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Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge)

NCT04000503 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2019

Last updated 2022-11-03

No results posted yet for this study

Summary

The purpose of this pragmatic cluster randomized control trial is to test the effectiveness of cervical cancer screening follow-up completion using two implementation approaches for self-collected HPV testing in a rural, low-resource setting: 1) community health workers recruiting women door-to-door and 2) community health workers recruiting women at community health meetings.

This study will also help to further understand how current patient referral systems are working between health facilities, patient and provider preferences for integrated care and health system related barriers to integrated cervical cancer screening.

Hypothesis: More women will receive screening via the community health meeting but the engagement to care (i.e., visual inspection with acetic acid-our main outcome) will be greater in the door-to-door arm.

Conditions

  • Human Papillomavirus 16
  • Human Papillomavirus 18
  • Papillomavirus Infections
  • Cervical Cancer
  • Pre-Cancerous Dysplasia

Interventions

BEHAVIORAL

Self-collected HPV testing for cervical cancer screening

Self-collection cervical cancer screening, STI screening, and education on HIV by a community health worker. Women who test positive for high-risk HPV types will be referred to a designated health centre for VIA follow-up and treatment if indicated.

Sponsors & Collaborators

  • Uganda Cancer Institute

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Gina Ogilvie, MD · Women's Health Research Institute of British Columbia

  • Sheona Mitchell-Foster, MD · University of Northern British Columbia

  • Carolyn Nakisige, MD · Uganda Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2021-07-31
Completion
2022-10-31

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04000503 on ClinicalTrials.gov