Clinical trial NCT04418037: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV/AIDS
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Gilead Sciences
name: ViiV Healthcare
First posted: 2020-06-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: An accurate measure of medication taking adherence captured by the DHFS
timeFrame: 16 weeks
Secondary outcomes:
measure: Achieving <90% adherence as detected by DHFS over the study intervention (weeks 0-16).
timeFrame: 16 weeks
measure: Percentage of participants who require adherence support to maintain adherence over 90% during weeks 0-16.
timeFrame: 16 weeks
measure: Satisfaction rating for DHFS use for HIV treatment as 'satisfactory' or higher.
timeFrame: 16 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD AntiViral Research Center
state: California
Study officials:
affiliation: UC San Diego
name: Sara H Browne, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: