mHealth Facilitated Intervention to Improve HIV Pre-Exposure Prophylaxis Adherence

NCT04990583 | Withdrawn

• 1 other identifier: 012820
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Exposure Prophylaxis; Telemedicine; Medication Adherence

Keywords

PrEP; Adherence; mHealth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Pill counts

  Baseline, 1-, 3-, 6-, and 12-month follow-ups.

• PrEP Care Retention

  12-month follow-up.

• HIV/STI Status

  Baseline and 12-month follow-up.

• Alcohol and Drug Use

  Baseline, 1-, 3-, 6-, and 12-month follow-ups.

• HIV Risk Behavior

  Baseline, 1-, 3-, 6-, and 12-month follow-ups.

Other Outcomes (5)

• Indices of Feasibility

  12-month follow-up.

• Indices of Acceptability

  12-month follow-up.

• System Usability Scale

  6- and 12-month follow-up.

Study Arms (2)

Carium Condition

EXPERIMENTAL

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; Behavioral: Adherence Coaching Facilitated by Carium Adherence App

Control Condition

ACTIVE COMPARATOR

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

Behavioral: Face-to-Face PrEP Adherence Intervention Based on LifeSteps

Interventions

Face-to-Face PrEP Adherence Intervention Based on LifeSteps 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.

Carium Condition; Control Condition

Adherence Coaching Facilitated by Carium Adherence App 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

Carium Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: August 4, 2021
• Study Start: March 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: July 31, 2022
• Last Updated: April 5, 2023

Record last verified: 2020-11

Locations

US (1)