People who started HIV treatment in Swaziland under a universal test and treat policy were seven times more likely to still be in care and to have a fully suppressed viral load six months after starting treatment when compared to management of patients under the existing standard of care, Velephi Okello of the Swazi Ministry of Health reported at the 22nd International AIDS Conference (AIDS 2018) in Amsterdam today.
The findings come from the MaxART study, a comparison of providing treatment according to a standard model or through a universal test and treat approach. The study was designed to evaluate the real-world performance of a universal test and treat policy in a country with a very high prevalence of HIV and a predominantly rural population who receive care through primary health clinics.
In particular, researchers wanted to understand the impact of the universal test and treat policy on the health system, its acceptability to patients and how to achieve a high rate of linkage to care after people test HIV positive. Evidence for the feasibility and effectiveness of universal test and treat remains limited; the trial is designed to gather evidence on patient outcomes as well as costs, resource use and cost-effectiveness of treating everyone as soon as possible after their HIV diagnosis.
The study was conducted in 14 public health facilities in the Hhohho region of Swaziland (recently renamed eSwatini). The facilities were randomised to begin offering universal test and treat in stages, with a new group of facilities moving to test and treat every four months. Prior to initiating a test and treat policy, all clinics offered antiretroviral therapy (ART) according to the national guidelines.
The universal test and treat intervention included:
- Community mobilisation to sensitise people to the benefits of early ART and stimulate demand for testing and treatment.
- Door-to-door visits to offer education and home-based testing and counselling.
- The offer of treatment to everyone diagnosed with HIV regardless of CD4 cell count.
- Same-day counselling and treatment initiation if the patient is ready.
Patients in the standard-of-care group received two or three sessions of pre-ART counselling prior to treatment initiation according to national guidelines. Swaziland national treatment guidelines recommended antiretroviral treatment for adults with CD4 counts below 350 cells/mm3 until December 2015 when the eligibility criteria were expanded to recommend treatment for all adults with CD4 cell counts below 500 cells/mm3.
The recommended regimen for first-line treatment is tenofovir, emtricitabine and efavirenz, with alternatives when one of these agents cannot be used.
The study enrolled 3405 people between September 2014 and August 2017. Sixty-two percent of participants were women (although the study excluded pregnant or breastfeeding women as universal ART is already recommended for this population). Thirty-four per cent were aged 20-29 years and 36% aged 30-39 years. Forty-nine per cent had a CD4 cell count below 350 cells/mm3 at the time of enrolment and 36% had a high viral load (above 100,000 copies/ml). Two-thirds of study participants had been diagnosed with HIV less than one year prior to enrolment in the study.
The study evaluated two primary outcomes: retention in care twelve months after starting treatment, and viral suppression twelve months after starting treatment. Retention in care has been identified as a particular concern for universal test and treat programmes: some have questioned whether people who are well at the time of diagnosis will stay in care if they begin treatment immediately.
When the research group looked at outcomes six months after enrolment, they found that universal test and treat was associated with a 94% increased likelihood of retention (aHR 1.94, 95% CI 1.33-2.82, p = 0.0006) and a sevenfold increase in the likelihood of both being retained in care and having an undetectable viral load (aHR 6.90 95% CI 3.11-15.31, p < 0.0001).
Retention was 60% higher in the intervention arm than the control arm after 12 months, although confidence intervals on this estimate were wide (HR 1.60, 95% CI 1.15-2.21, p = 0.005) and retention in the control group continued to decline after the first year.