Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps) (PrEPSteps)
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ClinicalTrials.gov Identifier: NCT03512418 |
Recruitment Status :
Active, not recruiting
First Posted : April 30, 2018
Last Update Posted : March 15, 2024
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Condition or disease | Intervention/treatment | Phase |
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HIV Infections Substance Use Disorders | Behavioral: PrEPsteps Device: Digital pill Drug: Truvada | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Pilot randomized controlled trial |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps) |
Actual Study Start Date : | June 20, 2019 |
Estimated Primary Completion Date : | May 31, 2024 |
Estimated Study Completion Date : | May 31, 2024 |
Arm | Intervention/treatment |
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Experimental: PrEPsteps
Participants receive the digital pills with Truvada, plus the PrEPsteps intervention that is programmed at the randomization study visit (Study Visit 2). Participants will use PrEPsteps and the digital pill to measure Truvada adherence for months 1-3.
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Behavioral: PrEPsteps
Smartphone-based adherence intervention based in 1) LifeSteps, 2) Contingent Reinforcement/Corrective Feedback, and 3) Screening Brief Intervention and Referral to Treatment (SBIRT). Device: Digital pill The digital pill comprises a standard gelatin capsule with an integrated radiofrequency emitter that overencapsulates the desired medication (Truvada). When participants ingest the digital pill, the chloride ion gradient in the stomach activates the radiofrequency emitter which transmits direct evidence of medication ingestion to a wearable reader which relays this data to the participant's smartphone and cloud server. Drug: Truvada Participants receive once daily Truvada as PrEP to prevent HIV. |
Active Comparator: Control
Participants receive digital pills with Truvada alone. Participants will use digital pills with Truvada for months 1-3.
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Device: Digital pill
The digital pill comprises a standard gelatin capsule with an integrated radiofrequency emitter that overencapsulates the desired medication (Truvada). When participants ingest the digital pill, the chloride ion gradient in the stomach activates the radiofrequency emitter which transmits direct evidence of medication ingestion to a wearable reader which relays this data to the participant's smartphone and cloud server. Drug: Truvada Participants receive once daily Truvada as PrEP to prevent HIV. |
- Acceptability of the adherence intervention based on qualitative and quantitive questionnaire [ Time Frame: three month study visit ]Acceptability as determined by the mean score of the following questions during study visits (graded on a 1-10 scale): "How satisfied were you with PrEPsteps? How likely are you to recommend PrEPsteps to someone who needs PrEP? How likely are you to recommend PrEPsteps to someone who needs PrEP and uses stimulants?
- Feasibility of the adherence intervention qualitative and quantitive questionnaire [ Time Frame: three month study visit ]Feasibility of PrEPstesps as determined by the mean number of times intervention was accessed by each study participant during the trial
- Potential of PrEPsteps to improve adherence [ Time Frame: one/two/three month study visits ]Comparison of adherence rate in PrEPsteps group versus control
- Acceptability of the digital pill [ Time Frame: three month visit ]Acceptance of digital pills to monitor PrEP adherence through qualitative interviews
- Accuracy of digital pill compared to pill counts and dried blood spot for adherence [ Time Frame: one and three month study visits ]Accuracy of digital pill in measuring PrEP adherence as compared to dried blood spot testing for tenofovir diphosphate
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | cisgender men who have sex with men (MSM) |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Cisgender MSM
- Moderate to severe non-alcohol substance use disorder
- Self-reported missed PrEP doses (> or equal to 2 doses in 1 week over past 3 months)
- HIV negative
- On PrEP or initiating PrEP
- Has qualifying laboratory testing: Cr clearance, HBV, liver function tests
- Owns a smartphone with Android or iOS
- Age 18 or older
Exclusion Criteria:
- Non-English speaker
- HIV positive
- History of Crohn's disease or ulcerative colitis
- History of gastric bypass, bowel stricture
- History of GI malignancy or radiation to abdomen
- Unable/unwilling to ingest a digital pill
- Allergy to gelatin, silver or zinc (components of the digital pill)
- Does not qualify for PrEP (abnormal liver function, or Cr Clearance <60)
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): NCT03512418
United States, Massachusetts | |
Fenway Health | |
Boylston, Massachusetts, United States, 02215 |
Principal Investigator: | Peter R Chai, MD, MMS | Brigham and Women's Hospital |
Responsible Party: | Peter R Chai MD, Emergency Medicine Physician, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT03512418 |
Other Study ID Numbers: |
2019P000792 |
First Posted: | April 30, 2018 Key Record Dates |
Last Update Posted: | March 15, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
HIV Prevention Pre-exposure Prophylaxis Digital Pill Substance Use Disorder |
Substance-Related Disorders Drug Misuse Chemically-Induced Disorders Mental Disorders Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents |