A stepped-wedge randomised trial on the impact of early ART initiation on HIV-patients’ economic outcomes in Eswatini

Abstract

Background: Since 2015, the World Health Organisation (WHO) recommends immediate initiation of antiretroviral therapy (ART) for all HIV-positive patients. Epidemiological evidence points to important health benefits of immediate ART initiation; however, the policy's economic impact remains unknown. Methods: We conducted a stepped-wedge cluster-randomised controlled trial in Eswatini to determine the causal impact of immediate ART initiation on patients' economic welfare. Fourteen healthcare facilities were non-randomly matched in pairs and then randomly allocated to transition from the standard of care (ART eligibility at CD4 counts of < 350 cells/mm3 until September 2016 and <500 cells/mm3 thereafter) to the 'Early Initiation of ART for All' (EAAA) intervention at one of seven timepoints. Patients, healthcare personnel, and outcome assessors remained unblinded. Data was collected via standardised paper-based surveys with HIV-positive, ART-naïve adults who were neither pregnant nor breastfeeding. Outcomes were patients' time use, employment status, household expenditures and household wealth. Results: A total sample of 3,019 participants were interviewed over the duration of the study. The mean number of participants approached at each facility and time step varied from 4 to 112 participants. Using mixed-effects negative binomial regressions accounting for time trends and clustering, we found no significant difference between study arms for any economic outcome. Specifically, the EAAA intervention had no significant effect on non-resting time use (RR= 1.00, [CI: 0.96, 1.05, p=0.93]) or income-generating time use (RR= 0.94, [CI: 0.73,1.20, p=0.61]). Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93 [CI: 0.82, 1.04, p=0.21] and 0.92 [CI: 0.79, 1.06, p=0.26], respectively. We also found no significant treatment effect on households' asset ownership and living standards (RR=0.96, [CI 0.92, 1.00, p=0.253]). Lastly, there was no evidence of heterogeneity in effect estimates by patients' sex, age, education, timing of HIV diagnosis and ART initiation. Conclusions: Given the neutral effect on patients' economic welfare but positive effects on health, our findings support further investments into scaling-up immediate ART for all HIV patients. Trial Registration: ClinicalTrials.gov, NCT02909218 and NCT03789448; ethical approval: Eswatini National Health Service Review Board & Harvard T.H. Chan School of Public Health Review Board.

The Impact of Immediate Initiation of Antiretroviral Therapy on Patients' Healthcare Expenditures: A Stepped-Wedge Randomized Trial in Eswatini

“…While this paper focused on the effect of EAAA on patients’ health expenditures, universal test-and-treat programs may have substantial welfare benefits in addition to reducing health expenditures. As reported in separate manuscripts [ 42 , 43 ] we did not find that the EAAA intervention improved patient satisfaction nor increased patients’ productivity levels, employment, and living standards. These null effects, however, may be explained by a relatively short follow-up period.…”

Effect of universal HIV testing and treatment on socioeconomic wellbeing in rural Kenya and Uganda: a cluster-randomised controlled trial

“…These findings are in slight contrast to a stepped-wedge trial in Eswatini which found that immediate initiation of ART reduced health-care expenditures but had no shortterm improvement on employment. 32,33 Overall, our results suggest that the considerable investments needed to expand access to ART might have significant shortterm and long-term economic returns.…”

“…Our study builds upon the existing literature that has shown large and significant increases in employment and income following ART initiation. [8][9][10]17,18,32,33 However, with the exception of one study that evaluated economic outcomes of people living with HIV and their household members, relatively few of these studies have used a cluster-randomised trial design to evaluate the effects of early ART initiation on socioeconomic outcomes. Our results support the hypothesis that earlier ART initiation can protect employment and other economic indicators for adults and lead to benefits in children's education.…”

Out-of-pocket Expenses and Time Spent on Clinic Visits Among HIV Pre-exposure Prophylaxis Users and Other Clinic Attendees in Eswatini

“…The final sample size was determined by pragmatic aspects such as the availability of a research assistant on a scheduled study day and the travel time to a clinic. Tablet-assisted personal interviews were conducted based on a self-developed questionnaire with new, adapted, and previously used questions [ 30 , 31 ] (Supplement A). The interview included questions about different categories of OOPE, the arrival time at the clinic, travel time to the clinic, forgone earning opportunities, and lost income.…”