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Accelerated Resolution Therapy for HIV Positive African, Caribbean and Black

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649607
Recruitment Status : Not yet recruiting
First Posted : August 28, 2018
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief Summary:
Nearly two-thirds of ACB people living in Ontario are classified as immigrant, refugee or undocumented [non-status/NS] (IRNS) individuals. IRNS people are more likely than the general population to be exposed to events that are associated with posttraumatic stress disorder (PTSD). Furthermore, the diagnosis of HIV is itself a traumatic life event. Nonetheless, significant gaps remain regarding the best strategies for supporting trauma-informed care among ACB IRNS individuals with HIV. Accelerated Resolution Therapy (ARTh) is an exposure-based therapy that incorporates rapid eye movements in a standardized administration over 1-5 sessions. ARTh is an effective brief treatment for PTSD symptoms; but, it's range of therapeutic benefit when applied to people with co-morbid HIV infections is unknown. No studies have leveraged neuroimaging to validate the self-reported empirical therapeutic benefit of ARTh. The investigators propose to investigate the implementation of ARTh, including understanding factors influencing its therapeutic outcomes. The three specific aims of this study are to (1) identify factors influencing the response to ARTh (2) identity neuroimaging indicators for treatment effects of ARTh, and (3) to identify factors influencing ARTh implementation. The investigators will conduct a pre-/post- evaluation of intervention outcomes of ARTh implemented in a sample (n=40) of HIV-positive ACB IRNS ages 18-45 years (Aim 1). The investigators will use statistical analyses to identify factors that may moderate the treatment response of ARTh on PTSD symptoms, HIV symptoms distress and quality of life (Aim 1). The investigators will use diffusion tensor imaging and resting state functional magnetic resonance imaging (fMRI) metrics to assess structural and functional connectivity and examine their associations with PTSD symptoms and HIV symptom distress (Aim 2). Finally, the investigators will use process measures to study two specific implementation factors (acceptability and appropriateness) regarding ARTh use in this population. As a consequence of this research, the investigators expect to generate data that will be used to refine an ARTh implementation protocol that will be integrated into an adaptive implementation trial to reduce gaps in the HIV care continuum through the use of intervention packages for ACB people customized to the individual's needs.

Condition or disease Intervention/treatment Phase
HIV Post Traumatic Stress Disorder Other: Accelerated Resolution Therapy Not Applicable

Detailed Description:

STUDY OVERVIEW - PURPOSE AND BACKGROUND

African, Caribbean and Black (ACB) individuals represent only 4.7% of Ontario's population, yet account for 30% of HIV prevalence in the province. Nearly two-thirds of ACB people living in Ontario are classified as immigrant, refugee or non-status (IRNS) individuals. IRNS people are more likely than the general population to be exposed to events that are associated with posttraumatic stress disorder (PTSD). Furthermore, the diagnosis of HIV is itself a traumatic life event. Nonetheless, significant gaps remain regarding the best strategies for supporting trauma-informed care among ACB IRNS individuals with HIV. For example, IRNS women are more likely than Canadian-born women to have experienced rape, non-sexual physical assault, and civil conflict. ACB IRNS men who have sex with men (MSM) are more likely than non-MSM to have emigrated to Canada as asylum-seekers after fleeing some form of persecution or imminent threat in their countries of origin. Furthermore, while it is known that stigma contributes to exacerbation and severity of HIV symptoms—via the activation of physiological stress responses—there is no known intervention that has been shown to interrupt the pathway by which HIV stigma effects stress and HIV symptoms. Accelerated Resolution Therapy (ART®) is an exposure-based therapy that incorporates rapid eye movements in a standardized administration over 5 sessions in a 3-week period. ART® is effective brief treatment for PTSD symptoms; but, it's range of therapeutic benefit when applied to people with HIV infections is unknown. Although evidence shows that the amygdala is the brain region most reactive to changes in stress stimuli, it remains unknown if therapeutic responses can be reliably validated with biomarkers. No studies have leveraged neuroimaging to validate the self-reported empirical therapeutic benefit of ART®.

The purpose of this study is to investigate the implementation of ART®, including understanding factors influencing its therapeutic outcomes.

The central hypothesis is that ART® will reduce HIV symptom distress by down-modulating the effects of stigma and posttraumatic stress—leading to improved self-reported quality of life. The hypothesis is based on previous research showing that adaptive coping strategies buffer the effects of stigma on stress, as well as evidence from a randomized trial of ART® which demonstrated statistically significant treatment effects for trauma related distress (d=1.88), anxiety (d=1.62), and depression (d=1.41), as well as a clinically meaningful 23-point reduction on the civilian PTSD checklist.[5] The investigators will investigate our central hypothesis by pursuing the following specific aims in a sample of ACB immigrant, refugee and non-status people with HIV.

  1. Identify factors influencing the response to ART®
  2. Identity neuroimaging indicators for treatment effects of ART®
  3. Identify factors influencing ART® implementation

The secondary purpose of this study is to determine if ART® treatment of posttraumatic stress symptoms can decrease inflammation and its effects on HIV symptoms.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Implementation Trial of Accelerated Resolution Therapy for Treatment of Post-Traumatic Stress in HIV Positive Immigrant, Refugee and Undocumented Africans, Caribbean and Black Canadians
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Accelerated Resolution Therapy
Participants will complete a clinical intake assessment before meeting with the therapist and initiating the ART® protocol. Participants will receive the ART intervention over a 21-day period, where imaginal exposure and imagery re-scripting will be used replace previous traumatic experiences. The ART intervention will be assessed through pre- and post-test measures at 60-days post enrolment.
Other: Accelerated Resolution Therapy
ART was developed to treat both physiological and cognitive aspects of PTSD, which has been described as a consequence of failed memory processing. The use of Voluntary Image Replacement (VIR) parallels imaging re-scripting in which a preexisting negative mental image is transformed into a more benign image. This has been successfully used to treat survivors of traumatic industrial accidents suffering from PTSD. Participants will complete five sessions over a 21-day period.




Primary Outcome Measures :
  1. HIV Symptom Distress Scale (SDS). [ Time Frame: Symptom distress score 60 days post the study start date. ]
    This 20-item instrument is used to measure overall HIV symptom frequency, distress and clinically relevant clusters. Participants are asked to indicate which of the 20 symptoms they have experienced in the past 2 weeks. Participants are then asked to rate symptom that are present, on the extent to which the symptoms are bothersome (0=do not have symptom; 25=have symptom, but no bother; 50=have symptom, little bother; 75=have symptom, bothers me some; 100= have symptom, bothers me a lot). Scores range from 0 to 100. Higher scores indicate greater symptom distress.


Secondary Outcome Measures :
  1. HIV Associated Neurocognitive Disease (HAND). [ Time Frame: Composite Z-score 60 days post the study start date. ]

    The HAND assessment includes a battery of measures commonly used to evaluate neurocognitive functioning in 6 domains: executive function, speed of information processing, attention and working memory, and learning memory. The neurocognitive evaluation will be performed by trained staff and supervised by Dr. Adwoa Agyei with consultation from Dr. Giovanni Schifitto.

    The assessment will include tests of:

    • Executive Function using "Trailmaking Test Part B, Stroop Interference task"
    • Speed of Information Processing using "Symbol Digit Modalities Test and Stroop Color Naming"
    • Attention Memory using "CalCAP(CRT4) and WAIS-III Letter-Number Sequencing"

  2. Working and learning memory [ Time Frame: Composite Z-score 60 days post the study start date. ]

    Patient's learning and working memory will be assessed using the following tests: Rey Complex Figure Test Immediate Recall, Rey Auditory Verbal Learning, Test RAVLT Delayed Recall, Rey Complex Figure Test Delayed Recall.

    The working and memory test will be part of the HAND assessment.



Other Outcome Measures:
  1. HIV Viral Load [ Time Frame: Number of viral particles per ml of plasma 60 days post the study start date. ]
    The investigators will assess the volume of HIV in serum measured using reverse transcriptase polymerase chain reaction (RT PCR). The HIV viral load is a measure of the number of viral particles per ml of plasma. Higher numbers of HIV viral copies indicate inadequate viral suppression and insufficient immune function. The data will be entered directly into REDCap by the St. Michael's Hospital lab personnel. The investigators will code viral suppression as <50 HIV copies/mL of blood as "=yes" and ≥50 "=no."

  2. Post Traumatic Stress Disorder (PTSD) Checklist - Civilian Version (PCL-5) [ Time Frame: Posttraumatic stress score 60 days post the study start date. ]
    This 20-item measure assesses symptoms of posttraumatic stress. It assesses an individual's symptoms based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for PTSD. The PCL-5 focuses on four aspects of distressing memories: re-experiencing the event, avoidance, mitigation and hyperarousal. The scale uses a 5-point Likert scale that ranges from 0 to 4 (0 [Not at all]; 1[A little bit]; 2 [Moderately]; 3 [Quite a bit]; 4 [Extremely]) to rate each of the 20 items on the degree to which symptoms were present and bothersome in the prior 30-days. For PTSD diagnosis, the score must be above certain cut-point indicating moderate to high symptom severity. The PCL-5 showed good internal consistency in a study with HIV-positive patients in Ghana (α=0.79).

  3. HIV/AIDS Related Quality of Life [ Time Frame: Quality of life measure 60 days post the study start date. ]
    There is a 34-item tool that measures experiences in overall function, life satisfaction, health and financial worries, worries about medication, HIV disclosure, living with HIV and doctor satisfaction in the past month. Check boxes to 5 specific answers (All the time; A lot of the time; Some of the time; A little of the time; None of the time) are used to measure and evaluate quality of life.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Inclusion Criteria:

    A person will be eligible for study participation if they:

    • identify as Black African, Caribbean and/or Canadian
    • are able to consent to participate/have capacity to consent
    • have previously been diagnosed with HIV
    • score >33 on the PTSD Checklist - Civilian (PCL-5)
    • currently live in the Greater Toronto metropolitan area
    • can speak and understand either English or French
    • are on stable combination antiretroviral therapy for the past six months or more
  2. Exclusion Criteria:

A person will be excluded from this study if they meet any of the following conditions:

  • born in Canada
  • unable to consent to provide documentation of HIV seropositive status
  • unable to consent to an MRI, including intolerance due to claustrophobia
  • are older than 50 years old.
  • have a major psychiatric disorder likely to impede treatment (e.g. psychosis), current suicidal ideation, current treatment for substance addiction, or diagnosis of eye movement disorder.
  • severe premorbid or comorbid psychiatric disorders. Among these exclusions are a diagnosis of schizophrenia; bipolar disorder and active depression that will confound the neurological assessments. Subjects with a mild or stable depression including those on stable tricyclic antidepressants, serotonin-reuptake antagonists, or monoamine oxidase (MAO) inhibitors are eligible to enroll.
  • chronic seizures, stroke not consistent with cerebral small vessel disease (CSVD), head trauma resulting in loss of consciousness >30 min, and multiple sclerosis.
  • brain infection (except for HIV-1), including any fungal meningitis, toxoplasmosis, progressive multifocal leukoencephalopathy. Subjects with any space-occupying brain lesions requiring acute or chronic therapy, for example Central nervous system (CNS) lymphoma, will be excluded from participation.
  • metallic implant, e.g., in skull, cardiac devices that do not meet safety standards for MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649607


Contacts
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Contact: Pascal Djiadeu, PhD 4168646060 ext 77370 djiadeup@smh.ca
Contact: LLana James 4167164771 jamesll@smh.ca

Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: LaRon Nelson, PhD, RN, FNP St. Michael's Hospital, Toronto

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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03649607    
Other Study ID Numbers: 18028
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No one outside of the principal investigator, research assistant, therapists administering ART®, study medical director and a medical provider with a clinical "need to know" will have access to any identifiable data. The research assistant will need access to basic identifying data such as name, phone number for follow-up contact purposes to aid in recruitment, enrollment and data collection. If an urgent clinical issue arises (such as, a participant experiencing acute psychological distress) it may be necessary to link the participant's contact information to subject's identity in order to provide clinical follow-up. No data will be shared without the participant's written informed consent to release medical information. It is in keeping with the principle of beneficence to ensure continuity of care by making it possible (not mandatory) for participants to share information with the medical provider.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders