Effect of self-collection of HPV DNA offered by community health workers at home visits on uptake of screening for cervical cancer (the EMA study): a population-based cluster-randomised trial

Summary Background Control of cervical cancer in developing countries has been hampered by a failure to achieve high screening uptake. HPV DNA self-collection could increase screening coverage, but implementation of this technology is difficult in countries of middle and low income. We investigated whether offering HPV DNA self-collection during routine home visits by community health workers could increase cervical screening. Methods We did a population-based cluster-randomised trial in the province of Jujuy, Argentina, between July 1, 2012, and Dec 31, 2012. Community health workers were eligible for the study if they scored highly on a performance score, and women aged 30 years or older were eligible for enrolment by the community health worker. 200 community health workers were randomly allocated in a 1:1 ratio to either the intervention group (offered women the chance to self-collect a sample for cervical screening during a home visit) or the control group (advised women to attend a health clinic for cervical screening). The primary outcome was screening uptake, measured as the proportion of women having any HPV screening test within 6 months of the community health worker visit. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02095561. Findings 100 community health workers were randomly allocated to the intervention group and 100 were assigned to the control group; nine did not take part. 191 participating community health workers (94 in the intervention group and 97 in the control group) initially contacted 7650 women; of 3632 women contacted by community health workers in the intervention group, 3049 agreed to participate; of 4018 women contacted by community health workers in the control group, 2964 agreed to participate. 2618 (86%) of 3049 women in the intervention group had any HPV test within 6 months of the community health worker visit, compared with 599 (20%) of 2964 in the control group (risk ratio 4·02, 95% CI 3·44–4·71). Interpretation Offering self-collection of samples for HPV testing by community health workers during home visits resulted in a four-fold increase in screening uptake, showing that this strategy is effective to improve cervical screening coverage. This intervention reduces women's barriers to screening and results in a substantial and rapid increase in coverage. Our findings suggest that HPV testing could be extended throughout Argentina and in other countries to increase cervical screening coverage. Funding Instituto Nacional del Cancer (Argentina).