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Comparing Mobile Health Strategies for HIV Prevention

This study is comparing two mobile health tools, PrEPmate and Dot Diary, to see which is better at helping people use PrEP (pre-exposure prophylaxis) as prescribed. PrEP is a daily medication taken by HIV-negative individuals to prevent HIV infection. You might be able to join if you are 15 or older, identify as a cisgender man, transgender man, or transgender woman, and have had sex with a cisgender man, transgender woman, or anyone assigned male at birth in the last year. The study will look at how well participants take their PrEP medication and how satisfied and engaged they are with their medical care over 12 months. The current recruitment status is unclear.

Study design
This is a randomized study comparing two mobile technologies, PrEPmate and Dot Diary, for about 300 participants. All participants will receive standard PrEP care.
What's involved
You would use either the PrEPmate text messaging intervention or the Dot Diary mobile app for about 12 months. This involves weekly check-ins, logging pill-taking and sexual behaviors, and receiving reminders.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for approximately 12 months after starting the study interventions.

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NCT04855773

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

Recruiting
NAAges 15+Interventional
Public Health Foundation Enterprises, Inc.
~300 participants
Updated 2022-09-28 on ClinicalTrials.gov
What's tested:PrEPmateDot Diary

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PrEP adherence as measured by tenofovir diphosphate levels in dried blood spots
Measured over DBS measured through 12 months
+2 more outcomes measured

Conditions

HIV Infections
Sexually Transmitted Diseases

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Where it's being run

4 sites across 3 states
California2
District of Columbia1
Florida1

Who to contact

Rikki Montoya
[email protected]
415-920-3653
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • PrEP adherence as measured by tenofovir diphosphate levels in dried blood spotsDBS 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 careSatisfaction 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 engagementPatient engagement measured through 12 months

    Patient engagement will be measured by the short-version Patient Activation Measure (PAM).