NCT04000503: ASPIRE

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

Completed NA Last updated 3 November 2022

What this trial tests

NA trial testing Self-collected HPV testing for cervical cancer screening in Human Papillomavirus 16 in 2,019 participants. Completed in 31 October 2022.

Timeline

1 August 2019

Primary endpoint
31 July 2021

31 October 2022

Quick facts

Lead sponsor	University of British Columbia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	2,019
Start date	1 August 2019
Primary completion	31 July 2021
Estimated completion	31 October 2022
Sites	1 location across Uganda

Drugs / interventions tested

• Self-collected HPV testing for cervical cancer screening

Conditions studied

• Human Papillomavirus 16 — all drugs for Human Papillomavirus 16 →
• Human Papillomavirus 18 — all drugs for Human Papillomavirus 18 →
• Papillomavirus Infections — all drugs for Papillomavirus Infections →
• Cervical Cancer — all drugs for Cervical Cancer →

Sponsor

University of British Columbia

Who can join

Adults 25 to 49, female only, with Human Papillomavirus 16 or Human Papillomavirus 18. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Integrated cervical cancer screening in Mayuge District Uganda (ASPIRE Mayuge): a pragmatic sequential cluster randomized trial protocol.
   Nakisige C, Trawin J, Mitchell-Foster S, Payne BA, et al · · 2020 · cited 30× · PMID 32005202 · DOI 10.1186/s12889-020-8216-9
2. Community-integrated self-collected HPV-based cervix screening in a low-resource rural setting: a pragmatic, cluster-randomized trial.
   Gottschlich A, Payne BA, Trawin J, Albert A, et al · · 2023 · cited 12× · PMID 37037880 · DOI 10.1038/s41591-023-02288-6
3. "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.
   Rawat A, Mithani N, Sanders C, Namugosa R, et al · · 2023 · cited 7× · PMID 35384556 · DOI 10.1007/s13187-022-02163-x
4. Women's cellphone access and ownership in rural Uganda: implications for self-care interventions.
   Leahy W, Abomoslim M, Booth A, Gottschlich A, et al · · 2024 · cited 2× · PMID 39681893 · DOI 10.1186/s44263-024-00038-5