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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV/AIDS, Substance Use Disorders, Adherence, Medication

Intervention / Treatment
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* Device: Digital pill
* Drug: Truvada


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Single group pilot demonstration project
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Pills<br>Digital Pills containing Truvada ingested once daily as PrEP | Device: Digital pill<br>* Digital pills over encapsulating Truvada<br>* Other names: eTectRx ID Cap;Drug: Truvada<br>* Truvada prescribed with digital pills for PrEP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Months 1, 2, and 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | Months 1 and 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PrEP, Substance Use Disorder, Digital Pills, Medication Adherence