Journal of acquired immune deficiency syndromes (1999) 2017 05 23() doi 10.1097/QAI.0000000000001456
Lack of accessible laboratory infrastructure limits HIV antiretroviral (ART) treatment initiation, monitoring and retention in many resource-limited settings. Point-of-care testing (POCT) is advocated as a mechanism to overcome these limitations. We executed a pragmatic, prospective, randomized, controlled trial comparing the impact of POCT versus standard-of-care (SOC) on treatment initiation and retention in care.
Selected POC technologies were embedded at 3 primary health clinics in South Africa. Confirmed HIV-positive participants were randomized to either SOC or POC: SOC participants were venesected and specimens referred to the laboratory with patient follow-up as per algorithm (∼3visits); POC participants had phlebotomy and POCT immediately on-site using PIMA CD4 to assess ART eligibility followed by haematology, chemistry and tuberculosis screening with the goal of receiving same-day adherence counselling and treatment initiation. Participant outcomes measured at recruitment, 6, 12months post-initiation.
432/717 treatment eligible participants enrolled between May 2012-September 2013: 198 (56.7%) SOC; 234 (63.6%) POC. Mean age was 37.4years; 60.5% female. Significantly more participants were initiated using POC (aPR 0.83; 95%CI:0.74-0.93; p<0.0001), the median time to initiation was 1day for POC and 26.5days for SOC. The proportion of patients in care and on ART was similar for both arms at 6months (47 vs. 50%) (aPR 0.96; 95%CI:0.79-1.16) and 12months (32 vs. 32%) (aPR 1.05; 95%CI:0.80-1.38), with similar mortality rates. Loss to follow-up at 12months was higher for POC (36% versus 51%) (aPR 0.82; 95%CI:0.65-1.04). CONCLUSION
Adoption of POCT accelerated ART initiation but once on treatment, there was unexpectedly higher loss to follow-up on POC, and no improvement in outcomes at 12months over SOC.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial License 4.0 (CCBY-NC), where it is permissible to download, share, remix, transform, and buildup the work provided it is properly cited. The work cannot be used commercially without permission from the journal.