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

NCT04000503CompletedNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

University of British Columbia

Enrollment

2019

Start Date

2019-08-01

Completion Date

2021-07-31

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Self-collected HPV testing for cervical cancer screening

Conditions

Human Papillomavirus 16Human Papillomavirus 18Papillomavirus InfectionsCervical CancerPre-Cancerous Dysplasia

Eligibility

Age Range

25 Years – 49 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

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

Time frame: Outcome measured within 6 weeks of self-collection for HPV test

Secondary Outcomes

HPV prevalence

Total number of women who test positive for HPV out of the total number of samples obtained

Time frame: 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

Time frame: Baseline

HPV and co-morbid conditions

Association (adjusted OR) estimated between HPV and HIV; other STIs

Time frame: 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.

Time frame: 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

Time frame: Outcome measured within 6 weeks of self-collection for HPV test

Locations

Uganda Cancer Institute, Kampala, Uganda

Linked Investigators

Angeli Rawat

Anna Gottschlich

Gina S. Ogilvie

Gina Ogilvie is a Senior Scientist at BCCDC. She is also a Senior Advisor at BC Women's Hospital Health Centre, Assistant Director of the Women's Health Research Institute, and a professor in the UBC School of Population & Public Health. Research Dr. Ogilvie’s clinical and research focuses on both the public health and clinical aspects of reproductive health, human papillomavirus infection and vaccines, HIV in women and care for marginalized populations, and other sexually transmitted infections. She has been awarded with several recognitions and awards, including UBC’s Killam Faculty Research Prizes 2020, ASTDA Annual Legacy Awards 2021, American Sexually Transmitted Diseases Association (ASTDA) Achievement Award 2020, President’s Award, and Medical Staff Association of Children’s and Women’s Health Centre. Dr. Ogilvie is also a Tier 1 Canada Research Chair at Global Control of HPV Related Disease and Cancer. She is principal investigator on over 10 million dollars in research grants and has received funding from PHAC, CIHR, Michael Smith Foundation for Health Research, Canadian Foundation for Innovation and private foundations. Bio Dr. Ogilvie obtained her medical degree and family practice certification at McMaster University, and then did a fellowship in population health at McMaster University. She completed her Masters of Science (MSc) in clinical epidemiology at UBC, focusing on the care of HIV-positive women, and her Doctor of Public Health (DrPH) in HPV primary screening at the University of North Carolina at the Gillings School of Global Public Health. She has published over 150 peer reviewed manuscripts and provides advice and consultation to national and international institutions, including the Canadian Partnership Against Cancer, Public Health Agency of Canada, the World Health Organization (WHO), and Ministries of Health on STI, HIV and HPV vaccine policy and programming

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