HIVNCT03649607
Accelerated Resolution Therapy for HIV Positive African, Caribbean and Black
A study testing Accelerated Resolution Therapy in people with HIV and Post Traumatic Stress Disorder, run by Unity Health Toronto.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- HIV, Post Traumatic Stress Disorder
- What is being tested?
- Accelerated Resolution Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
- 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
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Identify factors influencing the response to ART®
- Identity neuroimaging indicators for treatment effects of ART®
- 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.
- Conditions
- HIV, Post Traumatic Stress Disorder
- Being tested
- Accelerated Resolution Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated Resolution TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Accelerated Resolution Therapy | Other | 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. Receives: Other: Accelerated Resolution Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Symptom Distress Scale (SDS).
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.
Measured: Symptom distress score 60 days post the study start date.
Secondary outcomes (2)
HIV Associated Neurocognitive Disease (HAND).
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"
Measured: Composite Z-score 60 days post the study start date.
Working and learning memory
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.
Measured: Composite Z-score 60 days post the study start date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study startSep 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LaRon Nelson, PhD, RN, FNP, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649607
- Sponsor's protocol ID
- 18028
- Status last verified
- Apr 2019
- First submitted
- 24 Aug 2018
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03649607
- Acronym / sponsor ID
- 18028
- Conditions
- HIV, Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 28 Aug 2018 (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.
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.
- Identify factors influencing the response to ART®
- Identity neuroimaging indicators for treatment effects of ART®
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accelerated Resolution Therapy | Other | Other: Accelerated Resolution TherapyParticipants 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. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Accelerated Resolution TherapyART 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. | Other | Accelerated Resolution Therapy |
Primary outcome
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.
2 secondary outcomes
HIV Associated Neurocognitive Disease (HAND).
Time frame: Composite Z-score 60 days post the study start date.
Working and learning memory
Time frame: Composite Z-score 60 days post the study start date.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Individual participant dataSharing planned: No. 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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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.
LaRon Nelson, PhD, RN, FNP principal investigator
Unity Health Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated Resolution Therapy in people with HIV and Post Traumatic Stress Disorder, run by Unity Health Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pascal Djiadeu, PhD (4168646060 ext. 77370, djiadeup@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Symptom Distress Scale (SDS). (time frame: Symptom distress score 60 days post the study start date.). 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 10 Apr 2019.