Randomized controlled trial of an adherence intervention in youth living with HIV

ABSTRACT

Background: Youth living with HIV (YLWH) have low rates of viral suppression (VS). We evaluated the impact of a 12-week intervention using remote coaching, electronic dose monitoring (EDM) and tailored outreach (the Triggered Escalating Real-Time Adherence [TERA] intervention) compared to standard of care (SOC) on VS and electronic dose monitored adherence of antiretroviral therapy (ART), among viremic (HIV-1 RNA≥200 copies/ml) youth (ages 13-24 yrs) in the United States. Methods: 89 YLWH were randomized to TERA intervention versus SOC and followed for 48 weeks with study visits at weeks 0, 4, 12, 24, 36 and 48. Remote coaching sessions were delivered at Weeks 0, 4 and 12, with continuous EDM monitoring for delayed or missed ART doses and as needed outreach from coach by text and phone in the TERA arm. Primary outcome was VS at week 12 (HIV-1 RNA <200 cp/ml at 10-14 weeks). RNA ≥ 200 cp/ml (10-14 wks) or missing set to failure. Proportions with VS were compared by arm (Fisher's exact test and log binomial regression for adjusted comparisons). Secondary outcomes included EDM adherence summarized in 12-week intervals using percent days device was opened (PCT12) and incidence rates (IR) of number of ≥7-day gaps between openings (GAPIR), compared using Wilcoxon rank sum tests. Results are reported using data collected before the study paused due to COVID-19 in March 2020. Results: 88 YLWH completed study entry 55% male, 85% Black/African American, median age 22 (range 13-24 yrs), 44% acquired HIV perinatally and 30% on ≥3rd ART regimen. VS was achieved in 15/43 (35%;95% CI 21%, 51%) TERA arm and 16/45 (36%;95% CI 22%, 51%) SOC arm participants;difference (TERA-SOC) was-1% (95% CI-21%, 20%). No differences by arm were apparent at weeks 24, 36 or 48 or after adjusting for sex, age or mode of transmission. Of 54 participants with opportunity for follow-up to week 48, 14% (4/29) and 8% (2/25) in the TERA and SOC arms, respectively, achieved consistent VS (TERA-SOC 6%;95% CI 15%, 25%). Median (Q1, Q3) PCT12 over the first 12 weeks was 72% (47%, 89%) versus 41% (21%, 59%) in the TERA and SOC arms, respectively (p<0.001). GAPIRs were higher in the SOC arm than TERA arm with SOC/TERA IR ratio of 2.51 (95% CI 1.90, 3.33). Conclusion: The 12-week TERA intervention improved adherence to ART but not VS among YLWH failing treatment. TERA will be further assessed for indication, timing, and outcome duration in YLWH.