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.|
|ClinicalTrials.gov Identifier: NCT03414372|
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : May 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hiv HIV/AIDS Disclosure||Behavioral: Tough Talks Online Behavioral: Tough Talks Clinic Behavioral: Standard of Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|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.
|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|
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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03414372
|Contact: Alyssa Vecchio, MDemail@example.com|
|Contact: Lisa Hightow-Weidman, MD||(919) firstname.lastname@example.org|
|United States, North Carolina|
|UNC Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Alyssa Vecchio, MD 919-843-9993 email@example.com|
|Contact: Zach Soberano 919-966-2537 firstname.lastname@example.org|
|Principal Investigator: Lisa Hightow-Weidman, MD, MPH|
|Principal Investigator:||Kate Muessig, PhD||UNC-Chapel Hill|
|Principal Investigator:||Lisa Hightow-Weidman, MD||UNC-Chapel Hll|