UNAIDS goals specify that country programs should achieve viral suppression in at least 90% of those who start antiretroviral treatment (ART). In South Africa, only 51-68% of those on antiretroviral treatment (ART) achieve viral suppression, both through poor adherence and loss to care. The greatest losses occur in the first year on ART, with the up to 27% of people leaving care within the first four months of treatment.
Early detection of poor adherence and linkage to support for new patients is critical. The evidence shows that patients who miss doses of tablets early in treatment go on to miss clinic visits, exhibit poor outcomes, and are disproportionately lost to care. The most widely used way to monitor adherence (e.g., self-report) is largely unreliable.
The objective of this study is to improve ART adherence, retention and viral outcomes in people commencing ART in the South African public sector, a low-resource setting, over 24 months using five evidence-based adherence strategies to enable rapid identification and management of people with poor adherence. We will test the combinations of these components using a Multiphase Optimization STrategy (MOST) design, which allows us to explore the benefit of various combinations of these five effective and feasible ART adherence monitoring (M) or support (S) components.
We began recruiting 510 patients initiating ART at three City of Cape Town (CoCT) ART clinics in March 2022; recruitment will continue through December 2023. The patients have been randomized to one of 16 experimental conditions. Each condition includes a unique combination of five adherence intervention components. Three of these components focus on identifying individuals with poor adherence with increasing degrees of sophistication (M1, M2 and M3) with immediate linkage to adherence support. Two components focus on supporting good adherence (S1 and S2). They both supplement the existing adherence support program delivered at CoCT clinics (standard of care component) which will continue for all participants. In addition, every person will have their adherence monitored using the Wisepill® electronic adherence monitoring device (EAM).
The five intervention components include:
- Standard of Care (SoC): After a viral load (VL) test shows unsuppressed virus, patient is alerted at the next clinic visit and given a counselling session
- Immediate phone call to patient on receipt at the clinic of an unsuppressed VL test result (M1/OTR)
- Pharmacy Refill Monitoring (PRM) and phone call to the patient if a week late for collection of ART (M2/PRM)
- Electronic Adherence Monitoring (EAM) using Wisepill® device and immediate phone call to the patient if miss ≥4 doses or any 3 consecutive doses in a 14-day period (M3/EAM)
- Weekly check-in text messages (S1/Text)
- Peer group support: Basic (B) or Enhanced (E) (S2/Peer)
We postulate these intervention components will: 1) enhance feelings of autonomy support, social support, and knowledge; 2) improve motivation and self-competence; and 3) increase ART retention, adherence, and viral suppression. We will rigorously assess patient outcomes, implementation effectiveness, and cost effectiveness of the interventions.
The study is a collaboration of the Desmond Tutu Health Foundation (Dr. Catherine Orrell, Dr. Lauren Jennings, Ms. Laura Myers), the Boston University School of Public Health (Dr. Lora Sabin, Dr. Nafisa Halim, Dr. William MacLeod, Dr. Allen Gifford, Ms. Rebecca West), Massachusetts General Hospital (Dr. Jessica E. Haberer), New York University (Dr. Marya Gwadz), and the City of Cape Town (Dr. Natacha Berkowitz).
More information on the study design, patient eligibility criteria, and study ethics can be found in the downloadable study protocol below and at: https://clinicaltrials.gov/ct2/show/NCT05040841
The informed consent forms and data collection instruments (time and motion studies, questionnaires, and in-depth interview guides) have also been included to download below.