Retention Intervention for Cervical Cancer and HIV
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston University Charles River Campus
Disqualifiers: HIV-negative, No cervix, Psychiatric illness, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The investigators will conduct the formative work that is necessary to develop a novel, multi-level intervention (inclusive of patient- and provider-level components), which will increase awareness of and modify the complex, intersecting factors that contribute to cervical cancer development among cisgender women with HIV (WWH). In Aim 1a, the investigators will explore the multi-level barriers and facilitators to follow-up appointment attendance among WWH who have had a recent high-risk abnormal Pap smear in the past six months, via qualitative interviews with WWH who have either attended at least one follow-up visit (n\<10) or have not yet attended a follow-up visit (n\<10). In Aim 1b, the investigators will explore provider awareness of the HIV-cervical cancer relationship and perspectives on barriers to retention in care via qualitative interviews (n\<8). For Aim 2, The study team will leverage the Aim 1 data, develop a patient-level intervention (1-2 sessions) and a provider toolkit, with the goal of increasing retention in care among WWH who are at heightened risk for cervical cancer. The study team will seek feedback on the manual and the toolkit from providers and from a community advisory board. In Aim 3a, the investigators will test the feasibility and acceptability of the intervention in a pilot randomized control trial (RCT) (n\<60). The study team will also assess (1) changes in self-efficacy to attend cervical cancer-related healthcare appointments pre-post intervention, (2) the proportion of women who attend a follow-up appointment, and, of those participants, (3) the proportion of women who complete the next phase of treatment. In Aim 3b, the investigators will explore the feasibility of intervention implementation in the clinic and acceptability of the provider-level intervention components in qualitative interviews with providers, clinic staff, the interventionalists, and other key stakeholders (n\<10).
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 data supports the effectiveness of the treatment Retention in cervical cancer care intervention for cervical cancer and HIV?
The research highlights the importance of patient navigators and innovative programs in improving cervical cancer care for women living with HIV, suggesting that similar supportive interventions can enhance retention and follow-up care.
12345How does the Retention Intervention for Cervical Cancer and HIV differ from other treatments?
This treatment is unique because it focuses on improving follow-up care and retention in treatment for women with cervical cancer and HIV, addressing barriers like poor adherence and access to care, which are common in low-resource settings.
14678Eligibility Criteria
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
I am 18 years old or older.
Living with HIV
I had an abnormal Pap test result in the last month.
+1 more
Exclusion Criteria
I do not have a cervix due to a hysterectomy.
I am under 18 years old.
HIV-negative
+2 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Participant interventionExperimental Treatment1 Intervention
The intervention group will likely consist of one to two sessions, conducted in-person, coupled with text- or phone-based client navigation.The intervention group will complete three major assessments: baseline (T1), at the conclusion of the intervention (T2), and a six-month follow-up (T3). Until the follow-up assessment, the interventionist will send participants up to 6 SMS messages (one-way) per month. The content of these messages will be developed collaboratively between the participant and the interventionist during the second session; messages could include reminders about follow-ups and/or prompts to use new skills and resources for navigating specific barriers.
Group II: Treatment as usualActive Control1 Intervention
The treatment as usual (TAU) group will receive treatment as usual, including being notified of their abnormal Pap results via SMS and instructed to set up a follow-up appointment, as is typical in routine care. The TAU group will complete the T1 assessment and will complete T2 assessment two-months post-baseline.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
Boston UniversityBoston, MA
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Who Is Running the Clinical Trial?
Boston University Charles River CampusLead Sponsor
Massachusetts General HospitalCollaborator
University of Witwatersrand, South AfricaCollaborator
References
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. [2023]To assess the impact of HIV on access to invasive cervical cancer (ICC) care and overall survival (OS) in a time of universal access to antiretroviral therapy (ART).
Five-year overall survival following chemoradiation therapy for locally advanced cervical carcinoma in women living with and without HIV infection in Botswana. [2022]To compare updated prospective 5-year survival outcomes of cervical cancer patients living with and without human immunodeficiency virus (HIV) infection who initiated curative chemoradiation therapy (CRT) in a resource-limited setting.
Suppressive antiretroviral therapy associates with effective treatment of high-grade cervical intraepithelial neoplasia. [2019]To assess if women living with HIV (WLWH) have poorer outcome after treatment of cervical intraepithelial neoplasia grade 2, grade 3, adenocarcinoma in situ or cervical cancer (CIN2+) than HIV-negative women (HNW) and to identify predictors of CIN2+ treatment failure and recurrence in WLWH.
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. [2020]This study was conducted to identify barriers and facilitators to cervical cancer screening, diagnosis, follow-up care, and treatment among human immunodeficiency virus (HIV)-infected women and clinicians and to explore the acceptability of patient navigators in Tanzania.
Cervical cancer screening and treatment for PLWHIV: experiences from an innovative program in Nigeria. [2023]We evaluated cervical cancer program for women living with HIV (WLHIV) to determine program screening rate, primary case finder screening accuracy and treatment and post-treatment screening rate among screen-positive patients.
Cervical cancer screening by visual inspection in Côte d'Ivoire, operational and clinical aspects according to HIV status. [2021]Cervical cancer screening is not yet standard of care of women attending HIV care clinics in Africa and presents operational challenges that need to be addressed.
High Rate of Loss to Follow-Up Among Patients Undergoing Treatment for Premalignant Cervical Lesions at Mbarara Regional Referral Hospital, Southwestern Uganda: A Retrospective Cohort Study. [2023]For a cervical cancer control program to be effective in reducing the incidence of the disease, there should be high compliance to treatment and follow-up of women diagnosed with precursor lesions. Screening programs in low-resource countries such as Uganda are challenged by poor adherence to follow-up following treatment for premalignant cervical lesions. This study sought to describe the burden and factors associated with loss to follow-up among women undergoing treatment for premalignant cervical lesions at a tertiary hospital in southwestern Uganda.
Enhancing physical well-being and overall quality of life among underserved Latina-American cervical cancer survivors: feasibility study. [2021]Evidence for the effectiveness of behavioral interventions are lacking for cervical cancer survivors (CCS). Disparities in survivorship outcomes exist for CCS, especially Latina-Americans. This study assessed the feasibility of implementing a culturally sensitive intervention delivered in a telephonic format.