HIVImpACT+NCT04793217
A Randomized Trial of ImpACT+, a Coping Intervention for HIV Infected Women With Sexual Trauma in South Africa
A study testing Improving AIDS Care After Trauma + and Adapted Problem-Solving Therapy in people with HIV and Trauma Exposure, run by Columbia University at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV, Trauma Exposure
- What is being tested?
- Improving AIDS Care After Trauma + and Adapted Problem-Solving Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteSouth Africa
- Study dates
- 18 Feb 2021to 3 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- High suicide risk
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 U.S. and globally.
- Conditions
- HIV, Trauma Exposure
- Being tested
- Improving AIDS Care After Trauma +, Adapted Problem-Solving Therapy
- Keywords
- South Africa, HIV, Mental health, Trauma, Women
- Medical subject headings
- Psychological Well-Being, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improving AIDS Care After Trauma +Behavioural
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.
Adapted Problem-Solving TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Adapted Problem-Solving Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Viral Suppression at the 12-month Assessment
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.
Measured: Up to 12 months
Secondary outcomes (7)
HIV Care Engagement - Number of Participants With Missed Visits
The number of participants with missed visits as determined by medical record review. A missed visit was defined as missing a scheduled visit by more than two weeks from the scheduled date, which aligned with the clinics' definition.
Measured: up to 12 Months
HIV Care Engagement- Visit Adherence
Visit adherence defined as the number of scheduled visits attended.
Measured: Up to 12 months
HIV Care Engagement- Number of Participants With Gaps in Care
Gaps in care defined as whether >90 days have elapsed between visits without sufficient numbers of pills given to cover the gap, as determined by medical record abstraction.
Measured: Up to 12 months
HIV Care Engagement- Visit Constancy
Visit constancy defined as the number of 90-day intervals with >1 completed visit, determined by medical record abstraction.
Measured: Up to 12 months
Number of Participants With ART Adherence - Dried Blood Spots
Dried blood spots measuring levels of tenofovir-diphosphate, dichotomized as adherent or non-adherent based on a cutoff of 400 fmol/punch.
Measured: At 12 months
ART Adherence - Pharmacy Visits
ART adherence as defined by the number of pharmacy visits. Determined through medical record abstraction.
Measured: Up to 12 months
ART Adherence - Total Number of Pills Dispensed
ART adherence as defined by pharmacy refill data, total number of pills dispensed. Determined through medical record abstraction.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start18 Feb 2021
- Primary completion3 Jul 2025
- Study completion3 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kathleen J. Sikkema, PhD, Columbia University
- Investigators
- Kathleen J Sikkema, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793217
- Sponsor's protocol ID
- AAAS3667
- Other IDs
- 1R01MH118004
- Acronym
- ImpACT+
- Status last verified
- Aug 2026
- First submitted
- 9 Mar 2021
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share an anonymized dataset following publications.
Publications
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.
PubMed 26606250Carver 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.
PubMed 16250744Folkman 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.
PubMed 3279520Hansen 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.
PubMed 22453164Knettel 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.
PubMed 31855042Knettel 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.
PubMed 30821168Meade 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.
PubMed 17968646Namir 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.
PubMed 29597104Sikkema 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.
PubMed 29270789Sikkema 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.
PubMed 23025248Sikkema 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.
PubMed 18176319Watt 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.
PubMed 27866288Rabie 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. 2026 Feb;30(2):392-402. doi: 10.1007/s10461-025-04886-6. Epub 2025 Sep 23.
PubMed 40983787Sikkema 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.
PubMed 35982485
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04793217
- Acronym / sponsor ID
- ImpACT+ / AAAS3667
- Conditions
- HIV, Trauma Exposure
- Keywords
- South Africa, HIV, Mental health, Trauma, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- University of Cape Town, National Institute of Mental Health (NIMH)
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Posted 28 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 U.S. and globally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Improving AIDS Care after Trauma+ | Experimental | Behavioral: 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. |
| Adapted Problem-Solving Therapy | Active comparator | Behavioral: Adapted Problem-Solving TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- High suicide risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Improving AIDS Care after Trauma+ |
| Adapted Problem-Solving TherapyParticipants 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. | Behavioural | Adapted Problem-Solving Therapy |
Primary outcome
Number of Participants With Viral Suppression at the 12-month Assessment
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 <50 copies/ml. Continuous measures of viral load, modeled using a log10 transformation.
7 secondary outcomes
HIV Care Engagement - Number of Participants With Missed Visits
Time frame: up to 12 Months
HIV Care Engagement- Visit Adherence
Time frame: Up to 12 months
HIV Care Engagement- Number of Participants With Gaps in Care
Time frame: Up to 12 months
HIV Care Engagement- Visit Constancy
Time frame: Up to 12 months
Number of Participants With ART Adherence - Dried Blood Spots
Time frame: At 12 months
ART Adherence - Pharmacy Visits
Time frame: Up to 12 months
ART Adherence - Total Number of Pills Dispensed
Time frame: Up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26606250Blevins 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.
- Background: PubMed 16250744Carver 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.
- Background: PubMed 3279520Folkman 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.
- Background: PubMed 22453164Hansen 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.
- Background: PubMed 31855042Knettel 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.
- Background: PubMed 30821168Knettel 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.
- Background: PubMed 17968646Meade 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.
- BackgroundNamir 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: PubMed 29597104Sikkema 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.
- Background: PubMed 29270789Sikkema 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.
- Background: PubMed 23025248Sikkema 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.
- Background: PubMed 18176319Sikkema 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.
- Individual participant dataSharing planned: Yes. The investigators will share an anonymized dataset following publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen J Sikkema, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improving AIDS Care After Trauma + and Adapted Problem-Solving Therapy in people with HIV and Trauma Exposure, run by Columbia University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Viral Suppression at the 12-month Assessment (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04793217, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.