Trial Outcomes & Findings for CPT-L to Improve Outcomes for Individuals With HIV and PTSD (NCT NCT05275842)
NCT ID: NCT05275842
Last Updated: 2025-03-04
Results Overview
The percentage of participants that were classified as eligible out of all participants that were screened for the purpose of the study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Study Screening Visit
Results posted on
2025-03-04
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
|
Overall Study
COMPLETED
|
12
|
17
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant did not have Viral Load data available in medical record at study baseline.
Baseline characteristics by cohort
| Measure |
Cognitive Processing Therapy-Lifesteps (CPT-L) [Group A]
n=20 Participants
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.
|
Lifesteps [Group B]
n=21 Participants
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.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=20 Participants
|
20 Participants
n=21 Participants
|
37 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=20 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=41 Participants
|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 11.8 • n=20 Participants
|
40.8 years
STANDARD_DEVIATION 11.6 • n=21 Participants
|
44.8 years
STANDARD_DEVIATION 12.3 • n=41 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=20 Participants
|
8 Participants
n=21 Participants
|
15 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=20 Participants
|
13 Participants
n=21 Participants
|
26 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=20 Participants
|
14 Participants
n=21 Participants
|
25 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=20 Participants
|
4 Participants
n=21 Participants
|
12 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
21 participants
n=21 Participants
|
41 participants
n=41 Participants
|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
|
33.5 units on a scale
STANDARD_DEVIATION 8.8 • n=20 Participants
|
37.0 units on a scale
STANDARD_DEVIATION 9.7 • n=21 Participants
|
35.3 units on a scale
STANDARD_DEVIATION 9.3 • n=41 Participants
|
|
PTSD Checklist for DSM-5 (PCL-5)
|
36.8 units on a scale
STANDARD_DEVIATION 12.3 • n=20 Participants
|
42.6 units on a scale
STANDARD_DEVIATION 11.3 • n=21 Participants
|
39.7 units on a scale
STANDARD_DEVIATION 12 • n=41 Participants
|
|
Detectible Viral Load
|
9 Participants
n=20 Participants • One participant did not have Viral Load data available in medical record at study baseline.
|
7 Participants
n=20 Participants • One participant did not have Viral Load data available in medical record at study baseline.
|
16 Participants
n=40 Participants • One participant did not have Viral Load data available in medical record at study baseline.
|
|
Medication Compliance
|
90.9 Percentage of Doses Taken
STANDARD_DEVIATION 21.9 • n=17 Participants • Data as collected as a part of the baseline survey and some data is item missing.
|
93.8 Percentage of Doses Taken
STANDARD_DEVIATION 11.5 • n=17 Participants • Data as collected as a part of the baseline survey and some data is item missing.
|
92.4 Percentage of Doses Taken
STANDARD_DEVIATION 17.3 • n=34 Participants • Data as collected as a part of the baseline survey and some data is item missing.
|
PRIMARY outcome
Timeframe: Study Screening VisitPopulation: Screened population
The percentage of participants that were classified as eligible out of all participants that were screened for the purpose of the study.
Outcome measures
| Measure |
Cohort
n=534 Participants
flow of participant prior to randomization, noted as the number eligible out of the screened population
|
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.
|
|---|---|---|
|
Percent of Eligible Participants
|
85 Participants
|
—
|
PRIMARY outcome
Timeframe: 6-week end of study visitThe percentage of participants that were enrolled and completed the study protocol.
Outcome measures
| Measure |
Cohort
n=20 Participants
flow of participant prior to randomization, noted as the number eligible out of the screened population
|
Lifesteps [Group B]
n=21 Participants
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.
|
|---|---|---|
|
Percent of Completed Participants
|
12 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Approximately 24 months of active recruitmentPopulation: flow rate of randomized participants during study recruitment
The average number of recruited participants per month (across the entirety of the enrollment window).
Outcome measures
| Measure |
Cohort
n=41 Participants
flow of participant prior to randomization, noted as the number eligible out of the screened population
|
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.
|
|---|---|---|
|
Average Number of Enrolled Participants Per Month
|
1.71 Participants per month
Interval 0.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cohort
n=11 Participants
flow of participant prior to randomization, noted as the number eligible out of the screened population
|
Lifesteps [Group B]
n=17 Participants
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.
|
|---|---|---|
|
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
|
18.5 units on a scale
Standard Deviation 15.1
|
29.4 units on a scale
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cohort
n=11 Participants
flow of participant prior to randomization, noted as the number eligible out of the screened population
|
Lifesteps [Group B]
n=17 Participants
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.
|
|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
|
18.5 units on a scale
Standard Deviation 20.5
|
33.7 units on a scale
Standard Deviation 16.8
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Cohort
n=15 Participants
flow of participant prior to randomization, noted as the number eligible out of the screened population
|
Lifesteps [Group B]
n=13 Participants
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.
|
|---|---|---|
|
Number of Patients With Suppressed Viral Load
|
14 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 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)
Self Reported percentage of doses taken during the past 30 days. Range 0.0 - 100.0.
Outcome measures
| Measure |
Cohort
n=7 Participants
flow of participant prior to randomization, noted as the number eligible out of the screened population
|
Lifesteps [Group B]
n=13 Participants
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.
|
|---|---|---|
|
Medication Pill Count / Compliance
|
99.1 percentage of doses taken
Standard Deviation 1.5
|
89.2 percentage of doses taken
Standard Deviation 27.1
|
Adverse Events
Cognitive Processing Therapy-Lifesteps (CPT-L) [Group A]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lifesteps [Group B]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place