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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Pills | Experimental | Digital Pills containing Truvada ingested once daily as PrEP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital pill | Device | Digital pills over encapsulating Truvada |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Completed Qualitative Interview to Evaluate Acceptability of Digital Pills | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fenway Health | Boylston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35089449 | Derived | Chai PR, Goodman GR, Bronzi O, Gonzales G, Baez A, Bustamante MJ, Najarro J, Mohamed Y, Sullivan MC, Mayer KH, Boyer EW, O'Cleirigh C, Rosen RK. Real-World User Experiences with a Digital Pill System to Measure PrEP Adherence: Perspectives from MSM with Substance Use. AIDS Behav. 2022 Jul;26(7):2459-2468. doi: 10.1007/s10461-022-03594-9. Epub 2022 Jan 28. | |
| 34753871 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One participant was lost to follow-up. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | One participant was temporarily lost to follow-up, so they were excluded from analysis. In Month 1, the total number of DPS-recorded ingestion events (411) exceeded the total expected ingestion events from pill counts (402), as a result of one participant returning nine more unused pills than anticipated at the end of the month. The total expected ingestions for Month 1 is listed as 411 in the table below for clarity. | Posted | Count of Units | Expected ingestions per pill counts | Months 1, 2, and 3 | Expected ingestions per pill counts | Expected ingestions per pill counts |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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(1) Most participants were White and well-educated, limiting generalizability. (2) Opportunities for technical DPS improvements arose during the study, which required some participants to temporarily manually record doses. (3) The assay utilized for TFV-DP has not been cross-validated and may result in errors in assayed concentration of TFV-DP. (4) Reliance on pill counts may have decreased the measured accuracy of the DPS among participants who did not return unused pills each month.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter R. Chai, MD, MMS | Brigham and Women's Hospital | 617-732-5640 | pchai@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 5, 2019 | Sep 3, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 3, 2021 | Sep 3, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D019966 | Substance-Related Disorders |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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Single group pilot demonstration project
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| Truvada | Drug | Truvada prescribed with digital pills for PrEP |
|
| 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 |
| Month 3 |
| Chai PR, Mohamed Y, Bustamante MJ, Goodman GR, Najarro J, Castillo-Mancilla J, Baez A, Bronzi O, Sullivan MC, Pereira LM, Baumgartner SL, Carnes TC, Mayer KH, Rosen RK, Boyer EW, O'Cleirigh C. DigiPrEP: A Pilot Trial to Evaluate the Feasibility, Acceptability, and Accuracy of a Digital Pill System to Measure PrEP Adherence in Men Who Have Sex With Men Who Use Substances. J Acquir Immune Defic Syndr. 2022 Feb 1;89(2):e5-e15. doi: 10.1097/QAI.0000000000002854. |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | One participant was lost to follow-up. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | One participant was lost to follow-up. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | One participant was lost to follow-up. | Count of Participants | Participants |
|
| Region of Enrollment | One participant was lost to follow-up. | Count of Participants | Participants |
|
| Education | One participant was lost to follow-up. | Count of Participants | Participants |
|
| Sexual Orientation | One participant was lost to follow-up. | Count of Participants | Participants |
|
| STI in prior 12 month | One participant was lost to follow-up. | Count of Participants | Participants |
|
| Reported substance use | One participant was lost to follow-up. | Count of Participants | Participants |
|
| Prescribed PrEP | One participant lost to follow-up. | Count of Participants | Participants |
|
| Nonadherent to PrEP in prior 2 weeks (self-report) | Defined as missing >2 doses of PrEP over the past two weeks. | One participant was lost to follow-up. Additionally, the denominator for this variable is 14, as 14 participants had already been prescribed PrEP, and one had not. | Count of Participants | Participants |
|
|
|
| Secondary | 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. | One participant was temporarily lost to follow-up. | Posted | Count of Units | Recorded ingestions | Months 1, 2, and 3 | Recorded ingestions | Recorded ingestions |
|
|
|
| Secondary | 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. | One participant was temporarily lost to follow-up, so they were excluded from the analysis. | Posted | Number | 95% Confidence Interval | percentage of ingestions DPS recorded | Months 1, 2, and 3 | Expected ingestions based on pill counts | Expected ingestions based on pill counts |
|
|
|
| Secondary | 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. | One participant was temporarily lost to follow-up. | Posted | Count of Units | Manually-reported ingestions | Months 1, 2, and 3 | Manually-reported ingestions | Manually-reported ingestions |
|
|
|
| Secondary | 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. | One participant was temporarily lost to follow-up. | Posted | Count of Units | Ingestions successfully detected by DPS | Months 1, 2, and 3 | Ingestions successfully detected by DPS | Ingestions successfully detected by DPS |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | correlation coefficient | Months 1 and 3 | Paired DBS samples | Paired DBS samples |
|
|
|
| Other Pre-specified | Number of Participants That Completed Qualitative Interview to Evaluate Acceptability of Digital Pills | 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. | Qualitative user experience data were collected via interviews from the 15 participants who completed the study. | Posted | Count of Participants | Participants | Month 3 |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D000068679 |
| Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
|