Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05817370
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2023-03-14
Brief Title:
Implementation of Anal Cancer Screening and Treatment in Nigeria
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Integrated Model for the Prevention of Anal Cancer Using Screen and Treat for High-grade Intraepithelial Lesions IMPACT
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPACT
Brief Summary:
The study is a feasibility pilot trial testing 2 types of training protocols on a single physician The first training protocol is the current standard and was developed in high-income settings The second training protocol will be developed so tailored to the Nigerian setting Investigators will test if the physician performs differently in their ability to conduct anal cancer screening and treatment between the 2 training protocols
Detailed Description:
In Aim 1 anal cancer screening and treatment based on standard training protocols of how to screen and treat high-grade intraepithelial lesions HSILs to prevent anal cancer as developed in high-income settings will be conducted Investigators will identify barriers and facilitators with learning the procedure with standard training using the Consolidated Framework for Implementation Research CFIR In Aim 2 Investigators will identify strategies to modify the standard training to improve learning on a complicated procedure using the Expert Recommendations for Implementing Change ERIC framework An implementation science committee will co-design and develop an enhanced training on Screening and Treatment of HSIL e-STH by matching the barriers identified with CFIR with strategies in ERIC Investigators will then take an iterative improvement approach to test and refine the implementation of the enhanced training intervention to ensure that HSIL screening and treatment is readily adopted and maintained as part of HIV care In Aim 3 CLINICAL TRIAL AIM Investigators will conduct a Hybrid Type 2 trial using an interrupted time series design to monitor and evaluate outcomes along the implementation continuum The trial will be conducted at a single clinic to minimize variability The participant Physician will have a pre-period of HSIL screening and treatment for 12 months after standard training Next investigators will roll out e-STH for 6 months Then there will be a post-period of screening for 12 months to evaluate the impact of e-STH Lastly there will be 6 months of screening and treatment with minimal involvement of the investigative team to evaluate sustainability
The study will compare e-STH to standard training in proportion of HSIL detected and treated with secondary outcomes evaluating reach efficacy implementation and sustainability
The study will compare e-STH to standard training in proportion of HSIL detected and treated with secondary outcomes evaluating reach efficacy implementation and sustainability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01CA275053 | NIH | None | httpsreporternihgovquickSearchU01CA275053 |