Clinical trial NCT03713034: An Accessible Digital Intervention to Promote HIV Testing/Counseling and Prevention Among Adolescents
Official title: An Accessible Digital Intervention to Promote the Use of School-based Health Centers and to Empower Adolescents With Their Sexual Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention
Keywords: HIV testing and counseling (HTC)
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-10-19
Enrollment: 296
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is Phase II of a study previously registered on ClinicalTrials.gov (NCT02812329). Phase II focuses on adapting and expanding the reach of a previously developed video game aimed at HIV prevention. The game will be adapted to include web access/distribution and be evaluated using a randomized controlled trial.

Detailed description: The specific aims for Phase II of this study are to:

Further adapt and expand our culturally and socially-tailored videogame to have a greater focus on HIV testing and counseling (HTC) in addition to HIV prevention in an older age group of 14-18 year old boys and girls.

This will be accomplished by refining the conceptual model of the theoretical mechanisms of behavior change to be applied specifically within the game. New content will be created with additional input from 4 focus groups of 5 adolescents each (n = 20, aged 14-18) and these participants will also play-test the game. In addition, this model will inform new intervention manuals ("Game Playbooks") targeting these new outcomes. Building the new content from focus groups into the game are intended to adapt and expand its scope.

A system will be established for the newly adapted game for web access/distribution and program integration. Work will continue with commercialization partners on widespread distribution of the adapted game.

The final piece of the study will be to conduct a randomized controlled trial in 296 adolescents (aged 14-18) to evaluate the acceptability and efficacy of the adapted game on its new web-based platform compared with a set of control games.

Eligibility criteria: Inclusion Criteria:

* Ability to participate in a web-based videogame (willing to sit for 60 minutes/session to play the game)
* Have not been tested for HIV in the past year
* Ability to provide assent/parental/guardian consent+
* Have a completed and signed enrollment form for their school's health clinic allowing them, if they choose, to access the clinic for testing and health care

  * Students can be older than 18 as long as they were 18 or younger at the time of signing consent

Exclusion Criteria:

* Failure to meet any of the eligibility criteria

Primary outcomes:
measure: Attitudes Around HIV Testing and Counseling
timeFrame: Baseline, 4 weeks, 3 months and 6 months
Secondary outcomes:
measure: Intentions to Get Tested for HIV
timeFrame: Baseline, 4 weeks, 3 months and 6 months
measure: Number of Students Tested for HIV at Month 1
timeFrame: Month 1
measure: Number of Students Tested for HIV at Month 2
timeFrame: Month 2
measure: Number of Students Tested for HIV at Month 3
timeFrame: Month 3
measure: Number of Students Tested for HIV at Month 4
timeFrame: month 4
measure: Number of Students Tested for HIV at Month 5
timeFrame: Month 5
measure: Number of Students Tested for HIV at Month 6
timeFrame: Month 6
measure: Knowledge About HTC
timeFrame: Baseline, 4 weeks, 3 months, 6 months
measure: Self-efficacy Around HIV Testing and Counseling
timeFrame: Baseline, 4 weeks, 3 months, 6 months
measure: Self-efficacy Around Overall Health
timeFrame: Baseline, 4 weeks, 3 months, 6 months
measure: HIV Testing and Counseling Behavior (Self-Report)
timeFrame: Baseline, 4 Weeks, 3 Months, 6 Months
measure: Perceived Barriers to HIV Testing
timeFrame: Baseline
measure: Perceived Barriers to HIV Testing
timeFrame: 4 weeks
measure: Perceived Barriers to HIV Testing
timeFrame: 3 months
measure: Perceived Barriers to HIV Testing
timeFrame: 6 months
measure: Perceived Barriers to STI Testing
timeFrame: Baseline
measure: Perceived Barriers to STI Testing
timeFrame: 4 weeks
measure: Perceived Barriers to STI Testing
timeFrame: 3 months
measure: Perceived Barriers to STI Testing
timeFrame: 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Associate Professor of Medicine (General Medicine) and in the Child Study Center; Director, Yale Center for Health & Learning Games; Director, play2PREVENT Lab at Yale
name: Lynn Fiellin, MD
role: PRINCIPAL_INVESTIGATOR
References: