mHealth Facilitated Intervention to Improve HIV Pre-Exposure Prophylaxis Adherence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Rhode Island Hospital
- Locations
- 1
- Primary Endpoint
- Change in PrEP Adherence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Face-to-Face PrEP Adherence Intervention Based on LifeSteps (Behavioral)
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.
Intervention: Adherence Coaching Facilitated by Carium Adherence App (Behavioral)
Control Condition
Participants assigned to the Control condition will receive a single session intervention only.
Intervention: Face-to-Face PrEP Adherence Intervention Based on LifeSteps (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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.)
- Center for Epidemiologic Studies Depression Scale (CES-D)(Baseline, 1-, 3-, 6-, and 12-month follow-ups.)
- HIV Risk Behavior(Baseline, 1-, 3-, 6-, and 12-month follow-ups.)
- Pill counts(Baseline, 1-, 3-, 6-, and 12-month follow-ups.)
- Treatment Received(Baseline, 1-, 3-, 6-, and 12-month follow-ups.)
- PrEP Care Dropout and Non-Adherence(12-month follow-up.)
- Medications(Baseline, 1-, 3-, 6-, and 12-month follow-ups.)