CPT-L to Improve Outcomes for Individuals With HIV and PTSD

Study Overview
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Brief Summary
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This study plans to adapt and examine the acceptability and feasibility of an evidence-based PTSD treatment that has reduced other HIV transmission behavior (e.g., sexual risk), Cognitive Processing Therapy (CPT), at an HIV clinic as a strategy to improve HIV outcomes in this population.

Detailed Description
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The prevalence of trauma exposure, and post-traumatic stress disorder (PTSD) in particular, among individuals living with HIV (30-74%) is higher than the general population (7-10%). Individuals with co-occurring PTSD and HIV are at high-risk for negative HIV-related outcomes, including low adherence to antiretroviral therapy (ART), faster disease progression, more hospitalizations, and almost twice the rate of death, as well as increased mental health problems. In addition to PTSD resulting from traumatic events, such as sexual and physical assault/abuse, negative reinforcement conceptual models suggest that the avoidant behavior (a hallmark symptom of PTSD) tied to HIV status-related PTSD can also contribute to poor ART adherence and to less success of viral suppression (e.g., by avoiding cues, such as ART medications, that serve as reminders of the HIV status). Despite the high rates of persons living with HIV/AIDS (PLWH) who report PTSD - and the poorer HIV patient outcomes among this population versus those without co-occurring PTSD- evaluation of the impact of evidence-based treatment for PTSD among populations living with HIV on HIV outcomes has been highly neglected in clinical research. In other words, no research to date has examined the critical question of whether HIV outcomes can be improved among the large number of PLWH with co-morbid PTSD and related consequences (e.g., substance misuse) by treating PTSD symptoms. To address this tremendous void in the field, we propose to adapt and examine the acceptability and feasibility of an evidence-based PTSD treatment that has reduced other HIV transmission behavior (e.g., sexual risk), Cognitive Processing Therapy (CPT), at an HIV clinic as a strategy to improve HIV outcomes in this population.

Official Title
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Development and Feasibility Testing of an Integrated PTSD and Adherence Intervention Cognitive Processing Therapy-Lifesteps (CPT-L) to Improve HIV Outcomes

Conditions
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PTSD, Hiv

Intervention / Treatment
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* Behavioral: Cognitive Processing Therapy- Lifesteps (CPT-L)
* Behavioral: Lifesteps


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals that are 18 years and older Linked with and/or eligible for treatment at a Ryan White clinic in South Carolina. Participant meets clinically significant threshold of DSM-V PTSD criteria as determined by a Clinician Administered PTSD Scale for DSM-5 (CAPS-5) clinical interview. No changes in psychotropic medication within 4 weeks of study enrollment. Able to speak, read, and write English. Meet at least one of the following HIV care criteria: Diagnosed with HIV in the last 3 months; Detectable viral load in the last 12 months; Failed to show up for or missed 1 or more HIV care appointments in the past 12 months; Last HIV care visit was more than 6 months ago; Self-reporting less than 90% ART adherence in the past 4 weeks. A score of at least 10 on the Montreal Cognitive Assessment test (MoCA) Exclusion Criteria: Evidence of significant cognitive impairment as assessed by the Montreal Cognitive Assessment Test (MoCA; in the severe range). Evidence of developmental delays, or pervasive developmental disorder, or active suicidal or homicidal ideations. Evidence of psychotic symptoms (e.g., active hallucinations, delusions, impaired thought processes).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Processing Therapy-Lifesteps (CPT-L) [Group A]<br> | Behavioral: Cognitive Processing Therapy- Lifesteps (CPT-L)<br>* CPT-L is designed to help people with HIV and PTSD take their medications as prescribed. Cognitive Processing Therapy (CPT) uses education and cognitive training to help individuals identify thoughts and feelings about their trauma and gives them tools to help them change unhelpful beliefs. Lifesteps (L) includes education on the need for people with HIV to take their medications as prescribed and what could happen if you do not, as well as gives you tools to help motivate and remind you to take your medications on time. Participants will receive a 12-session Cognitive Processing Therapy-Lifesteps (CPT-L) treatment program at the Ryan White clinic. The CPT-L program will be delivered twice a week for 6 weeks. Each session last about 90-minutes.<br>Behavioral: Lifesteps<br>* Lifesteps (L) includes education on the need for people with HIV to take their medications as prescribed and what could happen if you do not, as well as gives you tools to help motivate and remind you to take your medications on time. Participants will complete one Lifesteps education session. This session lasts about 60 minutes. Participants may attend this session either in-person or over the internet if they have an internet ready device with audio.<br>|
| Active Comparator: Lifesteps [Group B]<br> | Behavioral: Lifesteps<br>* Lifesteps (L) includes education on the need for people with HIV to take their medications as prescribed and what could happen if you do not, as well as gives you tools to help motivate and remind you to take your medications on time. Participants will complete one Lifesteps education session. This session lasts about 60 minutes. Participants may attend this session either in-person or over the internet if they have an internet ready device with audio.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of eligible participants | The percentage of participants that were classified as eligible out of all participants that were screened for the purpose of the study. | These measures of eligibility are based on the duration of enrollment window for the study, which is approximately 18 months. | 
| Percent of completed participants | The percentage of participants that were enrolled and completed the study protocol. | At the conclusion of the study (based on duration of enrollment window of approximately 18 months), project completers will be examined. | 
| Average number of enrolled participants per month | The average number of recruited participants per month (across the entirety of the enrollment window). | Approximately 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean score of PTSD symptoms | PTSD symptoms are measured by the PCL scale, an empirically supported self-report instrument. PCL-5 includes 20 items with a likert scale of 0 (not at all) to 4 (extremely). Scores range from total symptom count of 0-80, with a score of 33 or above indicative of probable clinically significant PTSD. Scores lower than 33 indicate subthreshold symptoms of PTSD. | These measures will be collected at baseline. | 
| Mean score of PTSD symptoms | PTSD symptoms are measured by the PCL scale, an empirically supported self-report instrument. PCL-5 includes 20 items with a likert scale of 0 (not at all) to 4 (extremely). Scores range from total symptom count of 0-80, with a score of 33 or above indicative of probable clinically significant PTSD. Scores lower than 33 indicate subthreshold symptoms of PTSD. | These measures will be collected at end of treatment (approximately 6 weeks from enrollment). | 
| Mean score of PTSD symptoms | PTSD symptoms are measured by the PCL scale, an empirically supported self-report instrument. PCL-5 includes 20 items with a likert scale of 0 (not at all) to 4 (extremely). Scores range from total symptom count of 0-80, with a score of 33 or above indicative of probable clinically significant PTSD. Scores lower than 33 indicate subthreshold symptoms of PTSD. | These measures will be collected at 3 month follow up. | 
| Mean score of WHOQOL-HIV BREF (World Health Organization Quality of Life- HIV ) | A 26-item measure categorized into four domains (i.e., physical health, psychological well-being, social relationships, and environment); measures effects of disease and health interventions on an individual's perception of quality of life and assesses changes in quality of life across treatment. The scale's domain score ranges from 4 to 20. Higher scores indicate a better quality of life. | These measures will be collected at baseline. | 
| Mean score of WHOQOL-HIV BREF (World Health Organization Quality of Life- HIV) | A 26-item measure categorized into four domains (i.e., physical health, psychological well-being, social relationships, and environment); measures effects of disease and health interventions on an individual's perception of quality of life and assesses changes in quality of life across treatment. The scale's domain score ranges from 4 to 20. Higher scores indicate a better quality of life. | These measures will be collected at end of treatment (approximately 6 weeks from enrollment). | 
| Mean score of WHOQOL-HIV BREF (World Health Organization Quality of Life- HIV) | A 26-item measure categorized into four domains (i.e., physical health, psychological well-being, social relationships, and environment); measures effects of disease and health interventions on an individual's perception of quality of life and assesses changes in quality of life across treatment. The scale's domain score ranges from 4 to 20. Higher scores indicate a better quality of life. | These measures will be collected at 3 month follow up. | 
| Mean score of viral load | Results from standard clinical assays (collected for clinical purposes). An HIV viral load less than 200 will be considered consistent with virologic suppression. The results of a viral load are described as the number of copies of HIV RNA in a milliliter of blood. A viral load of 10,000 would be considered low; 100,000 or above would be considered high. | These measures will be collected at baseline. | 
| Mean score of viral load | Results from standard clinical assays (collected for clinical purposes). An HIV viral load less than 200 will be considered consistent with virologic suppression. The results of a viral load are described as the number of copies of HIV RNA in a milliliter of blood. A viral load of 10,000 would be considered low; 100,000 or above would be considered high. | These measures will be collected at 6 months after enrollment. |