A Pragmatic Trial of An Adaptive eHealth HIV Prevention Program for Diverse Adolescent MSM

Adolescent (ages 13-18) men who have sex with men (AMSM) experience a dramatic health
disparity as they represent 2% of young people but account for almost 80% of HIV diagnoses in
youth. Despite this disproportionate burden, current evidence-based HIV prevention programs
focus primarily on adults and heterosexual youth. Because issues affecting sexual health
decisions among AMSM are unique, interventions need to be designed to ensure appropriate
content that resonates with AMSM. Prevention programs must also be responsive to minority
AMSM that experience disparities in incidence or lack of access to prevention services. For
example, Hispanics represent 27% of HIV infections among MSM, but Spanish speaking MSM face
significant language barriers to accessing HIV services.

Implementation issues are particularly critical as traditional HIV prevention delivery
channels have significant limitations for AMSM: few adolescents attend LGBT youth oriented
programs, schools place many restrictions on discussions of MSM sexual health, and major
questions remain as to the feasibility of enrolling parents of AMSM into HIV prevention
programs. With 92% of adolescents (across all races and income levels) going online every
day, eHealth interventions represent a critical modality for delivering AMSM- specific
intervention material where youth "are." Combining online recruitment with intervention
delivery across a range of devices can overcome many access barriers to engagement of AMSM in
HIV prevention.

Unfortunately, there will be no single magic solution that will work for all AMSM and public
health programmers should not continue to deliver the same fixed intervention when a
participant is not responding. Alternatively, stepped-care strategies increase in intensity
to meet the needs of those who do not respond to a less intense intervention. Using a
Sequential Multiple Assignment Randomized Trial (SMART) design, the investigators will
evaluate the impact of a package of increasingly intensive interventions that have already
shown evidence of efficacy with diverse adolescent and young adult MSM. The SMART methodology
is an ideal approach because SMART designs mimic treatment decisions as they are made in
real-world clinical settings, components of traditional RCTs are embedded within the design,
and participant data can be used post-hoc to inform decision rules in order to optimize
implementation. Collectively the investigators brand this package of eHealth interventions as
the SMART Program (Sexual Minority Adolescent Risk Taking). The SMART Program package
includes: (1) a universally-delivered, brief, online sexual health education program designed
for sexual and gender minority youth regardless of whether they are sexually active ("Queer
Sex Ed") (2) a more intensive online intervention designed for diverse AMSM engaging in HIV
transmission risk behaviors ("Keep It Up!"); and (3) a more intensive motivational
interviewing (MI) intervention that will be delivered by MI therapists via online videochat
("Young Men's Health Project"). The investigators will evaluate the impact of the SMART
Program and carefully document implementation context to inform scale out with the following
aims:

Aim 1: Evaluate the impact of the SMART Program and its constituent components at reducing
HIV risk among AMSM. To do this, the investigators will:

1. Involve diverse AMSM (e.g., Youth Advisory Council) in developmentally adapting existing
SMART Program components for AMSM ages 13-18 using the ADAPT-ITT framework.

2. Culturally and linguistically adapt the SMART Program for Spanish speaking Latino AMSM
in the US.

3. Embed the SMART Program content into an eHealth platform that will allow access on a
range of devices and accommodate updates. Perform alpha and beta testing.

4. Enroll a national sample of 1,938 AMSM who are diverse in terms of race/ethnicity, age,
geographic region, socioeconomic status, and sexual experience history.

5. Test the effectiveness of the SMART Program at reducing HIV risk taking behaviors,
increasing HIV testing, and improving prevention intentions. Consistent with a SMART
design, the investigators operationalize and power the primary test of effectiveness as
the first point of randomization, which tests the effectiveness of "Keep It Up!".
Additional comparisons will allow the investigators to establish the response rate for
"Queer Sex Ed", examine whether the more intensive "Young Men's Health Project"
outperforms the less intensive "Keep It Up!" among non-responders to "Queer Sex Ed," and
determine whether "Young Men's Health Project" provides added benefit to AMSM who did
not respond to "Keep it Up!".

Aim 2: Test if the SMART Program has differential efficacy across important sub-groups of
AMSM. Consistent with the RFA, the investigators will test intervention effects within each
of the NIH designated health disparity populations (racial/ethnicity minorities, rural, low
SES), and by age and language (Spanish).

Aim 3: Evaluate the delivery of the SMART Program nationally to inform scale out and
determine cost-effectiveness. To reduce the science-practice gap, the investigators will
utilize mixed methods to identify facilitators and barriers to the implementation of the
SMART Program using a Hybrid Type 1 Effectiveness-Implementation trial design. The
investigators will assess process metrics and indicators of its acceptability among AMSM and
key national stakeholders, scale out feasibility, sustainability potential, and conduct a
cost analysis to estimate the cost of program implementation compare to monetized benefits.

Inclusion Criteria:

- identifying as male-assigned at birth

- reporting attraction to men;

- 13-18 years old

- self-reported HIV-negative at the beginning of the study (or have never been HIV
tested/do not know their HIV status)

- able to read English or Spanish,

- has a usable e-mail address, textable phone number, and access to the internet or
smart-phone/-device

Exclusion Criteria:

- identifying as female-assigned at birth

- reporting no attraction men

- identifying as under 13 years of age

- identifying as 19 years old or older

- self-reported HIV-positive

- unable to read English or Spanish

- unable to have access to or use email, text messaging, voice calling

- unable to have access to the internet or a smart-phone/-device