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

> **NIH NIH U01** · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2021 · $1,425,982

## Abstract

Background. Young transgender women (YTW) have the highest HIV prevalence/incidence than any other
risk group in the U.S. The repeated exposure to gender minority stigma compounded by the psychosocial
challenges associated with social disadvantage and economic marginalization exacerbates disparities in HIV
incidence and invalidates YTW’s gender identity. This can lead to behaviors (e.g., substance use, sex work,
healthcare avoidance) that potentiate HIV acquisition risk. In order to decrease HIV incidence among YTW, an
intervention needs to 1) address HIV risk as part of YTW’s life contexts; 2) be accessible and far-reaching such
that the entire at-risk population can participate (e.g., rural areas) during a time most convenient for them; and
3) be highly sustainable with low associated costs to implement in real-world settings. Preliminary Research.
The current proposal is a culmination of over 10 years of research with this population, which included: 1)
developing and pilot testing an empowerment-based, group-delivered (in person) HIV prevention intervention
for YTW ages 16-29, called Project LifeSkills; 2) conducting a full-scale, multisite randomized controlled trial
(RCT) of Project LifeSkills (NIMH R01; MPIs: Garofalo/Mimiaga), where we demonstrated the efficacy of this
intervention to reduce HIV risk (note: Project LifeSkills is currently the only “best evidence” HIV risk reduction
intervention for YTW included among the CDC’s compendium of evidence-based interventions); 3) adapting
the face-to-face version of Project LifeSkills to an online-delivered, mobile app platform (containing 4 online
modules) via an NIMH-funded R56 (MPIs: Kuhns, Mimiaga), called “LifeSkills Mobile”; and 4) completing an
iterative usability pilot trial of the LifeSkills Mobile app to enhance participant acceptability/feasibility of study
procedures and conducted exit interviews to evaluate the app’s look, feel, and functional components.
Conceptual Model. LifeSkills Mobile is an mHealth intervention to promote biobehavioral HIV prevention
strategies based on empowerment theory and was developed using a community-based participatory research
approach. Overview of Study Design. We propose to conduct an RCT to assess the efficacy of the LifeSkills
Mobile intervention in comparison to a standard of care (SOC) condition among 5,000 YTW recruited online.
The primary outcome is reduction in incident HIV infections; a secondary outcome is total condomless anal/
vaginal sex acts occurring in the context of insufficient PrEP protection. At baseline and every 6 months
through 48 months, enrolled participants will complete an online survey sent via a link to their mobile phone
and will be mailed an OraQuick In-Home HIV Test kit . We will also estimate the total and incremental costs of
the LifeSkills Mobile intervention relative to SOC, from healthcare sector and societal perspectives. Real
World Applicability. Given inherent limitations to widespread dissemination of face-to...

## Key facts

- **NIH application ID:** 10131355
- **Project number:** 1U01AI156875-01
- **Recipient organization:** UNIVERSITY OF CALIFORNIA LOS ANGELES
- **Principal Investigator:** MARVIN E BELZER
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,425,982
- **Award type:** 1
- **Project period:** 2021-03-09 → 2026-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10131355

## Citation

> US National Institutes of Health, RePORTER application 10131355, Digital, Limited Interaction Efficacy Trial of LifeSkills Mobile to Reduce HIV Incidence in Young Transgender Women (1U01AI156875-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10131355. Licensed CC0.

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