NCT02929069

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable hiv

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2020

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 4, 2022

Completed
Last Updated

October 18, 2022

Status Verified

September 1, 2022

Enrollment Period

3.8 years

First QC Date

October 6, 2016

Results QC Date

November 4, 2021

Last Update Submit

September 23, 2022

Conditions

HIVAcquired Immunodeficiency Syndrome

Keywords

Minority Stress

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (51)

  • Minority Stress: GRRS

    Baseline

  • Minority Stress: GRRS

    4 Months

  • Minority Stress: GRRS

    8 Months

  • Minority Stress: GRRS

    12 Months

  • Minority Stress: IHS

    Baseline

  • +46 more secondary outcomes

Other Outcomes (6)

  • HIV Test

    Baseline

  • HIV Test

    12 Months

  • Gonorrhea Test

    Baseline

  • +3 more other outcomes

Study Arms (3)

ESTEEM

EXPERIMENTAL

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: ESTEEMBehavioral: VCT

Community Mental Health Treatment (CMHT)

ACTIVE COMPARATOR

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: CMHTBehavioral: VCT

Voluntary Counselling and Testing (VCT)

ACTIVE COMPARATOR

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

Interventions

ESTEEMBEHAVIORAL

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.

ESTEEM
CMHTBEHAVIORAL

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.

Community Mental Health Treatment (CMHT)
VCTBEHAVIORAL

Voluntary Counselling and Testing (VCT).

Community Mental Health Treatment (CMHT)ESTEEMVoluntary Counselling and Testing (VCT)

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

School of Public Health, Yale University

New Haven, Connecticut, 06520, United States

Location

Clinical Research Building, University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (2)

  • Keefe JR, Rodriguez-Seijas C, Jackson SD, Branstrom R, Harkness A, Safren SA, Hatzenbuehler ML, Pachankis JE. Moderators of LGBQ-affirmative cognitive behavioral therapy: ESTEEM is especially effective among Black and Latino sexual minority men. J Consult Clin Psychol. 2023 Mar;91(3):150-164. doi: 10.1037/ccp0000799. Epub 2023 Feb 13.

    PMID: 36780265DERIVED

  • 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.

    PMID: 31399071DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
John Pachankis, PhD
Organization
Yale University
john.pachankis@yale.edu
(203) 785-3710

Study Officials

  • John Pachankis, PhD

    MYSM School Of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2016

First Posted

October 10, 2016

Study Start

September 1, 2016

Primary Completion

June 16, 2020

Study Completion

June 16, 2020

Last Updated

October 18, 2022

Results First Posted

January 4, 2022

Record last verified: 2022-09

Locations

US(2)