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Cash vs. food assistance to improve adherence to antiretroviral therapy among HIV-infected adults in Tanzania.

ABSTRACT: OBJECTIVE:We evaluated the effectiveness of short-term cash and food assistance to improve adherence to antiretroviral therapy (ART) and retention in care among people living with HIV in Tanzania. METHODS:At three clinics, 805 participants were randomized to three groups in a 3?:?3?:?1 ratio, stratified by site?:?nutrition assessment and counseling (NAC) and cash transfers (?$11/month, n?=?347), NAC and food baskets (n?=?345), and NAC-only (comparison group, n?=?113, clinicaltrials.gov NCT01957917). Eligible people living with HIV were at least 18 years, initiated ART 90 days or less prior, and food insecure. Cash or food was provided for 6 or less consecutive months, conditional on visit attendance. The primary outcome was medication possession ratio (MPR???95%) at 6 months. Secondary outcomes were appointment attendance and loss to follow-up (LTFU) at 6 and 12 months. RESULTS:The primary intent-to-treat analysis included 800 participants. Achievement of MPR???95% at 6 months was higher in the NAC?+?cash group compared with NAC-only (85.0 vs. 63.4%), a 21.6 percentage point difference [95% confidence interval (CI): 9.8, 33.4, P?

SUBMITTER: McCoy SI

PROVIDER: S-EPMC5342932 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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Cash vs. food assistance to improve adherence to antiretroviral therapy among HIV-infected adults in Tanzania.

McCoy Sandra I SI Njau Prosper F PF Fahey Carolyn C Kapologwe Ntuli N Kadiyala Suneetha S Jewell Nicholas P NP Dow William H WH Padian Nancy S NS

AIDS (London, England) 20170301 6

<h4>Objective</h4>We evaluated the effectiveness of short-term cash and food assistance to improve adherence to antiretroviral therapy (ART) and retention in care among people living with HIV in Tanzania.<h4>Methods</h4>At three clinics, 805 participants were randomized to three groups in a 3 : 3 : 1 ratio, stratified by site : nutrition assessment and counseling (NAC) and cash transfers (∼$11/month, n = 347), NAC and food baskets (n = 345), and NAC-only (comparison group, n = 113, clinicaltrial ...[more]

PMID: 28107221

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Project description:BackgroundFood insecurity is an important barrier to retention in care and adherence to antiretroviral therapy (ART) among people living with HIV infection (PLHIV). However, there is a lack of rigorous evidence about how to improve food security and HIV-related clinical outcomes. To address this gap, this randomized trial will evaluate three delivery models for short-term food and nutrition support for food insecure PLHIV in Shinyanga, Tanzania: nutrition assessment and counseling (NAC) alone, NAC plus food assistance, and NAC plus cash transfers.Methods/designAt three HIV care and treatment sites, 788 participants will be randomized into one of three study arms in a 3:3:1 ratio, stratified by site: NAC plus food assistance, NAC plus cash transfer, and NAC only. Eligible participants are: 1) at least 18 years of age; 2) living with HIV infection; 3) initiated ART in the past 90 days; and 4) food insecure, as measured with the Household Hunger Scale. PLHIV who are severely malnourished (body mass index (BMI) < 16 kg/m(2)) will be excluded. Participants randomized to receive food or cash transfers are eligible to receive assistance for up to six months, conditional on attending regularly scheduled visits with their HIV care provider. Participants will be followed for 12 months: the initial 6-month intervention period and then for another 6 months post-intervention. The primary outcome is ART adherence measured with the medication possession ratio. Secondary outcomes include 1) retention in care; 2) nutritional indicators including changes in food security, BMI, and weight gain; 3) viral suppression and self-reported ART adherence; and 4) participation in the labor force.DiscussionThis rigorously designed trial will inform policy decisions regarding supportive strategies for food insecure PLHIV in the early stages of treatment. The study will measure outcomes immediately after the period of support ends as well as 6 months later, providing information on the duration of the interventions' effect. The comparison of food to cash transfers will better inform policies favoring cash assistance or will provide rationale for the continued investment in food and nutrition interventions for PLHIV.Trial registrationClinicalTrials.gov: NCT01957917.

Project description:ObjectivesSelf-reported adherence assessment in HIV-infected patients on antiretroviral therapy (ART) is challenging and may overestimate adherence. The aim of this study was to improve the ability of health care providers to elicit patients' reports of nonadherence using a "patient-centred" approach in a rural sub-Saharan African setting.MethodsA prospective interventional cohort study of HIV-infected patients on ART for ≥ 6 months attending an HIV clinic in rural Tanzania was carried out. The intervention consisted of a 2-day workshop for health care providers on patient-centred communication and the provision of an adherence assessment checklist for use in the consultations. Patients' self-reports of nonadherence (≥ 1 missed ART dose/4 weeks), subtherapeutic plasma ART concentrations (< 2.5th percentile of published population-based pharmacokinetic models), and virological and immunological failure according to the World Health Organization definition were assessed before and after (1-3 and 6-9 months after) the intervention.ResultsBefore the intervention, only 3.3% of 299 patients included in the study reported nonadherence. Subtherapeutic plasma ART drug concentrations and virological and immunological failure were recorded in 6.5%, 7.7% and 14.5% of the patients, respectively. Two months after the intervention, health care providers detected significantly more patients reporting nonadherence compared with baseline (10.7 vs. 3.3%, respectively; P < 0.001), decreasing to 5.7% after 6-9 months. A time trend towards higher drug concentrations was observed for efavirenz but not for other drugs. The virological failure rate remained unchanged whereas the immunological failure rate decreased from 14.4 to 8.7% at the last visit (P = 0.002).ConclusionsPatient-centred communication can successfully be implemented with a simple intervention in rural Africa. It increases the likelihood of HIV-infected patients reporting problems with adherence to ART; however, sustainability remains a challenge.

Project description:Adherence to HIV antiretroviral therapy (ART) among children in developing settings is poorly understood.To understand the level, distribution, and correlates of ART adherence behavior, we prospectively determined monthly ART adherence through multiple measures and six-monthly HIV RNA levels among 121 Ugandan children aged 2-10 years for one year. Median adherence levels were 100% by three-day recall, 97.4% by 30-day visual analog scale, 97.3% by unannounced pill count/liquid formulation weights, and 96.3% by medication event monitors (MEMS). Interruptions in MEMS adherence of ? 48 hours were seen in 57.0% of children; 36.3% had detectable HIV RNA at one year. Only MEMS correlated significantly with HIV RNA levels (r = -0.25, p = 0.04). Multivariable regression found the following to be associated with <90% MEMS adherence: hospitalization of child (adjusted odds ratio [AOR] 3.0, 95% confidence interval [CI] 1.6-5.5; p = 0.001), liquid formulation use (AOR 1.4, 95%CI 1.0-2.0; p = 0.04), and caregiver's alcohol use (AOR 3.1, 95%CI 1.8-5.2; p<0.0001). Child's use of co-trimoxazole (AOR 0.5, 95%CI 0.4-0.9; p = 0.009), caregiver's use of ART (AOR 0.6, 95%CI 0.4-0.9; p = 0.03), possible caregiver depression (AOR 0.6, 95%CI 0.4-0.8; p = 0.001), and caregiver feeling ashamed of child's HIV status (AOR 0.5, 95%CI 0.3-0.6; p<0.0001) were protective against <90% MEMS adherence. Change in drug manufacturer (AOR 4.1, 95%CI 1.5-11.5; p = 0.009) and caregiver's alcohol use (AOR 5.5, 95%CI 2.8-10.7; p<0.0001) were associated with ? 48-hour interruptions by MEMS, while second-line ART (AOR 0.3, 95%CI 0.1-0.99; p = 0.049) and increasing assets (AOR 0.7, 95%CI 0.6-0.9; p = 0.0007) were protective against these interruptions.Adherence success depends on a well-established medication taking routine, including caregiver support and adequate education on medication changes. Caregiver-reported depression and shame may reflect fear of poor outcomes, functioning as motivation for the child to adhere. Further research is needed to better understand and build on these key influential factors for adherence intervention development.

Dataset Information

Cash vs. food assistance to improve adherence to antiretroviral therapy among HIV-infected adults in Tanzania.

Publications

Cash vs. food assistance to improve adherence to antiretroviral therapy among HIV-infected adults in Tanzania.

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