Implementation of Anal Cancer Screening and Treatment in Nigeria

NCT05817370 | Recruiting DMC

• 2 other identifiers: HP-00101383U01CA275053
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Education, Medical

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in Reach of intended population

  12 months and 30 months

• Change in Efficacy of conducting HSIL screening and treatment

  12 months and 30 months

• Change in Implementation of HSIL screening and treatment

  12 months and 30 months

• Change in Maintenance of HSIL screening and treatment

  18 months and 36 months

Study Arms (2)

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

EXPERIMENTAL

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)

Standard Screening and treatment of HSIL

NO INTERVENTION

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

Interventions

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

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.

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

International Center for Advocacy on Right to Health (ICARH)

Abuja, Nigeria

RECRUITING

Central Study Contacts

Rebecca Nowak, PhD

CONTACT

4107064642; rnowak@ihv.umaryland.edu

Sylvia Adebajo

CONTACT

SAdebajo@mgic.umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 18, 2023
• Study Start: May 2, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

NG (1)