Food Insecurity During the COVID-19 Pandemic: A Longitudinal Mixed-Methods Study from a Cohort of HIV Clients in Uganda.

The COVID-19 pandemic threatens the food security of people in low-income countries. This is important for people living with HIV (PLWH) because HIV medication should be taken with food to avoid side-effects. We used survey data (n = 314) and qualitative interviews (n = 95) to longitudinally explore how the pandemic impacted food insecurity among PLWH in Kampala, Uganda. Prior to March 2020, 19.7% of respondents were food insecure. Our regression models estimate that food insecurity rose by 9.1 percentage points in our first round of surveys (June-September 2020; p < 0.05; t = 2.17), increasing to 17.2 percentage points in the second round of surveys (July-November 2021; p < 0.05; t = 2.32). Qualitative interviews reveal that employment loss and deteriorating support systems led to reduced meals and purchasing of cheaper foods. Respondents reported continuing to take their HIV medication even in the presence of food insecurity. Strategies for ensuring that PLWH have enough food should be prioritized so that the millions of PLWH in sub-Saharan Africa can take their medication without experiencing uncomfortable side-effects.Clinical Trials Registration Number NCT03494777.

Randomized Controlled Trial of Rise, A Community-Based Culturally Congruent Counseling Intervention to Support Antiretroviral Therapy Adherence Among Black/African American Adults Living with HIV.

Structural inequities have led to HIV disparities, including relatively low antiretroviral therapy adherence and viral suppression rates among Black Americans living with HIV. We conducted a randomized controlled trial of Rise, a community-based culturally congruent adherence intervention, from January 2018 to December 2021 with 166 (85 intervention, 81 control) Black adults living with HIV in Los Angeles County, California [M (SD) = 49.0 (12.2) years-old; 76% male]. The intervention included one-on-one counseling sessions using basic Motivational Interviewing style to problem solve about adherence, as well as referrals to address unmet needs for social determinants of health (e.g., housing services, food assistance). Assessments included electronically monitored adherence; HIV viral load; and baseline, 7-month follow-up, and 13-month follow-up surveys of sociodemographic characteristics, HIV stigma, medical mistrust, and HIV-serostatus disclosure. Repeated-measures intention-to-treat regressions indicated that Rise led to significantly (two-fold) higher adherence likelihood, lower HIV stigmatizing beliefs, and reduced HIV-related medical mistrust. Effects on HIV viral suppression, internalized stigma, and disclosure were non-significant. Moreover, Rise was cost-effective based on established standards: The estimated cost per person to reach optimal adherence was $335 per 10% increase in adherence. Interventions like Rise, that are culturally tailored to the needs of Black populations, may be optimal for Black Americans living with HIV (ClinicalTrials.gov #NCT03331978).

RESUMEN: Las desigualdades estructurales han dado lugar a disparidades relacionadas con el VIH, incluyendo la relativamente baja adherencia a la terapia antirretroviral (TAR) y las tasas de supresión viral entre los afroamericanos que viven con el VIH. Conducimos una prueba controlada aleatoria de Rise, una intervención de adherencia culturalmente congruente basada en la comunidad, desde Enero de 2018 hasta Diciembre de 2021 con 166 (85 intervención, 81 controlada) adultos afroamericanos que viven con el VIH en el condado de Los Ángeles, California [M (SD) = 49.0 (12,2) años; 76% de hombres]. La intervención incluyó sesiones de asesoramiento individualizadas, usando el estilo básico Motivacional para las entrevistas, para resolver los problemas de adherencia como también referencias para confrontar sus necesidades insatisfechas de los determinantes sociales de la salud (por ejemplo, servicios de vivienda y asistencia de alimentos). Las evaluaciones incluyeron la adherencia monitoreada electrónicamente; la carga viral del VIH; y encuestas de referencia, seguimiento a los 7 meses y seguimiento a los 13 meses sobre características sociodemográficas, el estigma del VIH, la desconfianza médica y divulgación del estado serológico respecto al VIH. Los efectos sobre la supresión viral del VIH, el estigma interiorizado y la revelación de información no fueron significativos. Además, Rise fue rentable según los estándares establecidos: El costo estimado por persona para alcanzar la adherencia óptima fue de 335 dólares por cada 10% de aumento en la adherencia. Las intervenciones como Rise, que se adaptan culturalmente a las necesidades de las poblaciones afroamericana, podrían ser óptimas para los estadounidenses afroamericanos que viven con el VIH.

A qualitative exploration of health-related present bias among HIV-positive adults in Uganda.

Decision-making errors such as present bias (PB) can have important consequences for health behaviors, but have been largely studied in the financial domain. We conducted a mixed-method study on PB in the context of ART adherence among clinic-enrolled adults in Uganda (n = 39). Specifically, we quantified PB by asking about preferences between medication available sooner to minimize headaches versus available later to cure headaches. We describe demographic similarities among PB participants and qualitatively explored how participants reflected on their PB (or absence thereof) in the context of health. Participants reporting PB were predominantly male, single/unmarried, older, had higher levels of education and income and more advanced HIV progression. Three common reasons for more present-biased choices provided were: (1) wanting to avoid pain, (2) wanting to return to work, and (3) fear of one's health worsening if s/he did not address their illness immediately. While PB in the financial domain often suggests that poorer individuals are more likely to prefer immediate rewards over their wealthier counterparts, our results suggest poor health is potentially a driving factor of PB. Further research is needed to build on these finding and inform how programs can frame key messages regarding ART adherence to patients displaying PB.Trial registration: ClinicalTrials.gov identifier: NCT03494777.

Increased Depression during COVID-19 Lockdown Associated with Food Insecurity and Antiretroviral Non-Adherence among People Living with HIV in Uganda.

The health and economic threats posed by the COVID-19 pandemic can be sources of great distress among people living with HIV, which in turn can impact the management of their HIV disease. We examined change in depression from pre- to post-lockdown restrictions and correlates of elevated depressive symptoms, including antiretroviral therapy (ART) adherence. Participants enrolled in a randomized controlled trial of an ART adherence intervention in Uganda. The month-12 follow-up assessment was fully administered just prior to the start of the pandemic-related lockdown in March 2020; at the conclusion of the lockdown three months later, we administered a mixed-methods phone-based assessment. ART adherence was electronically monitored throughout the study period, including during and after the lockdown. Depression was assessed with the 8-item Patient health questionnaire (PHQ-8), on which scores > 9 signify a positive screen for elevated depressive symptoms. A sample of 280 participants completed both the month-12 and post-lockdown assessments. Rates of elevated depressive symptoms nearly tripled from month 12 (n = 17, 6.1%) to the post-lockdown assessment (n = 50, 17.9%; McNemar test < .001). Elevated depressive symptoms at post-lockdown were associated with being female, indicators of economic struggles at month 12 (unemployment, low income, high food insecurity), and lower ART adherence during the 3-month lockdown period [mean of 71.9% (SD = 27.9) vs. 80.8% (SD = 24.1) among those not depressed; p = .041] in bivariate analysis. In multiple regression analysis, higher food insecurity [adj. OR (95% CI) = 4.64 (2.16-9.96)] and perception that the pandemic negatively impacted ART adherence [adj. OR (95% CI) = 1.96 (1.22-3.16)] remained associated with a greater likelihood of elevated depressive symptoms, when other correlates were controlled for. Qualitative data suggested that economic stressors (lack of food, work, and money) were key contributors to elevated depressive symptoms, and these stressors led to missed ART doses because of lack of food and stress induced forgetfulness. Elevated depressive symptoms significantly increased during the COVID-19 lockdown and was associated with food insecurity and reduced ART adherence. Mechanisms for identifying and treating depression and food insecurity are needed to help PLHIV cope with and mitigate the harmful effects of unexpected crises that may impede disease management and access to food.

"The one who doesn't take ART medication has no wealth at all and no purpose on Earth" - a qualitative assessment of how HIV-positive adults in Uganda understand the health and wealth-related benefits of ART.

BACKGROUND: Increases in life expectancy from antiretroviral therapy (ART) may influence future health and wealth among people living with HIV (PLWH). What remains unknown is how PLWH in care perceive the benefits of ART adherence, particularly in terms of improving health and wealth in the short and long-term at the individual, household, and structural levels. Understanding future-oriented attitudes towards ART may help policymakers tailor care and treatment programs with both short and long-term-term health benefits in mind, to improve HIV-related outcomes for PLWH. METHODS: In this qualitative study, we conducted semi-structured interviews among a subsample of 40 PLWH in care at a clinic in Uganda participating in a randomized clinical trial for treatment adherence in Uganda (clinicaltrials.gov: NCT03494777). Interviews were transcribed verbatim and translated from Luganda into English. Two co-authors independently reviewed transcripts, developed a detailed codebook, achieved 93% agreement on double-coded interviews, and analyzed data using inductive and deductive content analysis. Applying the social-ecological framework at the individual, household, and structural levels, we examined how PLWH perceived health and wealth-related benefits to ART. RESULTS: Our findings revealed several benefits of ART expressed by PLWH, going beyond the short-term health benefits to also include long-term economic benefits. Such benefits largely focused on the ability of PLWH to live longer and be physically and mentally healthy, while also fulfilling responsibilities at the individual level pertaining to themselves (especially in terms of positive long-term habits and motivation to work harder), at the household level pertaining to others (such as improved relations with family and friends), and at the structural level pertaining to society (in terms of reduced stigma, increased comfort in disclosure, and higher levels of civic responsibility). CONCLUSIONS: PLWH consider short and long-term health benefits of ART. Programming designed to shape ART uptake and increase adherence should emphasize the broader benefits of ART at various levels. Having such benefits directly integrated into the design of clinic-based HIV interventions can be useful especially for PLWH who face competing interests to increase medication adherence. These benefits can ultimately help providers and policymakers better understand PLWH's decision-making as it relates to improving ART-related outcomes.

Cost-effectiveness and economic returns of group-based parenting interventions to promote early childhood development: Results from a randomized controlled trial in rural Kenya.

BACKGROUND: Early childhood development (ECD) programs can help address disadvantages for the 43% of children under 5 in low- and middle-income countries (LMICs) experiencing compromised development. However, very few studies from LMIC settings include information on their program's cost-effectiveness or potential returns to investment. We estimated the cost-effectiveness, benefit-cost ratios (BCRs), and returns on investment (ROIs) for 2 effective group-based delivery models of an ECD parenting intervention that utilized Kenya's network of local community health volunteers (CHVs). METHODS AND FINDINGS: Between October 1 and November 12, 2018, 1,152 mothers with children aged 6 to 24 months were surveyed from 60 villages in rural western Kenya. After baseline, villages were randomly assigned to one of 3 intervention arms: a group-only delivery model with 16 fortnightly sessions, a mixed-delivery model combining 12 group sessions with 4 home visits, and a control group. At endline (August 5 to October 31, 2019), 1,070 children were retained and assessed for primary outcomes including cognitive and receptive language development (with the Bayley Scales of Infant Development, Third Edition) and socioemotional development (with the Wolke scale). Children in the 2 intervention arms showed better developmental outcomes than children in the control arm, although the group-only delivery model generally had larger effects on children. Total program costs included provider's implementation costs collected during the intervention period using financial reports from the local nongovernmental organization (NGO) implementer, as well as societal costs such as opportunity costs to mothers and delivery agents. We combined program impacts with these total costs to estimate incremental cost-effectiveness ratios (ICERs), as well as BCRs and the program's ROI for the government based on predictions of future lifetime wages and societal costs. Total costs per child were US$140 in the group-only arm and US$145 in the mixed-delivery arm. Because of higher intention-to-treat (ITT) impacts at marginally lower costs, the group-only model was the most cost-effective across all child outcomes. Focusing on child cognition in this arm, we estimated an ICER of a 0.37 standard deviation (SD) improvement in cognition per US$100 invested, a BCR of 15.5, and an ROI of 127%. A limitation of our study is that our estimated BCR and ROI necessarily make assumptions about the discount rate, income tax rates, and predictions of intervention impacts on future wages and schooling. We examine the sensitivity of our results to these assumptions. CONCLUSIONS: To the best of our knowledge, this study is the first economic evaluation of an effective ECD parenting intervention targeted to young children in sub-Saharan Africa (SSA) and the first to adopt a societal perspective in calculating cost-effectiveness that accounts for opportunity costs to delivery agents and program participants. Our cost-effectiveness and benefit-cost estimates are higher than most of the limited number of prior studies from LMIC settings providing information about costs. Our results represent a strong case for scaling similar interventions in impoverished rural settings, and, under reasonable assumptions about the future, demonstrate that the private and social returns of such investments are likely to largely outweigh their costs. TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov, NCT03548558, June 7, 2018. American Economic Association RCT Registry trial AEARCTR-0002913.

HIV Care Experiences During the COVID-19 Pandemic: Mixed-Methods Telephone Interviews with Clinic-Enrolled HIV-Infected Adults in Uganda.

COVID-19 measures that restrict movement may negatively impact access to HIV care and treatment. To contribute to the currently limited evidence, we used telephone interviews with quantitative and qualitative questions to examine how clients perceived COVID-19 and its effect on their HIV care and ART adherence. One hundred (n = 100) Ugandan adults on ART from an existing study were randomly selected and enrolled. Interviews were recorded, transcribed, and analyzed using descriptive statistics and rapid content analyses. 76% of clients indicated that COVID-19 negatively impacted travel to HIV clinics; 54% perceived that coming to the clinic increased their risk of acquiring COVID-19; and 14% said that COVID-19 had negatively impacted their ART adherence. Qualitative feedback suggests that fear of COVID-19 infection discouraged clinic attendance while stay-at-home orders helped routinize ART adherence and employ new community-based approaches for HIV care. Addressing negative unintended consequences of COVID-19 lockdowns on HIV care is urgently needed.

Lessons learned from a mobile technology-based intervention informed by behavioral economics to improve ART adherence among youth in Uganda.

Evidence suggests that simple text messaging interventions may not suffice to improve ART adherence among youth in low-resource settings. To address this shortcoming, we developed an intervention that shared weekly real-time adherence feedback to youth in Uganda using short message services (SMS), based on information tracked by an electronic device (Wisepill). We present results from 7 formative and 6 exit focus groups (FGs) in Mulago and Entebbe, Uganda with youth ages 15-24, providers, and Community Advisory Board members. Participants consistently conveyed positive impressions of Wisepill, noting that it helped store their medications, facilitated travel, served as a reminder, and motivated adherence. Participants raised phone-related issues before the study; most were addressed but some remained (e.g., limited network access, electricity for powering phones). Further, they highlighted the importance of carefully crafting text messages (e.g., use slang rather than potentially stigmatizing words) and viewed personalizing messages favorably but were divided on the desirability of including their name in study-related texts. Exit FGs confirmed that sharing group adherence levels with participants tapped into the competitive spirit common among youth. Our results suggest future mobile technology-based interventions can be improved by providing messages that go beyond simple reminders to provide individual and group-level adherence feedback.

Habit formation in support of antiretroviral medication adherence in clinic-enrolled HIV-infected adults: a qualitative assessment using free-listing and unstructured interviewing in Kampala, Uganda.

BACKGROUND: Despite initial high motivation, individuals receiving antiretroviral therapy (ART) for several years may experience incomplete adherence over time, increasing their risk of HIV-related morbidity and mortality. Habits, defined as automatic and regular practices, do not rely on conscious effort, and may therefore support high long-term ART adherence. METHODS: This qualitative study contributes to the evidence on how clients with adherence problems remember and form habits to take ART medications. Free-listing and unstructured interviewing were used among 42 clinic-enrolled adults in Kampala, Uganda who were receiving ART and participating in a randomized clinical trial for treatment adherence (clinicaltrials.gov: NCT03494777). Data were coded and analyzed using inductive content analysis. RESULTS: Findings indicated that clients' most routine habits (eating, bathing, sleeping) did not always occur at the same time or place, making it difficult to reliably link to pill-taking times. Efforts to improve ART habits included having a relative to ask about pill-taking, re-packaging medications, leaving medications in view, using alarms, carrying water, or linking pill-taking to radio/prayer schedules. Reported challenges were adhering to ART schedules during changing employment hours, social activities, and travel. CONCLUSION: While habit-forming interventions have the potential to improve ART adherence, targeting treatment-mature clients' existing routines may be crucial in this population.

"How am I going to live?": exploring barriers to ART adherence among adolescents and young adults living with HIV in Uganda.

BACKGROUND: Studies from sub-Saharan Africa (SSA) document how barriers to ART adherence present additional complications among adolescents and young adults living with HIV. We qualitatively explored barriers to ART adherence in Uganda among individuals age 14-24 to understand the unique challenges faced by this age group. METHODS: We conducted focus group (FG) discussions with Community Advisory Board members (n = 1), health care providers (n = 2), and male and female groups of adolescents age 14-17 (n = 2) and youth age 18-24 (n = 2) in Kampala, Uganda. FGs were transcribed verbatim and translated from Luganda into English. Two investigators independently reviewed all transcripts, developed a detailed codebook, achieved a pooled Cohen's Kappa of 0.79 and 0.80, and used a directed content analysis to identify key themes. RESULTS: Four barriers to ART adherence emerged: 1) poverty limited adolescents' ability to buy food and undercut efforts to become economically independent in their transition from adolescence to adulthood; 2) school attendance limited their privacy, further disrupting ART adherence; 3) family support was unreliable, and youth often struggled with a constant change in guardianship because they had lost their biological parents to HIV. In contrast peer influence, especially among HIV-positive youth, was strong and created an important network to support ART adherence; 4) the burden of taking multiple medications daily frustrated youth, often leading to so-called 'drug holidays.' Adolescent and youth-specific issues around disclosure emerged across three of the four barriers. CONCLUSIONS: To be effective, programs and policies to improve ART adherence among youth in Uganda must address the special challenges that adolescents and young adults confront in achieving optimal adherence. For example, training on budgeting and savings practices could help promote their transition to financial independence. School staff could develop strategies to help students take their medications consistently and confidentially. While challenging to extend the range of services provided by HIV clinics, successful efforts will require engaging the family, peers, and larger community of health and educational providers to support adolescents and young adults living with HIV to live longer and healthier lives. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02514356 . Registered August 3, 2015.

Behavioral Economic Incentives to Support HIV Care: Results From a Randomized Controlled Trial in Uganda.

BACKGROUND: This study tests behavioral economics incentives to improve adherence to antiretroviral treatment (ART), with 1 approach being low cost. SETTING: Three hundred twenty-nine adults at Mildmay Hospital in Kampala, Uganda, on ART for at least 2 years and showing adherence problems received the intervention for about 15 months until the study was interrupted by a nation-wide COVID-19 lockdown. METHODS: We randomized participants into 1 of 3 (1:1:1) groups: usual care ("control" group; n = 109) or 1 of 2 intervention groups where eligibility for nonmonetary prizes was based on showing at least 90% electronically measured ART adherence ("adherence-linked" group, n = 111) or keeping clinic appointments as scheduled ("clinic-linked"; n = 109). After 12 months, participants could win a larger prize for consistently high adherence or viral suppression. Primary outcomes were mean adherence and viral suppression. Analysis was by intention-to-treat using linear regression. This trial is registered with ClinicalTrials.gov, NCT03494777 . RESULTS: Neither incentive arm increased adherence compared with the control; we estimate a 3.9 percentage point increase in "adherence-linked" arm [95% confidence interval (CI): -0.70 to 8.60 ( P = 0.10)] and 0.024 in the "clinic-linked" arm [95% CI: -0.02 to 0.07 ( P = 0.28)]. For the prespecified subgroup of those with initial low adherence, incentives increased adherence by 7.60 percentage points (95% CI: 0.01, 0.15; P = 0.04, "adherence-linked") and 5.60 percentage points (95% CI: -0.01, 0.12; P = 0.10, "clinic-linked"). We find no effects on clinic attendance or viral suppression. CONCLUSIONS: Incentives did not improve viral suppression or ART adherence overall but worked for the prespecified subgroup of those with initial low adherence. More effectively identifying those in need of adherence support will allow better targeting of this and other incentive interventions.

The role of material deprivations in determining ART adherence: Evidence from a conjoint analysis among HIV-positive adults in Uganda.

Despite sustained global scale-up of antiretroviral therapy (ART), adherence to ART remains low. Less than half of those in HIV care in Uganda achieve 85% adherence to their ART medication required for clinically meaningful viral suppression, leaving them at higher risk of transmission. Key barriers to ART adherence include poverty-related structural barriers that are inter-connected and occur simultaneously, making it challenging to examine and disentangle them empirically and in turn design effective interventions. Many people living with HIV (PLWH) make tradeoffs between these various barriers (e.g., between expenses for food or transportation) and these can influence long-term health behavior such as adherence to ART. To be able to estimate the distinct influence of key structural barriers related to poverty, we administered a conjoint analysis (CA) to 320 HIV-positive adults currently taking ART at an urban clinic in Uganda between July 2019 and September 2020. We varied the levels of four poverty-related attributes (food security, sleep deprivation, monthly income, and physical pain) that occur simultaneously and asked respondents how they would adhere to their medication under different combinations of attribute levels. This allows us to disentangle the effect of each attribute from one another and to assess their relative importance. We used regression analysis to estimate the effects of each attribute level and found that food security impacts expected adherence the most (treatment effect = 1.3; 95% CI 1.11-1.49, p<0.001), followed by income (treatment effect = 0.99; 95% CI 0.88-1.10, p<0.001. Sleep and pain also impact adherence, although by a smaller magnitude. Sub-group analyses conducted via regression analysis examine heterogeneity in results and suggest that the effects of material deprivations on expected adherence are greater among those with high levels of existing food insecurity. Results from this CA indicate that external factors inherent in the lives of the poor and unrelated to direct ART access can be important barriers to ART adherence. This study applies a CA (typically administered in marketing applications) among PLWH to better understand individual-level perceptions relating to poverty that often occur simultaneously. Policy interventions should address food insecurity and income to improve adherence among HIV-positive adults.

Impact of the COVID-19 Pandemic on Use of HIV Care, Antiretroviral Therapy Adherence, and Viral Suppression: An Observational Cohort Study From Uganda.

INTRODUCTION: Recent studies project thousands of additional AIDS-related deaths because of COVID-19-related disruptions in HIV care. However, the extent to which disruptions in care have materialized since the start of the pandemic is not well understood. METHODS: We use electronic health records to investigate how the pandemic has affected clinic visits, patients' antiretroviral therapy (ART) supply, and viral suppression for a cohort of 14,632 HIV clients from a large HIV clinic in Kampala, Uganda. We complement this with an analysis of electronically measured longitudinal ART adherence data from a subcohort of 324 clients. RESULTS: Clinic visits decreased by more than 50% after a national lockdown started. The risk of patients running out of ART on a given day increased from 5% before the lockdown to 25% 3 months later (Relative Risk Ratio of 5.11, 95% confidence interval: 4.99 to 5.24) and remained higher than prelockdown 6 months later at 13% (Relative Risk Ratio of 2.60; 95% confidence interval: 2.52 to 2.70). There was no statistically significant change in electronically measured adherence or viral suppression. CONCLUSION: We document substantial gaps in HIV care after the start of the COVID-19 pandemic in Uganda. This suggests that measures to improve access should be explored as the pandemic persists. However, ART adherence was unaffected for the subcohort for whom we measured electronic adherence. This suggests that some clients may have stockpiles of ART tablets from previous prescriptions that allowed them to keep taking their medication even when they could not visit the clinic for ART refills.

Group-based parenting interventions to promote child development in rural Kenya: a multi-arm, cluster-randomised community effectiveness trial.

BACKGROUND: Early childhood development (ECD) programmes can help address early disadvantages for the 43% of children younger than 5 years in low-income and middle-income countries who have compromised development. We aimed to test the effectiveness of two group-based delivery models for an integrated ECD responsive stimulation and nutrition education intervention using Kenya's network of community health volunteers. METHODS: We implemented a multi-arm, cluster-randomised community effectiveness trial in three rural subcounties across 60 villages (clusters) in western Kenya. Eligible participants were mothers or female primary caregivers aged 15 years or older with children aged 6-24 months at enrolment. If married or in established relationships, fathers or male caregivers aged 18 years or older were also eligible. Villages were randomly assigned (1:1:1) to one of three groups: group-only delivery with 16 fortnightly sessions; mixed delivery combining 12 group sessions with four home visits; and a comparison group. Villages in the intervention groups were randomly assigned (1:1) to invite or not invite fathers and male caregivers to participate. Households were surveyed at baseline and immediately post-intervention. Assessors were masked. Primary outcomes were child cognitive and language development (score on the Bayley Scales of Infant Development third edition), socioemotional development (score on the Wolke scale), and parental stimulation (Home Observation for Measurement of the Environment inventory). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03548558. FINDINGS: Between Oct 1 and Nov 12, 2018, 1152 mother-child dyads were enrolled and randomly assigned (n=376 group-only intervention, n=400 mixed-delivery intervention, n=376 comparison group). At the 11-month endline survey (Aug 5-Oct 31, 2019), 1070 households were assessed for the primary outcomes (n=346 group only, n=373 mixed delivery, n=351 comparison). Children in group-only villages had higher cognitive (effect size 0·52 SD [95% CI 0·21-0·83]), receptive language (0·42 SD [0·08-0·77]), and socioemotional scores (0·23 SD [0·03-0·44]) than children in comparison villages at endline. Children in mixed-delivery villages had higher cognitive (0·34 SD [0·05-0·62]) and socioemotional scores (0·22 SD [0·05-0·38]) than children in comparison villages; there was no difference in language scores. Parental stimulation also improved for group-only (0·80 SD [0·49-1·11]) and mixed-delivery villages (0·77 SD [0·49-1·05]) compared with the villages in the comparison group. Including fathers in the intervention had no measurable effect on any of the primary outcomes. INTERPRETATION: Parenting interventions delivered by trained community health volunteers in mother-child groups can effectively promote child development in low-resource settings and have great potential for scalability. FUNDING: Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health.

"Our Choice" improves use of safer conception methods among HIV serodiscordant couples in Uganda: a cluster randomized controlled trial evaluating two implementation approaches.

BACKGROUND: Safer conception counseling (SCC) to promote the use of safer conception methods (SCM) is not yet part of routine family planning or HIV care. Guidelines for the use of SCM have been published, but to date there are no published controlled evaluations of SCC. Furthermore, it is unknown whether standard methods commonly used in resource constrained settings to integrate new services would be sufficient, or if enhanced training and supervision would result in a more efficacious approach to implementing SCC. METHODS: In a hybrid, cluster randomized controlled trial, six HIV clinics were randomly assigned to implement the SCC intervention Our Choice using either a high (SCC1) or low intensity (SCC2) approach (differentiated by amount of training and supervision), or existing family planning services (usual care). Three hundred eighty-nine HIV clients considering childbearing with an HIV-negative partner enrolled. The primary outcome was self-reported use of appropriate reproductive method (SCM if trying to conceive; modern contraceptives if not) over 12 months or until pregnancy. RESULTS: The combined intervention groups used appropriate reproductive methods more than usual care [20.8% vs. 6.9%; adjusted OR (95% CI)=10.63 (2.79, 40.49)], and SCC1 reported a higher rate than SCC2 [27.1% vs. 14.6%; OR (95% CI)=4.50 (1.44, 14.01)]. Among those trying to conceive, the intervention arms reported greater accurate use of SCM compared to usual care [24.1% vs. 0%; OR (95% CI)=91.84 (4.94, 1709.0)], and SCC1 performed better than SCC2 [34.6% vs. 11.5%; OR (95% CI)=6.43 (1.90, 21.73)]. The arms did not vary on modern contraception use among those not trying to conceive. A cost of $631 per person was estimated to obtain accurate use of SCM in SCC1, compared to $1014 in SCC2. CONCLUSIONS: More intensive provider training and more frequent supervision leads to greater adoption of complex SCM behaviors and is more cost-effective than the standard low intensity implementation approach. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03167879 ; date registered May 23, 2017.

Behavioral Economics Incentives to Support HIV Treatment Adherence (BEST): Protocol for a randomized controlled trial in Uganda.

BACKGROUND: Many HIV-positive patients do not appropriately adhere to their antiretroviral medication (ART). This leads to higher viral loads and greater probability of HIV transmission. Present bias-a tendency to give in to short-term temptations at the expense of long-term outcomes-is a potential driver of low adherence. In this study we test a novel intervention rooted in behavioral economics that is designed to overcome present bias and increase ART adherence. METHODS/DESIGN: We will enroll 330 HIV-positive patients at Mildmay Hospital in Kampala, Uganda, into a 2-year randomized controlled trial. Participants will be randomized to one of three groups. The first intervention group (T1, n = 110) will be eligible for small lottery prizes based on timely clinic visits and demonstration of viral suppression. Group 2 (T2, n = 110) will be eligible for the same lottery prizes conditional on high adherence measured by a medication event management system (MEMS) cap. The control group (n = 110) will receive the usual standard of care. Adherence will be measured continuously throughout the intervention period and for 12 months post-intervention to evaluate effect persistence. Surveys will be conducted at baseline and then every 6 months. Viral loads will be measured annually. Primary outcomes are whether the viral load is detectable and MEMS-measured adherence. Secondary outcomes are the log-transformed viral load as a continuous measure and a binary measure for whether the person took at least 90% of their ART pills. DISCUSSION: Our study is one of the first to investigate the effectiveness of lottery incentives for improving ART adherence, and in addition, it compares the relative efficacy of using electronically measured adherence versus viral load to determine lottery eligibility. MEMS caps are relatively costly, whereas viral load testing is now part of routine clinical care in Uganda. BEST will test whether directly incentivizing viral suppression (which can be implemented using readily available clinic data) is as effective as incentivizing electronically measured adherence. Cost-effectiveness analyses of the two implementation modes will also be performed. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03494777. Registered on 11 April 2018.

The costs of integrated community case management (iCCM) programs: A multi-country analysis.

BACKGROUND: Integrated community case management (iCCM) can be an effective strategy for expanding the provision of diarrhea, pneumonia, and malaria services to children under 5 years old but there are concerns in some countries about the corresponding cost and impact. This paper presents and compares findings from a multi-country analysis of iCCM program costs. METHODS: Data on coverage, utilization, and costs were collected as part of two sets of studies conducted between 2011 and 2013 for iCCM programs in seven sub-Saharan African countries: Cameroon, the Democratic Republic of the Congo, Malawi, Senegal, Sierra Leone, South Sudan and Zambia. The data were used to compare some elements of program performance as well as costs per capita and costs per service (which are key indicators of resource allocation and efficiency). RESULTS: Among the seven countries, iCCM utilization ranged from a total of 0.26 to 3.05 contacts per capita (children 2-59 months) per year for the diseases treated, representing a range of 2.7% to 36.7% of the expected numbers of cases. The total recurrent cost per treatment ranged from US$ 2.44 to US$ 13.71 for diarrhea; from US$ 2.17 to US$ 17.54 for malaria (excluding rapid diagnostic testing); and from US$ 1.70 to US$ 12.94 for pneumonia. In some of the country programs, the utilization of iCCM services was quite low and this, together with significant fixed costs, particularly for management and supervision, resulted in services being quite costly. Given the differences across the countries and programs, however, these results should be treated as indicative and not definitive. CONCLUSION: A comprehensive understanding of iCCM program costs and results can help countries obtain resources and use them efficiently. To be cost-effective and affordable, iCCM programs must be well-utilized while program management and supervision should be organized to minimize costs and ensure quality of care. iCCM programs will not always be low-cost, however, particularly in small, remote villages where supervision and supply challenges are greater. Further research is needed to determine the cost-effectiveness of iCCM programs and corresponding patient and service delivery costs.

Cost-related medication underuse: prevalence among hospitalized managed care patients.

BACKGROUND: The affordability of prescription medications continues to be a major public health issue in the United States. Estimates of cost-related medication underuse come largely from surveys of ambulatory patients. Hospitalized patients may be vulnerable to cost-related underuse and its consequences, but have been subject to little investigation. OBJECTIVE: To determine impact of medication costs in a cohort of hospitalized managed care beneficiaries. METHODS: We surveyed consecutive patients admitted to medical services at an academic medical center. Questions about cost-related underuse were based on validated measures; predictors were assessed with multivariable models. Participants were asked about strategies to improve medication affordability, and were contacted after discharge to determine if they had filled newly prescribed medications. RESULTS: One-hundred thirty (41%) of 316 potentially eligible patients participated; 93 (75%) of these completed postdischarge surveys. Thirty patients (23%) reported cost-related underuse in the year prior to admission. In adjusted analyses, patients of black race were 3.39 times (95% confidence interval [CI], 1.05 to 11.02) more likely to report cost-related underuse than non-Hispanic white patients. Virtually all respondents (n = 123; 95%) endorsed at least 1 strategy to make medications more affordable. Few (16%) patients, prescribed medications at discharge, knew how much they would pay at the pharmacy. Almost none had spoken to their inpatient (4%) or outpatient (2%) providers about the cost of newly prescribed drugs. CONCLUSIONS: Cost-related underuse is common among hospitalized patients. Individuals of black race appear to be particularly at risk. Strategies should be developed to address this issue around the time of hospital discharge.

Medicare beneficiaries' knowledge of and choices regarding Part D, 2005 to the present.

In the months before and years since Medicare Part D's implementation in January 2006, many have been concerned with beneficiaries' ability to benefit from the complex program. A systematic review of published Medline and gray literature from January 1, 2005, to August 20, 2009, was undertaken to evaluate Medicare beneficiaries' knowledge about Part D and how this knowledge informed decisions regarding enrollment and plan choice. Thirty articles that reported original results describing seniors' knowledge of the Part D benefit, decision to enroll, or selection of plans; results from patient surveys addressing these issues; or results that analyzed enrollment data or plan selection patterns were included. Of these 30 articles, 10 described beneficiaries' knowledge, 12 described enrollment and plan choices, and eight described knowledge and choice. Across studies and years, beneficiaries' knowledge of the Part D program and benefit structure and design was poor, particularly with regard to the coverage gap and the low-income subsidy. Beneficiaries had great difficulty choosing the lowest-cost Part D plans and were disinclined to switch plans to improve their benefits. Knowledge deficits, enrollment problems, and plan choice difficulties were most pronounced during Part D implementation in early 2006 but persisted in subsequent years of the benefit. Beneficiaries' knowledge and choices should be monitored on an ongoing basis to inform potential changes to the Part D program.