Strategies to Close the Gap From CC Diagnosis to Treatment in Botswana

Study Overview
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Brief Summary
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Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a pragmatic trial design.

Detailed Description
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Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a hybrid (type III) and pragmatic Sequential Multiple Assignment Randomized Trial (SMART) design. The adaptive strategies are designed to target patient- and system-level determinants identified in preliminary data, including delayed communication of results, individual and structural barriers to accessing treatment, and suboptimal care coordination between referring and cancer treatment clinics. The strategies draw upon key principles in behavioral economics and are supported by systematic evidence of the effectiveness of nudge strategies in preventive, HIV, and cancer care. The overarching rationale for the study is that enhancing coordination, communication, and navigation through centralized outreach and nudge strategies will increase timely treatment adoption and be scalable and sustainable in the long-term.

Official Title
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Thibang Diphatlha: Testing Adaptive Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana

Conditions
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Cervical Cancer

Intervention / Treatment
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* Behavioral: Clinic Outreach
* Behavioral: Enhanced Outreach
* Behavioral: Low-Touch Strategy
* Behavioral: High-Touch Strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be eligible if they: are biological females are aged 18 or older have pathology-confirmed invasive cervical cancer diagnosis have pathology results evaluated at National Health Laboratory in Botswana are citizens of Botswana have no prior history of invasive cervical cancer Exclusion Criteria: Patients will be excluded if they: are biological males or otherwise born without a cervix are below the age of 18 due to the rarity of cervical cancer in this population do not meet study inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Pragmatic Sequential Multiple Assignment Randomized Trial (SMART). This study uses a sequential randomization design in which all eligible participants will be randomized into one of two interventions at Stage 1 and then participants that do not respond to Stage 1 interventions will be randomized to receive Stage 2 interventions
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stage 1 Clinic Outreach + Stage 2 Low Touch<br>All participants receive direct clinic outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging (stage 2). | Behavioral: Clinic Outreach<br>* A member of the pathology team will contact the referring clinic to communicate the readiness of results.<br>Behavioral: Low-Touch Strategy<br>* Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging.<br>|
| Experimental: Stage 1 Clinic Outreach + Stage 2 High Touch<br>All participants receive direct clinic outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging in combination with synchronous patient navigation (stage 2). | Behavioral: Clinic Outreach<br>* A member of the pathology team will contact the referring clinic to communicate the readiness of results.<br>Behavioral: High-Touch Strategy<br>* Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging in combination with synchronous telephone-based patient navigation.<br>|
| Experimental: Stage 1 Enhanced Outreach + Stage 2 Low-Touch<br>All participants receive direct clinic outreach plus enhanced outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging (stage 2). | Behavioral: Enhanced Outreach<br>* A member of the pathology team will contact both the referring clinic and the patient directly to communicate the readiness of results.<br>Behavioral: Low-Touch Strategy<br>* Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging.<br>|
| Experimental: Stage 1 Enhanced Outreach + Stage 2 High-Touch<br>All participants receive direct clinic outreach plus enhanced outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging in combination with synchronous patient navigation. | Behavioral: Enhanced Outreach<br>* A member of the pathology team will contact both the referring clinic and the patient directly to communicate the readiness of results.<br>Behavioral: High-Touch Strategy<br>* Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging in combination with synchronous telephone-based patient navigation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adoption | Defined as the initiation of cervical cancer treatment within 90 days of randomization. | Within 90 days of randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fidelity | Defined as completion of evidence-based cancer treatment according to international guidelines and measured using medical record data. | 12 months after randomization | 
| Reach: First Appointment | Defined by the proportion of patients who complete an initial treatment visit divided by those randomized | 12 months after randomization | 
| Reach: First Stage | Defined by the proportion of patients who complete an enhanced outreach phone call divided by those contacted. | 12 months after randomization | 
| Reach: Second Stage | Defined by the proportion of patients who complete a patient navigation phone call (high touch strategy) divided by those contacted. | 12 months after randomization | 
| Reach: Results | Defined by the proportion of patients with confirmation of results received divided by those randomized. | 12 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Botswana, Treatment, Patient