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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 belowSelect...
I identify as a woman or along the feminine spectrum and was assigned male at birth.
Select...
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)
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 moreLifeSkills 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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for HIV prevention include pre-exposure prophylaxis (PrEP) and behavioral interventions. PrEP involves taking antiretroviral medications that inhibit the virus's ability to replicate, thereby preventing infection.
Behavioral interventions, such as those provided by the LifeSkills Mobile app, focus on education, resources, and support to reduce HIV risk behaviors. These interventions promote safer sexual practices and regular HIV testing.
Combining PrEP with behavioral interventions is crucial as it addresses both biological and behavioral risk factors, enhancing overall prevention effectiveness.
Find a Location
Who is running the clinical trial?
Children's Hospital Los AngelesOTHER
236 Previous Clinical Trials
5,071,996 Total Patients Enrolled
Ann & Robert H Lurie Children's Hospital of ChicagoOTHER
261 Previous Clinical Trials
5,184,178 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,538 Previous Clinical Trials
10,261,931 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 16 and 29 years old.I tested positive for HIV using a home test kit.I identify as a woman or along the feminine spectrum and was assigned male at birth.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: LifeSkills Mobile
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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