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

April 3, 2023 updated by: Rhode Island Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in PrEP Adherence
Time Frame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pill counts
Time Frame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
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
Time Frame: 12-month follow-up.
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
Time Frame: Baseline and 12-month follow-up.
Results of HIV and STI tests will be extracted from participants' medical records.
Baseline and 12-month follow-up.
Alcohol and Drug Use
Time Frame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
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
Time Frame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
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)
Time Frame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
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
Time Frame: 12-month follow-up.
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
Time Frame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
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
Time Frame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Indices of Feasibility
Time Frame: 12-month follow-up.
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
Time Frame: 12-month follow-up.
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
Time Frame: 6- and 12-month follow-up.
Satisfaction with the intervention will be assessed with the System Usability Scale.
6- and 12-month follow-up.
Paradata from Carium App
Time Frame: 12-month follow-up
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
Time Frame: 12-month follow-up.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rhode Island Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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