About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
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
BehavioralHealth 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
BehavioralProviders in the control group will not receive ISS support
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
Service Outcome 1A: Program Effectiveness in increase provider self-efficacy
The first service outcome of interest is Program Effectiveness, defined as the impact of the ISS on healthcare workers' self-efficacy in implementing HOPE 2.0 within their facilities. Program effectiveness outcomes will be measured at provider and management levels using activity log sheets
Service Outcome 1B: Program Effectiveness in increase provider self-efficacy
The first service outcome of interest is Program Effectiveness, defined as the impact of the ISS on healthcare workers' self-efficacy in implementing HOPE 2.0 within their facilities. Program effectiveness outcomes will be measured at provider and management levels using interviews at 1 and 6 months post-randomization.
Service Outcome 1C: Program Effectiveness in increase provider self-efficacy
The first service outcome of interest is Program Effectiveness, defined as the impact of the ISS on healthcare workers' self-efficacy in implementing HOPE 2.0 within their facilities. Program effectiveness outcomes will be measured at provider level using a survey to measure the program effectiveness at the providers' level at 1 and 6 months post-randomization.
Service Outcome 2A: Patients' cervical screening uptake
The service outcome of interest is screening uptake, defined as the completion and return of a self-sample kit and pap test completion. Screening uptake will be measured at the patients' level using surveys at the 1 month and 6 months post-randomization.
Sponsors and contacts
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Baylor University
Lead sponsor
National Cancer Institute (NCI)
Collaborator