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Trans STAIR and PrEP Well for Transgender and Nonbinary Individuals

This study is testing two interventions: Trans STAIR and PrEP Well. Trans STAIR is a mental health treatment for people who have experienced multiple traumas, based on cognitive-behavioral principles. PrEP Well helps transgender and gender diverse (TGD) individuals get and stay on PrEP (pre-exposure prophylaxis), a medication to prevent HIV, by offering peer support and addressing other needs like housing. You may be able to join if you identify as transgender or nonbinary, are 18 or older, HIV-negative, eligible for PrEP, and have symptoms of PTSD or depression. The study wants to see if these interventions help people start and continue taking PrEP. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 90 participants. In Phase 2, 70 participants will be randomly assigned to receive either PrEP Well + Trans STAIR or PrEP Well alone.
What's involved
Participants will attend 8 group sessions for Trans STAIR. The study will measure PrEP uptake at 30-day and 90-day visits, and PrEP adherence at the 90-day follow-up visit.
Compensation
Not stated in the trial record.
Follow-up
PrEP uptake will be measured at 30-day and 90-day visits. PrEP adherence will be measured at the 90-day follow-up visit.

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NCT06724965

Trans STAIR: Implementing an Evidence Based Trauma Treatment With Community Led PrEP Navigation

Not Yet Recruiting
NAAges 18+InterventionalPrevention
San Diego State University
~90 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Trans STAIRPrEP Well

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PrEP Uptake
Measured over Collected at 30-day and at 90-day visits.
+1 more outcome measured

Conditions

PrEP Uptake Experiences
PrEP Adherence Experiences
Mental Health Symptoms

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DepressionInjury

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Erik Storholm, PhD · PRINCIPAL_INVESTIGATOR · San Diego State University

Who to contact

Erik D Storholm, PhD
[email protected]
8056806480
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • PrEP UptakeCollected 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 AdherenceCollected 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.