PTSDNCT05275842

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

A study testing Cognitive Processing Therapy- Lifesteps (CPT-L) and Lifesteps in people with PTSD and Hiv, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: PTSD, Hiv
What is being tested?: Cognitive Processing Therapy- Lifesteps (CPT-L) and Lifesteps
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteUnited States
Study dates: 13 Jul 2022to 30 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

Show all 12Show fewer

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)

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

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

Read the 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.

Conditions: PTSD, Hiv
Being tested: Cognitive Processing Therapy- Lifesteps (CPT-L), Lifesteps
Medical subject headings: Stress Disorders, Post-Traumatic, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive Processing Therapy- Lifesteps (CPT-L)Behavioural
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.
LifestepsBehavioural
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.

Study groups in NCT05275842
Study group	Role	What they receive
Cognitive Processing Therapy-Lifesteps (CPT-L) [Group A]	Experimental	Not described Receives: Behavioral: Cognitive Processing Therapy- Lifesteps (CPT-L); Behavioral: Lifesteps
Lifesteps [Group B]	Active comparator	Not described Receives: Behavioral: Lifesteps

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Study Screening Visit
Percent of Completed Participants
The percentage of participants that were enrolled and completed the study protocol.
Measured: 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).
Measured: Approximately 24 months of active recruitment

Secondary outcomes (4)

Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
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.
Measured: These measures will be collected at baseline and the 6 week end of study treatment visit.
PTSD Checklist for DSM-5 (PCL-5)
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.
Measured: These measures will be collected at baseline and the 6 week end of study treatment visit.
Number of Patients With Suppressed 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.
Measured: These measures will be collected at 6 months after enrollment.
Medication Pill Count / Compliance
Self Reported percentage of doses taken during the past 30 days. Range 0.0 - 100.0.
Measured: Measure taken at study baseline and at the close of study treatment (6 week visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 202230 Aug 2024

First posted11 Mar 2022
Study start13 Jul 2022
Primary completion30 Aug 2024
Study completion30 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for PTSDStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05275842
Sponsor's protocol ID: Pro00106801
Other IDs: 1R34MH125706-01A1
Status last verified: Feb 2025
First submitted: 25 Feb 2022
Last updated: 4 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40502775
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.
PubMed 39819749

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Feasibility Testing of an Integrated PTSD and Adherence Intervention Cognitive Processing Therapy-Lifesteps (CPT-L) to Improve HIV Outcomes
ClinicalTrials.gov ID: NCT05275842
Acronym / sponsor ID: Pro00106801
Conditions: PTSD, Hiv
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 13 Jul 2022 (actual)
Primary completion: 30 Aug 2024 (actual)
Study completion: 30 Aug 2024 (actual)
First posted: 11 Mar 2022 (actual)
Results: Posted 4 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (3 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive Processing Therapy- Lifesteps (CPT-L)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.	Behavioural	Cognitive Processing Therapy-Lifesteps (CPT-L) [Group A]
LifestepsLifesteps (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.	Behavioural	Cognitive Processing Therapy-Lifesteps (CPT-L) [Group A], Lifesteps [Group B]

Primary outcome

Percent of Eligible Participants
Time frame: 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
Time frame: 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
Time frame: Approximately 24 months of active recruitment
The average number of recruited participants per month (across the entirety of the enrollment window).

4 secondary outcomes

Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: These measures will be collected at baseline and the 6 week end of study treatment visit.
PTSD Checklist for DSM-5 (PCL-5)
Time frame: These measures will be collected at baseline and the 6 week end of study treatment visit.
Number of Patients With Suppressed Viral Load
Time frame: These measures will be collected at 6 months after enrollment.
Medication Pill Count / Compliance
Time frame: Measure taken at study baseline and at the close of study treatment (6 week visit)

Results and safety

Results posted to the registry on 4 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cognitive Processing Therapy-Lifesteps (CPT-L) [Group A]	20	12
Lifesteps [Group B]	21	17

Primary outcome: Percent of Eligible Participants

Time frame: Study Screening Visit. Count of participants. Unit: Participants

Measure	Cohort n = 534
Value	85

Population analysed: Screened population

Primary outcome: Percent of Completed Participants

Time frame: 6-week end of study visit. Count of participants. Unit: Participants

Measure	Cognitive Processing Therapy-Lifesteps (CPT-L) [Group A] n = 20	Lifesteps [Group B] n = 21
Value	12	17

Primary outcome: Average Number of Enrolled Participants Per Month

Time frame: Approximately 24 months of active recruitment. Mean (Full Range). Unit: Participants per month

Measure	Cohort n = 41
Value	1.71 (0 to 6)

Population analysed: flow rate of randomized participants during study recruitment

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events are monitored from study enrollment through the completion of 3-month study follow up visit, an average of 3 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cognitive Processing Therapy-Lifesteps (CPT-L) [Group A]	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Lifesteps [Group B]	0 of 21 (0%)	0 of 21 (0%)	0 of 21

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40502775Lopez 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.
Derived from this study: PubMed 39819749Lopez 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cristina Lopez, PhD principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Processing Therapy- Lifesteps (CPT-L) and Lifesteps in people with PTSD and Hiv, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Eligible Participants (time frame: Study Screening Visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05275842, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.