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

NCT05275842 | Completed Results DMC

• 2 other identifiers: Pro001068011R34MH125706-01A1
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD; Hiv

Outcome Measures

Primary Outcomes (3)

• 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.

  Study Screening Visit

• Percent of Completed Participants

  The percentage of participants that were enrolled and completed the study protocol.

  6-week end of study visit

• Average Number of Enrolled Participants Per Month

  The average number of recruited participants per month (across the entirety of the enrollment window).

  Approximately 24 months of active recruitment

Secondary Outcomes (4)

• 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 Checklist for DSM-5 (PCL-5)

  These measures will be collected at baseline and the 6 week end of study treatment visit.

• Number of Patients With Suppressed Viral Load

  These measures will be collected at 6 months after enrollment.

• Medication Pill Count / Compliance

  Measure taken at study baseline and at the close of study treatment (6 week visit)

Study Arms (2)

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

EXPERIMENTAL

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

Lifesteps [Group B]

ACTIVE COMPARATOR

Behavioral: Lifesteps

Interventions

Cognitive Processing Therapy- Lifesteps (CPT-L) BEHAVIORAL

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.

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

Lifesteps BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (2)

• Lopez C, Baker N, Amaya S, Bisca E, Wilson T, Eckard AR, Moreland A, Resick PA, Safren SA, Danielson CK. Integrated PTSD and Adherence Treatment for People with HIV: Main Findings of a Feasibility Pilot for Cognitive Processing Therapy-Lifesteps (CPT-L). Res Sq [Preprint]. 2025 May 27:rs.3.rs-6567722. doi: 10.21203/rs.3.rs-6567722/v1.

  PMID: 40502775 DERIVED

• Lopez CM, Moreland AD, Amaya S, Bisca E, Mujica C, Wilson T, Baker N, Richey L, Eckard AR, Resick PA, Safren SA, Danielson CK. Assessment, Decision, Adaptation, Production, Topical Experts-Integration, Training, and Testing (ADAPT-ITT) Framework to Tailor Evidence-Based Posttraumatic Stress Disorder Treatment for People With HIV to Enhance Engagement and Adherence: Qualitative Results from a Feasibility Randomized Controlled Trial. JMIR Form Res. 2025 Jan 16;9:e64258. doi: 10.2196/64258.

  PMID: 39819749 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

Viral load often not collected clinically within time frame of data collection in electronic medical record; method used to collect objective pill count produced 66% missing so it could not be analyzed or summarized; recruitment challenges with staff turnover, institutional barriers to specifying information on project flyers, resulting in many eligibility screens that did not meet criteria; recruitment barriers getting into certain clinics who had not collaborated on research projects before.

Results Point of Contact

• Title: Cristina Lopez
• Organization: Medical University of South Carolina

lopezcm@musc.edu

843-792-2945

Study Officials

• Cristina Lopez, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 11, 2022
• Study Start: July 13, 2022
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)