Effectiveness of an mHealth intervention to increase adherence to triage of HPV DNA positive women who have performed self-collection (the ATICA study) : A hybrid type I cluster randomised effectiveness- implementation trial

Background Human Papillomavirus (HPV) self-collection offered by community health workers (CHWs) during home visits has been hampered by low levels of triage Pap among HPV-positive women. We investigated effective-ness of a mHealth intervention to increase adherence to triage Pap.Methods We conducted a hybrid type I cluster randomised effectiveness-implementation trial in Jujuy, Argentina. CHWs (clusters) were eligible if actively offering HPV self-collection and served at least 26 women aged 30 years and over. Women were eligible if they conducted self-collection and provided a mobile phone number. 260 CHWs were randomly allocated (3:2 ratio) to a multi-component intervention (Up to four SMS messages sent to HPV-posi-tive women, and one SMS message to CHWs to prompt a visit of women with no triage Pap 60 days after a positive -test), or control group (Usual care: Women instructed to attend their health centre 30 days after HPV self-collection to pick-up results). The primary effectiveness outcome was percentage of HPV-positive women with triage 120 days after the HPV-test result. We evaluated implementation of the intervention using the RE-AIM framework.Findings 221 CHWs (132 intervention, 89 control group) contacted 5389 women; and 5351 agreed to participate (3241 intervention, 2110 control group). In total 314/445 (70.5%) HPV-positive women of the intervention group had triage at 120 days after the HPV result, compared to 163/292 (55.1%) in the control group: 15.5% point improvement; 95%CI: 6.8-24.1; relative risk: 1.28; 95%CI: 1.11-1.48. 97.2% of women accepted the intervention and 86.9% of CHWs agreed to its adoption.Interpretation The multicomponent mHealth intervention was effective in increasing the percentage of HPV-posi-tive women who had triage Pap, allowing for many more women at risk of cervical cancer to receive timely follow-up.Funding National Cancer Institute of the National Institutes of Health (USA) under Award Number R01CA218306.Copyright (c) 2022 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/) The