Clinical trial NCT04990583: mHealth Facilitated Intervention to Improve HIV Pre-Exposure Prophylaxis Adherence
Official title: mHealth Facilitated Intervention to Improve HIV Pre-Exposure Prophylaxis Adherence
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pre-Exposure Prophylaxis
Telemedicine
Medication Adherence
Keywords: PrEP
Adherence
mHealth
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in PrEP Adherence
timeFrame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
Secondary outcomes:
measure: Pill counts
timeFrame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
measure: PrEP Care Retention
timeFrame: 12-month follow-up.
measure: HIV/STI Status
timeFrame: Baseline and 12-month follow-up.
measure: Alcohol and Drug Use
timeFrame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
measure: HIV Risk Behavior
timeFrame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
measure: PrEP Care Dropout and Non-Adherence
timeFrame: 12-month follow-up.
measure: Treatment Received
timeFrame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
measure: Medications
timeFrame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
Other outcomes:
measure: Indices of Feasibility
timeFrame: 12-month follow-up.
measure: Indices of Acceptability
timeFrame: 12-month follow-up.
measure: System Usability Scale
timeFrame: 6- and 12-month follow-up.
measure: Paradata from Carium App
timeFrame: 12-month follow-up
measure: Intervention Feedback
timeFrame: 12-month follow-up.
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
References: