Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Mixed-Methods Approach to Evaluate a mHealth Intervention to Increase Adherence to Triage of HPV+ Women Who Have Performed Self-collection
Brief Summary: 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.


Options:
A: Arm Label: General health information; Type: PLACEBO_COMPARATOR; Interventions: Other: general health information | Arm Label: Influenza and general health information; Type: ACTIVE_COMPARATOR; Interventions: Other: influenza and general health information | Intervention Type: OTHER; Name: influenza and general health information; Assigned to Arm(s): Influenza and general health information | Intervention Type: OTHER; Name: general health information; Assigned to Arm(s): General health information
B: Arm Label: Multicomponent mHealth Intervention; Type: ACTIVE_COMPARATOR; Interventions: Other: Multicomponent mHealth Intervention | Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Multicomponent mHealth Intervention; Assigned to Arm(s): Multicomponent mHealth Intervention
C: Arm Label: Encouragement Arm; Type: EXPERIMENTAL; Interventions: Other: digital family planning screening and referral service | Arm Label: Control Arm; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: digital family planning screening and referral service; Assigned to Arm(s): Encouragement Arm
D: Arm Label: ISAP SMS; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: ISAP SMS | Arm Label: No ISAP SMS; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: ISAP SMS; Assigned to Arm(s): ISAP SMS

Answer: B