Early Initiation ART Adherence Clubs vs. Standard of Care to Enhance Patient Retention In Care A Pilot Study

The guidelines recommend providing lifelong antiretroviral treatment to all people diagnosed and living with HIV, regardless of CD4 count or WHO clinical stage. A pilot study was conducted to evaluate the effectiveness of the test and treat strategy, coupled with ART initiation at the patient's first clinic visit and follow-up at initiation adherence clubs, compared to standard of care. The study was a randomized controlled trial of 300 patients, with 150 patients in each arm. The follow-up period was six months. The primary objective was to evaluate whether the test and treat strategy, coupled with ART initiation at the patient's first clinic visit and follow-up at initiation adherence clubs, would result in improved patient outcomes and greater retention in care compared to standard of care at six months. Secondary objectives included determining patient predictors of retention in care within the context of the South African Department of Health test and treat strategy, determining the frequency of and reasons for initiation club discontinuation, and performing qualitative research to evaluate acceptability and patient experience in the initiation clubs. As part of routine care, patients received baseline blood tests, physical examination, and TB screening. If eligible, ART was initiated on the same day or within two weeks post-diagnosis. Patients were then asked to return after two weeks to review blood test results and response to ART. Patients were screened for eligibility, informed about the study, and invited to participate. If they agreed to participate, they were randomized to either standard of care or initiation clubs. Inclusion criteria included age 18 or older, ART-naive status, initiation of ART on the day of diagnosis, CD4 count of at least 200, and normal baseline blood test results. Exclusion criteria included age under 18, previous ART use, presumed TB or TB treatment, pregnancy, current co-morbidity or other chronic condition, contraindication for fixed-dose combination (FDC) ART, refusal of ART, abnormal kidney or liver function tests, and severe side effects to ART. The study procedure involved newly diagnosed HIV-positive patients being initiated on ART on the same day or within two weeks after diagnosis. Patients were then screened for eligibility for the randomized controlled trial. Eligible patients were referred to the research coordinator for consenting, enrolled, and randomized to either initiation clubs or standard of care. Patients in the standard of care arm were followed up according to the clinic's standard operating procedure (SOP), and in-depth interviews were administered to 12 patients in this arm.