Text messaging versus a smartphone app to help people take PrEP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a clinic-based, multi-site, randomized two-arm trial comparing an interactive SMS program (PrEPmate) to a smartphone app (Dot Diary) to support PrEP adherence and continuation. All participants receive PrEP per standard of care at participating clinics and are followed for about 12 months. PrEPmate uses bidirectional weekly check-ins, daily pill reminders, and links to online PrEP education; Dot Diary provides a digital pill and sexual diary, reminders, reward badges, and real-time feedback on protection. Clinic staff will also be interviewed about implementation challenges and their experiences working with patients using these technologies.

Why it matters

Who can join: the full rules

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.

Where it's running

• San Francisco AIDS Foundation
  San Francisco, California, United States Recruiting
• Whitman-Walker Health
  Washington D.C., District of Columbia, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting
• Bridge HIV, San Francisco Department of Public Health
  San Francisco, California, United States Active not recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.