Clinical trial · Interventional
Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge)
Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge): A Pragmatic Cluster Randomized Control Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Human Papillomavirus 16 | — | UNRESOLVED | — |
| Human Papillomavirus 18 | — | UNRESOLVED | — |
| Papillomavirus Infections | — | UNRESOLVED | — |
| Pre-Cancerous Dysplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Self-collected HPV testing for cervical cancer screening | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Community Health Worker Self-Collection
- description
- Door-to-door recruitment of women for self-collected HPV testing
- interventionNames
- Behavioral: Self-collected HPV testing for cervical cancer screening
- type
- EXPERIMENTAL
- label
- Community Health Meeting Self-Collection
- description
- Community health meeting recruitment of women for self-collected HPV testing
- interventionNames
- Behavioral: Self-collected HPV testing for cervical cancer screening
Primary outcomes (1)
- measure
- VIA follow-up and treatment when indicated (screen and treat)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 49 Years
Show eligibility criteria text
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.
References
Publications (5)
- DERIVEDLeahy 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
- DERIVEDGottschlich 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
- DERIVEDGottschlich 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
- DERIVEDRawat 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
- DERIVEDNakisige 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