ADDRESSING NON-ADHERENCE TO CARE AND ANTIRETROVIRAL TREATMENT AMONG U.S. YOUTH IN A RANDOMIZED CONTROLLED TRIAL OF A TECH-ENHANCED COMMUNITY NURSING INTERVENTION

• Published in: Journal of adolescent health Vol. 68; no. 2S; p. S29
• Main Authors: Agwu, Allison L, Rathore, Mobeen, D'Angelo, Lawrence, Marchesi, Jeanette, Rowell, Julia, Smith, Raina, Toppins, Jackie, Trexler, Connie, Johnson, Betty, Huettner, Steven, Mahmoudi, Saniyyah, Black, Susan, Guadamuz, Jisell, Martins, Mariana Guerreiro, Yusuf, Hasiya, Trent, Maria
• Format: Journal Article
• Language: English
• Published: New York Elsevier BV 01.02.2021
• Subjects: Adherence; Antiretroviral drugs; Antiretroviral therapy; Clinical outcomes; Clinical trials; Community health; Community nursing; Computerization; Demography; Dropping out; Feasibility; Health status; HIV; Human immunodeficiency virus; Intervention; Medical technology; Nursing; Perinatal; Personal safety; Reminders; Review boards; Triage; Youth
• ISSN: 1054-139X; 1879-1972

Purpose: Health status for youth with HIV (YHIV) is complicated by low rates of adherence to antiretroviral treatment (ART) and clinical care visits. As such, resultant consequences include poor clinical outcomes and increased risk of secondary transmission. The standard of care (SOC) approach relies on clinic-based interactions to address nonadherence, but many YHIV face barriers to accessing care. This study aims to assess the feasibility and acceptability of a technology-enhanced community health nursing intervention (teCHN) as an alternate paradigm of care. Methods: TECH2CHECK is a randomized controlled trial of SOC vs. a technology-enhanced community health nursing (CHN) intervention designed to address ART adherence (# NCT03600103) being conducted at youth-serving HIV clinics in high burden locales (Baltimore, Maryland, Washington DC, and Jacksonville, Florida). Eligible participants, YHIV 12-25 years, prescribed ART, with viral load (VL) >20 copies/ml, are randomized to SOC vs. CHN. All participants complete baseline and follow-up audio computerized self-interviews assessing demographic and behavioral characteristics, and have VL and toxicity monitoring at study visits (1,3,6,12, and 18 months). The intervention involves 5 CHN visits (2, 6,19,14, and 26 weeks) where adherence and barriers to care are addressed, monitoring labs drawn, and basic triage performed to address if more urgent care is needed. Intervention participants are provided the eMochaTM smartphone app, which provides customized care reminders, video upload for directly observed ART, surveys about adherence and symptoms, and site-specific resource lists. Outreach workers support study retention in both arms. The primary outcome is viral suppression. Descriptive and bivariate data analyses are used to evaluate feasibility and acceptability of the study design. Institutional review boards at all sites approved the study and participants consented to the study. Results: As of April 30.2020, the study is 50% accrued. Of 102 eligible YHIV, 59 (58%) were enrolled (30 CHNf 29 SOC) across 3 sites; 39 male, 23 perinatal/36 non-perinatal (19 MSM), 55 aged 18-25 years. Median VL at enrollment was 93 copies/ml (interquartile range 19, 1,550). 26% had not been engaged in clinical care in >6 months. Overall per protocol study visit completion rates have been 96%, 95%, 93%, 86%, and 86% at the 1-, 3-, 6-, 12-, and 18-month visits, respectively. Completion rates for the CHN visits in the intervention arm have been 77% (2 weeks), 80% (6 weeks), 78% (10 weeks), 96% (14 weeks), and 81% (26 weeks). To date, only one patient has been lost to follow-up. Most CHN visits have taken place in the home; no safety issues have occurred. Conclusions: The TECH2CHECK study is ongoing; however, preliminary data suggests that nonadherent YHIV can successfully attend study visits and that theTECH2CHECI< intervention demonstrates high feasibility and acceptability as evidenced by high CHN visit completion rates and minimal dropout over 18 months.