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

Not Applicable

Completed

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

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

Brief 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.

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Community Health Worker Self-Collection	Self-collected HPV testing for cervical cancer screening	Door-to-door recruitment of women for self-collected HPV testing
Community Health Meeting Self-Collection	Self-collected HPV testing for cervical cancer screening	Community health meeting recruitment of women for self-collected HPV testing

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Barriers and facilitators of engagement in care	FGDs within 3 months of recruitment completion	Semi-structured focus group discussions with women who did and did not attend follow-up screening in each study arm.
Identify mediators of engagement of care	Outcome measured within 6 weeks of self-collection for HPV test	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
HPV prevalence	Baseline	Total number of women who test positive for HPV out of the total number of samples obtained
STI-HPV co-infection rate (Gonorrhea, Syphilis, etc.)	Baseline	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
HPV and co-morbid conditions	Baseline	Association (adjusted OR) estimated between HPV and HIV; other STIs