Implementation of Anal Cancer Screening and Treatment in Nigeria
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enhanced Training on screening and treatment of HSIL (e-STH).
- Who it may be relevant to
- Registry conditions: Education, Medical. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Nigeria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Integrated Model for the Prevention of Anal Cancer Using Screen and Treat for High-grade Intraepithelial Lesions (IMPACT)
Overview
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.
Detailed 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.
Interventions
- Behavioral Enhanced Training on screening and treatment of HSIL (e-STH)
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 outcome measures
- Change in HSIL detection [Time frame: 12 months and 30 months]
- Change in HSIL treatment [Time frame: 12 months and 30 months]
Secondary outcome measures (4)
- Change in Reach of intended population [Time frame: 12 months and 30 months]
- Change in Efficacy of conducting HSIL screening and treatment [Time frame: 12 months and 30 months]
- Change in Implementation of HSIL screening and treatment [Time frame: 12 months and 30 months]
- Change in Maintenance of HSIL screening and treatment [Time frame: 18 months and 36 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Nigeria · 1 center
- International Center for Advocacy on Right to Health (ICARH) — Abuja
Identifiers
NCT: NCT05817370 · HP-00101383 · U01CA275053