclear. This exploratory sequential mixed methods paper examined mental health and COVID-19 elements that exacerbated or mitigated adverse consequences for AGYW in low-income communities in Mumbai. METHODS:We conducted semi-structured interviews with AGYW (aged 15-25 years; N = 60) and adults (parents, healthcare providers, community-based organization representative; N = 30). We administered a structured survey to AGYW (N = 150) to assess health concerns, depression and anxiety symptoms (using the PHQ-8 and GAD-7 scales), and experiences during COVID-19. We analyzed qualitative data using the constant comparative approach in Atlas.ti, and quantitative data using R and SPSS. RESULTS:Qualitative data revealed that AGYW faced stressors and had limited agency during lockdowns due to limited access to education, financial insecurity, and community violence. Quantitative data indicated that limited agency in the context of COVID-19 was significantly associated with depression and anxiety. Financial resources to address COVID-19 created new employment and leadership opportunities for AGYW to become COVID educators and preschool teachers; participation in these opportunities was associated with less anxiety. DISCUSSION/CONCLUSIONS:Pandemic stress was difficult for low-income AGYW in Mumbai. Mitigating programs for COVID-19 control helped address acute needs and enable capabilities. Exploring similar themes among a broader population of youth can help design strategies and opportunities for young people in low-income communities during health emergencies.

INTRODUCTION/UNASSIGNED:Scaling up interventions targeting non-communicable diseases (NCDs) is a global health priority, and implementation research can contribute to that effort. In 2019, the Global Alliance for Chronic Diseases funded 27 implementation research studies to improve evidence for scaling up interventions targeting prevention and/or control of hypertension and/or diabetes in low-resource settings. We examined these studies to improve the understanding of the implementation factors, including challenges and facilitators, that influence the early implementation phase of scale-up research projects targeting NCDs. METHODS/UNASSIGNED:This qualitative study was undertaken between August 2020 and July 2021. 43 semi-structured interviews were conducted with project investigators, implementers and policymakers, across 19 diverse scale-up projects, being implemented in 20 countries. The transcripts were inductively, open-coded using thematic analysis. Generated themes were mapped systematically to four out of five domain categorisations of the Consolidated Framework for Implementation Research (CFIR); the innovation domain fell outside the scope of this study. RESULTS/UNASSIGNED:Highlighted findings using CFIR are: (i) outer setting: influence of politics, lack of coordination between government departments and differing agendas towards NCDs hindered implementation while reliable and trustworthy government connections proved useful; (ii) inner setting: commitment of resources for implementation was a challenge while research capacity, work culture and trustworthy networks facilitated implementation; (iii) individuals: high-level stakeholder support and leadership was essential; (iv) process: extensive time and efforts required for stakeholder engagement towards local contextualisation was challenging, while collaborating, joint reflection, effective communication and adaptation facilitated. COVID-19 provided both challenges and opportunities and these varied depending on the intervention characteristics and study objectives. CONCLUSION/UNASSIGNED:Researchers supporting the scale-up of complex interventions targeting NCDs need to leverage on existing trusting relationships and foster equitable stakeholder partnerships through research. Interpersonal skills and good communication are essential complements to research expertise and must be considered during capacity building.

BACKGROUND:Poverty can be a robust barrier to HIV care engagement. We assessed the extent to which delivering care for HIV, diabetes and hypertension within community-based microfinance groups increased savings and reduced loan defaults among microfinance members living with HIV. METHODS:We analyzed cluster randomized trial data ascertained during November 2020-May 2023 from 57 self-formed microfinance groups in western Kenya. Groups were randomized 1:1 to receive care for HIV and non-communicable diseases in the community during regular microfinance meetings (intervention) or at a health facility during routine appointments (standard care). Community and facility care provided clinical evaluations, medications, and point-of-care testing. The trial enrolled 900 microfinance members, with data collected quarterly for 18-months. We used a two-part model to estimate intervention effects on microfinance shares purchased, and a negative binomial regression model to estimate differences in loan default rates between trial arms. We estimated effects overall and by participant characteristics. RESULTS:Participants' median age and distance from a health facility was 52 years and 5.6 km, respectively, and 50% reported earning less than $50 per month. The probability of saving any amount (>$0) through purchasing microfinance shares was 2.7 percentage points higher among microfinance group members receiving community vs. facility care. Community care recipients and facility care patients saved $44.90 and $25.24 over 18-months, respectively, and the additional amount saved by community care recipients was statistically significant (p = 0.036). Overall and in stratified analyses, loan defaults rates were not statistically significantly different between community and facility care patients. CONCLUSIONS:Receiving integrated care in the community was significantly associated with modest increases in savings. We did not find any significant association between community-delivered care and reductions in loan defaults among HIV-positive microfinance group members. Longer follow up examination and formal mediation analyses are warranted.

IMPORTANCE/UNASSIGNED:Despite higher atherosclerotic cardiovascular disease (ASCVD) risk, people with HIV (PWH) experience unique barriers to ASCVD prevention, such as changing models of HIV primary care. OBJECTIVE/UNASSIGNED:To test whether a multicomponent nurse-led strategy would improve systolic blood pressure (SBP) and non-high-density lipoprotein (HDL) cholesterol level in a diverse population of PWH receiving antiretroviral therapy (ART). DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This randomized clinical trial enrolled PWH at 3 academic HIV clinics in the US from September 2019 to January 2022 and conducted follow-up for 12 months until January 2023. Included patients were 18 years or older and had a confirmed HIV diagnosis, an HIV-1 viral load less than 200 copies/mL, and both hypertension and hypercholesterolemia. Participants were stratified by trial site and randomized 1:1 to either the multicomponent EXTRA-CVD (A Nurse-Led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention) intervention group or the control group. Primary analyses were conducted according to the intention-to-treat principle. INTERVENTION/UNASSIGNED:The EXTRA-CVD group received home BP monitoring guidance and BP and cholesterol management from a dedicated prevention nurse at 4 in-person visits (baseline and 4, 8, and 12 months) and frequent telephone check-ins up to every 2 weeks as needed. The control group received general prevention education sessions from the prevention nurse at each of the 4 in-person visits. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Study-measured SBP was the primary outcome, and non-HDL cholesterol level was the secondary outcome. Measurements were taken over 12 months and assessed by linear mixed models. Prespecified moderators tested were sex at birth, baseline ASCVD risk, and trial site. RESULTS/UNASSIGNED:A total of 297 PWH were randomized to the EXTRA-CVD arm (n = 149) or control arm (n = 148). Participants had a median (IQR) age of 59.0 (53.0-65.0) years and included 234 males (78.8%). Baseline mean (SD) SBP was 135.0 (18.8) mm Hg and non-HDL cholesterol level was 139.9 (44.6) mg/dL. At 12 months, participants in the EXTRA-CVD arm had a clinically significant 4.2-mm Hg (95% CI, 0.3-8.2 mm Hg; P = .04) lower SBP and 16.9-mg/dL (95% CI, 8.6-25.2 mg/dL; P < .001) lower non-HDL cholesterol level compared with participants in the control arm. There was a clinically meaningful but not statistically significant difference in SBP effect in females compared with males (11.8-mm Hg greater difference at 4 months, 9.6 mm Hg at 8 months, and 5.9 mm Hg at 12 months; overall joint test P = .06). CONCLUSIONS AND RELEVANCE/UNASSIGNED:Results of this trial indicate that the EXTRA-CVD strategy effectively reduced BP and cholesterol level over 12 months and should inform future implementation of multifaceted ASCVD prevention programs for PWH. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT03643705.

INTRODUCTION/UNASSIGNED:The burden of multimorbidity is recognised increasingly in low- and middle-income countries (LMICs), creating a strong emphasis on the need for effective evidence-based interventions. A core outcome set (COS) appropriate for the study of multimorbidity in LMIC contexts does not presently exist. This is required to standardise reporting and contribute to a consistent and cohesive evidence-base to inform policy and practice. We describe the development of two COS for intervention trials aimed at the prevention and treatment of multimorbidity in LMICs. METHODS/UNASSIGNED:To generate a comprehensive list of relevant prevention and treatment outcomes, we conducted a systematic review and qualitative interviews with people with multimorbidity and their caregivers living in LMICs. We then used a modified two-round Delphi process to identify outcomes most important to four stakeholder groups with representation from 33 countries (people with multimorbidity/caregivers, multimorbidity researchers, healthcare professionals, and policy makers). Consensus meetings were used to reach agreement on the two final COS. Registration: https://www.comet-initiative.org/Studies/Details/1580. RESULTS/UNASSIGNED:The systematic review and qualitative interviews identified 24 outcomes for prevention and 49 for treatment of multimorbidity. An additional 12 prevention, and six treatment outcomes were added from Delphi round one. Delphi round two surveys were completed by 95 of 132 round one participants (72.0%) for prevention and 95 of 133 (71.4%) participants for treatment outcomes. Consensus meetings agreed four outcomes for the prevention COS: (1) Adverse events, (2) Development of new comorbidity, (3) Health risk behaviour, and (4) Quality of life; and four for the treatment COS: (1) Adherence to treatment, (2) Adverse events, (3) Out-of-pocket expenditure, and (4) Quality of life. CONCLUSION/UNASSIGNED:Following established guidelines, we developed two COS for trials of interventions for multimorbidity prevention and treatment, specific to LMIC contexts. We recommend their inclusion in future trials to meaningfully advance the field of multimorbidity research in LMICs.

Air pollution is a critical global health issue that significantly impacts cardiovascular health. The air pollutant PM_2.5 (particulate matter with a diameter of 2.5 micrometres or less) has been positioned as a leading environmental risk factor for morbidity and mortality, especially from cardiovascular diseases (CVDs). Using data from the World Health Organization (WHO), Global Health Observatory, and the United Nations Environment Programme, we explored global trends in air pollution, with a focus on PM_2.5 levels, the implications for cardiovascular health, and the policy measures aimed at reducing their impact. Despite progress in reducing pollution levels in high-income countries, global trends show a limited annual reduction in PM_2.5 concentration. The analysis highlights disparities between regions, with low- and middle-income countries bearing the brunt of air pollution-related CVDs. In 2019 alone, ambient air pollution was responsible for approximately 4.2 million deaths worldwide. Of these, 70% were caused by CVDs, with approximately 1.9 million deaths from ischemic heart disease and 900,000 deaths from stroke. Policy gaps remain a challenge, with many countries lacking adequate legally binding air quality standards. We recommend the adoption of WHO air quality guidelines, enhanced monitoring of air pollution levels, and increased investment in interdisciplinary research to understand the full scope of air pollution's effects on cardiovascular health. Addressing the global cardiovascular crisis linked to air pollution will require coordinated efforts from policymakers, healthcare systems, and global health organisations.

INTRODUCTION:Governments must scale-up evidence-based interventions to reduce the burden of non-communicable diseases (NCDs). Implementation research can help develop contextually appropriate strategies and optimise interventions for scale-up. We aimed to determine the priorities of the Global Alliance for Chronic Diseases (GACD) 2019 funding round for scale-up research targeting NCD interventions. The research questions were: (a) What was the purpose of the call and what were the specific issues considered by funders when supporting the selected projects? (b) How did the selected research projects align with the objectives of GACD scale-up call? METHODS:We undertook a mixed-methods study to examine the projects funded by the GACD in 2019. We completed semistructured interviews with representatives from 5 out of 8 funding agencies and complemented this by reviewing project documents from 21 (78%) of the 27 funded studies. A literature review of scale-up frameworks informed the interview guide and data extraction template. The transcripts were open-coded using thematic analysis to identify critical issues for funders. Data were extracted to identify the common elements considered when planning, implementing and evaluating interventions for scale-up. RESULTS:Interviews with the funders revealed three enabling themes related to scale-up: local research priorities (contextualisation through engagement), capacity building (developing knowledge base) and connections (networking opportunities). We further identified that timelines (more flexibility) and equity (funding low-income and middle-income researchers) could be considered for future funding investments. Multidisciplinary international research teams led the development of diverse studies to address funder's priorities. The detailed plans included a range of implementation frameworks to help develop contextual scale-up strategies. CONCLUSIONS:Fundamental to NCD scale-up research are (1) funding opportunities that reflect the complexity and time necessary to enable contextualisation; (2) investment in building multidisciplinary research capacity and leadership and (3) better networking to encourage cohesive action and align NCD-related scale-up research activities globally.