Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04793217
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2021-03-09
Brief Title:
A Randomized Trial of ImpACT a Coping Intervention for HIV Infected Women With Sexual Trauma in South Africa
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Project Someleze A Randomized Trial of ImpACT a Coping Intervention to Improve Clinical and Mental Health Outcomes Among HIV-infected Women With Sexual Trauma in South Africa
Status:
ACTIVE_NOT_RECRUITING
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:
ImpACT Improving AIDS Care after Trauma is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories We propose a full-scale randomized controlled trial to examine the effect of ImpACT on clinical outcomes in the period after ART initiation and to understand mental health and behavioral mechanisms through which viral suppression can be achieved ImpACT will target women who are initiating ART in order to take advantage of a window of opportunity in HIV care and maximize care engagement The aims are to test the effectiveness of ImpACT and explore its potential for implementation
Detailed Description:
Addressing sexual trauma in the context of HIV care is essential to improve clinical outcomes and mental health among women in South Africa Women represent nearly two-thirds of the South African HIV epidemic and they report disproportionately high rates of sexual trauma which negatively impacts their mental health and may lead to avoidant coping behaviors The psychological sequaelae of trauma can adversely impact retention in HIV care and adherence to antiretroviral therapy ART which may in turn reduce viral suppression and increase the risk of HIV transmission to others HIV care engagement may be particularly challenging in South Africa where women face dual epidemics of HIV and sexual violence with limited access to mental health treatment In this setting interventions that address barriers to effective HIV care engagement and improve health outcomes across the care continuum are urgently needed The primary objective of this study is to evaluate the effectiveness of ImpACT Improving AIDS Care after Trauma an individual-level intervention based on theories of stress and coping on clinical outcomes among HIV-infected women with sexual trauma Secondary objectives include determining whether reductions in traumatic stress and avoidant coping mediate intervention effects on clinical outcomes and assessing potential for scalability and full-scale implementation ImpACT was developed and culturally adapted to the South African context targeting women who are initiating ART classified clinically as naïve initiators restarters or defaulters to make use of a window of opportunity in HIV care and maximize impact on care engagement The proposed five-year study seeks to rigorously evaluate ImpACT using a hybrid effectiveness-implementation design Hybrid Type I with three specific aims 1 evaluate the effectiveness of ImpACT on viral suppression ART adherence and HIV care engagement 2 assess the degree to which reductions in PTSD symptoms and avoidant coping mediate intervention effects and 3 explore potential for scalability and full-scale implementation The trial will enroll 350 women who have initiated ART and have a history of sexual trauma and elevated traumatic stress Participants will be randomized to the ImpACT intervention condition six weekly sessions with six maintenance check-ins over the 12-month follow-up period or the control condition three weekly sessions of Problem Solving Therapy PST All participants will complete a baseline assessment at enrollment within four months of initiating ART with additional behavioral assessments and viral load testing at 4-month 8-month and 12-month follow-up ART adherence will also be assessed using dried blood spot DBS biomarkers and care engagement data will be extracted from medical records at the end of the study period This study is one of the first full-scale trials of a trauma-informed intervention on clinical outcomes for HIV-infected women If effective ImpACT will fill a critical void in evidence-based trauma interventions in this setting and combat the drop-off across the HIV continuum of care in South Africa as well as inform such approaches in the US and globally
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 1R01MH118004 | NIH | None | httpsreporternihgovquickSearch1R01MH118004 |