In a pragmatic cluster-randomised study conducted in rural Mayuge district of Uganda, The Advances in Screening and Prevention in Reproductive Cancers (ASPIRE) Mayuge investigators used an approach focused on intervention implementation to demonstrate the feasibility of integrating self-collected human papillomavirus (HPV)-based cervix screening programmes into existing health systems in low-resource settings with a high burden of cervical cancer. Both implementation strategies, Door-to-Door and Community Health Day, embedded within a region’s existing health system and infrastructure in terms of health staff and treatment clinics, were feasible and showed high uptake of screening and treatment attendance in a community where prior screening participation was almost non-existent.
Women who were allocated to the Door-to-Door arm were more likely to attend treatment than those in the Community Health Day arm, even though they reported longer walking time to the health centre. The findings are reported by Anna Gottschlich of the BC Women’s Hospital and Health Center, Women’s Health Research Institute, and Faculty of Medicine, University of British Columbia, both in Vancouver, British Columbia, Canada and colleagues on 10 April 2023 in the Nature Medicine.
The authors wrote in the background that evidence suggests that self-collected HPV-based cervix screening is a feasible and cost-effective solution to addressing barriers to screening, especially in low-resourced and rural areas. Compared to conventional cytology-based screening, which can be delivered only with a pelvic examination conducted by healthcare practitioners, HPV-based screening programmes can offer self-collected screening options to women in their homes or private areas in their communities via community health workers.
Active invitation to self-collected HPV-based cervix screening programmes has consistently shown high uptake across diverse populations, and, following the World Health Organization recommended screen-and-treat approach, HPV-positive women can be referred for visual inspection with acetic acid and treatment with cryotherapy or thermal ablation at their nearest health facility.
Although improved screening is an essential aspect in the elimination of cervical cancer, the availability of and attendance at treatment is equally as important to the success of any elimination strategy, as pre-cancerous lesions identified through screening must be effectively treated to prevent progression to cancer for screening to offer benefits. Although many studies have focused on screening uptake, data confirming that self-collected HPV-based cervix screening leads to an increase in treatment after an abnormal screen are more limited.
As it will take decades for the HPV vaccination to realise its full benefits, insufficient coverage of screening and treatment remains the greatest short-term barrier to cervical cancer prevention across the world. It is critical to generate evidence that will define best practice of how to improve attendance at treatment situated in existing health systems. This evidence can then be used as a roadmap to facilitate deployment of self-collected HPV-based cervix screening programmes across other similar settings.
Uganda has one of the highest rates of cervical cancer incidence in the world, at 56.2 cases per 100,000 women. The ASPIRE Mayuge study investigated the impact of self-collected HPV-based cervix screening programmes embedded into existing health infrastructure on coverage of screening and treatment in a rural population in Uganda with low rates of cervical cancer screening participation. The study team included investigators from the Uganda Cancer Institute who selected the Mayuge district as a priority region to conduct the study.
The study team conducted this pragmatic cluster-randomised study allowing the intervention to occur at the community level. They used an approach that focused on findings relevant for implementation and assessed screening and treatment strategies that were grounded in the realities of Ugandan health systems, deploying two feasible strategies that differed in the ways in which women were recruited for screening. A pragmatic study design was used to assess the success of the intervention and evaluate the impact of the intervention in the real-world setting of a low-resource community.
The study aimed to determine attendance at treatment for HPV-positive participants after self-collected HPV-based cervix screening and compare those rates across different implementation strategies to inform a roadmap for implementation of self-collected HPV-based cervix screening programmes to decision-makers across similar settings. The study investigators also measured additional outcomes to further inform the decision-makers who plan to implement cervical cancer screening programmes that are integrated into existing health infrastructure in a low-resource setting with a high burden of cervical cancer, such as screening knowledge, uptake and participant experience.
The ASPIRE Mayuge compared the superiority of two recruitment implementation strategies for self-collected HPV-based cervix screening: Door-to-Door versus Community Health Day. Villages were randomised (unblinded), 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 self-collected HPV-based cervix screening. The primary outcome was rate of attendance at treatment after a positive self-collected HPV-based cervix screening.
The study investigators randomised 31 villages with 2019 participants included, of which 16 clusters with 1055 participants in the Door-to-Door and 15 clusters with 964 participants in the Community Health Day. Among HPV-positive participants, attendance at treatment rates were 75% in the Door-to-Door and 67% in the Community Health Day (p = 0.049). Participants in the Community Health Day intervention were less likely to attend treatment compared to Door-to-Door with risk ratio 0.78 (95% confidence interval 0.64–0.96). No adverse events were reported.
The study provides evidence on how to improve coverage of cervical cancer screening and treatment attendance using self-collected HPV-based cervix screening programmes, particularly in rural, low-resource settings. It also provides evidence on the impact of two promising and feasible strategies for self-collected HPV-based cervix screening, both of which obtain a high coverage rate for screening and treatment. This evidence can provide an important contribution to the policies as countries strive to achieve the goal of cervical cancer elimination.
Future analyses will investigate if the Community Health Day strategy requires fewer personnel and effectively allows for the bundling of health services, allowing for those who are planning the implementation of self-collected HPV-based cervix screening programmes to consider this trade-off while still feeling confident that either approach will have strong impact relative to baseline.
This work was supported by a Canadian Health Research Institutes Foundation grant.
Gottschlich A, Payne BA, Trawin J, et al. Community-integrated self-collected HPV-based cervix screening in a low-resource rural setting: a pragmatic, cluster-randomized trial. Nature Medicine; Published online 10 April 2023. DOI: https://doi.org/10.1038/s41591-023-02288-6