Evaluation of an Mhealth Intervention to Increase Adherence to Triage of HPV+ Women Who Have Performed HPV-Test Self-collection
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Number of HPV test positive women with Pap test registered in SITAM
研究概览
简要总结
Cervical cancer remains a serious health problem, particularly in developing countries. It is the leading cause of cancer death among women and mainly affects women of low socioeconomic status.
Evidence has shown that HPV-test self-collection can reduce social and health services barriers to screening and increase coverage. However, high coverage will not result in a decrease of disease burden if women are not diagnosed/treated. The HPV-test indicates whether a woman is positive or not, and a triage test is needed to identify HPV-positive women who need to perform diagnostic procedures. Several triage methods are available. In Argentina, cytology is used as triage method; therefore, all HPV-positive women who have performed self-collection at home need to attend health centers to undergo cytology. However, the proportion of women who have completed triage is low, therefore new innovative strategies are needed to increase attendance to cytology of these women.
This study will be carried out in Jujuy, one of the Argentinian provinces with highest cervical cancer mortality rates and where HPV- self-collection has been introduced as programmatic strategy for screening under-users.
This trial is population-based cluster-randomized study that aims to evaluate the effectiveness of a mHealth intervention versus usual care to increase adherence to cytological triage among women with HPV-positive self-collected tests.
An overall number of 240 Community Health Workers (CHWs) from the Primary Health Care System (PHCS) of the Province of Jujuy will be randomized into two groups:
- mHealth Intervention Group: Women with HPV self-collected tests will receive a mixed intervention which includes counseling through an interactive Apps specifically devised to increase adherence to triage which will be run on a tablet, and SMS text messages to remind them to attend triage. In addition, Heads of CHWs, chiefs of gynecology services and CHWs will receive reminders via e-mails and SMS message to contact women if after 60 days from the HPV-results HPV+ they have not performed triage.
- Usual Care Group: Women with HPV self-collected tests receive usual care.
A database built specifically for the study will be used; it will include data about randomization Group, agreement to participate in the study and socio-demographic data. Data on HPV-testing and triage will be uploaded importing the data from SITAM, using the Unique Identification Number (DNI).
Data Analysis
Effectiveness to enhance adherence to cytological triage: Adherence to triage will be considered for each CHW. This will be defined as the number of women with triage smears within 30, 60 and 90 days. There will be a comparison of the percentage of HPV-positive women that did the Pap test within those time intervals in the mHealth intervention group and the Usual Care group. The effect of the mHealth intervention against usual care will be estimated using a means difference test or a non-parametric test for independent samples.
详细描述
Description of the problem and study rationale
Cervical cancer remains a serious health problem, particularly in developing countries. In Argentina, every year 5,000 women are diagnosed with cervical cancer and more than 1,800 die from the disease 1. In several Latin American countries, it is the leading cause of cancer death among women and mainly affects women of low socioeconomic status. This is due in part to the difficulties of health policies to promote women's participation in prevention programs, namely accessing screening, follow-up and treatment of precancerous lesions.
Proof of the causal link between HPV and cervical cancer has allowed for the recent development of HPV-based screening tests, which detect HPV types considered high-risk. These tests have important advantages over the Pap as a screening test: high sensitivity (over 90%)2 and high negative predictive value3, allowing for a reduction in screening frequency as well as for the identification of HPV positive women who, even without presenting a precancerous lesion, constitute a high-risk group that requires special follow-up within the health system. Very importantly, through self-collection, HPV-testing can reduce barriers to screening and increase coverage.4 The method is highly accurate5,6, and is acceptable for women in different countries.7-10
Argentina has become a pioneer in the introduction of new technologies for HPV-based cervical cancer prevention. The National Ministry of Health has approved the incorporation of the test as a nation-wide screening method. In this context the PI conducted the Jujuy Demonstration Project (JDP) to introduce HPV-testing for primary screening.11 This project was part of a national strategy to strengthen cervical cancer screening re-launched in 2008,12 which also included introduction of HPV vaccination in 2011.13 The JDP is a four-year implementation project (2011-2014) to develop, implement and evaluate the programmatic components of an HPV-based screening strategy11.
In addition, in 2012 the PI conducted a population-based cluster randomized trial (Self-collection Modality Trial, initials EMA in Spanish). The study was the first carried out in a programmatic, real-world context of a low-resource region with the main objective to assess the effect on women´s screening uptake of HPV self-collection offered by CHWs during home visits and to assess the self-test acceptability by women and CHWs. Our intervention resulted in a four-fold increase in screening uptake (85.9% vs 20.2%), showing that offering HPV self-collection at home visits through CHWs is an effective strategy to improve cervical screening coverage10.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 30 years and older living in a household visited by Community Health Workers (CHWs).
排除标准
- •Women with a previous HPV test.
- •Women with precancerous lesion or cervical cancer.
- •Current pregnancy.
- •Women with Mental disability.
结局指标
主要结局
Number of HPV test positive women with Pap test registered in SITAM
时间窗: 90 days
Adherence to triage will be considered for each CHW. This will be defined as the number of women with Pap smears within 90 days registered in SITAM (SITAM is the national online information system that registers screening/diagnosis/treatment events from women attending the public health system). There will be a comparison of the percentage of HPV-positive women that did the Pap test in the mHealth intervention group and the Usual Care group.
次要结局
未报告次要终点
研究者
Silvina Arrossi
PhD
Centro de Estudio de Estado y Sociedad