HIV InfectionPhase 3NextGenNCT05592613
Next Generation Ingestible Sensors for Medication Adherence Measurement
A Phase 3 study testing Next-generation Reader and ID-Cap System, Truvada for pre-exposure prophylaxis (PrEP) and Biktarvy for antiretroviral therapy (ART) in people with HIV Infection and Adherence, Medication, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, Adherence, Medication, Adherence, Treatment
- What is being tested?
- Next-generation Reader and ID-Cap System, Truvada for pre-exposure prophylaxis (PrEP) and Biktarvy for antiretroviral therapy (ART)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2023to 25 Jul 2024
- Phase
- Phase 3
- 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
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- Implanted cardiac device, nerve stimulator, or drug infusion pump
- Not willing to operate DPS
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ID Cap System: Next Generation Ingestible Sensors for Medication Adherence Measurement
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.
Read the detailed description
This is a single-arm, observational trial (N=30), which will enroll N=15 people living with HIV (PLWH) using Biktarvy as antiretroviral therapy (ART) and N=15 HIV-negative individuals using Truvada as pre-exposure prophylaxis (PrEP). Potential participants will be approached and pre-screened. Those who meet pre-screening criteria will attend a Screening Visit (Visit 1), where the informed consent process will be conducted and eligibility will be confirmed. Eligible participants will attend a total of 3 study visits: the Screening Visit (Visit 1), Enrollment Visit (Visit 2), and Month 1 Visit (Visit 3). Participants will take one digital pill per day (Biktarvy as ART or Truvada as PrEP) for 30 days total, while using the next-generation Reader with a digital pill system, the ID-Cap System. Timeline followback discussions will be conducted at the Month 1 Visit to understand the context of any nonadherence detected by the digital pill system. Qualitative user experience exit interviews, quantitative assessments, dried blood spots (DBS), and pill counts of unused medication will also be conducted at the Month 1 Visit.
- Conditions
- HIV Infection, Adherence, Medication, Adherence, Treatment, Pre-Exposure Prophylaxis, Antiretroviral Therapy
- Being tested
- Next-generation Reader and ID-Cap System, Truvada for pre-exposure prophylaxis (PrEP), Biktarvy for antiretroviral therapy (ART)
- Keywords
- Digital Pill System, Pre-Exposure Prophylaxis, Antiretroviral Therapy, Adherence
- Medical subject headings
- HIV Infections, Medication Adherence, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next-generation Reader and ID-Cap SystemDevice
Also called Digital pill system
The digital pill system (DPS) is comprised of an ingestible radiofrequency emitter, integrated into a standard gelatin capsule, which then over-encapsulates the study medication (PrEP or ART). On ingestion, the radiofrequency emitter is activated by chloride ions in the stomach, projecting a signal approximately three feet off the body. This radio signal is acquired by a wearable device (Reader) which stores and forwards data to a smartphone, enabling on-demand access to adherence data. The next-generation Reader is a wrist-borne device.
Truvada for pre-exposure prophylaxis (PrEP)Drug
Participants will ingest one Truvada digital pill as PrEP per day, for 30 days total.
Biktarvy for antiretroviral therapy (ART)Drug
Participants will ingest one Biktarvy digital pill as ART per day, for 30 days total.
| Study group | Role | What they receive |
|---|---|---|
| PrEP Participants | Experimental | Participants will ingest one Truvada digital pill as PrEP per day, for 30 days total, while using the next-generation Reader and ID-Cap System. Receives: Device: Next-generation Reader and ID-Cap System; Drug: Truvada for pre-exposure prophylaxis (PrEP) |
| ART Participants | Experimental | Participants will ingest one Biktarvy digital pill as ART per day, for 30 days total, while using the next-generation Reader and ID-Cap System. Receives: Device: Next-generation Reader and ID-Cap System; Drug: Biktarvy for antiretroviral therapy (ART) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Next-Generation ID-Cap System to Measure PrEP/ART Adherence
Participants' engagement with the digital pill system (DPS) -- the next-generation ID-Cap System -- will be measured over the 30-day study period. The percentages for the total expected ingestions recorded by the DPS each month will be compared to adherence detected by the DPS.
Measured: Month 1 study visit
Correlation of PrEP/ART Adherence with DBS Concentrations and Pill Counts
Correlation of PrEP/ART adherence patterns, as detected by the next-generation ID-Cap System, with tenofovir diphosphate concentrations in dried blood spots (DBS) and pill counts of unused digital pills following the 30-day study period.
Measured: Month 1 study visit
Acceptability of Next-Generation ID-Cap System, via System Usability Scale
Acceptability will be measured via the System Usability Scale (SUS). The SUS is a 10-item measure of perceived usability of a technological system, scored on a 5-point Likert scale (1: strongly disagree, 5: strongly agree), with higher scores indicating greater perceived usability. A mean score of >68 will be used to indicate that the technology is acceptable.
Measured: Month 1 study visit
Acceptability of Next-Generation ID-Cap System, via Qualitative Interviews
Acceptability will be evaluated via qualitative interviews exploring participants' lived experiences operating the next-generation ID-Cap system and suggestions for improving the design of the technology.
Measured: Month 1 study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start6 Feb 2023
- Primary completion25 Jul 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 3
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- For 30 days, the next-generation Reader and ID-Cap System will be used in an open-label, observational trial with N=30 participants (N=15 HIV-negative individuals on PrEP and N=15 PLWH on ART).
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Fenway Institute
- Responsible party
- Principal investigator, Peter R Chai MD, Brigham and Women's Hospital
- Investigators
- Peter Chai, MD, MMS, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592613
- Sponsor's protocol ID
- 2022P002497
- Acronym
- NextGen
- Status last verified
- Sep 2024
- First submitted
- 12 Oct 2022
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ID Cap System: Next Generation Ingestible Sensors for Medication Adherence Measurement
- ClinicalTrials.gov ID
- NCT05592613
- Acronym / sponsor ID
- NextGen / 2022P002497
- Conditions
- HIV Infection, Adherence, Medication, Adherence, Treatment, Pre-Exposure Prophylaxis, Antiretroviral Therapy
- Keywords
- Digital Pill System, Pre-Exposure Prophylaxis, Antiretroviral Therapy, Adherence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- The Fenway Institute
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 24 Oct 2022 (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 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.
Detailed description
This is a single-arm, observational trial (N=30), which will enroll N=15 people living with HIV (PLWH) using Biktarvy as antiretroviral therapy (ART) and N=15 HIV-negative individuals using Truvada as pre-exposure prophylaxis (PrEP). Potential participants will be approached and pre-screened. Those who meet pre-screening criteria will attend a Screening Visit (Visit 1), where the informed consent process will be conducted and eligibility will be confirmed. Eligible participants will attend a total of 3 study visits: the Screening Visit (Visit 1), Enrollment Visit (Visit 2), and Month 1 Visit (Visit 3). Participants will take one digital pill per day (Biktarvy as ART or Truvada as PrEP) for 30 days total, while using the next-generation Reader with a digital pill system, the ID-Cap System. Timeline followback discussions will be conducted at the Month 1 Visit to understand the context of any nonadherence detected by the digital pill system. Qualitative user experience exit interviews, quantitative assessments, dried blood spots (DBS), and pill counts of unused medication will also be conducted at the Month 1 Visit.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For 30 days, the next-generation Reader and ID-Cap System will be used in an open-label, observational trial with N=30 participants (N=15 HIV-negative individuals on PrEP and N=15 PLWH on ART).
| Arm | Type | Receives |
|---|---|---|
| PrEP Participants | Experimental | Device: Next-generation Reader and ID-Cap System, Drug: Truvada for pre-exposure prophylaxis (PrEP)Participants will ingest one Truvada digital pill as PrEP per day, for 30 days total, while using the next-generation Reader and ID-Cap System. |
| ART Participants | Experimental | Device: Next-generation Reader and ID-Cap System, Drug: Biktarvy for antiretroviral therapy (ART)Participants will ingest one Biktarvy digital pill as ART per day, for 30 days total, while using the next-generation Reader and ID-Cap System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- PrEP Participants:
- ART Participants:
Key exclusion criteria (16 listed)
- PrEP Participants:
- ART Participants:
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 |
|---|---|---|
| Next-generation Reader and ID-Cap SystemAlso: Digital pill systemThe digital pill system (DPS) is comprised of an ingestible radiofrequency emitter, integrated into a standard gelatin capsule, which then over-encapsulates the study medication (PrEP or ART). On ingestion, the radiofrequency emitter is activated by chloride ions in the stomach, projecting a signal approximately three feet off the body. This radio signal is acquired by a wearable device (Reader) which stores and forwards data to a smartphone, enabling on-demand access to adherence data. The next-generation Reader is a wrist-borne device. | Device | ART Participants, PrEP Participants |
| Truvada for pre-exposure prophylaxis (PrEP)Participants will ingest one Truvada digital pill as PrEP per day, for 30 days total. | Drug | PrEP Participants |
| Biktarvy for antiretroviral therapy (ART)Participants will ingest one Biktarvy digital pill as ART per day, for 30 days total. | Drug | ART Participants |
Primary outcome
Feasibility of Next-Generation ID-Cap System to Measure PrEP/ART Adherence
Time frame: Month 1 study visit
Participants' engagement with the digital pill system (DPS) -- the next-generation ID-Cap System -- will be measured over the 30-day study period. The percentages for the total expected ingestions recorded by the DPS each month will be compared to adherence detected by the DPS.
Correlation of PrEP/ART Adherence with DBS Concentrations and Pill Counts
Time frame: Month 1 study visit
Correlation of PrEP/ART adherence patterns, as detected by the next-generation ID-Cap System, with tenofovir diphosphate concentrations in dried blood spots (DBS) and pill counts of unused digital pills following the 30-day study period.
Acceptability of Next-Generation ID-Cap System, via System Usability Scale
Time frame: Month 1 study visit
Acceptability will be measured via the System Usability Scale (SUS). The SUS is a 10-item measure of perceived usability of a technological system, scored on a 5-point Likert scale (1: strongly disagree, 5: strongly agree), with higher scores indicating greater perceived usability. A mean score of >68 will be used to indicate that the technology is acceptable.
Acceptability of Next-Generation ID-Cap System, via Qualitative Interviews
Time frame: Month 1 study visit
Acceptability will be evaluated via qualitative interviews exploring participants' lived experiences operating the next-generation ID-Cap system and suggestions for improving the design of the technology.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Peter Chai, MD, MMS principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Next-generation Reader and ID-Cap System, Truvada for pre-exposure prophylaxis (PrEP) and Biktarvy for antiretroviral therapy (ART) in people with HIV Infection and Adherence, Medication, run by Brigham and Women's Hospital at 1 site 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 12 inclusion and 16 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: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of Next-Generation ID-Cap System to Measure PrEP/ART Adherence (time frame: Month 1 study visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2024.