Cervical Cancer ScreeningHOPE-inGNCT06800664
Home-based Self-sampling for Cervical Cancer Prevention Education Intervention in Ghana
A study testing 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 in people with Cervical Cancer Screening and HIV, run by Baylor University at 1 site in Ghana.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Cervical Cancer Screening, HIV, Self-sampling
- What is being tested?
- 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteGhana
- Study dates
- 11 Nov 2025to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Healthcare provider eligibility: Inclusion criteria include an individual (no gender restrictions) who
Show all 13Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ghana1 site, 1 recruiting
- Recruiting
University of Cape Coast
Cape Coast, Central Region
Dorcas Obiri-Yeboah, PhD, +233244-527387, dobiri-yeboah@ucc.edu.gh
About this study
Official title: The Impact of an Evidence-Based, Behavioral Cervical Cancer Screening Intervention Among Women Living With HIV in Ghana (HOPE-inG): A Type 2 Hybrid Effectiveness Implementation 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.
Read the detailed description
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.
- Conditions
- Cervical Cancer Screening, HIV, Self-sampling, Implementation Science, Intervention (Training) Condition, Implementation Strategies
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 planBehavioural
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 GroupBehavioural
Providers in the control group will not receive ISS support
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 42 month post-randomization
Secondary outcomes (8)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 6 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start11 Nov 2025
- Primary completionNov 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Matt Asare, Baylor University
- Investigators
- Matthew Asare, PhD, Principal investigator, Baylor UniversityDorcas Obiri-Yeboah, PhD, Principal investigator, University of Cape CoastNadia Sam-Agudu, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800664
- Sponsor's protocol ID
- 1U01CA294757-01
- Other IDs
- 1U01CA294757-01
- Acronym
- HOPE-inG
- Status last verified
- Jun 2026
- First submitted
- 12 Dec 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sam-Agudu NA, Coker KAR, Frueh E, Cudjoe O, Ken-Amoah S, Enyan NIE, Nuer-Allornuvor GF, Abrefah E, Dankyi AB, Akakpo PK, Obiri-Yeboah D, Asare M. Determinants and Strategies for Implementation of the HOPE Self-Sampling Cervical Screening Intervention for Women Living with HIV in Ghana: A Context Assessment and Implementation Mapping Study. Res Sq [Preprint]. 2026 Sep 8:rs.3.rs-10695564. doi: 10.21203/rs.3.rs-10695564/v1.
PubMed 42818955Asare M, Sam-Agudu NA, Cudjoe O, Frueh E, Coker KAR, Dankyi AB, Ken-Amoah S, Akakpo PK, Enyan NIE, Sturdivant RX, Asmah EE, Nuer-Allornuvor GF, Obiri-Yeboah D. HOme-based self-sampling for cervical cancer prevention education among women living with HIV in Ghana (HOPE-inG): study protocol for a cluster-randomized type 2 hybrid effectiveness implementation trial. BMC Public Health. 2026 Mar 27;26(1):1110. doi: 10.1186/s12889-026-26505-2.
PubMed 41888748
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an Evidence-Based, Behavioral Cervical Cancer Screening Intervention Among Women Living With HIV in Ghana (HOPE-inG): A Type 2 Hybrid Effectiveness Implementation Trial
- ClinicalTrials.gov ID
- NCT06800664
- Acronym / sponsor ID
- HOPE-inG / 1U01CA294757-01
- Conditions
- Cervical Cancer Screening, HIV, Self-sampling, Implementation Science, Intervention (Training) Condition, Implementation Strategies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | 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 GroupHealth 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 | No intervention | –Providers and management in the control group will not receive any ISS or implementation plan training |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 planHealth 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 | Behavioural | Intervention Group |
| Control GroupProviders in the control group will not receive ISS support | Behavioural | Intervention Group |
Primary outcome
Implementation Outcome 1A: HOPE 2.0 Program Adoption
Time frame: 24 months post-randomization
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
Time frame: 24 months post-randomization
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
Time frame: 24 months post-randomization
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
Time frame: 24 months post-randomization
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.
Implementation Outcome 2A: HOPE 2.0 Implementation cost
Time frame: 24 months post-randomization
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.
Implementation Outcome 2B: HOPE 2.0 Implementation cost
Time frame: 24 months post-randomization
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
Implementation Outcome 3A: Fidelity of Implementing HOPE 2.0
Time frame: During 24 months post-randomization
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.
Implementation Outcome 3B: Fidelity of Implementing HOPE 2.0
Time frame: During 24 months post-randomization
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.
Implementation Outcome 3C: Fidelity of Implementing HOPE 2.0
Time frame: During 24 months post-randomization
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.
Implementation Outcome 3D: Fidelity of Implementing HOPE 2.0
Time frame: During 24 months post-randomization
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.
Implementation Outcome 4A: HOPE 2.0 Program Penetration in the clinics
Time frame: 6 months post-randomization
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.
Implementation Outcome 4B: HOPE 2.0 Program Penetration in the clinics
Time frame: 6 months post-randomization
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.
Implementation Outcome 5A: HOPE 2.0 Sustainment in the facilities
Time frame: 42 month post-randomization
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.
Implementation Outcome 5B: HOPE 2.0 Sustainment in the facilities
Time frame: 42 month post-randomization
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.
8 secondary outcomes
Service Outcome 1A: Program Effectiveness in increase provider self-efficacy
Time frame: 6 months post-randomization
Service Outcome 1B: Program Effectiveness in increase provider self-efficacy
Time frame: 6 months post-randomization
Service Outcome 1C: Program Effectiveness in increase provider self-efficacy
Time frame: 6 months post-randomization
Service Outcome 2A: Patients' cervical screening uptake
Time frame: 6 months post-randomization
Service Outcome 2B: Patients' cervical screening uptake
Time frame: 6 months post-randomization
Client Outcome 3A: Patient follow-up treatment.
Time frame: 12 months post randomization.
Client Outcome 3B: Patient follow-up treatment.
Time frame: 12 months post randomization.
Client Outcome: Patient Satisfaction
Time frame: 6 months post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Derived from this study: PubMed 42818955Sam-Agudu NA, Coker KAR, Frueh E, Cudjoe O, Ken-Amoah S, Enyan NIE, Nuer-Allornuvor GF, Abrefah E, Dankyi AB, Akakpo PK, Obiri-Yeboah D, Asare M. Determinants and Strategies for Implementation of the HOPE Self-Sampling Cervical Screening Intervention for Women Living with HIV in Ghana: A Context Assessment and Implementation Mapping Study. Res Sq [Preprint]. 2026 Sep 8:rs.3.rs-10695564. doi: 10.21203/rs.3.rs-10695564/v1.
- Derived from this study: PubMed 41888748Asare M, Sam-Agudu NA, Cudjoe O, Frueh E, Coker KAR, Dankyi AB, Ken-Amoah S, Akakpo PK, Enyan NIE, Sturdivant RX, Asmah EE, Nuer-Allornuvor GF, Obiri-Yeboah D. HOme-based self-sampling for cervical cancer prevention education among women living with HIV in Ghana (HOPE-inG): study protocol for a cluster-randomized type 2 hybrid effectiveness implementation trial. BMC Public Health. 2026 Mar 27;26(1):1110. doi: 10.1186/s12889-026-26505-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Asare, PhD principal investigator
Baylor University
Dorcas Obiri-Yeboah, PhD principal investigator
University of Cape Coast
Nadia Sam-Agudu, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Cervical Cancer Screening and HIV, run by Baylor University at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Asare, PhD (5136416482, Matt_asare@baylor.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation Outcome 1A: HOPE 2.0 Program Adoption (time frame: 24 months post-randomization). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06800664, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.