Actively Recruiting

Phase Not Applicable
All Genders
Healthy Volunteers
ID05817370

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

Led by University of Maryland, Baltimore · Updated on 2025-06-26

1

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Maryland, Baltimore

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating two different training protocols for a physician to improve anal cancer screening and treatment in Nigeria. The study focuses on high-grade intraepithelial lesions (HSILs), which are precancerous changes that can lead to anal cancer, aiming to compare the current standard training developed in high-income countries with a new training tailored specifically for the Nigerian setting. This pilot trial assesses whether the physician's ability to perform screening and treatment differs between the two training approaches. The study first applies the standard training for 12 months, then develops and rolls out an enhanced training intervention (e-STH) tailored to address barriers unique to Nigeria over a 6-month period. After this, there is a 12-month post-intervention period to evaluate the impact of the enhanced training, followed by a 6-month sustainability phase with minimal study team involvement. The enhanced training is refined iteratively by an implementation science committee to promote adoption and maintenance of HSIL screening and treatment. During the trial, the physician's performance in detecting and treating HSIL will be monitored continuously. Researchers will assess outcomes including changes in detection and treatment rates, reach and efficacy of screening, implementation success, and maintenance of the program. The study uses an interrupted time series design at a single clinic to minimize variability and will involve regular monitoring over a total period of about 3 years.

CONDITIONS

Brief Title

Implementation of Anal Cancer Screening and Treatment in Nigeria

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Possess a medical degree in medical sciences (MBBS or equivalent)
  • Have at least 2 to 5 years of experience working with the clinical HIV/AIDS community
  • Be registered with the medical and dental council of Nigeria
  • Possess a current medical practicing license
  • Be willing to work with the Sexual Gender Minority Community
Not Eligible

You will not qualify if you...

  • None listed

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Standard Screening and Treatment Period

Duration - 12 months

Participants undergo standard training and perform HSIL screening and treatment as outlined by the International Anal Neoplasia Society to establish baseline practices.

Ongoing clinical activities as part of routine care

Enhanced Training Implementation

Duration - 6 months

Participants receive tailored enhanced training on HSIL screening and treatment designed to overcome barriers and improve implementation, developed over iterative cycles.

Training sessions spread over the implementation period

Post-Enhanced Training Screening and Treatment Period

Duration - 12 months

Participants continue HSIL screening and treatment following enhanced training to evaluate the impact of the new training model.

Ongoing clinical activities as part of routine care

Sustainability Evaluation Period

Duration - 6 months

Participants perform HSIL screening and treatment with minimal involvement from the investigative team to assess sustainability of the enhanced training effects.

Ongoing clinical activities as part of routine care

Trial Site Locations

Total: 1 location

1

International Center for Advocacy on Right to Health (ICARH)

Abuja, Nigeria

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Research Team

R

Rebecca Nowak, PhD

S

Sylvia Adebajo

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

2

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