Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Digital Health Feedback System (DHFS) for Longitudinal Monitoring of ARVs Used in HIV Pre-exposure Prophylaxis (PrEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03693040
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : October 2, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Gilead Sciences
Proteus Digital Health, Inc.
Information provided by (Responsible Party):
University of California, San Diego

Brief Summary:

This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect information about patients taking their Pre-Exposure Prophylaxis (PrEP) medication for HIV prevention. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which gives healthcare providers information about when patients have taken their PrEP medication.

The purpose of the study is to demonstrate that the DHFS is easy to use and acceptable to people taking PrEP; that patients will persist with its use; and that the system provides valid, accurate measures of adherence.


Condition or disease Intervention/treatment Phase
HIV Prevention Device: Digital Health Feedback System Not Applicable

Detailed Description:

This study is a prospective single arm open label intervention study over 12 weeks using the DHFS with participants initiating or continuing HIV PrEP. The study intervention has an initiation (Phase 1), persistence (Phase 2) and follow-up period up to 96 weeks. In phase 1 participants will use the DHFS with close follow-up incorporating visits with directly observed ingestions. In Phase 2 the participants utilize the DHFS in their natural setting with sporadic study visits until 12 weeks. Eligible HIV seronegative participants will receive an ingestible sensor enabled oral antiretroviral (IS-ARV) of TDF/FTC (Truvada®). The study will be conducted at the UCSD AVRC. Participants will be recruited from UCSD AVRC, UCSD Owen Clinic, related or affiliated UCSD primary care programs or community primary care clinics. Following the 12 week intervention participants will undergo HIV testing and continuation on HIV PrEP and followed for up to 96 weeks. The primary outcome will be an accurate measure of adherence i.e. the number of doses of selected IS-ARVs ingested, as captured by the DHFS, over the number of doses prescribed, adjusted for positive detection accuracy (PDA), defined as the percentage of detected sensors that have been administered under direct observation.The investigators will also assess the acceptability and feasibility of longitudinal monitoring in real time of the ingestion rate utilizing the DHFS. In addition the investigators will evaluate the ability of the DHFS to identify participants whose longitudinal medication taking and timing patterns in the first 12 weeks of ARV treatment puts them at risk for HIV infection as far out as 96 weeks from start of treatment.

Pharmacokinetic Substudy

• To obtain TDF/FTC serum levels data comparing co-encapsulated IS-Truvada formulation to native Truvada® as supplemental information to dissolution studies.

A subset of 12 participants prescribed IS-Truvada®:(tenofovir disoproxil fumarate/emtiritabine) for PrEP will be enrolled in a PK sub-study to provide supplementary data to dissolution studies conducted by Gilead Sciences on the co-encapsulated IS-Truvada formulation. On Day 14 of treatment, when drug concentrations are expected to be close to steady state, sub-study participants will have a PK profile for Tenofovir and Emtricitabine obtained over a single dosing interval (at time 0 (pre-dose Ctrough), 2, 4, 6, 8 and 24 hours). Participants will be seen at the AVRC in a fasting state prior to taking their dose of IS-Truvada® and will remain fasting for 2 hours after the observed ingestion. The time and date of the previous doses of IS-Truvada® will be recorded by and available from the DHFS prior to initiating the PK procedures. The following day, Day 15, the participant will return to the AVRC in a fasting state. The 24 hour plasma sample will be drawn. Participants will then receive an observed dose of native Truvada. Participants will remain fasting for 2 hours after the observed ingestion and will have plasma samples drawn at 2, and 4 hours after ingestion.

Samples will be analyzed for tenofovir and emtricitabine drug concentration levels either individually or in batches at the central specialized laboratory.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Digital Health Feedback System (DHFS) for Longitudinal Monitoring of ARVs Used in HIV Pre-exposure Prophylaxis (PrEP)
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: DHFS with IS-Truvada
Digital Health Feedback System (DHFS) with IS-Truvada 1 capsule daily for 12 weeks
Device: Digital Health Feedback System
This intervention uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new technologies approved by the FDA, to collect information about patients taking their PrEP medication. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which provides information about when patients have taken their PrEP medication.




Primary Outcome Measures :
  1. Medication Taking Adherence [ Time Frame: 12 weeks ]
    Medication taking adherence, defined as the number of doses ingested as captured by the DHFS over the number of doses prescribed, adjusted for Positive Detection Accuracy ( determined by the percentage of PrEP medication ingestion detected by the DHFS administered under witnessed observation).

  2. The system positive detection accuracy (PDA) will be derived [ Time Frame: 12 weeks ]
    2. PDA is determined by the percentage of HIV PrEP ingestion detected by the DHFS administered under witnessed observation, overall for all study subjects. PDA will be based upon proper DHFS use. The PDA will be calculated for a single tablet regimen.


Secondary Outcome Measures :
  1. Determine the percentage of participants starting or continuing HIV PrEP who find the DHFS acceptable and easy to use. [ Time Frame: 12 weeks ]
    Acceptability and participant satisfaction with the DHFS will be accessed based on the self-report DHFS User Experience questionnaires which include open ended questions and a detailed DHFS User Experience questionnaire with Likert scale covering overall assessment, ease of use, time needed to use the system, perceived personal benefit and negative impressions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Adult non-pregnant HIV-seronegative participants who are starting or continuing HIV PrEP with IS-TDF/FTC (Truvada®), who are able to use the DHFS mobile device, and to tolerate a wearable sensor patch
  2. Laboratory values obtained by screening laboratories within 14 days of entry:

    • Absolute neutrophil count (ANC) ≥ 1,000/mm3.
    • Hemoglobin ≥ 9.0 g/dL.
    • Platelet count ≥ 75,000/mm3.
    • AST (SGOT), ALT (SGPT), and alkaline phosphatase ≤ 3 x ULN.
    • Estimated GFR by Cockcroft-Gault equation of >50 ml/min, if starting treatment with Truvada®(TDF/FTC).
    • HIV Ag/Ab test negative
    • Hepatitis B serology negative
  3. Females of childbearing potential must agree to use an acceptable form of contraception throughout the protocol.
  4. 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.
  5. Willing to follow all protocol requirements.
  6. No symptoms or clinical suspicion of acute HIV infection.

Exclusion Criteria:

  1. Female who is pregnant, breast-feeding, or of childbearing potential and declines to use contraception throughout the study period.
  2. Use of any of the prohibited medications or other non-informed medications within 30 days of study entry (Day 0).
  3. Known allergy/sensitivity to any of the study drugs.
  4. Known sensitivity to skin adhesives.
  5. Serious medical (serious infection or acute therapy for other medical illness) or psychiatric illness requiring systemic treatment and/or hospitalization until participant either completes therapy or is clinically stable on therapy, in the opinion of the investigators, for at least 30 days prior to study entry (Day 0).
  6. Active drug or alcohol use, or dependence, or other conditions that, in the opinion of the site investigators, would significantly interfere with ability to follow to study requirements.

    -


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): NCT03693040


Contacts
Layout table for location contacts
Contact: Sara H Browne, MD. MPH 858 8226563 shbrowne@ucsd.edu
Contact: Amanda J Tucker Maytom, MD 619 543 3145 a1tucker@ucsd.edu

Locations
Layout table for location information
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: Amanda J Tucker Maytom, MD    6195433145    a1tucker@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
National Institute of Mental Health (NIMH)
Gilead Sciences
Proteus Digital Health, Inc.
Investigators
Layout table for investigator information
Study Chair: Sara H Browne, MD MPH UCSD AntiViral Research Center
Study Chair: Constance A Benson, MD UCSD AntiViral Research Center

Layout table for additonal information
Responsible Party: University of California, San Diego
ClinicalTrials.gov Identifier: NCT03693040     History of Changes
Other Study ID Numbers: 161618
R01MH110057 ( U.S. NIH Grant/Contract )
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: July 2018