Clinical trial NCT06739772: Development of Implementation Toolkits
Official title: Development of Implementation Toolkits to Promote HPV Self-sampling Behavior Among Women Living with HIV in Ghana
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Self Sampling
Communication Model
Implementation Science
HIV
Lead sponsor: Baylor University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 108
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* General eligibility criteria for these stakeholders include (1) the ability to give consent per Institutional Review Board stipulations, (2) residing in the central region of Ghana, (3) having no medical, psychological, or social characteristics that would interfere with the ability to fully participate, and (4) the willingness to participate in this study.

  1. Specific eligibility for Intervention participants (WLWH). Study inclusion/exclusion criteria for potential participants will be assessed using E-tracker data and include women (identified female at birth) who (1) are living with HIV between 25 and 65 years old5 and (2) have never had a cervical cancer screening like pap test or HPV test before, or have not had pap test or HPV testing for the past 5 years

Exclusion Criteria:

* Women will be excluded if they are pregnant or have had a hysterectomy. WLWH (female-identified at birth) who have a cervix are the main target population to develop the HOPE toolkit.

Primary outcomes:
measure: Cervical cancer screening uptake
timeFrame: 6 weeks
Secondary outcomes:
measure: Screening Test Results
timeFrame: 6 weeks
measure: Treatment follow-up
timeFrame: 6 weeks
Other outcomes:
measure: Actionable outcome : Implementation experience
timeFrame: 6 weeks after the intervention
measure: Actionable factor: Operational experience
timeFrame: 6 weeks after the intervention
measure: Actionable factor: Adoption or level of endorsement
timeFrame: 6 weeks after the intervention
measure: Implementation cost
timeFrame: Throughout the intervention period (about 12 months)
Locations:
city: Cape Coast
country: Ghana
facility: University of Cape Coast Teaching Hospital
state: Central Region
Study officials:
affiliation: Baylor University
name: Matthew Asare, PhD
role: PRINCIPAL_INVESTIGATOR
References: