# 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

> **NIH NIH R01** · COLUMBIA UNIVERSITY HEALTH SCIENCES · 2021 · $593,472

## Abstract

PROJECT SUMMARY
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 newly initiating ART 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 newly 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 criti...

## Key facts

- **NIH application ID:** 10153891
- **Project number:** 5R01MH118004-03
- **Recipient organization:** COLUMBIA UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** KATHLEEN J SIKKEMA
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $593,472
- **Award type:** 5
- **Project period:** 2019-08-23 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10153891

## Citation

> US National Institutes of Health, RePORTER application 10153891, 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 (5R01MH118004-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10153891. Licensed CC0.

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