Clinical trial NCT05275842: CPT-L to Improve Outcomes for Individuals With HIV and PTSD
Official title: Development and Feasibility Testing of an Integrated PTSD and Adherence Intervention Cognitive Processing Therapy-Lifesteps (CPT-L) to Improve HIV Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Hiv
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-03-11
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Individuals that are 18 years and older
2. Linked with and/or eligible for treatment at a Ryan White clinic in South Carolina.
3. 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.
4. No changes in psychotropic medication within 4 weeks of study enrollment.
5. Able to speak, read, and write English.
6. 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.
7. A score of at least 10 on the Montreal Cognitive Assessment test (MoCA)

Exclusion Criteria:

1. Evidence of significant cognitive impairment as assessed by the Montreal Cognitive Assessment Test (MoCA; in the severe range).
2. Evidence of developmental delays, or pervasive developmental disorder, or active suicidal or homicidal ideations.
3. Evidence of psychotic symptoms (e.g., active hallucinations, delusions, impaired thought processes).

Primary outcomes:
measure: Percent of Eligible Participants
timeFrame: Study Screening Visit
measure: Percent of Completed Participants
timeFrame: 6-week end of study visit
measure: Average Number of Enrolled Participants Per Month
timeFrame: Approximately 24 months of active recruitment
Secondary outcomes:
measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: These measures will be collected at baseline and the 6 week end of study treatment visit.
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: These measures will be collected at baseline and the 6 week end of study treatment visit.
measure: Number of Patients With Suppressed Viral Load
timeFrame: These measures will be collected at 6 months after enrollment.
measure: Medication Pill Count / Compliance
timeFrame: Measure taken at study baseline and at the close of study treatment (6 week visit)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Cristina Lopez, PhD
role: PRINCIPAL_INVESTIGATOR
References: