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
|Condition or disease||Intervention/treatment||Phase|
|HIV Trauma Exposure||Behavioral: Improving AIDS Care After Trauma + Behavioral: Adapted Problem-Solving Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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.
- 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.
- HIV Care Engagement- Number of Missed Visits [ Time Frame: Up to 12 months ]The number of missed visits as determined by medical record review.
- HIV Care Engagement- Visit Adherence [ Time Frame: Up to 12 months ]Visit adherence defined as the number of scheduled visits attended.
- 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.
- 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.
- 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.
- 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.
- ART Adherence - Pharmacy Refill [ Time Frame: Up to 12 months ]ART adherence as defined by pharmacy refill data. Determined through medical record abstraction.
- 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).
- 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 , 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).
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
|Contact: Kathleen J Sikkema, PhDfirstname.lastname@example.org|
|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|
|Principal Investigator:||Kathleen J Sikkema, PhD||Columbia University|