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Title
Enhanced linkage to care following home-based HIV testing improves linkage, ART initiation and retention, and 12-month viral suppression—the Ekkubo study: a cluster randomized trial in Uganda
Presenter
Susan Maria Kiene
Authors
S.M. Kiene1,2, R. Naigino1,2, K. Schmarje Crockett1, M. Ediau1,2, A. Anecho2, C.-D. Lin3, N.A. Menzies4, M. Bateganya5, S. Sekamatte6, S.C. Kalichman7, R.K. Wanyenze2
Institutions
1San Diego State University, School of Public Health, San Diego, United States, 2Makerere University School of Public Health, Kampala, Uganda, 3San Diego State University, Department of Mathematics and Statistics, San Diego, United States, 4Harvard T.H. Chan School of Public Health, Department of Global Health and Population, Boston, United States, 5USAID, Msasani, Tanzania, United Republic of, 6Gombe Hospital, Gombe, Uganda, 7University of Connecticut, Institute for Collaboration on Health, Intervention, and Policy, Storrs, United States

BACKGROUND: HIV testing in the universal test and treat (UTT) era in settings where immediate ART initiation is not feasible may require support for care engagement to achieve viral suppression. The Ekkubo study, a cluster randomized trial in rural Uganda, tested an enhanced linkage to care intervention vs standard-of-care+referrals to care in the context of home-based HIV testing.
METHODS: Between November 2015 and March 2020, home-based HIV testing was conducted in pair-matched villages randomized to intervention or comparator arms across 4 districts in central Uganda. Individuals aged 15-59 newly diagnosed HIV positive or previously diagnosed but never linked to care in intervention villages received 3 brief sessions at-home and 1 phone follow-up focused on overcoming barriers to care, eliciting a plan to engage in care, and social support resources to address stigma and other needs. Those in standard-of-care+ villages received 2 brief sessions at-home referring them to care and reinforcing the referral. The primary outcome was viral suppression (<20 copies/mL) at 12 months. Secondary outcomes included linkage, ART initiation, time to ART initiation, and ART retention. Intention-to-treat analyses accounted for the cluster design. Trial registration: NCT02545673
RESULTS: In the 56 clusters/villages (28 per arm), 284 (62.3% female) and 283 (62.9% female) individuals were enrolled in intervention and comparator arms, respectively. Average cluster size was 10.31 (SD 13.97, range 1-57). Average age was 30.77 (SD 9.45), 543 (95.8%) were newly diagnosed. At 12 months, 134/284 (47.2%) and 114/283 (40.3%) of participants in intervention and comparator clusters respectively achieved VL <20 (adjOR, 1.60, 95%CI 1.13-2.26, p=0.008). Intervention participants also did better for linkage to care (assessed as a 2nd visit; adjOR, 1.65, 95%CI 1.09-2.49, p=0.017) and ART initiation (adjOR, 1.97, 95%CI 1.33-2.90, p<0.001) and retention (adjOR 4.16, 95%CI 1.14-13.87, p=0.015) than standard-of-care+ participants, but there was no difference for time to ART initiation among those who initiated (adjHR 1.06, 95%CI 0.78-1.46, p=0.69). 12-month study retention was >84% in both arms, including deaths.
CONCLUSIONS: Focused linkage support at diagnosis and shortly thereafter increased linkage, ART initiation, retention, and viral suppression. This intervention may have utility with populations experiencing linkage and viral suppression challenges.