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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:
Full 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:
Objective 2: Develop a model of the determinants of treatment success
In order to achieve this objective, the study aims to:
Objective 3: Understand the links between treatment and prevention
In order to achieve this objective, the study aims to:
The study aims to investigate effective AIDS treatment and support in settings where free ARV treatment has been introduced already, with issues of scale-up and sustainability as a result representing an important issue. The study therefore is being conducted in twelve phase I ARV assessment sites in the Free State province, i.e. sites where ARV treatment first became available when the ARV treatment programme was launched in the Free State province in 2004/05.
Type of study The study is a prospective, cohort study with a patient, household, facility and provider survey component. The study has a social scientific focus, with a clinical component, and comprises two behavioural interventions.
Description of experimental design The study is a combination of a group time-series quasi-experimental design and a a variation of a double randomised consent design. The study comprises four groups of households, three of which include patients on ARV treatment (Figure 1). The provision of ARV treatment represents a quasi- or field experiment, while the peer adherence support and nutritional interventions represent a randomised-control experiment executed in accordance with a Zelen-type double randomised consent design. This study design is deemed appropriate given the fact that: blinding is not practicable or possible; the use of classical randomisation and informed consent procedures significantly threatens internal validity; the interventions are highly attractive; the control group receives standard care; the study focuses on a clinically relevant objective(s) and offers important new insights (Kaptchuk, 2001; MacLehose et al, 2001; Rains & Penzien, 2005).
Figure 1: Experimental study design
Group A: Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme Sample size: n~216]
Group B: Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme PLUS Adherence support provided by a trained peer adherence supporter during twice weekly visits to the patient [Sample size: n~216]
Group C: Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme PLUS Adherence support provided by a trained peer adherence supporter during twice weekly visits to the patient PLUS Nutritional supplementation: weekly delivery of two 400g cans of meatballs and spaghetti in tomato sauce by peer adherence supporter [Sample size: n~216]
Group D: Randomly selected households from the general community served by the selected health facility, excluding households where someone is known to receive ARV treatment [Sample size: n~180]
Sample size estimation:
The sample size calculation for the arms of the study is based on the method proposed by Freedman (1982). The sample size estimation is based on the following assumptions:
The affordable sample size was 801 households with 177 for the control arm and 208 for each of the intervention arms. This sample is expected to yield statistically significant results for the analysis of all measures contemplated. Although the statistical power of the study design with this sample size can be considered good the sample size was rounded up to ~828 households, with ~180 households in the control arm and ~216 households in each of the intervention arms. This was done to represent multiples of 12 since the study will be conducted in 12 facilities.
Method of randomisation From among the ~648 ARV patients recruited into the study [~54/study site], individual patients will be assigned randomly to the control group [Group A; n~216] and to the two experimental arms of the study [Group B & C; n~216 each], using the relevant random sampling selection commands in version 10 of the Stata software programme.
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648 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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