HIV Clinical Trial
— ImpACT+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
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.
Status | Recruiting |
Enrollment | 350 |
Est. completion date | May 30, 2026 |
Est. primary completion date | May 30, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Women with HIV 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 |
Country | Name | City | State |
---|---|---|---|
South Africa | University of Cape Town | Cape Town |
Lead Sponsor | Collaborator |
---|---|
Columbia University | National Institute of Mental Health (NIMH), University of Cape Town |
South Africa,
Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25. — View Citation
Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6. — View Citation
Folkman S, Lazarus RS. The relationship between coping and emotion: implications for theory and research. Soc Sci Med. 1988;26(3):309-17. doi: 10.1016/0277-9536(88)90395-4. — View Citation
Hansen NB, Harrison B, Fambro S, Bodnar S, Heckman TG, Sikkema KJ. The structure of coping among older adults living with HIV/AIDS and depressive symptoms. J Health Psychol. 2013 Feb;18(2):198-211. doi: 10.1177/1359105312440299. Epub 2012 Mar 27. — View Citation
Knettel BA, Mulawa MI, Knippler ET, Ciya N, Robertson C, Joska JA, Sikkema KJ. Women's perspectives on ImpACT: a coping intervention to address sexual trauma and improve HIV care engagement in Cape Town, South Africa. AIDS Care. 2019 Nov;31(11):1389-1396. doi: 10.1080/09540121.2019.1587368. Epub 2019 Mar 1. — View Citation
Knettel BA, Robertson C, Ciya N, Coleman JN, Elliott SA, Joska JA, Sikkema KJ. "I cannot change what happened to me, but I can learn to change how I feel": A case study from ImpACT, an intervention for women with a history of sexual trauma who are living with HIV in Cape Town, South Africa. Psychotherapy (Chic). 2020 Mar;57(1):90-96. doi: 10.1037/pst0000263. Epub 2019 Dec 19. — View Citation
Meade CS, Kershaw TS, Hansen NB, Sikkema KJ. Long-term correlates of childhood abuse among adults with severe mental illness: adult victimization, substance abuse, and HIV sexual risk behavior. AIDS Behav. 2009 Apr;13(2):207-16. doi: 10.1007/s10461-007-9326-4. Epub 2007 Oct 30. — View Citation
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
Sikkema KJ, Choi KW, Robertson C, Knettel BA, Ciya N, Knippler ET, Watt MH, Joska JA. Development of a coping intervention to improve traumatic stress and HIV care engagement among South African women with sexual trauma histories. Eval Program Plann. 2018 Jun;68:148-156. doi: 10.1016/j.evalprogplan.2018.02.007. Epub 2018 Mar 6. — View Citation
Sikkema KJ, Mulawa MI, Robertson C, Watt MH, Ciya N, Stein DJ, Cherenack EM, Choi KW, Kombora M, Joska JA. Improving AIDS Care After Trauma (ImpACT): Pilot Outcomes of a Coping intervention Among HIV-Infected Women with Sexual Trauma in South Africa. AIDS Behav. 2018 Mar;22(3):1039-1052. doi: 10.1007/s10461-017-2013-1. — View Citation
Sikkema KJ, Ranby KW, Meade CS, Hansen NB, Wilson PA, Kochman A. Reductions in traumatic stress following a coping intervention were mediated by decreases in avoidant coping for people living with HIV/AIDS and childhood sexual abuse. J Consult Clin Psychol. 2013 Apr;81(2):274-83. doi: 10.1037/a0030144. Epub 2012 Oct 1. — View Citation
Sikkema KJ, Wilson PA, Hansen NB, Kochman A, Neufeld S, Ghebremichael MS, Kershaw T. Effects of a coping intervention on transmission risk behavior among people living with HIV/AIDS and a history of childhood sexual abuse. J Acquir Immune Defic Syndr. 2008 Apr 1;47(4):506-13. doi: 10.1097/QAI.0b013e318160d727. Erratum In: J Acquir Immune Defic Syndr. 2010 Oct 1;55(2):286. — View Citation
Watt MH, Dennis AC, Choi KW, Ciya N, Joska JA, Robertson C, Sikkema KJ. Impact of Sexual Trauma on HIV Care Engagement: Perspectives of Female Patients with Trauma Histories in Cape Town, South Africa. AIDS Behav. 2017 Nov;21(11):3209-3218. doi: 10.1007/s10461-016-1617-1. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Coping Strategies Scale Score | 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). | Up to 12 months | |
Other | Traumatic Stress Score | 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). | Up to 12 months | |
Primary | Viral suppression/viral load | HIV-1 RNA viral load (COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0, Roche). Viral suppression defined as <50 copies/ml. Continuous measures of viral load, modeled using a log10 transformation. | Up to 12 months | |
Secondary | HIV Care Engagement- Number of Missed Visits | The number of missed visits as determined by medical record review. | Up to 12 months | |
Secondary | HIV Care Engagement- Visit Adherence | Visit adherence defined as the number of scheduled visits attended. | Up to 12 months | |
Secondary | HIV Care Engagement- Gaps in Care | Gaps in care defined as whether >90 days have elapse between visits, as determined by medical record abstraction. | Up to 12 months | |
Secondary | HIV Care Engagement- Visit Constancy | Visit constancy defined as the number of 90-day intervals with >1 completed visit, determined by medical record abstraction. | Up to 12 months | |
Secondary | ART Adherence - Dried Blood Spots | Dried blood spots measuring levels of tenofovir-diphosphate, dichotomized as adherent or non-adherent. | Up to 12 months | |
Secondary | ART Adherence - Pharmacy Visits | ART adherence as defined by the number of pharmacy visits. Determined through medical record abstraction. | Up to 12 months | |
Secondary | ART Adherence - Pharmacy Refill | ART adherence as defined by pharmacy refill data. Determined through medical record abstraction. | Up to 12 months |
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