Clinical trial NCT04902820: PrEPTECH Phase 2 Study of a PrEP Telehealth Intervention
Official title: PrEPTECH Phase 2 Study: Randomized-Controlled Trial of a Telehealth Intervention Delivering PrEP to Young Men Who Have Sex With Men and Transgender Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Exposure Prophylaxis
HIV
Telemedicine
Keywords: Randomized Controlled Trial
Online systems
Sexual and Gender Minorities
Transgender Persons
Adolescent
Sexual health
Lead sponsor: ETR Associates
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 229
Sex: MALE
Minimum age (years): 15
Maximum age (years): 27
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 \[n = 40\]).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Self-reported PrEP initiation
timeFrame: 3 months post enrollment
Secondary outcomes:
measure: Self-reported PrEP initiation
timeFrame: 6 months post enrollment
measure: Self-reported PrEP persistence
timeFrame: 3 months post enrollment and 6 months post enrollment
measure: Self-reported PrEP adherence, continuous (3 months)
timeFrame: 3 months post enrollment
measure: Self-reported PrEP adherence, continuous (6 months)
timeFrame: 6 months post enrollment
measure: Self-reported PrEP adherence, categorical (3 months)
timeFrame: 3 months
measure: Self-reported PrEP adherence, categorical (6 months)
timeFrame: 6 months
measure: PrEP coverage at 3 months post-enrollment
timeFrame: 3 months post enrollment
measure: PrEP coverage at 6 months post-enrollment
timeFrame: 6 months post enrollment
measure: Self-reported PrEP medication prescription, self-reported
timeFrame: 3-months post enrollment and 6 months post enrollment
measure: PrEP medication prescription, observed
timeFrame: 3-months post enrollment and 6 months post enrollment
measure: System Usability Scale
timeFrame: 6 months post enrollment
measure: Reported likelihood of recommending PrEPTECH
timeFrame: 6 months post enrollment
measure: Reported interest in continuing in PrEPTECH beyond the study period
timeFrame: 6 months post enrollment
measure: Transition to community care
timeFrame: 6 months post enrollment
Other outcomes:
Locations:
city: Scotts Valley
country: United States
facility: ETR
state: California
Study officials:
affiliation: ETR
name: Rebecca Braun, DrPH, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Refugio ON, Kimble MM, Silva CL, Lykens JE, Bannister C, Klausner JD. Brief Report: PrEPTECH: A Telehealth-Based Initiation Program for HIV Pre-exposure Prophylaxis in Young Men of Color Who Have Sex With Men. A Pilot Study of Feasibility. J Acquir Immune Defic Syndr. 2019 Jan 1;80(1):40-45. doi: 10.1097/QAI.0000000000001873.