Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574139
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Evaluation of Unstained
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Unstained
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized trial is to learn if the Unstained intervention has a positive impact on the sexual health behaviors of sexually active youth between the ages of 14 and 19 years old who are at risk for or involved in the juvenile justice system The primary research questions it aims to answer are
Three months after being offered the intervention does Unstained impact youths receipt of sexually transmitted infection testing in the past four months
Nine months after being offered the intervention does Unstained impact youths frequency of having vaginal and anal sex without condoms in the past four months
Researchers will compare participants randomized to receive Unstained treatment group to participants randomized to receive a control condition that contains no sexual or reproductive health information control group
Participants randomized to the treatment group will be offered Unstained as a virtual individual-based intervention delivered during three 60 minute sessions over a 3-6 week period Participants randomized to the control group will be offered a virtually delivered control condition
Three months after being offered the intervention does Unstained impact youths receipt of sexually transmitted infection testing in the past four months
Nine months after being offered the intervention does Unstained impact youths frequency of having vaginal and anal sex without condoms in the past four months
Researchers will compare participants randomized to receive Unstained treatment group to participants randomized to receive a control condition that contains no sexual or reproductive health information control group
Participants randomized to the treatment group will be offered Unstained as a virtual individual-based intervention delivered during three 60 minute sessions over a 3-6 week period Participants randomized to the control group will be offered a virtually delivered control condition
Detailed Description:
This is an individual-level randomized control trial to rigorously evaluate the impact of the Unstained intervention Participant outcomes will be assessed using self-reported individual-level data gathered using a structured questionnaire administered at three time points baseline enrollment three months post-intervention five months after baseline and nine months post-intervention eleven months after baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None