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NCT04793217: ImpACT+
A Randomized Trial of ImpACT+, a Coping Intervention for HIV Infected Women With Sexual Trauma in South Africa
NA trial testing Improving AIDS Care After Trauma + in HIV in 350 participants. Participants enrolled and being followed up; not accepting new ones.
30 May 2025
Quick facts
| Lead sponsor | Columbia University |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 350 |
| Start date | 18 February 2021 |
| Primary completion | 30 May 2025 |
| Estimated completion | 30 May 2026 |
| Sites | 1 location across South Africa |
Drugs / interventions tested
- Improving AIDS Care After Trauma +
- Adapted Problem-Solving Therapy
Conditions studied
- HIV — all drugs for HIV →
- Trauma Exposure — all drugs for Trauma Exposure →
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):
-
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 -
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 -
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:
- PubMed search for NCT04793217
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04793217 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Columbia University
- Last refreshed: 8 July 2025
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