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

NCT04000503 | Completed

• 1 other identifier: H17-03332
• Study Type: interventional
• Target: 2,019
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Human Papillomavirus DNA Tests; Visual inspection with acetic acid; Global Health; Developing Countries; Self-collection; Cervical Cancer Screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• HPV prevalence

  Baseline

• STI-HPV co-infection rate (Gonorrhea, Syphilis, etc.)

  Baseline

• HPV and co-morbid conditions

  Baseline

• Barriers and facilitators of engagement in care

  FGDs within 3 months of recruitment completion

• Identify mediators of engagement of care

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

Other Outcomes (3)

• Cost-effectiveness of each model of community-based cervical cancer screening

  Modeled lifetime estimates after 1 year follow-up

• Process evaluation for integrated community-based cervical cancer screening

  Within 6 months of final recruitment

• Male partner knowledge of cervical cancer screening

  Baseline

Study Arms (2)

Community Health Worker Self-Collection

EXPERIMENTAL

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

Behavioral: Self-collected HPV testing for cervical cancer screening

Community Health Meeting Self-Collection

EXPERIMENTAL

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

Behavioral: Self-collected HPV testing for cervical cancer screening

Interventions

Self-collected HPV testing for cervical cancer screening 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 Worker Self-Collection

Eligibility Criteria

• Age: 25 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women with no previous history of hysterectomy
• aged 25-49 years old
• no previous history of treatment for cervical cancer
• provided written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Uganda Cancer Institute: collaborator

Study Sites (1)

Uganda Cancer Institute

Kampala, Uganda

Location

Related Publications (5)

• Leahy W, Abomoslim M, Booth A, Gottschlich A, Mwandacha N, Dau H, Naguti P, Payne B, Smith L, Nakisige C, Ogilvie G. Women's cellphone access and ownership in rural Uganda: implications for self-care interventions. BMC Glob Public Health. 2024 Feb 5;2(1):8. doi: 10.1186/s44263-024-00038-5.

  PMID: 39681893 DERIVED

• Gottschlich A, Payne BA, Trawin J, Albert A, Jeronimo J, Mitchell-Foster S, Mithani N, Namugosa R, Naguti P, Pedersen H, Rawat A, Simelela PN, Singer J, Smith LW, van Niekerk D, Orem J, Nakisige C, Ogilvie G. Community-integrated self-collected HPV-based cervix screening in a low-resource rural setting: a pragmatic, cluster-randomized trial. Nat Med. 2023 Apr;29(4):927-935. doi: 10.1038/s41591-023-02288-6. Epub 2023 Apr 10.

  PMID: 37037880 DERIVED

• Gottschlich A, Payne BA, Trawin J, Albert A, Jeronimo J, Mitchell-Foster S, Mithani N, Namugosa R, Naguti P, Orem J, Rawat A, Simelela PN, Singer J, Smith LW, van Niekerk D, Nakisige C, Ogilvie G. Experiences with thermal ablation for cervical precancer treatment after self-collection HPV-based screening in the ASPIRE Mayuge randomized trial. Int J Cancer. 2023 Apr 15;152(8):1630-1639. doi: 10.1002/ijc.34369. Epub 2022 Nov 28.

  PMID: 36408923 DERIVED

• Rawat A, Mithani N, Sanders C, Namugosa R, Payne B, Mitchell-Foster S, Orem J, Ogilvie G, Nakisige C. "We Shall Tell them with Love, Inform them what we have Learnt and then Allow them to go" - Men's Perspectives of Self-Collected Cervical Cancer Screening in Rural Uganda: A Qualitative Inquiry. J Cancer Educ. 2023 Apr;38(2):618-624. doi: 10.1007/s13187-022-02163-x. Epub 2022 Apr 6.

  PMID: 35384556 DERIVED

• Nakisige C, Trawin J, Mitchell-Foster S, Payne BA, Rawat A, Mithani N, Amuge C, Pedersen H, Orem J, Smith L, Ogilvie G. Integrated cervical cancer screening in Mayuge District Uganda (ASPIRE Mayuge): a pragmatic sequential cluster randomized trial protocol. BMC Public Health. 2020 Jan 31;20(1):142. doi: 10.1186/s12889-020-8216-9.

  PMID: 32005202 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Gina Ogilvie, MD

  Women's Health Research Institute of British Columbia

  PRINCIPAL INVESTIGATOR

• Sheona Mitchell-Foster, MD

  University of Northern British Columbia

  PRINCIPAL INVESTIGATOR

• Carolyn Nakisige, MD

  Uganda Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pragmatic cluster randomized control trial

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 27, 2019
• Study Start: August 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: October 31, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)