Background Facility-based, multimonth dispensing of antiretroviral therapy (ART) for HIV could reduce burdens on patients and providers and improve retention in care. We assessed whether 6-monthly ART dispensing was non-inferior to standard of care and 3-monthly ART dispensing.Methods We did a pragmatic, cluster-randomised, unblinded, non-inferiority trial (INTERVAL) at 30 health facilities in Malawi and Zambia. Eligible participants were aged 18 years or older, HIV-positive, and were clinically stable on ART. Before randomisation, health facilities (clusters) were matched on the basis of country, ART cohort size, facility type (ie, hospital vs health centre), and region or province. Matched clusters were randomly allocated (1:1:1) to standard of care, 3-monthly ART dispensing, or 6-monthly ART dispensing using a simple random allocation sequence. The primary outcome was retention in care at 12 months, defined as the proportion of patients with less than 60 consecutive days without ART during study follow-up, analysed by intention to treat. A 2•5% margin was used to assess noninferiority. This study is registered with ClinicalTrials.gov, NCT03101592.

Purpose of Review-In this report, we review the need for point-of-care (POC) or near realtime testing for antiretrovirals, progress in the field, evidence for guiding implementation of these tests globally, and future directions in objective antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) adherence monitoring.Recent Findings-Two cornerstones to end the HIV/AIDS pandemic are ART, which provides individual clinical benefits and eliminates forward transmission, and PrEP, which prevents HIV acquisition with high effectiveness. Maximizing the individual and public health benefits of these powerful biomedical tools requires high and sustained antiretroviral adherence. Routine monitoring of medication adherence in individuals receiving ART and PrEP may be an important component in interpreting outcomes and supporting optimal adherence. Existing practices and subjective metrics for adherence monitoring are often inaccurate or unreliable, and therefore, are generally ineffective for improving adherence. Laboratory measures of antiretroviral

Clients with HIV on antiretroviral therapy (ART) perceived the 6-month ART dispensing interval as highly acceptable due to reduced transport costs and increased time for income-generating activities. Providers reported benefits in reduced clinic workload and improved ability to see clients who need more support. Before implementing this dispensing interval on a large scale, countries should conduct further research on how to encourage client health-seeking behaviors for health problems, ensure women have access to family planning services outside of ART clinic visits, and encourage providers to use best practices for counseling messages.

No abstract