Journal of Clinical Trials
Open Access

Abstract

Using the Knocking Out Infections through Safer Sex and Screening (KISS) Adapted Behavioral Intervention to Reduce Sexually Transmitted Infections in U.S. Army Medical Beneficiaries: Study Protocol for a Randomized Controlled Trial

Brennan R Cebula*, Addison Walling, Alexus Reynolds, Adam Yates, Heather L Follen, Shannon Clark, Maureen M Sevilla, Paul M Faestel, Gina M Wingood, Ralph J DiClemente, Trevor A Crowell, Julie A Ake, Tatjana P Calvano, Anjali Kunz and Donn J Colby

Background: Sexually Transmitted Infections (STIs) and Human Immunodeficiency Virus (HIV) in the U.S. Military population impair servicemembers’ ability to perform their duties, negatively impacting a unit’s operational capability in support of national defense. As such, the increasing incidence of STIs in the U.S Military is of significant concern. Sexual behaviors are a key driver of STI incidence, and the U.S. Centers for Disease Control and Prevention and the U.S. Preventive Services Task Force recommend evidence-based behavioral interventions targeting the reduction of health risk behaviors as part of a comprehensive approach to STI/HIV prevention. However, there is no behavioral intervention with demonstrated efficacy in reducing high-risk sexual behaviors and the incidence of STI/HIV in the military population.

Methods: A prior pilot study of an evidence-based behavioral intervention adapted for the military population, the Knocking-out Infections through Safer-sex and Screening (KISS) intervention, demonstrated initial feasibility and acceptability in active-duty U.S. Army personnel and their medical beneficiaries. Based on pilot findings, we designed and implemented a multi-site randomized controlled trial to reduce high-risk sexual behaviors and STI/ HIV incidence in a behaviorally vulnerable population of U.S. Army personnel and their medical beneficiaries. Here we describe the design and implementation of the randomized controlled trial.

Conclusion: The results of this study will inform best-practices and policy regarding STI/HIV prevention in the U.S. Military population to potentially provide a much-needed evidence-based intervention to temper the increasing incidence of STI/HIV among the U.S. Military population.

Clinical trials registration number: NCT04547413

Published Date: 2024-05-31; Received Date: 2024-05-01