Trial Summary
What is the purpose of this trial?Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a pragmatic trial design.
What data supports the idea that Treatment Access Strategies for Cervical Cancer in Botswana is an effective treatment?The available research shows that access to cancer care is a significant barrier for women in Botswana, which can lead to later stages of cervical cancer diagnosis and increased mortality. Although the studies do not directly evaluate the effectiveness of the Treatment Access Strategies, they highlight the importance of overcoming barriers like travel distance to clinics. By addressing these barriers, the treatment strategies could potentially improve early diagnosis and treatment initiation, which are crucial for better outcomes in cervical cancer care.16789
Is the treatment in the trial 'Treatment Access Strategies for Cervical Cancer in Botswana' a promising treatment?The trial focuses on improving access to cervical cancer treatment in Botswana, where access issues are a major barrier. By addressing these barriers, the treatment strategy could help more women receive timely care, potentially reducing cancer deaths. This makes the treatment strategy promising for improving health outcomes.25789
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
What safety data exists for the cervical cancer treatment strategies in Botswana?The research provided does not directly address safety data for the specific treatment strategies in Botswana, such as Clinic Outreach, Enhanced Outreach, High-Touch Strategy, or Low-Touch Strategy. However, it does mention the successful scale-up of the see-and-treat approach in Botswana, which includes visual inspection with acetic acid (VIA) followed by immediate cryotherapy. This suggests that the treatment was implemented with high adherence to guidelines, indicating a level of safety and effectiveness in the national program.13469
Eligibility Criteria
This trial is for biological females aged 18 or older in Botswana who have been diagnosed with invasive cervical cancer confirmed by pathology. Participants must have their pathology results evaluated at the National Health Laboratory in Botswana.Treatment Details
The study is examining four strategies to improve the timeliness of cervical cancer treatment adoption: Low-Touch Strategy, Clinic Outreach, Enhanced Outreach, and High-Touch Strategy. The effectiveness of these approaches will be compared using a practical trial design.
4Treatment groups
Experimental Treatment
Group I: Stage 1 Enhanced Outreach + Stage 2 Low-TouchExperimental Treatment2 Interventions
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).
Group II: Stage 1 Enhanced Outreach + Stage 2 High-TouchExperimental Treatment2 Interventions
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.
Group III: Stage 1 Clinic Outreach + Stage 2 Low TouchExperimental Treatment2 Interventions
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).
Group IV: Stage 1 Clinic Outreach + Stage 2 High TouchExperimental Treatment2 Interventions
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).
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of PennsylvaniaPhiladelphia, PA
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Who is running the clinical trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
University of BotswanaCollaborator
National Cancer Institute (NCI)Collaborator
References
Cervical cancer prevention in Malawi: a qualitative study of women's perspectives. [2022]Researchers posit that cervical cancer knowledge is central to participation in prevention behaviors. However, of the many barriers to cervical cancer prevention in low- and middle-income countries, cervical cancer knowledge remains severely limited among communities at great risk for the disease. Malawi is one such country where the burden of cervical cancer is considerably high. Formative research targeting cervical cancer prevention is needed, particularly research that explores ways to deliver cervical cancer information efficiently and effectively to Malawian women. In this study, the authors aimed to garner Malawian women's understanding of cervical cancer and to shed light on preferences for health information delivery, including community health advocacy. Qualitative, in-depth interviews were conducted with 30 Malawian women and analyzed for recurring themes. In general, women had limited cervical cancer knowledge, which supported misperceptions about the disease, including factors pertaining to risk and prevention. Nonetheless, women reported that receiving cervical cancer information from trusted sources would help promote preventive behaviors. Women noted that they received most of their health information from hospital personnel, but distance was a barrier. Women also expressed interest in community health advocacy. Perspectives from Malawian women may be vital toward informing efforts to increase cervical cancer knowledge and prevention.
Determinants of access and utilization of cervical cancer treatment and palliative care services in Harare, Zimbabwe. [2020]Cervical cancer treatment and care services have remained largely centralized in Zimbabwe thereby entrenching inequities to access amongst patients. The objective of this study was to investigate the determinants of access to treatment and care among women with cervical cancer in Harare, Zimbabwe.
Assessing Nurses' Adherence to the See-and-Treat Guidelines of Botswana's National Cervical Cancer Prevention Programme. [2021]The see-and-treat approach for cervical cancer screening [visual inspection with acetic acid (VIA) followed by immediate cryotherapy] was first pilot tested in Botswana in 2009. Botswana's Ministry of Health and the Botswana-UPenn Partnership collaborated to expand see-and-treat to five additional sites throughout the country in 2014. The purpose of this study was to evaluate whether nurses' adherence to guideline-based screening was maintained during scale-up. Therefore, we compared nurses' adherence between the pilot and scaled-up sites and determined main drivers of nonadherence across all sites. We conducted a retrospective review of 6,644 medical charts from Botswana's National Cervical Cancer Prevention Programme between February 2014 and October 2015. Using multivariable regression modeled with generalized estimating equations, we determined whether nurses' adherence to the see-and-treat guideline differed between the pilot and scale-up sites after controlling for significant covariates. Overall, adherence to the guideline was high (88.4%). Although the scaled-up sites had higher adherence compared with the pilot site (90.9% vs. 80.2%, respectively), the difference between sites was not statistically significant in the multivariable model (P = 0.221). Of the nonadherent clinical encounters, the three most frequent visit types were VIA not performed (178, 23.3%), VIA negative: HIV unknown (163, 21.3%), and VIA negative: HIV negative (144, 18.9%). The most common reason for nonadherence was misspecification of follow-up times. Despite known challenges of scaling-up health innovations in resource-limited settings, our study shows that nurses maintained guideline-adherent care in Botswana's national see-and-treat program. The successful scale-up may have been attributable to the program's intensive quality assurance monitoring.
Women's experiences in a community-based screen-and-treat cervical cancer prevention program in rural Malawi: a qualitative study. [2021]Malawi has the world's highest cervical cancer incidence and mortality due to high rate of HIV coupled with inadequate screening and treatment services. The country's cervical cancer control program uses visual inspection with acetic acid (VIA) and cryotherapy, but screening is largely limited by poor access to facilities, high cost of cryotherapy gas, and high loss-to-follow-up. To overcome these limitations, we implemented a community-based screen-and-treat pilot program with VIA and thermocoagulation. Through a qualitative study, we explore the experiences of women who underwent this community-based pilot screening program.
Model strategies to address barriers to cervical cancer treatment and palliative care among women in Zimbabwe: a public health approach. [2021]Cervical cancer treatment and care remains limited in Zimbabwe despite the growing burden of the disease among women. This study was aimed at investigating strategies to address barriers in accessing treatment and care by women with cervical cancer in Harare, Zimbabwe.
Barriers to follow-up after an abnormal cervical cancer screening result and the role of male partners: a qualitative study. [2022]Cervical cancer is the leading cause of cancer deaths among women in Malawi, but preventable through screening. Malawi primarily uses visual inspection with acetic acid (VIA) for screening, however, a follow-up for positive screening results remains a major barrier, in rural areas. We interviewed women who underwent a community-based screen-and-treat campaign that offered same-day treatment with thermocoagulation, a heat-based ablative procedure for VIA-positive lesions, to understand the barriers in accessing post-treatment follow-up and the role of male partners in contributing to, or overcoming these barriers.
Evaluating the geographic distribution of cervical cancer patients presenting to a multidisciplinary gynecologic oncology clinic in Gaborone, Botswana. [2023]In Botswana, cervical cancer is the leading cause of cancer death for females. With limited resources, Botswana is challenged to ensure equitable access to advanced cancer care. Botswana's capital city, Gaborone, houses the only gynecologic oncology multi-disciplinary team (MDT) and the one chemoradiation facility in the country. We aimed to identify areas where fewer women were presenting to the MDT clinic for care.
Distance to Multidisciplinary Team Clinic in Gaborone, Botswana, and Stage at Cervical Cancer Presentation for Women Living With and Without HIV. [2023]Cervical cancer is the leading cause of cancer death for women in Botswana. Barriers in access to cancer care can lead to later stages at diagnosis and increased mortality. This study evaluated access, defined as travel time from a patient's residential village to a multidisciplinary team clinic in Gaborone, with stage of cervical cancer at presentation. In addition, because of the high HIV prevalence in Botswana, we explored the association between travel time and HIV status.
A Multi-Institutional Study of Barriers to Cervical Cancer Care in Sub-Saharan Africa. [2023]The global rise in cancer incidence has been accompanied by disproportionately high morbidity and mortality rates in low- and middle-income countries. Many patients who are offered potentially curative treatment for cervical cancer in low- and middle-income countries never return to start treatment for reasons that are poorly documented and little understood. We investigated the interplay of sociodemographic, financial, and geographic factors as barriers to care among such patients in Botswana and Zimbabwe.