PrEP iT! Mobile App Intervention (PrEP iT!)

June 21, 2023 updated by: Keith Horvath, San Diego State University

PrEP iT!: A Pilot Test of a Mobile Peer Support Intervention to Optimize PrEP Adherence and Retention in PrEP Care

The long-term goal of this research is to create an effective and sustainable program to support retention in PrEP care and PrEP adherence among 18-29 year old men who have sex with men (MSM). To reach this goal, we will develop and pilot test a mobile intervention tailored to young MSM, called PrEP iT! Primary aims include:

Aim 1: Develop the PrEP iT! mobile intervention through focus groups with young MSM and refine iterations through input from a community advisory board (CAB).

Aim 2: Conduct a pilot randomized controlled trial to assess the feasibility, acceptability and preliminary impact of the PrEP iT! intervention for young MSM.

Study Overview

Detailed Description

Study Design:

We propose to evaluate the feasibility, acceptability and preliminary impact of PrEP iT! in a pilot RCT (n=80). Young men who have sex with men (YMSM) recently (re)initiating PrEP will be randomized to receive either PrEP iT! plus usual care or usual care alone, and followed for 6 months with assessments at baseline, and 3- and 6-months.

PrEP iT! will use open source software that conforms to current programming standards, and can be used across all devices (desktop, laptop, smartphone, and tablet) to ensure sustainability. PrEP iT! will be developed from feedback from PrEP-using YMSM through focus groups and a community advisory board (CAB). PrEP iT! is grounded in the Information, Motivation, and Behavioral Skills model, and also draws from a model of technology adoption.

PrEP iT! intervention components are:

  • PrEP Adherence, PrEP Appointment, and Sexual Activity Self-Monitoring
  • Tailored feedback on PrEP adherence/non-adherence
  • PrEP and sexual health information tailored for YMSM
  • Text message reminders for PrEP adherence and healthcare appointments
  • An "ask the expert" feature

Control arm participants will receive usual PrEP care only. Locally this entails, clinic visits every 3 months in the initial period following PrEP initiation, including HIV/STI screening and laboratory toxicity testing.

Study Sample:

Recruitment will be stratified by age in a 1:1 ratio (i.e., n=40 per group) of 18-24 and 25-29 year olds, and will reflect 50% Black and/or Hispanic YMSM participation. This will allow us to explore subgroup differences (e.g., by age and race/ethnicity) for PrEP iT! to better inform future trials.

Recruitment and Clinical Sites:

Participants will be recruited from two clinics in Minneapolis that provide PrEP care. The clinical sites include the HIV clinic at Hennepin Healthcare (HH) and the Hennepin County STD clinic. We will recruit and enroll study participants concurrent with their PrEP clinical visits when possible.

Participants will be recruited in four ways: a) PrEP clinic patients who are new or returning to care (i.e., are not currently receiving PrEP) will be identified by clinic staff and referred to research coordinators on the day of their clinic visit when possible; b) flyers will be hung in PrEP clinics and other HIV/AIDS NGO service organizations within the Twin Cities; and c) the study team will engage and solicit referrals from other community HIV/AIDS NGO with focused PrEP and prevention campaigns.

Enrollment, Randomization, and Follow-up Visits:

Study candidates will undergo a separate screening visit with a brief questionnaire at/after PrEP clinic visits. Participants will have a rapid HIV test as part of usual care. Persons whose test positive for HIV will be referred for same-day evaluation and care. Participants are randomized 1:1 to either the intervention (PrEP iT! + usual care) or control (usual care) arm. The randomization sequence will be stratified by age (18-24 v. 25-29 yrs) and use blocks of ten.

After informed consent, participants will complete a computer-assisted baseline survey. All participants will be provided usual PrEP educational information encouraged to attend their regular healthcare visits. Participants randomized to the treatment arm (PrEP iT! + usual care) will be guided through setting up their user account and user profile, provided with basic training on how to navigate and use intervention components, and given the opportunity to ask questions. YMSM in the treatment arm will have immediate access to PrEP iT! after the initial visit.

YMSM will undergo a 3- and 6-month follow-up assessment, with multiple reminders sent to participants prior to each visit. The 3- and 6-month stud procedures include completing a short computerized assessment, and submitting a dried blood spot specimen for the TFV-DP analyses. Study data will also be collected from the month 3 and month 6 healthcare visits that include laboratory and clinical data generated routinely as part of standard PrEP care (e.g., testing for HIV Ab and other STIs). We anticipate that most HIV tests results data will be extracted from participant's medical record to confirm their HIV-negative status. In the event that we must conduct an HIV test (e.g., we are unable to extract that from the medical record or if there is an expressed concern that the participant's HIV status has changed), they will be conducted at the Hennepin Healthcare clinical laboratory, using standard clinical assays (we use the HIV Ab/Ag combination test for diagnosis). This information would be captured in our CRFs via REDCap, and this information will be securely transferred to SDSU but would be via a de-identified file.

Study retention protocols involve the use of multiple contact methods, including telephone calls, text messages and e-mail reminders. We anticipate no more than 20% attrition.

Exit Interviews: A random subset of participants randomized to the PrEP iT! arm will be asked if he would be willing to participate in 30-60 minute exit interview to assess a) his experience in the intervention, b) suggestions for modifications to the existing interface, c) suggestions for new features; and d) and changes to the study procedures. Recruitment for exit interviews will entail sufficient numbers for the goal of achieving ten men completing the exit interview.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • 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 Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center

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

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria for the pilot RCT are:

  1. Prescribed PrEP by a healthcare provider;
  2. Self-reported 18-29 years of age;
  3. Assigned male at birth;
  4. Current male gender identification;
  5. Gay, bisexual or other non-heterosexual identity or has had sex with a man in the past year;
  6. Confirmed HIV-negative status (before starting PrEP);
  7. Started PrEP in the past 6 months (either taking PrEP for the first time or restarting PrEP after prior use) and has a current PrEP prescription;
  8. English-speaking (as the intervention will be built in English);
  9. Able to meet with project staff at baseline and follow-up visits;
  10. Regular access to SMS or the internet, either through a mobile device, tablet computer, and/or desktop or laptop computer

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PrEP iT! (plus usual PrEP care)
The PrEP iT! intervention is a mobile-optimized website with components tailored for young men who have sex with men on PrEP.

The PrEP iT! intervention is a mobile-optimized website, with the following components:

  • PrEP Adherence, PrEP Appointment, and Sexual Activity Self-Monitoring
  • Tailored feedback on PrEP adherence/non-adherence
  • PrEP and sexual health information tailored for YMSM
  • Text message reminders for PrEP adherence and healthcare appointments
  • An "ask the expert" feature
Placebo Comparator: Usual PrEP care only
Clinic visits every 3 months in the initial period following PrEP initiation, including HIV/STI screening and laboratory toxicity testing
Clinic visits every 3 months in the initial period following PrEP initiation, including HIV/STI screening and laboratory toxicity testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High Protective Level of PrEP Adherence From Tenofovir Diphosphate (TVF-DP) Levels
Time Frame: 6-month follow up assessment
Adherence thresholds estimated through analysis of tenofovir diphosphate (TVF-DP) levels from dried blood spot (DBS) specimens were used to categorize each participant as having a high protective level (i.e., a high likelihood of protection from HIV) of PrEP (800 or greater of emtricitabine-tenofovir disoproxil fumarate [FTC-TDF] and 950 or greater of FTC-tenofovir alafenamide [FTC-TAF]) or not. Results reported here are for high protective levels of PrEP.
6-month follow up assessment
Proportion of Participants With High Self-reported PrEP Adherence in the Past 7 Days
Time Frame: 6-month follow up assessment
Participants were asked at the month 6 survey to respond to the following item: "In the past 7 days, how many days did you take PrEP?" Response options ranging from 0 days to 7 days, with 1 day increments. Responses of 4, 5, 6, or 7 days were categorized as having a high protective level of PrEP (i.e., a high likelihood of protection from HIV). Results reported here are for high protective levels of PrEP.
6-month follow up assessment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV and PrEP knowledge
Time Frame: Baseline, 3- and 6- month follow up assessment
17-item HIV and PrEP knowledge scale
Baseline, 3- and 6- month follow up assessment
PrEP attitudes
Time Frame: Baseline, 3- and 6- month follow up assessment
13-items to assess PrEP attitudes
Baseline, 3- and 6- month follow up assessment
PrEP Stigma
Time Frame: Baseline, 3- and 6-month follow up assessment
PrEP stigma measures
Baseline, 3- and 6-month follow up assessment
Sex risk
Time Frame: Baseline, 3- and 6-month follow up assessment
Adapted from the CDC's 2017 Stand High School Youth Risk Behavior Survey; 11 items assessing lifetime male and female partners, condomless sex with HIV+/HIV-/HIV unknown male partners past 3 months, and substance use before sex past 3 months
Baseline, 3- and 6-month follow up assessment
Substance Use
Time Frame: Baseline, 3- and 6-month follow up assessment
ASSIST - Alcohol, Smoking and Substance Involvement Screening Test developed for the World Health Organization to detect psychoactive substance use
Baseline, 3- and 6-month follow up assessment
Depression
Time Frame: Baseline, 3- and 6-month follow up assessment
10-item Center for Epidemiological Studies Depression Scale (CES-D), range 0-30, with higher scores associated with greater depressive symptoms
Baseline, 3- and 6-month follow up assessment
Social Support
Time Frame: Baseline, 3- and 6-month follow up assessment
Medical Outcomes Study (MOS) Survey
Baseline, 3- and 6-month follow up assessment
Technology Use
Time Frame: Baseline, 3- and 6-month follow up assessment
Use of internet and mobile devices
Baseline, 3- and 6-month follow up assessment
e-Health Literacy
Time Frame: Baseline, 3- and 6-month follow up assessment
e-Heals Scale, range from 8 - 40, with higher scores representing higher e-health literacy
Baseline, 3- and 6-month follow up assessment
Demographics
Time Frame: Baseline
Age, Gender, Race/Ethnicity
Baseline
Medical History
Time Frame: Baseline, 3- and 6-month follow up assessment
Current Diagnosis, past STIs
Baseline, 3- and 6-month follow up assessment
Medication
Time Frame: Baseline, 3- and 6-month follow up assessment
Concomitant medications
Baseline, 3- and 6-month follow up assessment
HIV Status
Time Frame: Baseline, 3- and 6-month follow up assessment
HIV Test
Baseline, 3- and 6-month follow up assessment
eGFR Testing Kidney Function
Time Frame: Baseline, 3- and 6-month follow up assessment
eGFR
Baseline, 3- and 6-month follow up assessment
Creatinine Testing Kidney Function
Time Frame: Baseline, 3- and 6-month follow up assessment
Serum Creatinine
Baseline, 3- and 6-month follow up assessment
STIs
Time Frame: Baseline, 3- and 6-month follow up assessment
STI testing during routine screening
Baseline, 3- and 6-month follow up assessment

Collaborators and Investigators

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

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)

March 1, 2021

Primary Completion (Actual)

April 15, 2022

Study Completion (Actual)

April 15, 2022

Study Registration Dates

First Submitted

March 23, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • HS-2019-0291
  • R34MH116878 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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