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

NCT07576842 | Not Yet Recruiting

• 5 other identifiers: 813535UG1CA275414UG1CA275416U24CA275417C2001P-CS3
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Feasibility for a Future Clinical Trial

  To describe the feasibility for a future clinical trial testing various management strategies for women with non-16/18 hrHPV by examining the proportion of potentially eligible women agreeing to study participation, the timeliness and proportion of women receiving the HPV results, the proportion returning for baseline evaluation, and the proportion retained for the Month 6 visit.

  From enrollment through Month 6 visit

• Proportion Receiving Treatment Under Different Management Strategies

  To estimate the proportion of women living with HIV (WLWH) with hrHPV infection and cervical high-grade squamous intraepithelial lesions (hHSIL) who receive treatment under three different management strategies: visual inspection with acetic acid (VIA) triage, genotype restriction alone, and genotype restriction plus HPV viral load.

  Baseline through Month 6 visit

Secondary Outcomes (3)

• hrHPV Prevalence and Genotype Distribution

  Screening

• Alternative CT Value Cutoffs for Management

  Baseline through Month 6 visit

• Rate of Invasive Cancer or CIN 3 Managed With No Treatment

  Baseline through Month 6 visit

Study Arms (1)

Primary HPV screen with management based on HPV types and VIA status

EXPERIMENTAL

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)

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.

Primary HPV screen with management based on HPV types and VIA status

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.

Also known as: VIA

Primary HPV screen with management based on HPV types and VIA status

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.

Primary HPV screen with management based on HPV types and VIA status

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.

Also known as: Thermal Ablation, LEEP/LLETZ, LEEP, LLETZ

Primary HPV screen with management based on HPV types and VIA status

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 infection, as documented by:
• any FDA-approved, licensed HIV rapid test performed in conjunction with screening (oral immunoblot, ELISA test kit, and confirmed by Western blot or other approved test), OR
• a physician's written record that documents HIV infection with supporting information on the participant's relevant medical history and/or current management of HIV infection, OR
• documentation of a prescription of an approved antiretroviral regimen by either possession of pill bottles or packages with prescriber's name or ARVs dispensed from an HIV clinical treatment program with participant identifiers affixed to the bottles or packages.
• Aged 25 or older.
• Ability to understand and the willingness to sign a written informed consent document by the participant or by the legal representative(s) of the participant.
• Have an intact cervix.

You may not qualify if:

• Current symptoms or concern for cervical cancer.
• History of cervical, vulvar, vaginal, perianal, anal cancer or oral cancer or current symptoms of cervical, vulvar, vaginal, perianal, anal cancer or oral cancer.
• Have undergone cervical hHSIL treatment in the past year.
• Have a history of hysterectomy with removal of the cervix.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including opportunistic infections of AIDS and/or genitourinary infections), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Any other medical condition or social situation that would put the participant, the study staff, or the study outcomes at risk, as determined by the site investigators.

Sponsors & Collaborators

• University of California, San Diego: lead
• Frontier Science & Technology Research Foundation, Inc.: collaborator
• Botswana Harvard Health Partnership: collaborator
• Brigham and Women's Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: collaborator
• University of North Carolina, Chapel Hill: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Botswana Harvard Health Partnership

Gaborone, South-East District, Botswana

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Acquired Immunodeficiency Syndrome; Uterine Cervical Dysplasia

Interventions

Watchful Waiting; Acetic Acid; Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Precancerous Conditions

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Timothy J Wilkin, MD, MPH

  University of California, San Diego

  STUDY CHAIR

Central Study Contacts

Caique Mello, MPH

CONTACT

858-253-6394; camello@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

BO (1)