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NCT06203951: PrIMI
Improving Perinatal Outcomes Among Kenyan Pregnant Women With an Integrated STI Testing Model
NA trial testing Xpert® CT/NG and TV testing in Hiv in 3,132 participants. Currently enrolling.
31 December 2027
Quick facts
| Lead sponsor | University of Washington |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 3,132 |
| Start date | 27 January 2025 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2028 |
| Sites | 8 locations across Kenya |
Drugs / interventions tested
- Xpert® CT/NG and TV testing
Conditions studied
- Hiv — all drugs for Hiv →
- Sexually Transmitted Infections (Not HIV or Hepatitis) — all drugs for Sexually Transmitted Infections (Not HIV or Hepatitis) →
Sponsor
University of Washington
Who can join
Eligibility, female only, with Hiv or Sexually Transmitted Infections (Not HIV or Hepatitis). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigators will conduct a 3-arm individual-level RCT in Kisumu and Siaya, Kenya to compare perinatal outcomes associated with 3 models of STI testing and management in antenatal care. The investigators will enroll 3132 pregnant women and randomize 1:1:1 to receive standard-of-care (syndromic management only without CT, NG, or TV testing) vs. CT, NG, and TV testing using Xpert® assays universally vs. only among women without STI symptoms. All women with STIs detected and/or symptoms per Ministry of Health algorithms will receive immediate treatment, EPT per national guidelines, and tests of cure. All participants will be enrolled during routine antenatal care and followed through 9-months postpartum. The investigators will quantify and compare a composite outcome of pregnancy loss/stillbirth, PTB, LBW, SGA, and neonatal death, between randomization arms, in addition to several secondary and exploratory outcomes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06203951
- 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 NCT06203951 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Washington
- Last refreshed: 16 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/NCT06203951.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing