Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana

Not Applicable

Recruiting

• Conditions: Cervical Cancer
• Interventions: Behavioral: Clinic Outreach; Behavioral: Enhanced Outreach; Behavioral: Low-Touch Strategy; Behavioral: High-Touch Strategy

• Registration Number: NCT05952141
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-07-11
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-19
• Study Start: 2023-09-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2026-12-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 680

Inclusion Criteria

Patients will be eligible if they:

1. are biological females
2. are aged 18 or older
3. have pathology-confirmed invasive cervical cancer diagnosis
4. have pathology results evaluated at National Health Laboratory in Botswana
5. are citizens of Botswana
6. have no prior history of invasive cervical cancer

Exclusion Criteria

Patients will be excluded if they:

1. are biological males or otherwise born without a cervix
2. are below the age of 18 due to the rarity of cervical cancer in this population
3. do not meet study inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Stage 1 Clinic Outreach + Stage 2 Low Touch	Low-Touch Strategy	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).
Stage 1 Enhanced Outreach + Stage 2 Low-Touch	Low-Touch Strategy	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).
Stage 1 Clinic Outreach + Stage 2 Low Touch	Clinic Outreach	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).
Stage 1 Clinic Outreach + Stage 2 High Touch	Clinic Outreach	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).
Stage 1 Clinic Outreach + Stage 2 High Touch	High-Touch Strategy	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).
Stage 1 Enhanced Outreach + Stage 2 Low-Touch	Enhanced Outreach	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).
Stage 1 Enhanced Outreach + Stage 2 High-Touch	Enhanced Outreach	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.
Stage 1 Enhanced Outreach + Stage 2 High-Touch	High-Touch Strategy	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.

Primary Outcome Measures

Name	Time	Method
Adoption	Within 90 days of randomization	Defined as the initiation of cervical cancer treatment within 90 days of randomization.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Nyangabgwe Referral Hospital; 🇧🇼 Francistown, North East District, Botswana

Princess Marina Hospital; 🇧🇼 Gaborone, Botswana

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States