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

6 novembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Zambia
    • Copperbelt
      • Ndola, Copperbelt, Zambia
        • Tropical Diseases Research Centre Ndola
        • Contatto:
          • Sam Miti, MD
          • Numero di telefono: +260 96 6293508
        • Investigatore principale:
          • Sam Miti, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Tertiary Care Cohort: Changes in HPV knowledge
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Washington University School of Medicine

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Investigatore principale: Michelle Silver, PhD, ScM, Washington University School of Medicine
  • Investigatore principale: Jean Hunleth, PhD, MPH, Washington University School of Medicine

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 dicembre 2026

Completamento primario (Stimato)

31 agosto 2027

Completamento dello studio (Stimato)

31 agosto 2027

Date di iscrizione allo studio

Primo inviato

6 novembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 novembre 2026

Primo Inserito (Effettivo)

13 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 202211001
  • U01CA275033 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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