Hiv Clinical Trial
Official title:
AllyQuest: Engaging HIV+ YMSM in Care Through Social Networking and Gamification
AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ young men who have sex with men (YMSM). The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis. AllyQuest will be an interactive mobile phone intervention for HIV+ YMSM that utilizes social networking, game-based mechanics and a story-based framework to guide behavior change. Grounded in Social Cognitive Theory, narrative communication and the principles of persuasive technology, the intervention is designed to capitalize on social involvement as a means through which HIV+ YMSM can receive information and social support, experience social norms and reflective appraisals, and feel a sense of connectedness to peers.
Specific Aim 1 Design and develop AllyQuest a novel theory-based mobile health (mHealth)
intervention for newly diagnosed HIV+ YMSM. Using an iterative research design the
investigators will work with our YABs and Ayogo, a global leader in the application of game
psychology and health behavior change, to develop and tailor the intervention content for
maximal relevance and usability for newly diagnosed HIV+ YMSM. The investigators will use
content within existing evidence based interventions(EBIs) developed for persons living with
HIV, including MSM and youth to develop the informational content to be delivered in
AllyQuest. Activities from the EBIs will be translated into the daily activities that
participants within AllyQuest receive. To maximize intervention appeal and appropriateness
for our target population, the investigators will convene two youth advisory boards (YABs) to
provide insight and feedback during the intervention development process. The investigators
will recruit 4-5 HIV+ YMSM from each site (Chicago and North Carolina) to serve as YAB
members over the first year of the study. The investigators will ensure that YAB members are
representative of the target population in terms of age, race/ethnicity, sexual
orientation/identity, and length of time since diagnosis. At monthly in-person meetings, our
two Youth Advisory Boards (YAB) - each consisting of 4 to 5 HIV+ MSM—will evaluate
intervention content as it is developed (including imagery and messaging) for acceptability
and relevance. Specifically, the investigators will ask YAB members to react to the written
tailored content in terms of the content's readability, comprehension, and relevance. The
investigators will also elicit the YABs' views on the following areas of intervention design:
(a) intervention structure and format [e.g., organization of the intervention,
appropriateness and appeal of language/images, ease of navigating the web-based content]; (b)
intervention content [e.g., relevance/applicability of intervention content to the
population, comprehension of content, interest in the content]; (c) intervention activities
[e.g., comprehension of activity instructions, acceptability/relevance of activities, desire
to engage in activities]; and (d) overall impressions of the intervention [e.g., overall
utility, overall interest, overall enjoyment]. Two YABs are being utilized to ensure maximal
diversity of viewpoints and developmental stages during intervention development. During the
first six months of year one, YAB members will meet with the research team monthly, as this
will be a critical time to develop intervention materials. In addition, web-based meetings
and email communication will be used to review materials in between in-person sessions.
Intervention Development and Usability Testing Prototype ideas will be developed in an
iterative fashion with Ayogo to develop low-fidelity clickable prototypes that demonstrate
the information architecture and high-level features of the application. Members of the
research and app development team will conduct internal usability "beta testing" to ensure
functionality. After any discovered problems are fixed, 4-5 members of the target population
recruited as described above from the North Carolina site and 4-5 members of the target
population from the Chicago site will participate in usability testing. Usability testing
will assess users comprehension of the educational content, understanding and use of
intervention features, and overall impressions of app relevance and appeal. Testing will be
conducted in accordance with NIH usability guidelines. Each participant will be asked to meet
with a research team member and a member of the development team for a guided, interactive
tour through the app. Participants will be asked to share their thoughts and impressions
aloud as they move through the different components and features of the app. Audiotapes of
the testing sessions along with video tapes of the app screen and participants' hands will be
analyzed for patterns of use or usability problems, and results will be compiled into a
report for the developers and research team, including any recommendations to address
problems identified. Ongoing adjustments require an agile, iterative approach throughout
usability testing with members of the target population.
Specific Aim 2 Conduct a one-month pilot trial of AllyQuest with 20 newly diagnosed HIV+
YMSM. To ensure that the features, platform and content of AllyQuest are acceptable to the
target population and that there are no technical challenges or user concerns, the
investigators will conduct a one-month pilot trial of use. The research assistant (RA) will
meet with participants in person to explain the study in detail, facilitate app download and
login onto participants' phones, and provide an app site tour to highlight features.
Participants will complete a baseline demographic and risk assessment administered via a
computer assisted survey instrument (CASI). At the end of the one-month field trial,
participants will undergo a debriefing session to evaluate their experience using the app,
overall satisfaction and any problems they encountered. Individuals will be instructed to
contact the research coordinator immediately to report difficulties with any app components
or to report any problems with their phone or phone service. A help link will be embedded
within the app that directly links to study staff if assistance is needed. Strategies used in
prior team research studies such as employing research staff with training in cultural
sensitivity and experience working with HIV+YMSM, providing appropriate monetary incentives
for participation in study evaluations, and using available resources to maintain contact
will be employed. The investigators will evaluate participant experience with AllyQuest to
understand their technology utilization with a specific focus on usability and mechanisms of
action that might underlie the potential effectiveness of the intervention (quality/timing of
messages, privacy concerns) and quality of the patient-technology relationship (trust,
communication, intrusiveness, health promotion). The investigators will also examine barriers
and facilitators for implementation. At the end of the one-month pilot trial, participants
will complete a quantitative survey administered via a computer assisted survey instrument
(CASI). Qualitative exit interviews will allow for a more in-depth and nuanced understanding
of intervention acceptability. Interviews will be semistructured and focus on how
participants used AllyQuest over the one-month pilot trial and how they perceive that use of
the intervention could translate into behavior change.
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