HIV-positive IndividualsMyTPillNCT03978793
MyTPill: A Novel Strategy to Monitor Antiretroviral Adherence Among HIV+ Prescription Opioid Users
An observational study of HIV-positive Individuals, run by Ohio State University at 1 site in United States.
Trial summary
This study compares several different antiretroviral adherence measures, including digital pills, in HIV+ individuals who are maintained on opioid analgesics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-positive Individuals
- What is being tested?
- MyTPill, a digital pill
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 30 Apr 2025
- Phase
- Observational
- 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
Study population: HIV+
Who may be able to join
- HIV+, Viral load >200copies/mL, on single pill containing TDF/FTC, receiving prescription for opioid analgesics
Who cannot join
- Severe renal or hepatic disease
- Hypersensitivity to silver, magnesium, or zinc following oral use
- Pregnancy
- non-English speaking
- History of Crohn's disease or Ulcerative Colitis
- History of bowel surgery, gastric bypass, or bowel stricture
- History of gastrointestinal malignancy or radiation to the abdomen.
Trial locations and contacts
1 site in 1 country.
About this study
This study compares several different antiretroviral adherence measures, including digital pills, in HIV+ individuals who are maintained on opioid analgesics.
Read the detailed description
This study compares digital pills, electronic pill bottles, self-report, and dried blood spots, in measuring adherence to antiretroviral medications containing emtricitabine and tenofovir.
- Conditions
- HIV-positive Individuals
- Being tested
- MyTPill, a digital pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyTPill, a digital pillDevice
Also called Wisepill, a digital pillbox
MyTPill is a digital pill containing an approved medication
| Study group | Role | What they receive |
|---|---|---|
| MyTPill | Participants receive digital pills for three months, have a 2-week washout, then switch to Wisepill. Receives: Device: MyTPill, a digital pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dried blood spots
Measurement of dried blood spots for TDF/FTC concentrations
Measured: six months
Adherence per two different electronic adherence measures
Secondary outcomes are the identification of multi-level factors that are prevalent in the target population most closely linked to ART non-adherence and EAM non-adherence.
Measured: Six months
Secondary outcomes (1)
Pill counts
Count numbers of antiretroviral pills at followup sessions
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Feb 2021
- Primary completion12 Mar 2025
- Study completion30 Apr 2025
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-positive IndividualsStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, The Miriam Hospital, Massachusetts General Hospital, National Institute on Drug Abuse (NIDA), Florida International University
- Responsible party
- Principal investigator, Edward Boyer, Ohio State University
- Investigators
- Edward W Boyer, MD PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978793
- Sponsor's protocol ID
- 2021X0070
- Other IDs
- R01DA047236, K24DA037109
- Acronym
- MyTPill
- Status last verified
- May 2025
- First submitted
- 4 Jun 2019
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bischof JJ, Chai P, Mohamed Y, Padappayil R, Merchant RC, Boyer EW, Rosen R, Reyes-Gibby CC, Viamonte M, W Carrico A. MyTPill: study protocol for a cross-over randomised controlled trial comparing novel strategies to monitor antiretroviral adherence among HIV+ prescription opioid users. BMJ Open. 2023 Jan 10;13(1):e062805. doi: 10.1136/bmjopen-2022-062805.
PubMed 36627157
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyTPill: A Novel Strategy to Monitor Antiretroviral Adherence Among HIV+ Prescription Opioid Users
- ClinicalTrials.gov ID
- NCT03978793
- Acronym / sponsor ID
- MyTPill / 2021X0070
- Conditions
- HIV-positive Individuals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- University of Miami, The Miriam Hospital, Massachusetts General Hospital, National Institute on Drug Abuse (NIDA), Florida International University
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 7 Jun 2019 (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 compares several different antiretroviral adherence measures, including digital pills, in HIV+ individuals who are maintained on opioid analgesics.
Detailed description
This study compares digital pills, electronic pill bottles, self-report, and dried blood spots, in measuring adherence to antiretroviral medications containing emtricitabine and tenofovir.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MyTPill | – | Device: MyTPill, a digital pillParticipants receive digital pills for three months, have a 2-week washout, then switch to Wisepill. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV+
Key inclusion criteria (1 listed)
- HIV+, Viral load >200copies/mL, on single pill containing TDF/FTC, receiving prescription for opioid analgesics
Key exclusion criteria (7 listed)
- Severe renal or hepatic disease
- Hypersensitivity to silver, magnesium, or zinc following oral use
- Pregnancy
- non-English speaking
- History of Crohn's disease or Ulcerative Colitis
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 |
|---|---|---|
| MyTPill, a digital pillAlso: Wisepill, a digital pillboxMyTPill is a digital pill containing an approved medication | Device | MyTPill |
Primary outcome
Dried blood spots
Time frame: six months
Measurement of dried blood spots for TDF/FTC concentrations
Adherence per two different electronic adherence measures
Time frame: Six months
Secondary outcomes are the identification of multi-level factors that are prevalent in the target population most closely linked to ART non-adherence and EAM non-adherence.
1 secondary outcome
Pill counts
Time frame: Six months
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 3 Aug 2025.
- Background: PubMed 36627157Bischof JJ, Chai P, Mohamed Y, Padappayil R, Merchant RC, Boyer EW, Rosen R, Reyes-Gibby CC, Viamonte M, W Carrico A. MyTPill: study protocol for a cross-over randomised controlled trial comparing novel strategies to monitor antiretroviral adherence among HIV+ prescription opioid users. BMJ Open. 2023 Jan 10;13(1):e062805. doi: 10.1136/bmjopen-2022-062805.
- 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.
Edward W Boyer, MD PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-positive Individuals, run by Ohio State University 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 1 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: finished, as of the sponsor's last update on 3 Aug 2025. 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.
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?
Dried blood spots (time frame: six months). 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 NCT03978793, 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 3 Aug 2025.