Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
108 participants
INTERVENTIONAL
2025-02-10
2025-11-03
Brief Summary
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Detailed Description
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Systematic adaptation and implementation toolkits are needed to translate self-sampling into healthcare practices. We develop a Home-based self-collected sampling for the cervical cancer Prevention Education (HOPE) toolkits to promote cervical cancer screening in Ghana. HOPE toolkit core components such as (a) self-sample HPV testing kits and (b) the 3R (Reframe, Reprioritize, and Reform) communication model will not change as they are evidence-based. The content and the intervention delivery modalities of HOPE will go through the cultural adaptation iterative processes.
This R21 resubmission seeks to develop contextually appropriate adaptation and implementation toolkits in Ghana. A three-step approach will be used for the adaption process and evaluation of the toolkit. First, we will organize focus group discussions (FGDs) to identify contextual factors affecting the toolkit adaptation and nominal group techniques (NGTs) to determine the different compositions of the toolkits and select the final toolkit. A sample of 35 stakeholder advisory board members representing three organizational levels: potential intervention participants (i.e., WLWH), community leaders, and healthcare workers (e.g., doctors, nurses, administrators) will participate in the focus group FGDs and NGTs. Second, we will recruit 45 participants including WLWH and healthcare workers to evaluate the feasibility, acceptability, appropriateness, and adoptability of the selected toolkit. Third, we will test the preliminary efficacy of HOPE on cervical cancer screening defined as cervical cancer screening uptake among WLWH in the intervention arm (n=54) and control arm (n = 54). Participants will be recruited from the Cape Coast Teaching Hospital (CCTH). Specific aims of HOPE are:
Aim I: Develop and adapt the HOPE toolkit: Hypothesis: Stakeholders will identify and prioritize community needs and translate findings into a culturally adapted toolkit. Aim II: Evaluate the characteristics of the HOPE toolkit: Hypothesis: We hypothesize that 80% of participants will find HOPE toolkits feasible, acceptable, appropriate, and adoptable. Aim III: Assess the efficacy of HOPE on CCS. Hypothesis: We hypothesize that CCS behavior will increase significantly among women in the intervention group compared to those in the control group. Aim IV: Identify actionable factors and implementation costs that influence the adoption of the toolkit. Hypothesis: The Actionable factors and implementation costs will significantly influence the toolkit adoption.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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HPV Self sampling
Participants in the intervention group will receive HPV self sampling and behavioral intervention
HPV Self-Sampling and Behavior Intervention
Participants in the intervention group will receive HPV self sampling and behavioral intervention
Participants in the intervention group will receive HPV self sampling and behavioral intervention
Received enhance standard care
Control Group
Participants in the control group will receive enhance standard care
No interventions assigned to this group
Interventions
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HPV Self-Sampling and Behavior Intervention
Participants in the intervention group will receive HPV self sampling and behavioral intervention
Participants in the intervention group will receive HPV self sampling and behavioral intervention
Received enhance standard care
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
25 Years
65 Years
FEMALE
No
Sponsors
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Baylor University
OTHER
Responsible Party
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Matt Asare
Assistant Professor
Principal Investigators
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Matthew Asare, PhD
Role: PRINCIPAL_INVESTIGATOR
Baylor University
Locations
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University of Cape Coast Teaching Hospital
Cape Coast, Central Region, Ghana
Countries
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Central Contacts
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Facility Contacts
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Dorcas Obiri-Yeboah, PhD
Role: primary
Other Identifiers
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