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

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.

Study Overview

• Status: Completed
• Conditions: Acquired Immunodeficiency Syndrome; HIV
• Intervention / Treatment: Behavioral: ESTEEM; Behavioral: VCT; Behavioral: CMHT

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
• Enrollment (Actual): 254
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • School of Public Health, Yale University
  • Florida
    • Miami, Florida, United States, 33136
      • Clinical Research Building, University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• self-identification as a gay, bisexual or queer man;
• HIV-negative status confirmed through in-office testing;
• diagnosis of any DSM-5 depressive, anxiety, or trauma-/stress-related disorder;
• risk of HIV transmission through sexual activity (≥ 1 act of past-90-day-condomless anal sex involving a flesh penis with a partner with an unknown HIV status or an HIV-positive status, unless with an HIV-positive primary or main partner with known undetectable viral load or an HIV-negative primary or main partner who is known to be adherent to PrEP);
• not themselves currently adherent to PrEP (defined as taking PrEP on ≥ 4 days/week);
• NYC or Miami residential stability and planned availability for 12 months;
• English-language proficiency; and (9) provision of informed consent.

Exclusion Criteria:

• current active suicidality or homicidality (but not passive suicidality);
• evidence of active untreated mania, psychosis, or gross cognitive impairment;
• current enrollment in another intervention study;
• currently receiving 1 or more mental health treatment sessions/month or 8 or more CBT sessions within the past year;
• HIV-positive status (confirmed through in-office testing).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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: VCT; Voluntary Counselling and Testing (VCT).; 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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any Condomless Anal Sex Acts	Our primary outcome is the presence (yes/no) of any 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.	8 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minority Stress: GRRS	Assessments at baseline 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). Scores range from 1 to 36 where higher scores indicate higher stress.	Baseline
Minority Stress: GRRS	Assessments at 4 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). Scores range from 1 to 36 where higher scores indicate higher stress.	4 Months
Minority Stress: GRRS	Assessments at 8 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). Scores range from 1 to 36 where higher scores indicate higher stress.	8 Months
Minority Stress: GRRS	Assessments at 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). Scores range from 1 to 36 where higher scores indicate higher stress.	12 Months
Minority Stress: IHS	Assessments at baseline 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). The IHS has a range of 1 to 4 with higher scores indicating higher stress.	Baseline
Minority Stress: IHS	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). The IHS has a range of 1 to 4 with higher scores indicating higher stress.	4 Months
Minority Stress: IHS	Assessments at 8 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). The IHS has a range of 1 to 4 with higher scores indicating higher stress.	8 Months
Minority Stress: IHS	Assessments at 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). The IHS has a range of 1 to 4 with higher scores indicating higher stress.	12 Months
Minority Stress: SOCS	Assessments at baseline 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). The SOCS has a range of 1-4 with higher scores indicating higher concealment.	Baseline
Minority Stress: SOCS	Assessments at 4 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). The SOCS has a range of 1-4 with higher scores indicating higher concealment.	4 Months
Minority Stress: SOCS	Assessments at 8 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). The SOCS has a range of 1-4 with higher scores indicating higher concealment.	8 Months
Minority Stress: SOCS	Assessments at 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). The SOCS has a range of 1-4 with higher scores indicating higher concealment.	12 Months
Minority Stress: DERS	Assessments at baseline 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). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty.	Baseline
Minority Stress: DERS	Assessments at 4 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). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty.	4 Months
Minority Stress: DERS	Assessments at 8 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). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty.	8 Months
Minority Stress: DERS	Assessments at 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). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty.	12 Months
Minority Stress: Brooding	Assessments at baseline 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. This scale has a range of 5 to 20 with the higher score indicating greater severity.	Baseline
Minority Stress: Brooding	Assessments at 4 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. This scale has a range of 5 to 20 with the higher score indicating greater severity.	4 Months
Minority Stress: Brooding	Assessments at 8 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. This scale has a range of 5 to 20 with the higher score indicating greater severity.	8 Months
Minority Stress: Brooding	Assessments at 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. This scale has a range of 5 to 20 with the higher score indicating greater severity.	12 Months
Minority Stress: Rathus Assertiveness Schedule	Assessments at baseline 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. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness.	Baseline
Minority Stress: Rathus Assertiveness Schedule	Assessments at 4 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. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness.	4 Months
Minority Stress: Rathus Assertiveness Schedule	Assessments at 8 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. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness.	8 Months
Minority Stress: Rathus Assertiveness Schedule	Assessments at 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. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness.	12 Months
Any Condomless Anal Sex Acts	This measure presents the presence (yes/no) of any 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.	Baseline
Any Condomless Anal Sex Acts	This measure presents the presence (yes/no) of any 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.	4 Months
Any Condomless Anal Sex Acts	This measure presents the presence (yes/no) of any 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.	12 Months
Safer Sex Self-Efficacy	HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed.	Baseline
Safer Sex Self-Efficacy	HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed.	4 Months
Safer Sex Self-Efficacy	HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed.	8 Months
Safer Sex Self-Efficacy	HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed.	12 Months
Decisional Balance	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. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex.	Baseline
Decisional Balance	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. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex.	4 Months
Decisional Balance	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. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex.	8 Months
Decisional Balance	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. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex.	12 Months
Depression: HAM-D	To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression.	Baseline
Depression: HAM-D	To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression.	4 Months
Depression: HAM-D	To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression.	8 Months
Depression: HAM-D	To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression.	12 Months
Depression: BSI GSI	The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely).	Baseline
Depression: BSI GSI	The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely).	4 Months
Depression: BSI GSI	The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely).	8 Months
Depression: BSI GSI	The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely).	12 Months
Substance Use: SIP-AD	Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15.	Baseline
Substance Use: SIP-AD	Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15.	4 months
Substance Use: SIP-AD	Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15.	8 Months
Substance Use: SIP-AD	Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15.	12 Months
Any Pre-Exposure Prophylaxis (PrEP) Use	Participants will be asked if they had used PrEP in the last 3 months.	Baseline
Any Pre-Exposure Prophylaxis (PrEP) Use	Participants will be asked if they had used PrEP in the last 3 months.	4 Months
Any Pre-Exposure Prophylaxis (PrEP) Use	Participants will be asked if they had used PrEP in the last 3 months.	8 Months
Any Pre-Exposure Prophylaxis (PrEP) Use	Participants will be asked if they had used PrEP in the last 3 months.	12 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV Test	Orasure Rapid HIV-1/2 Antibody Test will be used to test participants for HIV at Baseline.	Baseline
HIV Test	Orasure Rapid HIV-1/2 Antibody Test will be used to test participants for HIV at 12 months.	12 Months
Gonorrhea Test	Oral, rectal and urine samples will be collected to test participants for Gonorrhea at Baseline.	Baseline
Gonorrhea Test	Oral, rectal and urine samples will be collected to test participants for Gonorrhea at 12 months.	12 Months
Chlamydia Test	Oral, rectal and urine samples will be collected to test participants for Chlamydia at Baseline.	Baseline
Chlamydia Test	Oral, rectal and urine samples will be collected to test participants for Chlamydia at 12 months.	12 Months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: John Pachankis, PhD, MYSM School Of Medicine

Publications and helpful links

General Publications

• Pachankis JE, McConocha EM, Reynolds JS, Winston R, Adeyinka O, Harkness A, Burton CL, Behari K, Sullivan TJ, Eldahan AI, Esserman DA, Hatzenbuehler ML, Safren SA. Project ESTEEM protocol: a randomized controlled trial of an LGBTQ-affirmative treatment for young adult sexual minority men's mental and sexual health. BMC Public Health. 2019 Aug 9;19(1):1086. doi: 10.1186/s12889-019-7346-4.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): June 16, 2020
• Study Completion (Actual): June 16, 2020

Study Registration Dates

• First Submitted: October 6, 2016
• First Submitted That Met QC Criteria: October 6, 2016
• First Posted (Estimate): October 10, 2016

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Minority Stress
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: 1509016430; 1R01MH109413-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided