mHealth Facilitated Intervention to Improve HIV Pre-Exposure Prophylaxis Adherence (SMART PrEP)

If taken every day, PrEP is an effective method for preventing HIV. However, many prescribed PrEP in the U.S. do not take it every day, as prescribed. The goal of this study is to develop and test an intervention, facilitated by a mobile app, meant to improve adherence to PrEP. To that end, 60 individuals prescribed PrEP who do not take their PrEP every day as prescribed will be recruited. Participants will complete an initial research interview, receive a one-on-one PrEP adherence session with an adherence coach, and complete follow-up interviews at 1, 3, 6, and 12 months. In addition, some participants will be randomized to receive access to a mobile app and adherence coaching via the app for 12-months. The primary outcome is self-reported adherence to PrEP. This study will examine whether this intervention is effective at improving adherence to PrEP, is feasible to use, and found acceptable by those who use it.

Study Overview

• Status: Withdrawn
• Conditions: Medication Adherence; Telemedicine; Pre-Exposure Prophylaxis
• Intervention / Treatment: Behavioral: Face-to-Face PrEP Adherence Intervention Based on LifeSteps; Behavioral: Adherence Coaching Facilitated by Carium Adherence App

Detailed Description

HIV pre-exposure prophylaxis (PrEP), involves the use of antiretroviral (ART) medications (Truvada or Descovy) by persons uninfected with HIV to prevent HIV acquisition. The efficacy of PrEP for preventing HIV acquisition is highly impacted by one's medication adherence. Within the U.S., adherence to PrEP is suboptimal. Commonly cited barriers to PrEP adherence include forgetfulness, low HIV risk perception, stigma, and cost. There is a need for interventions that improve adherence to PrEP, are readily disseminable, and that make efficient use of resources. To that end the current project will examine the feasibility, acceptability, and preliminary efficacy of an intervention tailored for PrEP adherence, facilitated by mHealth. Individuals prescribed PrEP (n = 60) who report taking, on average, fewer than 6 doses per week in the past month will be recruited. Participants will be randomly assigned to the intervention (Carium) or control condition. Data collection will consist of a baseline interview and follow-ups at 1, 3, 6, and 12 months. The primary outcome is PrEP adherence. PrEP adherence will be measured via self-report, pill counts, and use of a urine test developed by UrSure. The urine test is for research use only and will only be used to detect the presence of PrEP in urine if participants self-report taking PrEP in the last 48 hours. It is expected that participants in the Carium condition, relative to control, will report better adherence to PrEP.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• at least 18 years of age,
• has a prescription for PrEP
• received first prescription for PrEP at least one month ago
• reports taking an average of fewer than 6 PrEP doses per week of over the past month
• has phone that is compatible with the Carium app.

Exclusion Criteria:

• cognitive impairment that would jeopardize informed consent and/or intervention comprehension
• active psychosis
• not fluent in English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carium Condition; Participants assigned to the Carium condition will receive a single session intervention and receive 12 months of access to the Carium adherence application.	Behavioral: Face-to-Face PrEP Adherence Intervention Based on LifeSteps; This single session intervention, based on LifeSteps, will occur with a study adherence coach either in-person or remotely via HIPAA compliant videoconferencing software. The topics covered during the session will include: experience taking PrEP, risk behavior education, mental health and substance use as barriers to adherence, other barriers to adherence, formulating a dosing schedule, storing and transporting medications, and response to slips in adherence. Participants assigned to the Carium condition will also receive an introduction to the Carium app.; Behavioral: Adherence Coaching Facilitated by Carium Adherence App; The Carium app will be used to deliver medication reminders to participants, track medication adherence, engage in two-way secure messaging with participants, and connect with participants through a secure video feature. The adherence coach will use the secure messaging feature to support the participant with their adherence
Active Comparator: Control Condition; Participants assigned to the Control condition will receive a single session intervention only.	Behavioral: Face-to-Face PrEP Adherence Intervention Based on LifeSteps; This single session intervention, based on LifeSteps, will occur with a study adherence coach either in-person or remotely via HIPAA compliant videoconferencing software. The topics covered during the session will include: experience taking PrEP, risk behavior education, mental health and substance use as barriers to adherence, other barriers to adherence, formulating a dosing schedule, storing and transporting medications, and response to slips in adherence. Participants assigned to the Carium condition will also receive an introduction to the Carium app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PrEP Adherence	PrEP adherence will be measured via self-report and confirmed by examining concentration of PrEP in participants' urine.	Baseline, 1-, 3-, 6-, and 12-month follow-ups.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pill counts	Pill counts of PrEP medication will occur in-person or remotely. Date of prescription will be compared to the number of pills remaining.	Baseline, 1-, 3-, 6-, and 12-month follow-ups.
PrEP Care Retention	Medical records will be examined to confirm retention in PrEP care. PrEP care retention will be defined as attending 3-month clinical appointments (+/- 1 month). This information will be extracted from participants' medical records at the 12-month follow-up.	12-month follow-up.
HIV/STI Status	Results of HIV and STI tests will be extracted from participants' medical records.	Baseline and 12-month follow-up.
Alcohol and Drug Use	Daily alcohol and drug use will be assessed with the Timeline Followback (TLFB). The TLFB will provide data on the number of standard drinks consumed per day and types of drug classes used each day.	Baseline, 1-, 3-, 6-, and 12-month follow-ups.
HIV Risk Behavior	The Timeline Followback interview will be used to assess daily drug and sex risk behavior. In addition, the HIV Risk Assessment Battery (RAB) will serve as a measure of overall sex and drug risk.	Baseline, 1-, 3-, 6-, and 12-month follow-ups.
Center for Epidemiologic Studies Depression Scale (CES-D)	The CESD will be used to measure level of depressive symptoms. This measure is widely used and has good sensitivity and specificity and high internal consistency.	Baseline, 1-, 3-, 6-, and 12-month follow-ups.
PrEP Care Dropout and Non-Adherence	Participants who have dropped out of PrEP care or report a period of non-adherence, will be asked open-ended questions at the 12-month follow-up to assess the reasons for treatment dropout and/or non-adherence.	12-month follow-up.
Treatment Received	Receipt of case management, psychiatric, substance use, and other treatment services will be assessed with the Treatment Services Review.	Baseline, 1-, 3-, 6-, and 12-month follow-ups.
Medications	Participants will also be asked about their use of medications for medical, psychiatric, or substance use indications.	Baseline, 1-, 3-, 6-, and 12-month follow-ups.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indices of Feasibility	Patient eligibility rate, enrollment refusal rate, rate of recruitment, and follow-up completion rate in order to evaluate the feasibility of conducting a subsequent larger study using this protocol.	12-month follow-up.
Indices of Acceptability	The study team will compile a study dropout rate and intervention session completion rate, as indices of acceptability.	12-month follow-up.
System Usability Scale	Satisfaction with the intervention will be assessed with the System Usability Scale.	6- and 12-month follow-up.
Paradata from Carium App	Paradata will be extracted from the Carium app. This information will provide context about how often participants used the app in the intervention condition.	12-month follow-up
Intervention Feedback	A semi-structured interview will be conducted with participants. The point of the semi-structured interview will be to get feedback about the intervention.	12-month follow-up.

Collaborators and Investigators

• Sponsor: Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Adherence; PrEP; mHealth
• Other Study ID Numbers: 012820

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No