LifeSkills Mobile for HIV Prevention

(LifeSkills Trial)

Recruiting at 1 trial location

Overseen By Lisa Kuhns, PhD, MPH

Age: < 65

Sex: Male

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Severe mental illness, Substance intoxication, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 6 months

5100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the LifeSkills Mobile app can help reduce new HIV cases among young transgender women in the U.S. Participants will either use the app, which includes helpful activities over six months, or receive standard HIV prevention care, such as home testing and information about protective measures. The trial seeks transgender women, ages 16-29, who have recently had condomless sex and are HIV-negative. Participants must speak English and have access to a smartphone or computer. As an unphased trial, this study offers a unique opportunity to contribute to innovative HIV prevention strategies tailored for the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the LifeSkills Mobile app is safe for young transgender women?

Research has shown that the LifeSkills Mobile app has been tested in studies with young transgender women. In these studies, participants who used the app reported engaging in fewer risky behaviors, such as having sex without a condom. This suggests the app might help lower the risk of HIV.

Using a mobile app is generally safe, with no reports of physical side effects since it is a digital tool. Instead, the app provides educational content and activities to help users make safer choices.

Overall, while specific safety data for this app is lacking, research on similar tools suggests it is well-tolerated. Participants can use the app at their own pace, making it user-friendly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LifeSkills Mobile program for HIV prevention because it leverages the convenience and accessibility of a mobile app to deliver comprehensive, engaging education. Unlike traditional methods that may require in-person attendance or rigid schedules, LifeSkills Mobile offers flexibility, allowing participants to engage with the content at their own pace. This app features four interactive modules with 20 activities spread over six months, providing a structured yet adaptable learning experience. By focusing on digital accessibility, the LifeSkills Mobile program aims to empower users with knowledge and skills to reduce their risk of HIV infection in a way that fits seamlessly into their daily lives.

What evidence suggests that the LifeSkills Mobile app is effective for HIV prevention?

Research has shown that the LifeSkills Mobile app, available to participants in this trial, helps reduce the risk of HIV among young transgender women. In earlier studies, participants using the LifeSkills program reduced risky sexual behaviors by 39.8%. Another study found that users of the LifeSkills program had 40% fewer instances of sex without a condom, which is important for preventing HIV. These results suggest that LifeSkills Mobile could be a useful tool for lowering HIV rates in this group. ^{1 5 6 7 8}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing and able to provide informed consent/assent

I am between 16 and 29 years old.

Self-reported lifetime history of condomless sex or recent history of sex (anal or vaginal in the past 12 months)

Exclusion Criteria

Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at time of enrollment

I tested positive for HIV using a home test kit.

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete an online survey and receive an OraQuick In-Home HIV Test kit

1 week

1 visit (virtual)

Treatment

Participants in the LifeSkills Mobile group complete 4 modules with 20 activities over 6 months

6 months

Self-paced online access

Follow-up

Participants are monitored for changes in sexual risk behavior and HIV incidence

12-48 months

Online surveys every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• LifeSkills Mobile

Trial Overview 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.

How Is the Trial Designed?

Group I: LifeSkills Mobile Experimental Treatment 1 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 Care Active Control 1 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.

LifeSkills Mobile is already approved in United States for the following indications:

Approved in United States as LifeSkills Mobile for:

• HIV prevention

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials

275

Recruited

5,182,000+

Published Research Related to This Trial

A life skills education program in KwaZulu-Natal, South Africa, involving 2222 youth aged 14-24, showed modest improvements in sexual-reproductive health knowledge and increased condom use during sexual encounters.

While the program effectively communicated important information and skills to reduce HIV risk, it did not significantly change behaviors like age of sexual initiation or secondary abstinence, raising questions about its long-term impact on the HIV/AIDS epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of life skills education on adolescent sexual risk behaviors in KwaZulu-Natal, South Africa. Magnani, R., Macintyre, K., Karim, AM., et al.[2021]

The PositiveLinks mobile health intervention significantly improved retention in care for People Living with HIV, increasing from 51% at baseline to 88% at 6 months and 81% at 12 months, indicating its effectiveness in keeping patients engaged with their healthcare.

Participants also experienced notable clinical improvements, with viral load suppression rising from 47% at baseline to 87% at 6 months, and mean CD4 counts increasing significantly, demonstrating the intervention's potential to enhance health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PositiveLinks: A Mobile Health Intervention for Retention in HIV Care and Clinical Outcomes with 12-Month Follow-Up. Dillingham, R., Ingersoll, K., Flickinger, TE., et al.[2019]

An educational booklet titled 'My motivational booklet for change!' was developed to promote healthy lifestyles among people with HIV, covering six key areas such as nutrition, exercise, and stress control.

The booklet received high approval ratings, with 92.4% from expert judges and 98.9% from individuals with HIV, indicating strong validity and potential effectiveness for encouraging healthy behavior changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of a booklet to promote ealthy lifestyle in people with HIV. Fontenele, MSM., Cunha, GHD., Lopes, MVO., et al.[2021]

Self-management education programs for adults living with HIV/AIDS have been shown to lead to short-term improvements in physical health, psychosocial well-being, and health knowledge, based on a systematic review of 8 studies involving 1178 participants.

While these programs demonstrated statistically significant benefits compared to control groups, there is not enough evidence to determine the long-term effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management education programs for people living with HIV/AIDS: a systematic review. Millard, T., Elliott, J., Girdler, S.[2022]

A tablet-based mobile learning (mLearning) training program significantly improved the clinical skills and knowledge of maternal child health nurses in Mozambique, with a threefold increase in competencies compared to control clinics.

Nurse managers at intervention clinics showed an even greater improvement, with a 9- to 10-fold increase in skills, indicating that mLearning is an effective and acceptable method for enhancing healthcare training in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and Feasibility of an Innovative mLearning Approach for Nurses Providing Option B+ Services in Manica and Sofala Provinces, Mozambique. Kim, J., Floriano, F., De Castro, G., et al.[2020]

The life skills and HIV/AIDS education program in South African secondary schools faced significant implementation challenges, including lack of commitment from teachers and principals, which hindered its effectiveness.

Despite some improvements in learners' knowledge and attitudes towards HIV/AIDS, the program did not succeed in reducing high-risk behaviors, indicating that simply providing education is not enough to change behavior without proper implementation and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Life skills training as HIV/AIDS preventive strategy in secondary schools: evaluation of a large-scale implementation process. Visser, MJ.[2016]

The PositiveLinks (PL) mHealth app has shown promise in improving care engagement and viral load suppression among people with HIV, indicating its potential effectiveness as a supportive tool in chronic disease management.

An interim analysis of implementation at four Ryan White HIV clinics identified key facilitators, such as the app's alignment with clinic needs and effective training resources, as well as barriers like Wi-Fi access and patient privacy concerns, which will help optimize future implementation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Implementation Strategy to Expand Mobile Health Use in HIV Care Settings: Rapid Evaluation Study Using the Consolidated Framework for Implementation Research. Cohn, WF., Canan, CE., Knight, S., et al.[2021]

Life skills-based education for HIV prevention has been widely implemented and evaluated across various regions, showing positive effects on knowledge, attitudes, and skills among young people.

However, these programs have not consistently changed sexual behavior or biological outcomes, suggesting that while they enhance understanding and intentions, they may not directly lead to the desired behavioral changes in HIV prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects and effectiveness of life skills education for HIV prevention in young people. Yankah, E., Aggleton, P.[2008]

The evaluation of a lifeskills-based HIV/AIDS education program in South African schools revealed six key themes—communication, empowerment, resources, networking, motivation, and evaluation—that are essential for effective implementation.

A survey of 30 educators showed a generally positive attitude towards the program, indicating broad support for its continuation and potential for improvement, regardless of the educators' demographics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Appreciative inquiry into lifeskills-based HIV/AIDS education in South African schools. Govender, S., Edwards, S.[2015]

The iREACH intervention is a randomized controlled trial designed to test an online life skills program aimed at reducing HIV risk among approximately 600 adolescent men who have sex with men (AMSM), focusing on a diverse racial and ethnic population across four U.S. regions.

This innovative approach addresses the unique developmental and social contexts of AMSM, potentially filling a critical gap in effective HIV prevention strategies tailored to their specific needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing HIV Vulnerability Through a Multilevel Life Skills Intervention for Adolescent Men (The iREACH Project): Protocol for a Randomized Controlled Trial. Bauermeister, J., Sullivan, PS., Gravens, L., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30105381/

The Project LifeSkills Randomized Clinical Trial - PubMed - NIH Conclusions and relevance: Among YTW at sexual risk of HIV acquisition or transmission, the LifeSkills intervention resulted in a 39.8% greater ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5603056/

Project LifeSkills - a randomized controlled efficacy trial of ... This paper describes the design of a group-based intervention trial to reduce sexual risk for HIV acquisition and transmission in young transgender women.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01575938

HIV Prevention Intervention for Young Transgender Women The purpose of this study is to test the efficacy of a uniquely targeted HIV risk reduction intervention for young transgender women (YTW), ages 16 to 29, ...

4. fenwayhealth.org fenwayhealth.org/study-examines-efficacy-of-interventions-for-young-transgender-women-in-reducing-hiv-infection-risks/

Study Examines Efficacy of Interventions for Young ... The positive results show that young transgender women who received the LifeSkills intervention had 40% fewer condomless sex acts compared to ...

5. jamanetwork.com jamanetwork.com/journals/peds/articlepdf/2696430/jamapediatrics_garofalo_2018_oi_180043.pdf

Efficacy of an Empowerment-Based, Group-Delivered HIV ... Prevention Intervention for Young Transgender Women. The Project LifeSkills Randomized Clinical Trial. Robert Garofalo, MD, MPH; Lisa M. Kuhns ...

6. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-017-4734-5

Project LifeSkills - a randomized controlled efficacy trial of a ... This paper describes the design of a group-based intervention trial to reduce sexual risk for HIV acquisition and transmission in young transgender women.

7. trialx.com trialx.com/clinical-trials/listings/239131/digital-limited-interaction-efficacy-trial-of-lifeskills-mobile-to-reduce-hiv-incidence-in-ytw/

Digital Limited Interaction Efficacy Trial of LifeSkills Mobile ... 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 ...

8. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03155841

Reducing HIV Vulnerability Through A Multilevel Life Skills ... The investigators propose to deliver and test a life skills intervention targeting the key domains that fuel HIV disparities among adolescent (ages 13-18) ...