Disclosure, Hiv, HIV/AIDS
Conditions
Keywords
MSM, HIV, disclosure, eHealth, virtual reality
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.
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.
Interventions
BEHAVIORALTough 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.
BEHAVIORALTough 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.
BEHAVIORALStandard 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.
Sponsors
Virtually Better, Inc.
National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
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) (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).
Eligibility
Sex/Gender
MALE
Age
16 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* HIV negative * assigned female at birth * 15 or younger * 30 or older
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Suppressed Viral Load | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intention to Disclose Score | Month 6 | 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. |
| Mean Disclosure Self-Efficacy Score | Month 6 | 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. |
| Mean Consequences of Disclosure (Cost) Score | Month 6 | 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. |
| Mean Consequences of Disclosure (Rewards) Score | Month 6 | 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. |
| Number of Participants Who Had Condomless Anal Intercourse With a Potentially Susceptible Partner | Month 6 | 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. |
| Mean Disclosure Self-Regulation (Peers) Score | Month 6 | 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. |
| Mean Disclosure Self-Regulation (Sexual Partners) Score | Month 6 | 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. |
| Mean Disclosure Outcome Expectations (Self-Evaluative) Score | Month 6 | 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. |
| Mean Disclosure Outcome Expectations (Hedonistic) Score | Month 6 | 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. |
| Mean Disclosure Self-Regulation (Family) Score | Month 6 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tough Talks Online Participants will use Tough Talks Online
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. | 53 |
| Tough Talks Clinic Participants will use receive Tough Talks in a clinic
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. | 51 |
| Standard of Care Participants will receive the standard of care (SOC).
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. | 52 |
| Total | 156 |
Baseline characteristics
| Characteristic | Tough Talks Online | Total | Standard of Care | Tough Talks Clinic |
|---|---|---|---|---|
| Age, Continuous | 23.19 years STANDARD_DEVIATION 3.5 | 23.78 years STANDARD_DEVIATION 3.45 | 24.23 years STANDARD_DEVIATION 3.46 | 23.92 years STANDARD_DEVIATION 3.35 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 41 Participants | 13 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 115 Participants | 39 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants | 93 Participants | 28 Participants | 33 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 15 Participants | 10 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 13 Participants | 37 Participants | 13 Participants | 11 Participants |
| Region of Enrollment United States | 53 Participants | 156 Participants | 52 Participants | 51 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 53 Participants | 156 Participants | 52 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 51 | 1 / 52 |
| other Total, other adverse events | 0 / 53 | 0 / 51 | 0 / 52 |
| serious Total, serious adverse events | 0 / 53 | 0 / 51 | 0 / 52 |
Outcome results
Primary
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
Population: Data are reported for those participants who had a Month 6 viral load assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tough Talks Online | Number of Participants With Suppressed Viral Load | 29 Participants |
| Tough Talks Clinic | Number of Participants With Suppressed Viral Load | 31 Participants |
| Standard of Care | Number of Participants With Suppressed Viral Load | 30 Participants |
Secondary
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
Population: Participants could choose not to respond to any of the eight questions. Responses for participants who chose not to respond to any of the eight questions were not counted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tough Talks Online | Mean Consequences of Disclosure (Cost) Score | 23.40 score on a scale | Standard Deviation 8.19 |
| Tough Talks Clinic | Mean Consequences of Disclosure (Cost) Score | 24.07 score on a scale | Standard Deviation 8.84 |
| Standard of Care | Mean Consequences of Disclosure (Cost) Score | 19.20 score on a scale | Standard Deviation 8.95 |
Secondary
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
Population: Participants could choose not to respond to any of the ten questions. Responses for participants who chose not to respond to any of the ten questions were not counted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tough Talks Online | Mean Consequences of Disclosure (Rewards) Score | 32.22 score on a scale | Standard Deviation 6.02 |
| Tough Talks Clinic | Mean Consequences of Disclosure (Rewards) Score | 34.18 score on a scale | Standard Deviation 6.15 |
| Standard of Care | Mean Consequences of Disclosure (Rewards) Score | 34.31 score on a scale | Standard Deviation 5.35 |
Secondary
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
Population: Although the protocol was not amended to remove this assessment, this scale was not used as study staff anticipated the questions included may be offensive to young participants.
Secondary
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
Population: Although the protocol was not amended to remove this assessment, this scale was not used as study staff anticipated the questions included may be offensive to young participants.
Secondary
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
Population: Participants could choose not to respond to any of the six questions. Responses for participants who chose not to respond to any of the six questions were not counted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tough Talks Online | Mean Disclosure Self-Efficacy Score | 22.89 score on a scale | Standard Deviation 7.69 |
| Tough Talks Clinic | Mean Disclosure Self-Efficacy Score | 23.03 score on a scale | Standard Deviation 6.54 |
| Standard of Care | Mean Disclosure Self-Efficacy Score | 25.64 score on a scale | Standard Deviation 7.24 |
Secondary
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
Population: Participants were free to choose not to answer this question. Data reported for all non-missing values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tough Talks Online | Mean Disclosure Self-Regulation (Family) Score | 2.57 score on a scale | Standard Deviation 1.53 |
| Tough Talks Clinic | Mean Disclosure Self-Regulation (Family) Score | 2.51 score on a scale | Standard Deviation 1.48 |
| Standard of Care | Mean Disclosure Self-Regulation (Family) Score | 2.59 score on a scale | Standard Deviation 1.58 |
Secondary
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
Population: Participants were free to choose not to answer this question. Data reported for all non-missing values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tough Talks Online | Mean Disclosure Self-Regulation (Peers) Score | 2.49 score on a scale | Standard Deviation 1.49 |
| Tough Talks Clinic | Mean Disclosure Self-Regulation (Peers) Score | 2.33 score on a scale | Standard Deviation 1.18 |
| Standard of Care | Mean Disclosure Self-Regulation (Peers) Score | 2.67 score on a scale | Standard Deviation 1.49 |
Secondary
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
Population: Participants were free to choose not to answer this question. Data reported for all non-missing values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tough Talks Online | Mean Disclosure Self-Regulation (Sexual Partners) Score | 2.08 score on a scale | Standard Deviation 1.4 |
| Tough Talks Clinic | Mean Disclosure Self-Regulation (Sexual Partners) Score | 1.68 score on a scale | Standard Deviation 1.03 |
| Standard of Care | Mean Disclosure Self-Regulation (Sexual Partners) Score | 1.71 score on a scale | Standard Deviation 1.22 |
Secondary
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
Population: Participants were free to choose not to answer this question. Data reported for all non-missing values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tough Talks Online | Mean Intention to Disclose Score | 1.45 score on a scale | Standard Deviation 0.5 |
| Tough Talks Clinic | Mean Intention to Disclose Score | 1.33 score on a scale | Standard Deviation 0.47 |
| Standard of Care | Mean Intention to Disclose Score | 1.15 score on a scale | Standard Deviation 0.36 |
Secondary
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
Population: Data are reported for those participants who completed Month 6 survey and for which non-missing data are present.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tough Talks Online | Number of Participants Who Had Condomless Anal Intercourse With a Potentially Susceptible Partner | 11 Participants |
| Tough Talks Clinic | Number of Participants Who Had Condomless Anal Intercourse With a Potentially Susceptible Partner | 6 Participants |
| Standard of Care | Number of Participants Who Had Condomless Anal Intercourse With a Potentially Susceptible Partner | 8 Participants |