An interventional study of 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 and Control Group in Cervical Cancer Screening, HIV and Self-sampling, sponsored by Baylor University. Recruiting at 1 site in Ghana. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Baylor University · Not applicable, Interventional, and Prevention
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.
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.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Baylor University is the lead sponsor of 42 studies on the registry; 9 are open to participants now.
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General criteria
the willingness to participate in this study.
(a) Healthcare provider eligibility: Inclusion criteria include an individual (no gender restrictions) who
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Providers and management in the control group will not receive any ISS or implementation plan training
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
Providers in the control group will not receive ISS support
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
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
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
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
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 42 month post-randomization
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
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
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
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
Service Outcome 2B: 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 by verifying the electronic medical records at one month and 6 months post-randomization.
Time frame: 6 months post-randomization
Client Outcome 3A: Patient follow-up treatment.
The client outcome is patient treatment follow-up, defined as whether patients with positive results follow up for treatment or not. The outcomes will be measured at the patients' level using surveys at 6 and 12 months post-receiving the test results.
Time frame: 12 months post randomization.
Client Outcome 3B: Patient follow-up treatment.
The client outcome is patient treatment follow-up, defined as whether patients with positive results follow up for treatment or not. The outcomes will be measured at the patients' level by verifying the patient clinical records at 6 and 12 months post-receiving the test results
Time frame: 12 months post randomization.
Client Outcome: Patient Satisfaction
The client outcome of interest is patient satisfaction, defined as the degree to which patients feel their expectations, needs, and preferences are met by participating in the program. Satisfaction outcomes will be measured at the patients' level by using a satisfaction survey at one post-completing intervention and 6 months after receiving treatment for positive results.
Time frame: 6 months post-randomization
Started Nov 2025 (actual). Primary completion is estimated for Nov 2028, 36 months after the start.
Of 445 non-industry interventional studies with no phase under Uterine Cervical Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 71. This study's planned 36 months is above that.
Counting every sponsor, half of 461 studies reached it within 33 months; a quarter within 15 and three quarters within 71.
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