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NCT Number: NCT05952141

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nyangabgwe Referral Hospital, Francistown, North-East District, Botswana

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinic Outreach

Behavioral

A member of the pathology team will contact the referring clinic to communicate the readiness of results.

Enhanced Outreach

Behavioral

A member of the pathology team will contact both the referring clinic and the patient directly to communicate the readiness of results.

Low-Touch Strategy

Behavioral

Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging.

High-Touch Strategy

Behavioral

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 outcomes

  1. Adoption

    Time frame: Within 90 days of randomization

    Defined as the initiation of cervical cancer treatment within 90 days of randomization.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. Reach: Results

    Time frame: 12 months after randomization

    Defined by the proportion of patients with confirmation of results received divided by those randomized.

Other outcomes

  1. 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.

  2. Clinical Outcomes: Survival

    Time frame: 12 months after randomization

    Defined as overall survival at one year after randomization measured using medical record data.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Toneff, MSW, MA

CONTACT

[email protected]

267-882-3186

Katharine Rendle, PhD,MSW,MPH

CONTACT

[email protected]

215-349- 5442

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of Botswana

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 19, 2023
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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