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A Unified Intervention for Young Gay and Bisexual Men's Minority Stress, Mental Health, and HIV Risk

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ClinicalTrials.gov Identifier: NCT02929069
Recruitment Status : Recruiting
First Posted : October 10, 2016
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
The intent of the proposed randomized controlled trial is to test the efficacy of a principle-based, transdiagnostic cognitive behavioral therapy (CBT) intervention that addresses the pathways through which minority stress compromises young gay and bisexual men's (YGBM) co-occurring mental (e.g., depression), behavioral (e.g., substance use), and sexual (e.g., condomless anal sex) health problems.

Condition or disease Intervention/treatment Phase
HIV Acquired Immunodeficiency Syndrome Behavioral: ESTEEM Behavioral: CMHT Behavioral: VCT Not Applicable

Detailed Description:

ESTEEM (Effective Skills to Empower Effective Men) is a 10-session skills-building intervention designed to reduce young gay and bisexual men's (YGBM) co-occurring health risks by reducing the underlying cognitive, affective, and behavioral pathways through which minority stress impairs YGBM's health. ESTEEM is based on the Unified Protocol, a cognitive-behavioral therapy (CBT) approach with efficacy across mental health and risk behaviors. In an initial study to create ESTEEM , the Unified Protocol was adapted by conducting interviews with 21 YGBM-expert mental health providers and 20 depressed, anxious YGBM at high risk for HIV infection. In a preliminary trial (NCT02448186), ESTEEM significantly reduced YGBM's spectrum of interrelated health threats, making it the first evidence-based intervention to simultaneously improve mental health, substance use, and sexual health outcomes among YGBM.

Important questions remain in order to validate the efficacy and potential cost-effectiveness of ESTEEM. Accordingly, we propose a 3-arm RCT that would examine (1) whether ESTEEM (arm 1) demonstrates significant improvements compared to existing LGBT-affirmative community mental health treatment (CMHT; arm 2) or standard HIV/STD voluntary counseling and testing (VCT; arm 3) for high-risk depressed and anxious YGBM and (2) whether it improves outcomes through reducing hypothesized cognitive, affective, and behavioral minority stress processes.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Unified Intervention for Young Gay and Bisexual Men's Minority Stress, Mental Health, and HIV Risk
Study Start Date : September 2016
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ESTEEM
Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change.
Behavioral: ESTEEM
ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change.

Behavioral: VCT
Voluntary Counselling and Testing (VCT).

Active Comparator: Community Mental Health Treatment (CMHT)
Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.
Behavioral: CMHT
CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.

Behavioral: VCT
Voluntary Counselling and Testing (VCT).

Active Comparator: Voluntary Counselling and Testing (VCT)
Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM.
Behavioral: VCT
Voluntary Counselling and Testing (VCT).




Primary Outcome Measures :
  1. Incidence of condomless anal sex [ Time Frame: 8 Months ]
    Our primary outcome is incidence of condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months.


Secondary Outcome Measures :
  1. Minority Stress: GRRS [ Time Frame: Baseline ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS).

  2. Minority Stress: GRRS [ Time Frame: 4 Months ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS).

  3. Minority Stress: GRRS [ Time Frame: 8 Months ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS).

  4. Minority Stress: GRRS [ Time Frame: 12 Months ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS).

  5. Minority Stress: IHS [ Time Frame: Baseline ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS).

  6. Minority Stress: IHS [ Time Frame: 4 Months ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS).

  7. Minority Stress: IHS [ Time Frame: 8 Months ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS).

  8. Minority Stress: IHS [ Time Frame: 12 Months ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS).

  9. Minority Stress: SOCS [ Time Frame: Baseline ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS).

  10. Minority Stress: SOCS [ Time Frame: 4 Months ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS).

  11. Minority Stress: SOCS [ Time Frame: 8 Months ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS).

  12. Minority Stress: SOCS [ Time Frame: 12 Months ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS).

  13. Minority Stress: DERS [ Time Frame: Baseline ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS).

  14. Minority Stress: DERS [ Time Frame: 4 Months ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS).

  15. Minority Stress: DERS [ Time Frame: 8 Months ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS).

  16. Minority Stress: DERS [ Time Frame: 12 Months ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS).

  17. Minority Stress: Brooding [ Time Frame: Baseline ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale.

  18. Minority Stress: Brooding [ Time Frame: 4 Months ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale.

  19. Minority Stress: Brooding [ Time Frame: 8 Months ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale.

  20. Minority Stress: Brooding [ Time Frame: 12 Months ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale.

  21. Minority Stress: Rathus Assertiveness Schedule [ Time Frame: Baseline ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule.

  22. Minority Stress: Rathus Assertiveness Schedule [ Time Frame: 4 Months ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule.

  23. Minority Stress: Rathus Assertiveness Schedule [ Time Frame: 8 Months ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule.

  24. Minority Stress: Rathus Assertiveness Schedule [ Time Frame: 12 Months ]
    Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule.

  25. Incidence of condomless anal sex [ Time Frame: Baseline ]
    Incidence of of condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners will be measured using the Time-Line Follow-Back Interview (TLFB). TLFB will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months.

  26. Incidence of condomless anal sex [ Time Frame: 4 Months ]
    Incidence of of condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners will be measured using the Time-Line Follow-Back Interview (TLFB). TLFB will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months.

  27. Incidence of condomless anal sex [ Time Frame: 12 Months ]
    Incidence of of condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners will be measured using the Time-Line Follow-Back Interview (TLFB). TLFB will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months.

  28. Safer Sex Self-Efficacy [ Time Frame: Baseline ]
    HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 14-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research.

  29. Safer Sex Self-Efficacy [ Time Frame: 4 Months ]
    HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 14-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research.

  30. Safer Sex Self-Efficacy [ Time Frame: 8 Months ]
    HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 14-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research.

  31. Safer Sex Self-Efficacy [ Time Frame: 12 Months ]
    HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 14-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research.

  32. Decisional Balance [ Time Frame: Baseline ]
    HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use.

  33. Decisional Balance [ Time Frame: 4 Months ]
    HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use.

  34. Decisional Balance [ Time Frame: 8 Months ]
    HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use.

  35. Decisional Balance [ Time Frame: 12 Months ]
    HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use.

  36. Depression: HAM-D [ Time Frame: Baseline ]
    To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D).

  37. Depression: HAM-D [ Time Frame: 4 Months ]
    To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D).

  38. Depression: HAM-D [ Time Frame: 8 Months ]
    To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D).

  39. Depression: HAM-D [ Time Frame: 12 Months ]
    To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D).

  40. Depression: BSI [ Time Frame: Baseline ]
    To determine depression symptom severity, interviewers will complete the Brief Symptom Inventory (BSI).

  41. Depression: BSI [ Time Frame: 4 Months ]
    To determine depression symptom severity, interviewers will complete the Brief Symptom Inventory (BSI).

  42. Depression: BSI [ Time Frame: 8 Months ]
    To determine depression symptom severity, interviewers will complete the Brief Symptom Inventory (BSI).

  43. Depression: BSI [ Time Frame: 12 Months ]
    To determine depression symptom severity, interviewers will complete the Brief Symptom Inventory (BSI).

  44. Substance Use: SIP-AD [ Time Frame: Baseline ]
    To capture information around substance use, participants will complete the 10-item self-report Short Inventory of Problems-Alcohol and Drugs (SIP-AD). This instrument is designed to capture negative consequences of substance use across life domains (e.g., health, financial, social) .

  45. Substance Use: SIP-AD [ Time Frame: 8 Months ]
    To capture information around substance use, participants will complete the 10-item self-report Short Inventory of Problems-Alcohol and Drugs (SIP-AD). This instrument is designed to capture negative consequences of substance use across life domains (e.g., health, financial, social) .

  46. Substance Use: SIP-AD [ Time Frame: 12 Months ]
    To capture information around substance use, participants will complete the 10-item self-report Short Inventory of Problems-Alcohol and Drugs (SIP-AD). This instrument is designed to capture negative consequences of substance use across life domains (e.g., health, financial, social) .

  47. Incidence of Pre-Exposure Prophylaxis (PrEP) Use [ Time Frame: Baseline ]
    Participants will be asked if they had used PrEP in the last 3 months.

  48. Incidence of Pre-Exposure Prophylaxis (PrEP) Use [ Time Frame: 4 Months ]
    Participants will be asked if they had used PrEP in the last 3 months.

  49. Incidence of Pre-Exposure Prophylaxis (PrEP) Use [ Time Frame: 8 Months ]
    Participants will be asked if they had used PrEP in the last 3 months.

  50. Incidence of Pre-Exposure Prophylaxis (PrEP) Use [ Time Frame: 12 Months ]
    Participants will be asked if they had used PrEP in the last 3 months.


Other Outcome Measures:
  1. Incidence of HIV [ Time Frame: Baseline ]
    Orasure Rapid HIV-1/2 Antibody Test will be used to test participants for HIV at Baseline and 12 months.

  2. Incidence of HIV [ Time Frame: 12 Months ]
    Orasure Rapid HIV-1/2 Antibody Test will be used to test participants for HIV at Baseline and 12 months.

  3. Incidence of Gonorrhea [ Time Frame: Baseline ]
    Oral, rectal and urine samples will be collected to test participants for Gonorrhea at Baseline and 12 months.

  4. Incidence of Gonorrhea [ Time Frame: 12 Months ]
    Oral, rectal and urine samples will be collected to test participants for Gonorrhea at Baseline and 12 months.

  5. Incidence of Chlamydia [ Time Frame: Baseline ]
    Oral, rectal and urine samples will be collected to test participants for Chlamydia at Baseline and 12 months.

  6. Incidence of Chlamydia [ Time Frame: 12 Months ]
    Oral, rectal and urine samples will be collected to test participants for Chlamydia at Baseline and 12 months.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Identify as gay or bisexual.
  • HIV-negative status.
  • Diagnosis of any DSM depressive, anxiety, or trauma- and stressor-related disorder.
  • HIV sexual risk (≥1 act of condomless anal with a male partner of unknown status or HIV+ status, unless with HIV+ partner with known undetectable viral load).
  • Not currently taking PrEP.
  • NYC or Miami residential stability and planned availability for 12 months.
  • Provision of informed consent.

Exclusion Criteria:

  • Current suicidal or homicidal ideation.
  • Evidence of active psychosis or gross cognitive impairment.
  • Current enrollment in an intervention study.
  • HIV-positive status.

Information from the National Library of Medicine

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): NCT02929069


Contacts
Contact: Oluwaseyi Adeyinka, MPH (646) 344-4060 oluwaseyi.adeyinka@yale.edu

Locations
United States, Connecticut
School of Public Health, Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Oluwaseyi Adeyinka, MPH    646-344-4060    mailto:oluwaseyi.adeyinka@yale.edu   
Contact: Timothy J Sullivan, BA    (646) 344-4060    tj.sullivan@yale.edu   
Principal Investigator: John E Pachankis, PhD         
United States, Florida
Clinical Research Building, University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Ivan Ivardic, MS    305-243-3508    iivardic@miami.edu   
Contact: Jasper S Lee, BS    (305) 243-3508    jslee@miami.edu   
Principal Investigator: Steve A Safren, PhD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: John Pachankis, PhD MYSM School Of Medicine

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02929069     History of Changes
Other Study ID Numbers: 1509016430
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yale University:
Minority Stress

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases