An interventional study of Tough Talks Online and Tough Talks Clinic in Hiv, HIV/AIDS and Disclosure, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to male participants aged 16 Years to 29 Years. Per ClinicalTrials.gov, last updated 2023-03-06.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Supportive care
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Among 39 studies in Acquired Immunodeficiency Syndrome by University of North Carolina, Chapel Hill — none open to participants now, 1 under way, none of them phase 3. Acquired Immunodeficiency Syndrome · University of North Carolina, Chapel Hill.
Among the 39 studies in Acquired Immunodeficiency Syndrome by University of North Carolina, Chapel Hill, this one is the 12th largest by enrollment of the 30 interventional ones that give a count, is one of 3 that started in 2019, is one of 22 with no phase, and was the 29th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →None of the 39 studies in Acquired Immunodeficiency Syndrome by University of North Carolina, Chapel Hill is open now. The open studies under Acquired Immunodeficiency Syndrome, anywhere →
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 16 Years to 29 Years · male · no healthy volunteers.
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39 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 156 is above the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 92 across the 30 interventional studies, 206 across the 9 observational. Of the 37 that completed or were terminated, 13 (35%) have results posted.
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University of North Carolina, Chapel Hill is the lead sponsor of 1,373 studies on the registry; 134 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
1 of the studies in Acquired Immunodeficiency Syndrome by University of North Carolina, Chapel Hill that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06358885University of North Carolina, Chapel HillIGHID 12230 - An Implementation Trial of an Experiential Brief Alcohol Intervention for HIV Prevention | 2026-11 |
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Among the 39 studies in Acquired Immunodeficiency Syndrome by University of North Carolina, Chapel Hill, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will use Tough Talks Online
Behavioral: Tough Talks Online
Participants will use receive Tough Talks in a clinic
Behavioral: Tough Talks Clinic
Participants will receive the standard of care (SOC).
Behavioral: Standard of Care
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
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.
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.
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.
Time frame: Month 6
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 6
| Milestone | Tough Talks Online | Tough Talks Clinic | Standard of Care |
|---|---|---|---|
| Started | 53 | 51 | 52 |
| Completed | 43 | 42 | 44 |
| Not completed | 10 | 9 | 8 |
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.
| Participants | Tough Talks Online | Tough Talks Clinic | Standard of Care |
|---|---|---|---|
| Number of Participants With Suppressed Viral Load | 29 | 31 | 30 |
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.
| Participants | Tough Talks Online | Tough Talks Clinic | Standard of Care |
|---|---|---|---|
| Number of Participants Who Had Condomless Anal Intercourse With a Potentially Susceptible Partner | 11 | 6 | 8 |
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.
| score on a scale | Tough Talks Online | Tough Talks Clinic | Standard of Care |
|---|---|---|---|
| Mean Intention to Disclose Score | 1.45 ± 0.50 | 1.33 ± 0.47 | 1.15 ± 0.36 |
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.
| score on a scale | Tough Talks Online | Tough Talks Clinic | Standard of Care |
|---|---|---|---|
| Mean Disclosure Self-Efficacy Score | 22.89 ± 7.69 | 23.03 ± 6.54 | 25.64 ± 7.24 |
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.
| score on a scale | Tough Talks Online | Tough Talks Clinic | Standard of Care |
|---|---|---|---|
| Mean Consequences of Disclosure (Cost) Score | 23.40 ± 8.19 | 24.07 ± 8.84 | 19.20 ± 8.95 |
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.
| score on a scale | Tough Talks Online | Tough Talks Clinic | Standard of Care |
|---|---|---|---|
| Mean Consequences of Disclosure (Rewards) Score | 32.22 ± 6.02 | 34.18 ± 6.15 | 34.31 ± 5.35 |
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.
| score on a scale | Tough Talks Online | Tough Talks Clinic | Standard of Care |
|---|---|---|---|
| Mean Disclosure Self-Regulation (Family) Score | 2.57 ± 1.53 | 2.51 ± 1.48 | 2.59 ± 1.58 |
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.
| score on a scale | Tough Talks Online | Tough Talks Clinic | Standard of Care |
|---|---|---|---|
| Mean Disclosure Self-Regulation (Peers) Score | 2.49 ± 1.49 | 2.33 ± 1.18 | 2.67 ± 1.49 |
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.
| score on a scale | Tough Talks Online | Tough Talks Clinic | Standard of Care |
|---|---|---|---|
| Mean Disclosure Self-Regulation (Sexual Partners) Score | 2.08 ± 1.40 | 1.68 ± 1.03 | 1.71 ± 1.22 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over From signing of informed consent through study completion, a total of up to 7 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tough Talks Online | 0/53 (0%) | 0/53 (0%) | 0/53 (0%) |
| Tough Talks Clinic | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| Standard of Care | 1/52 (1.9%) | 0/52 (0%) | 0/52 (0%) |
| Age, Continuous(years) | Tough Talks Online | Tough Talks Clinic | Standard of Care | Total |
|---|---|---|---|---|
| Mean | 23.19 ± 3.50 | 23.92 ± 3.35 | 24.23 ± 3.46 | 23.78 ± 3.45 |
| Sex: Female, Male(Participants) | Tough Talks Online | Tough Talks Clinic | Standard of Care | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 53 | 51 | 52 | 156 |
| Ethnicity (NIH/OMB)(Participants) | Tough Talks Online | Tough Talks Clinic | Standard of Care | Total |
|---|---|---|---|---|
| Hispanic or Latino | 15 | 13 | 13 | 41 |
| Not Hispanic or Latino | 38 | 38 | 39 | 115 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Tough Talks Online | Tough Talks Clinic | Standard of Care | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 | 2 |
| Asian | 1 | 2 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| Black or African American | 32 | 33 | 28 | 93 |
| White | 13 | 11 | 13 | 37 |
| More than one race | 4 | 1 | 10 | 15 |
| Unknown or Not Reported | 2 | 3 | 0 | 5 |
| Region of Enrollment(Participants) | Tough Talks Online | Tough Talks Clinic | Standard of Care | Total |
|---|---|---|---|---|
| United States | 53 | 51 | 52 | 156 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — The investigators are not planning on making individual participant data available to other researchers.
Ran from May 2019 to primary completion in Apr 2022, 35 months.
Results were first posted in Mar 2023, 10 months after primary completion.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 35 months is above that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
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