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

NCT04793217 | Active Not Recruiting DMC

• 2 other identifiers: AAAS36671R01MH118004
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Trauma Exposure

Keywords

South Africa; HIV; Mental health; Trauma; Women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• HIV Care Engagement- Number of Missed Visits

  Up to 12 months

• HIV Care Engagement- Visit Adherence

  Up to 12 months

• HIV Care Engagement- Gaps in Care

  Up to 12 months

• HIV Care Engagement- Visit Constancy

  Up to 12 months

• ART Adherence - Dried Blood Spots

  Up to 12 months

Other Outcomes (2)

• Coping Strategies Scale Score

  Up to 12 months

• Traumatic Stress Score

  Up to 12 months

Study Arms (2)

Improving AIDS Care after Trauma+

EXPERIMENTAL

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 +

Adapted Problem-Solving Therapy

ACTIVE COMPARATOR

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

Interventions

Improving AIDS Care After Trauma + BEHAVIORAL

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.

Improving AIDS Care after Trauma+

Adapted Problem-Solving Therapy BEHAVIORAL

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.

Adapted Problem-Solving Therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only women are eligible for this study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- High suicide risk

Sponsors & Collaborators

• Columbia University: lead
• University of Cape Town: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Cape Town

Cape Town, South Africa

Location

Related Publications (15)

• 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.

  PMID: 26606250 BACKGROUND

• 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.

  PMID: 16250744 BACKGROUND

• 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.

  PMID: 3279520 BACKGROUND

• 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.

  PMID: 22453164 BACKGROUND

• 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.

  PMID: 31855042 BACKGROUND

• 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.

  PMID: 30821168 BACKGROUND

• 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.

  PMID: 17968646 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 29597104 BACKGROUND

• 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.

  PMID: 29270789 BACKGROUND

• 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.

  PMID: 23025248 BACKGROUND

• 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.

  PMID: 18176319 BACKGROUND

• 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.

  PMID: 27866288 BACKGROUND

• Rabie S, Poudyal A, Mirti A, Wilson P, Joska JA, Sikkema KJ. The Factorial Structure, Reliability, and Validity of a Coping Measure Among Women with HIV and Sexual Trauma in Cape Town, South Africa. AIDS Behav. 2025 Sep 23. doi: 10.1007/s10461-025-04886-6. Online ahead of print.

  PMID: 40983787 DERIVED

• Sikkema KJ, Rabie S, King A, Watt MH, Mulawa MI, Andersen LS, Wilson PA, Marais A, Ndwandwa E, Majokweni S, Orrell C, Joska JA. ImpACT+, a coping intervention to improve clinical outcomes for women living with HIV and sexual trauma in South Africa: study protocol for a randomized controlled trial. Trials. 2022 Aug 18;23(1):680. doi: 10.1186/s13063-022-06655-5.

  PMID: 35982485 DERIVED

MeSH Terms

Conditions

Psychological Well-Being; Wounds and Injuries

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Kathleen J Sikkema, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stephen Smith Professor of Sociomedical Sciences; Chair, Department of Sociomedical Sciences

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 11, 2021
• Study Start: February 18, 2021
• Primary Completion: May 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Following outcome publications.
• Access Criteria: Access will be granted upon reasonable requests.

Locations

ZA (1)