Retention Intervention for Cervical Cancer and HIV

Not yet recruiting at 2 trial locations
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Boston University Charles River Campus
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist women living with HIV who have received high-risk abnormal Pap smear results. The goal is to develop and test a new intervention to improve follow-up care, making it easier for these women to attend necessary healthcare appointments and manage their cervical cancer care. Participants will receive either a personalized support program, which includes sessions and text message reminders, or standard care. This personalized support program is part of the retention in cervical cancer care intervention. Women with HIV, a cervix, and a recent high-risk abnormal Pap result may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative care solutions for women facing similar health challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this intervention is safe for women with HIV?

Research has shown that programs designed to help people stay in cervical cancer care are generally safe. While specific safety data for this exact program is not available, these types of programs usually include supportive sessions and reminder messages, which participants typically handle well.

In similar studies, women with HIV who joined these programs reported very few, if any, negative effects. These programs mainly help patients follow their healthcare plans by providing support, rather than involving medical procedures or drugs. As a result, there are usually very few safety concerns.

Since this trial focuses on improving follow-up care through sessions and messages, it is expected to be low-risk. Similar programs have not shown any major side effects, making it a safe option for participants.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to keep patients engaged in cervical cancer care, especially those also living with HIV. Unlike standard treatments that focus solely on medical procedures, this intervention includes personalized in-person sessions and ongoing support through text messages. This approach is designed to help patients overcome barriers to care by providing regular reminders and custom strategies, potentially leading to better health outcomes. By combining human interaction with digital communication, the trial aims to enhance patient retention and adherence, which is crucial for managing both cervical cancer and HIV effectively.

What evidence suggests that this intervention is effective for retention in cervical cancer care among women with HIV?

Research has shown that integrating cervical cancer prevention with HIV care can effectively address both health issues. Studies have found that women with HIV often struggle to continue their care after cervical cancer screenings due to lack of support and financial difficulties. For example, a study in Côte d'Ivoire found that only 54% of women with HIV began cancer treatment, highlighting the need for better ways to keep them in care. Increasing awareness among healthcare providers about the link between HIV and cervical cancer can also help. In this trial, the intervention group will receive support sessions and reminder messages, which may improve attendance at follow-up appointments and completion of treatment. Meanwhile, the treatment-as-usual group will receive standard care, including notifications of abnormal Pap results and instructions to set up follow-up appointments.12367

Are You a Good Fit for This Trial?

This trial is for cisgender individuals with cervixes and women living with HIV in South Africa who have recently had a high-risk abnormal Pap smear. Participants should either have attended at least one follow-up visit or not yet attended any. The study aims to help them keep up with cervical cancer care appointments.

Inclusion Criteria

Living with HIV
I had an abnormal Pap test result in the last month.
I have a cervix.

Exclusion Criteria

I do not have a cervix due to a hysterectomy.
I am under 18 years old.
HIV-negative
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development of a patient-level intervention and provider toolkit based on formative work and feedback

1-2 months

Pilot Randomized Control Trial

Testing the feasibility and acceptability of the intervention in a pilot RCT

6 months
3 major assessments: baseline, post-intervention, and 6-month follow-up

Follow-up

Participants are monitored for changes in self-efficacy and follow-up appointment attendance

7 months

What Are the Treatments Tested in This Trial?

Interventions

  • Retention in cervical cancer care intervention
Trial Overview The trial is developing an intervention that includes both patient- and provider-level components to improve retention in cervical cancer care among women with HIV. It involves interviews, creating a brief patient intervention, a provider toolkit, and testing these tools' feasibility and acceptability.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Participant interventionExperimental Treatment1 Intervention
Group II: Treatment as usualActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials
125
Recruited
14,100+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

University of Witwatersrand, South Africa

Collaborator

Trials
107
Recruited
10,090,000+

Published Research Related to This Trial

In a study of 294 women with invasive cervical cancer (ICC) in Côte d'Ivoire, women living with HIV (WLHIV) had a higher rate of initiating cancer care (54.0%) compared to HIV-uninfected women (39.0%), suggesting better access to screening services for WLHIV.
Despite the higher access to care, HIV status did not affect overall survival rates among these women, with advanced clinical stage being the only significant predictor of mortality, indicating that timely diagnosis and treatment are crucial for improving outcomes.
Impact of HIV infection on access to cancer care and survival among women with invasive cervical cancer in Côte d'Ivoire: A prospective cohort study.Boni, SP., Horo, A., Didi-Kouko-Coulibaly, J., et al.[2023]
In a cervical cancer screening program involving 2,998 HIV-positive women, 9.0% tested positive for visual inspection, significantly higher than the 3.9% positive rate in 1,047 HIV-negative women, indicating that HIV-positive women are at greater risk for cervical lesions.
A phone-based tracking system effectively reduced the number of women who did not attend follow-up consultations after a positive screening from 36.5% to 19.8%, highlighting a practical solution to improve follow-up care in cervical cancer screening programs.
Cervical cancer screening by visual inspection in Côte d'Ivoire, operational and clinical aspects according to HIV status.Horo, A., Jaquet, A., Ekouevi, DK., et al.[2021]
HIV-positive women in Tanzania face significant barriers to cervical cancer care, including fear, stigma, misinformation, and limited access to screening and treatment, as identified through focus group discussions.
Both patients and clinicians agree that implementing a patient navigation program could effectively assist women in accessing cervical cancer screening, diagnosis, follow-up care, and treatment, highlighting the need for supportive resources in the healthcare system.
Barriers and Facilitators to Cervical Cancer Screening, Diagnosis, Follow-Up Care and Treatment: Perspectives of Human Immunodeficiency Virus-Positive Women and Health Care Practitioners in Tanzania.Bateman, LB., Blakemore, S., Koneru, A., et al.[2020]

Citations

Retention Intervention for Cervical Cancer and HIVIn a study of 294 women with invasive cervical cancer (ICC) in Côte d'Ivoire, women living with HIV (WLHIV) had a higher rate of initiating cancer care (54.0%) ...
Barriers and facilitators of retention in care after cervical ...Our study revealed barriers to retention in care after cervical cancer screening, including lack of partner support, financial and educational constraints, and ...
Identifying and Addressing Barriers to Retention in the ...In Aim 1b, the investigators will explore provider awareness of the HIV-cervical cancer relationship and perspectives on barriers to retention in care via ...
Cervical Cancer Outcomes in Women With HIV in the Age ...This cross-sectional study investigates the outcomes for women living with HIV and cervical cancer in the US after the emergence of ...
Effectiveness of integrating cervical cancer prevention ...Integration of cervical cancer prevention strategies into HIV care programs shows promise in effectively addressing this dual burden.
Cervical Cancer Outcomes in Women With HIV in the Age of ...This cross-sectional study investigates the outcomes for women living with HIV and cervical cancer in the US after the emergence of ...
NCT07209917 | Secondary Cervical Cancer Prevention of ...The primary outcome is HR-HPV persistence (consecutive positivity for same HR-HPV type, separated by 12-18 months). Secondary outcomes include ...
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