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

Abramson Cancer Center at Penn Medicine

Status: Enrolling

Conditions: Cervical Cancer

Treatments: Behavioral: Low-Touch Strategy; Behavioral: Clinic Outreach; Behavioral: High-Touch Strategy; Behavioral: Enhanced Outreach

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05952141

UPCC 23822

U01CA275032-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 680 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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680 participants in 4 patient groups

Stage 1 Clinic Outreach + Stage 2 Low Touch

Experimental group

Description:

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).

Treatment:

Behavioral: Clinic Outreach

Behavioral: Low-Touch Strategy

Stage 1 Clinic Outreach + Stage 2 High Touch

Experimental group

Description:

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).

Treatment:

Behavioral: High-Touch Strategy

Behavioral: Clinic Outreach

Stage 1 Enhanced Outreach + Stage 2 Low-Touch

Experimental group

Description:

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).

Treatment:

Behavioral: Enhanced Outreach

Behavioral: Low-Touch Strategy

Stage 1 Enhanced Outreach + Stage 2 High-Touch

Experimental group

Description:

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.

Treatment:

Behavioral: Enhanced Outreach

Behavioral: High-Touch Strategy