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NCT07576842

C2001P-CS3: Testing the Feasibility of Different HPV Screening and Care Strategies for Women Living With HIV

StatusNot Yet Recruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later, primary endpoint(s) modified.

See at-risk trials from University of California, San Diego

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jun 1, 2027 to May 31, 2028 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Start date: Jun 1, 2026 to Nov 30, 2026
    • Interventions: Cervical Histology (Biopsy Procedures) (Procedure), Cervical Treatment (Thermal Ablation or LEEP/LLETZ) (Procedure), HPV DNA Testing… to Cervical Histology (Biopsy Procedures) (Procedure), Cervical Treatment (Thermal Ablation or LEEP/LLETZ) (Procedure), HPV DNA Testing…
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 3 to 5
    • Collaborators: details revised at 2 of 7 entries
    • Study title expanded, about 1 word
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Proportion of Potentially Eligible Participants Providing Informed Consent
Timeframe: Screening.
Time to Clinic Receipt of HPV Test Results
Timeframe: From sample collection at enrollment to clinic receipt of HPV test results.
Percentage of Participants Receiving HPV Test Results
Timeframe: Within 6 months of screening.
Proportion of Participants Returning for Baseline Evaluation
Timeframe: From enrollment through baseline.
Proportion of Participants Retained for the Month 6 Visit
Timeframe: From baseline through Month 6.
Proportion of Participants With Cervical HSIL Classified for Treatment
Timeframe: From baseline through Month 6.

Secondary (5)

hrHPV Prevalence and Genotype Distribution
Alternative Abbott Alinity m CT Cutoffs for Detection of Cervical HSIL
Sensitivity of Alternative Abbott Alinity m CT Cutoffs for Cervical HSIL
Specificity of Alternative Abbott Alinity m CT Cutoffs for Cervical HSIL
Proportion of Participants With Invasive Cervical Cancer or CIN 3 Classified for No Treatment Under Each Management Strategy

Arms and interventions

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

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 tests: HPV DNA Testing (Abbott Alinity m HPV Assay)

Procedures: Visual Inspection with Acetic Acid, Cervical Histology (Biopsy Procedures), Cervical Treatment (Thermal Ablation or LEEP/LLETZ)

Sites

1 site in 1 country

  • Botswana Harvard Health PartnershipGaborone, South-East District, Botswana