Compared with their cisgender, heterosexual peers [1-8], sexual and gender minority youth (SGMY, aged 14-29 years) face increased risks to their well-being, including rejection by family [9], exclusion from society [10], depression [10,11], substance use [12], elevated suicidality [13,14], and harassment [15-19]. In the pilot study that informed this protocol, participants attributed the stress of their SGM status as a significant contributor to their risks [20]. Yet, there remains a dearth of research and services for SGMY [21]. Existent risks and the lack of targeted programs [21-25] exacerbate their risk for HIV infection [12,26]. In 2013, nearly 25% of the 2090 Canadians diagnosed with HIV were aged between 15 and 29 years, and 43% of those youth contracted HIV through same-sex exposure (compared with only 26% in 2004) [12,26,27].

There is a particular lack of research with female-identified SGMY, who report higher rates of HIV-related risk behaviors than their male-SGMY and non-SGMY peers [28-37]. These risks include sex with multiple partners [28,29], unprotected vaginal intercourse [30], injection drug use [31], and pregnancy [32,33]. SGMY risk factors are further increased in female-identified SGMY, as they have higher rates of mental health concerns compared with male-identified SGMY, including depressive symptoms and suicidality at younger ages, suggesting earlier onset of co-occurring concerns [34-36].

Thus, multiple factors such as depression [10], sexual health-risk behaviors [31], discrimination [16] and perceptions that HIV is not a threat [28-30] may interact to exacerbate SGMYs’ risk [3]. Female-identified SGMY—as well as transgender, gender diverse, and racialized SGMY—experience even greater vulnerabilities to mental health stressors, which in turn can exacerbate sexual health risk [38-40]. Holistic interventions that affirm SGMY identities and cultivate a sense of community, may mitigate these risks [41,42]. As nearly 70% of premature adult deaths are related to behaviors initiated in adolescence (eg, unsafe sex and substance abuse) [43], this age range is a critical period to implement interventions that help youth cope with the risks they experience.

Syndemics, minority stress, and community-based research theories provide insight toward SGMY intervention development. Syndemics theory highlights social inequities as root causes of synergistic interaction of 2 or more coexistent issues (eg, SGMY status and depression) or mutually reinforcing epidemics (eg, HIV) contributing to health disparities among marginalized populations [40,44-47]. Vulnerable individuals may encounter lifelong adversity, particularly from social marginalization and stigma [45], posing a greater risk for problems [44,46] that can lead to poorer sexual and health outcomes [47]. For SGMY, as the number of psychosocial health problems increases, the risk of major negative health outcomes also increases [47-49]. To comprehensively combat sexual health risks, overlapping vulnerabilities must be addressed concurrently [48,49].

Minority stress theory posits that marginalized populations experience a unique form of stress because of conflict between their identities and social expectations [50-53]. It partially explains why SGMY encounter disproportionate chronic stress, discrimination, and victimization [52], which subsequently increases likelihood of sexual risk taking, depressive anxiety, and substance abuse disorders [52,53]. An influential stressor, internalized homophobia (negative beliefs about one’s own SGMY status) [54], is related to unprotected sex [54,55] and increased depression [10]. Minority stress may increase internalized homophobia and stress-related cortisol production associated with heightened depression, anxiety, and suicidal ideation [50,54]. SGMY may not learn to cope with stressors through traditional means (eg, family or community support) [55-58], resulting in vulnerability to health and mental health threats [48] and increasing likelihood of engaging in risky behaviors [49]. As traditional approaches do not address many of the co-occurring stressors for SGMY, interventions that enhance coping skills are critical [59-82].

Building on a rich history of community engagement in HIV/AIDS service delivery, community-based research is critical to intervention development with SGMY, particularly in diverse communities [83-88]. Community-based approaches build on shared values, belief systems, and social practices, allowing for discussions of HIV and sexual health-risk behaviors in a culturally sensitive manner [84-87]. Youth interventions developed in partnership with community also have a much higher rate of agency adoption than those with only academic stakeholders [88]. It is increasingly recognized that future youth interventions must include nimble design and flexible delivery [89-91]. Community feasibility studies improve an intervention’s implementation potential while maintaining rigor in evaluation [92,93].

Cognitive behavioral therapy (CBT) suggests that people’s behaviors and emotions are influenced by their perceptions of life events [60-62] and how one interprets their situation will impact the way they feel or behave [63]. As an example, a person who is depressed may experience unhelpful interpretations or perceptions of themselves because of their problems and life events [61,62]. CBT interventions support clients by generating alternative ways of interpreting their problems and beliefs about themselves [59,63]. Generating alternative ways of thinking and beliefs may facilitate positive changes in one’s behaviors and emotional states [64].

CBT tailored to the experiences of SGMY may help improve mood and increase coping by teaching youth how to identify, challenge and change maladaptive thoughts, beliefs, and behaviors [59,66,67]. Continuing to practice CBT skills after each session (ie, via an action plan) further strengthens adaptive and affirming beliefs and behaviors. This process may lead to changing deeply ingrained problematic ways of thinking and behaving [65-67]. The process of identifying and challenging unhelpful beliefs about sexual and gender identities in an affirming and supportive environment may facilitate a decrease in internalized homo-, bi-, and transphobic cognitions and emotions and lead to improvement in mood and coping [67-69]. Ultimately, CBT within an affirmative therapeutic context can support SGMY in challenging maladaptive coping skills (eg, negative beliefs, isolation, substance misuse, and self-harm) and learning adaptive coping skills (eg, balanced thinking, enhancing social supports, and goal-setting) through education, modeling, practicing skills, and positive reinforcement [15,69]. 

CBT has been effective at treating depression and sexual health-risk behaviors among minority status adolescents [70-72] and lesbian, gay, bisexual, transgender, and queer (LGBTQ) adults [66,72]. However, its effectiveness for SGMY is largely unknown [69]. While the majority of studies do not assess long-term treatment gains, some evidence suggests that such interventions have mental and sexual health benefits for minority populations [79]. Longitudinal research is needed to determine the sustained effectiveness of CBT interventions on adolescent and young adult SGM populations [80]. A few existing studies show promise with sustained reductions in depression found at 12 months [76,77] and 18 months [78], as well as sexual risk of young men who have sex with men at 6 months [72]. Despite the calls for resilience and coping-based research and interventions for SGMY [80], scholarship has maintained a focus on negative health and psychosocial outcomes [81]. To date, no studies have identified the utility of a large-scale implementation of CBT tailored for community-based, diverse groups of SGMY and drawing on an affirmative approach. This study is designed to fill that gap.

This pragmatic trial is designed to evaluate AFFIRM, a manualized group intervention for SGMY, which follows the structure described in Textbox 1 and is described in more detail elsewhere [20].

This project is intended to scale-up implementation and delivery of AFFIRM, an 8-session manualized group coping skills intervention focused on reducing sexual risk behaviors and psychosocial distress among SGMY. This project aims to decrease sexual risk taking, depression, and internalized homophobia and increase levels of sexual self-efficacy and proactive coping among SGMY (ages 14-29 years). This project has the following research questions:

Given these research questions, the study has the following hypotheses:

AFFIRM participant data are exclusively collected using Web-based surveys, each of which takes approximately 20 min to complete. However, data collection takes place in 2 different settings: (1) via tablets (eg, Android tablets) while at the intervention locations (ie, some Web-based screenings, some pre- and posttests); and (2) independently Web-based (eg, some Web-based screenings, some pretests, or follow-ups). Secure collection of data is facilitated by the use of software with secure servers (Qualtrics). Instead of a unique identifier, which participants could forget over the course of the year, participants report their name, age, date of birth, 2 email addresses, gender identity, and sexual orientation at each time point.

All measures are completed at all time points, including demographics, as identities and circumstances are generally very flexible for SGMY because of their developmental stage, marginalized sexual and/or gender identities, and contextual circumstances. Measures include the following: (1) demographics (eg, age, sexual identity, gender identity, ethno-racial identity, and socioeconomic-status); (2) sexual health self-efficacy and capacity, including sexual health capacity [100] and abstinence and protection self-efficacies [101]; (3) mental health, including current mood [109], depression [102], and DSM-V cross-cutting symptoms [103]; (4) coping, including proactive coping [105] and coping strategies such as active coping, denial, and humor [106]; (5) stress appraisal, including perceiving stress as challenge or threat, and seeking out resources to overcome stress [104]; (6) hope, including agency and planning to meet goals [107]; (7) experiences with everyday discrimination [110]; (8) internalized homophobia [108]; (9) microaggressions, including interpersonal and environmental microaggressions [111]; (10) AFFIRM Satisfaction Survey, a 20-item questionnaire developed for AFFIRM completed after intervention delivery, which includes questions regarding (1) satisfaction, (2) overall experience, and (3) suggestions for improvement. For details of adaptation of existing survey measures, please see Table 1.

Table 2 shows the schedule of events. Participants complete a Web-based screening questionnaire, which includes their preferred site to participate in AFFIRM. For every 2 participants allocated to the intervention-only group, 1 participant is allocated to the wait-list group. The intervention-only group completes 4 data collection time points (pretest, posttest, 6-month follow-up, and 12-month follow-up). The wait-list group completes 5 data collection time points (prewait, pretest, posttest, 6-month follow-up, and 12-month follow-up). The prewait survey is completed immediately following their wait-listed control allocation, so that the pretest for the wait-list group serves as the follow-up on outcomes for the control group. Participants complete the pretests and posttests before the first week and at the last week of the intervention, respectively. The Web-based pretest is completed independently shortly before the first group session. The posttest is completed on tablets (eg, Android tablets) at the intervention location following the final group session. Participants complete the prewait (if applicable), the 6-month follow-up, and the 12-month Web-based independent follow-up. Participants are reminded to participate via email and provided the link to the survey. If participants do not participate following the initial email, up to 2 follow-up emails are sent as reminders for each time point. The follow-up emails are sent at 2 weeks and 4 weeks after the initial email (ie, every 2 weeks for 1 month). If participants indicated in their Web-based screening that SMS text message or phone call is their preferred form of communication, they also receive follow-up SMS text messages at 2 to 4 weeks after the initial email.

Approximately 300 participants will participate in AFFIRM. Each CCAS has agreed to complete a minimum of 1 AFFIRM iteration, comprising 1 intervention group and 1 wait-list group. This sample was primarily determined to assess the implementation-based outcomes. In addition, this sample would be sufficient for analysis of exploratory objectives, as described below.

Potential participants are recruited in multiple ways (1) via CCASs and other local community organizations (which are provided with flyers and cards directing potential participants to the independent Web-based screening); (2) via emails to local organizations and community groups serving SGMY (which are provided e-versions of the flyers and cards); and (3) Web-based postings on Facebook and Instagram. The Web-based postings involve geographically and demographically targeted paid boosts using Facebook’s Ad Manager.

Data are downloaded from Qualtrics, cleaned, and saved as password-protected files on an encrypted research drive. After data collection and cleaning for the entire study is completed, the data will then be deleted from Qualtrics servers. A data monitoring committee is not required at this stage, as the current phase is primarily focused on implementation acceptability in community sites; however, one will be formed before instigation of a larger trial.

As a psychosocial study, risks for adverse effects are negligible or nonexistent. The study’s distress plan, discussed above, will be used if participants present in crisis.

This study has been approved by the University of Toronto’s HIV/AIDS Research Ethics Board (protocol ID#35229). As an uncontrolled, nonrandomized trial, registration at this stage was not completed. If this implementation stage proves promising and the study proceeds to a full-scale multicenter trial, a new protocol will be registered and submitted for publication before participant enrollment.