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NCT03600103Completed

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

Technology Based Community Health Nursing to Improve cART Adherence and Virologic Suppression in Youth Living With HIV (TECH-N 2 CHECK-IN): A Regional Multi-site Study

Source: ClinicalTrials.gov · Last updated 12 Jun 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
76 (actual)
First submitted
15 May 2018
Start date
11 Jul 2018
Primary completion date
31 Dec 2023
Lead sponsor
Johns Hopkins University
Diseases
HIV
NCT number
NCT03600103

What you commit to

  • Study type: Interventional
  • Participants enrolled: 76
  • From 11 Jul 2018 to the primary completion date, 31 Dec 2023
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Severe illness requiring hospitalization at the time of enrollment. This will be assessed at the team meetings designed to generate referrals.

Other

  • Mental health, cognitive, or behavioral dysfunction that in the opinion of the site PI would impair effective participation

Who the study is looking for

  • 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.

Age in the registry: 12 years to 25 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Johns Hopkins Hospital
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
University of Florida
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.