Implementation of Anal Cancer Screening and Treatment in Nigeria

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Maryland, Baltimore

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

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

    Behavioral

    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 groups

1 Participants
are divided into 2 treatment groups
Group A: Enhanced Training on screening and treatment of HSIL (e-STH)Experimental treatment 1 intervention
Group B: Standard Screening and treatment of HSILNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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University of Maryland, Baltimore

Lead sponsor

National Cancer Institute (NCI)

Collaborator