search
Back to results

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

Primary Purpose

Education, Medical

Status
Recruiting
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Enhanced Training on screening and treatment of HSIL (e-STH)
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Education, Medical

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

Sites / Locations

  • International Center for Advocacy on Right to Health (ICARH)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Enhanced Training on screening and treatment of HSIL (e-STH)

Standard Screening and treatment of HSIL

Arm Description

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.

The standard screening and treatment of HSIL outlined by the International Anal Neoplasia Society

Outcomes

Primary Outcome Measures

Change in HSIL detection
Evaluate change in HSIL detected between the pre and post period (standard vs e-STH)
Change in HSIL treatment
Evaluate change in HSIL treated between the pre and post period (standard vs e-STH)

Secondary Outcome Measures

Change in Reach of intended population
Change in number screened per number eligible between the pre and post period
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
Change in Implementation of HSIL screening and treatment
Compare number of biopsies taken per screening between the pre and post period
Change in Maintenance of HSIL screening and treatment
Compare number who return for a 12-month screening between the pre and post period

Full Information

First Posted
March 14, 2023
Last Updated
May 16, 2023
Sponsor
University of Maryland, Baltimore
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT05817370
Brief Title
Implementation of Anal Cancer Screening and Treatment in Nigeria
Acronym
IMPACT
Official Title
Integrated Model for the Prevention of Anal Cancer Using Screen and Treat for High-grade Intraepithelial Lesions (IMPACT)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Education, Medical

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
1 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Training on screening and treatment of HSIL (e-STH)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Screening and treatment of HSIL
Arm Type
No Intervention
Arm Description
The standard screening and treatment of HSIL outlined by the International Anal Neoplasia Society
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Training on screening and treatment of HSIL (e-STH)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in HSIL detection
Description
Evaluate change in HSIL detected between the pre and post period (standard vs e-STH)
Time Frame
12 months and 30 months
Title
Change in HSIL treatment
Description
Evaluate change in HSIL treated between the pre and post period (standard vs e-STH)
Time Frame
12 months and 30 months
Secondary Outcome Measure Information:
Title
Change in Reach of intended population
Description
Change in number screened per number eligible between the pre and post period
Time Frame
12 months and 30 months
Title
Change in Efficacy of conducting HSIL screening and treatment
Description
Compare number needed to screen to reach a plateau in the detection of HSIL between the pre and post period
Time Frame
12 months and 30 months
Title
Change in Implementation of HSIL screening and treatment
Description
Compare number of biopsies taken per screening between the pre and post period
Time Frame
12 months and 30 months
Title
Change in Maintenance of HSIL screening and treatment
Description
Compare number who return for a 12-month screening between the pre and post period
Time Frame
18 months and 36 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Nowak, PhD
Phone
4107064642
Email
rnowak@ihv.umaryland.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvia Adebajo
Email
SAdebajo@mgic.umaryland.edu
Facility Information:
Facility Name
International Center for Advocacy on Right to Health (ICARH)
City
Abuja
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvia Adebajo, PhD
Email
SAdebajo@mgic.umaryland.edu

12. IPD Sharing Statement

Learn more about this trial

Implementation of Anal Cancer Screening and Treatment in Nigeria

We'll reach out to this number within 24 hrs