There is substantial attrition from HIV testing to initiation of care and antiretroviral therapy (ART). We tested three strategies to accelerate entry-into-care and ART initiation after testing positive at mobile HIV counselling and testing (HCT) units deployed in communities and workplaces in South Africa.
We conducted an unmasked individually randomized pragmatic trial. Following enrollment, participants were allocated equally into four arms: standard of care (SOC), point-of-care CD4 (POC CD4), POC CD4 plus strengths based care facilitation (CF), or POC CD4 plus transport reimbursement. Randomization was stratified by urban/rural status. POC CD4 count testing was accompanied by standardized counseling. CF consisted of five standardized sessions along with text messaging and ad hoc communication. Transport reimbursement was provided via cell phone transfer or at grocery stores. We assessed outcomes by self-report and by clinical documentation and calculated hazard ratios using Cox regression adjusted for randomization stratum. Here we present final results for the primary outcome of 90 day entry-into-care and a secondary outcome of 180 day ART initiation.
We enrolled 2,558 participants, of whom 160 were excluded after randomization. Of the remaining 2398 participants, 1497 (62%) were women, the median age was 33 (IQR: 27, 41) years, and the median CD4+ T-cell count (in arms offering POC CD4) was 427 cells/mm3 (IQR: 287, 595). During the first 90 days following enrollment, 1,236 (52%) participants self-reported entry into care, with no difference by arm (Table). Overall, 764 (32%) participants had documented entry-into-care within 90 days to any of 90 clinics, and 371 (15%) had documented ART initiation within 180 days, with the POC CD4 + CF arm showing significant improvement relative to SOC (HR 1.4, p=0.002 and HR 1.4, p=0.02 for 90 day entry and 180 day ART, respectively).
POC CD4, with or without transport reimbursement or care facilitation, did not improve self-reported 90-day entry into HIV care. POC CD4 with strengths-based care facilitation did increase the secondary outcomes of clinically documented entry-into-care and ART initiation by 40%. While care facilitation could improve the HIV care continuum in South Africa, community and clinic-level strategies are likely also needed to achieve substantial increases in initiation of care and ART.