U01AI156875

Digital, Limited Interaction Efficacy Trial of Lifeskills Mobile to Reduce HIV Incidence in Young Transgender Women - 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-face, group-based interventions, Lifeskills Mobile extends the potential reach of the intervention via the development of a mobile version and provides content on, and access to, current biobehavioral prevention technologies (e.g., PrEP).

Los Angeles University Of California

TO ASSIST PUBLIC AND PRIVATE NONPROFIT INSTITUTIONS AND INDIVIDUALS TO ESTABLISH, EXPAND AND IMPROVE BIOMEDICAL RESEARCH AND RESEARCH TRAINING IN INFECTIOUS DISEASES AND RELATED AREAS, TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS. TO ASSIST PUBLIC, PRIVATE AND COMMERCIAL INSTITUTIONS TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS, TO PROVIDE RESEARCH SERVICES AS REQUIRED BY THE AGENCY FOR PROGRAMS IN INFECTIOUS DISEASES, AND CONTROLLING DISEASE CAUSED BY INFECTIOUS OR PARASITIC AGENTS, ALLERGIC AND IMMUNOLOGIC DISEASES AND RELATED AREAS. PROJECTS RANGE FROM STUDIES OF MICROBIAL PHYSIOLOGY AND ANTIGENIC STRUCTURE TO COLLABORATIVE TRIALS OF EXPERIMENTAL DRUGS AND VACCINES, MECHANISMS OF RESISTANCE TO ANTIBIOTICS AS WELL AS RESEARCH DEALING WITH EPIDEMIOLOGICAL OBSERVATIONS IN HOSPITALIZED PATIENTS OR COMMUNITY POPULATIONS AND PROGRESS IN ALLERGIC AND IMMUNOLOGIC DISEASES. BECAUSE OF THIS DUAL FOCUS, THE PROGRAM ENCOMPASSES BOTH BASIC RESEARCH AND CLINICAL RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM EXPANDS AND IMPROVES PRIVATE SECTOR PARTICIPATION IN BIOMEDICAL RESEARCH. THE SBIR PROGRAM INTENDS TO INCREASE AND FACILITATE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATES AND FOSTERS SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. RESEARCH CAREER DEVELOPMENT AWARDS SUPPORT THE DEVELOPMENT OF SCIENTISTS DURING THE FORMATIVE STAGES OF THEIR CAREERS. INDIVIDUAL NATIONAL RESEARCH SERVICE AWARDS (NRSAS) ARE MADE DIRECTLY TO APPROVE APPLICANTS FOR RESEARCH TRAINING IN SPECIFIED BIOMEDICAL SHORTAGE AREAS. IN ADDITION, INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARDS ARE MADE TO ENABLE INSTITUTIONS TO SELECT AND MAKE AWARDS TO INDIVIDUALS TO RECEIVE TRAINING UNDER THE AEGIS OF THEIR INSTITUTIONAL PROGRAM.

93.242 - Mental Health Research Grants

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

National Institute of Mental Health (NIMH) [HHS - NIH]

Los Angeles, California 900958347 United States

Single Zip Code

Digital, Limited Interaction Trials and Epidemiology (D-LITE): Targeting HIV Incidence in the United States (U01 Clinical Trial Required) (RFA-AI-19-067)

Amendment Since initial award the total obligations have increased 1233% from $675,982 to $9,011,446.