PMID- 33306036 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20210514 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 9 IP - 12 DP - 2020 Dec 11 TI - 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. PG - e23480 LID - 10.2196/23480 [doi] LID - e23480 AB - 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 <20 copies/mL) and improved treatment adherence. Participants in the intervention arm receive community health nursing visits at 2 weeks, 6 weeks, 10 weeks, 14 weeks, and 26 weeks. The intervention arm also receives 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 2 weeks for the rest of the study duration. The control group receives appointment reminders and SOC per clinic protocol. Exploratory analysis will be conducted to determine differences in medication adherence and virologic suppression in the 2 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 (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. CI - (c)Allison Lorna Agwu, Hasiya Eihuri Yusuf, Lawrence D'Angelo, Mobeen Rathore, Jeanette Marchesi, Julia Rowell, Raina Smith, Jackie Toppins, Constance Trexler, Rashida Carr, Betty Johnson, Aaron Keith Selden, Saniyyah Mahmoudi, Susan Black, Jisell Guadamuz, Steven Huettner, Maria Trent. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 11.12.2020. FAU - Agwu, Allison Lorna AU - Agwu AL AUID- ORCID: 0000-0002-8449-222X AD - Department of Pediatric and Adult Infectious Diseases, Johns Hopkins School of Medicine, Baltimore, MD, United States. FAU - Yusuf, Hasiya Eihuri AU - Yusuf HE AUID- ORCID: 0000-0002-6948-8652 AD - Johns Hopkins School of Medicine, Baltimore, MD, United States. FAU - D'Angelo, Lawrence AU - D'Angelo L AUID- ORCID: 0000-0001-7142-3674 AD - Children's National Medical Center, Washington, DC, United States. FAU - Rathore, Mobeen AU - Rathore M AUID- ORCID: 0000-0001-7416-9755 AD - University of Florida Center for HIV/AIDS Research, Education and Service, University of Florida College of Medicine, Jacksonville, FL, United States. FAU - Marchesi, Jeanette AU - Marchesi J AUID- ORCID: 0000-0002-1590-6871 AD - Johns Hopkins School of Medicine, Baltimore, MD, United States. FAU - Rowell, Julia AU - Rowell J AUID- ORCID: 0000-0002-5221-8875 AD - Johns Hopkins School of Medicine, Baltimore, MD, United States. FAU - Smith, Raina AU - Smith R AUID- ORCID: 0000-0002-8754-2333 AD - Johns Hopkins School of Medicine, Baltimore, MD, United States. FAU - Toppins, Jackie AU - Toppins J AUID- ORCID: 0000-0002-7636-5044 AD - Johns Hopkins School of Medicine, Baltimore, MD, United States. FAU - Trexler, Constance AU - Trexler C AUID- ORCID: 0000-0003-0309-0219 AD - Children's National Medical Center, Washington, DC, United States. FAU - Carr, Rashida AU - Carr R AUID- ORCID: 0000-0002-3408-1166 AD - Children's National Medical Center, Washington, DC, United States. FAU - Johnson, Betty AU - Johnson B AUID- ORCID: 0000-0002-3371-5606 AD - Johns Hopkins School of Medicine, Baltimore, MD, United States. FAU - Selden, Aaron Keith AU - Selden AK AUID- ORCID: 0000-0002-2745-5481 AD - Children's National Medical Center, Washington, DC, United States. FAU - Mahmoudi, Saniyyah AU - Mahmoudi S AUID- ORCID: 0000-0002-2586-0416 AD - University of Florida Center for HIV/AIDS Research, Education and Service, University of Florida College of Medicine, Jacksonville, FL, United States. FAU - Black, Susan AU - Black S AUID- ORCID: 0000-0003-2174-4298 AD - University of Florida College of Medicine, Jacksonville, FL, United States. FAU - Guadamuz, Jisell AU - Guadamuz J AUID- ORCID: 0000-0001-5071-9118 AD - University of Florida College of Medicine, Jacksonville, FL, United States. FAU - Huettner, Steven AU - Huettner S AUID- ORCID: 0000-0003-4904-1455 AD - Johns Hopkins School of Medicine, Baltimore, MD, United States. FAU - Trent, Maria AU - Trent M AUID- ORCID: 0000-0002-4973-5417 AD - Johns Hopkins School of Medicine, Baltimore, MD, United States. AD - Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States. LA - eng SI - ClinicalTrials.gov/NCT03600103 GR - R01 MD011770/MD/NIMHD NIH HHS/United States PT - Journal Article DEP - 20201211 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 PMC - PMC7762679 OTO - NOTNLM OT - HIV OT - adherence OT - adolescent OT - community health nursing OT - mobile health OT - viral suppression OT - youth COIS- Conflicts of Interest: MT receives funding from the National Institutes of Health (NINR, NICHD, NIMHD) and research supplies from Hologic Inc and SpeeDx LLC through Johns Hopkins University. She also serves on the Trojan Sexual Health Advisory Council (Church and Dwight Inc). AA receives funding from the National Institutes of Health (NICHD, NIAID, NIMHD) and serves as a member of scientific advisory boards of Gilead Pharmaceuticals and expert advisor panel for Merck Pharmaceuticals. EDAT- 2020/12/12 06:00 MHDA- 2020/12/12 06:01 PMCR- 2020/12/11 CRDT- 2020/12/11 12:07 PHST- 2020/08/14 00:00 [received] PHST- 2020/09/29 00:00 [accepted] PHST- 2020/09/24 00:00 [revised] PHST- 2020/12/11 12:07 [entrez] PHST- 2020/12/12 06:00 [pubmed] PHST- 2020/12/12 06:01 [medline] PHST- 2020/12/11 00:00 [pmc-release] AID - v9i12e23480 [pii] AID - 10.2196/23480 [doi] PST - epublish SO - JMIR Res Protoc. 2020 Dec 11;9(12):e23480. doi: 10.2196/23480.