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

Cervical Cancer Clinical Trial

— ASPIRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04000503
• Other study ID #: H17-03332
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: October 31, 2022

Study information

• Verified date: October 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2019
• Est. completion date: October 31, 2022
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Uganda	Uganda Cancer Institute	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Uganda Cancer Institute

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	HPV prevalence	Total number of women who test positive for HPV out of the total number of samples obtained	Baseline
Secondary	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
Secondary	HPV and co-morbid conditions	Association (adjusted OR) estimated between HPV and HIV; other STIs	Baseline
Secondary	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
Secondary	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