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Technology Based Community Health Nursing to Improve Combination Anti-Retroviral Therapy (cART) Adherence and Virologic Suppression in Youth Living With HIV (Tech2Check)

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ClinicalTrials.gov Identifier: NCT03600103
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : November 2, 2018
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE May 15, 2018
First Posted Date  ICMJE July 25, 2018
Last Update Posted Date November 2, 2018
Actual Study Start Date  ICMJE July 11, 2018
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
Viral suppression [ Time Frame: 18 months ]
Viral suppression will be assessed by measuring plasma HIV-1 RNA (copies/mL). Viral suppression is defined as a viral load <20 copies/mL.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03600103 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
  • Management Cost difference [ Time Frame: 18 months ]
    To compare the cost of TECH2CHECK as compared to Standard of Care (SOC) for management of HIV in the outpatient setting. The costs of administering the different components of TECH2CHECK intervention and the standard of care will be based on a combination of direct observations, project records, and clinic invoices. The amount of staff and patient time (e.g. hours worked for CHN, patient transportation/visit time), consumable supplies (including miles traveled, antiretroviral costs, SMS costs, etc.), and equipment utilized (e.g., cell phones) for the intervention and SOC will be collected. Costs related to other health service utilization will be derived from ACASI, care utilization data.
  • Adherence to care as assessed by patient visits [ Time Frame: 18 months ]
    We will examine attendance to clinical visits (proportion of appointments attended/appointments scheduled). This will be based on a binary (Yes/No) response to a questionnaire given out to patients.
  • Adherence to care as assessed by HRSA retention measure [ Time Frame: 18 months ]
    We will also assess whether patients meet the Health Resources and Services Administration (HRSA) retention measure (2 provider visits in a 12-month period, with one appointment in each 6 month period, separated by at least 3 months)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Technology Based Community Health Nursing to Improve Combination Anti-Retroviral Therapy (cART) Adherence and Virologic Suppression in Youth Living With HIV
Official Title  ICMJE 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
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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • Adherence, Medication
Intervention  ICMJE Behavioral: Tech2Check
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.
Study Arms  ICMJE
  • No Intervention: Control
    Participants will receive standard of care.
  • Experimental: Intervention
    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.
    Intervention: Behavioral: Tech2Check
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2022
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 or Washington Metropolitan area
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Allison Agwu, MD, ScM 410-614-3917 ageorg10@jhmi.edu
Contact: Maria Trent, MD,MPH 410-955-2910 mtrent2@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03600103
Other Study ID Numbers  ICMJE IRB00161462
1R01MD011770-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Institute on Minority Health and Health Disparities (NIMHD)
Investigators  ICMJE
Principal Investigator: Allison Agwu, MD,ScM Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP