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Recruiting NCT05952141

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

No phase Interventional Cervical Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clinic Outreach, Enhanced Outreach, Low-Touch Strategy, High-Touch Strategy.
Who it may be relevant to
Registry conditions: Cervical Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Botswana
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral Clinic Outreach
    A member of the pathology team will contact the referring clinic to communicate the readiness of results.
  • 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.
  • Behavioral Low-Touch Strategy
    Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging.
  • 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.

Primary outcome measures

  • Adoption [Time frame: Within 90 days of randomization]
Secondary outcome measures (5)
  • Fidelity [Time frame: 12 months after randomization]
  • Reach: First Appointment [Time frame: 12 months after randomization]
  • Reach: First Stage [Time frame: 12 months after randomization]
  • Reach: Second Stage [Time frame: 12 months after randomization]
  • Reach: Results [Time frame: 12 months after randomization]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Single blind
Primary purpose
Health services research

Study locations

Botswana · 2 centers
  • Nyangabgwe Referral Hospital — Francistown
  • Princess Marina Hospital — Gaborone
United States · 1 center
  • University of Pennsylvania — Philadelphia

Publications

  • 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 39533437

Identifiers

NCT: NCT05952141 · UPCC 23822 · U01CA275032-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗