Clinical trial NCT05736588: Elimisha HPV (Human Papillomavirus)
Official title: A Stigma Responsive Service Delivery Model for HPV-based Screening Among Women Living With HIV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
HPV
HIV
Stigma
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2023-02-21
Enrollment: 946
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Overall HPV testing rates
timeFrame: Approximately 12 months
Secondary outcomes:
measure: HPV testing rates among women living with HIV (WLWH) enrolled in HIV care
timeFrame: Approximately 12 months
measure: Follow-up rates for HPV treatment
timeFrame: Approximately 12 months
measure: Follow-up rates for HPV treatment among WLWH
timeFrame: Approximately 12 months
measure: Proportion of WLWH enrolled in HIV care attending at least one visit within study period
timeFrame: Approximately 12 months
measure: Overall level of stigma related to cervical cancer, HPV and HIV
timeFrame: Approximately 12 months
measure: Level of stigma related to cervical cancer
timeFrame: Approximately 12 months
measure: Level of stigma related to HPV
timeFrame: Approximately 12 months
measure: Level of stigma related to HIV
timeFrame: Approximately 12 months
Other outcomes:
measure: Factors related to the success of the delivery model
timeFrame: Approximately 12 months
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute
Study officials:
References: