N/A
N=41
CPT-L to Improve Outcomes for Individuals With HIV and PTSD
PTSD · Hiv
Bottom Line
View on ClinicalTrials.gov: NCT05275842 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Percent of Eligible Participants — 85 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Processing Therapy- Lifesteps (CPT-L) (Behavioral); Lifesteps (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Eligible Participants |
85 | — |
| PRIMARY Percent of Completed Participants |
12; 17 | — |
| PRIMARY Average Number of Enrolled Participants Per Month |
1.71 | — |
| SECONDARY Clinician Administered PTSD Scale for DSM-5 (CAPS-5) |
18.5; 29.4 | — |
| SECONDARY PTSD Checklist for DSM-5 (PCL-5) |
18.5; 33.7 | — |
| SECONDARY Number of Patients With Suppressed Viral Load |
14; 10 | — |
| SECONDARY Medication Pill Count / Compliance |
99.1; 89.2 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT05275842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.