RECRUITING

Digital Limited Interaction Efficacy Trial of LifeSkills Mobile to Reduce HIV Incidence in YTW

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Conditions

HIV PreventionTransgender women (TGW)PrEPmHealthSexual Behavior

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The LifeSkills Mobile app will be evaluated in a randomized controlled trial (RCT) among 5,000 young transgender women (YTW), ages 16-29 in the United States (U.S.). Study findings will demonstrate if the intervention will reduce HIV incidence.

Official Title

Digital, Limited Interaction Efficacy Trial of LifeSkills Mobile to Reduce HIV Incidence in Young Transgender Women

Quick Facts

Study Start:2021-12-06
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05018611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 29 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Self-identified as transgender, woman, and/or along the feminine spectrum with a male assigned sex at birth
  2. * Ages 16-29
  3. * HIV uninfected at enrollment visit, verified via HIV home test kit
  4. * Self-reported lifetime history of condomless sex or recent history of sex (anal or vaginal in the past 12 months)
  5. * Able to speak/understand English
  6. * Owns a smartphone or home computer or willing to use one in the study
  7. * Willing and able to provide informed consent/assent
  1. * Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at time of enrollment
  2. * Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of the interview (these patients will be referred immediately for treatment, but may join the study when this is resolved)
  3. * A positive Home HIV test kit result at baseline; these individuals will be immediately linked to HIV clinical care in their local areas.

Contacts and Locations

Study Contact

Matthew J Mimiaga, ScD, MPH
CONTACT
617-901-9276
mmimiaga@ph.ucla.edu
Lisa Kuhns, PhD, MPH
CONTACT
312-227-6119
LKuhns@luriechildrens.org

Principal Investigator

Marvin Belzer, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital Los Angeles
Matthew J Mimiaga, ScD, MD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Lisa Kuhns, PhD, MPH
PRINCIPAL_INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago

Study Locations (Sites)

UCLA
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • Marvin Belzer, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Los Angeles
  • Matthew J Mimiaga, ScD, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles
  • Lisa Kuhns, PhD, MPH, PRINCIPAL_INVESTIGATOR, Ann & Robert H Lurie Children's Hospital of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-06
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2021-12-06
Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

  • Transgender women (TGW)
  • PrEP
  • mHealth
  • HIV Prevention
  • Sexual Behavior

Additional Relevant MeSH Terms

  • HIV Prevention