NCT04902820

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
229

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

February 12, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

1.4 years

First QC Date

April 14, 2021

Last Update Submit

September 7, 2023

Conditions

Pre-Exposure ProphylaxisHIVTelemedicine

Keywords

Randomized Controlled TrialOnline systemsSexual and Gender MinoritiesTransgender PersonsAdolescentSexual health

Outcome Measures

Primary Outcomes (1)

  • Self-reported PrEP initiation

    Percentage of participants reporting having taken at least one dose of PrEP medication at any point during the intervention period

    3 months post enrollment

Secondary Outcomes (14)

  • Self-reported PrEP initiation

    6 months post enrollment

  • Self-reported PrEP persistence

    3 months post enrollment and 6 months post enrollment

  • Self-reported PrEP adherence, continuous (3 months)

    3 months post enrollment

  • Self-reported PrEP adherence, continuous (6 months)

    6 months post enrollment

  • Self-reported PrEP adherence, categorical (3 months)

    3 months

  • +9 more secondary outcomes

Study Arms (2)

PrEPTECH intervention recipients

EXPERIMENTAL

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.

Other: PrEPTECH website

Control resource-list only recipients

ACTIVE COMPARATOR

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.

Other: Online PrEP resource list

Interventions

PrEPTECH websiteOTHER

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.

PrEPTECH intervention recipients
Online PrEP resource listOTHER

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.

Control resource-list only recipients

Eligibility Criteria

Age15 Years - 27 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsTransgender women and cis gender men are eligible.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ETR

Scotts Valley, California, 95066, United States

Location

Related Publications (3)

  • 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.

    PMID: 30272632BACKGROUND

  • Erenrich RK, Braun RA, Torres-Mendoza DM, Stevenson OL, Doan TP, Klausner JD. Effectiveness of PrEPTECH: Findings From a 180-Day Randomized Controlled Trial of a Pre-Exposure Prophylaxis Telehealth Intervention. J Acquir Immune Defic Syndr. 2024 Apr 15;95(5):463-469. doi: 10.1097/QAI.0000000000003375. Epub 2024 Mar 11.

    PMID: 38133600DERIVED

  • Braun RA, Erenrich RK, Coyle KK, Doan TP, Klausner JD. Effectiveness, Acceptability, and Feasibility of a Telehealth HIV Pre-Exposure Prophylaxis Care Intervention Among Young Cisgender Men and Transgender Women Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 15;12:e47932. doi: 10.2196/47932.

    PMID: 37713244DERIVED

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Rebecca Braun, DrPH, MPH

    ETR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants are randomly assigned and will be made aware of the condition to which they are assigned.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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 \[n = 40\]).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2021

First Posted

May 26, 2021

Study Start

February 12, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)