NCT03414372

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started May 2019

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 7, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2022

Completed
11 months until next milestone

Results Posted

Study results publicly available

March 6, 2023

Completed
Last Updated

March 6, 2023

Status Verified

February 1, 2023

Enrollment Period

2.9 years

First QC Date

January 22, 2018

Results QC Date

February 3, 2023

Last Update Submit

February 3, 2023

Conditions

HivHIV/AIDSDisclosure

Keywords

MSMHIVdisclosureeHealthvirtual reality

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Number of Participants Who Had Condomless Anal Intercourse With a Potentially Susceptible Partner

    Month 6

  • Mean Intention to Disclose Score

    Month 6

  • Mean Disclosure Self-Efficacy Score

    Month 6

  • Mean Consequences of Disclosure (Cost) Score

    Month 6

  • Mean Consequences of Disclosure (Rewards) Score

    Month 6

  • +5 more secondary outcomes

Study Arms (3)

Tough Talks Online

EXPERIMENTAL

Participants will use Tough Talks Online

Behavioral: Tough Talks Online

Tough Talks Clinic

EXPERIMENTAL

Participants will use receive Tough Talks in a clinic

Behavioral: Tough Talks Clinic

Standard of Care

PLACEBO COMPARATOR

Participants will receive the standard of care (SOC).

Behavioral: Standard of Care

Interventions

Tough Talks OnlineBEHAVIORAL

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.

Also known as: Tough Talks
Tough Talks Online
Tough Talks ClinicBEHAVIORAL

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.

Tough Talks Clinic
Standard of CareBEHAVIORAL

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.

Standard of Care

Eligibility Criteria

Age16 Years - 29 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsassigned male sex at birth and currently male identified
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • Hightow-Weidman LB, Muessig K, Soberano Z, Rosso MT, Currie A, Adams Larsen M, Knudtson K, Vecchio A. Tough Talks Virtual Simulation HIV Disclosure Intervention for Young Men Who Have Sex With Men: Development and Usability Testing. JMIR Form Res. 2022 Sep 8;6(9):e38354. doi: 10.2196/38354.

    PMID: 36074551DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Bryce Stamp, MPH
Organization
University of North Carolina at Chapel Hill
bstamp@ad.unc.edu
919-966-7430

Study Officials

  • Kate Muessig, PhD

    UNC-Chapel Hill

    PRINCIPAL INVESTIGATOR

  • Lisa Hightow-Weidman, MD

    UNC-Chapel Hll

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2018

First Posted

January 29, 2018

Study Start

May 7, 2019

Primary Completion

April 7, 2022

Study Completion

April 7, 2022

Last Updated

March 6, 2023

Results First Posted

March 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

The investigators are not planning on making individual participant data available to other researchers.

Locations

US(1)