PrEP Uptake ExperiencesNCT06724965
Trans STAIR: Implementing an Evidence Based Trauma Treatment With Community Led PrEP Navigation
A study testing Trans STAIR and PrEP Well in people with PrEP Uptake Experiences and PrEP Adherence Experiences, run by San Diego State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PrEP Uptake Experiences, PrEP Adherence Experiences, Mental Health Symptoms
- What is being tested?
- Trans STAIR and PrEP Well
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2026to 21 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Benji Jensen, MS contact
United States1 site, 1 recruiting
- Recruiting
Los Angeles LGBT Center
Los Angeles, California, 90028
Risa Flynn, 323-993-7500, rflynn@lalgbtcenter.org
About this study
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 (TWC) in LA since 2021. TWC is a first-of-its-kind community-led, trans-affirming, TGD community center made up of 5 community-based TGD service organizations that serve the local racially and ethnically diverse TGD community. Together with our community and implementation partners this NIMH-funded R34 will adapt evidence-based Skills Training in Affect and Interpersonal Regulation (STAIR) into a trans-affirming, culturally appropriate trauma treatment for TGD persons affected by HIV and violence (Trans STAIR); evaluate the acceptability, appropriateness, and feasibility of the Trans STAIR intervention (Phase 1 beta test; Aim 1); and conduct a Type 1: Hybrid Effectiveness-Implementation pilot randomized controlled trail (Phase 2 pilot RCT; Aims 2 and 3) of PrEP Well + Trans STAIR vs. PrEP Well alone to provide preliminary support for a fully powered larger multisite R01 to test the efficacy of PrEP Well + Trans STAIR.
Read the 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 STAIR intervention by running a preliminary test of Trans STAIR with 20 PrEP Well participants with demonstrated suboptimal PrEP adherence. The investigators will then conduct and analyze interviews with participants and staff to obtain feedback and work with our community and implementation partners to make suggested changes until the investigators reach consensus again among the team. The investigators will then conduct interviews with key leaders, administrators, and TWC staff to assess the perceived barriers to integration of Trans STAIR into the PrEP Well implementation strategy. The investigators will then select implementation strategies that will address the identified barriers. In Phase 2, the investigators will conduct a Type 1, hybrid effectiveness-implementation pilot RCT of 70 participants randomized to receive PrEP Well + Trans STAIR vs. PrEP Well alone. The overarching goals of the pilot RCT are twofold: 1) establish the feasibility, acceptability, adoptability; preliminary effects; and cost and sustainability, and potential scalability of the PrEP Well + Trans STAIR implementation intervention; and 2) estimate the non-response rates after second-stage randomization. The aims follow the phases of the EPIS (Exploration Preparation Implementation Sustainment) framework integrated with the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to assess outcomes. The investigators will systematically collect important data on factors relevant to implementation during the pilot RCT, including cost data (e.g., program budgets, interview questions leadership staff) on the resources necessary to successfully deliver the PrEP Well + Trans STAIR interventions. Consistent with a Hybrid Type I design, the investigators will leverage mixed methods data from the pilot RCT in key informant interviews with 30 participants and 10 key stakeholders/staff to document the perceptions of providers regarding implementation of PrEP Well + Trans STAIR in real-world clinical settings will set the stage for a planned multisite fully powered hybrid RCT.
- Being tested
- Trans STAIR, PrEP Well
- Keywords
- PrEP, HIV prevention, Trauma, Mental Health, PrEP adherence, PrEP uptake, STAIR, Skills Training in Affect and Interpersonal Regulation, Trauma Treatment
- Medical subject headings
- Wounds and Injuries, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans STAIRBehavioural
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 intervention to be culturally appropriate and acceptable for TGD persons, adding content related to TGD health and wellness, coping with minority stress, responding to stigma and microaggressions, social support, and community connectedness, self-compassion, celebrating trans joy, trans advocacy, sexual health and PrEP use.
PrEP WellBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| PrEP Well + Trans STAIR | Experimental | 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). Trans STAIR (Experimental Treatment) Skills Training in Affect and Interpersonal Regulation (STAIR) adapted for TGD is 8-session, group delivery of transdiagnostic evidenced-based treatment for individuals who have experienced multiple traumas. STAIR is based in cognitive-behavioral principles and delivered in a flexible manner, with demonstrated efficacy for the treatment of PTSD, depression and other mental health symptoms known to be associated with poor medication adherence. Receives: Behavioral: Trans STAIR; Behavioral: PrEP Well |
| PrEP Well | Active comparator | 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). Receives: Behavioral: PrEP Well |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Collected at 90-day follow up visit
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 30-day, and 90-day visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start17 Jul 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion21 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrEP Uptake ExperiencesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- Los Angeles LGBT Center, RAND, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Erik Storholm, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724965
- Sponsor's protocol ID
- HS-2024-0209
- Other IDs
- R34MH138228
- Status last verified
- Sep 2026
- First submitted
- 6 Dec 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NIMH requires data that involve human subjects to be shared using the NDA. Quantitative data from this pilot trial will be preserved to enable sharing via NDA data of sufficient quality to validate and replicate research findings described in the DSMP. All data collected from the randomized pilot intervention trial with 70 adult participants will be shared. De-identified survey and biomedical data will be stored within the NDA secure database. A linking file with an anonymized linking variable will also be stored if multiple datasets are required. In addition, interview protocols, codebooks, deidentified coded text, and summary findings collected from TGD participants, trans community center staff, intervention providers, and leadership will be stored in the NDA database as well.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans STAIR: Implementing an Evidence Based Trauma Treatment With Community Led PrEP Navigation
- ClinicalTrials.gov ID
- NCT06724965
- Acronym / sponsor ID
- HS-2024-0209
- Keywords
- PrEP, HIV prevention, Trauma, Mental Health, PrEP adherence, PrEP uptake, STAIR, Skills Training in Affect and Interpersonal Regulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- Los Angeles LGBT Center, RAND, National Institute of Mental Health (NIMH)
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 21 Aug 2027 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (TWC) in LA since 2021. TWC is a first-of-its-kind community-led, trans-affirming, TGD community center made up of 5 community-based TGD service organizations that serve the local racially and ethnically diverse TGD community. Together with our community and implementation partners this NIMH-funded R34 will adapt evidence-based Skills Training in Affect and Interpersonal Regulation (STAIR) into a trans-affirming, culturally appropriate trauma treatment for TGD persons affected by HIV and violence (Trans STAIR); evaluate the acceptability, appropriateness, and feasibility of the Trans STAIR intervention (Phase 1 beta test; Aim 1); and conduct a Type 1: Hybrid Effectiveness-Implementation pilot randomized controlled trail (Phase 2 pilot RCT; Aims 2 and 3) of PrEP Well + Trans STAIR vs. PrEP Well alone to provide preliminary support for a fully powered larger multisite R01 to test the efficacy of PrEP Well + Trans STAIR.
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 STAIR intervention by running a preliminary test of Trans STAIR with 20 PrEP Well participants with demonstrated suboptimal PrEP adherence. The investigators will then conduct and analyze interviews with participants and staff to obtain feedback and work with our community and implementation partners to make suggested changes until the investigators reach consensus again among the team. The investigators will then conduct interviews with key leaders, administrators, and TWC staff to assess the perceived barriers to integration of Trans STAIR into the PrEP Well implementation strategy. The investigators will then select implementation strategies that will address the identified barriers. In Phase 2, the investigators will conduct a Type 1, hybrid effectiveness-implementation pilot RCT of 70 participants randomized to receive PrEP Well + Trans STAIR vs. PrEP Well alone. The overarching goals of the pilot RCT are twofold: 1) establish the feasibility, acceptability, adoptability; preliminary effects; and cost and sustainability, and potential scalability of the PrEP Well + Trans STAIR implementation intervention; and 2) estimate the non-response rates after second-stage randomization. The aims follow the phases of the EPIS (Exploration Preparation Implementation Sustainment) framework integrated with the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to assess outcomes. The investigators will systematically collect important data on factors relevant to implementation during the pilot RCT, including cost data (e.g., program budgets, interview questions leadership staff) on the resources necessary to successfully deliver the PrEP Well + Trans STAIR interventions. Consistent with a Hybrid Type I design, the investigators will leverage mixed methods data from the pilot RCT in key informant interviews with 30 participants and 10 key stakeholders/staff to document the perceptions of providers regarding implementation of PrEP Well + Trans STAIR in real-world clinical settings will set the stage for a planned multisite fully powered hybrid RCT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrEP Well + Trans STAIR | Experimental | Behavioral: Trans STAIR, Behavioral: PrEP WellParticipants 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). Trans STAIR (Experimental Treatment) Skills Training in Affect and Interpersonal Regulation (STAIR) adapted for TGD is 8-session, group delivery of transdiagnostic evidenced-based treatment for individuals who have experienced multiple traumas. STAIR is based in cognitive-behavioral principles and delivered in a flexible manner, with demonstrated efficacy for the treatment of PTSD, depression and other mental health symptoms known to be associated with poor medication adherence. |
| PrEP Well | Active comparator | Behavioral: PrEP WellParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans STAIRSkills 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 intervention to be culturally appropriate and acceptable for TGD persons, adding content related to TGD health and wellness, coping with minority stress, responding to stigma and microaggressions, social support, and community connectedness, self-compassion, celebrating trans joy, trans advocacy, sexual health and PrEP use. | Behavioural | PrEP Well + Trans STAIR |
| PrEP WellThis 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) | Behavioural | PrEP Well, PrEP Well + Trans STAIR |
Primary outcome
PrEP Uptake
Time frame: Collected at 30-day and at 90-day visits.
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.
PrEP Adherence
Time frame: Collected at 90-day follow up visit
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.
5 secondary outcomes
Depressive symptoms (PHQ-9)
Time frame: Baseline, 30-day, and 90-day visits
Anxiety symptoms (GAD-7)
Time frame: Baseline, 30-day, and 90-day visits
PTSD symptoms (PC-PTSD-5)
Time frame: Baseline, 30-day, and 90-day visits
DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure--Adult
Time frame: Baseline, 30-day, and 90-day visits
Inventory of Interpersonal Problems (IIP-32)
Time frame: Baseline, 30-day, and 90-day visits
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. NIMH requires data that involve human subjects to be shared using the NDA. Quantitative data from this pilot trial will be preserved to enable sharing via NDA data of sufficient quality to validate and replicate research findings described in the DSMP. All data collected from the randomized pilot intervention trial with 70 adult participants will be shared. De-identified survey and biomedical data will be stored within the NDA secure database. A linking file with an anonymized linking variable will also be stored if multiple datasets are required. In addition, interview protocols, codebooks, deidentified coded text, and summary findings collected from TGD participants, trans community center staff, intervention providers, and leadership will be stored in the NDA database as well.
Related trials for PrEP Uptake Experiences
Not yet recruitingObservational study
PrEP-LANA (Pre-exposure Prophylaxis- Long-acting Novel Antiviral Agent)
PrEP, PrEP Adherence Experiences
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benji Jensen, MS contact
Erik Storholm, PhD principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans STAIR and PrEP Well in people with PrEP Uptake Experiences and PrEP Adherence Experiences, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erik D Storholm, PhD (8056806480, estorholm@sdsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP Uptake (time frame: Collected at 30-day and at 90-day visits.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.