Clinical trial NCT03600103: Technology Based Community Health Nursing to Improve Combination Anti-Retroviral Therapy (cART) Adherence and Virologic Suppression in Youth Living With HIV
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Adherence, Medication
Keywords: adolescent
community health nursing
text messaging
mobile health
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-07-26
Enrollment: 76
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Viral suppression
timeFrame: 18 months
Secondary outcomes:
measure: Management Cost difference
timeFrame: 18 months
measure: Adherence to care as assessed by patient visits
timeFrame: 18 months
measure: Adherence to care as assessed by HRSA retention measure
timeFrame: 18 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Allison Agwu, MD,ScM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.