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

Study Overview
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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.

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.

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

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

Intervention / Treatment
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* Behavioral: Self-collected HPV testing for cervical cancer screening


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic cluster randomized control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community Health Worker Self-Collection<br>Door-to-door recruitment of women for self-collected HPV testing | Behavioral: Self-collected HPV testing for cervical cancer screening<br>* 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.<br>|
| Experimental: Community Health Meeting Self-Collection<br>Community health meeting recruitment of women for self-collected HPV testing | Behavioral: Self-collected HPV testing for cervical cancer screening<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Papillomavirus DNA Tests, Visual inspection with acetic acid, Global Health, Developing Countries, Self-collection, Cervical Cancer Screening