Primary and Secondary Outcomes
viral suppression
SECONDARY
Our primary end point was viral suppression (HIV RNA <400 copies/mL) at 48 weeks of follow-up. Participants without viral suppression (HIV RNA ≥400 c/mL) or without an end point viral load measurement were treated as “failures,” while persons who withdrew consent, died, or formally transferred care to a nonstudy clinic were excluded from the primary analysis. The statistical analysis plan was full prespecified, including sensitivity analyses to assess the robustness of our analysis (see Table 1, Supplemental Digital Content, Secondary outcomes for the trial were (1) time retained in care in days over 48 weeks, with nonretained time defined as the number of days starting >2 weeks from a missed clinic visit until return to clinical care and (2) ART-covered time over 48 weeks, defined as the proportion of trial follow-up days when a participant had a full regimen of ART. Retention was defined as proportion of time in care, with “out-of-care” time starting 14 days after a missed visit and ending with reengagement in care. Data for the primary and secondary outcomes (viral suppression, ART possession, and retention in care) were collected from Ministry of Health medical and pharmacy records, while data on the choice of intervention components were collected using study tools. To describe intervention implementation, we evaluated uptake, by measuring choice of intervention components offered at study visits at baseline, 12, 24, and 36 weeks after enrollment for intervention participants. We also evaluated intervention uptake at unscheduled encounters when participants reached out to a mobility coordinator outside of scheduled study visits and recorded sites of participant–mobility coordinator encounters for intervention delivery (ie, clinic-based, community-based, or mobile hotline-based encounters).