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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03414372
• Other study ID #: 14-0345
• Secondary ID: 2R44MH104102-03
• Status: Completed
• Phase: N/A
• Start date: May 7, 2019
• Est. completion date: April 7, 2022

Study information

• Verified date: February 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: April 7, 2022
• Est. primary completion date: April 7, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Disclosure
• Hiv
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• Tough Talks Online
Those randomized to the online condition will receive information about how to access Tough Talks online and be given their unique log-in and password information and information on how to contact study personnel for any technical issues. Arm 1 participants will have 24-hour access to all of the intervention features and will be able to access the program for additional sessions at any time. Study staff will provide reminders using text or email (participant preference) if they have not accessed the intervention at the specified time intervals.
• Tough Talks Clinic
Those randomized to the in-clinic condition (Arm 2) will immediately begin the Tough Talks intervention. Study staff will ensure participants are logged on and will also be available to answer technical issues should they arise. After completion, those in this arm will have an in-person follow-up visit scheduled for approximately two weeks. The in-person sessions were adapted to be delivered via Zoom or a similar HIPAA compliant platform due to the COVID-19 pandemic.
• Standard of Care
Those randomized to the control arm (SOC) will receive a paper-based disclosure informational packet based on available Centers of Disease Control (CDC) guidance. At one-month, all participants will complete an online survey to assess intervention acceptability as well as to assess Social Cognitive Theory (SCT model) constructs.

Locations

Country	Name	City	State
United States	UNC Chapel Hill	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), Virtually Better, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Suppressed Viral Load	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.	Month 6
Secondary	Number of Participants Who Had Condomless Anal Intercourse With a Potentially Susceptible Partner	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.	Month 6
Secondary	Mean Intention to Disclose Score	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.	Month 6
Secondary	Mean Disclosure Self-Efficacy Score	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.	Month 6
Secondary	Mean Consequences of Disclosure (Cost) Score	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.	Month 6
Secondary	Mean Consequences of Disclosure (Rewards) Score	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.	Month 6
Secondary	Mean Disclosure Self-Regulation (Family) Score	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.	Month 6
Secondary	Mean Disclosure Self-Regulation (Peers) Score	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.	Month 6
Secondary	Mean Disclosure Self-Regulation (Sexual Partners) Score	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.	Month 6
Secondary	Mean Disclosure Outcome Expectations (Self-Evaluative) Score	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.	Month 6
Secondary	Mean Disclosure Outcome Expectations (Hedonistic) Score	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.	Month 6