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

NCT03763942 | Completed Results

• 2 other identifiers: IRB00102006R01DA045612
• Study Type: interventional
• Target: 658
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

HIV Infections

Keywords

Human Immunodeficiency Virus (HIV); Men who have sex with men (MSM); Pre-Exposure Prophylaxis (PrEP); HealthMindr

Outcome Measures

Primary Outcomes (1)

• PrEP Uptake

  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.

  3, 6, 9, and 12 months post-randomization

Study Arms (2)

HealthMindr App

EXPERIMENTAL

Participants in the intervention arm will receive access to all HealthMindr app capabilities. The app information will cover the importance of testing, links to HIV prevention resources, resources to locate HIV testing and PrEP services, the Substance Abuse and Mental Health Services Administration (SAMHSA) substance abuse treatment resource locator, and other prevention information specific to their area.

Behavioral: HealthMindr App

Control App

PLACEBO COMPARATOR

Participants in the control arm will be directed to download a study app that allows study staff to interact with them.

Behavioral: Control App

Interventions

HealthMindr App BEHAVIORAL

Participants in the intervention arm will receive access to the HealthMindr app with basic prevention services (HIV test planning and test locators; risk assessment; HIV treatment locators; and condom, HIV test kit, and at-home STI specimen collection kit distribution) plus monthly PrEP eligibility assessments, PrEP provider locator, enhanced information about PrEP, and referrals to local PrEP navigators. The app also provides information about obtaining health insurance coverage and paying for PrEP.

HealthMindr App

Control App BEHAVIORAL

Men in the control arm will have access to an app with information pertinent to their participation in the study, including a study events timeline. The app will also allow participants and study staff to communicate via a messaging feature. The control arm app will not contain HIV prevention information.

Control App

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Cisgender male
• years of age (inclusive)
• Resides in one of the study MSAs
• Intends to remain in study area for duration of the trial
• Owns an Android or Apple operating system (iOS) smartphone and willing to download study app
• Able to read and understand English without assistance
• Reports having anal sex with a man in the past 6 months
• Reports being HIV negative or never tested for HIV

You may not qualify if:

• Cisgender female, transgender male, transgender female, gender non-conforming
• Currently on PrEP
• \< 18 or \>34 years of age
• Reports being HIV positive
• Resides outside of the MSAs or plans to move outside study MSA within 12 months
• Current participant in another HIV prevention study
• Unable to download study app

Sponsors & Collaborators

• Emory University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (1)

• Jones J, Dominguez K, Stephenson R, Stekler JD, Castel AD, Mena LA, Jenness SM, Siegler AJ, Sullivan PS. A Theoretically Based Mobile App to Increase Pre-Exposure Prophylaxis Uptake Among Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Feb 21;9(2):e16231. doi: 10.2196/16231.

  PMID: 32130178 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Homosexuality

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Sexuality; Sexual Behavior; Behavior

Results Point of Contact

• Title: Dr. Jeb Jones
• Organization: Emory University

jeb.jones@emory.edu

404-712-2275

Study Officials

• Patrick Sullivan, DVM PhD

  Emory University

  PRINCIPAL INVESTIGATOR

• Jeb Jones, PhD

  Emory University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This trial will include 657 participants with 2:1 allocation for the intervention (438) and control (219) conditions. Recruitment strategies will be formulated to increase enrollment of MSM who identify as members of racial/ethnic minority groups.

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 4, 2018
• Study Start: January 28, 2020
• Primary Completion: March 17, 2023
• Study Completion: March 17, 2023
• Last Updated: June 4, 2024
• Results First Posted: June 4, 2024

Record last verified: 2024-05

Locations

US (3)