Adherence Guideline Impact Evaluation - Effectiveness of Fast-track Treatment Initiation Counselling 2015-2018

The sample size was 730 patients, slightly higher than the target sample size of 720 to allow for missing data. The RapIT study of rapid ART initiation conducted in Gauteng Province PHC clinics, found that about 60% of ART-eligible patients initiated under standard care within 30 days. Conservatively assuming 60% initiation without the intervention and 75% with the intervention, about 30 subjects in each of the 24 clusters were required to detect a difference of 15%. Sample sizes were determined using PASS software for cluster-randomised designs. Each sample size was determined to measure the short-term outcome and calculations assumed a site-clustered design with the clinic as the cluster and 24 clusters evenly split between intervention and control groups. We assumed power of 80% and an alpha of 0.05. Sample sizes accounted for the cluster-randomised design by assuming a coefficient of variation of 0.1.

Patients eligible for inclusion were aged 18 years or above and patients who were not resident in the facility's catchment area, were recorded as having an intention to transfer care to a different facility within 12 months, or were pregnant and eligible for prevention of mother to child transmission were excluded. The specific inclusion criteria for the Fast-track Treatment Initiation Counseling cohort followed the December 2014 national guidelines for HIV care and ART and July 2016 National Adherence Guidelines for Chronic Disease (HIV, tuberculosis and non-communicable diseases). In order to identify eligible patients to enrol, information recorded on their electronic medical record were consulted. At intervention sites, lists were reviewed against clinic records, registers and other documentation for each intervention to identify eligible patients. At control sites, we reviewed lists against clinic records to confirm eligibility. If the patient file was found and eligibility for a cohort was confirmed then patients were enrolled sequentially until the required sample size was reached for the cohort. Due to delays in electronic data capturing data was not complete. To account for this at some sites, individuals receiving each intervention were identified directly from registers for that intervention.

Clinic files were then reviewed to confirm eligibility and patients were enrolled until the required sample size was achieved. For each patient enrolled, regardless of the method used to identify them, patient files were reviewed and information was extracted using an electronic case report form to confirm patients met all eligibility criteria for the cohort.