Abstract
BackgroundHuman immunodeficiency virus (HIV) infections are increasing among young men who have sex with men (YMSM), yet few HIV prevention programs have studied this population. Keep It Up! (KIU!), an online HIV prevention program tailored to diverse YMSM, was developed to fill this gap. The KIU! 2.0 randomized controlled trial (RCT) was launched to establish intervention efficacy.ObjectiveThe objective of the KIU! study is to advance scientific knowledge of technology-based behavioral HIV prevention, as well as improve public health by establishing the efficacy of an innovative electronic health (eHealth) prevention program for ethnically and racially diverse YMSM. The intervention is initiated upon receipt of a negative HIV test result, based on the theory that testing negative is a teachable moment for future prevention behaviors.MethodsThis is a two-group, active-control RCT of the online KIU! intervention. The intervention condition includes modules that use videos, animation, games, and interactive exercises to address HIV knowledge, motivation for safer behaviors, self-efficacy, and behavioral skills. The control condition reflects HIV information that is readily available on many websites, with the aim to understand how the KIU! intervention improves upon information that is currently available online. Follow-up assessments are administered at 3, 6, and 12 months for each arm. Testing for urethral and rectal sexually transmitted infections (STIs) is completed at baseline and at 12-month follow-up for all participants, and at 3- and 6-month follow-ups for participants who test positive at baseline. The primary behavioral outcome is unprotected anal sex at all follow-up points, and the primary biomedical outcome is incident STIs at 12-month follow-up.ResultsConsistent with study aims, the KIU! technology has been successfully integrated into a widely-used health technology platform. Baseline enrollment for the RCT was completed on December 30, 2015 (N=901), and assessment of intervention outcomes is ongoing at 3-, 6-, and 12-month time points. Upon collection of all data, and after the efficacy of the intervention has been evaluated, we will explore whether the KIU! intervention has differential efficacy across subgroups of YMSM based on ethnicity/race and relationship status.ConclusionsOur approach is innovative in linking an eHealth solution to HIV and STI home testing, as well as serving as a model for integrating scalable behavioral prevention into other biomedical prevention strategies.Trial RegistrationClinicaltrials.gov NCT01836445; https://clinicaltrials.gov/ct2/show/NCT01836445 (Archived by WebCite at http://www.webcitation.org/6myMFlxnC)
Highlights
Annual HIV infections among gay or bisexual men have been stable in recent years, an encouraging sign after more than a decade of increases
Pre-exposure prophylaxis (PrEP) use among gay and bisexual men at high risk for HIV has increased in recent years, but significant gaps remain, among African Americans and Latinos
HIGH HIV PREVALENCE HIV is more prevalent among gay and bisexual men compared to heterosexual people—meaning gay and bisexual men face greater exposure risk than heterosexual people during sexual encounters
Summary
Annual HIV infections among gay or bisexual men have been stable in recent years, an encouraging sign after more than a decade of increases. HIV continues to disproportionately affect gay and bisexual men who are younger and African American or Latino. Nearly 330,000 gay and bisexual men with stage 3 HIV (AIDS) have died since the 1980s. There is an urgent need to expand access to HIV prevention and treatment for all gay and bisexual men, underscoring the importance of the federal initiative ‘Ending the Epidemic: A Plan for America’. OVER HALF of people with HIV are gay and bisexual men PEOPLE WITH HIV INFECTION IN THE U.S, 2016. MOST NEW HIV infections occur among gay and bisexual men NEW HIV INFECTIONS IN THE U.S, 2016
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