跳至主要内容
临床试验/NCT06880705
NCT06880705招募中不适用

A Gender-Affirming Stigma Intervention to Improve Substance Misuse and HIV Risk Among Transgender Women

Illinois Institute of Technology2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2026年4月14日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
124
试验地点
2
主要终点
Gender Minority Stress and Resilience Scale Internalized Transphobia

研究概览

简要总结

This study is testing a new mutual-help group called "the TLC program" for transgender adults who use substances or are recently in recovery. The TLC Program is based on Acceptance and Commitment Therapy or "ACT" which is a type of mental health counseling that focuses on using mindfulness skills to connect a person to their values and improve their mental health. The TLC Program was developed by transgender and gender diverse community members, mental health providers, and researchers.

详细描述

Transgender (trans) populations are disproportionately impacted by HIV compared to the general population (nearly 1 in 7 trans women are living with HIV; 3.2% of trans men are living with HIV compared to 0.3% in the general U.S. population). Trans people also experience stigma rooted in systems of oppression. To prevent the forward transmission of HIV, public health officials emphasize the need for consistent condom use, regular HIV testing, and linkage to HIV prevention and care services. Stigma, however, interferes with trans individuals' ability to engage in HIV prevention and care due to its negative affects across multiple socioecological levels, including structural policies that constrain resources for trans people, negative community attitudes and prejudicial norms towards trans people, interpersonal discrimination towards trans people resulting in social isolation, and trans individual's psychological and behavioral responses to such stigma and stress. This makes stigma a social and structural determinant of health.

Stigma also plays a significant role in increasing risk for substance misuse among trans adults broadly. Rates of current illicit drug use, cannabis consumption, and/or nonmedical prescription drug use among trans adults are high relative to the U.S. general population (29% vs. 10%, respectively). Heavy alcohol use is also high, with 23% of trans adults consuming alcohol on 11 or more days in the past month Prior research with trans women suggests that unmet gender affirmation needs (i.e., the multitude of ways people receive recognition and support for their gender identity) may lead trans women to seek affirmation in traumatizing and unsafe contexts, such as sex work and sex under the influence of substances. Trans women are also at an increased risk of being targeted for violence, including sexual and physical assault, and substance use is associated with increased risks of victimization.

The Model of Gender Affirmation illustrates that lack of gender affirmation (i.e., the multitude of ways people receive recognition and support for their gender identity) contributes to psychological distress, substance misuse, and HIV risk among trans women. Evidence demonstrates that those who experience stigma report attempts to cope by avoiding or controlling distressing thoughts or feelings (e.g., substance use), which in turn produces greater psychological distress, and interferes with self-care behaviors. Specialized evidence-based interventions delivered in community-based organizations have the potential to reduce the negative effects of internalized stigma on behavioral health.

Acceptance and Commitment Therapy (ACT) is one of the few evidence-based approaches that targets stigma related to a variety of conditions, including substance use disorders and HIV. ACT is a transdiagnostic psychotherapeutic intervention that increases psychological flexibility through mindfulness, acceptance, and behavior change processes. ACT for stigma focuses on the fears, shame, and identification with a stigmatized group that pose a barrier to living a life consistent with one's values. ACT is a promising, but not yet evaluated, intervention to improve stigma among trans adults.

Guided by a community-engaged research approach, the investigators are testing an ACT-based, peer-led, gender affirming mutual-help group (called "the TLC Program") to reduce substance misuse and HIV risk among trans adults. The TLC Program was developed through a needs assessment of adaptations to ACT for integration into community-based organizations serving trans populations. Focus groups and interviews with transgender adults and stakeholders (e.g., organization staff, providers who serve trans clients) identified necessary adaptations. A proof-of-concept test of the TLC Program in an open pilot with (N = 16) trans adults who experienced at least one substance use problem in the past year informed final refinements to the intervention. The TLC Program is now being tested in a randomized controlled feasibility/acceptability trial compared to standard of care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible transgender adults must:
  • be 18 years of age or older;
  • speak primarily English;
  • live in the U.S.;
  • have a gender identity different from their assumed gender, or sex assigned, at birth;
  • identify as a person of transgender experience;
  • endorse having experienced two or more problem(s) related to alcohol or other drug use within the past 12 months.

排除标准

  • 未提供

研究组 & 干预措施

Treatment as Usual (TAU)

No Intervention

Participants randomized to the control condition will receive treatment-as-usual (TAU), following SAMHSA guidelines for risky alcohol and other drug use and CDC established standards of care for STD/HIV prevention counseling. Participants meeting criteria for risky alcohol, drug use, or sexual behavior will be provided 15-25 minutes of brief counseling including: 1) a discussion that the participants drinking or drug use is more than the recommended limits for safe consumption, and that staying below these limits is important for their health; 2) a discussion of HIV risk-reduction interventions (i.e., consistent condom use, PrEP, ART treatment as prevention); and 3) referral to treatment (i.e., regular screening for HIV/STDs, HIV care, and/or substance use treatment).

The TLC Program

Experimental

Participants randomized to the TLC Program will receive TAU plus the telehealth, peer-delivered group intervention, "the TLC Program."

干预措施: The TLC Program (Behavioral)

结局指标

主要结局

Gender Minority Stress and Resilience Scale Internalized Transphobia

时间窗: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)

Minimum value = 0, Maximum value = 1, Higher score = worse outcome

Health Care Empowerment Inventory

时间窗: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)

Minimum value = 1, Maximum value = 5, Higher score = better outcome

Patient-Reported Outcomes Measurement Information System (PROMIS)

时间窗: Reported weekly, as well as at baseline assessment, post assessment (12 weeks), and follow-up assessment (24 weeks)

Measuring psychological distress (depression and anxiety), Minimum value = 1 (per subscale), Maximum value = 5 (per subscale), Higher score = worse outcome

Psychological Flexibility, Multidimensional Psychological Flexibility Inventory (MPFI)

时间窗: Reported at baseline assessment

Minimum value = 1 (per subscale), Maximum value = 6 (per subscale), Higher score = worse outcome

The Acceptability of Intervention Measure (AIM)

时间窗: Reported at post-assessment (12 weeks)

Minimum value = 1, Maximum value = 5, Higher score = better outcome

Intervention Appropriateness Measure

时间窗: Reported at post-assessment (12 weeks)

Minimum value = 1, Maximum value = 5, Higher score = better outcome

Feasibility of Intervention Measure (FIM)

时间窗: Reported at post-assessment (12 weeks)

Minimum value = 1, Maximum value = 5, Higher score = better outcome

次要结局

  • Substance Use Timeline Followback Interview(Over the past 30 days)
  • HIV Risk Questionnaire(Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arryn Guy

Assistant Professor of Psychology

Illinois Institute of Technology

研究点 (2)

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