Clinical trial · Interventional
Elimisha HPV (Human Papillomavirus)
A Stigma Responsive Service Delivery Model for HPV-based Screening Among Women Living With HIV
NCT05736588CI-TRIAL-00095318completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| HIV | — | UNRESOLVED | — |
| HPV | — | UNRESOLVED | — |
| Stigma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Elimisha HPV | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual care
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Behavioral: Elimisha HPV
Primary outcomes (1)
- measure
- Overall HPV testing rates
- timeFrame
- 1 day
- description
- Number of women screened for HPV/Number of women eligible for HPV-based cervical cancer screening during study period
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.