Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men (YMSM)

Not Applicable

Completed

• Conditions: Hiv; Disclosure; HIV/AIDS
• Interventions: Behavioral: Tough Talks Online; Behavioral: Tough Talks Clinic; Behavioral: Standard of Care

• Registration Number: NCT03414372
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

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.

Study Timeline

• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-29
• Study Start: 2019-05-07
• Primary Completion: 2022-04-07
• Study Completion: 2022-04-07
• Status Verified: 2023-02
• Results First Submitted: 2023-02-03
• Results First Submitted QC: 2023-02-03
• Last Update Submitted: 2023-02-03
• Results First Posted: 2023-03-06
• Last Update Posted: 2023-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 156

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

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Exclusion Criteria

• HIV negative
• assigned female at birth
• 15 or younger
• 30 or older

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tough Talks Online	Tough Talks Online	Participants will use Tough Talks Online
Tough Talks Clinic	Tough Talks Clinic	Participants will use receive Tough Talks in a clinic
Standard of Care	Standard of Care	Participants will receive the standard of care (SOC).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Suppressed Viral Load	Month 6	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.

Secondary Outcome Measures

Name	Time	Method
Mean Intention to Disclose Score	Month 6	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.
Mean Disclosure Self-Efficacy Score	Month 6	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.
Mean Disclosure Self-Regulation (Family) Score	Month 6	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.
Mean Disclosure Outcome Expectations (Self-Evaluative) Score	Month 6	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.
Mean Disclosure Outcome Expectations (Hedonistic) Score	Month 6	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.
Mean Consequences of Disclosure (Rewards) Score	Month 6	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.
Mean Disclosure Self-Regulation (Peers) Score	Month 6	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.
Mean Disclosure Self-Regulation (Sexual Partners) Score	Month 6	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.
Number of Participants Who Had Condomless Anal Intercourse With a Potentially Susceptible Partner	Month 6	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.
Mean Consequences of Disclosure (Cost) Score	Month 6	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.

Trial Locations

Locations (1)

UNC Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States