Randomized Controlled Trial of a Remote Coaching mHealth Adherence Intervention in Youth Living with HIV

Abstract

Youth living with HIV (YLWH) in the US have low rates of viral suppression (VS). In a prospective randomized clinical trial (ATN152) that enrolled 89 YLWH on antiretroviral therapy (ART) with detectable viral load, we evaluated a 12 week triggered escalating real-time adherence (TERA) intervention with remote coaching, electronic dose monitoring (EDM), and outreach for missed/delayed doses compared to standard of care (SOC). Median [Q1, Q3] percent days with EDM opening was higher in TERA (72% (47%, 89%)) versus SOC (41% (21%, 59%); p < 0.001) and incidence of numbers of 7 day gaps between openings were lower (TERA to SOC ratio: 0.40; 95% CI 0.30, 0.53; p < 0.001). There were no differences in VS at week 12 (TERA 35%; 95% CI 21%, 51% versus SOC 36%; 95% CI 22%, 51%; p > 0.99) or later time-points. The intervention improved adherence but not VS in heavily ART-experienced YLWH. Remote coaching more closely tailored to the unique dosing patterns and duration of need for youth struggling to reach VS warrants further investigation.

The Effectiveness of Face-To-Face Counseling and Telenursing on the Drug Adherence for Individuals Suffering From HIV/AIDS

“…This researcher differentiated the intervention group with virtual group counseling via the Telegram application. (13) The other nine studies provided intervention with some media, such as the mHealth platform (10, [15][16][17], virtual counseling (18), digital media application (19,20), computer-based implementation (21), and cellular phones. (19) The researchers summarized the medicine consumption adherence with CD4 and virtual load checkup (10, [15][16][17][19][20][21].…”

“…(13) The other nine studies provided intervention with some media, such as the mHealth platform (10, [15][16][17], virtual counseling (18), digital media application (19,20), computer-based implementation (21), and cellular phones. (19) The researchers summarized the medicine consumption adherence with CD4 and virtual load checkup (10, [15][16][17][19][20][21]. The researchers also found a technique to measure the patients' adherence.…”

“…Thus, they miss the clinical visit which leads to delayed VL suppression, viral load, cumulative rate, and increased mortality and morbidity. The research sites: Southern Africa (10), the United States of America (15,17,20,21,23) Thailand ( 14) Colombia (16), Kenya (21), Brazil, Haiti, India, Kenya, Malawi, Southern Africa, Thailand, Uganda, Zimbabwe (17) various studies discussed the potentials of phone applications for patients with chronic diseases. The mHelath technology was an effective medium to improve the results for chronic diseases (24).…”

Electronic Dose Monitoring Device Patterns in Youth Living With HIV Enrolled in an Adherence Intervention Clinical Trial

“…Although the original plan was to use all 48 weeks of EDM data, after 24 weeks on study, increasing numbers of participants in both arms (13 of 43 SOC participants and 11 of 42 TERA participants, see Figure S1, Supplemental Digital Content, http://links.lww.com/QAI/B990) had discontinued use, as indicated by increasing proportions of participants with a complete absence of opening events and no association between EDM events and viral suppression. 14 For this reason, the analysis plan was updated to focus on the intervention period and the 12 weeks postintervention. We included follow-up until the last time the bottle was opened, after which we assumed the participant had stopped using the device.…”

“…The primary analysis of the study reported a positive effect of the intervention on EDM-based adherence during the 12-week intervention phase of the study and the 12 weeks after the intervention, but no association of the intervention with percent of participants with suppressed viral load (HIV-1 RNA <200 or <50 copies/mL) throughout follow-up. 14 These analyses used EDM-based adherence aggregated over each 12-week period.…”