Trial Outcomes & Findings for Improving the Health of South African Women With Traumatic Stress in HIV Care (C0147) (NCT NCT02223390)
NCT ID: NCT02223390
Last Updated: 2024-07-24
Results Overview
Self-report, measured by the PTSD checklist, civilian version (PCL-5). 20-item self-report questionnaire, assessed severity of symptoms that parallel the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria for PTSD. Participants were asked to indicate the extent to which they were bothered by problems experienced in the past month in relation to a traumatic experience of abuse or act of violence (0 = not at all to 4 = extremely). Total severity score (range: 0-80; higher scores indicating higher symptom severity, \>= 33 indicating PTSD) and subscale totals (Avoidance - Cluster C, range: 0-8, higher scores indicating higher avoidance symptom severity; and Hyperarousal - Cluster E, range: 0-24, higher scores indicating higher hyperarousal symptom severity) were examined.
COMPLETED
NA
64 participants
90 Days, 180 days
2024-07-24
Participant Flow
Participant milestones
| Measure |
Mental Health Treatment
The experimental condition, ImpACT, was developed in the pilot phase of the study. The intervention will be 4 sessions of individual psychological treatment related to stress, coping, and HIV adherence, followed by three group sessions. Sessions will follow an intervention manual and be delivered by a psychiatric nurse (or equivalent nonspecialist in mental health) who is supervised by a trained clinical psychologist.
Improving AIDS Care after Trauma (ImpACT)
|
Standard of Care
Participants in standard of care will receive the three-session adherence counseling delivered in the clinic, along with referrals for trauma treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
23
|
28
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
| Measure |
Mental Health Treatment
The experimental condition, ImpACT, was developed in the pilot phase of the study. The intervention will be 4 sessions of individual psychological treatment related to stress, coping, and HIV adherence, followed by three group sessions. Sessions will follow an intervention manual and be delivered by a psychiatric nurse (or equivalent nonspecialist in mental health) who is supervised by a trained clinical psychologist.
Improving AIDS Care after Trauma (ImpACT)
|
Standard of Care
Participants in standard of care will receive the three-session adherence counseling delivered in the clinic, along with referrals for trauma treatment.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
4
|
Baseline Characteristics
Improving the Health of South African Women With Traumatic Stress in HIV Care (C0147)
Baseline characteristics by cohort
| Measure |
Mental Health Treatment
n=32 Participants
The experimental condition, ImpACT, was developed in the pilot phase of the study. The intervention will be 4 sessions of individual psychological treatment related to stress, coping, and HIV adherence, followed by three group sessions. Sessions will follow an intervention manual and be delivered by a psychiatric nurse (or equivalent nonspecialist in mental health) who is supervised by a trained clinical psychologist.
Improving AIDS Care after Trauma (ImpACT)
|
Standard of Care
n=32 Participants
Participants in standard of care will receive the three-session adherence counseling delivered in the clinic, along with referrals for trauma treatment.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.2 years
STANDARD_DEVIATION 6.6 • n=99 Participants
|
29.0 years
STANDARD_DEVIATION 8.4 • n=107 Participants
|
29.1 years
STANDARD_DEVIATION 7.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
South Africa
|
32 participants
n=99 Participants
|
32 participants
n=107 Participants
|
64 participants
n=206 Participants
|
|
PTSD Symptoms (PCL-5)
PCL - total symptom severity score
|
43.28 units on a scale
STANDARD_DEVIATION 21.94 • n=99 Participants
|
30.72 units on a scale
STANDARD_DEVIATION 20.27 • n=107 Participants
|
37.00 units on a scale
STANDARD_DEVIATION 21.89 • n=206 Participants
|
|
PTSD Symptoms (PCL-5)
PCL - Cluster C Avoidance
|
4.53 units on a scale
STANDARD_DEVIATION 2.93 • n=99 Participants
|
3.03 units on a scale
STANDARD_DEVIATION 2.62 • n=107 Participants
|
3.78 units on a scale
STANDARD_DEVIATION 2.86 • n=206 Participants
|
|
PTSD Symptoms (PCL-5)
PCL - Cluster E Arousal
|
12.88 units on a scale
STANDARD_DEVIATION 7.25 • n=99 Participants
|
8.31 units on a scale
STANDARD_DEVIATION 6.34 • n=107 Participants
|
10.59 units on a scale
STANDARD_DEVIATION 7.15 • n=206 Participants
|
PRIMARY outcome
Timeframe: 90 Days, 180 daysSelf-report, measured by the PTSD checklist, civilian version (PCL-5). 20-item self-report questionnaire, assessed severity of symptoms that parallel the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria for PTSD. Participants were asked to indicate the extent to which they were bothered by problems experienced in the past month in relation to a traumatic experience of abuse or act of violence (0 = not at all to 4 = extremely). Total severity score (range: 0-80; higher scores indicating higher symptom severity, \>= 33 indicating PTSD) and subscale totals (Avoidance - Cluster C, range: 0-8, higher scores indicating higher avoidance symptom severity; and Hyperarousal - Cluster E, range: 0-24, higher scores indicating higher hyperarousal symptom severity) were examined.
Outcome measures
| Measure |
Mental Health Treatment
n=32 Participants
The experimental condition, ImpACT, was developed in the pilot phase of the study. The intervention will be 4 sessions of individual psychological treatment related to stress, coping, and HIV adherence, followed by three group sessions. Sessions will follow an intervention manual and be delivered by a psychiatric nurse (or equivalent nonspecialist in mental health) who is supervised by a trained clinical psychologist.
Improving AIDS Care after Trauma (ImpACT)
|
Standard of Care
n=32 Participants
Participants in standard of care will receive the three-session adherence counseling delivered in the clinic, along with referrals for trauma treatment.
|
|---|---|---|
|
PTSD Symptoms
PCL - total symptom severity (3 mos)
|
25.79 score on a scale
Standard Error 5.40
|
23.04 score on a scale
Standard Error 3.60
|
|
PTSD Symptoms
PCL - total symptom severity (6 mos)
|
28.61 score on a scale
Standard Error 5.04
|
22.50 score on a scale
Standard Error 3.47
|
|
PTSD Symptoms
PCL - Cluster C Avoidance (3 mos)
|
2.21 score on a scale
Standard Error 0.63
|
2.23 score on a scale
Standard Error 0.39
|
|
PTSD Symptoms
PCL - Cluster C Avoidance (6 mos)
|
2.96 score on a scale
Standard Error 0.60
|
2.71 score on a scale
Standard Error 0.47
|
|
PTSD Symptoms
PCL - Cluster E Hyperarousal (3 mos)
|
7.47 score on a scale
Standard Error 1.36
|
8.00 score on a scale
Standard Error 1.21
|
|
PTSD Symptoms
PCL - Cluster E Hyperarousal (6 mos)
|
7.91 score on a scale
Standard Error 1.54
|
6.75 score on a scale
Standard Error 1.10
|
PRIMARY outcome
Timeframe: 180 daysPopulation: Subset of participants newly initiating ART (excluding re-initiators and non-initiators; n=54, 49 with biomarker data)
Assessed through biomarkers of dried blood spots (DBS) testing for presence of antiretroviral therapy (ART) (tenofovir, emtricitabine, and efavirenz) at 6 month assessment, supplemented by viral load (VL; considered adherent if VL \<=40 copies/ml) when DBS unavailable. Outcome dichotomized.
Outcome measures
| Measure |
Mental Health Treatment
n=23 Participants
The experimental condition, ImpACT, was developed in the pilot phase of the study. The intervention will be 4 sessions of individual psychological treatment related to stress, coping, and HIV adherence, followed by three group sessions. Sessions will follow an intervention manual and be delivered by a psychiatric nurse (or equivalent nonspecialist in mental health) who is supervised by a trained clinical psychologist.
Improving AIDS Care after Trauma (ImpACT)
|
Standard of Care
n=26 Participants
Participants in standard of care will receive the three-session adherence counseling delivered in the clinic, along with referrals for trauma treatment.
|
|---|---|---|
|
HIV Medication Adherence (% Adherent)
|
19 Participants
|
15 Participants
|
Adverse Events
Mental Health Treatment
Standard of Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kathleen Sikkema, PhD
Duke University (Currently at Columbia University)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place