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A Randomized Trial of ImpACT+, a Coping Intervention for HIV Infected Women With Sexual Trauma in South Africa (ImpACT+)

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ClinicalTrials.gov Identifier: NCT04793217
Recruitment Status : Recruiting
First Posted : March 11, 2021
Last Update Posted : May 19, 2021
Sponsor:
Collaborators:
University of Cape Town
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Kathleen J. Sikkema, PhD, Columbia University

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. The investigators propose a full-scale randomized controlled trial to examine the effect of ImpACT+ on clinical outcomes in the period after antiretroviral therapy (ART) initiation and to understand mental health and behavioral mechanisms through which viral suppression can be achieved. ImpACT+ will target women who are newly 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.

Condition or disease Intervention/treatment Phase
HIV Trauma Exposure Behavioral: Improving AIDS Care After Trauma + Behavioral: Adapted Problem-Solving Therapy Not Applicable

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 sequelae 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 newly initiating ART 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 newly 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 U.S. and globally.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 18, 2021
Estimated Primary Completion Date : May 30, 2024
Estimated Study Completion Date : May 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Improving AIDS Care after Trauma+
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. The ImpACT+ individual sessions will focus on coping skills and care engagement during an early critical period, while maintenance check-ins will serve to reinforce positive change and support the ongoing implementation of skills as new challenges arise.
Behavioral: Improving AIDS Care After Trauma +
ImpACT+ integrates skills for HIV treatment adherence and coping with trauma, tailored to the South African context. This includes exploration of values informing care engagement, recognizing the synergistic stress of sexual trauma and HIV, understanding the contribution of stressors to maladaptive coping, and developing adaptive methods for coping as alternatives to avoidance. ImpACT+ will be delivered in private spaces at the primary care clinic and will consist of 6 individual sessions followed by 6 maintenance check-ins. Individual sessions focus on coping, adherence, and care engagement during an early critical period, while maintenance check-ins reinforce positive change and support ongoing implementation of skills. Evidence supports a 6-session format in low-resource settings. Individual sessions will begin within 2 weeks after the baseline survey and be completed by the 4-month assessment. Maintenance check-ins will begin following the 4-month assessment.

Active Comparator: Adapted Problem-Solving Therapy
Participants randomly assigned to the control condition will receive a brief adapted version of problem-solving therapy (PST), based on Problem Management Plus, a component of the World Health Organization (WHO) Mental Health Gap Action Programme (mhGAP). PST is a psychoeducational treatment focused on managing the negative effects of stressful life events. PST has been found to be effective for a range of problems, such as depression, and is recommended for implementation in low-resource settings.
Behavioral: Adapted Problem-Solving Therapy
Participants will receive three weekly individual sessions of adapted PST. The goal of PST is to identify problems that interfere with daily activities and address them through problem-orientation work. We anticipate stressors will include (a) relationship difficulties, including family stress, (b) financial stress and unemployment, (c) general impact of HIV infection, and (d) overall chronic stress. Thus, PST may indirectly address stressors that may impact care engagement, but will not address the intersection of HIV and trauma specifically.




Primary Outcome Measures :
  1. Viral suppression/viral load [ Time Frame: Up to 12 months ]
    HIV-1 RNA viral load (COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0, Roche). Viral suppression defined as <40 copies/ml. The lower limit of detection (LDL) for HIV viral RNA = 20 copies/mL. If, for some reason, there is not enough plasma for the typical protocol, a result will be returned as LDL if < 100 copies/mL (COBAS) or < 50 copies/mL (Alinity). Continuous measures of viral load, modeled using a log10 transformation.


Secondary Outcome Measures :
  1. HIV Care Engagement- Number of Missed Visits [ Time Frame: Up to 12 months ]
    The number of missed visits as determined by medical record review.

  2. HIV Care Engagement- Visit Adherence [ Time Frame: Up to 12 months ]
    Visit adherence defined as the number of scheduled visits attended.

  3. HIV Care Engagement- Gaps in Care [ Time Frame: Up to 12 months ]
    Gaps in care defined as whether >90 days have elapse between visits, as determined by medical record abstraction.

  4. HIV Care Engagement- Visit Constancy [ Time Frame: Up to 12 months ]
    Visit constancy defined as the number of 90-day intervals with >1 completed visit, determined by medical record abstraction.

  5. ART Adherence - Dried Blood Spots [ Time Frame: Up to 12 months ]
    Dried blood spots measuring levels of tenofovir-diphosphate, dichotomized as adherent or non-adherent.

  6. ART Adherence - Pharmacy Visits [ Time Frame: Up to 12 months ]
    ART adherence as defined by the number of pharmacy visits. Determined through medical record abstraction.

  7. ART Adherence - Pharmacy Refill [ Time Frame: Up to 12 months ]
    ART adherence as defined by pharmacy refill data. Determined through medical record abstraction.


Other Outcome Measures:
  1. Coping Strategies Scale Score [ Time Frame: Up to 12 months ]
    Self report, measured by Coping Strategies scale (Sikkema et al., 2018; based on Carver, 1997; Folkman & Lazarus, 1988; Hansen et al., 2013; Namir et al., 1987). Coping will be assessed using 41 items that were previously used to measure coping in Sub-Saharan Africa or among HIV-infected individuals. Participants will be asked how often they used these strategies in the past month to help deal with their HIV illness (1 = not at all to 4 = most of the time).

  2. Traumatic Stress Score [ Time Frame: Up to 12 months ]
    Self report, measured by PTSD Checklist-Civilian version for the The Diagnostic and Statistical Manual of Mental Disorders (DSM-5; Blevins CA, Weathers FW, Davis MT, Witte TK, and Domino JKL, 2015). PCL-5 [51], a 20-item self-report questionnaire, will assess severity of symptoms that parallel DSM-5 diagnostic criteria for PTSD. Participants will be 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only women are eligible for this study
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infected women who receive care at either study clinic
  • >2 weeks to <4 months since ART initiation
  • History of sexual trauma
  • Meets criteria for traumatic stress
  • Xhosa speaking

Exclusion Criteria:

- High suicide risk


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04793217


Contacts
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Contact: Kathleen J Sikkema, PhD 212-305-8236 ks3364@cumc.columbia.edu

Locations
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South Africa
University of Cape Town Recruiting
Cape Town, South Africa
Contact: John Joska, MBChB,PhD    +27 21 404 2164    John.Joska@uct.ac.za   
Principal Investigator: John J Joska, MBChB,PhD         
Sponsors and Collaborators
Columbia University
University of Cape Town
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Kathleen J Sikkema, PhD Columbia University
Publications:
Namir S, Wolcott DL, Fawzy FI, Alumbaugh MJ. Coping with AIDS: Psychological and health implications. J Appl Soc Psychol. 1987;17(3):309-328. doi:10.1111/j.1559-1816.1987.tb00316.x

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Responsible Party: Kathleen J. Sikkema, PhD, Stephen Smith Professor of Sociomedical Sciences; Chair, Department of Sociomedical Sciences, Columbia University
ClinicalTrials.gov Identifier: NCT04793217    
Other Study ID Numbers: AAAS3667
1R01MH118004 ( U.S. NIH Grant/Contract )
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators will share an anonymized dataset following publications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Following outcome publications.
Access Criteria: Access will be granted upon reasonable requests.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kathleen J. Sikkema, PhD, Columbia University:
South Africa
HIV
Mental health
Trauma
Women
Additional relevant MeSH terms:
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Wounds and Injuries