Effective Aids Treatment and Support in the Free State (FEATS): Adherence and Nutritional Support for Effective and Sustainable Antiretroviral Treatment in Resource Constrained Settings
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 648
- Locations
- 12
- Primary Endpoint
- CD4 count
Study Overview
Brief Summary
The aim of this study is to investigate the benefits of ARV treatment to patients, to the family members of patients on ARV treatment, and to communities at large. The study also aims to investigate the impact of a peer adherence support and a nutritional intervention on measures of treatment success. To this end, 648 patients who had commenced ARV treatment in the past month at twelve selected health care facilities will be recruited into the study. In addition, 204 randomly sampled households from the communities served by the twelve selected clinics will be recruited into the study. Trained enumerators will at baseline conduct semi-structured interviews with patients and households. Following the baseline survey, patients recruited into the study will be randomly assigned to one of three groups:
- Patients receiving ARV treatment and the associated support currently provided in the public sector ARV treatment programme.
- Patients receiving (a) plus bi-weekly visits by an experienced ARV patient who has been trained as a peer adherence supporter
- Patients receiving (a) and (b) plus a weekly nutritional supplement in the form of two 400g cans of meatballs and spaghetti in tomato sauce The group of 'comparison' households comprises the fourth group. Trained enumerators will conduct follow-up interviews with all patients and households at approximately six- and at twelve-months respectively. In addition, the ARV coordinator and other providers working in the ARV treatment programme at each of the twelve selected health care facilities will be interviewed by trained enumerators, at baseline and again at six- and at twelve-months. Clinical data will be obtained from patient files at baseline and at completion of the study. Using these data, various outcomes of importance to the study will be compared between the four study groups, using experimental and non-experimental methods.
Detailed Description
The study has three main objectives, each with a set of more specific aims:
Objective 1: Present a broader view of treatment success
In order to achieve this objective, the study aims to:
- Investigate how access to antiretroviral treatment and to nutritional supplementation impacts labour productivity and time allocation of patients and other household members
- Investigate how access to antiretroviral treatment and to nutritional supplementation impacts household welfare
- Investigate how access to antiretroviral treatment and to nutritional supplementation impacts educational and health outcomes for children in households with patients on antiretroviral treatment
Objective 2: Develop a model of the determinants of treatment success
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •HIV-positive
- •Eligible for public sector ARV treatment (CD4<200 and/or WHO stage 4)
- •Commenced ARV treatment in past 4 weeks
- •Patient resident in town/village where ART clinic located
Exclusion Criteria
- •HIV-negative
- •Not eligible for public sector ARV treatment
- •Had not commenced ARV treatment
- •Commenced ARV treatment longer than one month ago
- •Patient not resident in town/village where ART clinic
Arms & Interventions
2
Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme - ARV treatment and ARV peer adherence support group
Intervention: ARV peer adherence support (PAS) (Behavioral)
1
Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme - ARV treatment only group
Intervention: ARV treatment (Drug)
2
Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme - ARV treatment and ARV peer adherence support group
Intervention: ARV treatment (Drug)
3
Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme - ARV treatment, ARV peer adherence support and nutritional support group
Intervention: ARV peer adherence support (PAS) (Behavioral)
3
Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme - ARV treatment, ARV peer adherence support and nutritional support group
Intervention: Nutritional support (Dietary Supplement)
3
Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme - ARV treatment, ARV peer adherence support and nutritional support group
Intervention: ARV treatment (Drug)
Outcomes
Primary Outcomes
CD4 count
Time Frame: 6-monthly
RNA viral load
Time Frame: 6-monthly
Haemoglobin
Time Frame: 6-monthly
self-reported adherence (CASE index)
Time Frame: 6-monthly
health-related quality of life (EQ-5D/EQ-VAS)
Time Frame: 6-monthly
anthropometrics
Time Frame: monthly to 6-monthly
food security (USDA scales)
Time Frame: 6-monthly
time allocation/physical activity levels
Time Frame: 6-monthly
household welfare
Time Frame: 6-monthly
Secondary Outcomes
- mental health (HADS/MHI scales)(6-monthly)
- labour force participation(6-monthly)
- employment status(6-monthly)
- self-reported sexual behaviour(6-monthly)
- school attendance/performance(6-monthly)