Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

PrEP iT! Mobile App Intervention (PrEP iT!)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04509076
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : March 18, 2021
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Hennepin Healthcare Research Institute
Information provided by (Responsible Party):
Keith Horvath, San Diego State University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Treatment Adherence and Compliance Behavioral: PrEP iT! (plus usual PrEP care) Behavioral: Usual PrEP care Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2-arm RCT with 1:1 randomization to PrEP iT! group or the usual care control group
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PrEP iT!: A Pilot Test of a Mobile Peer Support Intervention to Optimize PrEP Adherence and Retention in PrEP Care
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.
Behavioral: PrEP iT! (plus usual PrEP care)

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
Behavioral: Usual PrEP care
Clinic visits every 3 months in the initial period following PrEP initiation, including HIV/STI screening and laboratory toxicity testing




Primary Outcome Measures :
  1. Feasibility of recruitment [ Time Frame: baseline ]
    number of participants recruited

  2. Feasibility of retention [ Time Frame: 6-month follow up assessment ]
    number of participants retained

  3. Usability [ Time Frame: 6-month follow up assessment ]
    System Usability Scale, 10-item scale to assess intervention usability

  4. Intervention Acceptability [ Time Frame: 6-month follow up assessment ]
    Self-reported satisfaction with the intervention

  5. Antiretroviral Adherence [ Time Frame: 6-month follow up assessment ]
    Tenofovir-DP Dried Blood Spot Levels (via finger stick)

  6. Self-Reported Adherence [ Time Frame: 6-month follow up assessment ]
    Wilson 3-item Adherence measure, adaptation of a validated 3-item measure assessing the percentage of adherence and perceived adherence performance. Item responses for the three adherence items will be linearly transformed to a 0-100 scale with zero being the worst adherence, and 100 the best.

  7. Retention [ Time Frame: 6-month follow up assessment ]
    Attendance of routine PrEP clinic visits


Other Outcome Measures:
  1. HIV and PrEP knowledge [ Time Frame: Baseline, 3- and 6- month follow up assessment ]
    17-item HIV and PrEP knowledge scale

  2. PrEP attitudes [ Time Frame: Baseline, 3- and 6- month follow up assessment ]
    13-items to assess PrEP attitudes

  3. PrEP Stigma [ Time Frame: Baseline, 3- and 6-month follow up assessment ]
    PrEP stigma measures

  4. 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

  5. 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

  6. 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

  7. Social Support [ Time Frame: Baseline, 3- and 6-month follow up assessment ]
    Medical Outcomes Study (MOS) Survey

  8. Technology Use [ Time Frame: Baseline, 3- and 6-month follow up assessment ]
    Use of internet and mobile devices

  9. 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

  10. Demographics [ Time Frame: Baseline ]
    Age, Gender, Race/Ethnicity

  11. Medical History [ Time Frame: Baseline, 3- and 6-month follow up assessment ]
    Current Diagnosis, past STIs

  12. Medication [ Time Frame: Baseline, 3- and 6-month follow up assessment ]
    Concomitant medications

  13. HIV Status [ Time Frame: Baseline, 3- and 6-month follow up assessment ]
    HIV Test

  14. eGFR Testing Kidney Function [ Time Frame: Baseline, 3- and 6-month follow up assessment ]
    eGFR

  15. Creatinine Testing Kidney Function [ Time Frame: Baseline, 3- and 6-month follow up assessment ]
    Serum Creatinine

  16. STIs [ Time Frame: Baseline, 3- and 6-month follow up assessment ]
    STI testing during routine screening



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male at birth; Current male gender identification
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04509076


Contacts
Layout table for location contacts
Contact: Keith Horvath, PhD 619-594-3346 khorvath@sdsu.edu
Contact: Jason Baker, MD Jason.Baker@hcmed.org

Locations
Layout table for location information
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Ashley Black    612-873-6273    ABlack@hhrinstitute.org   
Sponsors and Collaborators
San Diego State University
National Institute of Mental Health (NIMH)
Hennepin Healthcare Research Institute
Layout table for additonal information
Responsible Party: Keith Horvath, Associate Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT04509076    
Other Study ID Numbers: HS-2019-0291
R34MH116878 ( U.S. NIH Grant/Contract )
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Keith Horvath, San Diego State University:
Pre-Exposure Prophylaxis (PrEP
HIV Prevention