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SEARCH-Youth: a cluster randomized trial of a multilevel health system intervention to improve virologic suppression in adolescents and young adults living with HIV in rural Kenya and Uganda

Title
SEARCH-Youth: a cluster randomized trial of a multilevel health system intervention to improve virologic suppression in adolescents and young adults living with HIV in rural Kenya and Uganda
Presenter
Florence Mwangwa
Authors
F. Mwangwa * (1), T. Ruel (2), L. Balzer (3), J. Ayieko (4), M. Nyabuti (4), W.E. Mugoma (4), J. Kabami (5), B. Kamugisha (1), D. Black (6), B. Nzarubara (1), F. Opel (4), J. Shrom (6), G. Agengo (4), J. Nakigudde (7), H. Nakato (1), J. Schwab (8), J. Peng (9), C. Camlin (10), S. Shade (11), E. Bukusi (4), B. Kapogiannis (12), E. Charlebois (13), M. Kamya (14), D. Havlir (6)
Institutions
(1) Infectious Diseases Research Collaboration, Kampala, Uganda, (2) University of California, San Francisco, Pediatrics, San Francisco, United States, (3) University of Massachusetts ' Amherst, Amherst, United States, (4) Kenya Medical Research Institute, Centre for Microbiology Research, Nairobi, Kenya, (5) Makerere University, Department of Medicine, Kampala, Uganda, (6) University of California, San Francisco, Department of Medicine, San Francisco, United States, (7) Makerere University, Department of Psychiatry, Kampala, Uganda, (8) University of California, Berkeley;, Division of Biostatistics, Berkeley, United States, (9) University of Washington, Department of Biostatistics, Seattle, United States, (10) University of California, San Francisco, Department of Obstetrics, Gynecology & Reproductive Sciences, San Francisco, United States, (11) University of California, San Francisco, Department of Epidemiology and Biostatistics, San Francisco, United States, (12) Eunice Kennedy Shriver National Institute of Child Health and Human Development, Maternal and Pediatric Infectious Diseases Branch, Bethesda, United States, (13) University of California, San Francisco, Medicine, San Francisco, United States, (14) Makerere University, Medicine, Kampala, Uganda

BACKGROUND: Social and cognitive developmental events disrupt care and medication adherence among adolescents and young adults living with HIV in sub-Saharan Africa. We hypothesized that a dynamic multilevel health system intervention helping adolescents and young adults and their providers navigate life-stage related events would increase virologic suppression compared to standard care.
METHODS: This was a cluster-randomized trial of 28 clinics and youth aged 15'24 years living with HIV in rural Kenya and Uganda. Participants in intervention clinics received life-stage specific assessment and counseling at the start of routine visits, choice of flexible clinic access and rapid viral load feedback. roviders had a secure mobile platform for inter-provider consultation. The primary endpoint was virologic suppression (< 400 copies/ml) two years from enrollment and compared by arm using targeted minimum loss-based estimation, adjusting for clustering by clinic.
RESULTS: Among 1834 participants, median age was 21 years and 82% were female; 85% of intervention participants had life-stage assessments performed '¥ 4 times, 60% opted for phone visits at least once, and >87% of participants in 13/14 clinics received viral load feedback within 72 hours. The proportion of participants with virologic suppression was higher in the intervention arm [88% (95%CI: 85-92%)] than in the control arm [80% (95%CI: 77-84%)], for an adjusted risk ratio of 1.10 (95%CI: 1.03-1.16; p=0.002). The intervention resulted in increased virologic suppression within subgroups of sex, age, and care-status at baseline, with greatest improvement among those re-engaging in care [adjusted risk ratio =1.60 (95% CI:1.00-2.55; p=0.03)] (Figure).
CONCLUSIONS: The multilevel SEARCH-Youth intervention resulted in increased virologic suppression compared to standard care, during a period of transition to dolutegravir and during the COVID19 pandemic. Added to current efforts, systematic life-stage-based assessment and support could help bring adolescents and young adults living with HIV closer towards a goal of universal virologic suppression.