HIV InfectionsNCT07137026
Trauma-informed Care for Youth With HIV in Memphis
A study testing Personnel intervention and patients in people with HIV Infections, run by Meharry Medical College at 1 site in United States.
Trial summary
Enhanced interventions are needed to mitigate the impact psychological trauma has on HIV appointment adherence among Black youth with HIV in the Southern United States (U.S.). We will adapt and test an HIV trauma treatment to improve outcomes for both youth with HIV and their HIV care providers in the priority region… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Personnel intervention and patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2025to 30 Jun 2028
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must:
- Have a documented HIV+ status and be receiving care from St. Jude HIV clinic
- Be able to participate in English and consent to intervention
- Screen positive for at least one trauma exposure
- Be between the ages of 18-24
- Personnel must:
Show all 9Show fewer
- Be an employee of St. Jude Childrens Research Hospital
- Be at least 18 years of age
- Be able to communicate in English
Who cannot join
- Patients:
- No patients below the age of 18 who cannot communicate in English
- Personnel:
- No past employees
- Must be a current St. Jude employee who interfaces with the HIV clinic patients in some capacity
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Childrens Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: Implementation of Trauma-informed HIV Care With Youth in Memphis, TN
Enhanced interventions are needed to mitigate the impact psychological trauma has on HIV appointment adherence among Black youth with HIV in the Southern United States (U.S.). We will adapt and test an HIV trauma treatment to improve outcomes for both youth with HIV and their HIV care providers in the priority region of Memphis, TN, which houses the third highest rate of new HIV infections, with a third among youth.
Read the detailed description
Investigators will reduce health disparities among underserved youth in a region with the third highest HIV incidence nationally. Shelby County, Tennessee (TN; Memphis) is a Phase I priority jurisdiction for the U.S. Ending the HIV Epidemic (EHE) initiative, where youth with HIV (YWH) suffer comparatively worse HIV outcomes: half of all YWH in Memphis are appointment non-adherent, representing a major threat to HIV viral suppression, morbidity, and disease transmission. Psychological trauma is a critical and understudied mechanism driving a multitude of HIV-related disparities that will only be eliminated through multi-level solutions. At the patient-level, YWH endure high rates of post-traumatic stress disorder (47%), with adversity due to skin color intensifying experiences among youth; at the personnel-level, repeated trauma exposures associated with HIV care provision contribute to vicarious trauma and degrades professional quality of life. At the clinic-level, trauma sequalae thwart patient-provider relationships and trust, which contributes to treatment fatigue, disengagement, and viral failure. Trauma-Informed care (TIC) is an evidence-based approach that improves multi-level outcomes (e.g., personnel practices, clinic climate, and patient appointment adherence) by ensuring personnel are adequately trained to Recognize and Respond to trauma and Resist Re-traumatization. Though the Memphis EHE plan cites TIC implementation as critical to advancing local goals, the HIV clinic at St. Jude Children's Research Hospital (SJCRH), primary care provider for YWH in the area, has not implemented TIC. Investigators have developed this proposal with SJCRH to support enhanced TIC for youth with HIV (TIC-YH) implementation in their HIV care clinic system. Investigators will conduct a Sequential Transformative Mixed Methods design study through the following three aims: 1) Adapt TIC protocols by incorporating novel contextual components; 2) Implement and assess impact of novel TIC-YH intervention on personnel attitudes, practices, and system culture; and 3) Implement and assess impact of novel TIC-YH on patient HIV appointment adherence and trauma response. This innovative and highly significant research is wholly consistent with NIH high priority areas of research to reduce health disparities in treatment outcomes of those living with HIV and training of workforce conducting high priority HIV-related research. By the end of the 5-year grant period, K01 candidate will have received extensive career development in the areas of implementation science and mixed methods design, enabling the development of a programmatic line of research to advance EHE goals. There is strong rationale to support the current TIC-YH intervention and proposed research methods as meaningful approaches to addressing disparities across a wide range of areas, including chronic diseases.
- Conditions
- HIV Infections
- Being tested
- Personnel intervention and patients
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personnel intervention and patientsBehavioural
Also called Personnel: Presence 5 for Racial Justice (P5RJ), Personnel: Trauma Stewardship (TS), Personnel: Trauma Resilience (TR), Patient intervention Description: This is an interrupted time series study where investigators will compare
The personnel intervention has three components. They are listed above. The patient intervention will include a brief assessment and intervention.
| Study group | Role | What they receive |
|---|---|---|
| Personnel and patients of the clinic | Experimental | This is an interrupted time series where we will compare before and after outcomes based on personnel and patients who receive brief interventions for psychological trauma, comparing personnel wellness outcomes, patient HIV appointment adherence and trauma response outcomes. Receives: Behavioral: Personnel intervention and patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in knowledge and attitudes of trauma-informed care
Personnel increases in knowledge and attitudes will be measured via the Trauma-informed Climate Scale (TICS); the Trauma-informed Belief Scale (TIBS); and novel items to accompany the Organizational Trauma Resilience (OTR) Assessment tools listed below.
TICS is a 5-point Likert scale (1 'Strongly Disagree' to 5 'Strongly Agree), with higher scores indicating higher levels of trauma-informed climate, and ranging from 10-50, with 50 indicating better outcomes.
TIBS is a 19-item scale measuring trauma-informed beliefs. Higher scores indicate greater outcomes, using a five-point Likert scale (1= Strongly Disagree to 5= Strongly Agree) and scores ranging from 19-95.
The novel items measure OTR knowledge and attitudes and will be tested for correlation with the TICS and TIBS. There are 29 items: 28 are on a five-point Likert scale and one is on an 8-point slider scale. Scores range from 29-148, with higher scores indicating better outcomes.
Measured: This will occur from years 2-3 of the grant (years 1-2 for this clinical trial timeline, as year one is only adaptation and not part of the trial)
Changes in perceived culture of organizational trauma resilience (OTR) in patients
Patients will respond to surveys to assess levels of Organizational Trauma Resilience (OTR) in the clinic, using the Organizational Trauma Resilience - Patient Reported Experience Measure, which is a 40-item instrument that has been validated in previous studies and uses a five-point Likert scale. Scores range from 40-200, with higher scores indicating better outcomes.
Measured: This will occur between years 2-5 of the grant (years 1-4 of the trial)
Changes in perceived culture of organizational trauma resilience (OTR) in personnel
Personnel will respond to surveys to assess levels of Organizational Trauma Resilience (OTR) in the clinic, using the Organizational Trauma Resilience Assessment. This is a 40-item instrument that has been validated in previous studies and uses a five-point Likert scale. Scores range from 40-200, with higher scores indicating better outcomes.
Measured: This will occur between years 2-5 of the grant (years 1-4 of the trial)
Number of patients adherent to medical appointment
Patient appointment adherence will be tracked (missed/attended versus scheduled appointments)
Measured: This will occur in years 3-5 of the study (years 2-4 of the trial)
Changes in trauma response: PTSD
Patients will be assessed for post-traumatic stress symptoms over time using the Short Post-Traumatic Stress Disorder Rating Interview scale (SPRINT). This is an 8-item instrument measuring PTSD symptoms on a five-point Likert scale (0= Not at all and 4= Very Much), with higher scores indicating worse outcomes. The possible range of scores is 0-32.
Measured: This will occur in years 3-5 of the study (years 2-4 of the trial)
Changes in trauma response: Complex PTSD
Patients will be assessed for post-traumatic stress symptoms over time using the International Trauma Questionnaire. This is an 18-item scale, using a five-point Likert scoring (0=Not at all, 5= Extremely), with a possible range of scores as 0-72 and higher scores as worse outcomes.
Measured: This will occur in years 3-5 of the study (years 2-4 of the trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start25 Feb 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an Interrupted Time Series design study that does not have a control group but rather outcomes are observed based on change between and within individuals from their pre-test scores to their post-test scores, quasi experimentally. There are two arms listed only because one arm is for personnel, which is a training-based intervention, and the other arm is for patients.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meharry Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137026
- Sponsor's protocol ID
- 22-08-1234
- Status last verified
- Jun 2025
- First submitted
- 7 May 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Trauma-informed HIV Care With Youth in Memphis, TN
- ClinicalTrials.gov ID
- NCT07137026
- Acronym / sponsor ID
- 22-08-1234
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Meharry Medical CollegeUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 22 Aug 2025 (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.
Enhanced interventions are needed to mitigate the impact psychological trauma has on HIV appointment adherence among Black youth with HIV in the Southern United States (U.S.). We will adapt and test an HIV trauma treatment to improve outcomes for both youth with HIV and their HIV care providers in the priority region of Memphis, TN, which houses the third highest rate of new HIV infections, with a third among youth.
Detailed description
Investigators will reduce health disparities among underserved youth in a region with the third highest HIV incidence nationally. Shelby County, Tennessee (TN; Memphis) is a Phase I priority jurisdiction for the U.S. Ending the HIV Epidemic (EHE) initiative, where youth with HIV (YWH) suffer comparatively worse HIV outcomes: half of all YWH in Memphis are appointment non-adherent, representing a major threat to HIV viral suppression, morbidity, and disease transmission. Psychological trauma is a critical and understudied mechanism driving a multitude of HIV-related disparities that will only be eliminated through multi-level solutions. At the patient-level, YWH endure high rates of post-traumatic stress disorder (47%), with adversity due to skin color intensifying experiences among youth; at the personnel-level, repeated trauma exposures associated with HIV care provision contribute to vicarious trauma and degrades professional quality of life. At the clinic-level, trauma sequalae thwart patient-provider relationships and trust, which contributes to treatment fatigue, disengagement, and viral failure. Trauma-Informed care (TIC) is an evidence-based approach that improves multi-level outcomes (e.g., personnel practices, clinic climate, and patient appointment adherence) by ensuring personnel are adequately trained to Recognize and Respond to trauma and Resist Re-traumatization. Though the Memphis EHE plan cites TIC implementation as critical to advancing local goals, the HIV clinic at St. Jude Children's Research Hospital (SJCRH), primary care provider for YWH in the area, has not implemented TIC. Investigators have developed this proposal with SJCRH to support enhanced TIC for youth with HIV (TIC-YH) implementation in their HIV care clinic system. Investigators will conduct a Sequential Transformative Mixed Methods design study through the following three aims: 1) Adapt TIC protocols by incorporating novel contextual components; 2) Implement and assess impact of novel TIC-YH intervention on personnel attitudes, practices, and system culture; and 3) Implement and assess impact of novel TIC-YH on patient HIV appointment adherence and trauma response. This innovative and highly significant research is wholly consistent with NIH high priority areas of research to reduce health disparities in treatment outcomes of those living with HIV and training of workforce conducting high priority HIV-related research. By the end of the 5-year grant period, K01 candidate will have received extensive career development in the areas of implementation science and mixed methods design, enabling the development of a programmatic line of research to advance EHE goals. There is strong rationale to support the current TIC-YH intervention and proposed research methods as meaningful approaches to addressing disparities across a wide range of areas, including chronic diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an Interrupted Time Series design study that does not have a control group but rather outcomes are observed based on change between and within individuals from their pre-test scores to their post-test scores, quasi experimentally. There are two arms listed only because one arm is for personnel, which is a training-based intervention, and the other arm is for patients.
| Arm | Type | Receives |
|---|---|---|
| Personnel and patients of the clinic | Experimental | Behavioral: Personnel intervention and patientsThis is an interrupted time series where we will compare before and after outcomes based on personnel and patients who receive brief interventions for psychological trauma, comparing personnel wellness outcomes, patient HIV appointment adherence and trauma response outcomes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have a documented HIV+ status and be receiving care from St. Jude HIV clinic
- Be able to participate in English and consent to intervention
- Screen positive for at least one trauma exposure
- Be between the ages of 18-24
- Be an employee of St. Jude Childrens Research Hospital
Key exclusion criteria (5 listed)
- No patients below the age of 18 who cannot communicate in English
- No past employees
- Must be a current St. Jude employee who interfaces with the HIV clinic patients in some capacity
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 |
|---|---|---|
| Personnel intervention and patientsAlso: Personnel: Presence 5 for Racial Justice (P5RJ), Personnel: Trauma Stewardship (TS), Personnel: Trauma Resilience (TR), Patient intervention Description: This is an interrupted time series study where investigators will compareThe personnel intervention has three components. They are listed above. The patient intervention will include a brief assessment and intervention. | Behavioural | Personnel and patients of the clinic |
Primary outcome
Changes in knowledge and attitudes of trauma-informed care
Time frame: This will occur from years 2-3 of the grant (years 1-2 for this clinical trial timeline, as year one is only adaptation and not part of the trial)
Personnel increases in knowledge and attitudes will be measured via the Trauma-informed Climate Scale (TICS); the Trauma-informed Belief Scale (TIBS); and novel items to accompany the Organizational Trauma Resilience (OTR) Assessment tools listed below. TICS is a 5-point Likert scale (1 'Strongly Disagree' to 5 'Strongly Agree), with higher scores indicating higher levels of trauma-informed climate, and ranging from 10-50, with 50 indicating better outcomes. TIBS is a 19-item scale measuring trauma-informed beliefs. Higher scores indicate greater outcomes, using a five-point Likert scale (1= Strongly Disagree to 5= Strongly Agree) and scores ranging from 19-95. The novel items measure OTR knowledge and attitudes and will be tested for correlation with the TICS and TIBS. There are 29 items: 28 are on a five-point Likert scale and one is on an 8-point slider scale. Scores range from 29-148, with higher scores indicating better outcomes.
Changes in perceived culture of organizational trauma resilience (OTR) in patients
Time frame: This will occur between years 2-5 of the grant (years 1-4 of the trial)
Patients will respond to surveys to assess levels of Organizational Trauma Resilience (OTR) in the clinic, using the Organizational Trauma Resilience - Patient Reported Experience Measure, which is a 40-item instrument that has been validated in previous studies and uses a five-point Likert scale. Scores range from 40-200, with higher scores indicating better outcomes.
Changes in perceived culture of organizational trauma resilience (OTR) in personnel
Time frame: This will occur between years 2-5 of the grant (years 1-4 of the trial)
Personnel will respond to surveys to assess levels of Organizational Trauma Resilience (OTR) in the clinic, using the Organizational Trauma Resilience Assessment. This is a 40-item instrument that has been validated in previous studies and uses a five-point Likert scale. Scores range from 40-200, with higher scores indicating better outcomes.
Number of patients adherent to medical appointment
Time frame: This will occur in years 3-5 of the study (years 2-4 of the trial)
Patient appointment adherence will be tracked (missed/attended versus scheduled appointments)
Changes in trauma response: PTSD
Time frame: This will occur in years 3-5 of the study (years 2-4 of the trial)
Patients will be assessed for post-traumatic stress symptoms over time using the Short Post-Traumatic Stress Disorder Rating Interview scale (SPRINT). This is an 8-item instrument measuring PTSD symptoms on a five-point Likert scale (0= Not at all and 4= Very Much), with higher scores indicating worse outcomes. The possible range of scores is 0-32.
Changes in trauma response: Complex PTSD
Time frame: This will occur in years 3-5 of the study (years 2-4 of the trial)
Patients will be assessed for post-traumatic stress symptoms over time using the International Trauma Questionnaire. This is an 18-item scale, using a five-point Likert scoring (0=Not at all, 5= Extremely), with a possible range of scores as 0-72 and higher scores as worse outcomes.
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 22 Aug 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personnel intervention and patients in people with HIV Infections, run by Meharry Medical College 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 9 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in knowledge and attitudes of trauma-informed care (time frame: This will occur from years 2-3 of the grant (years 1-2 for this clinical trial timeline, as year one is only adaptation and not part of the trial)). The study lists 6 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 22 Aug 2025.