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

HIV Clinical Trial

— ImpACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223390
• Other study ID #: C147
• Secondary ID: R34MH102001
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: July 2017

Study information

• Verified date: November 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Trauma Exposure

Intervention

Behavioral:
• Improving AIDS Care after Trauma (ImpACT)

Locations

Country	Name	City	State
South Africa	University of Cape Town	Cape Town

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institute of Mental Health (NIMH), University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	90 Days, 180 days
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.	180 days