An interventional study of Personnel intervention and patients in HIV Infections, sponsored by Meharry Medical College. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Meharry Medical College · Not applicable, Interventional, and Treatment
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.
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 70 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
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Patients must:
Personnel must:
Exclusion Criteria:
Patients:
Personnel:
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
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
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.
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)
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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: This will occur in years 3-5 of the study (years 2-4 of the trial)
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Meharry Medical College