Overview

Next Generation Ingestible Sensors for Medication Adherence Measurement

Status:
Not yet recruiting

Trial end date:
2023-07-30

Target enrollment:
0

Participant gender:
All

Summary

This study will investigate the use of a next-generation Reader as part of a digital pill system (DPS; ID-Cap System) to measure adherence to both antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) in people living with HIV (PLWH) and HIV-negative individuals, respectively. During the first (non-human subjects) component of this study, we developed a wrist-borne Reader according to design specifications and preferences shared by DPS users from our previous studies. Early bench testing by etectRx (manufacturer of the ID-Cap System) demonstrated that the wrist-borne version of the Reader acquires signal from the digital pill. This study will therefore evaluate the usability of and user response to a wrist-borne Reader component of the DPS among PLWH on ART and HIV-negative individuals on PrEP.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Fenway Community Health

Collaborator:

Brigham and Women's Hospital

Treatments:

Anti-Retroviral Agents
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Criteria

Inclusion Criteria:

1. PrEP Participants:

- Age 18 or older

- HIV negative

- Prescribed and currently taking Truvada for PrEP for at least 30 days

- Qualifying labs for PrEP (Cr clearance in past 6 months, HBV vaccination, liver
function tests)

- Owns a smartphone with Android or iOS

2. ART Participants:

- Age 18 or older

- Diagnosed with HIV

- Prescribed and taking Biktarvy for at least 6 months

- Undetectable viral load during prior 6 months

- Owns a smartphone with Android or iOS

Exclusion Criteria:

1. PrEP Participants:

- Does not speak English

- History of Crohn's disease or ulcerative colitis

- History of gastric bypass or bowel stricture

- History of GI malignancy or radiation to abdomen

- Allergy to gelatin, silver, or zinc

- Implanted cardiac device, nerve stimulator, or drug infusion pump

- Not willing to operate DPS

2. ART Participants:

- Does not speak English

- History of Crohn's disease or ulcerative colitis

- History of gastric bypass or bowel stricture

- History of GI malignancy or radiation to abdomen

- Allergy to gelatin, silver, or zinc

- Implanted cardiac device, nerve stimulator, or drug infusion pump

- Not willing to operate DPS