An Accessible Digital Intervention to Promote the Use of School-based Health Centers and to Empower Adolescents With Their Sexual Health
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 296
- Locations
- 2
- Primary Endpoint
- Attitudes Around HIV Testing and Counseling
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 14 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Attitudes Around HIV Testing and Counseling
Time Frame: Baseline, 4 weeks, 3 months and 6 months
HTC attitudes were assessed with 7 items (e.g., "I feel it is important for me to get tested for HIV"). The items were scored on a 5-point scale ranging from - 2 (strongly disagree) to +2 (strongly agree) with positive values indicating healthier attitudes towards HTC. Participants had the option to respond "not sure" which was given a neutral score of 0. A mean of the seven items was calculated for each participant. A few items were reverse coded, because the lower value was indicating healthier attitudes. Not sure was coded as a neutral option. Higher scores equal more positive attitudes toward HIV testing and counseling.
Secondary Outcomes
- Number of Students Tested for HIV at Month 2(Month 2)
- Number of Students Tested for HIV at Month 4(month 4)
- Number of Students Tested for HIV at Month 5(Month 5)
- Intentions to Get Tested for HIV(Baseline, 4 weeks, 3 months and 6 months)
- Number of Students Tested for HIV at Month 1(Month 1)
- Perceived Barriers to HIV Testing(6 months)
- Self-efficacy Around HIV Testing and Counseling(Baseline, 4 weeks, 3 months, 6 months)
- Number of Students Tested for HIV at Month 3(Month 3)
- Number of Students Tested for HIV at Month 6(Month 6)
- Self-efficacy Around Overall Health(Baseline, 4 weeks, 3 months, 6 months)
- Knowledge About HTC(Baseline, 4 weeks, 3 months, 6 months)
- HIV Testing and Counseling Behavior (Self-Report)(Baseline, 4 Weeks, 3 Months, 6 Months)
- Perceived Barriers to STI Testing(6 months)