Mixed-Methods Approach to Evaluate a mHealth Intervention to Increase Adherence to Triage of HPV+ Women Who Have Performed Self-collection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,389
- 试验地点
- 1
- 主要终点
- Percentage of Women With Triage Pap Smears at 120 Days After HPV Results
研究概览
简要总结
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. 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: Researchers 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. Reserchers 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). Researchers will conduct a self-administered, semi-structured survey of CHWs, semi-structured interviews with local health authorities, and a survey of HPV+ women.
详细描述
Cervical cancer is a disease of health and gender inequalities, and is primarily a cancer of poor, socially vulnerable women. Even though it is almost entirely preventable, in Latin America it is the leading cause of cancer death among women.1 In Argentina, it is the second cause of female cancer death: every year 5,000 women are diagnosed with cervical cancer and more than 1,800 die from the disease.1 In this country, and generally across Latin America, high mortality is related to problems in the continuity of the prevention process, including low screening coverage and loss to follow-up, diagnosis, and treatment.2,3 New screening tests detect the presence of high-risk types of HPV which cause cervical cancer. HPV tests have important advantages over the Pap as a primary screening test, including higher sensitivity (over 90%)4 and a high negative predictive value,5 which allow reduced screening frequencies. Very importantly, through self-collection strategies, HPV testing can reduce barriers to screening and increase coverage.6 HPV self-collection is highly accurate,7 and is acceptable among women in different countries.8-11 However, HPV screening identifies women who are HPV+ (around 10%). Triage tests for HPV+ women determine those who need additional diagnostic procedures. While several triage methods are available for detecting precancerous lesions, including cytology and colposcopy,12 to date most such triage methods require HPV+ women to attend health centers to determine appropriate follow-up. Although adherence to follow-up and treatment is a widespread problem for cervical cancer programs in Latin America,2 evidence for interventions to improve adherence to follow-up is lacking.
The introduction of self-administered HPV testing in Jujuy has been successful in increasing primary cervical cancer screening coverage. Yet the proportion of self-collected HPV+ cases who currently undertake cytological triage within 120 days of screening is low (about 30%), which hinders the impact of the increased HPV screening coverage attained.
Aims of the study
- To evaluate the effectiveness of a mHealth intervention targeted to women and health providers to increase adherence to cytological triage among self-tested HPV+ women compared to usual practice.
- To identify and understand the processes and factors which contribute to the success of the mHealth intervention strategy (or lack thereof).
Setting Jujuy province is located in northwest Argentina and 85% of its population live in urban areas.19 The primary health care (PHC) system has 270 health centres and employs about 700 full-time CHWs who visit approximately 110,000 households twice a year for health-related tasks.
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
- •In the Randomized Controlled Trial we will recruit a minimum of 4000 women, aged 30 and older living in the province of Jujuy, Argentina.
- •Inclusion criteria are:
- •Having performed self-collection of HPV-testing.
- •Mentally competent to understand the consent form.
- •Able to communicate with study staff.
- •Being able to provide a mobile phone telephone number.
排除标准
- •Current pregnancy.
- •Women with Mental disability.
研究组 & 干预措施
Multicomponent mHealth Intervention
Women with HPV self-collected tests will receive a multicomponent intervention which includes SMS text messages to remind them to attend triage. In addition, CHWs will receive reminders via e-mails to contact women if after 60 days from the HPV-results HPV+ they have not performed triage.
干预措施: Multicomponent mHealth Intervention (Other)
Usual Care
Women with HPV self-collected tests receive usual care. Upon opting for the HPV self-collected test, women will be instructed to go to the health care center in 30 days to pick up the results.
结局指标
主要结局
Percentage of Women With Triage Pap Smears at 120 Days After HPV Results
时间窗: 120 days
The percentage of women with triage Pap smears at 120 days after HPV results are registered in the national screening information system (SITAM). This will allow measurement of the overall effect of the multi-component intervention including two periods: a) the 60 day period between the Test results and the SMS message and e-mail sent to Community Health Workers (CHW) (days 1-59); and b) the 60 day period between the SMS message and e-mail sent to CHWs and triage measurement (days 60-120)
次要结局
- Percentage of Women With Triage Pap Smears at 60 Days After HPV Results(60 days)
