HIV risk is predicted by low self-worth, unassertiveness, and impulsivity [ 12 , 27 , 44 ]. These cognitive, affective, and behavioral pathways, in turn, mediate the relationship between minority stress and mental health and HIV risk and represent promising treatment targets [ 39 , 40 ].
The model guiding our intervention Fig. For example, chronic exposure to the types of stressors that young gay and bisexual men disproportionately face from an early age disrupts neurobiological stress pathways and yields rejection schemas, emotion dysregulation, unassertiveness, and impulsivity [ 48 ]. Some interventions promote condom use [ 49 ], some encourage PrEP initiation and maintenance [ 50 , 51 ], and others reduce substance use [ 52 ]. These treatments show moderate efficacy [ 53 ].
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None currently seeks to reduce mental health problems e. A unified, transdiagnostic approach that addresses the pathways that unite these conditions may increase effectiveness, reduce cost, and provide a streamlined treatment experience for the most vulnerable young gay and bisexual men, who are unlikely to seek multiple treatments for multiple health concerns. Outcomes across conditions will be primarily compared at the 8-month follow-up given that these cognitive, affective, and behavioral changes take time to take root; longitudinal modeling will examine change across all time points i.
The second objective of this study is to determine whether ESTEEM works through its hypothesized cognitive, affective, and behavioral minority stress processes. Follow-up assessments at 4-, 8-, and months will allow us to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. We are using active and passive recruitment strategies. Passive approaches involve advertising on young gay and bisexual men-oriented mobile apps and websites e.
As part of passive recruitment, we also contact participants from previous research studies who consented to be contacted for future studies. Intervention participants are excluded for any of the following: 1 current active suicidality or homicidality defined as active intent or concrete plan, as opposed to passive suicidal ideation ; 2 evidence of active untreated mania, psychosis, or gross cognitive impairment; 3 current enrollment in an intervention study; 4 current enrollment in intensive mental health treatment receiving treatment more than once per month or 8 or more sessions of cognitive-behavioral therapy CBT within the past year ; or 5 HIV-positive status.
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ESTEEM is a session intervention based on the Unified Protocol [ 54 ], an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders e. The Unified Protocol employs modules for motivation enhancement, interoceptive and situational exposure, cognitive restructuring, mindfulness, and self-monitoring techniques.
For example, modules were adapted to help young gay and bisexual men identify minority stress experiences; track unhealthy reactions to minority stress, focusing on avoidance reactions, like substance use and condomless anal sex; attribute distress to minority stress rather than to personal failure; and assert themselves against unjust minority stress in safe situations.
Adaptations were infused throughout the Unified Protocol Therapist Workbook [ 57 ]; this adaptation served as the therapist manual. If participants miss sessions or need to reschedule, we will make every effort to reschedule sessions such that participants stay as close to a one session per week schedule. If participants miss a week, they may be rescheduled to do two sessions in 1 week, but they will be told the goal is once per week.
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All sessions must be completed within 4 months. However, the efficacy of LGBTQ-affirmative psychotherapy has never been tested [ 59 ], despite several promising case studies [ 60 , 61 , 62 ]. We refer young gay and bisexual men to community clinicians who provide this standard of care. If participants miss sessions or need to reschedule, we make every effort to reschedule sessions such that participants stay as close to a one session per week schedule.
If participants miss a week, they may be rescheduled to do two sessions in 1 week, but they are told the goal is once per week. Participants randomized to the VCT-only arm do not receive any further intervention. Misconceptions are clarified. A personalized risk-reduction plan is created that includes specific, achievable goals the participant can implement to reduce risk [ 65 ].
These goals are written on the risk-reduction plan handout. Participants who receive a preliminary positive HIV test result are referred to their current medical provider or nearby community health centers for confirmatory testing and appropriate care.
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Urine, oral, and rectal samples are sent to a lab Quest Diagnostics for testing. We notify participants who screen positive for chlamydia or gonorrhea immediately upon receiving the lab results and refer them to a nearby community health center or their own medical provider for treatment. TLFB interviewers will be masked to study arm. We assess the minority stress pathways proposed to underlie our intervention Fig. Also, both therapists and participants complete short surveys after each therapy session at the appointment site regarding perceptions of treatment; ESTEEM participants complete a short comprehension quiz to assess engagement.
We used these estimates to inform our 8-month endpoint. Sample size calculations were carried out using PASS 12 for logistic regression. For secondary outcomes e. VCT-only, respectively, at a type I error rate of 0. These effect sizes are smaller than those found in the pilot. We will use a fixed sequence procedure to control for multiple testing of the primary comparisons: reduction in condomless anal sex in ESTEEM vs. Secondary outcomes of interest include: the absence of a mental health diagnosis and reduction in mental health illness severity e.
If the assumption of normality is violated, we will explore data transformation. To control the false discovery rate, we will use the Benjamini and Hochberg method [ 86 ]. In our mediation analyses, we will examine whether changes in the proposed mediators e. Using M plus v7. The study participants are at minimal risk for harm as a result of participation in the proposed research study. Although unlikely, one risk of the proposed study is that participants will experience emotional discomfort while completing the quantitative assessments or the intervention.
While every possible step will be taken to minimize such risk, consent documentation will make it clear that if participants have any concerns about any aspect of the study they may refuse to continue with the study at any time, without penalty.
In addition, we will remind participants during the course of their assessments that they can refuse to answer any questions and may discontinue participation at any time. This training will address the appropriate handling of imminent threats and provision of referrals to free counseling services in less imminent clinical situations.
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We have developed a protocol for immediately referring participants who learn, as a result of our study, that they are HIV-positive or infected with chlamydia or gonorrhea to a local LGBTQ-affirmative HIV care clinic. The primary potential risk to participants is breach of confidentiality. Breaches of confidentiality will occur if a participant reports a clear intention to harm himself or another person. Additionally, health care professionals are required by state law to report suspected cases of abuse or neglect. The likelihood that any additional breaches of confidentiality would occur is minimal, as steps will be taken to guard against this risk.
This information will not be stored with any other data and no other identifying information will appear on any form. All contact with participants will be made by counselors and research staff under explicit guidelines to preserve confidentiality when telephoning, emailing, or mailing information to participants.
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Participants will provide the respective site, Yale or Miami, with alternative contact information email, phone numbers, and mailing address for compensation and study retention purposes. Given the public health importance addressed by this study and the potential benefit of the information to be gained, we believe that the risk to subjects is reasonable. Sexual-risk behavior among young gay and bisexual men is a clear public health concern.
As all participants in the present study will be exposed to information about HIV-transmission risks, we anticipate that participants will acquire knowledge and skills and will receive support needed to improve their capacity for managing HIV risk. Benefits to society in general are anticipated through the dissemination of intervention findings and community trainings in the ESTEEM treatment approach, if it is found to be efficacious.
Results will better inform local and national public health agencies about potentially effective outreach and prevention strategies that can be delivered to young gay and bisexual men who experience lifetime stress-sensitive mental health disorders, such as depression and anxiety, and HIV-risk behavior. In sum, the potential benefits outweigh the potential risks to subjects. The principal investigator will be responsible for monitoring the data and assuring protocol compliance.
The principal investigator will apprise fellow investigators and study personnel of all unanticipated problems and adverse events that occur during the conduct of this research project e. Young gay and bisexual men represent the largest group of individuals infected with HIV in the U. By addressing key sources of HIV risk among gay and bisexual men, including stigma-related stress and associated mental health and substance use difficulties, the intervention developed in this project has the potential to reduce HIV-risk behavior among young gay and bisexual men and therefore the spread of HIV.
To date, no randomized controlled trial has been conducted to determine the efficacy of mental health treatment for young gay and bisexual men, let alone the efficacy of a mental health treatment also capable of reducing behavioral risks such as substance use, condomless anal sex, and lack of PrEP initiation. Because of its transdiagnostic nature, ESTEEM could eliminate the need for numerous provider trainings and stand-alone treatments for separate problems.
The RDoC provides a comprehensive list of mechanisms that cut across psychosocial problems in the general population to spur a more focused, efficient search for transdiagnostic treatment targets. The RDoC mechanisms parallel the pathways in our model Fig. However, dissemination and implementation of such treatments has not been ideal. Suicidality and depression disparities between sexual minority and heterosexual youth: a meta-analytic review. Sexual orientation and adolescent substance use: a meta-analysis and methodological review.
A longitudinal investigation of Syndemic conditions among young gay, bisexual, and other MSM: the P18 cohort study. AIDS Behav. A syndemic of psychosocial health disparities and associations with risk for attempting suicide among young sexual minority men. Am J Public Health. Centers for Disease Control and Prevention. HIV among gay and bisexual men; Accessed 27 July HIV surveillance in adolescents and young adults.