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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03842436

Acronym

DigiPrEP

Enrollment

Registered

2019-02-15

Start date

2018-10-01

Completion date

2020-04-22

Last updated

2022-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adherence, Medication, HIV/AIDS, Substance Use Disorders

Keywords

PrEP, Substance Use Disorder, Digital Pills, Medication Adherence

Brief summary

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

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.

Interventions

DEVICEDigital pill

Digital pills over encapsulating Truvada

DRUGTruvada

Truvada prescribed with digital pills for PrEP

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Single group pilot demonstration project

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. MSM (cisgender male) 2. Self-reported use of non-alcohol substances of abuse in past 6 months 3. Currently taking PrEP 4. Has qualifying laboratory tests (Cr, hepatitis B immunization, STI testing and syphilis) 5. Age 18 or older

Exclusion criteria

1. Does not speak English 2. HIV positive 3. Identifies as transgender 4. Estimated creatinine clearance \<60ml/min 5. Active hepatitis B treatment 6. Does not own a smartphone 7. Taking proton pump inhibitors 8. History of Crohn's disease or ulcerative colitis 9. History of bowel surgery, gastric bypass, bowel stricture 10. History of GI malignancy or radiation to abdomen 11. Unable/unwilling to ingest digital pill

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of Digital Pills to Measure PrEP Adherence	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.

Secondary

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

Other

Measure	Time frame	Description
Number of Participants That Completed Qualitative Interview to Evaluate Acceptability of Digital Pills	Month 3	Acceptability was assessed via individual, semi-structured, qualitative exit interviews conducted at the end of the 90-day study period. The qualitative interview guide was grounded in the Technology Acceptance Model. Questions explored participants' experiences using the digital pill system (DPS), including facilitators and barriers to use, engagement with the technology, and willingness to use the DPS long-term.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Digital Pills Digital Pills containing Truvada ingested once daily as PrEP Digital pill: Digital pills over encapsulating Truvada Truvada: Truvada prescribed with digital pills for PrEP	15
Total	15

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	1

Baseline characteristics

Characteristic	Digital Pills
Age, Continuous	32 years
Education College degree	7 Participants
Education Graduate degree/professional	6 Participants
Education Some college	2 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Nonadherent to PrEP in prior 2 weeks (self-report) No	11 Participants
Nonadherent to PrEP in prior 2 weeks (self-report) Yes	3 Participants
Prescribed PrEP No	1 Participants
Prescribed PrEP Yes	14 Participants
Race/Ethnicity, Customized Race Asian	1 Participants
Race/Ethnicity, Customized Race Black / African American	1 Participants
Race/Ethnicity, Customized Race More than one race	2 Participants
Race/Ethnicity, Customized Race Other	1 Participants
Race/Ethnicity, Customized Race White	10 Participants
Region of Enrollment United States	15 Participants
Reported substance use Alcohol	14 Participants
Reported substance use Hallucinogens	4 Participants
Reported substance use Marijuana	10 Participants
Reported substance use Other (poppers, amyl nitrate)	7 Participants
Reported substance use Stimulants	7 Participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	15 Participants
Sexual Orientation Bisexual	2 Participants
Sexual Orientation Homosexual or gay	13 Participants
STI in prior 12 month No	5 Participants
STI in prior 12 month Yes	10 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 15
other Total, other adverse events	0 / 15
serious Total, serious adverse events	0 / 15

Outcome results

Primary

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.