Improving the Health of South African Women With Traumatic Stress in HIV Care (C0147)

NCT ID: NCT02223390

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-07-31

Brief Summary

In this study, the investigators propose to develop Improving AIDS Care after Trauma (ImpACT), an intervention based on theories of stress and coping and evidence-based treatment for traumatic stress. The intervention will target women in South Africa who have histories of sexual trauma and are newly initiating antiretroviral therapy (ART) in order to reduce avoidant coping and traumatic stress, improve care engagement, and reduce HIV risk behaviors.

Detailed Description

HIV-infected women in South Africa report high rates of sexual trauma, which negatively impacts their mental health and potentially influences engagement in HIV care (retention in care and adherence to antiretroviral therapy) and risk behaviors. Addressing the traumatic stress resulting from sexual trauma could improve these HIV-related outcomes, which in turn may prevent HIV transmission through suppression of the virus and reduction in HIV risk behaviors. Intervention research among HIV-infected populations with trauma histories in the U.S. demonstrates that a coping approach, particularly one that reduces the use of avoidant coping strategies, is efficacious in reducing traumatic stress and improving health behaviors. Although South Africa faces dual epidemics of HIV and sexual violence, trauma treatment has not been well-integrated into the HIV care setting. The proposed 3-year study will develop and pilot test an intervention called ImpACT (Improving AIDS Care after Trauma) to reduce avoidant coping, traumatic stress, and risk behaviors, and increase engagement in care. The intervention will take place in a public ART clinic and will target women during the critical period when they initiate ART in order to maximize the impact on engagement in care. Qualitative data collection with staff, providers, and HIV-infected female patients at the study clinic will elicit feedback on the content and delivery of ImpACT and key aspects of the study protocol. ImpACT will then be piloted with 60 women who are new ART enrollees with a history of sexual trauma and elevated traumatic stress. Participants will be randomized to the control condition (standard of care, or SoC: 3 adherence counseling sessions required of all patients initiating ART at the clinic) or the intervention condition (SoC + ImpACT), and will complete assessments at baseline, 3, and 6 months post-randomization, with care engagement data extracted from medical records at the end of the study period. The study has three specific aims: 1) to develop a brief and scalable coping intervention for delivery in the South African HIV care setting for women with sexual trauma histories; 2) to establish the methodological details of an experimental protocol for a robust randomized control trial; and 3) to pilot test the ImpACT intervention with 60 HIV-infected women with histories of sexual trauma who are initiating ART in order to determine feasibility and acceptability in the HIV care setting, and explore the impact on avoidant coping, traumatic stress, engagement in care, and HIV risk behaviors. The goal at the completion of this study is to have a structured intervention curriculum that is culturally relevant for HIV infected women in South Africa, a full experimental protocol that is appropriate for the South African care setting, and data on feasibility, acceptability, and target outcomes. These products can be leveraged to inform an R01 application for rigorous evaluation of the ImpACT intervention. We are confident that this developmental work will significantly enhance the probability of success of a larger randomized control trial.

Conditions

HIV; Trauma Exposure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mental health treatment

The experimental condition, ImpACT, was developed in the pilot phase of the study. The intervention will be 4 sessions of individual psychological treatment related to stress, coping, and HIV adherence, followed by three group sessions. Sessions will follow an intervention manual and be delivered by a psychiatric nurse (or equivalent nonspecialist in mental health) who is supervised by a trained clinical psychologist.

Group Type: EXPERIMENTAL

Improving AIDS Care after Trauma (ImpACT)

Intervention Type: BEHAVIORAL

Standard of Care

Participants in standard of care will receive the three-session adherence counseling delivered in the clinic, along with referrals for trauma treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Improving AIDS Care after Trauma (ImpACT)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• HIV infected women who are newly initiating ART at the study clinic
• History of sexual trauma
• Meets criteria for traumatic stress

Exclusion Criteria

• Immediate suicide risk

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Cape Town

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Sikkema

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen Sikkema, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University (Currently at Columbia University)

Locations

University of Cape Town

Cape Town, , South Africa

Countries

South Africa

References

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.

Reference Type: DERIVED

PMID: 29270789 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R34MH102001

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2017-0979

Identifier Type: -

Identifier Source: org_study_id