Home-based cervical cancer self-sampling with education for women living with HIV in Ghana
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
Run by Baylor University · NCT06800664 · Data updated 2026-11-12
This study tests a home-based HPV self-sampling approach plus a 3R communication plan to help women with HIV in Ghana screen for cervical cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 25 Years to 65 Years |
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | Baylor University Academic / other |
| Locations | 1 site (Cape Coast, Central Region) |
| Status | Recruiting |
| Started | November 11, 2025 |
| Main results expected | November 2028 |
| Study ends | May 2029 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT06800664 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women living with HIV aged 25–65 in Ghana who have never been screened or have not been screened in the past 5 years and who reside in the Central Region.
✕Probably not a fit
Women who are pregnant, have had a hysterectomy, or do not have a cervix may not benefit from cervical cancer self-sampling.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This implementation study aims to adapt and deploy the HOPE intervention, which combines HPV self-sampling with a 3R communication model, into routine care for women living with HIV in Ghana. The trial uses a hybrid type 2 design to evaluate both effectiveness and implementation outcomes, leveraging existing secondary-level health facilities. Health providers and facility management will receive implementation support strategies and training to promote uptake, adoption, and sustainment of cervical cancer screening. The study builds on prior randomized evidence showing large increases in screening with HOPE and seeks to scale the approach within the Ghana health system. The eligibility criteria include WLWH aged 25-65 who have not recently been screened, and healthcare providers involved in HIV care at participating sites.
Why it matters
Potential benefit: If successful, the HOPE approach could substantially increase cervical cancer screening rates among WLWH and aid health systems in sustaining self-sampling-based screening.
How similar studies have gone: Prior randomized data in Ghana showed HOPE dramatically increased screening (100% vs 14.64%), supporting potential for successful implementation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. (a) Healthcare provider eligibility: Inclusion criteria include an individual (no gender restrictions) who * 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 Exclusion Criteria: * 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.
Where it's running
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University of Cape Coast
Cape Coast, Central Region, Ghana Recruiting
Study contacts
- Principal investigator: Matthew Asare, PhD — Baylor University
- Study coordinator: Matthew Asare, PhD
- Email: Matt_asare@baylor.edu
- Phone: 5136416482
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.