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

6. november 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Zambia
    • Copperbelt
      • Ndola, Copperbelt, Zambia
        • Tropical Diseases Research Centre Ndola
        • Kontakt:
          • Sam Miti, MD
          • Telefonnummer: +260 96 6293508
        • Ledende efterforsker:
          • Sam Miti, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tertiary Care Cohort: Changes in HPV knowledge
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Washington University School of Medicine

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Michelle Silver, PhD, ScM, Washington University School of Medicine
  • Ledende efterforsker: Jean Hunleth, PhD, MPH, Washington University School of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. december 2026

Primær færdiggørelse (Anslået)

31. august 2027

Studieafslutning (Anslået)

31. august 2027

Datoer for studieregistrering

Først indsendt

6. november 2026

Først indsendt, der opfyldte QC-kriterier

6. november 2026

Først opslået (Faktiske)

13. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 202211001
  • U01CA275033 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

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