What side effects are associated with this type of intervention?

Common treatments for HIV prevention, such as pre-exposure prophylaxis (PrEP), can have side effects including nausea, headache, and weight loss. Behavioral interventions, like those studied in the LifeSkills Mobile app trial, generally focus on education and support to reduce HIV risk behaviors and do not have direct physical side effects. However, they may require significant time and effort, which can be a barrier for some individuals.

What prior FDA approvals exist?

The FDA has approved several drugs for HIV prevention, most notably pre-exposure prophylaxis (PrEP) medications such as Truvada (emtricitabine/tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide). These medications are taken by HIV-negative individuals at high risk of HIV infection to reduce their chances of contracting the virus. In addition to pharmacological interventions, educational and support programs like the LifeSkills Mobile app are crucial in reducing HIV risk behaviors. These programs provide resources, education, and support to help individuals make informed decisions and adopt safer practices.

What other types of research exist?

Promising alternatives to the LifeSkills Mobile app for HIV prevention include: 1) My Life, My Quit - a program offering support via text or mobile app, 2) Smokefree Teen - a text message-based cessation program by the National Cancer Institute, and 3) Beyond the Pill - a website providing comprehensive reproductive health resources. These alternatives offer various forms of support and education aimed at reducing risk behaviors associated with HIV.

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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

Must not have

A positive Home HIV test kit result at baseline; these individuals will be immediately linked to HIV clinical care in their local areas.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the LifeSkills Mobile app, which helps young transgender women in the U.S. learn ways to prevent HIV. The app uses empowerment theory to provide information and strategies for avoiding HIV, and it was created with community input.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I tested positive for HIV using a home test kit.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

HIV incidence

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met

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.