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An Intervention to Increase Condom Use Among Users of Sexually Transmitted Infection Self-sampling Websites (Wrapped): Protocol for a Randomized Controlled Feasibility Trial

BACKGROUND: Reducing the rates of sexually transmitted infections (STIs) among young people is a public health priority. The best way to avoid STIs from penetrative sex is to use a condom, but young people report inconsistent use. A missed opportunity to intervene to increase condom use is when youn...

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Autores principales: Newby, Katie, Kwah, Kayleigh, Schumacher, Lauren, Crutzen, Rik, Bailey, Julia V, Jackson, Louise J, Bremner, Stephen, Brown, Katherine E
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10214115/
https://www.ncbi.nlm.nih.gov/pubmed/37166958
http://dx.doi.org/10.2196/43645
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author Newby, Katie
Kwah, Kayleigh
Schumacher, Lauren
Crutzen, Rik
Bailey, Julia V
Jackson, Louise J
Bremner, Stephen
Brown, Katherine E
author_facet Newby, Katie
Kwah, Kayleigh
Schumacher, Lauren
Crutzen, Rik
Bailey, Julia V
Jackson, Louise J
Bremner, Stephen
Brown, Katherine E
author_sort Newby, Katie
collection PubMed
description BACKGROUND: Reducing the rates of sexually transmitted infections (STIs) among young people is a public health priority. The best way to avoid STIs from penetrative sex is to use a condom, but young people report inconsistent use. A missed opportunity to intervene to increase condom use is when young people access self-sampling kits for STIs through the internet. The potential of this opportunity is enhanced by the increasing numbers of young people being tested through this route every year in England. Hence, in a cocreation by young people, stakeholders, and researchers, Wrapped was developed––a fully automated, multicomponent, and interactive digital behavior change intervention developed for users of STI self-sampling websites, who are aged 16-24 years. OBJECTIVE: This paper is a protocol for a feasibility randomized controlled trial (fRCT). The fRCT seeks to establish whether it is feasible to run a randomized controlled trial to test the effectiveness and cost-effectiveness of Wrapped. Wrapped aims to reduce the incidence of STIs through increasing correct and consistent use of condoms among users of STI self-sampling websites, who are aged 16-24 years. METHODS: A 2-arm parallel-group randomized fRCT of Wrapped plus usual care, compared to usual care only (basic information on STIs and condom use), with a nested qualitative study. A minimum of 230 participants (aged 16-24 years) are recruited from an existing chlamydia self-sampling website. Participants are randomized into 1 of 2 parallel groups (1:1 allocation). Primary outcomes are the percentage of users recruited to the fRCT and the percentage of randomized participants who return a chlamydia self-sampling kit at month 12. Additionally, besides chlamydia positivity based on biological samples, surveys at baseline, month 3, month 6, and month 12, are used to assess condom use attitude, behavioral capability, self-efficacy, and intention, along with details of any partnered sexual activity and condom use, and health economic data. Nested qualitative interviews with trial participants are used to gain insight into the factors affecting recruitment and attrition. RESULTS: Recruitment to the fRCT began in March 2021 and was completed in October 2021. Data collection was completed in December 2022. CONCLUSIONS: This feasibility study will provide data to inform the design of a future-definitive trial. This work is timely given a rapid rise in the use of internet testing for STIs and the sustained high levels of STIs among young people. TRIAL REGISTRATION: ISRCTN Registry ISRCTN17478654; http://www.isrctn.com/ISRCTN17478654 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43645
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spelling pubmed-102141152023-05-27 An Intervention to Increase Condom Use Among Users of Sexually Transmitted Infection Self-sampling Websites (Wrapped): Protocol for a Randomized Controlled Feasibility Trial Newby, Katie Kwah, Kayleigh Schumacher, Lauren Crutzen, Rik Bailey, Julia V Jackson, Louise J Bremner, Stephen Brown, Katherine E JMIR Res Protoc Protocol BACKGROUND: Reducing the rates of sexually transmitted infections (STIs) among young people is a public health priority. The best way to avoid STIs from penetrative sex is to use a condom, but young people report inconsistent use. A missed opportunity to intervene to increase condom use is when young people access self-sampling kits for STIs through the internet. The potential of this opportunity is enhanced by the increasing numbers of young people being tested through this route every year in England. Hence, in a cocreation by young people, stakeholders, and researchers, Wrapped was developed––a fully automated, multicomponent, and interactive digital behavior change intervention developed for users of STI self-sampling websites, who are aged 16-24 years. OBJECTIVE: This paper is a protocol for a feasibility randomized controlled trial (fRCT). The fRCT seeks to establish whether it is feasible to run a randomized controlled trial to test the effectiveness and cost-effectiveness of Wrapped. Wrapped aims to reduce the incidence of STIs through increasing correct and consistent use of condoms among users of STI self-sampling websites, who are aged 16-24 years. METHODS: A 2-arm parallel-group randomized fRCT of Wrapped plus usual care, compared to usual care only (basic information on STIs and condom use), with a nested qualitative study. A minimum of 230 participants (aged 16-24 years) are recruited from an existing chlamydia self-sampling website. Participants are randomized into 1 of 2 parallel groups (1:1 allocation). Primary outcomes are the percentage of users recruited to the fRCT and the percentage of randomized participants who return a chlamydia self-sampling kit at month 12. Additionally, besides chlamydia positivity based on biological samples, surveys at baseline, month 3, month 6, and month 12, are used to assess condom use attitude, behavioral capability, self-efficacy, and intention, along with details of any partnered sexual activity and condom use, and health economic data. Nested qualitative interviews with trial participants are used to gain insight into the factors affecting recruitment and attrition. RESULTS: Recruitment to the fRCT began in March 2021 and was completed in October 2021. Data collection was completed in December 2022. CONCLUSIONS: This feasibility study will provide data to inform the design of a future-definitive trial. This work is timely given a rapid rise in the use of internet testing for STIs and the sustained high levels of STIs among young people. TRIAL REGISTRATION: ISRCTN Registry ISRCTN17478654; http://www.isrctn.com/ISRCTN17478654 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43645 JMIR Publications 2023-05-11 /pmc/articles/PMC10214115/ /pubmed/37166958 http://dx.doi.org/10.2196/43645 Text en ©Katie Newby, Kayleigh Kwah, Lauren Schumacher, Rik Crutzen, Julia V Bailey, Louise J Jackson, Stephen Bremner, Katherine E Brown. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 11.05.2023. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Newby, Katie
Kwah, Kayleigh
Schumacher, Lauren
Crutzen, Rik
Bailey, Julia V
Jackson, Louise J
Bremner, Stephen
Brown, Katherine E
An Intervention to Increase Condom Use Among Users of Sexually Transmitted Infection Self-sampling Websites (Wrapped): Protocol for a Randomized Controlled Feasibility Trial
title An Intervention to Increase Condom Use Among Users of Sexually Transmitted Infection Self-sampling Websites (Wrapped): Protocol for a Randomized Controlled Feasibility Trial
title_full An Intervention to Increase Condom Use Among Users of Sexually Transmitted Infection Self-sampling Websites (Wrapped): Protocol for a Randomized Controlled Feasibility Trial
title_fullStr An Intervention to Increase Condom Use Among Users of Sexually Transmitted Infection Self-sampling Websites (Wrapped): Protocol for a Randomized Controlled Feasibility Trial
title_full_unstemmed An Intervention to Increase Condom Use Among Users of Sexually Transmitted Infection Self-sampling Websites (Wrapped): Protocol for a Randomized Controlled Feasibility Trial
title_short An Intervention to Increase Condom Use Among Users of Sexually Transmitted Infection Self-sampling Websites (Wrapped): Protocol for a Randomized Controlled Feasibility Trial
title_sort intervention to increase condom use among users of sexually transmitted infection self-sampling websites (wrapped): protocol for a randomized controlled feasibility trial
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10214115/
https://www.ncbi.nlm.nih.gov/pubmed/37166958
http://dx.doi.org/10.2196/43645
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