HIV Infections, Substance Use Disorders
Conditions
Keywords
HIV Prevention, Pre-exposure Prophylaxis, Digital Pill, Substance Use Disorder
Brief 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).
Detailed 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.
Interventions
BEHAVIORALPrEPsteps
Smartphone-based adherence intervention based in 1) LifeSteps, 2) Contingent Reinforcement/Corrective Feedback, and 3) Screening Brief Intervention and Referral to Treatment (SBIRT).
DEVICEDigital 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.
DRUGTruvada
Participants receive once daily Truvada as PrEP to prevent HIV.
Sponsors
Gilead Sciences
The Fenway Institute
National Institute on Drug Abuse (NIDA)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Pilot randomized controlled trial
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Adherence Intervention Qualitative and Quantitive Questionnaire | three month study visit | Number of participants who were able to complete the trial and record adherence events using the digital pill system in the intervention arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Potential of PrEPsteps to Improve Adherence | three month study visit | Number of digital pill recorded ingestions at week 13 (end of intervention period) recorded as percent adherence |
| Number of People Who Found the Digital Pill Acceptable to Use Within the Intervention Arm | three month visit | Qualitative interviews asking participants if they found the use of the digital pill system acceptable and did not interfere with their daily PrEP use. This outcome was only assessed in the PrEPSteps (intervention arm) only. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Digital Pill Compared to Pill Counts and Dried Blood Spot for Adherence | one and three month study visits | Accuracy of digital pill in measuring PrEP adherence as compared to dried blood spot testing for tenofovir diphosphate |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from a health clinic in Boston, MA. We also conducted community-based outreach in the greater Boston metropolitan area through flyers and postings. Interested participants contacted the study team and were prescreened for eligibility criteria.
Pre-assignment details
Potentially eligible participants were consented and started on the digital pill system (DPS). Standardized training was completed and participants were asked to use the DPS for 2 weeks as a run-in period prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| PrEPSteps (Intervention) A text-based cognitive behavioral adherence intervention delivered in response to adherence data obtained through a digital pill system (ingestible radio frequency system co-encapsulated with tenofovir disoproxil fumarate/emtricitabine). In response to nonadherence dates detected by the digital pill, PrEPSteps sends personalized adherence interventions presenting barriers to adherence and solutions to these barriers in real-time. | 14 |
| Control Operation of the digital pill system to measure daily adherence to tenofovir disoproxil fumarate/emtricitabine. Participants were trained on the use of the digital pill system and asked to operate it daily to record adherence. | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | PrEPSteps (Intervention) | Control | Total |
|---|---|---|---|
| Age, Continuous | 38 years | 37.5 years | 37.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 11 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Number of sexual partners | 14.8 partners | 3.36 partners | 3.5 partners |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 9 Participants | 21 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 28 Participants |
| Substance use during sex | 3.5 events | 2.5 events | 3 events |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Feasibility of the Adherence Intervention Qualitative and Quantitive Questionnaire
Number of participants who were able to complete the trial and record adherence events using the digital pill system in the intervention arm.
Time frame: three month study visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PrEPsteps | Feasibility of the Adherence Intervention Qualitative and Quantitive Questionnaire | 14 Participants |
| Control | Feasibility of the Adherence Intervention Qualitative and Quantitive Questionnaire | 14 Participants |
Secondary
Number of People Who Found the Digital Pill Acceptable to Use Within the Intervention Arm
Qualitative interviews asking participants if they found the use of the digital pill system acceptable and did not interfere with their daily PrEP use. This outcome was only assessed in the PrEPSteps (intervention arm) only.
Time frame: three month visit
Population: Only intervention arm (PrEPSteps) completed qualitative interviews at the 3 month study endpoint for this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PrEPsteps | Number of People Who Found the Digital Pill Acceptable to Use Within the Intervention Arm | 14 Participants |
Secondary
Potential of PrEPsteps to Improve Adherence
Number of digital pill recorded ingestions at week 13 (end of intervention period) recorded as percent adherence
Time frame: three month study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PrEPsteps | Potential of PrEPsteps to Improve Adherence | 86 percentage of pills taken appropriately | Standard Deviation 17.23 |
| Control | Potential of PrEPsteps to Improve Adherence | 72 percentage of pills taken appropriately | Standard Deviation 33.14 |
Other Pre-specified
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
Time frame: one and three month study visits