Elimisha HPV (Human Papillomavirus)

NCT05736588 | Completed

• 2 other identifiers: Pro001119291R01TW012415
• Study Type: interventional
• Target: 982
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; HPV; HIV; Stigma

Outcome Measures

Primary Outcomes (1)

• Overall HPV testing rates

  Number of women screened for HPV/Number of women eligible for HPV-based cervical cancer screening during study period

  1 day

Secondary Outcomes (8)

• HPV testing rates among women living with HIV (WLWH) enrolled in HIV care

  1 day

• Follow-up rates for HPV treatment

  1 day

• Follow-up rates for HPV treatment among WLWH

  1 day

• Proportion of WLWH enrolled in HIV care attending at least one visit within study period

  1 day

• Overall level of stigma related to cervical cancer, HPV and HIV

  1 day

Other Outcomes (1)

• Factors related to the success of the delivery model

  1 day

Study Arms (2)

Usual care

NO INTERVENTION

Elimisha HPV

EXPERIMENTAL

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.

Behavioral: Elimisha HPV

Interventions

Elimisha HPV BEHAVIORAL

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.

Elimisha HPV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A Community Health Volunteer (CHV) has registered the woman in the mSaada App (electronic HPV-based cervical cancer screening tracking tool) during the study period
• Is eligible for cervical cancer screening per the Kenya Ministry of Health guidelines include:
• Women living with HIV (WLWH) will be between the age of 25 and 65
• All other women will be between the age of 30 and 65
• All women should have an intact uterus and cervix

You may not qualify if:

• Does not understand the study purpose and details
• Is not willing to provide informed consent
• CHVs working through government-supported health facilities (Aim 2) We will work with CHV supervisors to approach CHVs for study participation and possible enrollment into the study for training and participation in the stigma-responsive service delivery model. Since study outcomes may appear to reflect CHV job performance, we will explain this as part of the informed consent and emphasize the voluntary nature of participation in the study. For both optimization of study activities and to avoid any coercion, CHVs will be able to decline participation without impact on their position in the facility.
• Age 18 or older
• Must be a Community Health Volunteer (CHV) at government-supported facilities in Kisumu County
• Does not understand the study purpose and details
• Is not willing to sign an informed consent
• Aim 3 Participants Participants will be purposively recruited from each study arm to achieve a sample with heterogeneous demographic and clinical characteristics (e.g., age, HIV and HPV status).
• Women attending government-supported health facilities (Aim 3) Investigators will enroll approximately 24 women with the option to recruit more if new themes are emerging in the IDIs.
• Will have completed an HPV screening test at one of the intervention or control facilities
• Agree to be audio recorded
• Does not understand the study purpose and details
• Is not willing to provide informed consent
• Community Health Volunteers (CHVs) and Peer Navigators (Aims 3) Investigators will enroll approximately 10 CHVs and peer navigators with the option to recruit more if new themes are emerging in the IDIs.
• Participated as a CHV or peer navigator at one of the facilities participating in the study

Sponsors & Collaborators

• Duke University: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Kenya Medical Research Institute

Kisumu, Kenya

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Social Stigma

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 21, 2023
• Study Start: September 25, 2023
• Primary Completion: November 26, 2024
• Study Completion: November 26, 2024
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

KE (1)