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

6 november 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

40

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Tertiary Care Cohort: Changes in HPV knowledge
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Washington University School of Medicine

Samarbetspartners

National Cancer Institute (NCI)

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 december 2026

Primärt slutförande (Beräknad)

31 augusti 2027

Avslutad studie (Beräknad)

31 augusti 2027

Studieregistreringsdatum

Först inskickad

6 november 2026

Först inskickad som uppfyllde QC-kriterierna

6 november 2026

Första postat (Faktisk)

13 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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