HIV/AIDSPhase 4DigiPrEPNCT03842436

Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use

A Phase 4 study testing Digital pill and Truvada in people with HIV/AIDS and Substance Use Disorders, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: HIV/AIDS, Substance Use Disorders, Adherence, Medication
What is being tested?: Digital pill and Truvada
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2018to 22 Apr 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

MSM (cisgender male)
Self-reported use of non-alcohol substances of abuse in past 6 months
Currently taking PrEP
Has qualifying laboratory tests (Cr, hepatitis B immunization, STI testing and syphilis)
Age 18 or older

Who cannot join

Does not speak English
HIV positive
Identifies as transgender
Estimated creatinine clearance <60ml/min
Active hepatitis B treatment
Does not own a smartphone

Show all 11Show fewer

Taking proton pump inhibitors
History of Crohn's disease or ulcerative colitis
History of bowel surgery, gastric bypass, bowel stricture
History of GI malignancy or radiation to abdomen
Unable/unwilling to ingest digital pill

Trial locations and contacts

1 site in 1 country.

United States1 site

Fenway Health
Boylston, Massachusetts, 02215

Other trials in United States

About this study

This study deploys a novel digital pill with Emtricitabine/Tenofovir (TDF/FTC) among MSM with substance use to monitor PrEP adherence. The investigators will enroll N=15 HIV uninfected MSM with self reported substance use who are on PrEP or initiating PrEP to use digital pills over encapsulating TDF/FTC for 3 months. The investigators will assess the feasibility of using digital pills in this study population as well as understand the acceptability of digital pills for adherence measurement using semi-structured individual interviews. Additionally, the investigators will measure adherence over time, as well as episodes of suboptimal PrEP adherence.

Read the detailed description

Eligible study participants will be screened and enrolled at Fenway Health (Boston, MA). Participants will complete a quantitative assessment on their history fo substance use, sexual risk and PrEP adherence, and be trained to use the digital pill for 90 days and instructed to take PrEP daily during the course of the study. Participants will return each month for a study visit to assess their use of the technology. At study visit 1 and 3, we will obtain dried blood spots (DBS) to measure drug levels and to confirm adherence detected by the digital pill. The investigators will also obtain drugs of abuse screens from DBS. At the final study visit (3 months), participants will undergo a semi-structured qualitative interview to understand the user response to digital pills.

Conditions: HIV/AIDS, Substance Use Disorders, Adherence, Medication
Being tested: Digital pill, Truvada
Keywords: PrEP, Substance Use Disorder, Digital Pills, Medication Adherence
Medical subject headings: Acquired Immunodeficiency Syndrome, Substance-Related Disorders, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Digital pillDevice
Also called eTectRx ID Cap
Digital pills over encapsulating Truvada
TruvadaDrug
Truvada prescribed with digital pills for PrEP

Study groups in NCT03842436
Study group	Role	What they receive
Digital Pills	Experimental	Digital Pills containing Truvada ingested once daily as PrEP Receives: Device: Digital pill; Drug: Truvada

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of Digital Pills to Measure PrEP Adherence
Participants' engagement with the digital pill system (DPS) was measured over the 90-day study period. The percentages for the total expected ingestions recorded by DPS each month were compared.
Measured: Months 1, 2, and 3

Secondary outcomes (5)

Digital Pill Performance - Number of Recorded Ingestions
The total number recorded ingestions recorded by the digital pill system (DPS) - which included both the number of Reader-detected and manually-reported ingestions - was collected. The Reader-detected ingestions count was used to reflect the number of times the DPS was operated correctly. Successful DPS operation was defined as ingestion of a digital pill, proper use of the wearable Reader, and confirmation of the ingestion on both the Reader and the app. Cumulative data collected at months 1, 2, and 3 are reported in the data table below.
Measured: Months 1, 2, and 3
Digital Pill Performance - System Accuracy
Accuracy of the digital pill system (DPS) in measuring PrEP adherence. To analyze the performance of the DPS, the ground truth of PrEP ingestion events was defined as the pill counts obtained each month (i.e., the number of unused pills returned, subtracted from the number of pills previously dispensed). The number of DPS-recorded ingestions - which included the number of both Reader-detected and manually-reported ingestions - was compared with the aggregate pill count at each monthly timepoint; this was defined as the overall performance metric for the DPS. Cumulative data collected at months 1, 2, and 3 are reported in the data table below.
Measured: Months 1, 2, and 3
Digital Pill Performance - Manually Reported Ingestions
The total number of manually reported ingestions was collected. The percentages for instances of manually reported ingestions were calculated. The two instances for manually recording ingestions included, a lack of engagement with the Reader or failure to use the Reader properly, and when reported ingestion was not detected by the Reader despite supporting use metrics indicating proper Reader use. Cumulative data collected at months 1, 2, and 3 are reported in the data table below.
Measured: Months 1, 2, and 3
Digital Pill Performance - Successful Operation of System
The total number of instances in which ingestions were successfully detected by the Reader (i.e., the radio frequency emitter was activated, and the ingestion was recorded by the DPS) was collected. The total number of instances in which manually reported ingestions were not detected by the Reader, despite supporting use metrics (e.g., accelerometer data) indicating proper Reader use was also collected. These counts were combined and interpreted as the number of times that the DPS was operated correctly. Cumulative data collected at months 1, 2, and 3 are reported in the data table below.
Measured: Months 1, 2, and 3
Dried Blood Spot Correlation With Digital Pill Adherence
We dichotomized TFV-DP levels using a cutoff of ≥700 fmol/punch to indicate at least four doses of PrEP ingested per week. Using TFV-DP in DBS <700 vs ≥700 fmol/punch as a dichotomous variable, and considering the granular continuous adherence data from the digital pill, we then calculated a point biserial correlation between TFV-DP in DBS and digital pill adherence. Additionally, drug concentrations of tenofovir diphosphate as measured in dried blood spot collection at months one and three were compared to DPS-recorded PrEP adherence.
Measured: Months 1 and 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201822 Apr 2020

First posted15 Feb 2019
Study start1 Oct 2018
Primary completion22 Apr 2020
Study completion22 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIV/AIDSStudies 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 4
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: Single group pilot demonstration project
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03842436
Sponsor's protocol ID: 2019P000793
Acronym: DigiPrEP
Status last verified: Dec 2022
First submitted: 13 Feb 2019
Last updated: 22 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Publications

Chai PR, Goodman GR, Bronzi O, Gonzales G, Baez A, Bustamante MJ, Najarro J, Mohamed Y, Sullivan MC, Mayer KH, Boyer EW, O'Cleirigh C, Rosen RK. Real-World User Experiences with a Digital Pill System to Measure PrEP Adherence: Perspectives from MSM with Substance Use. AIDS Behav. 2022 Jul;26(7):2459-2468. doi: 10.1007/s10461-022-03594-9. Epub 2022 Jan 28.
PubMed 35089449
Chai PR, Mohamed Y, Bustamante MJ, Goodman GR, Najarro J, Castillo-Mancilla J, Baez A, Bronzi O, Sullivan MC, Pereira LM, Baumgartner SL, Carnes TC, Mayer KH, Rosen RK, Boyer EW, O'Cleirigh C. DigiPrEP: A Pilot Trial to Evaluate the Feasibility, Acceptability, and Accuracy of a Digital Pill System to Measure PrEP Adherence in Men Who Have Sex With Men Who Use Substances. J Acquir Immune Defic Syndr. 2022 Feb 1;89(2):e5-e15. doi: 10.1097/QAI.0000000000002854.
PubMed 34753871

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
ClinicalTrials.gov ID: NCT03842436
Acronym / sponsor ID: DigiPrEP / 2019P000793
Conditions: HIV/AIDS, Substance Use Disorders, Adherence, Medication
Keywords: PrEP, Substance Use Disorder, Digital Pills, Medication Adherence
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Collaborators: Gilead Sciences
Study start: 1 Oct 2018 (actual)
Primary completion: 22 Apr 2020 (actual)
Study completion: 22 Apr 2020 (actual)
First posted: 15 Feb 2019 (actual)
Results: Posted 1 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single group pilot demonstration project

Arm	Type	Receives
Digital Pills	Experimental	Device: Digital pill, Drug: TruvadaDigital Pills containing Truvada ingested once daily as PrEP

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

MSM (cisgender male)
Self-reported use of non-alcohol substances of abuse in past 6 months
Currently taking PrEP
Has qualifying laboratory tests (Cr, hepatitis B immunization, STI testing and syphilis)
Age 18 or older

Key exclusion criteria (11 listed)

Does not speak English
HIV positive
Identifies as transgender
Estimated creatinine clearance <60ml/min
Active hepatitis B treatment

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 pillAlso: eTectRx ID CapDigital pills over encapsulating Truvada	Device	Digital Pills
TruvadaTruvada prescribed with digital pills for PrEP	Drug	Digital Pills

Primary outcome

Feasibility of Digital Pills to Measure PrEP Adherence
Time frame: Months 1, 2, and 3
Participants' engagement with the digital pill system (DPS) was measured over the 90-day study period. The percentages for the total expected ingestions recorded by DPS each month were compared.

5 secondary outcomes

Digital Pill Performance - Number of Recorded Ingestions
Time frame: Months 1, 2, and 3
Digital Pill Performance - System Accuracy
Time frame: Months 1, 2, and 3
Digital Pill Performance - Manually Reported Ingestions
Time frame: Months 1, 2, and 3
Digital Pill Performance - Successful Operation of System
Time frame: Months 1, 2, and 3
Dried Blood Spot Correlation With Digital Pill Adherence
Time frame: Months 1 and 3

Results and safety

Results posted to the registry on 1 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Digital Pills	16	15

Primary outcome: Feasibility of Digital Pills to Measure PrEP Adherence

Time frame: Months 1, 2, and 3. Count of units. Unit: Expected ingestions per pill counts

Measure	Digital Pills n = 14
Month 1: Total ingestions recorded by DPS	411
Month 2: Total ingestions recorded by DPS	368
Month 3: Total ingestions recorded by DPS	320

Population analysed: One participant was temporarily lost to follow-up, so they were excluded from analysis. In Month 1, the total number of DPS-recorded ingestion events (411) exceeded the total expected ingestion events from pill counts (402), as a result of one participant returning nine more unused pills than anticipated at the end of the month. The total expected ingestions for Month 1 is listed as 411 in the table below for clarity.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Digital Pills	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Limitations and caveats (from the sponsor): (1) Most participants were White and well-educated, limiting generalizability. (2) Opportunities for technical DPS improvements arose during the study, which required some participants to temporarily manually record doses. (3) The assay utilized for TFV-DP has not been cross-validated and may result in errors in assayed concentration of TFV-DP. (4) Reliance on pill counts may have decreased the measured accuracy of the DPS among participants who did not return unused pills each month.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35089449Chai PR, Goodman GR, Bronzi O, Gonzales G, Baez A, Bustamante MJ, Najarro J, Mohamed Y, Sullivan MC, Mayer KH, Boyer EW, O'Cleirigh C, Rosen RK. Real-World User Experiences with a Digital Pill System to Measure PrEP Adherence: Perspectives from MSM with Substance Use. AIDS Behav. 2022 Jul;26(7):2459-2468. doi: 10.1007/s10461-022-03594-9. Epub 2022 Jan 28.
Derived from this study: PubMed 34753871Chai PR, Mohamed Y, Bustamante MJ, Goodman GR, Najarro J, Castillo-Mancilla J, Baez A, Bronzi O, Sullivan MC, Pereira LM, Baumgartner SL, Carnes TC, Mayer KH, Rosen RK, Boyer EW, O'Cleirigh C. DigiPrEP: A Pilot Trial to Evaluate the Feasibility, Acceptability, and Accuracy of a Digital Pill System to Measure PrEP Adherence in Men Who Have Sex With Men Who Use Substances. J Acquir Immune Defic Syndr. 2022 Feb 1;89(2):e5-e15. doi: 10.1097/QAI.0000000000002854.
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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Digital pill and Truvada in people with HIV/AIDS and Substance Use Disorders, 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 5 inclusion and 11 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 22 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Digital Pills to Measure PrEP Adherence (time frame: Months 1, 2, and 3). 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 NCT03842436, which also lists 2 linked publications.

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 22 Dec 2022.