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NCT05934877 · ClinicalTrials.gov registry record · NA
ASK-PrEP (Assistance Services Knowledge-PrEP)
A NA study, sponsored by Friends Research Institute.
- Terminated
- Registry status
- NA
- Development phase
- 152
- Enrollment target
NCT05934877: Clinical Trial NA study, sponsored by Friends Research Institute.
NCT05934877 is a NA study that was terminated before completion, run by Friends Research Institute. The registered enrollment target is 152 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05934877, a NA study, was terminated before completion, sponsored by Friends Research Institute.
- TERMINATED
- Registry status
- NA
- Development phase
- 152 participants
- Enrollment target
Study Summary
ASK-PrEP is a two-arm randomized controlled trial (RCT), with a Stepped Care approach, among HIV-negative trans women and men who have sex with men with a substance use disorder (SUD). Participants will be randomized (3:1) to the ASK-PrEP Stepped Care arm or Standard of Care (SOC). Participants in the ASK-PrEP Stepped Care arm will receive 5 PrEP navigation sessions, with weekly text-messaging support, delivered over 3 months, at which point they will be assessed for intervention response. Responders will be maintained for an additional 3 months in ASK-PrEP to receive an additional 5 PrEP navigation session with weekly text-messaging support, while non-responders will receive added attention to their SUD via contingency management (CM). Non-responders will be re-randomized (1:1) to either a) receive ASK-PrEP + CM, or b) shift the primary focus to their SUD (CM alone) for an additional 3 months.
Primary Outcome
For those who initiate oral-daily PrEP, persistence is defined as a co-occurrence of ≥700fmol/punch and ongoing (i.e., minimum one every 3 months) confirmed PrEP care medical visits. At each time point, those who do not initiate PrEP, fail to attend a PrEP medical care visit in a given quarter, and/or evidence a Dried Blood Spot (DBS) of \<700 fmol/punch are coded "non-persistent;" participants who initiate PrEP, attend quarterly medical visits, and evidence a DBS ≥700 fmol/punch will be coded "
Interventions
- BEHAVIORAL Standard of Care
- BEHAVIORAL Contingency Management
- BEHAVIORAL PrEP navigation + text messaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2023-05-11 |
| Est. Completion | 2025-03-19 |
| Phase | NA |
Why NCT05934877 stopped before completion
NCT05934877 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which Standard of Care is the first listed.
NCT05934877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05934877 about?
NCT05934877 is a clinical study titled "ASK-PrEP (Assistance Services Knowledge-PrEP)". ASK-PrEP is a two-arm randomized controlled trial (RCT), with a Stepped Care approach, among HIV-negative trans women and men who have sex with men with a substance use disorder (SUD). Participants will be randomized (3:1) to the ASK-PrEP Stepped Care arm or Standard of Care (SOC). Participants in t...
What is the current status of trial NCT05934877?
This trial is currently terminated. It is a NA study. The enrollment target is 152 participants. The study started on 2023-05-11. Estimated completion is 2025-03-19.
What interventions are being tested in trial NCT05934877?
The interventions under investigation include: Standard of Care (BEHAVIORAL), Contingency Management (BEHAVIORAL), PrEP navigation + text messaging (BEHAVIORAL).
Who is sponsoring clinical trial NCT05934877?
This trial is sponsored by Friends Research Institute, which has 41 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05934877's enrollment target sits among peer trials
152 658th of 2000 higher than 1,340 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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