Elimisha HPV (Human Papillomavirus)

Not Applicable

Recruiting

• Conditions: Cervical Cancer; HPV; Stigma; HIV
• Interventions: Behavioral: Elimisha HPV

• Registration Number: NCT05736588
• Lead Sponsor: Duke University

Brief 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

Not available

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-21
• Study Start: 2023-09-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-07-19
• Study Completion: 2025-07-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 946

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elimisha HPV	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.

Primary Outcome Measures

Name	Time	Method
Overall HPV testing rates	Approximately 12 months	Number of women screened for HPV/Number of women eligible for HPV-based cervical cancer screening during study period

Secondary Outcome Measures

Name	Time	Method
HPV testing rates among women living with HIV (WLWH) enrolled in HIV care	Approximately 12 months	Number of WLWH enrolled in HIV care screened for HPV/Number of WLWH living in the study area
Follow-up rates for HPV treatment	Approximately 12 months	Number of women testing HPV+ seeking treatment within 3 months/Number of women testing HPV+
Overall level of stigma related to cervical cancer, HPV and HIV	Approximately 12 months	HPV and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale of 0 (strongly disagree) to 3 (strongly agree) within each health domain.
Follow-up rates for HPV treatment among WLWH	Approximately 12 months	Number of WLWH testing HPV+ seeking HPV treatment within 3 months/Number of WLWH testing HPV+
Proportion of WLWH enrolled in HIV care attending at least one visit within study period	Approximately 12 months
Level of stigma related to cervical cancer	Approximately 12 months	HPV and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale of 0 (strongly disagree) to 3 (strongly agree) within cervical cancer domain
Level of stigma related to HPV	Approximately 12 months	HPV and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale 0 (strongly disagree) to 3 (strongly agree) within HPV domain.
Level of stigma related to HIV	Approximately 12 months	HPV and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale of 0 (strongly disagree) to 3 (strongly agree) within HIV domain.

Trial Locations

Locations (1)

Kenya Medical Research Institute; 🇰🇪 Kisumu, Kenya