Mixed-methods approach to evaluate an mHealth intervention to increase adherence to triage of human papillomavirus-positive women who have performed self-collection (the ATICA study): study protocol for a hybrid type I cluster randomized effectiveness-implementation trial

The specific aims of the study are:

The study design will follow the structure of an effectiveness-implementation hybrid type I trial [27] and will use a mixed-methods approach [28, 29]. We will use a hybrid type I design as proposed by Curran and colleagues [27] to galvanize the translation of efficacious treatments to enhance their public health impact. This hybrid design is appropriate for the proposed intervention because the following conditions are met: it has strong face validity that will support applicability to a new setting or population, there is at least indirect evidence for the intervention that will support applicability to a new setting or population, and there is minimal risk associated with the intervention [27].

We combine a cluster randomized trial to evaluate the effectiveness of a multi-component mHealth intervention with a mixed-methods approach involving quantitative and qualitative evaluations of the implementation using the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) [30] and Consolidated Framework for Implementation Research (CFIR) [31] frameworks. The mixed-methods design will allow a deep understanding of the reasons for success or failure of the mHealth intervention and also quantify the intervention impact on the outcomes [32]. ATICA will integrate quantitative and qualitative methods in multiple ways: a) formative research with women to develop the framing and content of SMS messages; b) a pragmatic cluster randomized trial to measure the effectiveness of the intervention in improving triage adherence among HPV+ women; and c) the acceptability of the strategy will be measured during the post-intervention phase through 1) a quantitative survey among CHWs, 2) semi-structured interviews with health authorities and health professionals, and 3) interviews with HPV+ women using a structured questionnaire to gather reasons for triage adherence/nonadherence.

We will use the RE-AIM [30] and CFIR [31] frameworks at all stages of the research process. The RE-AIM framework is particularly appropriate to assess the public health impact of interventions [30], and the CFIR is useful to systematically assess contextual factors that influence implementation and adoption [31].

Following the Health Belief Model [33, 34], we anticipate that the SMS messages will serve as specific cues to action and stimulate triage behavior. The CHW visit will be an additional cue to action to nonresponders, as well as an opportunity to provide counseling and support which will change women’s perceived benefits of and barriers to screening, as well as the perceived threat of CC. We expect both of these components to increase adherence to triage in the intervention group.

The research will take place in the province of Jujuy, located in northwest Argentina (Jujuy total population: 673,307; women: 51%; urban population: 85% [35]). The rate of mobile phone penetration was 82% of urban households in 2011, though this percentage has probably increased [36]. The CC mortality rate in Jujuy is 10.6 per 100,000 women (2012–2014). The public health sector in Argentina includes a network of public hospitals and primary health care (PHC) centers which mostly provide care to people not covered by the social security sector (informal economy workers and unemployed people). For the uninsured, health services are provided free of cost. In Jujuy, the PHC system integrates approximately 700 paid full-time CHWs who twice yearly visit approximately 110,000 households for health-related tasks such as immunization and promoting maternal and child health. HPV testing was introduced in 2012 through the Jujuy Demonstration Project [8]; since then, it has become the primary screening test and is available to all women aged 30 and over at public health institutions. The provincial program on CC prevention uses the national screening information system (SITAM, for its initials in Spanish) [37]. SITAM registers all screening, diagnosis, and treatment events of women screened in the public health system and works as an online medical record. Results of HPV tests and Pap smears are immediately registered in SITAM to generate a diagnosis form, which is instantly available to providers at public health establishments with an online terminal. Since 2014, HPV self-collection is available and offered during the CHW routine home visits, and those women who accept the offer perform self-collection at home. Women who opt for self-collection are instructed to go to the health center within 30 days to pick up the results. In 2014 and 2015, approximately 38% of all women aged 30 years and over who were screened through the public health sector did it through self-collection [38].

We will use data from the CRT database and will also conduct a self-administered semi-structured survey of CHWs, semi-structured interviews with key stakeholders, and a survey of HPV+ women. RE-AIM and CFIR frameworks will guide the implementation evaluation (Table 2). The CFIR comprises 39 common constructs from published implementation frameworks and models and organizes these into five major domains [31]. In this study we will analyze the following domains: intervention characteristic (relative advantage, adaptability, complexity, cost); outer setting (patient needs and resources, external policies, incentives); inner setting (structural characteristics, tension for change, relative priority and available resources, access to knowledge and information); and characteristics of individuals (knowledge and beliefs about the intervention, perceived self-efficacy) [31].

Eight weeks after the CRT (intervention and measurement of primary outcome) is finished we will hold a workshop as a closing activity to present preliminary results to CHWs and health authorities. During this workshop, CHWs will be asked to complete an anonymous, self-administered semi-structured survey to evaluate their perspectives and acceptability of the intervention (see outcomes and qualitative evaluation in Table 2), and about barriers and facilitators of the intervention. We will administer the survey during the closing activity to assure a high response rate. Project staff members will emphasize that participation in the survey is anonymous and voluntary; all participating CHWs will sign consent forms. Those CHWs who are not able to attend this closing activity will receive the survey by mail and will be requested to send it to project staff in a blind envelope.

In the third year of the project we will conduct semi-structured interviews with stakeholders to evaluate their acceptability of the intervention and perspectives on how to build and enhance project sustainability (see qualitative evaluation in Table 2). Invited stakeholders will include directors and intermediate coordinators of the Minister and Secretaries of Health (the PHC Direction, the provincial Program on Cervical Cancer Prevention, etc.), and heads of gynecology services, and of the HPV laboratory. Constructs to be considered in the script will include: relative advantage, adaptability, complexity and cost; patient needs and resources, and external policies and incentives; structural characteristics; tension for change; relative priority; available resources; access to knowledge and information. Interviews with health authorities will also include questions to evaluate the potential for programmatic incorporation of the multi-component mHealth intervention to measure the maintenance dimension of RE-AIM. The sample size will be determined based on relevance and theoretical saturation [48]. We will select participants to guarantee that a wide range of responses is captured and to allow comparisons between them. To ensure we include enough stakeholders from relevant groups, we plan to conduct at least 20 interviews. With prior authorization of the participants, each interview will be audio-recorded.

Finally, we will carry out a structured questionnaire among all HPV+ women from the MH group (Women Survey) to evaluate their acceptability of the strategy, their perspectives about the implementation, and reasons for adherence and nonadherence to triage. All HPV+ women from the CRT intervention group (approximately 240 women) will be surveyed 5 months after their HPV test result (i.e., 1 month after measurement of the primary outcome), irrespective of their triage status. The questionnaire will include open and closed questions with dimensions related to women’s experiences and perceptions, including acceptability and relevance of SMS message frequency, receipt time, and content, the perceived effect of the multiple components of the intervention on their adherence, and reasons for adhering/not adhering to triage. The nominated list of these women and their contact details will be extracted from the CRT database. Trained interviewers will contact these women via telephone to make a home appointment to administer the questionnaire. The interviewers will be trained by the project staff; training will include formal aspects regarding applying the questionnaire as well as skills for developing a connection with the interviewees.