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

NCT06800664 | Not Yet Recruiting

• 1 other identifier: 1U01CA294757-01
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (14)

• Implementation Outcome 1A: HOPE 2.0 Program Adoption

  The first primary outcome of interest is program adoption, defined as the decision of healthcare management and provider's willingness to use HOPE 2.0 (consisting of self-sampling, 3R model, and patient navigators) and ISS materials in the facilities. Adoption will be measured at at 1, 3-, 6-, 12-, and 24 months post-randomization using a Log sheet.

  24 months post-randomization

• Implementation Outcome 1B: HOPE 2.0 Program Adoption

  The first primary outcome of interest is program adoption, defined as the decision of healthcare management and provider's willingness to use HOPE 2.0 (consisting of self-sampling, 3R model, and patient navigators) and ISS materials in the facilities. Adoption will be measured at at 1, 3-, 6-, 12-, and 24 months post-randomization using semi-structured interviews.

  24 months post-randomization

• Implementation Outcome 1C: HOPE 2.0 Program Adoption

  The first primary outcome of interest is implementation outcomes of adoption in providers defined as the decision of providers willingness to use HOPE 2.0 (consisting of self-sampling, 3R model, and patient navigators) and ISS materials in the facilities. Adoption will be measured 1, 3, 6- 12- and 24 months post-randomization using Likert Scale surveys.

  24 months post-randomization

• Implementation Outcome 1D: HOPE 2.0 Program Adoption

  The first primary outcome of interest is implementation outcomes of adoption in patients, defined as the decision of patients' willingness to use HOPE 2.0 (consisting of self-sampling, 3R model, and patient navigators) and ISS materials in the facilities. Adoption will be measured 1, 3, 6- 12- and 24 months post-randomization. At the patient level, adoption will be measured using a 6 item scale.

  24 months post-randomization

• Implementation Outcome 2A: HOPE 2.0 Implementation cost

  The second primary outcome of interest is implementation cost, defined as the total expenses for implementing HOPE 2.0. Cost will be assessed at the health facility and patient levels at 1, 3, 6, 12, and 24 months post-randomization. At both levels, implementation costs will be measured using a cost-tracking database.

  24 months post-randomization

• Implementation Outcome 2B: HOPE 2.0 Implementation cost

  The second primary outcome of interest is implementation cost, defined as the total expenses for implementing HOPE 2.0. Cost will be assessed at the patient levels at 1, 3, 6, 12, and 24 months post-randomization using an outpatient cost survey

  24 months post-randomization

• Implementation Outcome 3A: Fidelity of Implementing HOPE 2.0

  The third primary outcome of interest is Fidelity, defined as the degree to which HOPE 2.0/ISS is implemented as planned in the facilities. Fidelity outcome will be measured at the management level using process evaluation checklists throughout the intervention period.

  During 24 months post-randomization

• Implementation Outcome 3B: Fidelity of Implementing HOPE 2.0

  The third primary outcome of interest is Fidelity, defined as the degree to which HOPE 2.0/ISS is implemented as planned in the facilities. Fidelity outcome will be measured at management and provider levels using observations throughout the intervention period.

  During 24 months post-randomization

• Implementation Outcome 3C: Fidelity of Implementing HOPE 2.0

  The third primary outcome of interest is Fidelity, defined as the degree to which HOPE 2.0/ISS is implemented as planned in the facilities. Fidelity outcome will be measured at management and provider levels through regular review of log sheets.

  During 24 months post-randomization

• Implementation Outcome 3D: Fidelity of Implementing HOPE 2.0

  The third primary outcome of interest is Fidelity, defined as the degree to which HOPE 2.0/ISS is implemented as planned in the facilities. Fidelity outcome will be measured the provider level using a 7 item survey.

  During 24 months post-randomization

• Implementation Outcome 4A: HOPE 2.0 Program Penetration in the clinics

  The fourth primary outcome of interest is Program Penetration, defined as integrating HOPE 2.0/ISS within the clinic facilities. We will assess penetration at management and provider levels using activity log sheets at 1 and 6 months post-randomization.

  6 months post-randomization

• Implementation Outcome 4B: HOPE 2.0 Program Penetration in the clinics

  The fourth primary outcome of interest is Program Penetration, defined as integrating HOPE 2.0/ISS within the clinic facilities. We will assess penetration outcomes at management and provider levels using interviews at 1 and 6 months post-randomization.

  6 months post-randomization

• Implementation Outcome 5A: HOPE 2.0 Sustainment in the facilities

  The final implementation outcome of interest is sustainability, defined as the extent to which the intervention (HOPE 2.0 and ISS) is integrated within the clinics' routine operations. Sustainability will be measured at the provider and management levels using the Sustainment Measurement System Scale at 12, 24, 36, and 42 months (after a 36-42-month post-trial period) post-randomization.

  42 month post-randomization

• Implementation Outcome 5B: HOPE 2.0 Sustainment in the facilities

  The final implementation outcome of interest is sustainability, defined as the extent to which the intervention (HOPE 2.0 and ISS) is integrated within the clinics' routine operations. Sustainability will be measured at the provider and management levels using Interviews at 12, 36, and 42 months post-randomization.

  42 month post-randomization

Secondary Outcomes (8)

• Service Outcome 1A: Program Effectiveness in increase provider self-efficacy

  6 months post-randomization

• Service Outcome 1B: Program Effectiveness in increase provider self-efficacy

  6 months post-randomization

• Service Outcome 1C: Program Effectiveness in increase provider self-efficacy

  6 months post-randomization

• Service Outcome 2A: Patients' cervical screening uptake

  6 months post-randomization

• Service Outcome 2B: Patients' cervical screening uptake

  6 months post-randomization

Study Arms (2)

Intervention Group

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

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; Behavioral: Control Group

Control Group

NO INTERVENTION

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

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 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

Intervention Group

Control Group BEHAVIORAL

Providers in the control group will not receive ISS support

Intervention Group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Cape Coast

Capte Coast, Central Region, Ghana

Location

MeSH Terms

Interventions

Capacity Building; Control Groups

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services; Organization and Administration; Health Services Administration; Pandemic Preparedness; Disaster Planning; Disasters; Environment; Environment and Public Health; Communicable Disease Control; Public Health Practice; Public Health; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Matthew Asare, PhD

  Baylor University

  PRINCIPAL INVESTIGATOR

• Dorcas Obiri-Yeboah, PhD

  University of Cape Coast

  PRINCIPAL INVESTIGATOR

• Nadia Sam-Agudu, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Asare, PhD

CONTACT

5136416482; Matt_asare@baylor.edu

Dorcas Obiri-Yeboah, PhD

CONTACT

233+244-527387; dobiri-yeboah@ucc.edu.gh

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: January 30, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

GH (1)