Background
Men’s suboptimal HIV treatment outcomes hinder epidemic control efforts and jeopardize men’s health. Interventions tailored to men’s unique needs are essential, although rarely tested. We tested the effect of person-centered care interventions on ART engagement among men living with HIV but not in care in Malawi.
Methods
We conducted an individually randomized control trial at 13 health facilities (IDEaL Study, NCT05137210). Adult (15y+) men living with HIV but never not in care were randomized (1:1:1) to: 1) male-specific counseling (MC) delivered in communities by male lay-cadre; 2) MC Arm + home-based ART initiation by trained nurses (HB); and 3) stepped intervention (Stepped) that increased in intensity overtime until ART initiation was achieved (chronological steps were MC Arm -> ongoing psychosocial support from high-level mental health professionals -> HB Arm). Primary outcome was composite: ART initiation <90days after trial enrollment and 6month retention in HIV care (i.e., <28days out of care at 6months). Secondary outcomes were cost effectiveness and days with ART coverage. Outcomes were measured via medical records and community tracing. At endline clients whose facility medical records showed they did not initiate ART within 90 days or were >28days out of care 6months after initiation were traced and personal records ascertained. Intention-to-treat analyses were conducted. We compared the lowest cost arm (MC) against the highest cost (HB) and Stepped arms.
Results
Of 743 men screened, 569 (77%) were enrolled between Sept 2021-May 2023. Arms were balanced. Overall mean age was 39y (SD:12), 393/569 (69%) were married, and only 49/569 (9%) were ART naïve. Outcome ascertainment did not differ by arm. Primary outcome (initiation and 6month retention) was met by 147/193 (76%) in MC, 132/183 (71%) in HB, and 154/181 (84%) in Stepped arms (Table1) – no difference by arm. MC arm was more cost effective compared to both the HB and the Stepped arms. ART initiation was high across arms 514/557 (92%). MC performed slightly better than HB for retention: 6month retention after initiation (aRR:0.90; CI 95%:0.81,0.98) and optimal days covered with ART (aRR:0.88; CI 95%:0.78,0.99) were significantly worse in HB vs MC arms.
Conclusions
Male-specific interventions can achieve positive ART engagement outcomes. Men’s counseling provided by lay-cadres performed similar to more costly approaches, offering feasible solutions for men’s HIV care at scale.
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