An interventional study of Enhanced Training on screening and treatment of HSIL (e-STH) in Education, Medical, sponsored by University of Maryland, Baltimore. Recruiting at 1 site in Nigeria. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Prevention
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.
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.
University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Enhanced Training on screening and treatment of HSIL (e-STH)
The standard screening and treatment of HSIL outlined by the International Anal Neoplasia Society
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.
Change in HSIL detection
Evaluate change in HSIL detected between the pre and post period (standard vs e-STH)
Time frame: 12 months and 30 months
Change in HSIL treatment
Evaluate change in HSIL treated between the pre and post period (standard vs e-STH)
Time frame: 12 months and 30 months
Change in Reach of intended population
Change in number screened per number eligible between the pre and post period
Time frame: 12 months and 30 months
Change in Efficacy of conducting HSIL screening and treatment
Compare number needed to screen to reach a plateau in the detection of HSIL between the pre and post period
Time frame: 12 months and 30 months
Change in Implementation of HSIL screening and treatment
Compare number of biopsies taken per screening between the pre and post period
Time frame: 12 months and 30 months
Change in Maintenance of HSIL screening and treatment
Compare number who return for a 12-month screening between the pre and post period
Time frame: 18 months and 36 months
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