Digital limited interaction efficacy trial of LifeSkills Mobile to reduce HIV incidence in young transgender women: study protocol.

backgroundYoung transgender women are disproportionately impacted by HIV in comparison to other risk groups in the United States. Despite research documenting this vulnerability, few interventions have been developed and tested to reduce their risk and none to evaluate effects on HIV incidence. The LifeSkills Mobile app addresses the specific structural, developmental, and interpersonal challenges to HIV prevention among young transgender women ages 16-29 and is adapted from LifeSkills, a group-based intervention with evidence of efficacy to reduce sexual risk for HIV. The LifeSkills Mobile app was developed to increase the reach of LifeSkills, an evidence-based intervention, broadly via mobile access.

methodsThis study is a digital, limited interaction national randomized controlled trial. Participants are randomized (1:1) to the LifeSkills Mobile intervention or an HIV prevention standard of care condition. The study aims to enroll up to 5000 participants with follow-up visits at 6-month intervals up to 48 months, depending on the date of enrollment. The primary endpoint is incident HIV infection (confirmed via lab test or medical records). A log-rank test will be used to evaluate the null hypothesis of no difference in survival (cumulative HIV incidence) between the two study arms. Secondary endpoints are Behavioral risk is defined as total condomless sex acts in the context of insufficient PrEP protection and PrEP care linkage, initiation, and retention/constancy over time. DISCUSSION: This study will test the efficacy of the LifeSkills Mobile intervention on HIV incidence among young transgender women, ages 16-29 across the US. TRIAL REGISTRATION {2A, 2B}: ClinicalTrials.gov NCT05018611. Registered on August 24, 2021.