Last reviewed · How we verify
NCT06558825
Pre-exposure Prophylaxis (PrEP) Uptake and Adherence Intervention for Women with Trauma-related Conditions
NA trial testing Integrated Intervention to Promote PrEP Uptake in Substance Use in 60 participants. Currently enrolling.
31 March 2025
Quick facts
| Lead sponsor | The University of Texas Health Science Center, Houston |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 1 October 2024 |
| Primary completion | 31 March 2025 |
| Estimated completion | 30 June 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Integrated Intervention to Promote PrEP Uptake
- Standard Treatment Condition
Conditions studied
- Substance Use — all drugs for Substance Use →
Sponsor
The University of Texas Health Science Center, Houston
Who can join
18 and older, female only, with Substance Use. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigators have previously developed an integrated bio-behavioral intervention to promote PrEP uptake and adherence in cisgender women who are undergoing treatment for trauma-related mental health conditions and who are at a higher risk for HIV. The intervention is delivered within the mental health treatment setting and integrates knowledge, behavioral skills, and motivation to engage in and adhere to PrEP care. The purpose of this study is to assess the preliminary efficacy, feasibility, and acceptability of this intervention. The hypothesis is that, compared to standard treatment, the intervention will be feasible, acceptable, and associated with greater PrEP uptake and adherence.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Development and feasibility testing of a PrEP uptake and adherence intervention for women with trauma-related mental health conditions: Protocol for a randomized controlled trial.
Heads AM, An K, Hill MJ, Gameon JA, et al · · 2026 · PMID 42200033 · DOI 10.1016/j.conctc.2026.101645 -
Development and feasibility testing of a PrEP uptake and adherence intervention for women with trauma-related mental health conditions: Protocol for a randomized controlled trial
Heads A, An K, Hill M, Gameon J, et al · · 2026
Verify or expand the search:
- PubMed search for NCT06558825
- 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 NCT06558825 (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 The University of Texas Health Science Center, Houston
- Last refreshed: 30 December 2024
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/NCT06558825.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing