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

University of British Columbia

Status: Completed

Conditions: Pre-Cancerous Dysplasia; Human Papillomavirus 18; Human Papillomavirus 16; Cervical Cancer; Papillomavirus Infections

Treatments: Behavioral: Self-collected HPV testing for cervical cancer screening

Study type: Interventional

Funder types: Other

Identifiers

NCT04000503

H17-03332

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,019 patients

Sex: Female

Ages: 25 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,019 participants in 2 patient groups

Community Health Worker Self-Collection

Experimental group

Description:

Door-to-door recruitment of women for self-collected HPV testing

Treatment:

Behavioral: Self-collected HPV testing for cervical cancer screening

Community Health Meeting Self-Collection

Experimental group

Description:

Community health meeting recruitment of women for self-collected HPV testing

Treatment:

Behavioral: Self-collected HPV testing for cervical cancer screening