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NCT Number: NCT05817370

Implementation of Anal Cancer Screening and Treatment in Nigeria

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.

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Key information

Conditions

Education, Medical

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Center for Advocacy on Right to Health (ICARH)

Abuja, Nigeria

Location status: Recruiting

Location contact

Sylvia Adebajo, PhD

CONTACT

[email protected]

About this study

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 (Physician) 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Nowak, PhD

CONTACT

[email protected]

4107064642

Sylvia Adebajo

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: IMPACT

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 18, 2023
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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