Project LifeSkills - a randomized controlled efficacy trial of a culturally tailored, empowerment-based, and group-delivered HIV prevention intervention for young transgender women: study protocol

Lisa M. Kuhns,Sari L. Reisner,Katie Biello,Matthew J. Mimiaga,Robert Garofalo

doi:10.1186/s12889-017-4734-5

Abstract

BackgroundTransgender women in the U.S. have an alarmingly high incidence rate of HIV infection; condomless anal and vaginal sex is the primary risk behavior driving transmission. Young transgender women are the subpopulation at the highest risk for HIV. Despite this, there are no published randomized controlled efficacy trials testing interventions to reduce sexual risk for HIV among this group. This paper describes the design of a group-based intervention trial to reduce sexual risk for HIV acquisition and transmission in young transgender women.MethodsThis study, funded by the National Institutes of Health, is a randomized controlled trial of a culturally-specific, empowerment-based, and group-delivered six-session HIV prevention intervention, Project LifeSkills, among sexually active young transgender women, ages 16-29 years in Boston and Chicago. Participants are randomized (2:2:1) to either the LifeSkills intervention, standard of care only, or a diet and nutrition time- and attention-matched control. At enrollment, all participants receive standardized HIV pre- and post-test counseling and screening for HIV and urogenital gonorrhea and chlamydia infections. The primary outcome is difference in the rate of change in the number of self-reported condomless anal or vaginal sex acts during the prior 4-months, assessed at baseline, 4-, 8-, and 12-month follow-up visits.DiscussionBehavioral interventions to reduce sexual risk for HIV acquisition and transmission are sorely needed for young transgender women. This study will provide evidence to determine feasibility and efficacy in one of the first rigorously designed trials for this population.Trial registrationClinicalTrials.gov number, NCT01575938, registered March 29, 2012.

Highlights

Transgender women in the U.S have an alarmingly high incidence rate of Human Immunodeficiency Virus (HIV) infection; condomless anal and vaginal sex is the primary risk behavior driving transmission
In a critical review of behavioral interventions for HIV prevention among transgender women undertaken by members of our research team [14], we identified only five interventions formally tested for transgender women
The intervention draws both from empowerment theory and standard cognitive behavioral HIV prevention approaches to address HIV knowledge, motivation, and behavioral skills for sexual risk reduction

Summary

Introduction

Transgender women in the U.S have an alarmingly high incidence rate of HIV infection; condomless anal and vaginal sex is the primary risk behavior driving transmission. Condomless sex, anal and vaginal sex, represents transgender women’s primary risk for HIV acquisition and transmission with high rates of sexual risk reported in small studies, including among YTW [2, 4, 5]. Among transgender women taking PrEP in the iPrex trial, evidence suggests medication adherence was suboptimal [11] Given challenges with both uptake and adherence to PrEP, combination HIV prevention approaches, including promotion of condom use, are more effective than PrEP alone [12] in high risk populations and are recommended by the Centers for Disease Control and Prevention (CDC) [13]

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