Implementation of Anal Cancer Screening and Treatment in Nigeria

Education, Medical Clinical Trial

— IMPACT  

Official title:

Integrated Model for the Prevention of Anal Cancer Using Screen and Treat for High-grade Intraepithelial Lesions (IMPACT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05817370
• Other study ID #: HP-00101383
• Secondary ID: U01CA275053
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: June 2024
• Source: University of Maryland, Baltimore
• Contact: Rebecca Nowak, PhD
• Phone: 4107064642
• Email: rnowak[@]ihv.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Possess a medical degree in medical sciences (MBBS or equivalent)

2. At least 2-5 years of experience working with clinical HIV/AIDS community

3. Must be registered with the medical and dental council of Nigeria

4. Possess a current medical practicing license

5. Willing to work with the Sexual Gender Minority Community

Exclusion Criteria:

Related Conditions & MeSH terms

• Anus Neoplasms
• Education, Medical

Intervention

Behavioral:
• Enhanced Training on screening and treatment of HSIL (e-STH)
Tailored training developed to overcome key barriers and promote facilitators unique to implementing HSIL screening and treatment. The development will be driven by the implementation science committee over 3 iterations every 4 months for up to a year to refine the adoption of strategies with the greatest breadth to facilitate implementation.

Locations

Country	Name	City	State
Nigeria	International Center for Advocacy on Right to Health (ICARH)	Abuja

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Cancer Institute (NCI)

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HSIL detection	Evaluate change in HSIL detected between the pre and post period (standard vs e-STH)	12 months and 30 months
Primary	Change in HSIL treatment	Evaluate change in HSIL treated between the pre and post period (standard vs e-STH)	12 months and 30 months
Secondary	Change in Reach of intended population	Change in number screened per number eligible between the pre and post period	12 months and 30 months
Secondary	Change in Efficacy of conducting HSIL screening and treatment	Compare number needed to screen to reach a plateau in the detection of HSIL between the pre and post period	12 months and 30 months
Secondary	Change in Implementation of HSIL screening and treatment	Compare number of biopsies taken per screening between the pre and post period	12 months and 30 months
Secondary	Change in Maintenance of HSIL screening and treatment	Compare number who return for a 12-month screening between the pre and post period	18 months and 36 months