Technology Based Community Health Nursing to Improve Combination Anti-Retroviral Therapy (cART) Adherence and Virologic Suppression in Youth Living With HIV

NCT03600103 | Completed DMC

• 2 other identifiers: IRB001614621R01MD011770-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

Human immunodeficiency virus (HIV) infection has disproportionately persisted as a public health threat to adolescents and young adults (AYA) from minority communities in the United States. HIV has evolved into a chronic disease, which can be managed in the outpatient setting with antiretroviral therapy (ART) designed to achieve virologic suppression and life expectancy equivalent for uninfected individuals. Community health nurse (CHN) interventions have been shown to increase access to appropriate resources, enhance health care utilization, and promote risk-reducing behavior among AYA. Use of short messaging service (SMS) messaging can further enhance clinical care by improving attendance at medical visits, medication adherence, and communication with the health care team.Investigators have used these two modalities in randomized trials of youth with complex sexually transmitted infections (STIs) in low-income minority communities with high feasibility and acceptability amongst AYA and families, remarkable improvements in visit completion, medication adherence, and reduction in recurrent STIs. The overarching goal of this project is to build on the evidence from this trial and to re-purpose the intervention for Young people living with HIV (YLHIV) in the same community who are having challenges with care and medication non-adherence.Investigators aim to compare the effectiveness of a technology-enhanced community health nursing intervention (TECH2CHECK) to a standard of care control group using a randomized trial design. The central hypothesis is that the intervention will result in higher rates of adherence to ART and virologic suppression. Investigators have demonstrated investigators' interdisciplinary team's capacity to follow urban AYA in the community, utilizing the combination of CHNs and outreach workers to optimize care according to national standards. TECH2CHECK aims to enroll 120 YLHIV followed at clinics specializing in HIV care in the Baltimore-Washington Metropolitan area and Jacksonville, Florida who are challenged with treatment adherence and randomizing participants to receive TECH2CHECK vs. standard of care. Results of this trial will inform best practices for engaging YLHIV by addressing the distal component of the continuum, critical to achieving the elusive 90-90-90 HIV goals.

Conditions

HIV Infections; Adherence, Medication

Keywords

adolescent; community health nursing; text messaging; mobile health

Outcome Measures

Primary Outcomes (1)

• Viral suppression

  Viral suppression will be assessed by measuring plasma HIV-1 RNA (copies/mL). Viral suppression is defined as a viral load \<20 copies/mL.

  18 months

Secondary Outcomes (3)

• Management Cost difference

  18 months

• Adherence to care as assessed by patient visits

  18 months

• Adherence to care as assessed by HRSA retention measure

  18 months

Study Arms (2)

Control

NO INTERVENTION

Participants will receive standard of care.

Intervention

EXPERIMENTAL

TECH2CHECK involves field visits by a CHN trained in disease intervention protocols, including clinical assessment, case management, counseling, and a behavioral intervention coupled with text messaging support for medication and self-care reminders.

Behavioral: Tech2Check

Interventions

Tech2Check BEHAVIORAL

The intervention uses behaviors to improve HIV adherence and self-care. Investigators will use the Center for Disease Control (CDC) Partnership for Health (PfH) Medication Adherence.The CHN will administer PfH at all home/venue-based encounters, using communication styles that are more receptive to adolescents and young adults. Resources will be provided. At the end of the session, the participant will be able to state/demonstrate: goals of HIV care and adherence, meaning of CD4 and Viral Load (VL) measurements and the significance of their own measurements,signs of complications or problems for which participants need to seek additional care,understanding of optimal self-care.Further, CHNs will also provide tips to stay on schedule with taking their ART and problem-solve adherence barriers.

Intervention

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Eligible participants should be aged 12-25 years old diagnosed with HIV
• Eligible for ART, VL\>20 copies/ml
• English speaking (\>95% current clinic population)
• Aware of their HIV status
• Permanently reside in the Baltimore/Washington Metropolitan area or Jacksonville, Florida
• Willing to sign informed consent (including allowing communication with the participant's primary care provider). Informed consent includes being willing to complete study procedures; including randomization and community-based follow-up by our team.

You may not qualify if:

• Mental health, cognitive, or behavioral dysfunction that in the opinion of the site PI would impair effective participation
• Severe illness requiring hospitalization at the time of enrollment. This will be assessed at the team meetings designed to generate referrals.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

University of Florida

Jacksonville, Florida, 32209, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Agwu AL, Yusuf HE, D'Angelo L, Rathore M, Marchesi J, Rowell J, Smith R, Toppins J, Trexler C, Carr R, Johnson B, Selden AK, Mahmoudi S, Black S, Guadamuz J, Huettner S, Trent M. 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. JMIR Res Protoc. 2020 Dec 11;9(12):e23480. doi: 10.2196/23480.

  PMID: 33306036 DERIVED

MeSH Terms

Conditions

HIV Infections; Medication Adherence

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Allison Agwu, MD,ScM

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: July 26, 2018
• Study Start: July 11, 2018
• Primary Completion: December 31, 2023
• Study Completion: June 1, 2024
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)