JMIR Publications

ABSTRACT

Background:

Despite advances in human immunodeficiency virus (HIV) diagnosis and treatment, adolescents and young adults (AYA) 12-25 years have high HIV incidence, poor engagement and retention in treatment, and low rates of adherence and virologic suppression when compared to their older counterparts. HIV has emerged as a chronic disease for which antiretroviral therapy (ART) adherence is critical for virologic suppression and long-term survival. Virologic suppression has been elusive for many youth with HIV (YHIV). Novel strategies designed to facilitate health care systems’ support for YHIV between medical visits are essential for improving ART adherence, virologic suppression and long-term survival.

Objective:

The aim of this study is to compare the effectiveness of a technology-enhanced community health nursing intervention (TECH2CHECK) to a standard of care (SOC) control group for improving ART adherence and subsequent viral suppression using a randomized trial design. The objectives are to assess the feasibility, acceptability and cost-effectiveness of TECH2CHECK as compared to SOC for management of HIV in the outpatient setting, and to examine the sustainability of self-care behavior, adherence, and virologic suppression among youth following the intervention period

Methods:

120 adherence-challenged YHIV followed at clinics specializing in HIV care in the Baltimore-Washington Metropolitan area and in Jacksonville will be recruited to participate in this study. Eligible participants complete an audio computerized self-interview (ACASI) and are randomized to either TECH2CHECK intervention or the standard of care (60 participants in each arm). The primary outcome of interest is virologic suppression (viral copies <20 copies/ml) and improved treatment adherence. Participants in the intervention arm receive community health nursing visits at 2, 6, 10, 14 and 26 weeks. The intervention arm also receives short message service (SMS) messaging comprising daily adherence and appointment reminders, and positive reinforcement for medication adherence daily for 2 weeks, on alternate days for 2 weeks, thrice weekly for 1 month, weekly for 3 months and every two weeks for the rest of the study duration. The control group receives appointment reminders and standard of care per clinic protocol. Exploratory analysis will be conducted to determine differences in medication adherence and virologic suppression in the two arms and to assess cost-effectiveness and study feasibility and acceptability.

Results:

In the first 23 months of the study (July 2018-April 2020), 56 (55%) of 102 eligible patients were enrolled and randomized. At present, participating youths are primarily African American (94.6%), males (66%) and 18 years and older (94.6%).

Conclusions:

Preliminary accrual and retention data suggest that TECH2CHECK is feasible and acceptable. If TECH2CHECK proves to be effective, the results of this trial may inform best practices for engaging YHIV by addressing the distal component of the HIV continuum, critical to achieving the elusive 90-90-90 HIV goals. Clinical Trial: ClinicalTrials.gov NCT03600103 https://clinicaltrials.gov/ct2/show/NCT03600103