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临床试验 NCT06724965 针对PrEP Uptake Experiences,PrEP Adherence Experiences,Mental Health Symptoms目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情,或在此提出任何问题。 | ||
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Trans STAIR: Implementing an Evidence Based Trauma Treatment With Community Led PrEP Navigation 90 随机化 混合模式
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临床试验NCT06724965是一项针对PrEP Uptake Experiences,PrEP Adherence Experiences,Mental Health Symptoms的干预性研究试验,当前状态为尚未招募。试验尚未开始,计划于2026年2月1日开始,预计招募90名患者。该研究由圣地亚哥州立大学主导,计划于2026年12月1日完成。试验数据来源于ClinicalTrials.gov,最后更新时间为2025年9月15日。
简要概括
This pilot trial will leverage "PrEP Well," an ongoing multi-level implementation strategy for providing PrEP in transgender/gender diverse (TGD)-serving contexts by integrating peer-led PrEP navigation with programming that addresses other social and structural needs of the TGD community (e.g., housing, legal, employment, gender-affirmation, primary care). PrEP Well has been implemented at the Trans Wellness Center ...显示更多
详细描述
In Phase 1, together with community and implementation partners, the investigators will adapt evidence-based STAIR into a trans-affirming, culturally appropriate trauma treatment for TGD persons affected by HIV and violence (Trans STAIR), making suggested changes and reaching consensus at each step among the team. The investigators will then evaluate the acceptability, appropriateness, and feasibility of the Trans ST...显示更多
官方标题
Trans STAIR: Implementing an Evidence Based Trauma Treatment With Community Led PrEP Navigation for Transgender and Nonbinary Persons Affected by Violence
疾病
PrEP Uptake ExperiencesPrEP Adherence ExperiencesMental Health Symptoms其他研究标识符
- HS-2024-0209
- R34MH138228 (美国 NIH 拨款/合同)
NCT编号
实际开始日期
2026-02
最近更新发布
2025-09-15
预计完成日期
2026-12
计划入组人数
90
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
PrEP
HIV prevention
Trauma
Mental Health
PrEP adherence
PrEP uptake
STAIR
Skills Training in Affect and Interpersonal Regulation
Trauma Treatment
HIV prevention
Trauma
Mental Health
PrEP adherence
PrEP uptake
STAIR
Skills Training in Affect and Interpersonal Regulation
Trauma Treatment
主要目的
预防
分配方式
随机
干预模型
平行
盲法
无(开放性试验)
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性PrEP Well + Trans STAIR Participants assigned to this condition will be enrolled in 3 sessions of PrEP Well + 8 sessions of Trans STAIR over 90 days. PrEP Well is a multi-level implementation strategy for providing PrEP in TGD-serving contexts by integrating peer-led PrEP navigation with programming that addresses other social and structural needs of the TGD community (e.g., housing, legal, employment, gender-affirmation, primary care). Tra...显示更多 | Trans STAIR Skills Training in Affect and Interpersonal Regulation (STAIR) is a transdiagnostic evidenced-based mental health treatment for individuals who have experienced multiple traumas. STAIR is based in cognitive-behavioral principles and delivered in a flexible manner over 8 group sessions, with demonstrated efficacy for the treatment of PTSD and other mental health symptoms. This trial will adapt and pilot test the STAIR...显示更多 PrEP Well This pilot trial will leverage "PrEP Well," a multi-level implementation strategy for providing PrEP in TGD-serving contexts by integrating peer-led PrEP navigation with programming that addresses other social and structural needs of the TGD community (e.g., housing, legal, employment, gender-affirmation, primary care) |
阳性对照PrEP Well Participants assigned to this condition will be enrolled in 3 sessions of PrEP Well over 90 days, PrEP Well is a multi-level implementation strategy for providing PrEP in TGD-serving contexts by integrating peer-led PrEP navigation with programming that addresses other social and structural needs of the TGD community (e.g., housing, legal, employment, gender-affirmation, primary care). | PrEP Well This pilot trial will leverage "PrEP Well," a multi-level implementation strategy for providing PrEP in TGD-serving contexts by integrating peer-led PrEP navigation with programming that addresses other social and structural needs of the TGD community (e.g., housing, legal, employment, gender-affirmation, primary care) |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
PrEP Uptake | PrEP uptake measured via SureQuick test, a rapid point-of-care diagnostic assay used to detect the presence of tenofovir diphosphate (TFV-DP) in urine. | Collected at 30-day and at 90-day visits. |
PrEP Adherence | PrEP Adherence will be assessed via Dried Blood Spot (DBS) test, a laboratory method used for the quantitative assessment of long-term levels of Tenofovir Diphosphate (TFV-DP) in the blood, helping to monitor and confirm adherence PrEP medications such as Descovy® or Truvada®. DBS levels consistent with 4 or more average doses/week were considered adherent. | Collected at 90-day follow up visit |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Depressive symptoms (PHQ-9) | The PHQ-9 (Patient Health Questionnaire-9) is a self-administered screening tool designed to assess the presence and severity of depressive symptoms in individuals. It consists of nine questions that align with the diagnostic criteria for major depressive disorder, asking respondents about their feelings and behaviors over the previous two weeks. Each question is scored on a scale from 0 (not at all) to 3 (nearly every day), resulting in a total score that can range from 0 to 27. Higher scores indicate greater severity of depression, making the PHQ-9 a valuable measure for both clinical assessments and research studies aimed at evaluating treatment outcomes and mental health interventions. | Baseline, 30-day, and 90-day visits |
Anxiety symptoms (GAD-7) | The GAD-7 (Generalized Anxiety Disorder-7) is a widely recognized self-report questionnaire used to assess the severity of generalized anxiety disorder and other anxiety-related conditions. Comprising seven questions, the GAD-7 prompts respondents to evaluate how often they have experienced specific anxiety symptoms over the past two weeks, using a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms. This measure is frequently employed in both clinical and research settings to help identify individuals experiencing significant anxiety and to monitor changes in symptoms over time, facilitating effective treatment and intervention strategies. | Baseline, 30-day, and 90-day visits |
PTSD symptoms (PC-PTSD-5) | The PC-PTSD-5 (Primary Care Post-Traumatic Stress Disorder Screen for DSM-5) is a brief, validated screening tool designed to identify individuals at risk for post-traumatic stress disorder (PTSD) based on the diagnostic criteria specified in the DSM-5. It consists of five questions that focus on the presence of key PTSD symptoms, including intrusive thoughts, avoidance behaviors, negative changes in mood and cognition, and hyperarousal, experienced in the context of a traumatic event. Respondents answer each question with one of two options: "Yes" or "No," allowing for a quick assessment of PTSD risk. The PC-PTSD-5 is particularly useful in primary care and other clinical settings for early detection and referral for further evaluation and treatment of PTSD while being user-friendly for both patients and healthcare providers. | Baseline, 30-day, and 90-day visits |
DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure--Adult | The DSM-5 Cross-Cutting Symptoms Measurement is a comprehensive assessment tool designed to evaluate a range of mental health symptoms that may be present across various psychiatric disorders. This assessment includes 23 symptom domains, such as anxiety, depression, psychosis, and somatic symptoms, allowing clinicians to identify and assess the severity of symptoms that might not fit neatly into specific diagnostic categories. Each item on the measure is rated on a 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearBy capturing cross-cutting symptoms, this tool promotes a more holistic understanding of an individual's mental health and can facilitate better treatment planning and intervention strategies. It is particularly useful in clinical settings where comorbidity is common, as it aids in identifying overlapping symptoms that may impact overall functioning and well-being. | Baseline, 30-day, and 90-day visits |
Inventory of Interpersonal Problems (IIP-32) | The Inventory of Interpersonal Problems (IIP) is a 32-item psychological assessment tool designed to evaluate interpersonal difficulties and their impact on an individual's relationships and social functioning. The IIP consists of a series of items that assess different dimensions of interpersonal problems, such as assertiveness, reliance on others, and ability to communicate effectively. Respondents indicate the degree to which they experience difficulties in various social situations, helping to identify patterns of interpersonal behavior that may contribute to distress or dysfunction. Scores range from 0-128 with higher scores corresponding with greater interpersonal levels of dysfunction. This inventory is useful in both clinical and research settings, providing insights that can guide therapeutic interventions and enhance understanding of the relational challenges individuals face, ultimately fostering improved interpersonal dynamics and personal growth. | Baseline, 30-day, and 90-day visits |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- identify as transgender or nonbinary (non-cisgender)
- be age 18 or older
- confirmed HIV-negative status
- eligible for PrEP based on CDC guidelines
- indication of clinically significant PTSD or depressive symptoms
- ability to speak and read in English and/or Spanish
- under 18 years old
- cognitively impaired to the extent that it limits ability to consent
- currently in a relationship or home where violence is occurring
- 🏥Los Ange...
研究中心联系人
联系人: Erik D Storholm, PhD, 8056806480, [email protected]
联系人: Benji Jensen, MS, [email protected]
1 位于 1 个国家/地区的研究中心
California
Los Angeles LGBT Center, Los Angeles, California, 90028, United States