HIV PreventionNCT03693040
Digital Health Feedback System (DHFS) for Longitudinal Monitoring of ARVs Used in HIV Pre-exposure Prophylaxis (PrEP)
A study testing Digital Health Feedback System in people with HIV Prevention, run by University of California, San Diego at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Prevention
- What is being tested?
- Digital Health Feedback System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2016to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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.
- Aspartate aminotransferase (AST) , Alanine aminotransferase (ALT) , and alkaline phosphatase ≤ 3 x ULN.
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- Estimated Glomerular Filtration Rate (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
- Females of childbearing potential must agree to use an acceptable form of contraception throughout the protocol.
- 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.
- Willing to follow all protocol requirements.
- No symptoms or clinical suspicion of acute HIV infection.
Who cannot join
- Female who is pregnant, breast-feeding, or of childbearing potential and declines to use contraception throughout the study period.
- Use of any of the prohibited medications or other non-informed medications within 30 days of study entry (Day 0).
- Known allergy/sensitivity to any of the study drugs.
- Known sensitivity to skin adhesives.
- 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).
- 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.
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCSD AntiViral Research Center
San Diego, California, 92103
San Ysidro Health
San Diego, California, 92154
About this study
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.
Read the 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 (PK) 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.
- Conditions
- HIV Prevention
- Being tested
- Digital Health Feedback System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health Feedback SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| DHFS with IS-Truvada | Experimental | Digital Health Feedback System (DHFS) with IS-Truvada 1 capsule daily for 12 weeks Receives: Device: Digital Health Feedback System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Taking Adherence
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).
Measured: 12 weeks
The system positive detection accuracy (PDA) will be derived
- 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.
Measured: 12 weeks
Secondary outcomes (1)
Determine the percentage of participants starting or continuing HIV PrEP who find the DHFS acceptable and easy to use.
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 exit DHFS User Experience questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 Dec 2016
- Primary completion31 Dec 2021
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Gilead Sciences, Proteus Digital Health, Inc.
- Responsible party
- Principal investigator, Sara H. Browne, MD, MPH, University of California, San Diego
- Investigators
- Sara H Browne, MD MPH, Study chair, UCSD AntiViral Research CenterConstance A Benson, MD, Study chair, UCSD AntiViral Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693040
- Sponsor's protocol ID
- 161618
- Other IDs
- R01MH110057
- Status last verified
- Dec 2022
- First submitted
- 31 Jul 2018
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Browne S, Umlauf A, Moore DJ, Benson CA, Vaida F. User Experience of Persons Using Ingestible Sensor-Enabled Pre-Exposure Prophylaxis to Prevent HIV Infection: Cross-Sectional Survey Study. JMIR Mhealth Uhealth. 2024 May 3;12:e53596. doi: 10.2196/53596.
PubMed 38722201
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Health Feedback System (DHFS) for Longitudinal Monitoring of ARVs Used in HIV Pre-exposure Prophylaxis (PrEP)
- ClinicalTrials.gov ID
- NCT03693040
- Acronym / sponsor ID
- 161618
- Conditions
- HIV Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Gilead Sciences, Proteus Digital Health, Inc.
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (PK) 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DHFS with IS-Truvada | Experimental | Device: Digital Health Feedback SystemDigital Health Feedback System (DHFS) with IS-Truvada 1 capsule daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- Laboratory values obtained by screening laboratories within 14 days of entry:
- Females of childbearing potential must agree to use an acceptable form of contraception throughout the protocol.
- 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.
- Willing to follow all protocol requirements.
Key exclusion criteria (7 listed)
- Female who is pregnant, breast-feeding, or of childbearing potential and declines to use contraception throughout the study period.
- Use of any of the prohibited medications or other non-informed medications within 30 days of study entry (Day 0).
- Known allergy/sensitivity to any of the study drugs.
- Known sensitivity to skin adhesives.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Health Feedback SystemThis 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. | Device | DHFS with IS-Truvada |
Primary outcome
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).
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.
1 secondary outcome
Determine the percentage of participants starting or continuing HIV PrEP who find the DHFS acceptable and easy to use.
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Derived from this study: PubMed 38722201Browne S, Umlauf A, Moore DJ, Benson CA, Vaida F. User Experience of Persons Using Ingestible Sensor-Enabled Pre-Exposure Prophylaxis to Prevent HIV Infection: Cross-Sectional Survey Study. JMIR Mhealth Uhealth. 2024 May 3;12:e53596. doi: 10.2196/53596.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara H Browne, MD MPH study chair
UCSD AntiViral Research Center
Constance A Benson, MD study chair
UCSD AntiViral Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Health Feedback System in people with HIV Prevention, run by University of California, San Diego at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Taking Adherence (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03693040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.