NCT02223390

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2014

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 24, 2018

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

1.3 years

First QC Date

August 20, 2014

Results QC Date

August 23, 2018

Last Update Submit

July 13, 2024

Conditions

HIVTrauma Exposure

Keywords

South AfricaHIVMental healthTraumaWomen

Outcome Measures

Primary Outcomes (2)

  • PTSD Symptoms

    Self-report, measured by the PTSD checklist, civilian version (PCL-5). 20-item self-report questionnaire, assessed severity of symptoms that parallel the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria for PTSD. Participants were asked to indicate the extent to which they were bothered by problems experienced in the past month in relation to a traumatic experience of abuse or act of violence (0 = not at all to 4 = extremely). Total severity score (range: 0-80; higher scores indicating higher symptom severity, \>= 33 indicating PTSD) and subscale totals (Avoidance - Cluster C, range: 0-8, higher scores indicating higher avoidance symptom severity; and Hyperarousal - Cluster E, range: 0-24, higher scores indicating higher hyperarousal symptom severity) were examined.

    90 Days, 180 days

  • HIV Medication Adherence (% Adherent)

    Assessed through biomarkers of dried blood spots (DBS) testing for presence of antiretroviral therapy (ART) (tenofovir, emtricitabine, and efavirenz) at 6 month assessment, supplemented by viral load (VL; considered adherent if VL \<=40 copies/ml) when DBS unavailable. Outcome dichotomized.

    180 days

Study Arms (2)

Mental health treatment

EXPERIMENTAL

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.

Behavioral: Improving AIDS Care after Trauma (ImpACT)

Standard of Care

NO INTERVENTION

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

Interventions

Improving AIDS Care after Trauma (ImpACT)BEHAVIORAL
Mental health treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Immediate suicide risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cape Town

Cape Town, South Africa

Location

Related Publications (1)

  • 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.

    PMID: 29270789DERIVED

MeSH Terms

Conditions

Psychological Well-BeingWounds and Injuries

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Results Point of Contact

Title
Kathleen Sikkema, PhD
Organization
Duke University (Currently at Columbia University)
ks3364@cumc.columbia.edu
212-305-8236

Study Officials

  • Kathleen Sikkema, PhD

    Duke University (Currently at Columbia University)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 20, 2014

First Posted

August 22, 2014

Study Start

March 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 24, 2024

Results First Posted

October 24, 2018

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)