Trauma-informed Care for Youth With HIV in Memphis

NCT07137026 | Active Not Recruiting DMC

• 1 other identifier: 22-08-1234
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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 of Memphis, TN, which houses the third highest rate of new HIV infections, with a third among youth.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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)

  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.

  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.

  This will occur in years 3-5 of the study (years 2-4 of the trial)

Study Arms (1)

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.

Behavioral: Personnel intervention and patients

Interventions

Personnel intervention and patients BEHAVIORAL

The personnel intervention has three components. They are listed above. The patient intervention will include a brief assessment and intervention.

Also known as: 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

Personnel and patients of the clinic

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Be an employee of St. Jude Childrens Research Hospital
• Be at least 18 years of age
• Be able to communicate in English

You may not qualify if:

• 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

Sponsors & Collaborators

• Meharry Medical College: lead

Study Sites (1)

St. Jude Childrens Research Hospital

Memphis, Tennessee, 38105, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: August 22, 2025
• Study Start: February 25, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 22, 2025

Record last verified: 2025-06

Locations

US (1)