Implementation of Anal Cancer Screening and Treatment in Nigeria (IMPACT)

May 16, 2023 updated by: Rebecca Nowak, University of Maryland, Baltimore

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 (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.

Study Type

Interventional

Enrollment (Anticipated)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: Standard Screening and treatment of HSIL
The standard screening and treatment of HSIL outlined by the International Anal Neoplasia Society

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HSIL detection
Time Frame: 12 months and 30 months
Evaluate change in HSIL detected between the pre and post period (standard vs e-STH)
12 months and 30 months
Change in HSIL treatment
Time Frame: 12 months and 30 months
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
Time Frame: 12 months and 30 months
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
Time Frame: 12 months and 30 months
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
Time Frame: 12 months and 30 months
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
Time Frame: 18 months and 36 months
Compare number who return for a 12-month screening between the pre and post period
18 months and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Anticipated)

August 31, 2027

Study Completion (Anticipated)

August 31, 2027

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00101383
  • U01CA275053 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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