Last reviewed · How we verify
NCT05856942: HOT4PrEP
Hybrid Evaluation of a Home-based HIV Pre-exposure Prophylaxis Program
NA trial testing Health service - home-based PrEP monitoring in HIV Prevention in 458 participants. Currently enrolling.
8 March 2025
Quick facts
| Lead sponsor | University of Washington |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 458 |
| Start date | 8 March 2022 |
| Primary completion | 8 March 2025 |
| Estimated completion | 8 September 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Health service - home-based PrEP monitoring
Conditions studied
- HIV Prevention — all drugs for HIV Prevention →
- Pre-exposure Prophylaxis — all drugs for Pre-exposure Prophylaxis →
- STI — all drugs for STI →
Sponsor
University of Washington
Who can join
18 and older, any sex, with HIV Prevention or Pre-exposure Prophylaxis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study's aim is to implement a home-based PrEP (HB-PrEP) monitoring system (self-collected blood and extragenital specimens at home and telehealth follow-up) into a large, urban sexual health clinic while also evaluating the program's clinical effectiveness. Study participants will self-collect blood specimens using Tasso devices, which are currently designated as FDA Class 2 exempt medical devices (similar to a medical lancet). This study will be integrated into King County's Ending the HIV Epidemic plan and generate data to inform refinement, adaptation and scale-up of future HB-PrEP programs. Specific research aims are to: 1. Conduct a hybrid randomized trial to compare the impact of a HB-PrEP program versus standard of care (routine in-clinic monitoring) on PrEP retention over time and use mixed-methods assessments to define the factors that influence HB-PrEP implementation. Hypothesis: HB-PrEP will increase PrEP retention rates by \>10% at 18 months and 60% of those offered HB-PrEP will use it for over half of visits. 2. Perform a cost analysis of the HB-PrEP implementation strategy compared to standard care. Hypothesis: HB-PrEP cost will fall within the HIV prevention budget and be affordable with comparable costs to SOC. 3. Develop a qualitative tool to engage healthcare stakeholders and determine the wider scalability of HB-PrEP.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Implementation and Evaluation of a Home-Based Pre-Exposure Prophylaxis Monitoring Option: Protocol for a Randomized Controlled Trial.
Cannon C, Holzhauer K, Golden M. · · 2024 · cited 1× · PMID 39312771 · DOI 10.2196/56587 -
Implementation and Evaluation of a Home-Based Pre-Exposure Prophylaxis Monitoring Option: A Protocol for a Randomized Controlled Trial
Cannon CA, Holzhauer K, Golden M. · · 2023 · DOI 10.1101/2023.12.17.23300112
Verify or expand the search:
- PubMed search for NCT05856942
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for HIV Prevention
Currently open trials in the same condition.
- NCT07194902 — HIV Self-testing for Partners of HIV-uninfected Postpartum Women · NA · recruiting
- NCT07218211 — Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP · Phase 4 · recruiting
- NCT07349758 — Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers · Phase 1 · recruiting
- NCT07433985 — California MEPS Hub · NA · recruiting
- NCT07002866 — Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda · NA · recruiting
Other University of Washington trials
Trials by the same sponsor.
- NCT07430852 — Inherited and Environmental Risks Acting on Body Weight · NA · not yet recruiting
- NCT07466498 — Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Canc · Phase 2 · not yet recruiting
- NCT06422299 — Developing and Testing an Online Intervention for Alcohol and Cannabis Misuse and Healthy Relationship Skills Among Youn · NA · not yet recruiting
- NCT07322341 — SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer · Phase 2 · not yet recruiting
- NCT07332351 — Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle · Phase 2 · not yet recruiting
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 NCT05856942 (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 University of Washington
- Last refreshed: 10 May 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/NCT05856942.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing