Clinical trial NCT03649607: Accelerated Resolution Therapy for HIV Positive African, Caribbean and Black
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Post Traumatic Stress Disorder
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: HIV Symptom Distress Scale (SDS).
timeFrame: Symptom distress score 60 days post the study start date.
Secondary outcomes:
measure: HIV Associated Neurocognitive Disease (HAND).
timeFrame: Composite Z-score 60 days post the study start date.
measure: Working and learning memory
timeFrame: Composite Z-score 60 days post the study start date.
Other outcomes:
measure: HIV Viral Load
timeFrame: Number of viral particles per ml of plasma 60 days post the study start date.
measure: Post Traumatic Stress Disorder (PTSD) Checklist - Civilian Version (PCL-5)
timeFrame: Posttraumatic stress score 60 days post the study start date.
measure: HIV/AIDS Related Quality of Life
timeFrame: Quality of life measure 60 days post the study start date.
Locations:
Study officials:
affiliation: Unity Health Toronto
name: LaRon Nelson, PhD, RN, FNP
role: PRINCIPAL_INVESTIGATOR
References: