An Accessible Digital Intervention to Promote HIV Testing/Counseling and Prevention Among Adolescents

HIV Prevention Clinical Trial

Official title:

An Accessible Digital Intervention to Promote the Use of School-based Health Centers and to Empower Adolescents With Their Sexual Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03713034
• Other study ID #: 1604017531_II
• Secondary ID: 5R42HD088317-03
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Prevention

Intervention

Other:
• PlayTest!
Participants in the PlayTest! intervention arm played the game on their assigned iPads once per week for an hour over the course of 4-5 weeks.
• Control games
Participants in the control arm played the games on their assigned iPads once per week for an hour over the course of 4-5 weeks.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attitudes Around HIV Testing and Counseling	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.	Baseline, 4 weeks, 3 months and 6 months
Secondary	Intentions to Get Tested for HIV	Intentions were assessed with 7 items (e.g., "I intend to get tested for HIV at some point in the next 3 months" and "I intend to use a school-based health center 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 intentions. Participants had the option to respond "not sure" which was given a neutral score of 0. Higher scores equal greater intentions to get tested for HIV. The total range for scores was -14 to 14.	Baseline, 4 weeks, 3 months and 6 months
Secondary	Number of Students Tested for HIV at Month 1	The number of participants tested for HIV was measured by tracking data reported by school-based health center staff. The school-based health center staff recorded (by study Id number) if participant came in for testing in the last month and the date of the test.	Month 1
Secondary	Number of Students Tested for HIV at Month 2	The number of participants tested for HIV was measured by tracking data reported by school-based health center staff. The school-based health center staff recorded (by study Id number) if participant came in for testing in the last month and the date of the test.	Month 2
Secondary	Number of Students Tested for HIV at Month 3	The number of participants tested for HIV was measured by tracking data reported by school-based health center staff. The school-based health center staff recorded (by study Id number) if participant came in for testing in the last month and the date of the test.	Month 3
Secondary	Number of Students Tested for HIV at Month 4	The number of participants tested for HIV was measured by tracking data reported by school-based health center staff. The school-based health center staff recorded (by study Id number) if participant came in for testing in the last month and the date of the test.	month 4
Secondary	Number of Students Tested for HIV at Month 5	The number of participants tested for HIV was measured by tracking data reported by school-based health center staff. The school-based health center staff recorded (by study Id number) if participant came in for testing in the last month and the date of the test.	Month 5
Secondary	Number of Students Tested for HIV at Month 6	The number of participants tested for HIV was measured by tracking data reported by school-based health center staff. The school-based health center staff recorded (by study Id number) if participant came in for testing in the last month and the date of the test.	Month 6
Secondary	Knowledge About HTC	Participants' knowledge about HTC was measured with 12 questions (e.g., "If you are tested for HIV, you have to wait a long time to find out the results" and "The earlier HIV is caught, the better chance a person has of effectively managing the virus"). Participants responded true, false, or not sure. Responses were recoded into 1 (correct) or 0 (incorrect; responses of "not sure" were coded as incorrect) and a sum of all 12 items was calculated to provide a HTC knowledge score for each participant (Total range was from 0 to 12.) Higher values represent higher knowledge around HTC.	Baseline, 4 weeks, 3 months, 6 months
Secondary	Self-efficacy Around HIV Testing and Counseling	Self-efficacy for HTC was assessed with 4 items, rated on a confidence scale (e.g., "How confident are you that you could find information about how and where you can get STI and/or HIV testing?"). The total range was from 0-100. A higher score indicates a higher level of self-efficacy around HTC. A mean of the 4 items was calculated for each participant with higher scores indicating higher self-efficacy for HTC.	Baseline, 4 weeks, 3 months, 6 months
Secondary	Self-efficacy Around Overall Health	Self-efficacy for managing overall health was assessed with 4 items, rated on a 100% confidence scale (e.g., "How confident are you that you could discuss your health concerns with a health provider?"). The total range was from 0-100%.A mean of the 4 items was calculated for each participant with higher scores indicating higher self-efficacy for managing overall health.	Baseline, 4 weeks, 3 months, 6 months
Secondary	HIV Testing and Counseling Behavior (Self-Report)	At each time point the participants indicated whether they had ever been tested for HIV with the response options: yes, no, not sure, and decline to answer.	Baseline, 4 Weeks, 3 Months, 6 Months
Secondary	Perceived Barriers to HIV Testing	Perceived Barriers was measured with a one question instrument that asks participants what reasons would most likely keep them from getting tested if they thought they had HIV (examples of options were "I don't know where to go", "It costs too much"). The instrument allowed participants to select all reasons that apply.	Baseline
Secondary	Perceived Barriers to HIV Testing	Perceived Barriers was measured with a one question instrument that asks participants what reasons would most likely keep them from getting tested if they thought they had HIV (examples of options were "I don't know where to go", "It costs too much"). The instrument allowed participants to select all reasons that apply.	4 weeks
Secondary	Perceived Barriers to HIV Testing	Perceived Barriers was measured with a one question instrument that asks participants what reasons would most likely keep them from getting tested if they thought they had HIV (examples of options were "I don't know where to go", "It costs too much"). The instrument allowed participants to select all reasons that apply.	3 months
Secondary	Perceived Barriers to HIV Testing	Perceived Barriers was measured with a one question instrument that asks participants what reasons would most likely keep them from getting tested if they thought they had HIV (examples of options were "I don't know where to go", "It costs too much"). The instrument allowed participants to select all reasons that apply.	6 months
Secondary	Perceived Barriers to STI Testing	Perceived Barriers was measured with a one question instrument that asks participants what reasons would most likely keep them from getting tested if they thought they had an STI (examples of options were "I don't know where to go", "It costs too much"). The instrument allowed participants to select all reasons that apply.	Baseline
Secondary	Perceived Barriers to STI Testing	Perceived Barriers was measured with a one question instrument that asks participants what reasons would most likely keep them from getting tested if they thought they had an STI (examples of options were "I don't know where to go", "It costs too much"). The instrument allowed participants to select all reasons that apply.	4 weeks
Secondary	Perceived Barriers to STI Testing	Perceived Barriers was measured with a one question instrument that asks participants what reasons would most likely keep them from getting tested if they thought they had an STI (examples of options were "I don't know where to go", "It costs too much"). The instrument allowed participants to select all reasons that apply.	3 months
Secondary	Perceived Barriers to STI Testing	Perceived Barriers was measured with a one question instrument that asks participants what reasons would most likely keep them from getting tested if they thought they had an STI (examples of options were "I don't know where to go", "It costs too much"). The instrument allowed participants to select all reasons that apply.	6 months