Journal Article

Community-integrated self-collected HPV-based cervix screening in a low-resource rural setting: a pragmatic, cluster-randomized trial

Namugosa, Ruth, Jeronimo, Jose, Smith, Laurie W., Pedersen, Heather, Rawat, Angeli, Ogilvie, Gina, Singer, Joel, Trawin, Jessica, Simelela, Princess Nothemba, Mitchell-Foster, Sheona, van Niekerk, Dirk, Albert, Arianne, Gottschlich, Anna, Naguti, Priscilla, Nakisige, Carolyn, Payne, Beth A., Mithani, Nadia, Orem, Jackson

2023

Overview

Effective approaches to improve coverage of self-collected human papillomavirus (HPV)-based cervix screening (SCS) as well as attendance at treatment for HPV-positive participants are needed to inform policy on optimal integration of cervical cancer screening programs within existing infrastructure in low-resource settings. ASPIRE Mayuge was a pragmatic cluster-randomized trial in rural Mayuge district, Uganda, comparing the superiority of two recruitment implementation strategies for SCS: Door-to-Door versus Community Health Day. Villages were randomized (unblinded) to a strategy, and participants aged 25–49 years with no previous history of hysterectomy or treatment for cervical cancer or pre-cancer were eligible. Participants completed a survey and participated in SCS. The primary outcome was rate of attendance at treatment after a positive SCS. The trial randomized 31 villages and 2,019 participants included in these analyses (Door-to-Door: 16 clusters, 1,055 participants; Community Health Day: 15 clusters, 964 participants). Among HPV-positive participants, attendance at treatment rates were 75% (Door-to-Door) and 67% (Community Health Day) ( P  = 0.049). Participants in the Community Health Day intervention were less likely to attend treatment compared to Door-to-Door (risk ratio = 0.78, 95% confidence interval: 0.64–0.96). No adverse events were reported. Policymakers in low-resource settings can use these results to guide implementation of SCS programs. ISRCTN registration: 12767014 . ClinicalTrials.gov registration: NCT04000503 . The ASPIRE Mayuge trial in rural Uganda showed that implementation of door-to-door HPV screening led to better attendance of follow-up treatment services but requires more personnel compared to community health days.

• Publisher: Nature Publishing Group US,Nature Publishing Group
• Subject: 692/308/174 / 692/308/2779/777 / Biomedical and Life Sciences / Biomedicine / Cancer / Cancer Research / Cancer screening / Cervical cancer / Cervix / Cervix Uteri / Cluster analysis / Early Detection of Cancer - methods / Female / Human papillomavirus / Humans / Hysterectomy / Infectious Diseases / Mass Screening - methods / Medical screening / Metabolic Diseases / Molecular Medicine / Neurosciences / Papillomaviridae / Papillomavirus Infections - diagnosis / Uterine Cervical Neoplasms - diagnosis / Uterine Cervical Neoplasms - epidemiology / Uterine Cervical Neoplasms - therapy / Villages