CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 156 enrolled
Drug / intervention
Tough Talks Online +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03414372
NCT03414372N/ACompleted

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

University of North Carolina, Chapel Hill·interventional·Posted Jan 29, 2018·Updated Mar 6, 2023

In Brief

A clinical study evaluating Tough Talks Online, Tough Talks Clinic, and 1 other intervention for Hiv and 2 related conditions. Completed, enrolled 156 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHiv, HIV/AIDS, Disclosure
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 29, 2018
Enrollment StartMay 7, 2019
Primary CompletionApr 7, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.4 years ago

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.

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.

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.