C2001P-CS6: Testing the Feasibility of Different HPV Screening and Care Strategies for Women Living With HIV
NCT07925307, Not applicable, Recruiting, University of California, San Diego
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | C2001P-CS6: Testing the Feasibility of Different HPV Screening and Care Strategies for Women Living With HIV | ClinicalTrials.gov |
| NCT number | NCT07925307 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 750 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of California, San Diego | ClinicalTrials.gov |
| Conditions | Human Papillomavirus (HPV), HPV Associated Cancers, Cervical Cancer, Human Immunodeficiency Virus (HIV), Cervical Intraepithelial Neoplasia (CIN) | ClinicalTrials.gov |
| Interventions | HPV DNA Testing (Abbott Alinity m HPV Assay), Visual Inspection with Acetic Acid, Cervical Histology (Biopsy Procedures), Cervical Treatment (Thermal Ablation or LEEP/LLETZ) | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of Potentially Eligible Participants Providing Informed Consent | Screening. | Number of participants providing informed consent divided by the number approached for consent. | ClinicalTrials.gov |
| Primary | Time to Clinic Receipt of HPV Test Results | From sample collection at enrollment to clinic receipt of HPV test results. | Number of days from vaginal sample collection to clinic receipt of HPV test results. | ClinicalTrials.gov |
| Primary | Percentage of Participants Receiving HPV Test Results | Within 6 months of screening. | Percentage of participants who provided a vaginal sample and received their HPV test results. | ClinicalTrials.gov |
| Primary | Proportion of Participants Returning for Baseline Evaluation | From enrollment through baseline. | Number of participants returning for the baseline evaluation divided by the total number who provided a vaginal self-sample at enrollment. | ClinicalTrials.gov |
| Primary | Proportion of Participants Retained for the Month 6 Visit | From baseline through Month 6. | 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. | ClinicalTrials.gov |
| Primary | Proportion of Participants With Cervical HSIL Classified for Treatment | From baseline through Month 6. | 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. | ClinicalTrials.gov |
| Secondary | hrHPV Prevalence and Genotype Distribution | Screening. | 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. | ClinicalTrials.gov |
| Secondary | Alternative Abbott Alinity m CT Cutoffs for Detection of Cervical HSIL | Enrollment HPV testing and baseline cervical histology. | 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. | ClinicalTrials.gov |
| Secondary | Sensitivity of Alternative Abbott Alinity m CT Cutoffs for Cervical HSIL | Enrollment HPV testing and baseline cervical histology. | 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. | ClinicalTrials.gov |
| Secondary | Specificity of Alternative Abbott Alinity m CT Cutoffs for Cervical HSIL | Enrollment HPV testing and baseline cervical histology. | 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants With Invasive Cervical Cancer or CIN 3 Classified for No Treatment Under Each Management Strategy | From baseline through Month 6. | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)