Clinical trial NCT04000503: Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge)
Official title: Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge): A Pragmatic Cluster Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus 16
Human Papillomavirus 18
Papillomavirus Infections
Cervical Cancer
Pre-Cancerous Dysplasia
Keywords: Human Papillomavirus DNA Tests
Visual inspection with acetic acid
Global Health
Developing Countries
Self-collection
Cervical Cancer Screening
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Uganda Cancer Institute
First posted: 2019-06-27
Enrollment: 2019
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic cluster randomized control trial
Primary purpose: SCREENING

Brief 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.

Detailed description: A cluster randomized control trial will be conducted with the objective of understanding differences in the effectiveness of cervical cancer screening models using self-collected HPV testing on engagement in care. In 31 villages, women will be recruited for self-collected cervical cancer and sexually transmitted infection (STI) screening by: 1) Community health worker recruitment for self-collection (door-to-door), 2) community health meetings. Visual inspection with acetic acid (VIA), cryotherapy and thermocoagulation will be offered in local health facilities for all women who test positive for high-risk (HR)-HPV types. Women needing advanced cancer care will be referred to the Uganda Cancer Institute in Kampala.

The unit of randomization (2 arms) will be villages and the analysis will also account for clustering within this unit or randomization. All participants will receive an integrated package of cervical cancer screening and education and will participate in a survey at baseline. Samples will be tested using GeneXpert (XpertHPV) point of care testing at the Kigandalo health facility for HPV and high risk HPV (HR-HPV). Intervention arms will be implemented in phases by year to avoid temporal contamination.

Eligibility criteria: Inclusion Criteria:

* Women with no previous history of hysterectomy
* aged 25-49 years old
* no previous history of treatment for cervical cancer
* provided written informed consent.

Exclusion Criteria:

* Women who are under 25 or over 49 years of age,
* who have previously had a hysterectomy or been treated for cervical cancer
* unable to provided informed consent.

Primary outcomes:
measure: VIA follow-up and treatment when indicated (screen and treat)
timeFrame: Outcome measured within 6 weeks of self-collection for HPV test
Secondary outcomes:
measure: HPV prevalence
timeFrame: Baseline
measure: STI-HPV co-infection rate (Gonorrhea, Syphilis, etc.)
timeFrame: Baseline
measure: HPV and co-morbid conditions
timeFrame: Baseline
measure: Barriers and facilitators of engagement in care
timeFrame: FGDs within 3 months of recruitment completion
measure: Identify mediators of engagement of care
timeFrame: Outcome measured within 6 weeks of self-collection for HPV test
Other outcomes:
measure: Cost-effectiveness of each model of community-based cervical cancer screening
timeFrame: Modeled lifetime estimates after 1 year follow-up
measure: Process evaluation for integrated community-based cervical cancer screening
timeFrame: Within 6 months of final recruitment
measure: Male partner knowledge of cervical cancer screening
timeFrame: Baseline
Locations:
city: Kampala
country: Uganda
facility: Uganda Cancer Institute
Study officials:
affiliation: Women's Health Research Institute of British Columbia
name: Gina Ogilvie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Northern British Columbia
name: Sheona Mitchell-Foster, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uganda Cancer Institute
name: Carolyn Nakisige, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rawat A, Mithani N, Sanders C, Namugosa R, Payne B, Mitchell-Foster S, Orem J, Ogilvie G, Nakisige C. "We Shall Tell them with Love, Inform them what we have Learnt and then Allow them to go" - Men's Perspectives of Self-Collected Cervical Cancer Screening in Rural Uganda: A Qualitative Inquiry. J Cancer Educ. 2023 Apr;38(2):618-624. doi: 10.1007/s13187-022-02163-x. Epub 2022 Apr 6.
citation: Nakisige C, Trawin J, Mitchell-Foster S, Payne BA, Rawat A, Mithani N, Amuge C, Pedersen H, Orem J, Smith L, Ogilvie G. Integrated cervical cancer screening in Mayuge District Uganda (ASPIRE Mayuge): a pragmatic sequential cluster randomized trial protocol. BMC Public Health. 2020 Jan 31;20(1):142. doi: 10.1186/s12889-020-8216-9.