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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-65
SponsorBaylor University

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 volunteers

Qualifiers

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

Design model

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

    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

  • Control Group

    Behavioral

    Providers in the control group will not receive ISS support

Treatment groups

1,500 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 2 interventions
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
24 months post-randomization
2

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.

Time frame
24 months post-randomization
3

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.

Time frame
24 months post-randomization
4

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.

Time frame
24 months post-randomization

Secondary outcomes

1

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

Time frame
6 months post-randomization
2

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.

Time frame
6 months post-randomization
3

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.

Time frame
6 months post-randomization
4

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.

Time frame
6 months post-randomization

Other outcomes

Sponsors and contacts

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Baylor University

Lead sponsor

National Cancer Institute (NCI)

Collaborator