To hear about similar clinical trials, please enter your email below
Trial Title:
Implementation of Anal Cancer Screening and Treatment in Nigeria
NCT ID:
NCT05817370
Condition:
Education, Medical
Conditions: Official terms:
Anus Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
The way a physician is trained on the detection of HSIL screening and treatment to
prevent anal cancer will be modified so that the cancer prevention strategy is readily
adopted for a low-to middle-income setting. An implementation science committee will
guide the development of the modified training over 3 iterations every 4 months for up to
a year. To test if the modified training improves implementation of anal cancer screening
and treatment, the physician will first conduct screening after standard training for 12
months. Then the physician will conduct screening after the modified training for 12
months. Depending on the time of when the participants visit the clinic will determine
which arm they are enrolled. There is no randomization and the arms are sequential.
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Enhanced Training on screening and treatment of HSIL (e-STH)
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.
Arm group label:
Enhanced Training on screening and treatment of HSIL (e-STH)
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.
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.
Criteria for eligibility:
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:
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
International Center for Advocacy on Right to Health (ICARH)
Address:
City:
Abuja
Country:
Nigeria
Status:
Recruiting
Contact:
Last name:
Sylvia Adebajo, PhD
Email:
SAdebajo@mgic.umaryland.edu
Start date:
May 2, 2023
Completion date:
August 31, 2027
Lead sponsor:
Agency:
University of Maryland, Baltimore
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Maryland, Baltimore
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05817370
