What is this study trying to find out about HIV prevention?

This study is comparing two mobile health tools to see how well they help people take HIV pre-exposure prophylaxis (PrEP) as directed. The goal is to improve how patients stick to their daily medication to reduce HIV risk. The study is sponsored by Public Health Foundation Enterprises, Inc., and involves participants using either a text messaging system or a mobile app to support PrEP use.

Who may be eligible for this HIV prevention clinical trial?

People 15 years or older who identify as cisgender men, transgender men, or transgender women, and who have had sex with a cisgender man, transgender woman, or someone assigned male sex at birth in the past 12 months may be eligible. Participants must own a compatible mobile phone and be able to communicate in English or Spanish. Please review eligibility criteria for more details.

Is there any cost to participate in this HIV prevention clinical trial?

Study-related care, including the support tools and all trial visits, is provided at no cost. Personal travel or other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs related to attending study visits.

Actively Recruiting

Phase Not Applicable

Age: 15Years +

All Genders

Healthy Volunteers

ID04855773

Comparing Two Mobile Health Tools to Support HIV Prevention Using Pre-exposure Prophylaxis PrEP

Led by Public Health Foundation Enterprises, Inc. · Updated on 2022-09-28

300

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating two mobile health technologies designed to support people in taking HIV pre-exposure prophylaxis PrEP correctly to help prevent HIV infection. This study focuses on cisgender and transgender men who have sex with men, and transgender women, assessing how well these technologies encourage adherence and continuation of PrEP over time. Participants are randomly assigned to one of two groups. One group uses PrEPmate, an interactive text messaging system offering weekly check-ins, daily pill reminders, personalized communication with clinic staff, and access to educational materials. The other group uses Dot Diary, a mobile app that helps users track their pill-taking and sexual activity, offers real-time feedback on protection levels, and includes gamified features to encourage engagement. Both groups receive standard PrEP care from their clinics and are followed for about 12 months. Throughout the study, participants will be monitored for adherence to PrEP by measuring drug levels in blood samples. Researchers will also assess satisfaction with medical care, patient engagement, continuation of PrEP based on medication refills, sexual satisfaction, and confidence in sticking to the medication. Clinic staff will provide feedback on how the technologies are used in their settings. The total study period for participants is around one year.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 15Years +

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Self-identifies as a cisgender man, transgender man, or transgender woman
Has had sex with a cisgender man, transgender woman, or someone 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 can access the internet and send and receive text messages
Able to understand, read, and speak English or Spanish
Newly started PrEP or currently on PrEP and at risk for stopping it, including those who started PrEP within the past 6 months or have risk factors such as missed clinic visits, age under 30, African-American or Latino background, transgender identity, or illicit substance use

You will not qualify if you...

Currently enrolled in another PrEP intervention study
Unable to complete 12 months of study participation
Any medical, psychiatric, or social condition or other responsibilities that would make study participation unsafe, interfere with study goals, or complicate study results according to the investigator's judgment

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