Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)

HIV Infections Clinical Trial

— PrEPSteps  

Official title:

Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512418
• Other study ID #: 2019P000792
• Status: Completed
• Phase: Phase 3
• Start date: June 20, 2019
• Est. completion date: April 10, 2024

Study information

• Verified date: June 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will deploy a novel, personalized, smartphone-based intervention (PrEPSteps) that responds to real-time PrEP adherence and nonadherence detected through the use of a digital pill. The PrEPSteps intervention will be developed and refined through a series of focus groups. Participants will be screened at the Screening Visit, and, if eligible, will then begin using the digital pill system at Study Visit 1 for 2 weeks. At Study Visit 2, participants will undergo randomization to using either PrEPSteps + the digital pill, or the digital pill alone to measure PrEP adherence, for 90 days. Participants will then complete 3 monthly study visits (Study Visits 3-5) where the investigators will assess digital pill adherence, conduct manual pill counts, obtain dried blood spots to confirm adherence, provide substance use disorder counseling, and obtain urine drug screens. At Study Visit 5, the investigators will conduct a semi-structured qualitative interview with participants in the PrEPsteps arm, which will be grounded in the Technology Acceptance Model, in order to understand the user response to PrEPSteps and the digital pill. All participants will complete the final follow-up assessment 3 months after Study Visit 5 (Study Visit 6).

Description:

PrEPSteps is a novel, smartphone-based behavioral intervention that delivers PrEP adherence messages in response to detected PrEP ingestion via an innovative digital pill. PrEPSteps comprises 1) an adaptation of LifeSteps, an evidence-based medication adherence behavioral intervention, with smartphone-delivered booster sessions, 2) messages of contingent reinforcement and corrective feedback, and 3) stimulant use screening, brief assessment, and referral to treatment. In this K23, the investigators will first refine and inform the specification of PrEPSteps with a series of focus groups. The investigators will next test the feasibility, acceptability and potential for an effect of PrEPSteps to boost PrEP adherence in a pilot randomized controlled trial of men who have sex with men (MSM) with stimulant use. Finally, the investigators will conduct qualitative interviews among participants who used PrEPSteps to understand the participant response to living with the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 10, 2024
• Est. primary completion date: April 10, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Drug Misuse
• HIV Infections
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Fenway Health	Boylston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Gilead Sciences, The Fenway Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Accuracy of digital pill compared to pill counts and dried blood spot for adherence	Accuracy of digital pill in measuring PrEP adherence as compared to dried blood spot testing for tenofovir diphosphate	one and three month study visits
Primary	Acceptability of the adherence intervention based on qualitative and quantitive questionnaire	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?	three month study visit
Primary	Feasibility of the adherence intervention qualitative and quantitive questionnaire	Feasibility of PrEPstesps as determined by the mean number of times intervention was accessed by each study participant during the trial	three month study visit
Secondary	Potential of PrEPsteps to improve adherence	Comparison of adherence rate in PrEPsteps group versus control	one/two/three month study visits
Secondary	Acceptability of the digital pill	Acceptance of digital pills to monitor PrEP adherence through qualitative interviews	three month visit