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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hiv, HIV/AIDS, Disclosure

Intervention / Treatment
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* Behavioral: Tough Talks Online
* Behavioral: Tough Talks Clinic
* Behavioral: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study includes 3 phases: 1) formative research to refine and enhance Tough Talks with input from YMSM and their social/sexual networks; 2) (n=8) a technical pilot to optimize functionality and technical performance; and 3) (n=156) a three-arm RCT to evaluate efficacy and effectiveness of Tough Talks among HIV-infected YMSM. In the RCT, the investigators will conduct a combined efficacy/effectiveness trial to compare the intervention delivered online, in the clinic or standard of care clinic messaging. Primary outcomes will be assessed at intervention completion (1 month) and at 6 months and include HIV viral load and condomless anal intercourse (CAI).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tough Talks Online<br>Participants will use Tough Talks Online | Behavioral: Tough Talks Online<br>* 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.<br>* Other names: Tough Talks;|
| Experimental: Tough Talks Clinic<br>Participants will use receive Tough Talks in a clinic | Behavioral: Tough Talks Clinic<br>* 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.<br>|
| Placebo Comparator: Standard of Care<br>Participants will receive the standard of care (SOC). | Behavioral: Standard of Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MSM, HIV, disclosure, eHealth, virtual reality