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临床试验/NCT06739772
NCT06739772已完成不适用

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

Baylor University1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年2月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
1
主要终点
Cervical cancer screening uptake

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.
  • Specific eligibility for Intervention participants (WLWH). Study inclusion/

排除标准

  • 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.

研究组 & 干预措施

HPV Self sampling

Experimental

Participants in the intervention group will receive HPV self sampling and behavioral intervention

干预措施: HPV Self-Sampling and Behavior Intervention (Behavioral)

HPV Self sampling

Experimental

Participants in the intervention group will receive HPV self sampling and behavioral intervention

干预措施: Participants in the intervention group will receive HPV self sampling and behavioral intervention (Behavioral)

Control Group

No Intervention

Participants in the control group will receive enhance standard care

结局指标

主要结局

Cervical cancer screening uptake

时间窗: 6 weeks

The outcome is screening uptake (i.e., the completion and return of a self-sample kit and pap test completion). Measure: The screening completion outcome will be binary (yes/no), and it will be assessed via the patient clinical records by the doctors at 6 weeks post-intervention. The screening completion outcome will be binary (yes/no)

次要结局

  • Screening Test Results(6 weeks)
  • Treatment follow-up(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matt Asare

Assistant Professor

Baylor University

研究点 (1)

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