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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH125706-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Processing Therapy-Lifesteps (CPT-L) [Group A] | Experimental |
| |
| Lifesteps [Group B] | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | These measures will be collected at baseline and the 6 week end of study treatment visit. |
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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:
A score of at least 10 on the Montreal Cognitive Assessment test (MoCA)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristina Lopez, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40502775 | Derived | 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. | |
| 39819749 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Processing Therapy-Lifesteps (CPT-L) [Group A] | 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. Lifesteps: 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. |
| FG001 | Lifesteps [Group B] | Lifesteps: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline Population is denoted as all randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Processing Therapy-Lifesteps (CPT-L) [Group A] | 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. Lifesteps: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Screened population | Posted | Count of Participants | Participants | Study Screening Visit |
|
|
Adverse events are monitored from study enrollment through the completion of 3-month study follow up visit, an average of 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Processing Therapy-Lifesteps (CPT-L) [Group A] | 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. Lifesteps: 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristina Lopez | Medical University of South Carolina | 843-792-2945 | lopezcm@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2023 | Nov 22, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 13, 2023 | Nov 22, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D015658 | HIV Infections |
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|
| 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. |
|
| 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. | 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. | 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. | Measure taken at study baseline and at the close of study treatment (6 week visit) |
| BG001 | Lifesteps [Group B] | Lifesteps: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to: Make current (past month) diagnosis of PTSD Make lifetime diagnosis of PTSD Assess PTSD symptoms over the past week. Higher scores indicate greater PTSD symptoms. | Mean | Standard Deviation | units on a scale |
|
| PTSD Checklist for DSM-5 (PCL-5) | The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including: Monitoring symptom change during and after treatment Screening individuals for PTSD Making a provisional PTSD diagnosis Higher scores indicate greater PTSD symptoms. | Mean | Standard Deviation | units on a scale |
|
| Detectible Viral Load | One participant did not have Viral Load data available in medical record at study baseline. | Count of Participants | Participants |
|
| Medication Compliance | Self reported percentage of medication doses take in the past 30 days. Measured at study baseline. Range 0.0% to 100.0%. | Data as collected as a part of the baseline survey and some data is item missing. | Mean | Standard Deviation | Percentage of Doses Taken |
|
|
| Primary | Percent of Completed Participants | The percentage of participants that were enrolled and completed the study protocol. | Posted | Count of Participants | Participants | 6-week end of study visit |
|
|
|
| Primary | Average Number of Enrolled Participants Per Month | The average number of recruited participants per month (across the entirety of the enrollment window). | flow rate of randomized participants during study recruitment | Posted | Mean | Full Range | Participants per month | Approximately 24 months of active recruitment |
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| Secondary | 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. | analysis population is those who were randomized to study treatment and have data available at the end of study treatment. | Posted | Mean | Standard Deviation | units on a scale | These measures will be collected at baseline and the 6 week end of study treatment visit. |
|
|
|
| Secondary | 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. | analysis population is those who were randomized to study treatment and have data available at the end of study treatment. | Posted | Mean | Standard Deviation | units on a scale | These measures will be collected at baseline and the 6 week end of study treatment visit. |
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|
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| Secondary | 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. | those with available viral load data taken between end of study treatment and follow-up | Posted | Count of Participants | Participants | These measures will be collected at 6 months after enrollment. |
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| Secondary | Medication Pill Count / Compliance | Self Reported percentage of doses taken during the past 30 days. Range 0.0 - 100.0. | Available data at the close of study treatment (6-week visit) | Posted | Mean | Standard Deviation | percentage of doses taken | Measure taken at study baseline and at the close of study treatment (6 week visit) |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Lifesteps [Group B] | Lifesteps: 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. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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