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DHFS for Medication Adherence Support During Hospital Admissions for Person Living With HIV

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ClinicalTrials.gov Identifier: NCT04418037
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Gilead Sciences
ViiV Healthcare
Information provided by (Responsible Party):
Sara H. Browne, MD, MPH, University of California, San Diego

Brief Summary:
This study is a prospective single arm open label intervention study over 16 weeks using the DHFS and a telemedicine platform with persons living with HIV who are not virologically suppressed, admitted to UCSD Hillcrest Medical Center and initiating or restarting anti-retroviral therapy (ARVs). This proof of concept study will investigate the feasibility of using the DHFS in hospitalized individuals living with HIV to support ARV adherence. The Study intervention has an initiation phase of 2 weeks, a persistence phase of 14 weeks and a follow-up phase out to 48 weeks. Once study consent is obtained, the participant will receive a focused case navigation, psychiatric and substance abuse evaluation and will initiate digitized ARVs, either in hospital or at the AVRC within 14 days of hospital discharge, in collaboration with their providers. The study intervention will be considered to start from the point at which the DHFS is started. The study team will ensure the participants continue to utilize the DHFS both in hospital and after discharge. Following the 16 week intervention the study team will continue to follow participants to evaluate retention in care and viral suppression up to 48 weeks in collaboration with the outpatient care providers.

Condition or disease Intervention/treatment Phase
HIV/AIDS Device: Digital Health Feedback System(DHFS) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Digital Health Feedback System (DHFS) for Anti-Retroviral Therapy Medication Adherence and Transitions of Care Support During Hospital Admissions for Persons Living With HIV
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single arm using the Digital Health Feedback System
This protocol is designed to evaluate a novel technology that employs an ingestible sensor to detect medication ingestion for use by persons initiating or restarting antiretroviral (ARV) treatment for HIV infection during a hospital admission.
Device: Digital Health Feedback System(DHFS)
We will investigate the feasibility of using the DHFS in hospitalized individuals living with HIV to support ARV adherence.




Primary Outcome Measures :
  1. An accurate measure of medication taking adherence captured by the DHFS [ Time Frame: 16 weeks ]
    The number of doses ingested as captured by the DHFS over the number of doses prescribed, adjusted for positive detection accuracy (PDA). The system positive detection accuracy (PDA), based on prior studies, will allow an accurate measure of adherence with CI calculated.


Secondary Outcome Measures :
  1. Achieving <90% adherence as detected by DHFS over the study intervention (weeks 0-16). [ Time Frame: 16 weeks ]
    Participants with <90% adherence as detected by DHFS over the study intervention will be identified.

  2. Percentage of participants who require adherence support to maintain adherence over 90% during weeks 0-16. [ Time Frame: 16 weeks ]
    Percentage of participants who require adherence support to maintain adherence over 90% will be calculated.

  3. Satisfaction rating for DHFS use for HIV treatment as 'satisfactory' or higher. [ Time Frame: 16 weeks ]
    Characterize participant responses to study questionnaires on usability and exit questionnaire and summarize information regarding patient experience with the DHFS.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV seropositive status, as documented by positive licensed HIV antibody testing and a detectable viral load > 1000 copies/ml.
  2. Persons admitted to UCSD Hillcrest Medical Center with an HIV associated diagnosis and to receive HIV care through UCSD Owen Clinic, FHCSD HIV Clinic or San Ysidro Health HIV Clinic post hospital discharge.
  3. Persons initiating or continuing treatment for HIV infection by their HIV provider, that includes either:

    1. Dolutegravir/Tenofovir alafenamide/Emtricitabine: IS-DTG/TAF/FTC (Tivicay® and Descovy®)
    2. Bictegravir/ Tenofovir alafenamide/Emtricitabine: IS-BIC /TAF/FTC (Biktarvy®)
    3. Darunavir/Cobistat/Emtricitabine/Tenofovir alafenamide: IS-DRV/C/F/TAF (Symtuza™)
  4. Eligible for antiretroviral medications and in possession of prescriptions for above noted study eligible regimens.
  5. Laboratory values obtained by screening laboratories within 30 days of entry:

    1. Absolute neutrophil count (ANC) ≥ 1,000/mm3.
    2. Hemoglobin ≥ 7.0 g/dL.
    3. Platelet count ≥ 50,000/mm3.
    4. AST (SGOT), ALT (SGPT), and alkaline phosphatase ≤ 5 x ULN.
    5. Total bilirubin ≤ 3 x ULN and direct bilirubin.
    6. Estimated GFR by Cockcroft-Gault equation of greater than 30 ml/min.
  6. Females of childbearing potential (defined as girls who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e. who have had menses within the preceding 24 months, or have not undergone surgical sterilization (e.g. hysterectomy, bilateral oophorectomy, or salpingotomy) must have a negative serum or urine pregnancy test performed within 72 hours prior to study entry.

    If participating in activity that could lead to pregnancy, the participant must use at least one of the following forms of contraception throughout the protocol and for 6 weeks after stopping the IS-ARV medications.

    • Condoms (male or female) with a spermicidal agent
    • Diaphragm or cervical cap with spermicide
    • IUD
    • Oral contraception. Condoms in addition to other methods are highly recommended because their appropriate use is the only contraception method effective for preventing HIV-1 transmission.
  7. Men and women age ≥ 18 years.
  8. Basic competency in understanding written and verbal information as it applies to DHFS use. English and Spanish will be used for study documents and communication.
  9. Ability and willingness to follow all protocol requirements.
  10. Ability to use mobile device per investigator determination, and to wear PDH wearable sensor (i.e., no skin conditions precluding use).
  11. Ability and willingness of participant to give written informed consent.

Exclusion Criteria:

  1. Female who is pregnant, breast-feeding, or of childbearing potential and disagrees to use contraception throughout the study period.
  2. Use of any of the prohibited medications or other non-informed medications (Section 5.5.2) within 30 days of study entry (Day 0).
  3. Known allergy/sensitivity to any of the study drugs.
  4. Known sensitivity to skin adhesives.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04418037


Contacts
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Contact: Sara H Browne, MD MPH 619 5438080 shbrowne@health.ucsd.edu
Contact: Amanda J Tucker maytom, MD 619 543 3145 a1tucker@ucsd.edu

Locations
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United States, California
UCSD AntiViral Research Center Recruiting
San Diego, California, United States, 92103
Contact: Sara H Browne, MD MPH    858-822-6563    shbrowne@ucsd.edu   
Contact: Myrna J Castro    619543 8080    mscastro@health.ucsd.edu   
Principal Investigator: Sara H Browne, MD MPH         
Principal Investigator: Constance A Benson, MD         
Sponsors and Collaborators
University of California, San Diego
National Institute of Mental Health (NIMH)
Gilead Sciences
ViiV Healthcare
Investigators
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Principal Investigator: Sara H Browne, MD MPH UC San Diego
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Responsible Party: Sara H. Browne, MD, MPH, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04418037    
Other Study ID Numbers: 182100
R01MH110057 ( U.S. NIH Grant/Contract )
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases