Effective Aids Treatment and Support in the Free State (FEATS)

• Status: Unknown status
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre for Health Systems Research & Development, University of the Free State
• Collaborators: Bank-Netherlands Partnership Programme (BNPP); World Bank

Criteria

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