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

University of Maryland Baltimore (UMB)

Status: Enrolling

Conditions: Education, Medical

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05817370

U01CA275053 (U.S. NIH Grant/Contract)

HP-00101383

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 estimated patient

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 Criteria:

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

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

Experimental group

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.

Treatment:

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

Standard Screening and treatment of HSIL

No Intervention group

Description:

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