Implementation of Anal Cancer Screening and Treatment in Nigeria

Last updated: June 5, 2024
Sponsor: University of Maryland, Baltimore
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anal Dysplasia

Treatment

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

Clinical Study ID

NCT05817370
HP-00101383
U01CA275053
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Study Design

Total Participants: 1
Treatment Group(s): 1
Primary Treatment: Enhanced Training on screening and treatment of HSIL (e-STH)
Phase:
Study Start date:
May 02, 2023
Estimated Completion Date:
August 31, 2027

Study 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 (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.

Connect with a study center

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

    Abuja,
    Nigeria

    Active - Recruiting

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