An interventional study of HPV DNA Testing (Abbott Alinity m HPV Assay) and Visual Inspection with Acetic Acid in Human Papillomavirus (HPV), HPV Associated Cancers and Cervical Cancer, sponsored by University of California, San Diego. Recruiting at 1 site in Kenya. Open to female participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
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).
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 750 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
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-1 infection, as documented by:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: HPV DNA Testing (Abbott Alinity m HPV Assay) · Procedure: Visual Inspection with Acetic Acid · Procedure: Cervical Histology (Biopsy Procedures) · Procedure: Cervical Treatment (Thermal Ablation or LEEP/LLETZ)
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.
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.
Also known as: VIA
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.
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.
Also known as: Thermal Ablation, LEEP/LLETZ, LEEP, LLETZ
Proportion of Potentially Eligible Participants Providing Informed Consent
Number of participants providing informed consent divided by the number approached for consent.
Time frame: Screening.
Time to Clinic Receipt of HPV Test Results
Number of days from vaginal sample collection to clinic receipt of HPV test results.
Time frame: From sample collection at enrollment to clinic receipt of HPV test results.
Percentage of Participants Receiving HPV Test Results
Percentage of participants who provided a vaginal sample and received their HPV test results.
Time frame: Within 6 months of screening.
Proportion of Participants Returning for Baseline Evaluation
Number of participants returning for the baseline evaluation divided by the total number who provided a vaginal self-sample at enrollment.
Time frame: From enrollment through baseline.
Proportion of Participants Retained for the Month 6 Visit
Number of participants returning for the Month 6 visit divided by the number who completed the baseline visit more than 6 months before the end of the study.
Time frame: From baseline through Month 6.
Proportion of Participants With Cervical HSIL Classified for Treatment
Proportion of participants with hrHPV and histologically-confirmed cervical high-grade squamous intraepithelial lesions (HSIL) classified for treatment under each strategy: visual inspection with acetic acid (VIA), genotype restriction, and genotype restriction plus HPV viral load. The denominator includes estimated HSIL cases among participants who did not return for baseline evaluation. Results are reported separately for each strategy.
Time frame: From baseline through Month 6.
hrHPV Prevalence and Genotype Distribution
Proportion of participants with valid HPV results who test positive for any hrHPV, each Abbott Alinity m genotype channel, multiple channels, or hrHPV without HPV 16/18. Results are reported overall and by clinical enrollment unit.
Time frame: Screening.
Alternative Abbott Alinity m CT Cutoffs for Detection of Cervical HSIL
Alternative Abbott Alinity m cycle threshold (CT) cutoffs, in PCR cycles, associated with cervical HSIL. Cutoffs are derived using receiver operating characteristic (ROC) analysis and reported by non-16/18 hrHPV channel. Central histology review is used when available.
Time frame: Enrollment HPV testing and baseline cervical histology.
Sensitivity of Alternative Abbott Alinity m CT Cutoffs for Cervical HSIL
Proportion of participants with cervical HSIL classified as positive using alternative CT cutoffs, reported by non-16/18 hrHPV channel among participants positive for that channel with interpretable histology.
Time frame: Enrollment HPV testing and baseline cervical histology.
Specificity of Alternative Abbott Alinity m CT Cutoffs for Cervical HSIL
Proportion of participants without cervical HSIL classified as negative using alternative CT cutoffs, reported by non-16/18 hrHPV channel among participants positive for that channel with interpretable histology.
Time frame: Enrollment HPV testing and baseline cervical histology.
Proportion of Participants With Invasive Cervical Cancer or CIN 3 Classified for No Treatment Under Each Management Strategy
Number of participants with CIN 3 or invasive cervical cancer classified for no treatment under each strategy divided by the total number with hrHPV. Strategies include VIA, genotype restriction, and genotype restriction plus HPV viral load. Estimates account for participants who did not return for baseline evaluation.
Time frame: From baseline through Month 6.
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