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NCT06852508
TwySHE - An Mhealth Peer-navigator Intervention to Increase PrEP and Contraceptive Use
NA trial testing TwySHE in Hiv in 324 participants. Currently enrolling.
28 February 2026
Quick facts
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 324 |
| Start date | 18 February 2025 |
| Primary completion | 28 February 2026 |
| Estimated completion | 31 August 2026 |
| Sites | 1 location across Zambia |
Drugs / interventions tested
- TwySHE
Conditions studied
- Hiv — all drugs for Hiv →
- Contraception Behavior — all drugs for Contraception Behavior →
Sponsor
University of Colorado, Denver
Who can join
Adults 18 to 24, female only, with Hiv or Contraception Behavior. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to learn if the TwySHE intervention can increase the use of HIV prevention in at-risk female university students aged 18-24 in Zambia. The main question it aims to answer is: • Can a mhealth peer navigator intervention effectively promote HIV pre-exposure prophylaxis PrEP use among high-risk female students in Zambia? Researchers will compare the mhealth peer navigator intervention to treatment as usual to see if there are effects on female student's use and continuation of PrEP for HIV prevention. Participants in the intervention will be paired with a trained peer navigator who will offer education, social support, and help navigating the health systems to access PrEP and other sexual and reproductive health services. All participants in both arms will complete surveys at baseline, 6 months, and 12 months to evaluate health behaviors.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
TwySHE-an mHealth peer-navigator intervention to increase PrEP and contraceptive use among female university students in Zambia: study protocol of a hybrid effectiveness-implementation randomized controlled trial.
Hampanda K, Amstutz A, Nayame L, Sehrt M, et al · · 2026 · PMID 41781994 · DOI 10.1186/s13063-026-09545-2
Verify or expand the search:
- PubMed search for NCT06852508
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Colorado, Denver trials
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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 NCT06852508 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 University of Colorado, Denver
- Last refreshed: 28 February 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/NCT06852508.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing