Elimisha HPV (Human Papillomavirus)

Trial Title: Elimisha HPV (Human Papillomavirus)

NCT ID: NCT05736588

Condition: Cervical Cancer
HPV
HIV
Stigma

Conditions: Official terms:
Uterine Cervical Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Elimisha HPV
Description: 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.
Arm group label: Elimisha HPV

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.

Criteria for eligibility:
Criteria:
Women attending government-supported health facilities (Aim 2) For Aim 2, activity 4, investigators will enroll approximately 804 randomly selected women, (67 per facility in each of 12 facilities). - Inclusion criteria: *Has attended a study facility 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 - Exclusion criteria: - Does not understand the study purpose and details - Is not willing to provide informed consent CHVs working at government-supported health facilities (Aim 2) Investigators will enroll approximately 36 Community Health Volunteers (CHVs) across 12 sites. CHVs will be identified by CHV supervisors and will be recruited into the study for training and participation in the stigma-responsive service delivery model at the time of randomization. Since study outcomes may appear to reflect their 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. - Inclusion criteria: - Age 18 or older - Must be a Community Health Volunteer (CHV) at government-supported facilities in Kisumu County - Exclusion criteria: - Does not understand the study purpose and details - Is not willing to sign an informed consent HIV-peer navigators (Aim 2) Approximately 60 (10 per intervention health facility) HIV-peer navigator or a woman attending these facilities, including a woman living with HIV (WLWH). - Inclusion criteria: - Age 18 or older - Must have complete HPV screening and treatment in the past - Must be interested in getting trained as a peer navigator - Exclusion criteria: - 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. - Inclusion criteria: - Will have completed an HPV screening test at one of the intervention or control facilities - Agree to be audio recorded - Exclusion criteria: - 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. - Inclusion criteria: - Participated as a CHV or peer navigator at one of the facilities participating in the study - Agree to be audio recorded - Exclusion criteria: - Does not understand the study purpose and details - Is not willing to sign an informed consent Facility managers (Aim 3) Investigators will enroll approximately 12 facility managers. - Inclusion criteria: - Age 18 or older - A manager at one of the facilities participating in the study - Agree to be audio recorded - Exclusion criteria: - Does not understand the study purpose and details - Is not willing to sign an informed consent

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Kenya Medical Research Institute

Address:
City: Kisumu
Country: Kenya

Status: Recruiting

Contact:
Last name: Frankie Odhiambo, MD
Email: fodhiambo@kemri-rctp.org

Start date: September 25, 2023

Completion date: July 19, 2025

Lead sponsor:
Agency: Duke University
Agency class: Other

Collaborator:
Agency: Fogarty International Center of the National Institute of Health
Agency class: NIH

Source: Duke University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05736588