Evidence map›Paper›PMID 37776478›Full record

Trial reportAdvances in therapy2023

Psychometric Validation of the Perception of Injection (PIN) Questionnaire Using Data From Two Phase III, Open-Label, Active-Controlled, Non-Inferiority Studies in People Living With HIV.

Vasiliki Chounta, Hilary F Byrnes, Mickael Henry-Szatkowski, Dominy Browning, Christina Donatti, Jeremy Lambert

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIEquivalence Trial
In one paragraph

Trial report in Advances in therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.1field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02938520 phase3active not recruitingnot on this map

A Phase III, Randomized, Multicenter, Parallel-group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Participants

TypeinterventionalSponsorViiV HealthcareRan2016 to 2029Enrolled631ConditionsHIV InfectionsArmsCabotegravir (CAB) tablet, Rilpivirine (RPV) tablet, Cabotegravir - Injectable Suspension (CAB LA), Rilpivirine - Injectable Suspension (RPV LA), ABC/DTG/3TC STR - Tablet
NCT02951052 phase3active not recruitingnot on this map

A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current INI- NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-infected Adults Who Are Virologically Suppressed

TypeinterventionalSponsorViiV HealthcareRan2016 to 2029Enrolled618ConditionsInfection, Human Immunodeficiency Virus, HIV InfectionsArmsCabotegravir (CAB) tablet, Rilpivirine (RPV) tablet, Cabotegravir - Injectable Suspension (CAB LA), Rilpivirine - Injectable Suspension (RPV LA), 2 NRTIs plus an INI, NNRTI, or PI
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Vasiliki ChountaViiV Healthcare Ltd, Global Health Outcomes, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK.
Hilary F ByrnesICON plc, Patient Centred Outcomes, Blue Bell, PA, USA.
Mickael Henry-SzatkowskiICON plc, Patient Centred Outcomes, Lyon, France.
Dominy BrowningViiV Healthcare Ltd, Global Health Outcomes, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK.
Christina DonattiViiV Healthcare Ltd, Global Health Outcomes, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK. christina.x.donatti@viivhealthcare.com.
Jeremy Lambert *ICON plc, Patient Centred Outcomes, Lyon, France.
ViiV Healthcare (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCurrently, there are no patient-reported outcome tools specifically validated for use in people living with human immunodeficiency virus (PLHIV) to measure treatment injection acceptance and experience. The Perception of Injection (PIN) questionnaire was modified with consent from the Vaccinees' Perception of Injection (VAPI), a validated instrument developed by Sanofi Pasteur. The objective of developing the PIN was to provide information on participant experience with injectable therapies, including acceptance of pain, injection-site reactions, and tolerability following injections in PLHIV.

methodsThis post hoc analysis used data from participants who received the long-acting intramuscular cabotegravir plus rilpivirine combination treatment every 4 weeks, as part of the ATLAS (NCT02951052) and FLAIR (NCT02938520) studies, to evaluate the psychometric properties of the PIN questionnaire.

resultsThese findings support the reliability, validity, and responsiveness to change for the PIN questionnaire in PLHIV.

conclusionAs a clinical trial endpoint, the PIN questionnaire could provide valuable evidence around the acceptance and experience of injections in PLHIV which could have implications for treatment adherence in this population.

trial registrationATLAS (NCT02951052); 1 November, 2016. FLAIR (NCT02938520); 19 October, 2016.

Indexed as

Anti-HIV AgentsHIV-1HIV InfectionsHumansInjections, IntramuscularPerceptionPsychometricsPyridonesReproducibility of ResultsSurveys and QuestionnairesAnti-HIV AgentsPyridonesCabotegravir plus rilpivirineExperience of injectionHIVPatient-reported outcome (PRO)Psychometric validation

Identifiers

PMID37776478
PMCPMC10611592
OpenAlexW4387219404

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.