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

Primary Purpose

HIV/AIDS

Status

Active

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Digital Health Feedback System(DHFS)

About this trial

This is an interventional treatment trial for HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

HIV seropositive status, as documented by positive licensed HIV antibody testing and a detectable viral load > 1000 copies/ml.
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.
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™)
Eligible for antiretroviral medications and in possession of prescriptions for above noted study eligible regimens.
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.
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.
Men and women age ≥ 18 years.
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.
Ability and willingness to follow all protocol requirements.
Ability to use mobile device per investigator determination, and to wear PDH wearable sensor (i.e., no skin conditions precluding use).
Ability and willingness of participant to give written informed consent.

Exclusion Criteria:

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

Sites / Locations

UCSD AntiViral Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm using the Digital Health Feedback System

Arm Description

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.

Outcomes

Primary Outcome Measures

An accurate measure of medication taking adherence captured by the DHFS

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

Achieving <90% adherence as detected by DHFS over the study intervention (weeks 0-16).

Participants with <90% adherence as detected by DHFS over the study intervention will be identified.

Percentage of participants who require adherence support to maintain adherence over 90% during weeks 0-16.

Percentage of participants who require adherence support to maintain adherence over 90% will be calculated.

Satisfaction rating for DHFS use for HIV treatment as 'satisfactory' or higher.

Characterize participant responses to study questionnaires on usability and exit questionnaire and summarize information regarding patient experience with the DHFS.

Full Information

NCT ID

NCT04418037

First Posted

February 10, 2020

Last Updated

December 21, 2022

Sponsor

University of California, San Diego

Collaborators

National Institute of Mental Health (NIMH), Gilead Sciences, ViiV Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT04418037

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 15, 2019 (Actual)

Primary Completion Date

December 31, 2021 (Actual)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

National Institute of Mental Health (NIMH), Gilead Sciences, ViiV Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV/AIDS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single arm using the Digital Health Feedback System

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Digital Health Feedback System(DHFS)

Intervention Description

We will investigate the feasibility of using the DHFS in hospitalized individuals living with HIV to support ARV adherence.

Primary Outcome Measure Information:

Title

An accurate measure of medication taking adherence captured by the DHFS

Description

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Achieving <90% adherence as detected by DHFS over the study intervention (weeks 0-16).

Description

Participants with <90% adherence as detected by DHFS over the study intervention will be identified.

Time Frame

16 weeks

Title

Percentage of participants who require adherence support to maintain adherence over 90% during weeks 0-16.

Description

Percentage of participants who require adherence support to maintain adherence over 90% will be calculated.

Time Frame

16 weeks

Title

Satisfaction rating for DHFS use for HIV treatment as 'satisfactory' or higher.

Description

Characterize participant responses to study questionnaires on usability and exit questionnaire and summarize information regarding patient experience with the DHFS.

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: HIV seropositive status, as documented by positive licensed HIV antibody testing and a detectable viral load > 1000 copies/ml. 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. Persons initiating or continuing treatment for HIV infection by their HIV provider, that includes either: Dolutegravir/Tenofovir alafenamide/Emtricitabine: IS-DTG/TAF/FTC (Tivicay® and Descovy®) Bictegravir/ Tenofovir alafenamide/Emtricitabine: IS-BIC /TAF/FTC (Biktarvy®) Darunavir/Cobistat/Emtricitabine/Tenofovir alafenamide: IS-DRV/C/F/TAF (Symtuza™) Eligible for antiretroviral medications and in possession of prescriptions for above noted study eligible regimens. Laboratory values obtained by screening laboratories within 30 days of entry: Absolute neutrophil count (ANC) ≥ 1,000/mm3. Hemoglobin ≥ 7.0 g/dL. Platelet count ≥ 50,000/mm3. AST (SGOT), ALT (SGPT), and alkaline phosphatase ≤ 5 x ULN. Total bilirubin ≤ 3 x ULN and direct bilirubin. Estimated GFR by Cockcroft-Gault equation of greater than 30 ml/min. 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. Men and women age ≥ 18 years. 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. Ability and willingness to follow all protocol requirements. Ability to use mobile device per investigator determination, and to wear PDH wearable sensor (i.e., no skin conditions precluding use). Ability and willingness of participant to give written informed consent. Exclusion Criteria: Female who is pregnant, breast-feeding, or of childbearing potential and disagrees to use contraception throughout the study period. Use of any of the prohibited medications or other non-informed medications (Section 5.5.2) within 30 days of study entry (Day 0). Known allergy/sensitivity to any of the study drugs. Known sensitivity to skin adhesives.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sara H Browne, MD MPH

Organizational Affiliation

UC San Diego

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSD AntiViral Research Center

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

12. IPD Sharing Statement

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

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