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Testing Adaptive Strategies to Close the Gap from Cervical Cancer Diagnosis to Treatment in Botswana, Thibang Diphatlha Trial
Trial Status: active
This clinical trial tests strategies to increase timely adoption of cervical cancer treatment in Botswana. Delays and missed opportunities for timely treatment contribute significantly to unfavorable outcomes in cervical cancer. There is a critical need to identify effective strategies to ensure timely care. Four different strategies including clinic outreach alone or in combination with direct patient outreach and asynchronous nudges using framed messages alone or in combination with synchronous patient navigation will be tested and may help to increase timely adoption of cervical cancer treatment in Botswana. Enhancing coordination, communication, and navigation through centralized outreach and nudge strategies may increase timely treatment adoption for cervical cancer.
Inclusion Criteria
OBJECTIVE 1 (PATIENTS): Are biological females
OBJECTIVE 1 (PATIENTS): Are aged 18 or older
OBJECTIVE 1 (PATIENTS): Have pathology-confirmed cervical cancer diagnosis
OBJECTIVE 1 (PATIENTS): Have pathology results evaluated at national health laboratory in Botswana
OBJECTIVE 2 (PATIENTS): They participated in the pragmatic trial (objective 1)
OBJECTIVE 2 (PATIENTS): Are able and willing to provide verbal consent
OBJECTIVE 2 (PATIENTS): Are able to be interviewed in either Setswana or English
OBJECTIVE 2 (CLINICIANS): Are a clinician (e.g., nurses, physicians, community health workers) who is involved in the care of patients with cervical cancer at either referring clinics (e.g., screening and HIV clinics) and/or treatment clinics
OBJECTIVE 2 (CLINICIANS): Are able and willing to provide consent
OBJECTIVE 2 (CLINICIANS): Are able to be interviewed in either Setswana or English
Exclusion Criteria
OBJECTIVE 1 (PATIENTS): Are biological males or otherwise born without a cervix
OBJECTIVE 1 (PATIENTS): Are below the age of 18 due to the rarity of cervical cancer in this population
OBJECTIVE 1 (PATIENTS): Do not meet study inclusion criteria
OBJECTIVE 2 (PATIENTS): Patient interview participants will be excluded if they do not meet study inclusion criteria
OBJECTIVE 2 (CLINICIANS): Clinician interview participants will be excluded if they do not meet study inclusion criteria
Additional locations may be listed on ClinicalTrials.gov for NCT05952141.
I. To compare the effectiveness of four adaptive telehealth strategies on timely treatment adoption in females with invasive cervical cancer in Botswana using a pragmatic sequential multiple assignment randomized trial (SMART) design.
SECONDARY OBJECTIVE:
I. To evaluate multilevel mechanisms contributing to the effectiveness of adaptive strategies using surveys and mixed methods interviews with patients and clinicians.
OUTLINE:
STAGE 1: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive direct clinic outreach to communicate readiness of cervical cancer results. The pathology team contacts the referring clinic where the patient had the diagnostic procedure to communicate cervical cancer positive results and provide a scheduled appointment at the multidisciplinary team treatment clinic.
ARM II: Patients receive direct clinic outreach to communicate readiness of cervical cancer results. The pathology team contacts the referring clinic where the patient had the diagnostic procedure to communicate cervical cancer positive results and provide a scheduled appointment at the multidisciplinary team treatment clinic and the patient is also notified directly by the pathology team.
STAGE 2: Patients who do not complete an initial visit at the multidisciplinary team treatment clinic within 30 days of outreach are randomized to 1 of 2 arms.
ARM III: Patients receive a nudge consisting of messaging via text message and/or voice calls within 1 week of randomization and patients will be asked to confirm receipt.
ARM IV: Patients receive a nudge consisting of calls by a patient navigator within 1 week of randomization to talk through any questions they have about their diagnosis and to help mitigate any barriers to attending their scheduled visit including transportation, childcare, or other support for patients who may need it. Patients are contacted up to 3 times at varying times of the day and week until they are reached or lost to follow-up.
After initial randomization, patients are followed up for 12 months.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
