MyPEEPS Mobile for Young Transgender Men

NCT05424718 | Completed Results DMC

• 2 other identifiers: AAAT8624R34MH128163
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

The proposed MyPEEPS intervention for young transgender men is a novel and evidence-driven intervention using mobile technology to deliver HIV prevention information to high risk youth. The final product will be the basis for conducting a large-scale efficacy study in this population.

Conditions

HIV

Keywords

MyPEEPS; Mobile Intervention; Human Immunodeficiency Virus (HIV); Transgender Youth

Outcome Measures

Primary Outcomes (1)

• Change in Condomless Receptive Sex Acts

  Change in self-reported number of condomless receptive anal or vaginal sex acts with sex partners assigned male at birth

  Baseline, 3 and 6 months

Secondary Outcomes (5)

• Self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) Use

  3 and 6 months

• Self-reported Pre-exposure Prophylaxis (PrEP) Use

  3 and 6 months

• Self-reported HIV Testing

  3 and 6 months

• Self-reported Sexually Transmitted Infections (STI) Testing

  3 and 6 months

• Change in Partner PrEP Use and Adherence or Viral Suppression

  Baseline, 3 and 6 months

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.

Behavioral: MyPEEPS Mobile

Delayed Intervention

EXPERIMENTAL

Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.

Behavioral: MyPEEPS Mobile

Interventions

MyPEEPS Mobile BEHAVIORAL

Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).

Delayed Intervention; Immediate Intervention

Eligibility Criteria

• Age: 15 Years - 25 Years
• Gender Eligibility Details: Identify as a transgender man or along the transmasculine spectrum (including a transmasculine non-binary gender; e.g., male, trans male, transmasculine gender non-binary)
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• To participate in any aspect of the study, participants must be:
• Between 15 and 25 years of age;
• Female sex assigned at birth;
• Identify as a transgender man or along the transmasculine spectrum (including a transmasculine non-binary gender; e.g., male, trans male, transmasculine gender non-binary);
• Understand and read English;
• Live within the US;
• Own a smartphone;
• Self-report condomless receptive anal or vaginal penile sex with either a cisgender male or transgender woman (e.g., individual designated or assigned male at birth) in the past year; and
• Self-report HIV-negative or unknown status.

You may not qualify if:

• Youth are ineligible to participate in the trial if:
• HIV positive;
• Unable to provide informed consent due to severe mental or physical illness or substance intoxication at the time of enrollment;
• Concurrently enrolled in another HIV prevention study.

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Mental Health (NIMH): collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• Callen-Lorde Community Health Center: collaborator

Study Sites (3)

Ann & Robert H. Lurie Children's Hospital Chicago

Chicago, Illinois, 60640, United States

Location

Callen-Lorde Community Health Center

New York, New York, 10011, United States

Location

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Rebecca Schnall, PhD, MPH, RN-BC, FAAN, FACMI
• Organization: Columbia University

rb897@columbia.edu

212-342-6886

Study Officials

• Rebecca Schnall, PhD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion

Model Details: The intervention arm receives the intervention from baseline to 3 months and at the 3 month visit, access to the intervention is removed and the control/ delayed intervention arm then receives the intervention.

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: June 16, 2023
• Primary Completion: March 21, 2024
• Study Completion: March 21, 2024
• Last Updated: March 11, 2025
• Results First Posted: March 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)