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

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.

Conditions

• HIV/AIDS
• Food Insecurity
• HIV Infections

Interventions

BEHAVIORAL

ARV peer adherence support (PAS)

Adherence support provided during twice weekly visits to the patient by an experienced ART patients who received basic training in ARV peer adherence support

DIETARY_SUPPLEMENT

Nutritional support

Weekly delivery by peer adherence supporter (PAS) of two 400g cans of meatballs and spaghetti in tomato sauce

DRUG

ARV treatment

Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme

Sponsors & Collaborators

• World Bank

  collaborator OTHER

• Bank-Netherlands Partnership Programme (BNPP)

  collaborator UNKNOWN

• Centre for Health Systems Research & Development, University of the Free State

  lead OTHER

Principal Investigators

• Frikkie LR Booysen, PhD · University of the Free State

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-10-31

Primary Completion

2009-12-31

Completion

2010-06-30

Countries

• South Africa

Study Locations