NCT05736588

Elimisha HPV (Human Papillomavirus)

A Stigma Responsive Service Delivery Model for HPV-based Screening Among Women Living With HIV

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 982 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This research study aims to develop a stigma-responsive educational intervention which includes simplified scripts that provide clear messages about HPV and video aimed at addressing fears and misperceptions from a peer perspective. These educational components will be incorporated into 'Elimisha' HPV a multi-level stigma-responsive cervical cancer prevention service delivery model.

Detailed description

4.1.a. Detailed Description To determine the impact of this intervention on cervical cancer screening uptake and treatment we will carry out a cluster-RCT in community health units (CUs) nested within 12 government-supported health facilities. Over a twelve-month period, Community Health Volunteers within the CUs will offer HPV-based cervical cancer screening during routine home visits, coupled with themocoagulation free-of-charge by the providers in the parent health facility. Screening will be offered using the current standard of care model or using the enhanced Elimisha intervention, according to their assigned arm, described below. Control: CUs in control areas will offer HPV-testing via self-collection to all women in their catchment population using a standard of care model. Screening activities will be carried out by ten CHVs per facility, comprising one CU. CHVs within each CU will be overseen by their CU supervisor. CHVs will lead outreach and education activities, and individual counseling about HPV-testing during routine home visits, including instructions about self-collection, and processing of the specimens. Within two weeks, laboratory results will be sent to the CHVs to record in the facility register and notify women via text, phone call or home visit. Women who test positive for HPV will be referred to their parent health facility for visual inspection with acetic acid, followed by treatment with thermocoagulation as indicated, the current standard of care. Women with lesions not amenable to treatment with thermocoagulation will undergo loop electrosurgical excision procedure at the same visit. Women with lesions suspicious for cancer will undergo biopsy and have follow-up with the gynecologist at the district hospital for treatment planning. Women who are delayed in seeking follow-up (greater than three months since notification of diagnosis) will receive additional text message reminders and home visits, per clinic protocol. Elimisha HPV: a multi-level stigma-responsive delivery model for HPV-based cervical cancer screening (intervention): CHVs in community health units in the intervention arm will offer HPV-testing along with the additional components of Elimisha HPV. CHVs who have been trained in patient-centered care will provide education using standardized scripts reviewed to ensure content is not stigmatizing. For women not ready to screen at this point, counseling will be followed by a brief educational video in which a peer describes her experience with screening and treatment. Will will be provided an illustration to describe the self-sampling procedure. Laboratory process time and notification of results is the same as in control facilities. Women who decline screening will be offered the option to be linked with a peer supporter, who will reach out to her within the following week. Women who are delayed in seeking follow-up care will receive a phone call from a peer support person, who will offer to discuss how own experience and answer any questions about treatment process. Follow-up administration of stigma measurement tool: In months 9-12 of the c-RCT, the study team will recruit women attending study health facilities in both arms to complete the validated instrument to measure HPV, HIV and cervical cancer-related stigma. We will randomly select women who have completed their routine visits with the assumption that after that point in the study, they will have had exposure to the assigned cervical cancer screening delivery strategy, and for those who have tested positive for HPV, will have had time to follow-up for treatment. Women will be considered eligible if they are in the age eligibility range for cervical cancer screening (30-65), but may or may not report that they have been offered or accepted screening as that will be evaluated as an outcome. The instrument contains approximately 55 items, and will take 30 minutes to complete. Instruments have been translated and validated into Dhluo, and will be administered orally with computer-assisted answer entry to ensure confidentiality. 3618 women were screened for HPV but were not consented as the screening was part of their clinical care. 982 participants, including some women screened, and community health promoters (CHP) and CHP supervisors, consented to the study to complete the surveys and in depth interviews.

Conditions

• Cervical Cancer
• HPV
• HIV
• Stigma

Interventions

Type	Name	Description
BEHAVIORAL	Elimisha HPV	Elimisha HPV is a multi-level stigma-responsive cervical cancer prevention service delivery model that incorporates stigma-responsive education, peer navigation and a patient-centered delivery strategy, addressing drivers while mitigating harms from stigma.

Timeline

• Start date: 2023-09-25
• Primary completion: 2024-11-26
• Completion: 2024-11-26
• First posted: 2023-02-21
• Last updated: 2025-09-17

Locations

1 site across 1 country: Kenya