HIV InfectionsPCORI PrEPNCT04855773
Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention
A study testing PrEPmate and Dot Diary in people with HIV Infections and Sexually Transmitted Diseases, run by Public Health Foundation Enterprises, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases
- What is being tested?
- PrEPmate and Dot Diary
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Jul 2021to Aug 2023
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 3 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Susanne Doblecki-Lewis, MD, MSPH, FIDSA, 305-243-9213, sdoblecki@med.miami.edu
Susanne Doblecki-Lewis, MD, MSPH, FIDSA
- Active, not recruiting
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, 94102
- Recruiting
San Francisco AIDS Foundation
San Francisco, California, 94114
Rikki Montoya, 415-920-3653, rmontoya@sfaf.org
Jorge Roman, MSN, FNP-BC, 415-437-3417, jroman@sfaf.org
- Recruiting
Whitman-Walker Health
Washington D.C., District of Columbia, 20009
Rupa Patel, MD, MPH, 202-745-7000, rpatel@whitman-walker.org
Rupa Patel, MD, MPH
About this study
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.
Read the 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.
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Being tested
- PrEPmate, Dot Diary
- Keywords
- Pre-exposure Prophylaxis (PrEP), HIV Prevention, Mobile health (mHealth), Medication adherence
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEPmateOther
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.
Dot DiaryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PrEPmate | Experimental | 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. Receives: Other: PrEPmate |
| Dot Diary mobile application | Experimental | 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. Receives: Device: Dot Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: DBS measured through 12 months
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
Measured: Satisfaction measured through 12 months
Patient engagement
Patient engagement will be measured by the short-version Patient Activation Measure (PAM).
Measured: Patient engagement measured through 12 months
Secondary outcomes (3)
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.
Measured: PrEP continuation measured through 12 months
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)
Measured: Sexual satisfaction measured through 12 months
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
Measured: Adherence self-efficacy measured through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start21 Jul 2021
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Public Health Foundation Enterprises, Inc.
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Albert Liu, Public Health Foundation Enterprises, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855773
- Sponsor's protocol ID
- 20-32976
- Acronym
- PCORI PrEP
- Status last verified
- Sep 2022
- First submitted
- 1 Apr 2021
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention
- ClinicalTrials.gov ID
- NCT04855773
- Acronym / sponsor ID
- PCORI PrEP / 20-32976
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Keywords
- Pre-exposure Prophylaxis (PrEP), HIV Prevention, Mobile health (mHealth), Medication adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Public Health Foundation Enterprises, Inc.University, hospital or other
- 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
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrEPmate | Experimental | Other: PrEPmateParticipants 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. |
| Dot Diary mobile application | Experimental | Device: Dot DiaryParticipants randomized to this study arm will download and use the Dot Diary mobile application on a personal device, to support PrEP adherence and continuation. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEPmatePrEPmate 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. | Other | PrEPmate |
| Dot DiaryDot 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. | Device | Dot Diary mobile application |
Primary outcome
PrEP adherence as measured by tenofovir diphosphate levels in dried blood spots
Time frame: DBS measured through 12 months
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
Time frame: Satisfaction measured through 12 months
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
Time frame: Patient engagement measured through 12 months
Patient engagement will be measured by the short-version Patient Activation Measure (PAM).
3 secondary outcomes
PrEP continuation based on medication refills
Time frame: PrEP continuation measured through 12 months
Sexual satisfaction
Time frame: Sexual satisfaction measured through 12 months
Adherence self-efficacy
Time frame: Adherence self-efficacy measured through 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEPmate and Dot Diary in people with HIV Infections and Sexually Transmitted Diseases, run by Public Health Foundation Enterprises, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP adherence as measured by tenofovir diphosphate levels in dried blood spots (time frame: DBS measured through 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.