Implementation of Anal Cancer Screening and Treatment in Nigeria

Study Overview
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Brief Summary
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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
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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 (Physican) 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.

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

Conditions
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Education, Medical

Intervention / Treatment
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* Behavioral: Enhanced Training on screening and treatment of HSIL (e-STH)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Possess a medical degree in medical sciences (MBBS or equivalent) At least 2-5 years of experience working with clinical HIV/AIDS community Must be registered with the medical and dental council of Nigeria Possess a current medical practicing license Willing to work with the Sexual Gender Minority Community Exclusion Criteria:
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: The way a physician is trained on the detection of HSIL screening and treatment to prevent anal cancer will be modified so that the cancer prevention strategy is readily adopted for a low-to middle-income setting. An implementation science committee will guide the development of the modified training over 3 iterations every 4 months for up to a year. To test if the modified training improves implementation of anal cancer screening and treatment, the physician will first conduct screening after standard training for 12 months. Then the physician will conduct screening after the modified training for 12 months. Depending on the time of when the participants visit the clinic will determine which arm they are enrolled. There is no randomization and the arms are sequential.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Training on screening and treatment of HSIL (e-STH)<br>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. | Behavioral: Enhanced Training on screening and treatment of HSIL (e-STH)<br>* 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.<br>|
| No Intervention: Standard Screening and treatment of HSIL<br>The standard screening and treatment of HSIL outlined by the International Anal Neoplasia Society | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HSIL detection | Evaluate change in HSIL detected between the pre and post period (standard vs e-STH) | 12 months and 30 months | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Reach of intended population | Change in number screened per number eligible between the pre and post period | 12 months and 30 months | 
| 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 | 
| 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 | 
| 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 |