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Elimisha HPV (Human Papillomavirus)
Elimisha HPV (Human Papillomavirus)

NCT05736588

CompletedNA

Sponsor: Duke University

Conditions: Cervical Cancer, HPV, HIV, Stigma

Interventions: Elimisha HPV

Countries: Kenya

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Aim 2 Participants Women registered within the 12 community units participating in the study (Aim 2)

For Aim 2, activity 4, we will enroll approximately 804 randomly selected women, (67 per community unit in each of 12 facilities)

Inclusion criteria:

* 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

Exclusion criteria:

* 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.

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

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
Locations (1)
  • Kisumu, Kenya