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

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.

• Service Outcome 1A: Program Effectiveness in increase provider self-efficacy [Срок оценки: 6 months post-randomization]
• Service Outcome 1B: Program Effectiveness in increase provider self-efficacy [Срок оценки: 6 months post-randomization]
• Service Outcome 1C: Program Effectiveness in increase provider self-efficacy [Срок оценки: 6 months post-randomization]
• Service Outcome 2A: Patients' cervical screening uptake [Срок оценки: 6 months post-randomization]
• Service Outcome 2B: Patients' cervical screening uptake [Срок оценки: 6 months post-randomization]
• Client Outcome 3A: Patient follow-up treatment. [Срок оценки: 12 months post randomization.]
• Client Outcome 3B: Patient follow-up treatment. [Срок оценки: 12 months post randomization.]
• Client Outcome: Patient Satisfaction [Срок оценки: 6 months post-randomization]