PrEPTECH Phase 2 Study of a PrEP Telehealth Intervention
Completed · Not applicable
Conditions studied: Pre-Exposure Prophylaxis, HIV, Telemedicine
In brief
PrEPTECH Phase 2 is a 2-arm randomized controlled trial to assess the effectiveness of a telehealth intervention in increasing PrEP uptake among cisgender men and transgender women who have sex with men over six months. Participants (N = 400) will be randomized equally into one of two study conditions, treatment with a telehealth intervention called PrEPTECH or a control condition consisting of treatment as usual plus access to a listing of online and local PrEP resources, and assessed via surveys at baseline and at 90 and 180 days after baseline. Randomization of participants will be stratified by participant sub-group (adult men who have sex with men, adolescent men who have sex with men, and transgender women). The baseline and follow-up assessments will include questions on demographic characteristics, measures related to our primary and secondary outcomes, and psychosocial measures. The primary outcomes measure is self-reported PrEP initiation at 3-month post enrollment, the percentage of participants reporting having taken at least one dose of PrEP medication by that time point. In addition, usage data and medical data will be collected and analyzed.
Key facts
- Study ID
- NCT04902820
- Run by
- ETR Associates
- People needed
- 229
- Starts
- 2022-02-12
- Expected to finish
- 2023-06-30
- Last updated by the study team
- 2023-09-11
Who can join
Age: 15 and older, up to 27. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Live in the San Francisco Bay Area, CA (the 9-counties of Alameda, Contra Costa, Marin, Napa, San Mateo, Santa Clara, Solano, Sonoma, and San Francisco); Los Angeles County, CA; Miami-Dade County, FL; or Broward County, FL.
- Qualify for PrEP by virtue of self-reporting being diagnosed with a sexually transmitted infection (including chlamydia, genital herpes, gonorrhea, syphilis, genital warts, HPV, trichomoniasis, and other less common STIs) in the past six months or self-reporting unprotected anal intercourse in the past 90 days.
- Report having sex with men
- Either: Identify as a cisgender male and age 15-17 (in California only; minors in Broward or Miami-Dade Counties will not be eligible) OR identify as a cisgender male and age 18-27 OR identify as a transgender woman (or assigned male at birth and identify as a woman) and age 18-27
You may not qualify if…
- Must not have taken PrEP in the past 30 days
- Ever been diagnosed with HIV, hepatitis B, kidney disease, liver disease, or bone disease.
- Not meeting inclusion criteria
Where it is running
- ETR — Scotts Valley, California, United States
Full record on ClinicalTrials.gov
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