NCT03763942

HealthMindr App to Increase Pre-exposure Prophylaxis (PrEP) Uptake and Retention Among Men Who Have Sex With Men (MSM)

Completed NA Results posted Last updated 4 June 2024

What this trial tests

NA trial testing HealthMindr App in HIV Infections in 658 participants. Completed in 17 March 2023.

Timeline

28 January 2020

Primary endpoint
17 March 2023

17 March 2023

Quick facts

Lead sponsor	Emory University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	658
Start date	28 January 2020
Primary completion	17 March 2023
Estimated completion	17 March 2023
Sites	3 locations across United States

Drugs / interventions tested

• HealthMindr App
• Control App

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

Emory University

Who can join

Adults 18 to 34, male only, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

PrEP Uptake Primary · 3, 6, 9, and 12 months post-randomization

PrEP uptake was assessed at each follow-up timepoint (3, 6, 9, and 12 months) in the intervention and control groups. The primary measure of PrEP uptake will be self-report. Validation will occur through submission of a dried blood spot self-collection kit to detect tenofovir diphosphate (TFV-DP) and/or upload of a photo of a PrEP prescription bottle.

PrEP Uptake at 3 months post-randomization

Group	Value	95% CI
HealthMindr App	2.764	2.211 – 3.414
Control App	2.116	1.482 – 2.929

PrEP Uptake at 6 months post-randomization

Group	Value	95% CI
HealthMindr App	2.104	1.737 – 2.525
Control App	1.837	1.384 – 2.391

PrEP Uptake at 9 months post-randomization

Group	Value	95% CI
HealthMindr App	1.762	1.477 – 2.085
Control App	1.509	1.157 – 1.935

PrEP Uptake at 12 months post-randomization

Group	Value	95% CI
HealthMindr App	1.241	1.033 – 1.480
Control App	1.462	1.146 – 1.838

Sponsor's own description

This study is a randomized controlled clinical trial of a theoretically based mobile app, HealthMindr, to increase pre-exposure prophylaxis (PrEP) uptake among men who have sex with men (MSM) to prevent human immunodeficiency virus (HIV). Participants in the intervention arm will receive access to the HealthMindr app, with information about PrEP and other HIV prevention methods in addition to provider locators. Participants randomized to the control arm will receive standard of care. The primary aim for this study is to assess PrEP uptake in the intervention arm compared to the control arm.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Theoretically Based Mobile App to Increase Pre-Exposure Prophylaxis Uptake Among Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.
   Jones J, Dominguez K, Stephenson R, Stekler JD, et al · · 2020 · cited 25× · PMID 32130178 · DOI 10.2196/16231