Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)
| Status: | Recruiting |
|---|---|
| Conditions: | HIV / AIDS, Psychiatric |
| Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/14/2019 |
| Start Date: | June 20, 2019 |
| End Date: | May 1, 2023 |
| Contact: | Peter R Chai, MD, MMS |
| Email: | pchai@bwh.harvard.edu |
| Phone: | 6177325640 |
This study will deploy a novel, personalized, smartphone-based intervention (PrEPSteps) that
responds to real time PrEP adherence and non adherence 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 a baseline assessment, they will then use the
digital pill system for 2 weeks, then undergo randomization to using PrEPSteps + the digital
pill, or the digital pill alone to measure PrEP adherence. Participants will undergo 3
monthly study visits where the investigators will assess adherence, conduct pill counts,
obtain dried blood spots to confirm adherence, provide substance use disorder counseling and
obtain urine drug screens. At the final study visit, the investigators will conduct a
semi-structured qualitative interview grounded in the Technology Acceptance Model to
understand the user response to PrEPSteps and the digital pill.
responds to real time PrEP adherence and non adherence 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 a baseline assessment, they will then use the
digital pill system for 2 weeks, then undergo randomization to using PrEPSteps + the digital
pill, or the digital pill alone to measure PrEP adherence. Participants will undergo 3
monthly study visits where the investigators will assess adherence, conduct pill counts,
obtain dried blood spots to confirm adherence, provide substance use disorder counseling and
obtain urine drug screens. At the final study visit, the investigators will conduct a
semi-structured qualitative interview grounded in the Technology Acceptance Model to
understand the user response to PrEPSteps and the digital pill.
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.
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.
Inclusion Criteria:
- MSM with problematic stimulant use
- HIV negative
- On PrEP or initiating PrEP
- > 18 years old
Exclusion Criteria:
- Non-english speaker
- HIV positive
- Not initiating or does not qualify for PrEP
- History of bowel surgery, gastric bypass or bowel strictures
- History of Crohn's disease or ulcerative colitis
- Unwilling to ingest a digital pill
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