NCT04902820: PrEPTECH2

PrEPTECH Phase 2 Study of a PrEP Telehealth Intervention

Completed NA Last updated 11 September 2023

What this trial tests

NA trial testing PrEPTECH website in Pre-Exposure Prophylaxis in 229 participants. Completed in 30 June 2023.

Timeline

12 February 2022

Primary endpoint
30 June 2023

30 June 2023

Quick facts

Lead sponsor	ETR Associates
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	229
Start date	12 February 2022
Primary completion	30 June 2023
Estimated completion	30 June 2023
Sites	1 location across United States

Drugs / interventions tested

• PrEPTECH website
• Online PrEP resource list

Conditions studied

• Pre-Exposure Prophylaxis — all drugs for Pre-Exposure Prophylaxis →
• HIV — all drugs for HIV →
• Telemedicine — all drugs for Telemedicine →

Sponsor

ETR Associates

Who can join

Adults 15 to 27, male only, with Pre-Exposure Prophylaxis or HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effectiveness of PrEPTECH: Findings From a 180-Day Randomized Controlled Trial of a Pre-Exposure Prophylaxis Telehealth Intervention.
   Erenrich RK, Braun RA, Torres-Mendoza DM, Stevenson OL, et al · · 2024 · cited 9× · PMID 38133600 · DOI 10.1097/qai.0000000000003375
2. 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.
   Braun RA, Erenrich RK, Coyle KK, Doan TP, et al · · 2023 · cited 5× · PMID 37713244 · DOI 10.2196/47932