Primary Outcomes (explanation)
Our behavioral primary outcome will be electronically-monitored adherence. MEMS-data will be collected continuously over the course of the 24-month study period allowing us to investigate daily adherence and its timing, as well as for twelve months after the intervention ends. We will create a variable that captures the share of prescribed pills that were actually taken (i.e. number of actual bottle openings divided by the prescribed bottle openings).
Our biological primary outcome will be a binary indicator for whether the participant has an undetectable viral load. The AIDS Clinical Trials Group (ACTG) defines virologic failure as a confirmed viral load >200 copies/mL. We will indicate a viral load measure as undetectable if it is below 200 copies/mL. Viral load is the primary measure used to assess level of viral activity in a person’s blood, as well as response to ART. Although other factors besides adherence contribute to viral load, undetectable viral load is widely considered a strong indicator of good ART adherence. Furthermore, given the limitations of measures of behavioral adherence, viral load is considered by some to be the best indicator of adherence, and at the very least a valuable complement to behavioral adherence measures. Viral load measurements are now part of routine clinical care at Mildmay and will be chart abstracted. They are taken when a person tests HIV-positive, six and twelve months thereafter, and then every 12 months. We will line up recruitment so that all participants have a viral load measure taken at baseline, around month 12, and around month 24.