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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03414372
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : May 18, 2021
Virtually Better, Inc.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hiv HIV/AIDS Disclosure Behavioral: Tough Talks Online Behavioral: Tough Talks Clinic Behavioral: Standard of Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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) a technical pilot to optimize functionality and technical performance; and 3) 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 CAI.

Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Tough Talks Online
Participants will use Tough Talks Online
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.
Other Name: Tough Talks

Experimental: Tough Talks Clinic
Participants will use receive Tough Talks in a clinic
Behavioral: 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.

Placebo Comparator: Standard of Care
Participants will receive the standard of care (SOC).
Behavioral: 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.

Primary Outcome Measures :
  1. Viral Load Suppression [ Time Frame: 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.

  2. Condomless anal sex [ Time Frame: Month 6 ]
    Frequency of anal sex by position (insertive and receptive), with and without condoms, and seroconcordance with main and casual partners in past 90 days.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   assigned male sex at birth and currently male identified
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03414372

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Contact: Alyssa Vecchio, MD 9198439993
Contact: Lisa Hightow-Weidman, MD (919) 843-0033

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United States, North Carolina
UNC Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Alyssa Vecchio, MD    919-843-9993   
Contact: Zach Soberano    919-966-2537   
Principal Investigator: Lisa Hightow-Weidman, MD, MPH         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Virtually Better, Inc.
National Institute of Mental Health (NIMH)
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Principal Investigator: Kate Muessig, PhD UNC-Chapel Hill
Principal Investigator: Lisa Hightow-Weidman, MD UNC-Chapel Hll
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Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT03414372    
Other Study ID Numbers: 14-0345
2R44MH104102-03 ( U.S. NIH Grant/Contract )
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators are not planning on making individual participant data available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
virtual reality
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases