Clinical trial NCT04793217: A Randomized Trial of ImpACT+, a Coping Intervention for HIV Infected Women With Sexual Trauma in South Africa
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV
Trauma Exposure
Keywords: South Africa
HIV
Mental health
Trauma
Women
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: National Institute of Mental Health (NIMH)
First posted: 2021-03-11
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Viral suppression/viral load
timeFrame: Up to 12 months
Secondary outcomes:
measure: HIV Care Engagement- Number of Missed Visits
timeFrame: Up to 12 months
measure: HIV Care Engagement- Visit Adherence
timeFrame: Up to 12 months
measure: HIV Care Engagement- Gaps in Care
timeFrame: Up to 12 months
measure: HIV Care Engagement- Visit Constancy
timeFrame: Up to 12 months
measure: ART Adherence - Dried Blood Spots
timeFrame: Up to 12 months
measure: ART Adherence - Pharmacy Visits
timeFrame: Up to 12 months
measure: ART Adherence - Pharmacy Refill
timeFrame: Up to 12 months
Other outcomes:
measure: Coping Strategies Scale Score
timeFrame: Up to 12 months
measure: Traumatic Stress Score
timeFrame: Up to 12 months
Locations:
city: Cape Town
country: South Africa
facility: University of Cape Town
Study officials:
affiliation: Columbia University
name: Kathleen J Sikkema, PhD
role: PRINCIPAL_INVESTIGATOR
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