Comparison of Men's Prevention Apps to Research Efficacy

NCT03965221 | Completed

• 2 other identifiers: 19-02605U19HD089881
• Study Type: interventional
• Target: 381
• Locations: 1 country
• Sites: 8

Brief Summary

A randomized three arm control trial to examine the efficacy of two distinct apps (LYNX and MyChoices) developed for young men who have sex with men (YMSM) compared to standard of care (SOC) information about HIV testing and PrEP (Pre-Exposure Prophylaxis).

Conditions

HIV/AIDS; Sexually Transmitted Diseases; Pre-exposure Prophylaxis; Risk Reduction

Keywords

PrEP; HIV Testing; Sexually Transmitted Infections; Mobile app; Young men who have sex with men; Technology

Outcome Measures

Primary Outcomes (3)

• Efficacy for HIV testing: Proportion who complete >= 1 HIV test

  Proportion who complete \>= 1 HIV test

  6 months post baseline

• Efficacy for PrEP uptake: Proportion who uptake PrEP

  Proportion who uptake PrEP

  6 months post baseline

• Efficacy for STI testing: Proportion who complete >=1 STI test

  Proportion who complete \>=1 STI test

  6 months post baseline

Secondary Outcomes (3)

• Efficacy for HIV testing: Proportion who complete >= 1 HIV test

  12 months post baseline

• Efficacy for PrEP uptake: Proportion who uptake PrEP

  12 months post baseline

• Efficacy for STI testing: Proportion who complete >=1 STI test

  12 months post baseline

Study Arms (3)

LYNX

EXPERIMENTAL

LYNX is developed using IMB model and engages youth through entering sexual diary data, earning badges, and calculating a personalized sexual protection (Sex Pro) score, which informs and motivates youth around HIV/STI testing and PrEP uptake. Behavioral skills are built through HIV/STI testing reminders, presenting options for home HIV testing and/or linkage to nearby testing services, and access to an online chat with support for HIV/STI testing and PrEP referral.

Behavioral: LYNX

MyChoices

EXPERIMENTAL

MyChoices is adapted from an app for adult MSM, HealthMindr, developed using SCT. The app aims to increase HIV testing and PrEP uptake by increasing self- regulation, self-reflection, and self-efficacy around HIV testing and PrEP uptake. Brief surveys about sexual risk and protective health behaviors within the app are used to assist users in tracking and self-monitoring their behaviors and creating a personalized HIV testing plan. Quizzes, videos and infographics as well as "Help me Choose," "Ordering," and geofencing functions are used to maximize self-efficacy around HIV prevention and uptake of PrEP.

Behavioral: MyChoices

Standard of Care

NO INTERVENTION

Provision of referrals to local HIV/STI testing and PrEP resources.

Interventions

LYNX BEHAVIORAL

Access to the LYNX mobile app which includes the Sex Pro score tool, sex diary, badges, PrEP information and video testimonials, HIV/STI testing reminders and geo-location features, and asynchronous chat feature.

LYNX

MyChoices BEHAVIORAL

Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.

MyChoices

Eligibility Criteria

• Age: 15 Years - 29 Years
• Gender Eligibility Details: Cisgender men
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• to 29 years.
• Assigned male sex at birth and male identified.
• Self-report being HIV uninfected or HIV status-unknown at screening.
• Self-report having not had an HIV test in the past 3 months.
• Self-report not currently taking PrEP.
• Self-report at least one episode of anal intercourse with a male or transfemale partner during the last 12 months.
• Able to understand, read, and speak English.
• Owns or leases a phone with Android platform or iOS platform, has an active data plan Has phone setting in English or Spanish, or willing to use an English or Spanish phone setting over the course of the study (Spanish setting is only for bilingual participants who speak both English and Spanish fluently)
• Willing and able to attend an in-person baseline study visit in one of the study site areas, or willing to attend a remote online baseline study visit

You may not qualify if:

• Currently enrolled in another HIV intervention study.
• Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product.
• Enrollment in Aims 2 and 3 of the prior MyChoices (UNC IRB# 17-0256) or LYNX (UNC IRB# 17-0170) studies
• Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
• Not willing and/or not able to download the MyChoices and LYNX apps onto their phone

Sponsors & Collaborators

• Public Health Foundation Enterprises, Inc.: lead
• Adolescent Trials Network for HIV/AIDS Interventions: collaborator
• Adolescent and Young Adult Research (AYAR), CORE Center: collaborator
• Children's Hospital of Philadelphia: collaborator
• Baylor College of Medicine: collaborator
• University of South Florida: collaborator
• Emory University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Fenway Community Health: collaborator
• San Francisco Department of Public Health: collaborator
• University of North Carolina, Chapel Hill: collaborator
• The Children's Hospital at Montefiore (CHAM): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator
• Brown University: collaborator
• RAIN, Inc.: collaborator

Study Sites (8)

University of South Florida, Infectious Diseases

Tampa, Florida, 33606, United States

Location

PRISM Health

Atlanta, Georgia, 30322, United States

Location

Ayar @ Core

Chicago, Illinois, 60612, United States

Location

Fenway Health Center

Boston, Massachusetts, 02215, United States

Location

Montefiore Children's Hospital

The Bronx, New York, 10467, United States

Location

RAIN, Inc

Charlotte, North Carolina, 28202, United States

Location

Adolescent Initiative at Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Biello KB, Mayer KH, Scott H, Valente PK, Hill-Rorie J, Buchbinder S, Ackah-Toffey L, Sullivan PS, Hightow-Weidman L, Liu AY. The Effects of MyChoices and LYNX Mobile Apps on HIV Testing and Pre-Exposure Prophylaxis Use by Young US Sexual Minority Men: Results From a National Randomized Controlled Trial. JMIR Public Health Surveill. 2025 Feb 5;11:e63428. doi: 10.2196/63428.

  PMID: 39908084 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Albert Y Liu, MD, MPH

  San Francisco Department of Public Health

  PRINCIPAL INVESTIGATOR

• Katie B Biello, PhD, MPH

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 28, 2019
• Study Start: October 14, 2019
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share

Locations

US (8)