Hiv, PTSD
Conditions
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.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALLifesteps
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.
Sponsors
National Institute of Mental Health (NIMH)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Eligible Participants | 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 | 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 | Approximately 24 months of active recruitment | The average number of recruited participants per month (across the entirety of the enrollment window). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| Medication Pill Count / Compliance | Measure taken at study baseline and at the close of study treatment (6 week visit) | Self Reported percentage of doses taken during the past 30 days. Range 0.0 - 100.0. |
| PTSD Checklist for DSM-5 (PCL-5) | These measures will be collected at baseline and the 6 week end of study treatment visit. | 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. |
| Number of Patients With Suppressed Viral Load | These measures will be collected at 6 months after enrollment. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 21 |
| Total | 41 |
Baseline characteristics
| Characteristic | Cognitive Processing Therapy-Lifesteps (CPT-L) [Group A] | Lifesteps [Group B] | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 20 Participants | 37 Participants |
| Age, Continuous | 49.1 years STANDARD_DEVIATION 11.8 | 40.8 years STANDARD_DEVIATION 11.6 | 44.8 years STANDARD_DEVIATION 12.3 |
| Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | 33.5 units on a scale STANDARD_DEVIATION 8.8 | 37.0 units on a scale STANDARD_DEVIATION 9.7 | 35.3 units on a scale STANDARD_DEVIATION 9.3 |
| Detectible Viral Load | 9 Participants | 7 Participants | 16 Participants |
| Medication Compliance | 90.9 Percentage of Doses Taken STANDARD_DEVIATION 21.9 | 93.8 Percentage of Doses Taken STANDARD_DEVIATION 11.5 | 92.4 Percentage of Doses Taken STANDARD_DEVIATION 17.3 |
| PTSD Checklist for DSM-5 (PCL-5) | 36.8 units on a scale STANDARD_DEVIATION 12.3 | 42.6 units on a scale STANDARD_DEVIATION 11.3 | 39.7 units on a scale STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 14 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 4 Participants | 12 Participants |
| Region of Enrollment United States | 20 participants | 21 participants | 41 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 21 |
| other Total, other adverse events | 0 / 20 | 0 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 |
Outcome results
Primary
Average Number of Enrolled Participants Per Month
The average number of recruited participants per month (across the entirety of the enrollment window).
Time frame: Approximately 24 months of active recruitment
Population: flow rate of randomized participants during study recruitment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort | Average Number of Enrolled Participants Per Month | 1.71 Participants per month |
Primary
Percent of Completed Participants
The percentage of participants that were enrolled and completed the study protocol.
Time frame: 6-week end of study visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort | Percent of Completed Participants | 12 Participants |
| Lifesteps [Group B] | Percent of Completed Participants | 17 Participants |
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.
Time frame: Study Screening Visit
Population: Screened population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort | Percent of Eligible Participants | 85 Participants |
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.
Time frame: These measures will be collected at baseline and the 6 week end of study treatment visit.
Population: analysis population is those who were randomized to study treatment and have data available at the end of study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort | Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | 18.5 units on a scale | Standard Deviation 15.1 |
| Lifesteps [Group B] | Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | 29.4 units on a scale | Standard Deviation 14.3 |
Secondary
Medication Pill Count / Compliance
Self Reported percentage of doses taken during the past 30 days. Range 0.0 - 100.0.
Time frame: Measure taken at study baseline and at the close of study treatment (6 week visit)
Population: Available data at the close of study treatment (6-week visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort | Medication Pill Count / Compliance | 99.1 percentage of doses taken | Standard Deviation 1.5 |
| Lifesteps [Group B] | Medication Pill Count / Compliance | 89.2 percentage of doses taken | Standard Deviation 27.1 |
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.
Time frame: These measures will be collected at 6 months after enrollment.
Population: those with available viral load data taken between end of study treatment and follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort | Number of Patients With Suppressed Viral Load | 14 Participants |
| Lifesteps [Group B] | Number of Patients With Suppressed Viral Load | 10 Participants |
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.
Time frame: These measures will be collected at baseline and the 6 week end of study treatment visit.
Population: analysis population is those who were randomized to study treatment and have data available at the end of study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort | PTSD Checklist for DSM-5 (PCL-5) | 18.5 units on a scale | Standard Deviation 20.5 |
| Lifesteps [Group B] | PTSD Checklist for DSM-5 (PCL-5) | 33.7 units on a scale | Standard Deviation 16.8 |