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 impact on the economic aspects of patients' lives 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’ individual- and household-level economic outcomes. Fourteen healthcare facilities were non-randomly matched into 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 were collected via standardised paper-based surveys with HIV-positive adults who were neither pregnant nor breastfeeding. Outcomes were patients’ time use, employment status, household expenditures, and household living standards.
Results: A total sample of 3019 participants were interviewed over the duration of the study. The mean number of participants approached at each facility per time step varied from 4 to 112 participants. Using mixed-effects negative binomial regressions accounting for time trends and clustering at the level of the healthcare facility, 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: Our findings do not provide evidence that should discourage further investments into scaling up immediate ART for all HIV patients.
Funding: Funded by the Dutch Postcode Lottery in the Netherlands, Alexander von Humboldt-Stiftung (Humboldt-Stiftung), the Embassy of the Kingdom of the Netherlands in South Africa/Mozambique, British Columbia Centre of Excellence in Canada, Doctors Without Borders (MSF USA), National Center for Advancing Translational Sciences of the National Institutes of Health and Joachim Herz Foundation.
Clinical trial number: NCT02909218 and NCT03789448.
Keywords: HIV/AIDS; antiretroviral treatment; epidemiology; global health; health economics; healthcare expenditures; medicine; randomized controlled trial; virus.
Human immunodeficiency virus (HIV) is an incurable virus that attacks the immune system and affects around 39 million people worldwide. Once diagnosed, HIV can be treated with antiretroviral therapy (ART) to limit its effects and stop it spreading to other people. HIV rates vary across the world, but the African country of Eswatini has the highest prevalence with more than one in four (27%) people classed as HIV-positive. Until 2015, people living with HIV were typically only treated with ART once their immune system weakened. Recent studies found that starting treatment earlier enhances the positive effects of ART. This caused the World Health Organization (WHO) to change their guidelines and advise people living with HIV to begin ART as soon as they are diagnosed. While antiretroviral drugs are usually provided to patients free of charge, accessing care can be expensive for patients because of high transport costs or lost time from income-generating activities. This means starting treatment earlier and, thus, having more frequent healthcare visits, may result in a greater cost to the patient. The economic impact of this change is unclear, and for patients living in poverty, these added costs can affect their decision on whether to continue treatment. Steinert et al. interviewed 3,019 HIV-patients from 14 health facilities in Eswatini who began treatment with ART either immediately after diagnosis or after their immune system became suppressed. Patients were asked about their time spent being active to generate income, employment status, monthly household expenditures, and household living standards. On average, beginning ART earlier appears to have had no large negative effects on the economic wellbeing of patients. The same results were found for patient groups defined by sex, education, age, and time spent taking ART. These findings suggest that starting ART for HIV as soon as possible offers medical benefits and seems to have no large economic consequences for patients in the short term, even for poorer communities. This adds weight to the WHO advice on HIV treatment and supports the need to continue to deliver effective treatments to countries like Eswatini that have a high rate of HIV infection.
© 2020, Steinert et al.