Evidence map›Paper›PMID 35982485›Full record

ArticleTrials2022

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.

K J Sikkema, S Rabie, A King, M H Watt, M I Mulawa, L S Andersen, P A Wilson, A Marais, E Ndwandwa, S Majokweni and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04793217 (Project Someleze), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04793217 nacompletednot on this map

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

TypeinterventionalSponsorColumbia UniversityRan2021 to 2025Enrolled350ConditionsHIV, Trauma ExposureArmsImproving AIDS Care After Trauma +, Adapted Problem-Solving Therapy
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 3 countries.

K J SikkemaDepartment of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, NY, USA. ks3664@cumc.columbia.edu.ORCID http://orcid.org/0000-0003-0371-5119
S RabieDepartment of Psychiatry and Mental Health, HIV Mental Health Research Unit, Neuroscience Institute, University of Cape Town, Cape Town, South Africa.
A KingDepartment of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, NY, USA.
M H WattDepartment of Population Health Sciences, University of Utah, Salt Lake City, UT, USA.
M I MulawaDuke University School of Nursing and Duke Global Health Institute, Durham, NC, USA.
L S AndersenDepartment of Psychiatry and Mental Health, HIV Mental Health Research Unit, Neuroscience Institute, University of Cape Town, Cape Town, South Africa.
P A WilsonDepartment of Psychology, University of California, Los Angeles, USA.
A MaraisDepartment of Psychiatry and Mental Health, HIV Mental Health Research Unit, Neuroscience Institute, University of Cape Town, Cape Town, South Africa.
E NdwandwaDepartment of Psychiatry and Mental Health, HIV Mental Health Research Unit, Neuroscience Institute, University of Cape Town, Cape Town, South Africa.
S MajokweniDepartment of Psychiatry and Mental Health, HIV Mental Health Research Unit, Neuroscience Institute, University of Cape Town, Cape Town, South Africa.
C OrrellDesmond Tutu HIV Foundation, University of Cape Town Medical School, Cape Town, South Africa.
J A JoskaDepartment of Psychiatry and Mental Health, HIV Mental Health Research Unit, Neuroscience Institute, University of Cape Town, Cape Town, South Africa.
University of Cape Town · ZAColumbia University · USDesmond Tutu HIV Foundation · ZADuke University · USUniversity of California, Los Angeles · USUniversity of Copenhagen · DKUniversity of Utah · US

Funding

A randomized trial of ImpACT+, a coping intervention to improve clinical and mental health outcomes among HIV-infected women with sexual trauma in South AfricaR01MH118004 · NIMH · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI SIKKEMA, KATHLEEN J · 2019 to 2023
$3.0M
NIMH NIH HHS R01 MH118004NIMH NIH HHS R01MH118004
6 · The paper itself

Abstract

backgroundAddressing sexual trauma in the context of HIV care is essential to improve clinical outcomes and mental health among women in South Africa. Women living with HIV (WLH) report disproportionately high levels of sexual trauma and have higher rates of posttraumatic stress disorder. Adherence to antiretroviral therapy (ART) may be difficult for traumatized women, as sexual trauma compounds the stress associated with managing HIV and is often comorbid with other mental health disorders, further compromising care engagement and adherence. ART initiation represents a unique window of opportunity for intervention to enhance motivation, increase care engagement, and address the negative effects of trauma on avoidant coping behaviors. Mental health interventions delivered by non-specialists in low- and middle-income countries have potential to treat depression, trauma, and effects of intimate partner violence among WLH. This study will examine the effectiveness of Improving AIDS Care after Trauma (ImpACT +), a task-shared, trauma-focused coping intervention, to promote viral suppression among WLH initiating ART in a South African clinic setting.

methodsThis study will be conducted in Khayelitsha, a peri-urban settlement situated near Cape Town, South Africa. Using a hybrid type 1 effectiveness-implementation design, we will randomize 350 WLH initiating ART to the ImpACT + experimental condition or the control condition (three weekly sessions of adapted problem-solving therapy) to examine the effectiveness of ImpACT + on viral suppression, ART adherence, and the degree to which mental health outcomes mediate intervention effects. ImpACT + participants will receive six once-a-week coping intervention sessions and six monthly maintenance sessions over the follow-up period. We will conduct mental health and bio-behavioral assessments at baseline, 4, 8, and 12 months, with care engagement data extracted from medical records. We will explore scalability using the Consolidated Framework for Implementation Research (CFIR). DISCUSSION: This trial is expected to yield important new information on psychologically informed intervention models that benefit the mental health and clinical outcomes of WLH with histories of sexual trauma. The proposed ImpACT + intervention, with its focus on building coping skills to address traumatic stress and engagement in HIV care and treatment, could have widespread impact on the health and wellbeing of individuals and communities in sub-Saharan Africa.

trial registrationClinicaltrials.gov NCT04793217 . Retrospectively registered on 11 March 2021.

Indexed as

HIV InfectionsStress Disorders, Post-TraumaticAdaptation, PsychologicalFemaleHumansRandomized Controlled Trials as TopicSexual TraumaSouth AfricaAdherenceAntiretroviral therapyHIVRandomized controlled trialSexual violenceSouth AfricaTraumatic stress

Identifiers

PMID35982485
PMCPMC9386207
OpenAlexW4292416088

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.