Ignite Creation Date:
2024-05-06 @ 3:10 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02223390
Status:
COMPLETED
Last Update Posted:
2020-11-23
First Post:
2014-08-20
Brief Title:
Improving the Health of South African Women With Traumatic Stress in HIV Care C0147
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Improving the Health of South African Women With Traumatic Stress in HIV Care
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ImpACT
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 US 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34MH102001 | NIH | None | httpsreporternihgovquickSearchR34MH102001 |