Treatment Access Strategies for Cervical Cancer in Botswana

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Katharine A Rendle, PhD,MSW,MPH

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Biological males, Under 18, others

No Placebo Group

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.

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 data supports the effectiveness of the treatment strategies for cervical cancer in Botswana?

The research highlights that access to care, including travel time to clinics, is a significant barrier for cervical cancer treatment in Botswana. Strategies that improve access, such as outreach and community health advocacy, could potentially enhance early diagnosis and treatment adherence, as seen in similar contexts where distance and lack of information are major barriers. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The studies reviewed do not provide specific safety data for the treatment strategies mentioned, such as Clinic Outreach or High-Touch Strategy, in humans. ^{2 3 4 6 7}

Research Team

Katharine A Rendle, PhD,MSW,MPH

Principal Investigator

University of Pennsylvania

Surbhi Grover, MD, MPH

Principal Investigator

University of Pennsylvania

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.

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

I am under 18 years old.

Trial Timeline

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

Treatment Details

Interventions

• Clinic Outreach (Behavioral Intervention)
• Enhanced Outreach (Behavioral Intervention)
• High-Touch Strategy (Behavioral Intervention)
• Low-Touch Strategy (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Robert H. Vonderheide

Abramson Cancer Center at Penn Medicine

Chief Executive Officer since 2017

MD from Harvard Medical School

Dr. Bonnie Ky

Abramson Cancer Center at Penn Medicine

Chief Medical Officer

MD, MSCE from University of Pennsylvania

University of Botswana

Collaborator

Trials

15

Recruited

11,100+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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 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]

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]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A Multi-Institutional Study of Barriers to Cervical Cancer Care in Sub-Saharan Africa. [2023]

3. England 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Cervical cancer prevention in Malawi: a qualitative study of women's perspectives. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluating the geographic distribution of cervical cancer patients presenting to a multidisciplinary gynecologic oncology clinic in Gaborone, Botswana. [2023]

6. England 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Assessing Nurses' Adherence to the See-and-Treat Guidelines of Botswana's National Cervical Cancer Prevention Programme. [2021]