HARAMBEE: Integrated Community-Based HIV/NCD Care & Microfinance Groups in Kenya
Agency: NIH (National Institute of Mental Health: R01MH118075)
Period: 07/05/2019 – 04/30/2025
Project website: https://sites.brown.edu/harambeetrial/
Sustained viral suppression (VS) continues to present major challenges to HIV treatment and prevention. Retention in care is a particularly challenging issue for persons living with HIV (PLHIV) because of lack of convenient access and issues related to economic stability. Our long-term goal is to help achieve the 90-90-90 goals through improved care delivery based on rigorous implementation research. The objective of this project is to demonstrate the effectiveness and longer-term sustainability of a differentiated care delivery model for improving HIV treatment outcomes. The central hypothesis is that the integration of HIV care delivery and community-based primary care with group-based microfinance will improve retention and rates of VS among PLHIV in Kenya via two mechanisms: improved household economic status and easier access to care. Thus, the specific aims are as follows: (1) To evaluate the extent to which integrated community-based HIV care with group microfinance affects retention in care and VS among PLHIV in rural western Kenya using a cluster randomized intervention design of existing (fully HIV+) microfinance groups to receive either: (A) integrated community-based HIV care, or (B) standard care. We will also augment trial data with a matched contemporaneous control group of patients in standard care (group C) comparing outcomes in groups A, B and C; (2) To identify specific mechanisms through which microfinance and integrated community-based care impact VS: Using a mixed methods approach, we will characterize the mechanisms of effect on patient outcomes. We will conduct quantitative mediation analysis to examine two main mediating pathways (household economic conditions and easier access to care), as well as exploratory mechanisms (food security, social support, HIV- related stigma). We will also use qualitative methods and multi-stakeholder panels to contextualize the implementation of the intervention; and (3) To assess the cost-effectiveness of microfinance and integrated community-based care delivery to maximize future policy and practice relevance of this promising intervention strategy. Our working hypothesis is that the differentiated model will be cost-effective in terms of cost per HIV suppressed person-time, cost per patient retained in care, and cost per disability-adjusted life year saved. This project is part of the Academic Model Providing Access to Healthcare (AMPATH) program in western Kenya which cares for more than 150,000 PLHIV at over 500 sites in western Kenya since 2001. The main expected outcomes will be rigorous evidence of effectiveness, mechanisms and cost-effectiveness of a differentiated model for achieving the last key step in the HIV care continuum. These results are expected to have an important positive impact in terms of improved, high-quality services that address known individual and structural barriers to care and promote long-term sustainability of care for PLHIV in rural settings with high HIV prevalence.
Impact of Prescription Caps on Health Outcomes in People Infected with HIV
Agency: NIH (National Institute of Mental Health: R01MH122301)
Period: 8/01/2020 – 5/31/2025
The availability of contemporary antiretroviral therapy (ART) has changed infection into a manageable chronic disease for people living with HIV (PLWH) who have access to and are adherent with treatment. Adherence to medications for either HIV or major medical and mental health conditions is frequently suboptimal even for those with prescription coverage. Those with multiple, chronic diseases face compounded adverse consequences when they fail to take necessary medications. Prescription drug cost containment efforts may undermine long-term adherence with implications for adverse health consequences, though the body of literature is fairly limited and dated particularly in the context of HIV. Despite this understanding, plan managers, particularly states’ Medicaid programs, continue to implement restrictions through a variety of utilization management strategies such as prescription cap policies, limiting the number of medications covered per month. In our recent analyses of persistence rates for ART, renin angiotensin antagonists, and metformin in HIV+ versus HIV- Medicaid enrollees, we noted lower persistence in states with restrictive prescription caps. Our long-term research goal is to ensure effective medication utilization management policies which balance budget priorities with population quality and quantity of life. The objective of this application is to evaluate the how Medicaid prescription cap policies impact the health of persons with HIV and public expenditures. We propose to study national enrollment, prescription, hospital, and medical claims data across multiple years, exploiting the adoption of, changes to, and redaction of medication caps. In particular, we will study Medicaid and Medicare enrollees with HIV to illustrate how state-based policies contribute to outcomes in this particularly vulnerable population. These natural experiments will offer significant insights into the impact of restrictive prescription policies on patients’ health outcomes and public budgets. The central hypothesis is that prescription caps will lead patients with HIV to greater rates of HIV and non-HIV chronic disease complications, leading to additional costs. The rationale for this hypothesis is that people with HIV frequently have co-occurring conditions likely to require several prescriptions simultaneously and capping the number they receive each month may undermine their health. We have already made a large investment in and established extensive experience with Medicaid claims data from 14 high HIV prevalence states (2001- 2012). Through the addition of three more years of Medicaid claims (2013-2015) and the inclusion of Medicare Parts A, B and D claims from ~300,000 HIV infected beneficiaries across the country from 2006-2015, we will have a comprehensive infrastructure from which we can describe the impact of prescription caps on ART adherence, evaluate the impact of prescription cap policies on adherence to medications for major comorbid conditions (i.e., diabetes, cardiovascular disease, serious mental illness), and estimate the potentially avoidable health and economic effects of ART and chronic disease medication adherence.
Empirical testing of a widely available insurance-based monetary incentive program for exercise: A randomized trial
Agency: NIH (National Cancer Institute: R01CA262894)
Period: 7/15/2021 – 6/30/2026
Participation in regular physical activity (PA) has numerous health benefits including reduced risk of all-cause mortality,1-7 cardiovascular disease,8-12 diabetes,13-16 and cancers of the breast17-19 and colon,20-23 as well as energy balance.24 However, only 54% of U.S. adults meet national guidelines of expending > 1000 kcals/week through PA,25 and as few as 10% meet guidelines when objective assessments of PA are used.26 Thus, there is a need to improve adherence to PA programs using innovative approaches. Economic incentives have been shown to be powerful motivators for behavior change and for improving health outcomes.28-37 While there is evidence suggesting the general efficacy of incentive programs for increasing PA,38 research has not yet demonstrated the optimal format for incentive programs. Nonetheless, spurred by organizational incentives (i.e., tax breaks) provided by the Affordable Health Care Act, major insurance companies are now offering economic incentives for regular attendance at fitness facilities in the absence of empirical support. Thus, we propose to conduct an RCT to examine the efficacy of the exercise incentive program currently offered by three major US insurance companies39-41 consisting of a $200 rebate on fitness facility membership fees for at least 50 confirmed visits to the fitness facility (maximum 1/day, verified by objective swipe-card data) over 6 months. In the context of the RCT, we will also compare the insurance-based standard incentive program to a second, loss-frame incentive condition in which the same incentive schedule is used, but with participants told (and reminded during the course of the program) that $200 of their membership fee is being held and will be returned or forfeited depending on whether they use the gym at least 50 times in the next 6 months. The proposed RCT will be conducted in a community setting at the Greater Providence YMCAs. Aim 1. Conduct an RCT (N=330) comparing (a) the widely used insurance-based Standard incentives program (n=110), (b) a Loss-framed incentive program (n=110), and (c) no-incentive Control (n=110). Each participant will be enrolled for two consecutive 6-month periods for a total of 12 months per participant. The primary outcome will be number of visits to the fitness facility. Secondary outcomes will include total moderate-to-vigorous PA (MVPA) over 7-day periods at 3-month intervals through accelerometers and self-reported MVPA. We hypothesize that the two incentive conditions will result in higher attendance at the YMCA and more PA, with the Loss-framed incentive program outperforming the Standard insurance-based program. Aim 2. Examine habit formation and anticipated regret as putative mediators and household income and age as moderators of the incentive-based programs. Aim 3. Conduct a within trial cost-utility analysis from a societal perspective to quantify (a) the incremental costs per quality-adjusted life year (QALY) gained, (b) cost per change in YMCA attendance, and (c) cost per incremental change in PA. We will additionally apply a productivity model to estimate the economic impact of the intervention on future household and labor force participation.
PrEP Seguro Randomized Pilot Trial to Improve Antiretroviral-Based HIV Prevention Among Male Sex Workers
Agency: NIH (National Institutes of Mental Health) R34MH114664
Period: July/01/2019 – 06/30/2022
Project website: https://sites.brown.edu/prepseguro/
Adherence is essential for the effectiveness of pre-exposure prophylaxis (PrEP) in reducing HIV transmission. Male sex workers (MSW), men who sell sex to other men, can benefit from PrEP because they are at high risk of HIV acquisition and transmission. However, they have difficulties adhering to a daily pill because they commonly have low awareness of their risk and limited knowledge of new prevention tools, and face barriers to access prevention services. Our long-term goal is to advance implementation of PrEP to reduce HIV incidence in key populations in low- and middle-income countries (LMICs). The objective of this R34 application is to prepare for testing innovative user-centered ways to promote PrEP adherence at scale. Our central hypothesis is that adherence to PrEP can be improved among MSW if PrEP is provided for free along with highly-tailored conditional economic incentives (CEI). The specific aims are: Aim 1: To refine the design of PrEP adherence intervention with user-centered conditional economic incentives to maximize sustained adherence behaviors through a user-responsive computerized survey (n=200). We incorporate quantitatively identified preferences for CEIs through a user- responsive computerized survey. We use conjoint analysis to understand preferences for CEI intervention components and how CEIs should be integrated into an optimal combination package to be tested in Aim 2. Aim 2: Measure the extent to which a user-centered CEI intervention can help MSW increase their adherence to free PrEP in a randomized controlled pilot (n=100). Among MSW who accept to take free PrEP, and return at month 1 for a second pill bottle, we will randomize n=100 MSW to either: standard of care (SoC: information, prescription, free PrEP) or CEI (SoC + incentives contingent on sufficiently-high adherence to PrEP). We will assess the primary outcome (biomarker of adherence using scalp hair analysis) at months 3 and 6, as well as secondary outcomes: clinic attendance/retention, medication possession ratio, self-reported PrEP use, and sexual behavioral disinhibition (number of partners, condom use, incident STI). Aim 3: Estimate the preliminary cost-effectiveness of incentives for PrEP adherence to maximize future policy and practice relevance of this promising intervention strategy. Our working hypothesis is that conditional economic incentives for PrEP adherence will be cost-effective in terms of cost per fully- adherent month on PrEP, cost per HIV infection averted, and cost per disability-adjusted life year saved when compared to controls not receiving the conditional incentives. The expected outcome of this R34 is a demonstration that is feasible to implement user-centered CEIs in this context, as well as preliminary efficacy and cost-effectiveness data. The project will have positive impact because it is a critical step toward scaled-up implementation of PrEP in this highly-at-risk population of MSWs in Mexico, with implications for other concentrated epidemics among MSW worldwide.
Empowerment through Education and Entrepreneurship for Indigenous Adolescents in Ecuador
Agency: Brown University Population Studies and Training Center
Period: 03/01/2023 – 08/31/2024
We propose to adapt and evaluate a multifaceted program to break the cycle of low-skilled jobs and high fertility among Indigenous Adolescents (IA) in Ecuador. The program will enhance human capital in two ways: (1) by providing entrepreneurial skills to enable IA to start income-generating activities; and (2) by increasing access to comprehensive sexuality education to enable IA to make informed decisions about sex, reproduction, and marriage. Research activities will include program adaptation based on cultural norms, and a pilot to test feasibility and acceptability. Sexual health education will be delivered through an existing online platform, and vocational modules will be delivered in afterschool “entrepreneurship clubs”. We will culturally adapt the program to Cotacachi, Imbabura, Ecuador (a region with high indigenous concentration), and recruit N=60 male and female IA in their last years of high school in Cotacachi to participate in the pilot study. Thirty (30) IA will go through the program over a semester, and n=30 will serve as a control, comparison group. These clubs will provide safe spaces for IA to meet and socialize with other adolescents. Similar programs have been successful in Bangladesh (through BRAC) and Uganda; the proposed study will provide novel evidence of the program’s feasibility and acceptability in Latin America