Elimisha HPV (Human Papillomavirus)

Launched by DUKE UNIVERSITY · Feb 8, 2023

Keywords

ClinConnect Summary

The Elimisha HPV trial is focused on creating a new educational program to help women understand and overcome the stigma associated with Human Papillomavirus (HPV) and cervical cancer. The goal is to develop easy-to-understand materials and videos that address common fears and misconceptions from a relatable, peer perspective. This program will be offered at various health facilities in Kenya and aims to improve cervical cancer prevention services for women, especially those living with HIV.

Women between the ages of 25 and 65 who have visited participating health facilities may be eligible to join the study, as well as Community Health Volunteers and HIV-peer navigators. Participants can expect to receive training and support while contributing to an important cause that aims to improve health education and reduce stigma. It's important to note that participation is completely voluntary, and individuals will be fully informed about the study before agreeing to take part.

Gender

ALL

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