Abstract
Introduction: For clients on HIV treatment in sub-Saharan Africa, disengagement from HIV care in the early treatment period is a critical obstacle to achieving UNAIDS's second 95 target. While South Africa's Differentiated Service Delivery Guideline on Fast Track Initiation and Counseling (FTIC) define normative procedures, the effect of guideline implementation and the underlying drivers of disengagement remain unclear. Methods: The PREFER mixed-methods study enrolled a prospective cohort of adult clients initiating ART, returning to care after a period of disengagement or already on ART for <6 months at 18 public sector healthcare facilities in South Africa. A survey collected data on demographic and clinical characteristics and preferences of participants who were followed up through routinely-collected medical visit records for up to 7 months after treatment initiation to estimate continuity of HIV care (attended all scheduled visits within 28 days). Focus group discussions (FGDs) were conducted approximately 12 months after enrollment among a subset of participants who had expressed concerns about treatment retention. Results: During the study period 7/9/2022-30/6/2023, PREFER-SA enrolled 1,049 participants (72% female, median age=33 years, 24% with CD4 count<200 cells/mm3); 122 of whom also participated in focus group discussions. By 6 months on ART, 23% were not continuously in HIV care. Those newly initiating ART at study enrollment were more likely to have disengaged or interrupted treatment by 6 months as those who had remained in care for >1 visit. Disengagement was also more likely among men and younger (18-24 years) participants, those reporting food scarcity, and those initiated on regimens other than Dolutegravir. Disengagement did not differ by gender, relationship status, or CD4 count. Qualitative FGD results suggest participants experience barriers to adherence within and between all levels of the socio-ecologic model. Challenges related to the facility experience were most prominent. Conclusions: Among adults initiating or re-initiating ART in South Africa, the highest risk of disengagement is immediately after initiation. We identified several potentially modifiable individual and social characteristics associated with early disengagement. Improving the patient facility experience and strengthening implementation of SA's Service Delivery Guidelines may increase retention during the early treatment period.
Competing Interest Statement
Drs. Manganye and Malala are employees of the government agency that has supervisory authority over the study sites.
Funding Statement
Funding for the study was provided by the Bill & Melinda Gates Foundation through INV-031690 to Boston University. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
The PREFER study was approved by the Boston University Institutional Review Board (South Africa H-42726, May 20, 2022) and by the University of the Witwatersrand Human Research Ethics Committee (South Africa M220440, August 23, 2022). The protocol for South Africa was approved by Provincial Health Research Committees through the National Health Research Database for each study district (August 1, 2022 for West Rand; September 1, 2022 for King Cetshwayo and August 28, 2022 for Ehlanzeni). The study is registered with ClinicalTrials.gov (NCT05454839).
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Data Availability
Data generated by the study will be made publicly available in the Open BU repository (https://open.bu.edu/) after the PREFER study protocol has been closed (anticipated closure December 2025). Until then, data will remain under the supervision of the Boston University Medical Campus IRB and the University of the Witwatersrand Human Research Ethics Committee (HREC). Requests can be sent to the BUMC IRB at medirb@bu.edu. Data extracted from routine medical records are owned by the study sites and the South African National Department of Health and cannot be made publicly available by the authors.
