Clinical trial NCT06800664: Home-based Self-sampling for Cervical Cancer Prevention Education Intervention in Ghana
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Cancer Screening
HIV
Self-sampling
Implementation Science
Intervention (Training) Condition
Implementation Strategies
Lead sponsor: Baylor University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-01-30
Enrollment: 1500
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Aim 1: This study uses mixed-method approaches (qualitative and quantitative). Through nominal group techniques (NGT) (qualitative method), the investigators will support engaged stakeholders in selecting, prioritizing, and adapting culturally appropriate implementation support strategies (ISS) for HOPE. Surveys (quantitative method) will be used to evaluate the feasibility, acceptability, and appropriateness of HOPE 2.0 and prioritized/refined ISS.

Aims 2 \& 3: Investigators will conduct a hybrid type2 cluster RCT to evaluate the effectiveness of HOPE 2.0 and the implementation of HOPE 2.0 using bridging factor-focused ISS at secondary health facilities. HIV clinics at four secondary facilities will be cluster-randomized 1:1 in a two-arm trial. WLWH in the Intervention group will receive HOPE 2.0 from providers trained with ISS in implementing to be developed and adopted WLWH in the control group will also receive HOPE 2.0, but from providers who did not receive implementation training
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Implementation Outcome 1A: HOPE 2.0 Program Adoption
timeFrame: 24 months post-randomization
measure: Implementation Outcome 1B: HOPE 2.0 Program Adoption
timeFrame: 24 months post-randomization
measure: Implementation Outcome 1C: HOPE 2.0 Program Adoption
timeFrame: 24 months post-randomization
measure: Implementation Outcome 1D: HOPE 2.0 Program Adoption
timeFrame: 24 months post-randomization
measure: Implementation Outcome 2A: HOPE 2.0 Implementation cost
timeFrame: 24 months post-randomization
measure: Implementation Outcome 2B: HOPE 2.0 Implementation cost
timeFrame: 24 months post-randomization
measure: Implementation Outcome 3A: Fidelity of Implementing HOPE 2.0
timeFrame: During 24 months post-randomization
measure: Implementation Outcome 3B: Fidelity of Implementing HOPE 2.0
timeFrame: During 24 months post-randomization
measure: Implementation Outcome 3C: Fidelity of Implementing HOPE 2.0
timeFrame: During 24 months post-randomization
measure: Implementation Outcome 3D: Fidelity of Implementing HOPE 2.0
timeFrame: During 24 months post-randomization
measure: Implementation Outcome 4A: HOPE 2.0 Program Penetration in the clinics
timeFrame: 6 months post-randomization
measure: Implementation Outcome 4B: HOPE 2.0 Program Penetration in the clinics
timeFrame: 6 months post-randomization
measure: Implementation Outcome 5A: HOPE 2.0 Sustainment in the facilities
timeFrame: 42 month post-randomization
measure: Implementation Outcome 5B: HOPE 2.0 Sustainment in the facilities
timeFrame: 42 month post-randomization
Secondary outcomes:
measure: Service Outcome 1A: Program Effectiveness in increase provider self-efficacy
timeFrame: 6 months post-randomization
measure: Service Outcome 1B: Program Effectiveness in increase provider self-efficacy
timeFrame: 6 months post-randomization
measure: Service Outcome 1C: Program Effectiveness in increase provider self-efficacy
timeFrame: 6 months post-randomization
measure: Service Outcome 2A: Patients' cervical screening uptake
timeFrame: 6 months post-randomization
measure: Service Outcome 2B: Patients' cervical screening uptake
timeFrame: 6 months post-randomization
measure: Client Outcome 3A: Patient follow-up treatment.
timeFrame: 12 months post randomization.
measure: Client Outcome 3B: Patient follow-up treatment.
timeFrame: 12 months post randomization.
measure: Client Outcome: Patient Satisfaction
timeFrame: 6 months post-randomization
Other outcomes:
Locations:
city: Capte Coast
country: Ghana
facility: University of Cape Coast
state: Central Region
Study officials:
affiliation: Baylor University
name: Matthew Asare, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cape Coast
name: Dorcas Obiri-Yeboah, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Nadia Sam-Agudu, MD
role: PRINCIPAL_INVESTIGATOR
References: