Treatment Access Strategies for Cervical Cancer in Botswana

Recruiting at 2 trial locations

Overseen By Hannah Toneff, MSW, MA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Biological males, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

680 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best methods for ensuring timely cervical cancer treatment for patients in Botswana. Researchers are testing various outreach strategies, such as clinic visits and reminder messages, to determine which ones help patients begin treatment sooner. Women recently diagnosed with cervical cancer and who have received their test results from the National Health Laboratory in Botswana are suitable candidates for this study. Participants will be assigned to different strategies, such as the High-Touch Strategy or Low-Touch Strategy, to evaluate which is most effective in encouraging clinic visits. As an unphased trial, this study provides participants the chance to contribute to innovative strategies that could enhance treatment access for many women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these outreach strategies are safe for cervical cancer patients?

Research has shown that the outreach methods used in this trial are safe. For instance, studies have found that community outreach can increase cervical cancer screening rates without causing harm. This includes sending reminders and sharing information, which participants generally find manageable.

The trial tests two types of strategies: high-touch and low-touch. High-touch strategies offer more support, while low-touch strategies are less involved. Both aim to help people maintain their medical care, and no major safety issues have been reported with these methods.

Overall, these strategies aim to improve communication and support, proving safe and helpful for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for cervical cancer treatment access strategies in Botswana because it explores innovative ways to improve patient follow-up and engagement. Unlike traditional methods that rely solely on direct clinic outreach, this trial investigates the effectiveness of enhanced outreach and personalized communication strategies. The high-touch approach combines text reminders with patient navigation support, potentially improving clinic attendance and timely treatment. By testing both asynchronous and synchronous communication methods, the trial aims to identify the most effective strategy to ensure patients receive their results and follow-up care, which could significantly enhance outcomes in cervical cancer management.

What evidence suggests that this trial's treatments could be effective for cervical cancer?

Research has shown that various outreach methods can help patients begin cervical cancer treatment more quickly, especially in regions like Botswana. In this trial, participants will follow different strategies. One arm involves Clinic Outreach, where patients receive direct contact to inform them that their test results are ready, facilitating quicker treatment initiation. Another arm uses Enhanced Outreach, which includes additional communication efforts to further encourage treatment. The High-Touch Strategy, part of another arm, provides personalized support, such as a patient navigator, to assist patients in following through with their care. Meanwhile, the Low-Touch Strategy, tested in a separate arm, uses reminders, like text messages, to prompt timely treatment. These strategies aim to reduce delays in starting treatment, potentially saving lives by ensuring patients receive the care they need promptly. ^{6 7 8 9 10}

Who Is on the Research Team?

Katharine A Rendle, PhD,MSW,MPH

Principal Investigator

University of Pennsylvania

Surbhi Grover, MD, MPH

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patients' pathology results must be evaluated at National Health Laboratory in Botswana

I am a biological female.

I have never had invasive cervical cancer.

Exclusion Criteria

I am a biological male or was born without a cervix.

Patients must not meet study inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1: Clinic Outreach

All participants receive direct clinic outreach to communicate readiness of results

4 weeks

1 visit (in-person)

Stage 2: Low Touch or High Touch

Non-responders receive asynchronous text message reminders with or without synchronous patient navigation

4 weeks

1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Clinic Outreach
• Enhanced Outreach
• High-Touch Strategy
• Low-Touch Strategy

Trial Overview 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.

How Is the Trial Designed?

Group I: Stage 1 Enhanced Outreach + Stage 2 Low-Touch Experimental Treatment 2 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-Touch Experimental Treatment 2 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 Touch Experimental Treatment 2 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 Touch Experimental Treatment 2 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).

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

University of Botswana

Collaborator

Trials

15

Recruited

11,100+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Transportation challenges significantly hindered women's ability to attend post-treatment follow-up appointments after thermocoagulation for cervical cancer, despite the availability of same-day treatment.

Male partners played a dual role in women's follow-up care: they were seen as barriers for some women, while for others, they provided essential support and encouragement, highlighting the need for increased male involvement in cervical cancer screening initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to follow-up after an abnormal cervical cancer screening result and the role of male partners: a qualitative study. Chapola, J., Lee, F., Bula, A., et al.[2022]

A study of 990 cervical cancer patients in Botswana revealed significant geographic clustering in presentation rates, with some areas showing much lower rates of women seeking care, indicating disparities in access to treatment.

Patients from areas with lower presentation rates were more likely to report symptoms like abnormal vaginal bleeding and were often diagnosed at later stages of cancer, highlighting the need for targeted interventions to improve access and awareness in these communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the geographic distribution of cervical cancer patients presenting to a multidisciplinary gynecologic oncology clinic in Gaborone, Botswana. Friebel-Klingner, TM., Iyer, HS., Ramogola-Masire, D., et al.[2023]

In a study of 6,644 medical charts from Botswana's National Cervical Cancer Prevention Programme, nurses maintained a high adherence rate of 88.4% to the see-and-treat cervical cancer screening guidelines, even during the scale-up from pilot testing to broader implementation.

Adherence was slightly higher at scaled-up sites (90.9%) compared to the pilot site (80.2%), but this difference was not statistically significant, indicating that the quality of care remained consistent across different settings, likely due to effective quality assurance monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Nurses' Adherence to the See-and-Treat Guidelines of Botswana's National Cervical Cancer Prevention Programme. Johnson, LG., Ramogola-Masire, D., Teitelman, AM., et al.[2021]

Malawian women have limited knowledge about cervical cancer, which leads to misconceptions about its risks and prevention, highlighting a critical barrier to effective prevention behaviors.

Women expressed a strong preference for receiving cervical cancer information from trusted sources, such as hospital personnel, and showed interest in community health advocacy to improve awareness and promote preventive actions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical cancer prevention in Malawi: a qualitative study of women's perspectives. Ports, KA., Reddy, DM., Rameshbabu, A.[2022]

A community-based screen-and-treat program using visual inspection with acetic acid (VIA) and thermocoagulation in rural Malawi was well accepted by participants, with 17 out of 28 women reporting a positive experience and minimal discomfort during the procedure.

The program's immediate treatment following abnormal screening results was highly valued, and most women expressed openness to self-sampling for HPV testing as a potential alternative screening method, indicating a need for accessible cervical cancer prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's experiences in a community-based screen-and-treat cervical cancer prevention program in rural Malawi: a qualitative study. Lee, F., Bula, A., Chapola, J., et al.[2021]

A study involving 40 women in Botswana and Zimbabwe revealed that married and unemployed women faced more barriers to returning for cervical cancer treatment, highlighting the need for targeted interventions based on sociodemographic factors.

The intervention successfully connected patients with resources, resulting in 16 out of 20 patients in Botswana and 4 out of 20 in Zimbabwe returning for treatment, indicating that addressing financial and administrative barriers can improve treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multi-Institutional Study of Barriers to Cervical Cancer Care in Sub-Saharan Africa. Kambhampati, A., Meghani, K., Ndlovu, N., et al.[2023]

In a study of 959 cervical cancer patients in Botswana, longer travel times to treatment facilities were associated with later stages of cancer at diagnosis, with patients traveling more than 3 hours having significantly higher odds of presenting with advanced stages (II and IV) of the disease.

The study also found that patients living with HIV were more likely to present with cervical cancer as travel time increased, highlighting the need for improved access to care for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distance to Multidisciplinary Team Clinic in Gaborone, Botswana, and Stage at Cervical Cancer Presentation for Women Living With and Without HIV. Friebel-Klingner, TM., Bazzett-Matabele, L., Ramogola-Masire, D., et al.[2023]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-04688

Testing Adaptive Strategies to Close the Gap from Cervical ... This clinical trial tests strategies to increase timely adoption of cervical cancer treatment in Botswana. Delays and missed opportunities for timely ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11559231/

a sequential multiple assignment randomized trial designed to ... This innovative study seeks to decrease cervical cancer mortality in LMICs by developing and implementing effective and sustainable strategies.

3. withpower.com withpower.com/trial/phase-uterine-cervical-neoplasms-6-2023-72974

Treatment Access Strategies for Cervical Cancer in Botswana Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a pragmatic trial design.

4. trialx.com trialx.com/clinical-trials/listings/235489/strategies-to-close-the-gap-from-cervical-cancer-diagnosis-to-treatment-in-botswana/?&radius=10&place=Seoul,%20etc.&user_country=Korea,%20Republic%20of

Strategies to Close the Gap From Cervical Cancer ... Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a pragmatic ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4630577/

Cervical Cancer in Botswana: Current State and Future ... Botswana has a high burden of cervical cancer due to a limited screening program and high HIV prevalence. About 60% of the cervical cancer patients are HIV ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10471159/

Electronic data review, client reminders, and expanded ... Among the 94 patients who did not complete CCS, 22% patients were not reached, and a letter was sent, or a voicemail was left, 12% canceled or missed their ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12237950/

Cervical Cancer Screening Collaborations Between ... We describe interactions and identify opportunities to guide cancer centers that aim to strengthen cervical cancer prevention, screening, and treatment.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05470309

Community Outreach-based Study to Increase Cervical ... This study is an observational community outreach-based feasibility study. The study intervention that is being evaluated includes two different strategies of ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749379723002386

Uptake of Cervical Cancer Screening Among Female ... This study assessed cervical cancer screening uptake among female patients with health-related social needs who access care through a community-based mobile ...

10. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2812323

Strategies to Increase Cervical Cancer Screening With ... Conclusions and Relevance Within a US health care system, direct-mail self-sampling increased cervical cancer screening by more than 14% in ...