Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana
Thibang Diphatlha: Testing Adaptive Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana
2 other identifiers
interventional
610
2 countries
3
Brief Summary
Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a pragmatic trial design.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2023
CompletedFirst Posted
Study publicly available on registry
July 19, 2023
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
March 30, 2026
May 1, 2025
3.3 years
July 11, 2023
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adoption
Defined as the initiation of cervical cancer treatment within 90 days of randomization.
Within 90 days of randomization
Secondary Outcomes (5)
Fidelity
12 months after randomization
Reach: First Appointment
12 months after randomization
Reach: First Stage
12 months after randomization
Reach: Second Stage
12 months after randomization
Reach: Results
12 months after randomization
Other Outcomes (2)
Clinical Outcomes: Treatment
12 months after randomization
Clinical Outcomes: Survival
12 months after randomization
Study Arms (4)
Stage 1 Clinic Outreach + Stage 2 Low Touch
EXPERIMENTALAll 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
EXPERIMENTALAll 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
EXPERIMENTALAll 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
EXPERIMENTALAll 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.
Interventions
A member of the pathology team will contact the referring clinic to communicate the readiness of results.
A member of the pathology team will contact both the referring clinic and the patient directly to communicate the readiness of results.
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.
Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abramson Cancer Center at Penn Medicinelead
- National Cancer Institute (NCI)collaborator
- University of Botswanacollaborator
Study Sites (3)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Nyangabgwe Referral Hospital
Francistown, North-East District, Botswana
Princess Marina Hospital
Gaborone, Botswana
Related Publications (1)
Rendle KA, Ramogola-Masire D, Grover S; Thibang Diphatlha Collective. Thibang Diphatlha: a sequential multiple assignment randomized trial designed to increase timely adoption of cervical cancer treatment in Botswana. Implement Sci Commun. 2024 Nov 12;5(1):128. doi: 10.1186/s43058-024-00659-9.
PMID: 39533437DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katharine Rendle, PhD,MSW,MPH
University of Pennsylvania
- PRINCIPAL INVESTIGATOR
Surbhi Grover, MD, MPH
University of Pennsylvania
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 11, 2023
First Posted
July 19, 2023
Study Start
September 1, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
August 31, 2027
Last Updated
March 30, 2026
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share