PrEPTECH Phase 2 Study of a PrEP Telehealth Intervention
Condition: Pre-Exposure Prophylaxis; HIV; Telemedicine
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      A 2-arm randomized controlled trial will be conducted to assess the effectiveness of a
      telehealth intervention in increasing PrEP uptake among cisgender gay or bisexual men and
      transgender women over six months. PrEPTECH 2 is a follow-up to a pilot study of PrEPTECH
      undertaken in 25 adult men who have sex with men aged 18-25 years from the San Francisco Bay
      Area. In the pilot, PrEPTECH reached underserved populations, providing access to a
      pre-exposure prophylaxis (PrEP) regimen through a convenient telehealth system. The digital
      PrEPTECH 1 program provided digital PrEP education and resources to users, facilitated PrEP
      initiation and maintenance, simplified appointments needed to begin and maintain PrEP
      regimens through telemedicine appointments with physicians, eliminated the need for direct
      in-person follow-up with medical providers, provided a gay and bisexual male preferred
      telehealth method for accessing PrEP, offered personalized messaging to increase adherence
      and motivation for PrEP regimens, bypassed stigma and cost barriers for PrEP uptake in young
      men who have sex with men, and decreased the time required of clinicians managing PrEP
      patients. This follow-up study will extend our understanding of the PrEPTECH intervention and
      its capacity to increase PrEP uptake, adherence and maintenance, extending the populations
      served to include adolescent MSM ages 15-17 and transgender women.

      In this phase 2 study, participants (N = 400) will be randomized equally into one of two
      study conditions, treatment with the PrEPTECH telehealth intervention or a control condition.
      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). Those in the
      treatment arm will have access to PrEPTECH for six months. PrEPTECH features includes a
      platform for connecting the participant with a prescribing physician providing free PrEP
      care, optional email or text message reminders, free home lab testing, and a supply of free
      PrEP (a 6 month supply for adolescent and transgender gender women participants and a 1 month
      supply for all other participants). Those in the control arm will be provided with a list of
      online resources about PrEP and how to locate and pay for PrEP care and contact information
      for a professional PrEP navigator at a local community-based organization partnering with the
      study. Participants will complete brief online surveys at baseline and at 90- and 180-days
      following baseline.

      Participants will be recruited using a variety of methods, including through digital
      advertising on social media platforms and online dating/hook-up web sites and posting to
      community listservs, web sites offering resources on finding PrEP, and forums;
      community-based organizations partnering, that will assist with recruitment through social
      media and other online communication and in-person advertising with palm cards and flyers.

      Randomization. Stratified randomization will be used to allocate participants. Participants
      will be stratified by study site and participant sub-group, ensuring that half of
      participants in each study site will be allocated to the PrEPTECH condition and half to the
      control condition and that the participants in each of the three study populations (adult
      YMSM, minors, and transgender women) will also be allocated equally to each of the two
      conditions.

      Implementation. After randomization participants in the treatment group, will be granted
      access to the online PrEPTECH intervention, which includes a panel that sets-up text-message
      or email medication reminders, information about the intervention and PrEP, and a panel that
      guides the participant through the process of getting on PrEP: from ordering home lab
      testing, to completing a telehealth appointment with a study doctor, to ordering PrEP
      medication home delivery through an online pharmacy. Those in the control group will
      exclusively have access to a static web page offering links to online resources and
      information about local PrEP navigation resources available to them.

      Data Collection. Participants will be surveyed at three time points: 1) prior to
      randomization (baseline) 2) 3 months (90 days) after enrollment 4) and 6 months (180 days)
      after enrollment. Surveys will be created on Qualtrics, hosted on the PrEPTECH web site, and
      taken online. All survey data will be transferred to SPSS for survey analysis. Data will also
      be collected through the app on usage of the web site. Additional study data will come from
      the lab tests collected prior to the first prescription being administered (hepatitis B, HIV,
      creatinine, serum creatinine and syphilis, gonorrhea, and chlamydia test) and roughly 90 days
      later (HIV, syphilis, gonorrhea and chlamydia).
    

Intervention name(s): PrEPTECH website; Online PrEP resource list
Intervention type(s): Other; Other
Intervention description(s): The intervention is a web site delivering access to PrEP telehealth. The platform provides access to laboratory testing for PrEP eligibility delivered to a participant's home, telehealth care and PrEP prescriptions for those eligible delivered asynchronously through an online form for all adult participants and through telephone appointments for adolescent participants, and a mail-order pharmacy for PrEP. Additionally, free PrEP medication will be provided through the intervention. Transgender female and adolescent cisgender male participants will receive free PrEP medication (emtricitabine [200 mg]/tenofovir disoproxil fumarate [300 mg]) for the duration of their participation in the study, while adult cisgender male participants will receive a free 30-day supply of PrEP and subsequently have to pay for PrEP medication through insurance, patient assistance programs, or out of pocket.; Participants will receive access to an online list of web-based resources about PrEP and how to locate and pay for PrEP care and contact information for a professional PrEP navigator at a local community-based organization partnering with the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a two-arm randomized controlled trial with a one-to-one allocation ratio. Randomization will be stratified by sub-group (adult men who have sex with men ages 18-27 [n = 320], adult transgender women ages 18-27 [n = 40], and adolescent men who have sex with men ages 15-17 [n = 40]).
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Randomized Controlled Trial; Online systems; Sexual and Gender Minorities; Transgender Persons; Adolescent; Sexual health