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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2019 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2022-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pragmatic cluster randomized control trial

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Community Health Worker Self-Collection

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

Group Type EXPERIMENTAL

Self-collected HPV testing for cervical cancer screening

Intervention Type BEHAVIORAL

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.

Community Health Meeting Self-Collection

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

Group Type EXPERIMENTAL

Self-collected HPV testing for cervical cancer screening

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes