Integrated community-based HIV and non-communicable disease care within microfinance groups in Kenya: study protocol for the Harambee cluster randomised trial.

INTRODUCTION: In Kenya, distance to health facilities, inefficient vertical care delivery and limited financial means are barriers to retention in HIV care. Furthermore, the increasing burden of non-communicable diseases (NCDs) among people living with HIV complicates chronic disease treatment and strains traditional care delivery models. Potential strategies for improving HIV/NCD treatment outcomes are differentiated care, community-based care and microfinance (MF). METHODS AND ANALYSIS: We will use a cluster randomised trial to evaluate integrated community-based (ICB) care incorporated into MF groups in medium and high HIV prevalence areas in western Kenya. We will conduct baseline assessments with n=900 HIV positive members of 40 existing MF groups. Group clusters will be randomised to receive either (1) ICB or (2) standard of care (SOC). The ICB intervention will include: (1) clinical care visits during MF group meetings inclusive of medical consultations, NCD management, distribution of antiretroviral therapy (ART) and NCD medications, and point-of-care laboratory testing; (2) peer support for ART adherence and (3) facility referrals as needed. MF groups randomised to SOC will receive regularly scheduled care at a health facility. Findings from the two trial arms will be compared with follow-up data from n=300 matched controls. The primary outcome will be VS at 18 months. Secondary outcomes will be retention in care, absolute mean change in systolic blood pressure and absolute mean change in HbA1c level at 18 months. We will use mediation analysis to evaluate mechanisms through which MF and ICB care impact outcomes and analyse incremental cost-effectiveness of the intervention in terms of cost per HIV suppressed person-time, cost per patient retained in care and cost per disability-adjusted life-year saved. ETHICS AND DISSEMINATION: The Moi University Institutional Research and Ethics Committee approved this study (IREC#0003054). We will share data via the Brown University Digital Repository and disseminate findings via publication. TRIAL REGISTRATION NUMBER: NCT04417127.

The health and social consequences during the initial period of the COVID-19 pandemic among current and former people who inject drugs: A rapid phone survey in Baltimore, Maryland.

BACKGROUND: There is limited data on the health and social consequences of the COVID-19 pandemic among people who inject drugs (PWID). METHODS: We conducted a rapid telephone survey from April-June 2020 among participants of the community-based AIDS Linked to the IntraVenous Experience (ALIVE) cohort study in Baltimore, Maryland. This interviewer-administered survey collected information on COVID-19 knowledge, symptoms, testing, diagnosis, and prevention behaviors, recent substance use, housing conditions, interruptions to healthcare, access to harm reduction and drug treatment, mental health, and social support. RESULTS: Of 443 current and former PWID who participated in the survey, 36 % were female, 85 % were Black, 33 % were living with HIV and 50 % reported any substance use in the prior six months. COVID-19 awareness was high, but knowledge of symptoms and routes of transmission were lower. PWID reporting recent substance use were less likely to always socially distance (63 % vs. 74 % among those without recent use, p = 0.02), and Black PWID were more likely than non-Black to socially distance (73 % vs. 48 %, p < 0.0001) and use when alone (68 % vs.35 %, p < 0.01). Only 6% reported difficulty accessing healthcare, yet only 48 % of those on opioid-agonist treatment had a four-week supply available. While 34 % reported increased depressive symptoms, participants reported high levels of social support. CONCLUSIONS: This rapid assessment highlighted that PWID currently using drugs may be less able to practice social distancing and increased SARS-CoV-2 transmission may occur. Ongoing monitoring of substance use and mental health, as well as overdose prevention is necessary as the pandemic and public health responses continue.

Recent fentanyl use among people who inject drugs: Results from a rapid assessment in Baltimore, Maryland.

BACKGROUND: Fentanyl-related mortality continues to increase in the US, but knowledge of the drivers of fentanyl use (both intentional and unintentional) remains limited. We conducted a rapid assessment to characterize knowledge, attitudes and practices related to fentanyl use in a community-based cohort of current and former people who inject drugs (PWID) in Baltimore, Maryland. METHODS: Between November 2017 and June 2018, participants of the AIDS Linked to the IntraVenous Experience (ALIVE) cohort completed a survey related to fentanyl use. Correlates of recent (past 6 months) fentanyl use and preference for fentanyl-contaminated and -substituted heroin (FASH) were examined using logistic regression among persons who reported using drugs in the prior six months. RESULTS: Of 994 participants, 28% reported ever having used fentanyl, with 58% of those reporting recent use. Independent correlates of recent fentanyl use among the subset of participants reporting recent (past 6 month) drug use were younger age, male sex, homelessness, opioid use, cocaine use, and daily injection (p < 0.05 for all). 18% of those who recently used fentanyl reported preference for FASH, which was associated with younger age, homelessness and daily injection (p < 0.05 for all). CONCLUSIONS: Recent fentanyl use was commonly reported. Interventions to reduce the harms associated with fentanyl use should target young, homeless PWID who may be more likely to seek out fentanyl.

A state transition framework for patient-level modeling of engagement and retention in HIV care using longitudinal cohort data.

The human immunodeficiency virus (HIV) care cascade is a conceptual model used to outline the benchmarks that reflects effectiveness of HIV care in the whole HIV care continuum. The models can be used to identify barriers contributing to poor outcomes along each benchmark in the cascade such as disengagement from care or death. Recently, the HIV care cascade has been widely applied to monitor progress towards HIV prevention and care goals in an attempt to develop strategies to improve health outcomes along the care continuum. Yet, there are challenges in quantifying successes and gaps in HIV care using the cascade models that are partly due to the lack of analytic approaches. The availability of large cohort data presents an opportunity to develop a coherent statistical framework for analysis of the HIV care cascade. Motivated by data from the Academic Model Providing Access to Healthcare, which has provided HIV care to nearly 200,000 individuals in Western Kenya since 2001, we developed a state transition framework that can characterize patient-level movements through the multiple stages of the HIV care cascade. We describe how to transform large observational data into an analyzable format. We then illustrate the state transition framework via multistate modeling to quantify dynamics in retention aspects of care. The proposed modeling approach identifies the transition probabilities of moving through each stage in the care cascade. In addition, this approach allows regression-based estimation to characterize effects of (time-varying) predictors of within and between state transitions such as retention, disengagement, re-entry into care, transfer-out, and mortality. Copyright © 2017 John Wiley & Sons, Ltd.

Stages of change for adherence to antiretroviral medications.

Providers do not predict reliably which of their HIV-positive patients are having difficulty adhering to antiretroviral therapy (ART). The transtheoretical, or stages of change model, may be a useful tool to help providers identify patients who are having difficulty with ART adherence. The objective of the current study was to determine the relationship between stages of change and ART adherence among patients who were actively taking ART. Data from a randomized trial of a provider-focused intervention were used to examine the relationship between the stages of change and adherence, measured using electronic monitoring devices in the 30 days following the stages of change assessment. Individuals were eligible for inclusion if they were taking ART and had detectable plasma viral load (HIV-RNA). Repeated measures analysis of covariance was used to determine the impact of stages of change on adherence after controlling for potential confounders. The sample of 137 participants was 22% female, 48% white, 28% African-American, with a mean age of 42 years. Fifty-eight percent reported sex with a man as an HIV risk factor, while 13% reported sex with a woman, 14% reported injecting drugs and 15% reported other risk factors. In adjusted models, those in earlier stages of change (i.e., contemplation and preparation) had significantly lower adherence (-9.8%, p=0.04) compared to those in the action and maintenance phases. No demographic characteristics predicted adherence. The stages of change model may function as a screening tool for clinicians to discover patients at-risk of lower adherence.

Conditional economic incentives to improve HIV treatment adherence: literature review and theoretical considerations.

We present selected theoretical issues regarding conditional economic incentives (CEI) for HIV treatment adherence. High HIV treatment adherence is essential not only to improve individual health for persons living with HIV, but also to reduce transmission. The incentives literature spans several decades and various disciplines, thus we selectively point out useful concepts from economics, psychology and HIV clinical practice to elucidate the complex interaction between socio-economic issues, psychological perspectives and optimal treatment adherence. Appropriately-implemented CEI can help patients improve their adherence to HIV treatment in the short-term, while the incentives are in place. However, more research is needed to uncover mechanisms that can increase habit formation or maintenance effects in the longer-term. We suggest some potentially fruitful avenues for future research in this area, including the use of concepts from self-determination theory. This general framework may have implications for related research among disadvantaged communities with high rates of HIV/AIDS infection.

Limited uptake of hepatitis C treatment among injection drug users.

We characterized hepatitis C virus (HCV) treatment knowledge, experience and barriers in a cohort of community-based injection drug users (IDUs) in Baltimore, MD. In 2005, a questionnaire on HCV treatment knowledge, experience and barriers was administered to HCV-infected IDUs. Self-reported treatment was confirmed from medical records. Of 597 participants, 71% were male, 95% African-American, 31% HIV co-infected and 94% were infected with HCV genotype 1; 70% were aware that treatment was available, but only 22% understood that HCV could be cured. Of 418 who had heard of treatment, 86 (21%) reported an evaluation by a provider that included a discussion of treatment of whom 30 refused treatment, 20 deferred and 36 reported initiating treatment (6% overall). The most common reasons for refusal were related to treatment-related perceptions and a low perceived need of treatment. Compared to those who had discussed treatment with their provider, those who had not were more likely to be injecting drugs, less likely to have health insurance, and less knowledgeable about treatment. Low HCV treatment effectiveness was observed in this IDU population. Comprehensive integrated care strategies that incorporate education, case-management and peer support are needed to improve care and treatment of HCV-infected IDUs.