Developing a Video-Based eHealth Intervention for HIV-Positive Gay, Bisexual, and Other Men Who Have Sex with Men: Study Protocol for a Randomized Controlled Trial.
BACKGROUND
Gay, bisexual, and other men who have sex with men (GBMSM) accounted for 67% of new US human immunodeficiency virus (HIV) infections in 2012; however, less than 40% of HIV-positive GBMSM are virally suppressed. Preventing transmission from virally unsuppressed men who have condomless anal sex (CAS) with serodiscordant partners is a public health imperative. New HIV infections in GBMSM are attributed in part to online access to sex partners; therefore, low-cost eHealth interventions are a unique opportunity to reach men where they meet partners.


OBJECTIVE
To describe the protocol of a randomized controlled trial evaluating whether video-based messaging delivered online may lead to reductions in serodiscordant CAS and increased HIV disclosure.


METHODS
Sex Positive!([+]) is a two-arm, phase III, video-based randomized controlled trial delivered online to GBMSM living with HIV. Participants in the intervention arm receive 10 video vignettes grounded in social learning and social cognitive theories that are designed to elicit critical thinking around issues of HIV transmission and disclosure. Participants in the attention control arm receive 10 video vignettes that focus on healthy living. All videos are optimized for mobile viewing. The study protocol includes five online assessments conducted over a 1-year period among 1500 US white, black, or Hispanic/Latino GBMSM living with HIV who report suboptimal antiretroviral therapy (ART) adherence or a detectable viral load in the past 12 months and recent CAS (past 6 months) with HIV-negative or unknown status male partners. Compared to the control arm, we hypothesize that men who watch the intervention videos will report at 12-month follow-up significantly fewer serodiscordant CAS partners, increased HIV disclosure, and improved social cognition (eg, condom use self-efficacy, perceived responsibility).


RESULTS
Participant recruitment began in June 2015 and ended in December 2015.


CONCLUSIONS
This protocol describes the underlying theoretical framework and measures, study design, recruitment challenges, and antifraud measures for an online, video-based randomized controlled trial that has the potential to decrease HIV transmission risk behaviors among HIV-positive GBMSM who struggle with ART adherence. The Sex Positive!([+]) intervention allows for participation through multiple Internet-based mediums and has the potential to reach and engage a broader population of HIV-positive GBMSM who are virally unsuppressed.


BACKGROUND
ClinicalTrials.gov NCT02023580; https://clinicaltrials.gov/ct2/show/NCT02023580 (Archived by WebCite at http://www.webcitation.org/6iHzA8wRG).
Public Health Solutions, Research and Evaluation, New York, NY, United States. SHirshfield@healthsolutions.org.
Sabina
http://orcid.org/0000-0002-2649-469X
S
Hirshfield
Martin J
http://orcid.org/0000-0003-0283-399X
MJ
Downing
Jeffrey T
http://orcid.org/0000-0002-6875-7566
JT
Parsons
Christian
http://orcid.org/0000-0001-6871-3531
C
Grov
Rachel J
http://orcid.org/0000-0003-0267-3105
RJ
Gordon
Steven T
http://orcid.org/0000-0002-9882-6251
ST
Houang
Roberta
http://orcid.org/0000-0002-0574-0310
R
Scheinmann
Patrick S
http://orcid.org/0000-0002-7728-0587
PS
Sullivan
Irene S
http://orcid.org/0000-0002-8166-5922
IS
Yoon
Ian
http://orcid.org/0000-0002-5737-6020
I
Anderson
Mary Ann
http://orcid.org/0000-0002-4906-0667
MA
Chiasson
GBMSM; HIV disclosure; HIV prevention; eHealth interventions; randomized controlled trial; videos