HivNCT03414372
Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men (YMSM)
A study testing Tough Talks Online and Tough Talks Clinic in people with Hiv and HIV/AIDS, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 29 years, men only
- Conditions the study is for
- Hiv, HIV/AIDS, Disclosure
- What is being tested?
- Tough Talks Online and Tough Talks Clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2019to 7 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 29 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- HIV negative
- assigned female at birth
- 15 or younger
- 30 or older
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men
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.
Read the 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.
- Conditions
- Hiv, HIV/AIDS, Disclosure
- Being tested
- Tough Talks Online, Tough Talks Clinic, Standard of Care
- Keywords
- MSM, HIV, disclosure, eHealth, virtual reality
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tough Talks OnlineBehavioural
Also called Tough Talks
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 ClinicBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tough Talks Online | Experimental | Participants will use Tough Talks Online Receives: Behavioral: Tough Talks Online |
| Tough Talks Clinic | Experimental | Participants will use receive Tough Talks in a clinic Receives: Behavioral: Tough Talks Clinic |
| Standard of Care | Placebo comparator | Participants will receive the standard of care (SOC). Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 6
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start7 May 2019
- Primary completion7 Apr 2022
- Study completion7 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Virtually Better, Inc., National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Kate Muessig, PhD, Principal investigator, UNC-Chapel HillLisa Hightow-Weidman, MD, Principal investigator, UNC-Chapel Hll
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414372
- Sponsor's protocol ID
- 14-0345
- Other IDs
- 2R44MH104102-03
- Status last verified
- Feb 2023
- First submitted
- 22 Jan 2018
- Last updated
- 6 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators are not planning on making individual participant data available to other researchers.
Publications
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.
PubMed 36074551
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT03414372
- Acronym / sponsor ID
- 14-0345
- Conditions
- Hiv, HIV/AIDS, Disclosure
- Keywords
- MSM, HIV, disclosure, eHealth, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Virtually Better, Inc., National Institute of Mental Health (NIMH)
- Study start
- 7 May 2019 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 7 Apr 2022 (actual)
- First posted
- 29 Jan 2018 (actual)
- Results
- Posted 6 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Tough Talks Online | Experimental | Behavioral: Tough Talks OnlineParticipants will use Tough Talks Online |
| Tough Talks Clinic | Experimental | Behavioral: Tough Talks ClinicParticipants will use receive Tough Talks in a clinic |
| Standard of Care | Placebo comparator | Behavioral: Standard of CareParticipants will receive the standard of care (SOC). |
Who may qualify
- Ages
- 16 to 29 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 16-29 years
- assigned male at birth
- male identified
- HIV infected
- Owns a mobile device or has access to a laptop or desktop computer
Key exclusion criteria (4 listed)
- HIV negative
- assigned female at birth
- 15 or younger
- 30 or older
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tough Talks OnlineAlso: Tough TalksThose 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. | Behavioural | Tough Talks Online |
| Tough Talks ClinicThose 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. | Behavioural | Tough Talks Clinic |
| Standard of CareThose 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. | Behavioural | Standard of Care |
Primary outcome
Number of Participants With Suppressed Viral Load
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.
10 secondary outcomes
Number of Participants Who Had Condomless Anal Intercourse With a Potentially Susceptible Partner
Time frame: Month 6
Mean Intention to Disclose Score
Time frame: Month 6
Mean Disclosure Self-Efficacy Score
Time frame: Month 6
Mean Consequences of Disclosure (Cost) Score
Time frame: Month 6
Mean Consequences of Disclosure (Rewards) Score
Time frame: Month 6
Mean Disclosure Self-Regulation (Family) Score
Time frame: Month 6
Mean Disclosure Self-Regulation (Peers) Score
Time frame: Month 6
Mean Disclosure Self-Regulation (Sexual Partners) Score
Time frame: Month 6
Mean Disclosure Outcome Expectations (Self-Evaluative) Score
Time frame: Month 6
Mean Disclosure Outcome Expectations (Hedonistic) Score
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36074551Hightow-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.
- Individual participant dataSharing planned: No. The investigators are not planning on making individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Muessig, PhD principal investigator
UNC-Chapel Hill
Lisa Hightow-Weidman, MD principal investigator
UNC-Chapel Hll
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tough Talks Online and Tough Talks Clinic in people with Hiv and HIV/AIDS, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Suppressed Viral Load (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03414372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.