Retention Intervention for Cervical Cancer and HIV

Recruiting at 2 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Disqualifiers: HIV-negative, No cervix, Psychiatric illness, others

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

Compensation: Varies

Number of Visits: 3

80 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

How 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. ^{1 4 6 7 8}

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).

Eligibility 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

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

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

Treatment Details

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.

Participant Groups

Group I: Participant intervention Experimental Treatment 1 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 usual Active Control 1 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.

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 study of 143 women with locally advanced cervical cancer in Botswana, the 5-year overall survival rates were similar for those living with HIV (55.1%) and those without HIV (56.8%), indicating that HIV status does not negatively impact survival when the infection is well-managed.

Key factors associated with better survival included having a baseline hemoglobin level greater than 10 g/dL and being diagnosed at an earlier stage (I or II), suggesting that these factors are more critical for improving outcomes than HIV status itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year overall survival following chemoradiation therapy for locally advanced cervical carcinoma in women living with and without HIV infection in Botswana. MacDuffie, E., Bvochora-Nsingo, M., Chiyapo, S., et al.[2022]

Women living with HIV (WLWH) are three times more likely to experience treatment failure and five times more likely to have recurrence of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) compared to HIV-negative women, based on a cohort study of 179 WLWH and matched controls.

Suppressive antiretroviral therapy (ART) significantly reduces the risk of treatment failure in WLWH, highlighting the importance of early HIV diagnosis and effective ART for improving outcomes in CIN2+ treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suppressive antiretroviral therapy associates with effective treatment of high-grade cervical intraepithelial neoplasia. Carlander, C., Wagner, P., van Beirs, A., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 10,289 women living with HIV, cervical cancer screening using visual inspection with acetic acid (VIA) identified 7.1% with positive results, indicating a need for further evaluation and treatment.

The screening accuracy was moderate, with a sensitivity of 60.8% and specificity of 71.5%, suggesting that while the program is beneficial, improvements in screening methods and follow-up care are necessary to enhance outcomes for women treated for precancerous lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical cancer screening and treatment for PLWHIV: experiences from an innovative program in Nigeria. Ogunsola, OO., Ajayi, OA., Ojo, TO., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 298 women treated for premalignant cervical lesions in Uganda, 76.2% did not return for follow-up within one year, highlighting a significant issue with adherence to post-treatment care.

Factors such as failing to attend the six-week follow-up visit and receiving thermocoagulation treatment were associated with a higher risk of loss to follow-up, indicating the need for improved patient engagement strategies like reminders to ensure compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kajabwangu, R., Ssedyabane, F., Tusubira, D., et al.[2023]

A culturally sensitive telephone counseling intervention for 23 Latina-American cervical cancer survivors showed significant improvements in physical well-being and overall quality of life after 6 sessions.

The study indicates that such behavioral interventions are feasible and beneficial for this population, suggesting the need for further randomized controlled trials to assess long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing physical well-being and overall quality of life among underserved Latina-American cervical cancer survivors: feasibility study. Ashing-Giwa, KT.[2021]

References

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

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]

2. England pubmed.ncbi.nlm.nih.gov

Five-year overall survival following chemoradiation therapy for locally advanced cervical carcinoma in women living with and without HIV infection in Botswana. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Suppressive antiretroviral therapy associates with effective treatment of high-grade cervical intraepithelial neoplasia. [2019]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. England pubmed.ncbi.nlm.nih.gov

Cervical cancer screening and treatment for PLWHIV: experiences from an innovative program in Nigeria. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Cervical cancer screening by visual inspection in Côte d'Ivoire, operational and clinical aspects according to HIV status. [2021]

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

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]

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

Enhancing physical well-being and overall quality of life among underserved Latina-American cervical cancer survivors: feasibility study. [2021]