Recruitment of Youth Living With HIV to Optimize Adherence and Virologic Suppression: Testing the Design of Technology-Based Community Health Nursing to Improve Antiretroviral Therapy (ART) Clinical Trials
| Autor: | Saniyyah Mahmoudi, Hasiya E. Yusuf, Aaron Keith Selden, Constance Trexler, Lawrence J. D'Angelo, Mobeen H. Rathore, Rashida Carr, Susan Black, Raina Smith, Allison L. Agwu, Jisell Guadamuz, Julia Rowell, Steven Huettner, Maria Trent, Betty Johnson, Jackie Toppins, Jeanette Marchesi |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
viral suppression
Computer applications to medicine. Medical informatics Human immunodeficiency virus (HIV) R858-859.7 030312 virology medicine.disease_cause law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Nursing law Intervention (counseling) Health care Protocol Medicine 030212 general & internal medicine community health nursing adherence Young adult mobile health 0303 health sciences youth business.industry HIV General Medicine Clinical trial adolescent Community health business Viral load |
| Zdroj: | JMIR Research Protocols JMIR Research Protocols, Vol 9, Iss 12, p e23480 (2020) |
| ISSN: | 1929-0748 |
| Popis: | Background Despite advances in HIV diagnosis and treatment, adolescents and young adults 12-25 years old 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 We will recruit 120 adherence-challenged YHIV being followed at clinics specializing in HIV care in the Baltimore-Washington metropolitan area and in Jacksonville. Eligible participants complete an audio, computer-assisted self-interview and are randomized to either TECH2CHECK intervention or the SOC (60 participants in each arm). The primary outcome of interest is virologic suppression (viral load 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 (53/56, 95%), male (37/56, 66%), and ≥18 years old (53/56, 95%). Follow-up study visits, as required per the protocol, have been completed by 77% (43/56), 94% (45/48), 95% (37/39), 96% (24/25), and 100% (10/10) of participants at the 1-month, 3-month, 6-month, 12-month, and 18-month follow-ups, respectively. Conclusions Preliminary accrual and retention data suggest that TECH2CHECK is feasible and acceptable. Trial Registration ClinicalTrials.gov NCT03600103 https://clinicaltrials.gov/ct2/show/NCT03600103 International Registered Report Identifier (IRRID) DERR1-10.2196/23480 |
| Databáze: | OpenAIRE |
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