Design
This study is a nationwide two-arm randomized controlled trial among racially and ethnically diverse sexual minority young men, aged 13–18 years. Participants are randomized to either the MyPEEPS Mobile intervention or a delayed intervention comparison condition and followed at 3-, 6-, and 9-months post-baseline. The intervention is delivered in the period between baseline and the 3-month follow-up visit. The comparison group is crossed-over to intervention at the 9-month visit and followed to 12-months post-baseline (Fig. 1).
Identification and recruitment of participants
Participants are recruited locally within four regional hubs (Birmingham, AL, Chicago, IL, New York City, NY, Seattle, WA) and nationwide via the Internet. Local outreach occurs actively in youth- and sexual minority-focused community organizations and events, as well as passively via posted flyers. Internet-based outreach occurs primarily via paid and targeted ads on platforms frequented by adolescents (e.g., Instagram, Snapchat). Eligibility criteria include: (1) ages 13–18 years; (2) assigned male sex at birth and, at the time of enrollment, self-identify as male; (3) understand and read English; (4) live in the United States; and (5) own a smartphone (6) report sexual interest in other men (7) has either kissed another man or plan on having sex with a man in the next year and (7) self-reported HIV-negative or unknown HIV status. Participants are excluded if investigators determine that participation may be detrimental to them or the study (e.g., severe cognitive deficit) or they participated in the pilot phase of the study.
Our goal is to enroll 700 participants overall, and at least 70 participants of each year of age (i.e., aged 13, aged 14, etc.) in each of six racial/ethnic groups [i.e., American Indian or Alaskan native, Asian or Asian American, Black or African American, Latinx (of any race), Native Hawaiian or other Pacific Islander, and White]; and among youth living in rural-designated areas.
Randomization
On a rolling basis, participants are randomized in blocks of four with a 1:1 ratio to either MyPEEPS Mobile or a delayed intervention condition. The random assignments are generated by a computerized random number generator by the Principal Investigator (RS). Random assignments are concealed from both participants and study staff until they are revealed at the point of randomization after baseline data collection has been completed. The statistician will be blinded to condition for analysis to reduce potential bias during statistical analyses.
Description of the intervention: MyPEEPS Mobile
MyPEEPS Mobile is based on the Social-Personal Framework [19], which builds on Social Learning Theory [20] by adding important psychosocial (e.g., affect dysregulation) and contextual risk factors (e.g., family, peer, and partner relationships) related to youth vulnerability to HIV risk. MyPEEPS Mobile provides educational information about HIV and STIs among YMSM, raises awareness about minority stress (e.g., due to sexual identity), and builds skills for condom use, emotion regulation, and negotiating interpersonal and substance-related risk. The learning process is facilitated through the stories of four “peeps” (Philip, Nico, Artemio, and Tommy), who are composites of YMSM who participated in the formative phase of the original MyPEEPS intervention development process [11, 12]. A running theme throughout the intervention is sexual risk reduction and goal-setting through an activity called, “BottomLine,” in which participants are challenged to articulate how much risk they are willing to accept for different sexual acts (e.g., anal sex, oral sex) and to continually re-consider these limits after exposure to the intervention activities (i.e., building knowledge, self-awareness, as well as self-efficacy). Using a responsive web design, the conventional web site is viewable on small screens and usable with touch screens. The content is delivered through a series of games, scenarios and role-plays within 21 mobile activities that are divided into four sequential modules or “PEEPScapades,” which are targeted to younger and less sexually experienced sexual minority young men [18]. All content is accessible for the period between randomization and the 3-month follow-up visit (i.e., content does not expire and can be re-visited), and must be completed in a linear manner. Movement through the app is encouraged with both in-app “trophies” and monetary incentives for the time it takes to complete the activities. Privacy is protected via log-in and password credentials and automatic log-off of the app after 20 min of inactivity.
Delayed intervention condition
Participants in the delayed intervention condition are provided with access to the MyPEEPS Mobile app at the 9-month visit with log-in and password credentials. Procedures for app access and incentives for completion are the same as for the intervention condition. Access is provided through the 12-month study visit.
Study assessments
Participants are enrolled in-person or remotely (via videoconference with written electronic assent or consent) by study staff, then complete study assessments at baseline and follow-up via computer-assisted self-interviewing (CASI; either in-person or remotely via a web link). Follow-up assessments are conducted at 3-, 6- and 9-month follow-up visits, with an additional follow-up visit at 12-months for the delayed intervention group. Participants are required to show their ID, and the face on their ID are matched to their face on the videoconferencing screen. Each participant was given a survey link matched to their study ID upon confirmation of their identity. All study data are securely stored at the primary study site in a limited access database by study ID. All hard copy participant information (e.g., study checklists, consent forms) are securely stored at each study site in locked file cabinets with limited access.
Primary outcome
The primary outcome is number of male sex partners and frequency of anal sex acts with male partners (with and without condoms), sex under the influence of substances, and uptake of pre-and post-exposure prophylaxis (PrEP, PEP), as well as testing for HIV and other STIs (e.g., chlamydia, gonorrhea, hepatitis, HPV/genital warts, syphilis). Items assessing sexual behavior are self-administered and adapted for sexual minority men from the AIDS Risk Behavior Assessment (ARBA) [21]. Items assess sexual behavior in the prior 30 days and 3 months. The basis for construction of the primary outcome is a set of sequential questions asking the participant to estimate the number of sex partners they had in the recall period and the number of condomless sex acts by type of sex (anal, oral, vaginal) with these partners. Items to assess uptake of PrEP, PEP, and HIV testing history are based on those used in prior studies of YMSM [22, 23].
Statistical analysis
All multivariate analyses will be preceded by standard bivariate analyses to describe key variables and relationships among them. These analyses will include means, frequency tables, histograms, and examination of distributions to promote data quality. All statistical tests will be two-sided tests with the level of significance at 0.05. We propose to use generalized linear mixed models (GLMM) to analyze both count and binary outcomes to determine efficacy of the intervention. For the missing values at the baseline or partial baseline collected data, we will use a multiple imputation (MI) approach [24]. Models will also be run on the non-imputed data with full-information maximum likelihood (FIML) estimation as an alternative for the MI method [25]. Rates of reduction will be calculated controlling for all other covariates in the multivariable model. Models will be calculated by using the GLIMMIX and MIANALYZE procedures in SAS, version 9.4, and model fit will be evaluated by diagnostic statistics and residual plots.
Sample size calculation
We target enrollment of 700 participants overall, and at least 70 participants of each subgroups of age, racial/ethnicity, and rural-designated areas. We estimated the statistical power for the main outcome (recent number of condomless anal sex acts with male partners) based on two scenarios: (1) to examine overall effect with total subjects; and (2) to conduct stratified analysis to examine the effects in some subgroups (age, racial/ethnicity, and in rural areas). The following assumptions are used for the power estimation: (1) an 80% retention rate (analytic sample = 560 for total, and 56 for subgroups); (2) a conservative and high intra-cluster correlation (ICC) of 0.8, (3) mean number of recent condomless anal sex acts with male partners at baseline is 1.2 [14] and (4) all power estimations are based on α = 0.05 and 2-sided tests. Findings from the prior MyPEEPS study indicate that the post-intervention number of condomless anal sex acts decreased by 63%, or a relative risk (RR) of 0.37 [14]. However, the large effect was not statistically significant. Because the estimated effect size of the intervention was unreliable, instead, we use RR = 0.73, one standard error over the estimated RR of 0.37. This provides a conservative estimation of the minimum sample size need. For the subgroup analyses, we use the effect size of RR = 0.37. To examine overall effect with all participants, we will have 97% power to detect a relative risk of 0.73 with analytic sample size of 560. Secondly, for the stratified analyses, we will have 92% power to detect a relative risk of 0.37 in subgroups with analytic sample size of 56.
Primary study data will be analyzed as soon as possible after the end of data collection, with study findings disseminated in peer-review public health journals.
