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

Browse trials for

• Acquired Immunodeficiency Syndrome 2,035
• HIV Infections 4,256

Keywords

• MSM
• HIV
• disclosure
• eHealth
• virtual reality

Study arms

• Experimental
  Tough Talks Online

  Participants will use Tough Talks Online

  Behavioral: Tough Talks Online

• Experimental
  Tough Talks Clinic

  Participants will use receive Tough Talks in a clinic

  Behavioral: Tough Talks Clinic

• Placebo comparator
  Standard of Care

  Participants will receive the standard of care (SOC).

  Behavioral: Standard of Care

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.

  Also known as: Tough Talks

• 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.

Primary outcomes

1. 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

Secondary outcomes

1. 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

2. 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

3. 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

4. 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

5. 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

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

7. 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

8. 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

9. 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

10. 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

Baseline characteristics

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 documents

• Protocol and statistical analysis plan · May 13, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — The investigators are not planning on making individual participant data available to other researchers.