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

Open to people ages 18 years and up

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.

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.