R33HD107988

Optimizing an mHealth intervention to improve uptake and adherence of the HIV pre-exposure prophylaxis (PrEP) in vulnerable adolescents and emerging adults - transgender women (TGW), particularly young TGW (ages 18-29), are among the fastest growing HIV+ populations worldwide with HIV prevalence rates of 15-28%.

Thailand has the highest adult HIV seroprevalence in Asia, with high prevalence rates of HIV infection among TGW (18%). Despite their risk, few interventions have targeted young TGW. Effective developmentally- and culturally-tailored interventions are needed to prevent HIV transmission in this high-risk population.

Widespread technology offers opportunities for innovative mobile (mHealth) interventions. Pre-exposure prophylaxis (PrEP) is an efficacious HIV prevention strategy recommended by the CDC and WHO for at-risk individuals, including HIV-negative TGW. PrEP is highly effective when taken as prescribed, but PrEP uptake and adherence have been low, with high discontinuation rates among TGW.

To address these challenges, we propose to develop and pilot a multi-component, technology-based intervention to promote PrEP usage. We will adapt an existing two-session, technology-delivered, motivational interviewing intervention to focus on PrEP use in young Thai TGW, resulting in the Motivational Enhancement System for PrEP Uptake and Adherence (MES-PREP). We will also refine and enhance "YACOOL," a mobile app with integrated text messaging developed and used clinically by our Thai team, to develop "Enhanced YACOOL" for TGW self-management of gender/sexual health (including PrEP).

Our primary aim is to develop and assess preliminary efficacy of the resulting mHealth intervention. We will utilize a multiphase optimization strategy (MOST) to identify the most effective intervention component or combination of components to address PrEP usage in this population.

The proposed study includes 2 phases corresponding to the R21 and R33 study periods. Phase IA (R21) includes qualitative interviews with key stakeholders to explore barriers and facilitators of PrEP usage through thematic analysis to inform intervention adaptation. Phase IB (R21) consists of adapting and beta testing of MES-PREP and Enhanced YACOOL for functionality and feasibility using a community advisory board of HIV-negative Thai TGW.

In Phase II (R33), we will conduct a MOST design-based trial to evaluate the feasibility, acceptability, and preliminary efficacy of MES-PREP and YACOOL. Eighty HIV-negative young TGW who are on PrEP and 80 young TGW who are not starting PrEP will be randomized to four experimental conditions: 1) Standard PrEP counseling (SPC, control), 2) MES-PREP + SPC, 3) Enhanced YACOOL + SPC, and 4) MES-PREP + Enhanced YACOOL + SPC.

Feasibility and acceptability of the intervention will be assessed through usage patterns and the System Usability Scale. Preliminary impact will be assessed by evaluating the proportion of PrEP initiation and level of adherence to PrEP. TGW will complete assessments at baseline and 1, 3, 6, 9, and 12 months post-intervention. Biomarkers of adherence to PrEP and HIV/STI will be collected.

Upon project completion, we will have an optimized mHealth intervention to support TGW using PrEP which will be ready for testing in a larger efficacy trial.

University Of Massachusetts Medical School

TO CONDUCT AND SUPPORT LABORATORY RESEARCH, CLINICAL TRIALS, AND STUDIES WITH PEOPLE THAT EXPLORE HEALTH PROCESSES. NICHD RESEARCHERS EXAMINE GROWTH AND DEVELOPMENT, BIOLOGIC AND REPRODUCTIVE FUNCTIONS, BEHAVIOR PATTERNS, AND POPULATION DYNAMICS TO PROTECT AND MAINTAIN THE HEALTH OF ALL PEOPLE. TO EXAMINE THE IMPACT OF DISABILITIES, DISEASES, AND DEFECTS ON THE LIVES OF INDIVIDUALS. WITH THIS INFORMATION, THE NICHD HOPES TO RESTORE, INCREASE, AND MAXIMIZE THE CAPABILITIES OF PEOPLE AFFECTED BY DISEASE AND INJURY. TO SPONSOR TRAINING PROGRAMS FOR SCIENTISTS, DOCTORS, AND RESEARCHERS TO ENSURE THAT NICHD RESEARCH CAN CONTINUE. BY TRAINING THESE PROFESSIONALS IN THE LATEST RESEARCH METHODS AND TECHNOLOGIES, THE NICHD WILL BE ABLE TO CONDUCT ITS RESEARCH AND MAKE HEALTH RESEARCH PROGRESS UNTIL ALL CHILDREN, ADULTS, FAMILIES, AND POPULATIONS ENJOY GOOD HEALTH. THE MISSION OF THE NICHD IS TO ENSURE THAT EVERY PERSON IS BORN HEALTHY AND WANTED, THAT WOMEN SUFFER NO HARMFUL EFFECTS FROM REPRODUCTIVE PROCESSES, AND THAT ALL CHILDREN HAVE THE CHANCE TO ACHIEVE THEIR FULL POTENTIAL FOR HEALTHY AND PRODUCTIVE LIVES, FREE FROM DISEASE OR DISABILITY, AND TO ENSURE THE HEALTH, PRODUCTIVITY, INDEPENDENCE, AND WELL-BEING OF ALL PEOPLE THROUGH OPTIMAL REHABILITATION.

93.865 - Child Health and Human Development Extramural Research

National Institute of Child Health and Human Development (NICHD) [HHS - NIH]

Worcester, Massachusetts 01655 United States

Single Zip Code

Mobile Health: Technology and Outcomes in Low and Middle Income Countries (R21/R33 - Clinical Trial Optional) (PAR-19-376)

Termination This project grant was reported as terminated by the Department of Government Efficiency (DOGE) in July 2025. See All
Amendment Since initial award the total obligations have increased 332% from $283,675 to $1,225,072.