HIVImpACTNCT02223390
Improving the Health of South African Women With Traumatic Stress in HIV Care (C0147)
A study testing Improving AIDS Care after Trauma (ImpACT) in people with HIV and Trauma Exposure, run by Duke University at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV, Trauma Exposure
- What is being tested?
- Improving AIDS Care after Trauma (ImpACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Africa
- Study dates
- Mar 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected women who are newly initiating ART at the study clinic
- History of sexual trauma
- Meets criteria for traumatic stress
Who cannot join
- Immediate suicide risk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving the Health of South African Women With Traumatic Stress in HIV Care
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.
Read the 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.
- Conditions
- HIV, Trauma Exposure
- Being tested
- Improving AIDS Care after Trauma (ImpACT)
- Keywords
- South Africa, HIV, Mental health, Trauma, Women
- Medical subject headings
- Psychological Well-Being, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improving AIDS Care after Trauma (ImpACT)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Mental health treatment | Experimental | 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. Receives: Behavioral: Improving AIDS Care after Trauma (ImpACT) |
| Standard of Care | No intervention | Participants in standard of care will receive the three-session adherence counseling delivered in the clinic, along with referrals for trauma treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 Days, 180 days
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.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startMar 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Cape Town
- Responsible party
- Principal investigator, Kathleen Sikkema, Duke University
- Investigators
- Kathleen Sikkema, PhD, Principal investigator, Duke University (Currently at Columbia University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223390
- Sponsor's protocol ID
- 2017-0979
- Other IDs
- R34MH102001
- Acronym
- ImpACT
- Status last verified
- Jul 2024
- First submitted
- 20 Aug 2014
- Last updated
- 24 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sikkema KJ, Mulawa MI, Robertson C, Watt MH, Ciya N, Stein DJ, Cherenack EM, Choi KW, Kombora M, Joska JA. Improving AIDS Care After Trauma (ImpACT): Pilot Outcomes of a Coping intervention Among HIV-Infected Women with Sexual Trauma in South Africa. AIDS Behav. 2018 Mar;22(3):1039-1052. doi: 10.1007/s10461-017-2013-1.
PubMed 29270789
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Health of South African Women With Traumatic Stress in HIV Care
- ClinicalTrials.gov ID
- NCT02223390
- Acronym / sponsor ID
- ImpACT / 2017-0979
- Conditions
- HIV, Trauma Exposure
- Keywords
- South Africa, HIV, Mental health, Trauma, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Cape Town
- Study start
- Mar 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Posted 24 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental health treatment | Experimental | Behavioral: Improving AIDS Care after Trauma (ImpACT)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. |
| Standard of Care | No intervention | –Participants in standard of care will receive the three-session adherence counseling delivered in the clinic, along with referrals for trauma treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV infected women who are newly initiating ART at the study clinic
- History of sexual trauma
- Meets criteria for traumatic stress
Key exclusion criteria (1 listed)
- Immediate suicide risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improving AIDS Care after Trauma (ImpACT) | Behavioural | Mental health treatment |
Primary outcome
PTSD Symptoms
Time frame: 90 Days, 180 days
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.
HIV Medication Adherence (% Adherent)
Time frame: 180 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29270789Sikkema KJ, Mulawa MI, Robertson C, Watt MH, Ciya N, Stein DJ, Cherenack EM, Choi KW, Kombora M, Joska JA. Improving AIDS Care After Trauma (ImpACT): Pilot Outcomes of a Coping intervention Among HIV-Infected Women with Sexual Trauma in South Africa. AIDS Behav. 2018 Mar;22(3):1039-1052. doi: 10.1007/s10461-017-2013-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Sikkema, PhD principal investigator
Duke University (Currently at Columbia University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improving AIDS Care after Trauma (ImpACT) in people with HIV and Trauma Exposure, run by Duke University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Symptoms (time frame: 90 Days, 180 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02223390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.