Home-based Self-sampling for Cervical Cancer Prevention Education Intervention in Ghana

NCT ID: NCT06800664

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2029-05-31

Brief Summary

The investigators propose to develop and/or adapt implementation strategies and a structured implementation plan to translate the HOPE intervention into existing healthcare practice in Ghana.

These "implementation support strategies (ISS)" are implementation strategies relevant to implementation support, which is concerned with moving (implementation) research into (implementation) practice.

The ultimate goal is to facilitate health system adoption and sustainment.

Detailed Description

Over 69,000 women living with HIV, (WLWH) in Ghana have a six-fold increased risk of developing cervical cancer and require early and frequent cervical cancer screening (CCS). However, available data in Ghana show that the CCS rate among eligible women is as low as 2.7%, and there is no evidence that WLWH screen at higher rates. In response to the need to increase the uptake of CCS among WLWH, the investigators developed a Home-based self-sampling for cervical cancer Prevention Education (HOPE) intervention. HOPE consists of HPV self-sampling combined with a 3R (Reframing, Reprioritizing, and Reforming) communication model for promoting CCS. In a randomized controlled trial (RCT) in Ghana, the investigators demonstrated that HOPE significantly increased CCS among WLWH (100%) vs routine clinic-based screening (14.64%). Participating women found the self-sampling and 3R communication model acceptable and culturally appropriate. High-impact implementation strategies are needed to integrate and scale up HPV self-sampling into women's healthcare in Ghana. The investigators propose to develop and/or adapt implementation strategies to maximize the success of the HOPE intervention in increasing its health system adoption, patient uptake, and the sustainment of CCS among WLWH. The investigators' proposed hybrid type 2 effectiveness-implementation RCT trial will leverage existing relationships with secondary-level health facilities in Ghana. The investigators will select four secondary-level health facilities with comparable infrastructure and WLWH patient enrollment. Using the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework, the investigators will address the following specific aims.

Aim 1: To develop a culturally appropriate, evidence-based health system implementation plan and provider training content for successful HOPE implementation (Preparation phase). Through nominal group techniques (NGTs), the investigators will support engaged stakeholders in selecting, prioritizing, and adapting culturally appropriate implementation support strategies (ISS) for HOPE. Through NGTs, the investigators will modify HOPE and adopt HOPE 2.0

Aim 2: Assess the effectiveness of the HOPE 2.0 intervention and the success of the implementation plan in a hybrid type 2 trial (Implementation phase). The investigators will conduct a hybrid type 2 effectiveness-implementation RCT to evaluate the impact of implementation strategies. Four HIV secondary-level clinics will be cluster-randomized 1:1 in a two-arm RCT. Healthcare providers in the intervention group (IG, Arm 1) will receive evidence-based training validated in Aim 1. After training, trained providers will recruit WLWH (n = 576) from their HIV facilities and implement HOPE. Providers in the control group (CG, Arm 2) who will not be trained with our ISS materials will recruit WLWH (n = 576) and implement HOPE in their clinics.

Aim 3: Assess the impact of the implementation plan on the sustainment of the HOPE intervention at study sites (Sustainment phase). The investigators will assess the impact of HOPE on WLWH screening behaviors and the impact of strategy material on providers' self-efficacy for implementing HOPE across the study arms.

Conditions

Cervical Cancer Screening; HIV; Self-sampling; Implementation Science; Intervention (Training) Condition; Implementation Strategies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Health providers and management at IG sites will receive ISS (i.e., management support, capacity-building, and social network support) and training on the HOPE implementation plan

Group Type: EXPERIMENTAL

Health providers and management at IG sites will receive ISS (i.e., management support, capacity-building, and social network support) and training on the HOPE implementation plan

Intervention Type: BEHAVIORAL

Health providers and management at IG sites will receive ISS (i.e., management support, capacity-building, and social network support) and training on the HOPE implementation plan

Control Group

Intervention Type: BEHAVIORAL

Providers in the control group will not receive ISS support

Control Group

Providers and management in the control group will not receive any ISS or implementation plan training

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Health providers and management at IG sites will receive ISS (i.e., management support, capacity-building, and social network support) and training on the HOPE implementation plan

Health providers and management at IG sites will receive ISS (i.e., management support, capacity-building, and social network support) and training on the HOPE implementation plan

Intervention Type: BEHAVIORAL

Control Group

Providers in the control group will not receive ISS support

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

General criteria

• ability to give consent per Institutional Review Board stipulations
• residing in the Central Region
• having no medical characteristics that would interfere with the ability to participate fully
• the willingness to participate in this study.

• possesses healthcare qualifications (i.e., patient navigators, physicians, nurses, health facility management),
• works at the HIV health facility at study sites,
• is ≥18 years old. (b) Eligibility for women living with HIV (Patients)
• identified female at birth) who
• are living with HIV between 25 and 65 years old (age consistent with WHO CC screening guidelines)
• have never had CC screening (Pap or HPV test),
• have not had a screening for the past 5 years

Exclusion Criteria

• Women will be excluded if they are pregnant or have had a hysterectomy.
• WLWH who have a cervix are the main target population to develop the HOPE toolkit.
• Women who are below 25 and those who are above 65 years will be excluded.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Baylor University

OTHER

Sponsor Role: lead

Responsible Party

Matt Asare

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Asare, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor University

Dorcas Obiri-Yeboah, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cape Coast

Nadia Sam-Agudu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Cape Coast

Capte Coast, Central Region, Ghana

Countries

Ghana

Central Contacts

Matthew Asare, PhD

Role: CONTACT

Matt_asare@baylor.edu

5136416482

Dorcas Obiri-Yeboah, PhD

Role: CONTACT

dobiri-yeboah@ucc.edu.gh

233+244-527387

Facility Contacts

Dorcas Obiri-Yeboah, PhD

Role: primary

dobiri-yeboah@ucc.edu.gh

+233244-527387

Other Identifiers

1U01CA294757-01

Identifier Type: NIH

Identifier Source: secondary_id

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1U01CA294757-01

Identifier Type: NIH

Identifier Source: org_study_id

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