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

Not Applicable

Completed

Conditions: PTSD
Hiv

Interventions: Behavioral: Cognitive Processing Therapy- Lifesteps (CPT-L)
Behavioral: Lifesteps

Registration Number: NCT05275842

Lead Sponsor: Medical University of South Carolina

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 41

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:
1. Diagnosed with HIV in the last 3 months;
2. Detectable viral load in the last 12 months;
3. Failed to show up for or missed 1 or more HIV care appointments in the past 12 months;
4. Last HIV care visit was more than 6 months ago;
5. 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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Processing Therapy-Lifesteps (CPT-L) [Group A]	Lifesteps	-
Cognitive Processing Therapy-Lifesteps (CPT-L) [Group A]	Cognitive Processing Therapy- Lifesteps (CPT-L)	-
Lifesteps [Group B]	Lifesteps	-

Primary Outcome Measures

Name	Time	Method
Percent of Eligible Participants	Study Screening Visit	The percentage of participants that were classified as eligible out of all participants that were screened for the purpose of the study.
Percent of Completed Participants	6-week end of study visit	The percentage of participants that were enrolled and completed the study protocol.
Average Number of Enrolled Participants Per Month	Approximately 24 months of active recruitment	The average number of recruited participants per month (across the entirety of the enrollment window).

Secondary Outcome Measures

Name	Time	Method
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)	These measures will be collected at baseline and the 6 week end of study treatment visit.	PTSD symptoms are measured by the CAPS-5 scale, an empirically supported clinician-report instrument. CAPS-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. Higher scores indicate more severe PTSD symptoms.
PTSD Checklist for DSM-5 (PCL-5)	These measures will be collected at baseline and the 6 week end of study treatment visit.	PTSD symptoms are measured by the PCL-5 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. Higher scores indicate more severe PTSD symptoms.
Number of Patients With Suppressed Viral Load	These measures will be collected at 6 months after enrollment.	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.
Medication Pill Count / Compliance	Measure taken at study baseline and at the close of study treatment (6 week visit)	Self Reported percentage of doses taken during the past 30 days. Range 0.0 - 100.0.