Home-based Self-sampling for Cervical Cancer Prevention Education Intervention in Ghana
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Cervical Cancer Screening, HIV, Self-sampling, Implementation Science. Basic parameters: 25 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ghana
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Impact of an Evidence-Based, Behavioral Cervical Cancer Screening Intervention Among Women Living With HIV in Ghana (HOPE-inG): A Type 2 Hybrid Effectiveness Implementation Trial
Overview
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.
Interventions
- 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
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 - Behavioral Control Group
Providers in the control group will not receive ISS support
Primary outcome measures
- Implementation Outcome 1A: HOPE 2.0 Program Adoption [Time frame: 24 months post-randomization]
- Implementation Outcome 1B: HOPE 2.0 Program Adoption [Time frame: 24 months post-randomization]
- Implementation Outcome 1C: HOPE 2.0 Program Adoption [Time frame: 24 months post-randomization]
- Implementation Outcome 1D: HOPE 2.0 Program Adoption [Time frame: 24 months post-randomization]
- Implementation Outcome 2A: HOPE 2.0 Implementation cost [Time frame: 24 months post-randomization]
- Implementation Outcome 2B: HOPE 2.0 Implementation cost [Time frame: 24 months post-randomization]
- Implementation Outcome 3A: Fidelity of Implementing HOPE 2.0 [Time frame: During 24 months post-randomization]
- Implementation Outcome 3B: Fidelity of Implementing HOPE 2.0 [Time frame: During 24 months post-randomization]
- Implementation Outcome 3C: Fidelity of Implementing HOPE 2.0 [Time frame: During 24 months post-randomization]
- Implementation Outcome 3D: Fidelity of Implementing HOPE 2.0 [Time frame: During 24 months post-randomization]
Secondary outcome measures (8)
- Service Outcome 1A: Program Effectiveness in increase provider self-efficacy [Time frame: 6 months post-randomization]
- Service Outcome 1B: Program Effectiveness in increase provider self-efficacy [Time frame: 6 months post-randomization]
- Service Outcome 1C: Program Effectiveness in increase provider self-efficacy [Time frame: 6 months post-randomization]
- Service Outcome 2A: Patients' cervical screening uptake [Time frame: 6 months post-randomization]
- Service Outcome 2B: Patients' cervical screening uptake [Time frame: 6 months post-randomization]
- Client Outcome 3A: Patient follow-up treatment. [Time frame: 12 months post randomization.]
- Client Outcome 3B: Patient follow-up treatment. [Time frame: 12 months post randomization.]
- Client Outcome: Patient Satisfaction [Time frame: 6 months post-randomization]
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.
(a) Healthcare provider eligibility: Inclusion criteria include an individual (no gender restrictions) who
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Ghana · 1 center
- University of Cape Coast — Cape Coast
Publications
- Asare M, Sam-Agudu NA, Cudjoe O, Frueh E, Coker KAR, Dankyi AB, Ken-Amoah S, Akakpo PK, Enyan NIE, Sturdivant RX, Asmah EE, Nuer-Allornuvor GF, Obiri-Yeboah D. HOme-based self-sampling for cervical cancer prevention education among women living with HIV in Ghana (HOPE-inG): study protocol for a cluster-randomized type 2 hybrid effectiveness implementation trial. BMC Public Health. 2026 Mar 27;26(1 PMID 41888748
Identifiers
NCT: NCT06800664 · 1U01CA294757-01 · 1U01CA294757-01