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

July 21, 2026 updated by: Katharine Rendle, Abramson Cancer Center at Penn Medicine

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

610

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Botswana
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Active, not recruiting
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stage 1 Clinic Outreach + Stage 2 Low Touch
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
A member of the pathology team will contact the referring clinic to communicate the readiness of results.
Behavioral: Low-Touch Strategy
Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging.
Experimental: Stage 1 Clinic Outreach + Stage 2 High Touch
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
A member of the pathology team will contact the referring clinic to communicate the readiness of results.
Behavioral: High-Touch Strategy
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.
Experimental: Stage 1 Enhanced Outreach + Stage 2 Low-Touch
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: Low-Touch Strategy
Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging.
Behavioral: Enhanced Outreach
A member of the pathology team will contact both the referring clinic and the patient directly to communicate the readiness of results.
Experimental: Stage 1 Enhanced Outreach + Stage 2 High-Touch
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: High-Touch Strategy
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.
Behavioral: Enhanced Outreach
A member of the pathology team will contact both the referring clinic and the patient directly to communicate the readiness of results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adoption
Time Frame: Within 90 days of randomization
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
Time Frame: 12 months after randomization
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
Time Frame: 12 months after randomization
Defined by the proportion of patients who complete an initial treatment visit divided by those randomized
12 months after randomization
Reach: First Stage
Time Frame: 12 months after randomization
Defined by the proportion of patients who complete an enhanced outreach phone call divided by those contacted.
12 months after randomization
Reach: Second Stage
Time Frame: 12 months after randomization
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
Time Frame: 12 months after randomization
Defined by the proportion of patients with confirmation of results received divided by those randomized.
12 months after randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcomes: Survival
Time Frame: 12 months after randomization
Defined as overall survival at one year after randomization measured using medical record data.
12 months after randomization
Clinical Outcomes: Treatment
Time Frame: 12 months after randomization
Defined by the stage at diagnosis, type of cancer treatment the patient received (e.g., chemoradiation, surgery) measured using medical record data.
12 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

National Cancer Institute (NCI)
University of Botswana

Investigators

  • Principal Investigator: Katharine Rendle, PhD,MSW,MPH, University of Pennsylvania
  • Principal Investigator: Surbhi Grover, MD, MPH, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

July 11, 2023

First Submitted That Met QC Criteria

July 11, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 23822
  • U01CA275032-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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