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Improving the Health of South African Women With Traumatic Stress in HIV Care (C0147)

Improving the Health of South African Women With Traumatic Stress in HIV Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02223390
Acronym
ImpACT
Enrollment
64
Registered
2014-08-22
Start date
2016-03-31
Completion date
2017-07-31
Last updated
2024-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Trauma Exposure

Keywords

South Africa, HIV, Mental health, Trauma, Women

Brief summary

In this study, the investigators propose to develop Improving AIDS Care after Trauma (ImpACT), an intervention based on theories of stress and coping and evidence-based treatment for traumatic stress. The intervention will target women in South Africa who have histories of sexual trauma and are newly initiating antiretroviral therapy (ART) in order to reduce avoidant coping and traumatic stress, improve care engagement, and reduce HIV risk behaviors.

Detailed description

HIV-infected women in South Africa report high rates of sexual trauma, which negatively impacts their mental health and potentially influences engagement in HIV care (retention in care and adherence to antiretroviral therapy) and risk behaviors. Addressing the traumatic stress resulting from sexual trauma could improve these HIV-related outcomes, which in turn may prevent HIV transmission through suppression of the virus and reduction in HIV risk behaviors. Intervention research among HIV-infected populations with trauma histories in the U.S. demonstrates that a coping approach, particularly one that reduces the use of avoidant coping strategies, is efficacious in reducing traumatic stress and improving health behaviors. Although South Africa faces dual epidemics of HIV and sexual violence, trauma treatment has not been well-integrated into the HIV care setting. The proposed 3-year study will develop and pilot test an intervention called ImpACT (Improving AIDS Care after Trauma) to reduce avoidant coping, traumatic stress, and risk behaviors, and increase engagement in care. The intervention will take place in a public ART clinic and will target women during the critical period when they initiate ART in order to maximize the impact on engagement in care. Qualitative data collection with staff, providers, and HIV-infected female patients at the study clinic will elicit feedback on the content and delivery of ImpACT and key aspects of the study protocol. ImpACT will then be piloted with 60 women who are new ART enrollees with a history of sexual trauma and elevated traumatic stress. Participants will be randomized to the control condition (standard of care, or SoC: 3 adherence counseling sessions required of all patients initiating ART at the clinic) or the intervention condition (SoC + ImpACT), and will complete assessments at baseline, 3, and 6 months post-randomization, with care engagement data extracted from medical records at the end of the study period. The study has three specific aims: 1) to develop a brief and scalable coping intervention for delivery in the South African HIV care setting for women with sexual trauma histories; 2) to establish the methodological details of an experimental protocol for a robust randomized control trial; and 3) to pilot test the ImpACT intervention with 60 HIV-infected women with histories of sexual trauma who are initiating ART in order to determine feasibility and acceptability in the HIV care setting, and explore the impact on avoidant coping, traumatic stress, engagement in care, and HIV risk behaviors. The goal at the completion of this study is to have a structured intervention curriculum that is culturally relevant for HIV infected women in South Africa, a full experimental protocol that is appropriate for the South African care setting, and data on feasibility, acceptability, and target outcomes. These products can be leveraged to inform an R01 application for rigorous evaluation of the ImpACT intervention. We are confident that this developmental work will significantly enhance the probability of success of a larger randomized control trial.

Interventions

BEHAVIORALImproving AIDS Care after Trauma (ImpACT)

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Cape Town
CollaboratorOTHER
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* HIV infected women who are newly initiating ART at the study clinic * History of sexual trauma * Meets criteria for traumatic stress

Exclusion criteria

* Immediate suicide risk

Design outcomes

Primary

MeasureTime frameDescription
PTSD Symptoms90 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.
HIV Medication Adherence (% Adherent)180 daysAssessed 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.

Countries

South Africa

Participant flow

Participants by arm

ArmCount
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)
32
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.
32
Total64

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up94

Baseline characteristics

CharacteristicStandard of CareTotalMental Health Treatment
Age, Continuous29.0 years
STANDARD_DEVIATION 8.4
29.1 years
STANDARD_DEVIATION 7.5
29.2 years
STANDARD_DEVIATION 6.6
PTSD Symptoms (PCL-5)
PCL - Cluster C Avoidance
3.03 units on a scale
STANDARD_DEVIATION 2.62
3.78 units on a scale
STANDARD_DEVIATION 2.86
4.53 units on a scale
STANDARD_DEVIATION 2.93
PTSD Symptoms (PCL-5)
PCL - Cluster E Arousal
8.31 units on a scale
STANDARD_DEVIATION 6.34
10.59 units on a scale
STANDARD_DEVIATION 7.15
12.88 units on a scale
STANDARD_DEVIATION 7.25
PTSD Symptoms (PCL-5)
PCL - total symptom severity score
30.72 units on a scale
STANDARD_DEVIATION 20.27
37.00 units on a scale
STANDARD_DEVIATION 21.89
43.28 units on a scale
STANDARD_DEVIATION 21.94
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
32 Participants64 Participants32 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
South Africa
32 participants64 participants32 participants
Sex: Female, Male
Female
32 Participants64 Participants32 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 320 / 32
other
Total, other adverse events
0 / 320 / 32
serious
Total, serious adverse events
0 / 320 / 32

Outcome results

Primary

HIV Medication Adherence (% Adherent)

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.

Time frame: 180 days

Population: Subset of participants newly initiating ART (excluding re-initiators and non-initiators; n=54, 49 with biomarker data)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mental Health TreatmentHIV Medication Adherence (% Adherent)19 Participants
Standard of CareHIV Medication Adherence (% Adherent)15 Participants
p-value: 0.05Chi-squared
Primary

PTSD Symptoms

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.

Time frame: 90 Days, 180 days

ArmMeasureGroupValue (MEAN)Dispersion
Mental Health TreatmentPTSD SymptomsPCL - total symptom severity (3 mos)25.79 score on a scaleStandard Error 5.4
Mental Health TreatmentPTSD SymptomsPCL - total symptom severity (6 mos)28.61 score on a scaleStandard Error 5.04
Mental Health TreatmentPTSD SymptomsPCL - Cluster C Avoidance (3 mos)2.21 score on a scaleStandard Error 0.63
Mental Health TreatmentPTSD SymptomsPCL - Cluster C Avoidance (6 mos)2.96 score on a scaleStandard Error 0.6
Mental Health TreatmentPTSD SymptomsPCL - Cluster E Hyperarousal (3 mos)7.47 score on a scaleStandard Error 1.36
Mental Health TreatmentPTSD SymptomsPCL - Cluster E Hyperarousal (6 mos)7.91 score on a scaleStandard Error 1.54
Standard of CarePTSD SymptomsPCL - Cluster E Hyperarousal (3 mos)8.00 score on a scaleStandard Error 1.21
Standard of CarePTSD SymptomsPCL - total symptom severity (3 mos)23.04 score on a scaleStandard Error 3.6
Standard of CarePTSD SymptomsPCL - Cluster C Avoidance (6 mos)2.71 score on a scaleStandard Error 0.47
Standard of CarePTSD SymptomsPCL - total symptom severity (6 mos)22.50 score on a scaleStandard Error 3.47
Standard of CarePTSD SymptomsPCL - Cluster E Hyperarousal (6 mos)6.75 score on a scaleStandard Error 1.1
Standard of CarePTSD SymptomsPCL - Cluster C Avoidance (3 mos)2.23 score on a scaleStandard Error 0.39
Comparison: Statistical analyses reported below is for PCL - Total at 3 months.p-value: 0.08Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026