Last reviewed · How we verify

NCT04793217: ImpACT+

A Randomized Trial of ImpACT+, a Coping Intervention for HIV Infected Women With Sexual Trauma in South Africa

Active, enrolled NA Last updated 8 July 2025
What this trial tests

NA trial testing Improving AIDS Care After Trauma + in HIV in 350 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
18 February 2021
Primary endpoint
30 May 2025
30 May 2026

Quick facts

Lead sponsorColumbia University
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment350
Start date18 February 2021
Primary completion30 May 2025
Estimated completion30 May 2026
Sites1 location across South Africa

Drugs / interventions tested

Conditions studied

Sponsor

Columbia University

Who can join

18 and older, female only, with HIV or Trauma Exposure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The importance of assessing and addressing mental health barriers to PrEP use during pregnancy and postpartum in sub-Saharan Africa: state of the science and research priorities.
    Stanton AM, O'Cleirigh C, Knight L, Davey DLJ, et al · · 2022 · cited 10× · PMID 36251124 · DOI 10.1002/jia2.26026
  2. 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.
    Sikkema KJ, Rabie S, King A, Watt MH, et al · · 2022 · cited 6× · PMID 35982485 · DOI 10.1186/s13063-022-06655-5
  3. The Factorial Structure, Reliability, and Validity of a Coping Measure Among Women with HIV and Sexual Trauma in Cape Town, South Africa.
    Rabie S, Poudyal A, Mirti A, Wilson P, et al · · 2026 · PMID 40983787 · DOI 10.1007/s10461-025-04886-6

Verify or expand the search:

Other recruiting trials for HIV

Currently open trials in the same condition.

Other Columbia University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04793217.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing