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Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention (PCORI PrEP)

Primary Purpose

HIV Infections, Sexually Transmitted Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PrEPmate
Dot Diary
Sponsored by
Public Health Foundation Enterprises, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV Infections focused on measuring Pre-exposure Prophylaxis (PrEP), HIV Prevention, Mobile health (mHealth), Medication adherence

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Self-identifies as a cisgender man, transgender man (assigned female at birth, trans-masculine spectrum), or transgender woman (assigned male sex at birth, trans-feminine spectrum)
  • Report sex with a cisgender man or transgender woman or any individual assigned male sex at birth in the past 12 months
  • Age 15 years or older
  • Willing and able to provide written informed consent
  • Owns an iOS or Android mobile phone and able to access the internet and send and receive text messages
  • Able to understand, read, and speak English or Spanish

  • Newly initiated PrEP or currently on PrEP and at risk for PrEP discontinuation based on at least one of the following:

    • Initiated PrEP within the past 6 months, or
    • Has any of the following risk factors for PrEP discontinuation: missed clinic visits; age < 30; African-American or Latino; transgender gender identity; or self-reported illicit substance use

Exclusion Criteria:

  • Currently enrolled in another PrEP intervention study
  • Unable to complete 12 month study participation
  • Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Sites / Locations

  • Bridge HIV, San Francisco Department of Public Health
  • San Francisco AIDS FoundationRecruiting
  • Whitman-Walker HealthRecruiting
  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PrEPmate

Dot Diary mobile application

Arm Description

Participants randomized to this study arm will receive the PrEPmate mHealth intervention (bi-directional text messaging with PrEP navigators/clinic staff) to support PrEP adherence and continuation.

Participants randomized to this study arm will download and use the Dot Diary mobile application on a personal device, to support PrEP adherence and continuation.

Outcomes

Primary Outcome Measures

PrEP adherence as measured by tenofovir diphosphate levels in dried blood spots
PrEP adherence will be measured by tenofovir diphosphate (TFV-DP) levels in dried blood spots (DBS). Adequate adherence will be defined as having a TFV-DP ≥ 700 femtomoles/punch in DBS for daily PrEP users, which has been associated with high levels of protection in prior PrEP trials.
Satisfaction with medical care
Satisfaction with medical care will be measured by the Consumer Assessment of Health Care Processes and Services (CAHPS), a critical tool for evaluating patient satisfaction and patient-centeredness of care
Patient engagement
Patient engagement will be measured by the short-version Patient Activation Measure (PAM).

Secondary Outcome Measures

PrEP continuation based on medication refills
PrEP discontinuation will be defined as having a PrEP interruption of ≥30 days based on medication refill dates using blinded outcome ascertainment of electronic medical and pharmacy refill records.
Sexual satisfaction
Sexual satisfaction will be measured by the New Sexual Satisfaction Scale Short Version (NSSS-S), a validated 12-item questionnaire in which patients score their sexual satisfaction on five dimensions (sexual sensations, sexual presence/awareness, sexual exchange, emotional connection/closeness, and sexual activity)
Adherence self-efficacy
Patient-reported adherence self-efficacy will be measured by the self-efficacy scale for PrEP use, which has been validated for PrEP use

Full Information

First Posted
April 1, 2021
Last Updated
September 27, 2022
Sponsor
Public Health Foundation Enterprises, Inc.
Collaborators
Patient-Centered Outcomes Research Institute, University of California, San Francisco, University of Miami, Whitman-Walker Health, San Francisco AIDS Foundation, WelTel, San Francisco Department of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT04855773
Brief Title
Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention
Acronym
PCORI PrEP
Official Title
Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Public Health Foundation Enterprises, Inc.
Collaborators
Patient-Centered Outcomes Research Institute, University of California, San Francisco, University of Miami, Whitman-Walker Health, San Francisco AIDS Foundation, WelTel, San Francisco Department of Public Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the effectiveness of two mobile health technologies (text messaging or a mobile app) designed to help people take HIV pre-exposure prophylaxis (PrEP) as directed by the clinic. PrEP is the use of a daily anti-HIV medications by HIV-negative people to help prevent HIV infection.
Detailed Description
This is a clinic-based, multi-site, randomized, two-arm study to compare the effectiveness of two mobile technologies designed to support PrEP adherence and continuation in cisgender and transgender men who have sex with men (MSM) and transgender women (TGW). All study participants will receive PrEP per standard of care at each of the study sites. Participants randomized to PrEPmate will receive an interactive bidirectional text-messaging intervention that supports PrEP use through personalized communication between patients and providers. Key components include (1) weekly short message service (SMS) check-ins and a bidirectional SMS messaging platform; (2) customized daily SMS pill-taking reminders; (3) link to online PrEP Basics and videos and testimonials. Participants randomized to Dot Diary will receive a mobile app that promotes self-management of PrEP use and sexual health. Key components include (1) a digital pill-taking and sexual diary, with pill-taking reminders; (2) sex-positive badges earned via app use; and (3) real-time feedback on protection levels afforded by PrEP. Each participant will be followed for approximately 12 months. Staff at the participating clinics will also participate in in-depth interviews to give feedback on implementation challenges and experiences in the clinic-setting, and experience working with patients using the mobile technologies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Diseases
Keywords
Pre-exposure Prophylaxis (PrEP), HIV Prevention, Mobile health (mHealth), Medication adherence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PrEPmate
Arm Type
Experimental
Arm Description
Participants randomized to this study arm will receive the PrEPmate mHealth intervention (bi-directional text messaging with PrEP navigators/clinic staff) to support PrEP adherence and continuation.
Arm Title
Dot Diary mobile application
Arm Type
Experimental
Arm Description
Participants randomized to this study arm will download and use the Dot Diary mobile application on a personal device, to support PrEP adherence and continuation.
Intervention Type
Other
Intervention Name(s)
PrEPmate
Intervention Description
PrEPmate is a multi-component mHealth intervention grounded in the information, motivation, behavioral skills (IMB) theory of behavior change and developed through user-centered design. PrEPmate promotes personalized communication between patients and providers through interactive weekly "check-in" messages asking participants how PrEP is going, allowing navigators to identify patients needing more help in taking PrEP, and customized daily pill-taking reminder messages. Trained PrEP navigators reach out to participants who indicate they need assistance via text or phone call and provide tailored support. Additionally, the platform supports 2-way communication between patients and PrEP navigators, including reminders for upcoming clinic visits. Participants are provided links to key information about PrEP (PrEP Basics), and video testimonials of peers taking PrEP. Messages are available in English and Spanish. PrEPmate is aimed at both patients and PrEP navigators.
Intervention Type
Device
Intervention Name(s)
Dot Diary
Intervention Description
Dot Diary is a mobile phone app that integrates an electronic pill-taking and sex diary and delivers real-time feedback on PrEP protection. Using the self-management model to increase self-efficacy and patient empowerment, participants log daily PrEP pill-taking and sexual behaviors in the app, which then provides real-time feedback on the level of protection achieved from PrEP (high, medium, low), and customized instructions on doses of PrEP needed to achieve or maintain high protection. Participants can also view a weekly and monthly calendar, including visualizations of the proportion of sex acts covered by PrEP. Finally, the Dot Diary app incorporates gamification components, including an ability to earn sex-positive badges, to increase engagement. Dot Diary is aimed only at patients.
Primary Outcome Measure Information:
Title
PrEP adherence as measured by tenofovir diphosphate levels in dried blood spots
Description
PrEP adherence will be measured by tenofovir diphosphate (TFV-DP) levels in dried blood spots (DBS). Adequate adherence will be defined as having a TFV-DP ≥ 700 femtomoles/punch in DBS for daily PrEP users, which has been associated with high levels of protection in prior PrEP trials.
Time Frame
DBS measured through 12 months
Title
Satisfaction with medical care
Description
Satisfaction with medical care will be measured by the Consumer Assessment of Health Care Processes and Services (CAHPS), a critical tool for evaluating patient satisfaction and patient-centeredness of care
Time Frame
Satisfaction measured through 12 months
Title
Patient engagement
Description
Patient engagement will be measured by the short-version Patient Activation Measure (PAM).
Time Frame
Patient engagement measured through 12 months
Secondary Outcome Measure Information:
Title
PrEP continuation based on medication refills
Description
PrEP discontinuation will be defined as having a PrEP interruption of ≥30 days based on medication refill dates using blinded outcome ascertainment of electronic medical and pharmacy refill records.
Time Frame
PrEP continuation measured through 12 months
Title
Sexual satisfaction
Description
Sexual satisfaction will be measured by the New Sexual Satisfaction Scale Short Version (NSSS-S), a validated 12-item questionnaire in which patients score their sexual satisfaction on five dimensions (sexual sensations, sexual presence/awareness, sexual exchange, emotional connection/closeness, and sexual activity)
Time Frame
Sexual satisfaction measured through 12 months
Title
Adherence self-efficacy
Description
Patient-reported adherence self-efficacy will be measured by the self-efficacy scale for PrEP use, which has been validated for PrEP use
Time Frame
Adherence self-efficacy measured through 12 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
cisgender man, transgender man (assigned female sex at birth, trans-masculine spectrum), or transgender woman (assigned male sex at birth, trans-feminine spectrum)
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Self-identifies as a cisgender man, transgender man (assigned female at birth, trans-masculine spectrum), or transgender woman (assigned male sex at birth, trans-feminine spectrum) Report sex with a cisgender man or transgender woman or any individual assigned male sex at birth in the past 12 months Age 15 years or older Willing and able to provide written informed consent Owns an iOS or Android mobile phone and able to access the internet and send and receive text messages Able to understand, read, and speak English or Spanish Newly initiated PrEP or currently on PrEP and at risk for PrEP discontinuation based on at least one of the following: Initiated PrEP within the past 6 months, or Has any of the following risk factors for PrEP discontinuation: missed clinic visits; age < 30; African-American or Latino; transgender gender identity; or self-reported illicit substance use Exclusion Criteria: Currently enrolled in another PrEP intervention study Unable to complete 12 month study participation Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Facility Information:
Facility Name
Bridge HIV, San Francisco Department of Public Health
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
San Francisco AIDS Foundation
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rikki Montoya
Phone
415-920-3653
Email
rmontoya@sfaf.org
First Name & Middle Initial & Last Name & Degree
Jorge Roman, MSN, FNP-BC
Phone
415-437-3417
Email
jroman@sfaf.org
First Name & Middle Initial & Last Name & Degree
Jorge Roman, MSN, FNP-BC
Facility Name
Whitman-Walker Health
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupa Patel, MD, MPH
Phone
202-745-7000
Email
rpatel@whitman-walker.org
First Name & Middle Initial & Last Name & Degree
Rupa Patel, MD, MPH
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Doblecki-Lewis, MD, MSPH, FIDSA
Phone
305-243-9213
Email
sdoblecki@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Susanne Doblecki-Lewis, MD, MSPH, FIDSA

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention

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