Brief Summary
Tough Talks is a virtual reality based HIV disclosure intervention that allows HIV+ individuals to practice disclosing to romantic partners. Tough Talks allows participants to have the opportunity to practice disclosing using a variety of strategies and experience different outcomes including acceptance, confusion, lack of HIV knowledge, and rejection.
Brief Title
Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men (YMSM)
Detailed Description
During Phase I of this project, the investigators developed an iPad based virtual reality system that features three avatars, two virtual locations and three disclosure scenarios which represent a variety of common disclosure experiences and contexts experienced by YMSM. In Phase II the investigators will further enhance Tough Talks and develop a full-feature automated version to test via a multi-site, randomized controlled trial (RCT) through the newly created Center for Innovative Technologies (iTech) across the Prevention and Care Continuum, an NIH-funded center to support adolescent HIV research.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Hiv
HIV/AIDS
Disclosure
Eligibility Criteria
Inclusion Criteria:
* 16-29 years
* assigned male at birth
* male identified
* HIV infected
* Owns a mobile device or has access to a laptop or desktop computer
* able to understand, read, and speak English
* Reports 1 or more episodes of anal intercourse with a male partner in the last 6 months
Exclusion Criteria:
* HIV negative
* assigned female at birth
* 15 or younger
* 30 or older
* 16-29 years
* assigned male at birth
* male identified
* HIV infected
* Owns a mobile device or has access to a laptop or desktop computer
* able to understand, read, and speak English
* Reports 1 or more episodes of anal intercourse with a male partner in the last 6 months
Exclusion Criteria:
* HIV negative
* assigned female at birth
* 15 or younger
* 30 or older
Inclusion Criteria
Inclusion Criteria:
* 16-29 years
* assigned male at birth
* male identified
* HIV infected
* Owns a mobile device or has access to a laptop or desktop computer
* able to understand, read, and speak English
* Reports 1 or more episodes of anal intercourse with a male partner in the last 6 months
* 16-29 years
* assigned male at birth
* male identified
* HIV infected
* Owns a mobile device or has access to a laptop or desktop computer
* able to understand, read, and speak English
* Reports 1 or more episodes of anal intercourse with a male partner in the last 6 months
Gender
Male
Gender Based
false
Keywords
MSM
HIV
disclosure
eHealth
virtual reality
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
29 Years
Minimum Age
16 Years
NCT Id
NCT03414372
Org Class
Other
Org Full Name
University of North Carolina, Chapel Hill
Org Study Id
14-0345
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men
Primary Outcomes
Outcome Description
Chart review or drawn for study. Viral load suppression will be defined as HIV RNA \< lower limit of detection as per the laboratory at each clinical site.
Outcome Measure
Number of Participants With Suppressed Viral Load
Outcome Time Frame
Month 6
Secondary Ids
Secondary Id
2R44MH104102-03
Secondary Outcomes
Outcome Description
Number of participants at month 6 with \>/= 1 act of condomless anal intercourse with a partner who is not known to be HIV-positive within the last 3 months.
Outcome Time Frame
Month 6
Outcome Measure
Number of Participants Who Had Condomless Anal Intercourse With a Potentially Susceptible Partner
Outcome Description
Measured using the Intention to Disclose scale which asks a single item: "I plan on telling my HIV status to all of my new partners before we have sex" and is rated using a 5-point Likert-type response scale. Scores range from 1 to 5 where '1' is "Strongly agree" and '5' is "Strongly disagree. "Lower scores indicate increased intention to disclose.
Outcome Time Frame
Month 6
Outcome Measure
Mean Intention to Disclose Score
Outcome Description
Measure of perceived ability to disclose HIV-seropositive status to casual sex partners in six scenarios. Scores were summed with higher scores indicating increased perceived ability to disclose. Six Questions were asked using a 5 point Likert Scale: 1=Absolutely sure I cannot; 2=Somewhat sure I cannot; 3=Not sure; 4=Somewhat sure I can; and 5=Absolutely sure I can. Scores range from 6-30.
Outcome Time Frame
Month 6
Outcome Measure
Mean Disclosure Self-Efficacy Score
Outcome Description
Measure of a participant's perceived negative consequences of disclosing of their HIV status to a partner (e.g., "Relationship would get bad", "Person would not want to be around me"), with higher scores indicating higher perceived negative consequences of disclosure. Eight Questions rated using a 4-point Likert Scale 1=Strongly disagree 2=Disagree 3=Agree 4=Strongly Agree. Scores range from 8 to 32.
Outcome Time Frame
Month 6
Outcome Measure
Mean Consequences of Disclosure (Cost) Score
Outcome Description
Measure of a participant's perceived positive consequences of disclosing of their HIV status to a partner (e.g., "Keep them safe from HIV", "Improve the relationship"), with higher scores indicating higher perceived positive consequences of disclosure. Ten Questions rated using a 4-point Likert Scale 1=Strongly disagree; 2=Disagree; 3=Agree; and 4=Strongly Agree. Scores range from 10-40.
Outcome Time Frame
Month 6
Outcome Measure
Mean Consequences of Disclosure (Rewards) Score
Outcome Description
Measured using a single question: "How many of your immediate family members are not aware of your HIV status but to whom you want to disclose?" and rated using a 5-point Likert Scale: 1=None; 2=Some, but less than half; 3=About half; 4=More than half; and 5=All. Scores range from 1 to 5 with lower scores indicating increased disclosure behaviors.
Outcome Time Frame
Month 6
Outcome Measure
Mean Disclosure Self-Regulation (Family) Score
Outcome Description
Measured using a single question: "How many of your peers are not aware of your HIV status but to whom you want to disclose?" and rated using a 5-point Likert Scale: 1=None; 2=Some, but less than half; 3=About half; 4=More than half; and 5=All. Scores range from 1 to 5 with lower scores indicating increased disclosure behaviors.
Outcome Time Frame
Month 6
Outcome Measure
Mean Disclosure Self-Regulation (Peers) Score
Outcome Description
Measured using a single question: "How many of your current and past sexual partners are not aware of your HIV status but to whom you want to disclose?" and rated using a 5-point Likert Scale: 1=None; 2=Some, but less than half; 3=About half; 4=More than half; and 5=All. Scores range from 1 to 5 with lower scores indicating increased disclosure behaviors.
Outcome Time Frame
Month 6
Outcome Measure
Mean Disclosure Self-Regulation (Sexual Partners) Score
Outcome Description
Measure of how a participant anticipates their behavior impacts their feelings or assessment of HIV protective behaviors. Higher scores indicate a more favorable/stronger evaluation/endorsement of HIV protective behaviors. Participant's self-evaluation based on six questions using a 5-point Likert scale (1, strongly disagree to 5, strongly agree) ranging from 5 to 30.
Outcome Time Frame
Month 6
Outcome Measure
Mean Disclosure Outcome Expectations (Self-Evaluative) Score
Outcome Description
Measure of how a participant anticipates their behavior impacts their feelings or assessment of sexual pleasure or sensuality. Lower scores indicate a more favorable/stronger evaluation/endorsement of HIV protective behaviors. Participant's self-evaluation based on three questions using a 5-point Likert scale (1, strongly disagree to 5, strongly agree) ranging from 3 to 15.
Outcome Time Frame
Month 6
Outcome Measure
Mean Disclosure Outcome Expectations (Hedonistic) Score
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
29
Minimum Age Number (converted to Years and rounded down)
16
Investigators
Investigator Type
Principal Investigator
Investigator Name
Larry Bernstein
Investigator Email
labernst@montefiore.org
Investigator Phone