NCT06739772

Development of Implementation Toolkits

Development of Implementation Toolkits to Promote HPV Self-sampling Behavior Among Women Living with HIV in Ghana

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Baylor University · Academic / Other
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to conduct an intervention program aimed at increasing HPV self-sampling among women living with HIV in Ghana.

Detailed description

Women living with HIV, (WLWH), in low- and middle-income countries (LMICs) have a six-fold increased risk of developing cervical cancer (CC) compared to their uninfected counterparts. Our studies in Ghana show that self-sampling is acceptable, easy to use, and efficacious in detecting precancer lesions among WLWH. However, this screening mechanism has not been translated to healthcare practice in Ghana. 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

• Self Sampling
• Communication Model
• Implementation Science
• HIV

Interventions

Type	Name	Description
BEHAVIORAL	HPV Self-Sampling and Behavior Intervention	Participants in the intervention group will receive HPV self sampling and behavioral intervention
BEHAVIORAL	Participants in the intervention group will receive HPV self sampling and behavioral intervention	Received enhance standard care

Timeline

• Start date: 2025-02-10
• Primary completion: 2025-10-31
• Completion: 2025-11-03
• First posted: 2024-12-18
• Last updated: 2024-12-18

Locations

1 site across 1 country: Ghana