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

Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge): A Pragmatic Cluster Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; Papillomavirus Infections; Pre-Cancerous Dysplasia; Human Papillomavirus 16; Human Papillomavirus 18
• Intervention / Treatment: Behavioral: Self-collected HPV testing for cervical cancer screening

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.

• Study Type: Interventional
• Enrollment (Actual): 2019
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Uganda Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Community Health Worker Self-Collection; Door-to-door recruitment of women for self-collected HPV testing	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.
Experimental: Community Health Meeting Self-Collection; Community health meeting recruitment of women for self-collected HPV testing	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VIA follow-up and treatment when indicated (screen and treat)	Proportion of total screened women who complete VIA follow-up and treatment after testing positive for high-risk HPV type	Outcome measured within 6 weeks of self-collection for HPV test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV prevalence	Total number of women who test positive for HPV out of the total number of samples obtained	Baseline
STI-HPV co-infection rate (Gonorrhea, Syphilis, etc.)	Total number of women who test positive for STIs out of total number of women who test positive for HPV; total number of women who test negative for STIs out of total number of women who test positive for HPV; total number of women who test positive for STIs out of total number of women who test negative for HPV; total number of women who test negative for STIs out of total number of women who test negative for HPV	Baseline
HPV and co-morbid conditions	Association (adjusted OR) estimated between HPV and HIV; other STIs	Baseline
Barriers and facilitators of engagement in care	Semi-structured focus group discussions with women who did and did not attend follow-up screening in each study arm.	FGDs within 3 months of recruitment completion
Identify mediators of engagement of care	Mediation analysis using counterfactual approach to assess mediating effect of patient reported experience, knowledge change and co-infection status with other STIs on engagement in care after positive HR-HPV test	Outcome measured within 6 weeks of self-collection for HPV test

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness of each model of community-based cervical cancer screening	Measured using years of lives saved compared between each study arm and the ICER	Modeled lifetime estimates after 1 year follow-up
Process evaluation for integrated community-based cervical cancer screening	Evaluating reach, fidelity, barriers and facilitators of implementation in each arm from the community and health system perspective using mixed methods	Within 6 months of final recruitment
Male partner knowledge of cervical cancer screening	Assess men's knowledge level of HPV and cervical cancer and determine which factors impact the supportiveness towards a partner seeking screening.	Baseline

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Uganda Cancer Institute
• Investigators: Principal Investigator: Gina Ogilvie, MD, Women's Health Research Institute of British Columbia; Principal Investigator: Sheona Mitchell-Foster, MD, University of Northern British Columbia; Principal Investigator: Carolyn Nakisige, MD, Uganda Cancer Institute

Publications and helpful links

General Publications

• 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. 2022 Apr 6. doi: 10.1007/s13187-022-02163-x. Online ahead of print.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Cervical Cancer Screening; Developing Countries; Global Health; Human Papillomavirus DNA Tests; Visual inspection with acetic acid; Self-collection
• Additional Relevant MeSH Terms: Virus Diseases; Infections; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; DNA Virus Infections; Tumor Virus Infections; Uterine Cervical Neoplasms; Papillomavirus Infections
• Other Study ID Numbers: H17-03332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will be available on request through study investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No