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Clinical Trial NCT06724965 for PrEP Uptake Experiences, PrEP Adherence Experiences, Mental Health Symptoms is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Trans STAIR: Implementing an Evidence Based Trauma Treatment With Community Led PrEP Navigation 90 Randomized Hybrid Study
Clinical Trial NCT06724965 is an interventional study for PrEP Uptake Experiences, PrEP Adherence Experiences, Mental Health Symptoms and is currently not yet recruiting. Enrollment is planned to begin on February 1, 2026 and continue until the study accrues 90 participants. Led by San Diego State University, this study is expected to complete by December 1, 2026. The latest data from ClinicalTrials.gov was last updated on September 15, 2025.
Brief Summary
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 ...Show More
Detailed Description
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...Show More
Official Title
Trans STAIR: Implementing an Evidence Based Trauma Treatment With Community Led PrEP Navigation for Transgender and Nonbinary Persons Affected by Violence
Conditions
PrEP Uptake ExperiencesPrEP Adherence ExperiencesMental Health SymptomsOther Study IDs
- HS-2024-0209
- R34MH138228 (U.S. NIH Grant/Contract)
NCT ID Number
Start Date (Actual)
2026-02
Last Update Posted
2025-09-15
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
90
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
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
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPrEP 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...Show More | 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...Show More 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) |
Active ComparatorPrEP 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) |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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...
Study Central Contact
Contact: Erik D Storholm, PhD, 8056806480, [email protected]
Contact: Benji Jensen, MS, [email protected]
1 Study Locations in 1 Countries
California
Los Angeles LGBT Center, Los Angeles, California, 90028, United States