mHealth Facilitated Intervention to Improve HIV Pre-Exposure Prophylaxis Adherence

NCT ID: NCT04990583

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-07-31

Brief Summary

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.

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.

Conditions

Pre-Exposure Prophylaxis; Telemedicine; Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Face-to-Face PrEP Adherence Intervention Based on LifeSteps

Intervention Type: BEHAVIORAL

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.

Adherence Coaching Facilitated by Carium Adherence App

Intervention Type: BEHAVIORAL

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

Control Condition

Participants assigned to the Control condition will receive a single session intervention only.

Group Type: ACTIVE_COMPARATOR

Face-to-Face PrEP Adherence Intervention Based on LifeSteps

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rhode Island Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

012820

Identifier Type: -

Identifier Source: org_study_id