Testing the Feasibility of Different HPV Screening and Care Strategies for Women Living With HIV

Sponsor
University of California, San Diego
Study ID
NCT07576842
Status
Not Yet Recruiting

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Conditions

  • Cervical Cancer
  • Cervical Intraepithelial Neoplasia (CIN)
  • HPV Associated Cancers
  • Human Immunodeficiency Virus (HIV)
  • Human Papillomavirus (HPV)

Eligibility Criteria

Sex
FEMALE
Age
25 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HPV DNA Testing (Abbott Alinity m HPV Assay) — DIAGNOSTIC_TEST
    Women will self-collect a vaginal specimen for primary HPV testing to be evaluated on the Abbott Alinity m platform. The Alinity m HR HPV assay is a qualitative, real-time polymerase chain reaction (PCR) assay for the detection of high-risk HPV DNA. The assay detects 14 hrHPV genotypes by targeting the conserved L1 region of HPV DNA and provides individual or group-level genotyping results, including separate readouts for HPV 16, HPV 18, and HPV 45, and grouped detection of other high-risk types. The assay also provides a proxy for HPV viral load as measured by the cycle threshold (CT) value for the type- or group-specific readout.
  • Visual Inspection with Acetic Acid — PROCEDURE
    Participants with hrHPV detected will undergo visual inspection with acetic acid (VIA) during a speculum examination. Standard acetic acid (3-5%) is applied to the cervix, and the provider will assess for the presence of cervical lesions, determine suitability for ablative treatment, and characterize the transformation zone (TZ1, TZ2, or TZ3). VIA findings will be used to guide participant management and treatment decisions.
  • Cervical Histology (Biopsy Procedures) — PROCEDURE
    Cervical histology specimens will be obtained from participants with hrHPV detected. Biopsies may include lesion-directed cervical punch biopsies, endo- and ectocervical soft-brush biopsies, or endocervical curettage (ECC). At least two biopsies will be obtained even if no lesions are seen. For participants undergoing LEEP/LLETZ, histology will be obtained through the excisional procedure. Cervical histology will be processed locally and interpreted according to the lower anogenital squamous terminology (LAST), including p16 testing where available to confirm morphologic-appearing CIN 2.
  • Cervical Treatment (Thermal Ablation or LEEP/LLETZ) — PROCEDURE
    Women with HPV 16 and/or 18 will undergo immediate treatment. Women with non-16/18 hrHPV will undergo immediate treatment if cervical lesions are seen on VIA. Women who are not treated but are subsequently found to have cervical high-grade squamous intraepithelial lesions (hHSIL) on histology will return for cervical treatment. Treatment modality will be determined based on the extent of cervical lesions, with thermal ablation (TA) used for lesions appropriate for ablative therapy and LEEP/LLETZ used for more extensive lesions.

Study Details

The overall goal of this study is to inform the design and establish feasibility for a future clinical trial to determine the optimal management of women living with HIV (WLWH) with high-risk human papillomavirus (hrHPV) detected on HPV-based cervical cancer screening. WLWH have a higher diversity of anogenital HPV types causing cervical high-grade squamous intraepithelial lesions (hHSIL) and invasive cancer compared to women without HIV. While there is consensus that women testing positive for HPV 16 and/or 18 should be immediately managed and treated, optimal management strategies for women with other hrHPV types (non-16/18) are not well defined. This prospective cohort study will enroll WLWH undergoing cervical cancer screening using primary HPV testing. Women will self-collect vaginal specimens for hrHPV testing using the Abbott Alinity m HPV assay, which provides extended HPV genotyping and a proxy for HPV viral load based on cycle threshold (CT) values. Women with hrHPV detected will return for further evaluation and treatment as indicated. A subset of women will return at Month 6 for repeat evaluation. The study will evaluate feasibility for a future trial by examining recruitment, retention, return for evaluation, and completion of treatment. It will also explore management strategies for women with non-16/18 hrHPV based on extended genotyping and HPV viral load compared to standard of care approaches using visual inspection with acetic acid (VIA).

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
750 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Primary HPV screen with management based on HPV types and VIA status
    All women will self-collect a vaginal specimen for primary HPV testing to be evaluated on the Abbott Alinity m platform. WLWH who test hrHPV negative will exit the study. Women with hrHPV will return for speculum examination, cervical swab collection, VIA, and histology. Women with HPV 16/18 will undergo immediate treatment. Women with non-16/18 hrHPV will undergo immediate treatment only if cervical lesions are seen on VIA. Women who are not treated, but subsequently found to have cervical HSIL on histology, will return for cervical treatment. The choice of treatment modality (TA vs. LEEP/LLETZ) will be determined by the extent of cervical lesions seen on VIA. Women with extensive lesions will undergo LEEP/LLETZ treatment. All women who are enrolled (and therefore hrHPV positive) in the early months of the study will be asked to return for a visit 4-6 months later for repeat HPV testing and cervical histology.

Primary Outcome Measure

Feasibility for a Future Clinical Trial [ Time Frame: From enrollment through Month 6 visit ]

Central Contacts

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