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Behavioral Intervention

LifeSkills Mobile for HIV Prevention (LifeSkills Trial)

N/A

Recruiting

Led By Marvin Belzer, MD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-identified as transgender, woman, and/or along the feminine spectrum with a male assigned sex at birth

Ages 16-29

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-48 months post-baseline (depending on when participants enroll in the study)

Awards & highlights

LifeSkills Trial Summary

This trial will test if the LifeSkills app can help reduce HIV incidence among young transgender women in the US.

Who is the study for?

This trial is for young transgender women, ages 16-29 in the U.S., who have had condomless sex or recent sexual activity and are HIV negative. Participants must identify as transgender or along the feminine spectrum, speak English, be able to consent, own a smartphone or computer, and not suffer from severe mental illness.Check my eligibility

What is being tested?

The LifeSkills Mobile app is being tested in this study to see if it can reduce HIV incidence among participants. The effectiveness of the app will be evaluated through a randomized controlled trial involving 5,000 eligible individuals.See study design

What are the potential side effects?

Since this intervention involves using an educational mobile app rather than medication, traditional physical side effects are not expected. However, users may experience stress or emotional discomfort related to content about HIV prevention.

LifeSkills Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I identify as a woman or along the feminine spectrum and was assigned male at birth.

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I am between 16 and 29 years old.

LifeSkills Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-48 months post-baseline (depending on when participants enroll in the study)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-48 months post-baseline (depending on when participants enroll in the study)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-48 months post-baseline (depending on when participants enroll in the study) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

HIV incidence

Secondary outcome measures

Changes in sexual risk behavior at 12 months based on self-report

Changes in sexual risk behavior at 18 months based on self-report

Changes in sexual risk behavior at 24 months based on self-report

+7 more

LifeSkills Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: LifeSkills MobileExperimental Treatment1 Intervention

Access to LifeSkills Mobile app. Participants will complete 4 modules with 20 activities across 6 months. Participants can log in at their convenience but will not be able to access the next module until the previous module is completed.

Group II: Standard of CareActive Control1 Intervention

HIV home testing every 6 months, information regarding sexual and other behaviors that potentiate one's risk for HIV infection, receipt of a fact sheet about PrEP and PEP and referrals to the local PrEP clinics, and sexually transmitted infection testing via an on-line location findings app.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesOTHER

235 Previous Clinical Trials

5,071,584 Total Patients Enrolled

Ann & Robert H Lurie Children's Hospital of ChicagoOTHER

260 Previous Clinical Trials

5,184,138 Total Patients Enrolled

University of California, Los AngelesLead Sponsor

1,537 Previous Clinical Trials

10,262,400 Total Patients Enrolled

Media Library

LifeSkills Mobile (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05018611 — N/A

HIV Prevention Research Study Groups: Standard of Care, LifeSkills Mobile

HIV Prevention Clinical Trial 2023: LifeSkills Mobile Highlights & Side Effects. Trial Name: NCT05018611 — N/A

LifeSkills Mobile (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05018611 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been enrolled in this clinical trial thus far?

"Affirmative. According to the clinicaltrials.gov registry, this medical study is actively recruiting participants, having been posted on December 6th 2021 and last updated July 21st 2022. The trial requires 5100 patients from a single location for completion."

Answered by AI

Is this research available for patient participation at present?

"According to clinicaltrials.gov, this investigation is currently looking for participants and was initially listed on December 6th 2021 with the latest update occurring on July 21st 2022."

Answered by AI

Are senior citizens in the 65+ age range able to participate in this medical trial?

"This medical study requires that participants are aged 16 to 29. Additionally, there are 5 studies specifically for people younger than 18 and 16 trials catered towards those over 65."

Answered by AI