Clinical trial Recruiting at 1 site Interventional Ages 25 to 65

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.

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Quick facts

Study typeInterventional
Ages25 Years to 65 Years
SexAll
Enrollment1500 (estimated)
SponsorBaylor University
Academic / other
Locations1 site (Cape Coast, Central Region)
StatusRecruiting
StartedNovember 11, 2025
Main results expectedNovember 2028
Study endsMay 2029
Registry record updatedJuly 1, 2026
Trial IDNCT06800664 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

  • University of Cape Coast
    Cape Coast, Central Region, Ghana
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.