Integrating HPV Vaccination Into HIV Care Services for Adolescent Girls Living With HIV in Zambia

November 6, 2026 updated by: Washington University School of Medicine

Integrating HPV Vaccination Into HIV Care Services for Adolescent Girls Living With HIV in Zambia: A Mixed-Methods Feasibility and Implementation Evaluation Study

HPV vaccination can prevent up to 90% of cervical cancer cases, but adolescents living with HIV (ALHIV) require additional doses for sufficient protection beyond the single dose recommended for adolescent girls in Zambia. There are challenges to ensuring ALHIV receive all necessary doses without increasing burden and stigma on the girls. Integrating HPV vaccination into ART clinics can be an effective approach to doing so but requires a multi-pronged strategy for successful implementation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Zambia
    • Copperbelt
      • Ndola, Copperbelt, Zambia
        • Tropical Diseases Research Centre Ndola
        • Contact:
          • Sam Miti, MD
          • Phone Number: +260 96 6293508
        • Principal Investigator:
          • Sam Miti, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthcare workers providing HIV, adolescent or vaccination services at one of the 3 study sites (including registration, data collection, clinical care, pharmacy, administration)
  • Facility leadership, district, provincial, national health managers and program coordinators

Exclusion Criteria:

- No involvement in HIV, adolescent or vaccination services

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tertiary Care Cohort

Participants in this arm will complete the multi-component training that aims at improving healthcare worker competencies around HPV and HPV vaccines. Participants will complete pre- and post- training questionnaires, as well as quantitative surveys administered at baseline, 6 months, and 12 months that measure implementation outcomes.
Behavioral: HPV-HIV integration training and Audit & Feedback support

The HPV-HIV integration training covers six core modules. The six core modules include HPV epidemiology and vaccine indications, identification of eligible adolescents, adolescent-centered communication, workflow integration procedures, documentation and reporting systems, and strategies to reduce missed opportunities. The training will occur over a period of 3 days. Participants will receive facilitator manuals, screening tools, referral algorithms, and job aids. Audit & Feedback of vaccination data will support integration and documentation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tertiary Care Cohort: Changes in HPV knowledge
Time Frame: At time of pre-training assessment (day 1) and at time of post-training assessment (day 3) (total estimated time: 3 days)

Changes in HPV knowledge will be assessed by changes in the HPV knowledge portion of the pre/post training questionnaire. This portion of the questionnaire is composed of 10 questions that are answered True/False/Don't Know. Correct answers are scored as 1 point. The total score is calculated by the number of questions answered correctly with a total score range of 0-10. A higher score represents higher knowledge.
At time of pre-training assessment (day 1) and at time of post-training assessment (day 3) (total estimated time: 3 days)
Tertiary Care Cohort: Changes in HPV vaccine knowledge
Time Frame: At time of pre-training assessment (day 1) and at time of post-training assessment (day 3) (total estimated time: 3 days)

Changes in HPV vaccine knowledge will be assessed by changes in the HPV vaccine knowledge portion of the pre/post training questionnaire. This portion of the questionnaire is composed of 6 questions with one question being open ended, three questions answered as True/False/Don't Know, and two questions answered as Strongly disagree, Disagree, Agree, Strongly agree, or Don't Know. Correct answers are scored as 1 point. The total score is calculated by the number of questions answered correctly with a total score range of 0-6. A higher score represents higher knowledge.
At time of pre-training assessment (day 1) and at time of post-training assessment (day 3) (total estimated time: 3 days)
Tertiary Care Cohort: Changes in Self-Efficacy and Provider Confidence score
Time Frame: At time of pre-training assessment (day 1) and at time of post-training assessment (day 3) (total estimated time: 3 days)

Changes in Self-Efficacy and Provider Confidence score will be assessed by changes in the Self-Efficacy and Provider Confidence portion of the Post Training Survey. This portion of the questionnaire is composed of 4 questions answered as either Strongly disagree, Disagree, Neither agree nor disagree, Agree, or Strongly agree. Correct answers are scored as 1 point. The total score is calculated by the number of questions answered correctly with a total score range of 0-4. A higher score represents greater self-efficacy/confidence.
At time of pre-training assessment (day 1) and at time of post-training assessment (day 3) (total estimated time: 3 days)
Tertiary Care Cohort: Proportion of eligible/invited staff that attended training
Time Frame: At start of training through completion of training (total estimated time: 3 days)
At start of training through completion of training (total estimated time: 3 days)
Tertiary Care Cohort: Feasibility as assessed by training attendance
Time Frame: At start of training through completion of training (total estimated time: 3 days)
At start of training through completion of training (total estimated time: 3 days)
Tertiary Care Cohort: Feasibility of Intervention Measure (FIM) score
Time Frame: At time of post-session survey completion on day 3 (total estimated time: 1 day)

FIM will be assessed by implementation champions' response to the 4 items in from the FIM measure on the follow up survey. FIM is measured by a 5-point Likert scale: 1-Completely disagree, 2-Disagree, 3-Neither agree nor Disagree, 4-Agree, or 5-Completely agree. A higher score indicates greater feasibility of the intervention in practice. Scores above 3.0 are typically viewed as favorable/positive.
At time of post-session survey completion on day 3 (total estimated time: 1 day)
Tertiary Care Cohort: Adoption measured as rate of HPV vaccination
Time Frame: Through 12 months post training (total estimated time: 12 months 3 days)

Rate of HPV vaccination will be assessed through vaccination records.
Through 12 months post training (total estimated time: 12 months 3 days)
Tertiary Care Cohort: Acceptability measured as Acceptability of Intervention Measure (AIM) score
Time Frame: At time of post-session survey completion on day 3 (total estimated time: 1 day)

AIM will be assessed by implementation champions' response to the 4 items of the AIM measure on the follow up survey. AIM is 5-point Likert scale question measured as follows: 1-Completely disagree, 2-Disagree, 3-Neither agree nor Disagree, 4-Agree, or 5-Completely agree. A higher score indicates greater acceptability. Scores above 3.0 are typically viewed as favorable/positive.
At time of post-session survey completion on day 3 (total estimated time: 1 day)
Tertiary Care Cohort: Appropriateness measured as Intervention Appropriateness Measure (IAM) score
Time Frame: At time of post-session survey completion on day 3 (total estimated time: 1 day)

IAM will be assessed by implementation champions' response to 4 items from the IAM measure on the follow up survey. IAM is measured by a 5-point Likert scale: 1-Completely disagree, 2-Disagree, 3-Neither agree nor Disagree, 4-Agree, or 5-Completely agree. A higher score indicates greater appropriateness of the intervention. Scores above 3.0 are typically viewed as favorable/positive.
At time of post-session survey completion on day 3 (total estimated time: 1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michelle Silver, PhD, ScM, Washington University School of Medicine
  • Principal Investigator: Jean Hunleth, PhD, MPH, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202211001
  • U01CA275033 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual participant data that support publication findings will be shared upon request following publication. Requests for any additional data must include a proposal for use of the requested data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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