Self SamplingHOPENCT06739772
Development of Implementation Toolkits
A study testing HPV Self-Sampling and Behavior Intervention and Participants in the intervention group will receive HPV self sampling and behavioral intervention in people with Self Sampling and Communication Model, run by Baylor University at 1 site in Ghana.
Trial summary
The purpose of the study is to conduct an intervention program aimed at increasing HPV self-sampling among women living with HIV in Ghana. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Self Sampling, Communication Model, Implementation Science
- What is being tested?
- HPV Self-Sampling and Behavior Intervention and Participants in the intervention group will receive HPV self sampling and behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteGhana
- Study dates
- 10 Feb 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General eligibility criteria for these stakeholders include (1) the ability to give consent per Institutional Review Board stipulations, (2) residing in the central region of Ghana, (3) having no medical, psychological, or social characteristics that would interfere with the ability to fully participate, and (4) the willingness to participate in this study.
- Specific eligibility for Intervention participants (WLWH). Study inclusion/exclusion criteria for potential participants will be assessed using E-tracker data and include women (identified female at birth) who (1) are living with HIV between 25 and 65 years old5 and (2) have never had a cervical cancer screening like pap test or HPV test before, or have not had pap test or HPV testing for the past 5 years
Who cannot join
- Women will be excluded if they are pregnant or have had a hysterectomy. WLWH (female-identified at birth) who have a cervix are the main target population to develop the HOPE toolkit.
Trial locations and contacts
1 site in 1 country.
Ghana1 site
University of Cape Coast Teaching Hospital
Cape Coast, Central Region
About this study
Official title: Development of Implementation Toolkits to Promote HPV Self-sampling Behavior Among Women Living With HIV in Ghana
The purpose of the study is to conduct an intervention program aimed at increasing HPV self-sampling among women living with HIV in Ghana.
Read the detailed description
Women living with HIV, (WLWH), in low- and middle-income countries (LMICs) have a six-fold increased risk of developing cervical cancer (CC) compared to their uninfected counterparts. Our studies in Ghana show that self-sampling is acceptable, easy to use, and efficacious in detecting precancer lesions among WLWH. However, this screening mechanism has not been translated to healthcare practice in Ghana.
Systematic adaptation and implementation toolkits are needed to translate self-sampling into healthcare practices. We develop a Home-based self-collected sampling for the cervical cancer Prevention Education (HOPE) toolkits to promote cervical cancer screening in Ghana. HOPE toolkit core components such as (a) self-sample HPV testing kits and (b) the 3R (Reframe, Reprioritize, and Reform) communication model will not change as they are evidence-based. The content and the intervention delivery modalities of HOPE will go through the cultural adaptation iterative processes.
This R21 resubmission seeks to develop contextually appropriate adaptation and implementation toolkits in Ghana. A three-step approach will be used for the adaption process and evaluation of the toolkit. First, we will organize focus group discussions (FGDs) to identify contextual factors affecting the toolkit adaptation and nominal group techniques (NGTs) to determine the different compositions of the toolkits and select the final toolkit. A sample of 35 stakeholder advisory board members representing three organizational levels: potential intervention participants (i.e., WLWH), community leaders, and healthcare workers (e.g., doctors, nurses, administrators) will participate in the focus group FGDs and NGTs. Second, we will recruit 45 participants including WLWH and healthcare workers to evaluate the feasibility, acceptability, appropriateness, and adoptability of the selected toolkit. Third, we will test the preliminary efficacy of HOPE on cervical cancer screening defined as cervical cancer screening uptake among WLWH in the intervention arm (n=54) and control arm (n = 54). Participants will be recruited from the Cape Coast Teaching Hospital (CCTH). Specific aims of HOPE are:
Aim I: Develop and adapt the HOPE toolkit: Hypothesis: Stakeholders will identify and prioritize community needs and translate findings into a culturally adapted toolkit. Aim II: Evaluate the characteristics of the HOPE toolkit: Hypothesis: We hypothesize that 80% of participants will find HOPE toolkits feasible, acceptable, appropriate, and adoptable. Aim III: Assess the efficacy of HOPE on CCS. Hypothesis: We hypothesize that CCS behavior will increase significantly among women in the intervention group compared to those in the control group. Aim IV: Identify actionable factors and implementation costs that influence the adoption of the toolkit. Hypothesis: The Actionable factors and implementation costs will significantly influence the toolkit adoption.
- Conditions
- Self Sampling, Communication Model, Implementation Science, HIV
- Being tested
- HPV Self-Sampling and Behavior Intervention, Participants in the intervention group will receive HPV self sampling and behavioral intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV Self-Sampling and Behavior InterventionBehavioural
Participants in the intervention group will receive HPV self sampling and behavioral intervention
Participants in the intervention group will receive HPV self sampling and behavioral interventionBehavioural
Received enhance standard care
| Study group | Role | What they receive |
|---|---|---|
| HPV Self sampling | Experimental | Participants in the intervention group will receive HPV self sampling and behavioral intervention Receives: Behavioral: HPV Self-Sampling and Behavior Intervention; Behavioral: Participants in the intervention group will receive HPV self sampling and behavioral intervention |
| Control Group | No intervention | Participants in the control group will receive enhance standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical cancer screening uptake
The outcome is screening uptake (i.e., the completion and return of a self-sample kit and pap test completion). Measure: The screening completion outcome will be binary (yes/no), and it will be assessed via the patient clinical records by the doctors at 6 weeks post-intervention. The screening completion outcome will be binary (yes/no)
Measured: 6 weeks
Secondary outcomes (2)
Screening Test Results
Screening test results (positive, negative, or inadequate). Measure: The screening test results (positive, negative, or inadequate), will be treated as categorical outcome and it will be assessed via the patient clinical records by the doctors at 6 weeks post-intervention.
Measured: 6 weeks
Treatment follow-up
Whether patients with positive results follow up for treatment or not. Measures: The outcomes will be assessed via the patient clinical records by the doctors at 6 weeks post-intervention. The treatment follow-up (yes, no, or lost-to-follow-up) will be treated as categorical outcomes
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start10 Feb 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
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 Self SamplingStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matt Asare, Baylor University
- Investigators
- Matthew Asare, PhD, Principal investigator, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739772
- Sponsor's protocol ID
- 1R21TW012728-01A1
- Acronym
- HOPE
- Status last verified
- Apr 2026
- First submitted
- 11 Dec 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Asare M, Ebu Enyan NI, Sencherey VL, Lamptey-Mills E, Ken-Amoah S, Akakpo PK, Sturdivant RX, Obiri-Yeboah D. Culturally adapting and evaluating an evidence-based communication intervention with HPV self-sampling to improve cervical cancer screening among women living with HIV in Ghana: a mixed-methods study. BMJ Open. 2025 Dec 31;15(12):e105852. doi: 10.1136/bmjopen-2025-105852.
PubMed 41475829Asare M, Obiri-Yeboah D, Ken-Amoah S, Akakpo PK, Enyan NIE, Asmah E, Sturdivant RX. HPV self-sampling for cervical cancer screening among women living with HIV in Ghana: protocol for a hybrid type 1 effectiveness-implementation randomized controlled trial. Trials. 2025 Nov 26;26(1):550. doi: 10.1186/s13063-025-09262-2.
PubMed 41299750
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Implementation Toolkits to Promote HPV Self-sampling Behavior Among Women Living With HIV in Ghana
- ClinicalTrials.gov ID
- NCT06739772
- Acronym / sponsor ID
- HOPE / 1R21TW012728-01A1
- Conditions
- Self Sampling, Communication Model, Implementation Science, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 18 Dec 2024 (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 purpose of the study is to conduct an intervention program aimed at increasing HPV self-sampling among women living with HIV in Ghana.
Detailed description
Women living with HIV, (WLWH), in low- and middle-income countries (LMICs) have a six-fold increased risk of developing cervical cancer (CC) compared to their uninfected counterparts. Our studies in Ghana show that self-sampling is acceptable, easy to use, and efficacious in detecting precancer lesions among WLWH. However, this screening mechanism has not been translated to healthcare practice in Ghana.
Systematic adaptation and implementation toolkits are needed to translate self-sampling into healthcare practices. We develop a Home-based self-collected sampling for the cervical cancer Prevention Education (HOPE) toolkits to promote cervical cancer screening in Ghana. HOPE toolkit core components such as (a) self-sample HPV testing kits and (b) the 3R (Reframe, Reprioritize, and Reform) communication model will not change as they are evidence-based. The content and the intervention delivery modalities of HOPE will go through the cultural adaptation iterative processes.
This R21 resubmission seeks to develop contextually appropriate adaptation and implementation toolkits in Ghana. A three-step approach will be used for the adaption process and evaluation of the toolkit. First, we will organize focus group discussions (FGDs) to identify contextual factors affecting the toolkit adaptation and nominal group techniques (NGTs) to determine the different compositions of the toolkits and select the final toolkit. A sample of 35 stakeholder advisory board members representing three organizational levels: potential intervention participants (i.e., WLWH), community leaders, and healthcare workers (e.g., doctors, nurses, administrators) will participate in the focus group FGDs and NGTs. Second, we will recruit 45 participants including WLWH and healthcare workers to evaluate the feasibility, acceptability, appropriateness, and adoptability of the selected toolkit. Third, we will test the preliminary efficacy of HOPE on cervical cancer screening defined as cervical cancer screening uptake among WLWH in the intervention arm (n=54) and control arm (n = 54). Participants will be recruited from the Cape Coast Teaching Hospital (CCTH). Specific aims of HOPE are:
Aim I: Develop and adapt the HOPE toolkit: Hypothesis: Stakeholders will identify and prioritize community needs and translate findings into a culturally adapted toolkit. Aim II: Evaluate the characteristics of the HOPE toolkit: Hypothesis: We hypothesize that 80% of participants will find HOPE toolkits feasible, acceptable, appropriate, and adoptable. Aim III: Assess the efficacy of HOPE on CCS. Hypothesis: We hypothesize that CCS behavior will increase significantly among women in the intervention group compared to those in the control group. Aim IV: Identify actionable factors and implementation costs that influence the adoption of the toolkit. Hypothesis: The Actionable factors and implementation costs will significantly influence the toolkit adoption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPV Self sampling | Experimental | Behavioral: HPV Self-Sampling and Behavior Intervention, Behavioral: Participants in the intervention group will receive HPV self sampling and behavioral interventionParticipants in the intervention group will receive HPV self sampling and behavioral intervention |
| Control Group | No intervention | –Participants in the control group will receive enhance standard care |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- General eligibility criteria for these stakeholders include (1) the ability to give consent per Institutional Review Board stipulations, (2) residing in the central region of Ghana, (3) having no medical, psychological, or social characteristics that would interfere with the ability to fully participate, and (4) the willingness to participate in this study.
Key exclusion criteria (1 listed)
- Women will be excluded if they are pregnant or have had a hysterectomy. WLWH (female-identified at birth) who have a cervix are the main target population to develop the HOPE toolkit.
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 |
|---|---|---|
| HPV Self-Sampling and Behavior InterventionParticipants in the intervention group will receive HPV self sampling and behavioral intervention | Behavioural | HPV Self sampling |
| Participants in the intervention group will receive HPV self sampling and behavioral interventionReceived enhance standard care | Behavioural | HPV Self sampling |
Primary outcome
Cervical cancer screening uptake
Time frame: 6 weeks
The outcome is screening uptake (i.e., the completion and return of a self-sample kit and pap test completion). Measure: The screening completion outcome will be binary (yes/no), and it will be assessed via the patient clinical records by the doctors at 6 weeks post-intervention. The screening completion outcome will be binary (yes/no)
2 secondary outcomes
Screening Test Results
Time frame: 6 weeks
Treatment follow-up
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 41475829Asare M, Ebu Enyan NI, Sencherey VL, Lamptey-Mills E, Ken-Amoah S, Akakpo PK, Sturdivant RX, Obiri-Yeboah D. Culturally adapting and evaluating an evidence-based communication intervention with HPV self-sampling to improve cervical cancer screening among women living with HIV in Ghana: a mixed-methods study. BMJ Open. 2025 Dec 31;15(12):e105852. doi: 10.1136/bmjopen-2025-105852.
- Derived from this study: PubMed 41299750Asare M, Obiri-Yeboah D, Ken-Amoah S, Akakpo PK, Enyan NIE, Asmah E, Sturdivant RX. HPV self-sampling for cervical cancer screening among women living with HIV in Ghana: protocol for a hybrid type 1 effectiveness-implementation randomized controlled trial. Trials. 2025 Nov 26;26(1):550. doi: 10.1186/s13063-025-09262-2.
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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. This study is not recruiting at the moment.
Matthew Asare, PhD principal investigator
Baylor University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV Self-Sampling and Behavior Intervention and Participants in the intervention group will receive HPV self sampling and behavioral intervention in people with Self Sampling and Communication Model, 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 29 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical cancer screening uptake (time frame: 6 weeks). 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 NCT06739772, 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 29 Apr 2026.