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 effectiveness 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-positive 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-positive 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.

Changing the paradigm of cervical cancer prevention through introduction of HPV-testing: evaluation of the implementation process of the Jujuy Demonstration Project in Argentina.

INTRODUCTION: The Jujuy Demonstration Project (JDP) was a project carried out over the course of 4 years (2011-2014) to develop, implement and evaluate the programmatic components of a Human Papilloma Virus (HPV)-based screening programme in Argentina. The aim of this paper is to present a qualitative evaluation of the context and implementation process of the JDP. METHODS: We used an adaptation of the Health System Framework (HSF), which includes interconnected contextual factors that are considered key drivers for successful health interventions. We reviewed secondary documents, which included scientific reports, norms and regulations, information sheets, power point presentations and manuals and recommendations published by the National Programme for Cervical Cancer Prevention. We also carried out semi-structured interviews with key informants to explore their views about technology acceptability. RESULTS: Key components of the JDP implementation process were: a high level of political support and consensus among stakeholders, the demonstrated effectiveness of the technology and its acceptability by health authorities and providers, the funding of tests and diagnosis/treatment services, the implementation of an information system for monitoring and evaluation and the reorganisation of the network of screening, diagnosis and treatment services. CONCLUSION: This analysis examines the policy context in which the JDP was implemented and the system components that were key for the demonstrated effectiveness of the strategy. Such analyses provide useful insights into core components of HPV testing implementation that are needed to guarantee its potential effectiveness to reduce cervical cancer incidence and mortality.

Adherence to triage among women with HPV-positive self-collection: a study in a middle-low income population in Argentina.

INTRODUCTION: Screening for cervical cancer (CC) prevention has substantially changed with the introduction of human papillomavirus (HPV) tests. This technology compared to cytology has increased the detection of pre-malignant and malignant cervical lesions in real-world programmes in different settings. Very importantly, through self-collection, HPV testing can reduce barriers to screening and increase coverage. However, when using HPV self-collection, triage tests are a key step in the CC prevention process, and high adherence to triage has been difficult to obtain in low-middle income settings. The aim of this study was to measure adherence to triage among women with HPV+ self-collection and analysed factors associated with this adherence in a middle-low resource setting in Argentina. We also evaluated key indicators related to the implementation of the HPV self-collection strategy. METHODS: We analysed data on screening/triage/diagnosis/treatment from women aged 30+ who performed self-collection between 2015 and 2017 (n = 15,763), in the public health system in Tucuman, Argentina. We analysed secondary data from the national screening information system. The primary outcomes were: 1) adherence to cytology triage within the recommended timeframe (120 days) and 2) overall adherence to cytology triage including data at 18 months after screening. Multivariable regression was used to examine the association between age group, year of the screening test, record of the previous Pap-based screening and health insurance status with adherence to triage test as a primary outcome. We reported odds ratios, 95% confidence intervals and p-value of 0.05, which was considered the threshold for p-values). RESULTS: We analysed data of 2,389 HPV+ women. The overall adherence to triage at 18 months was 42.9%. The percentage of women completing cytology triage within the recommended timeframe of 120 days was lower (25.2%). Women with the record of a previous Pap-based screening had 1.86 times the odds of having a triage compared to women without a record of a previous Pap-based screening (95% CI: 1.64-2.64, p <0.001). Furthermore, the probability of having triage at the recommended timeframe was higher among women who were older and women with public health insurance. CONCLUSIONS: Our results showed that adherence to triage in the recommended timeframe was low. In addition, the probability of having triage at the recommended timeframe was higher among women with a record of a previous Pap-based screening, a proxy of the use of health services. Our results showed that adherence to triage in the context of the HPV-self-collection strategy is challenging. The implementation of alternative approaches that might facilitate adherence to triage should be further investigated.

Psycho-social impact of positive human papillomavirus testing in Jujuy, Argentina results from the Psycho-Estampa study.

Human papillomavirus (HPV) testing can have a negative impact on women's lives which might also result in abandoning the follow-up and treatment process. This study measured the psycho-social impact of HPV-positivity among HPV-tested women from Jujuy, Argentina, a middle-low income setting. In this cross-sectional study (2015-2016), the psycho-social impact of HPV-positivity was measured using the Psycho-Estampa Scale, specifically designed and validated to be used in screening contexts. We measured mean scores for each of the five scale domains, and the Overall Impact score (Values from 1: No impact to 4: Heavy impact). We compared scores according to cytology triage diagnosis using ordinal logistic regression. A total of 163 HPV-positive women were recruited at the Centro Carlos Alvarado hospital and included in the study sample; of these, 124 (76.1%) had normal triage cytologies. The overall Impact score was between low and moderate (mean:2.56, SD:0.65). The highest psycho-social impact was measured in the Worries about cancer and treatment domain (mean score:3.60, SD:0.60), followed by Sexuality domain (mean:2.50; SD:1.00). The Uncertainty about information provided by health providers domain had the lowest mean score (mean:2.14, SD:0.73). Compared to women with normal cytologies (n = 124), women with abnormal cytologies (n = 39) had a higher likelihood of greater overall Psycho-social Impact (OR: 2.91; p = 0.0036). No statistically significant differences were found in scores of specific domains according to cytology results. It is important to devise specific counseling interventions to reduce the psycho-social impact of HPV-Testing as primary screening and its potential effect on completion of the diagnosis/ treatment process.

Programmatic human papillomavirus testing in cervical cancer prevention in the Jujuy Demonstration Project in Argentina: a population-based, before-and-after retrospective cohort study.

BACKGROUND: Human papillomavirus (HPV) testing for cervical cancer prevention was introduced in Argentina through the Jujuy Demonstration Project (2011-14). The programme tested women aged 30 years and older attending the public health system with clinician-collected HPV tests. HPV self-collection was introduced as a programmatic strategy in 2014. We aimed to evaluate the effectiveness of programmatic HPV testing to detect cervical intraepithelial neoplasia (CIN) of grade 2 or worse (CIN2+) in comparison with cytology-based screening. METHODS: We did a population-based, before-and-after retrospective cohort study using data from the National Cervical Cancer Prevention Program for the Jujuy province in northwest Argentina. We obtained data for the cytology-based screening period from Jan 1, 2010, until Dec 31, 2011, and for the HPV-based screening period from Jan 1, 2012, until Dec 31, 2014. The primary outcome was detection of histologically diagnosed CIN2+ among women aged 30 years and older. To assess the outcomes in all individuals included in the study, we used multivariable logistic regression and propensity score matching. The reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework was used for the before-and-after analysis of programmatic dimensions. FINDINGS: Of the 29 631 women who underwent cytology-based screening in 2010-11, CIN2+ was detected in 236 (0·8%) individuals. Of the 49 565 women HPV tested in 2012-14 (clinician-collected tests, n=44 700; self-collection tests, n=4865), 693 (1·4%; 658 clinician-collected tests; 35 self-collection tests) were found to have CIN2+ after the first round of screening. Compared with cytology-based screening, the odds ratio of being diagnosed with a CIN2+ lesion was 2·34 (95% CI 2·01-2·73; p<0·0010) with clinician-collected tests, and 1·08 (0·74-1·52; p=0·68) when screened with self-collection tests, after controlling for age and health insurance status. Screening coverage was similar in both periods (52·7% vs 53·2%); improvements of programmatic indicators were observed in the HPV testing period in relation to laboratory centralisation, lower overscreening (6·6% vs 0·0%), higher adherance to age recommendations (79·3% vs 98·8%), and a decrease of inadequate samples (3·6% vs 0·2%). INTERPRETATION: HPV testing in middle-income settings increases detection of CIN2+ lesions and allows for improvement of programmatic indicators. Evidence suggests that the introduction of HPV testing will accelerate the reduction of cervical cancer burden. FUNDING: Argentinian National Cancer Institute and National Council of Scientific and Technologic Research.

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.

BACKGROUND: Cervical cancer is one of the leading causes of cancer death among women worldwide, with more than 85% of cases occurring in low- and middle-income countries. Human papillomavirus (HPV) screening allows for self-collection with the potential to increase coverage, but still requires triage to identify which HPV+ women need diagnostic and treatment procedures. However, achieving high levels of triage adherence can be challenging, especially among socially vulnerable women. This paper describes the ATICA protocol (Application of Communication and Information Technologies to Self-Collection, for its initials in Spanish), aimed at evaluating the implementation strategy and the effectiveness of a multi-component mobile health (mHealth) intervention to increase adherence to triage among women with HPV+ self-collected tests. METHODS: We will use an effectiveness-implementation hybrid type I trial with a mixed-methods evaluation approach. A cluster randomized trial design including 200 community health workers (CHWs) will evaluate whether the mHealth intervention increases adherence to triage among HPV+ women who self-collected at home during a CHW visit within 120 days after a positive result. The intervention includes an initial mobile phone text message (SMS) alert and subsequent reminders sent to HPV+ women. For those who do not adhere to triage within 60 days of a positive HPV test, an email and SMS will be sent to the CHWs to promote contact with these women during home visits. We will use the Consolidated Framework for Implementation Research (CFIR) as an organizing and analytic framework to evaluate the implementation of the intervention while also drawing on Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM). We will conduct a self-administered, semi-structured survey of CHWs, semi-structured interviews with local health authorities, and a survey of HPV+ women. Combining both qualitative and quantitative data will provide rich insights into local implementation challenges and successes. DISCUSSION: Findings from the implementation evaluation will be applicable to programs that use or are planning to incorporate HPV self-collection and/or mHealth interventions in different settings and countries. This innovative study will also serve as a model for using implementation science in the region. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03478397 . Registered on 20 March 2018.

Evaluation of scaling-up of HPV self-collection offered by community health workers at home visits to increase screening among socially vulnerable under-screened women in Jujuy Province, Argentina.

BACKGROUND: Self-collection has been proposed as a strategy to increase cervical screening coverage among hard-to-reach women. However, evaluations of the implementation of this strategy on a large scale are scarce. This paper describes the process and measurement of the scaling-up of self-collection offered by community health workers during home visits as a strategy to reach under-screened women aged 30+ with public health coverage, defined as the target women. METHODS: We used an adaptation of the Health System Framework to analyze key drivers of scaling-up. A content analysis approach was used to collect and analyze information from different sources. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) model was used to evaluate the impact of the strategy. RESULTS: HPV self-collection was scaled-up in the province of Jujuy in 2014 after a RCT (Self-collection Modality Trial, initials EMA in Spanish) was carried out locally in 2012 and demonstrated effectiveness of the strategy to increase screening uptake. Facilitators of scaling-up were the organizational capacity of the provincial health system, sustainable funding for HPV testing, and local consensus about the value of the technology. Reach: In 2014, 9% (2983/33,245) of target women were screened through self-collection in the Jujuy public health sector. Effectiveness: In 2014, 17% (n = 5657/33,245) of target women were screened with any HPV test (self-collected and clinician-collected tests) vs. 11.7% (4579/38,981) in 2013, the pre-scaling-up period (p < 0.0001). IMPLEMENTATION: Training about the strategy was provided to 84.2% (n = 609/723) of total community health workers (CHWs). Of 414 HPV+ women, 77.5% (n = 320) had follow-up procedures. Of 113 women with positive triage, 66.4% (n = 75) had colposcopic diagnosis. Treatment was provided to 80.7% of CIN2+ women (n = 21/26). Adoption: Of trained CHWs, 69.3% (n = 422/609) had at least one woman with self-collection; 85.2% (n = 315/368) of CHWs who responded to an evaluation survey were satisfied with self-collection strategy. Maintenance: During 2015, 100.0% (723/723) CHWs were operational and 63.8% (461/723) had at least one woman with self-collection. CONCLUSIONS: The strategy was successfully scaled-up, with a high level of adoption among CHWs, which resulted in increased screening among socially vulnerable under-screened women.

HPV testing: a mixed-method approach to understand why women prefer self-collection in a middle-income country.

BACKGROUND: HPV test self-collection has been shown to reduce barriers to cervical screening and increase uptake. However, little is known about women's preferences when given the choice between self-collected and clinician-collected tests. This paper aims to describe experiences with HPV self-collection among women in Jujuy, the first Argentinean province to have introduced HPV testing as the primary screening method, provided free of cost in all public health centers. METHODS: Between July and December 2012, data on acceptability of HPV self-collection and several social variables including past screening were collected from 2616 self-collection accepters and 433 non-accepters, and were analyzed using multivariate regression. In addition, in-depth interviews (n = 30) and 2 focus groups were carried out and analyzed using thematic analysis. RESULTS: Quantitative findings indicate that main reasons for choosing self-collection are those reducing barriers related to women's roles of responsibility for domestic work and work/family organization, and to health care services' organization. No social variables were significantly associated with acceptability. Among those who preferred clinician-collection, the main reasons were trust in health professionals and fear of hurting themselves. Qualitative findings also showed that self-collection allows women to overcome barriers related to the health system (i.e. long wait times), without sacrificing time devoted to work/domestic responsibilities. CONCLUSIONS: Findings have implications for self-collection recommendations, as they show it is the preferred method when women are given the choice, even if they are not screening non-attenders. Findings also highlight the importance of incorporating women's needs/preferences in HPV screening recommendations.

Implementation of HPV-testing for cervical cancer screening in programmatic contexts: The Jujuy demonstration project in Argentina.

The aim of this article is to present results of programmatic introduction of HPV testing with cytologic triage among women 30 years and older in the province of Jujuy, Argentina, including description of the planning phase and results of program performance during the first year. We describe the project implementation process, and calculate key performance indicators using SITAM, the national screening information system. We also compare disease detection rates of HPV testing in 2012 with cytology as performed during the previous year. HPV testing with cytology triage was introduced through a consensus-building process. Key activities included establishment of algorithms and guidelines, creating the HPV laboratory, training of health professionals, information campaigns for women and designing the referral network. By the end of 2012, 100% (n = 270) of public health care centers were offering HPV testing and 22,834 women had been HPV tested, 98.5% (n = 22,515) were 30+. HPV positivity among women over 30 was 12.7%, 807 women were HPV+ and had abnormal cytology, and 281 CIN2+ were identified. CIN2+ detection rates was 1.25 in 2012 and 0.62 in 2011 when the program was cytology based (p = 0.0002). This project showed that effective introduction of HPV testing in programmatic contexts of low-middle income settings is feasible and detects more disease than cytology.

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.

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 Cáncer (Argentina).

Lo que piensan las mujeres: conocimientos y percepciones sobre cáncer de cuello de útero y realización del Pap

El Programa Nacional de Prevención de Cáncer Cérvico-uterino con el apoyo de la OPS llevó a cabo la presente investigación formativa cuyo objetivo es analizar el conocimiento y las percepciones de mujeres de cuatro de las provincias argentinas con mayor mortalidad por esta causa (Jujuy, Misiones, Salta y Chaco1) y la Provincia de Buenos Aires acerca del cáncer de cuello de útero, sus causas y métodos de prevención y tratamiento, e identificar las barreras de acceso a los servicios de tamizaje. El propósito final del trabajo es contar con información que permita el diseño e implementación de estrategias de aumento de la cobertura del tamizaje teniendo en cuenta la perspectiva de las mujeres.