Mobile Health–Supported HIV Self-Testing Strategy Among Urban Refugee and Displaced Youth in Kampala, Uganda: Protocol for a Cluster Randomized Trial (Tushirikiane, Supporting Each Other)

BackgroundHIV is the leading cause of mortality among youth in sub-Saharan Africa. Uganda hosts over 1.43 million refugees, and more than 83,000 live in Kampala, largely in informal settlements. There is limited information about HIV testing uptake and preferences among urban refugee and displaced y...

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Main Authors: Logie, Carmen, Okumu, Moses, Hakiza, Robert, Kibuuka Musoke, Daniel, Berry, Isha, Mwima, Simon, Kyambadde, Peter, Kiera, Uwase Mimy, Loutet, Miranda, Neema, Stella, Newby, Katie, McNamee, Clara, Baral, Stefan D, Lester, Richard, Musinguzi, Joshua, Mbuagbaw, Lawrence
Format: Article
Language:English
Published: JMIR Publications 2021-02-01
Series:JMIR Research Protocols
Online Access:https://www.researchprotocols.org/2021/2/e26192
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author Logie, Carmen
Okumu, Moses
Hakiza, Robert
Kibuuka Musoke, Daniel
Berry, Isha
Mwima, Simon
Kyambadde, Peter
Kiera, Uwase Mimy
Loutet, Miranda
Neema, Stella
Newby, Katie
McNamee, Clara
Baral, Stefan D
Lester, Richard
Musinguzi, Joshua
Mbuagbaw, Lawrence
author_facet Logie, Carmen
Okumu, Moses
Hakiza, Robert
Kibuuka Musoke, Daniel
Berry, Isha
Mwima, Simon
Kyambadde, Peter
Kiera, Uwase Mimy
Loutet, Miranda
Neema, Stella
Newby, Katie
McNamee, Clara
Baral, Stefan D
Lester, Richard
Musinguzi, Joshua
Mbuagbaw, Lawrence
author_sort Logie, Carmen
collection DOAJ
description BackgroundHIV is the leading cause of mortality among youth in sub-Saharan Africa. Uganda hosts over 1.43 million refugees, and more than 83,000 live in Kampala, largely in informal settlements. There is limited information about HIV testing uptake and preferences among urban refugee and displaced youth. HIV self-testing is a promising method for increasing testing uptake. Further, mobile health (mHealth) interventions have been effective in increasing HIV testing uptake and could be particularly useful among youth. ObjectiveThis study aims to evaluate the feasibility and effectiveness of two HIV self-testing implementation strategies (HIV self-testing intervention alone and HIV self-testing combined with an mHealth intervention) in comparison with the HIV testing standard of care in terms of HIV testing outcomes among refugee/displaced youth aged 16 to 24 years in Kampala, Uganda. MethodsA three-arm cluster randomized controlled trial will be implemented across five informal settlements grouped into three sites, based on proximity, and randomization will be performed with a 1:1:1 method. Approximately 450 adolescents (150 per cluster) will be enrolled and followed for 12 months. Data will be collected at the following three time points: baseline enrollment, 8 months after enrollment, and 12 months after enrollment. Primary outcomes (HIV testing frequency, HIV status knowledge, linkage to confirmatory testing, and linkage to HIV care) and secondary outcomes (depression, condom use efficacy, consistent condom use, sexual relationship power, HIV stigma, and adolescent sexual and reproductive health stigma) will be evaluated. ResultsThe study has been conducted in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines. The study has received ethical approval from the University of Toronto (June 14, 2019), Mildmay Uganda (November 11, 2019), and the Uganda National Council for Science and Technology (August 3, 2020). The Tushirikiane trial launched in February 2020, recruiting a total of 452 participants. Data collection was paused for 8 months due to COVID-19. Data collection for wave 2 resumed in November 2020, and as of December 10, 2020, a total of 295 participants have been followed-up. The third, and final, wave of data collection will be conducted between February and March 2021. ConclusionsThis study will contribute to the knowledge of differentiated HIV testing implementation strategies for urban refugee and displaced youth living in informal settlements. We will share the findings in peer-reviewed manuscripts and conference presentations. Trial RegistrationClinicalTrials.gov NCT04504097; https://clinicaltrials.gov/ct2/show/NCT04504097. International Registered Report Identifier (IRRID)DERR1-10.2196/26192
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spelling doaj.art-4fc3fddb451a4d0e95315024df7f29e32022-12-21T17:23:13ZengJMIR PublicationsJMIR Research Protocols1929-07482021-02-01102e2619210.2196/26192Mobile Health–Supported HIV Self-Testing Strategy Among Urban Refugee and Displaced Youth in Kampala, Uganda: Protocol for a Cluster Randomized Trial (Tushirikiane, Supporting Each Other)Logie, CarmenOkumu, MosesHakiza, RobertKibuuka Musoke, DanielBerry, IshaMwima, SimonKyambadde, PeterKiera, Uwase MimyLoutet, MirandaNeema, StellaNewby, KatieMcNamee, ClaraBaral, Stefan DLester, RichardMusinguzi, JoshuaMbuagbaw, LawrenceBackgroundHIV is the leading cause of mortality among youth in sub-Saharan Africa. Uganda hosts over 1.43 million refugees, and more than 83,000 live in Kampala, largely in informal settlements. There is limited information about HIV testing uptake and preferences among urban refugee and displaced youth. HIV self-testing is a promising method for increasing testing uptake. Further, mobile health (mHealth) interventions have been effective in increasing HIV testing uptake and could be particularly useful among youth. ObjectiveThis study aims to evaluate the feasibility and effectiveness of two HIV self-testing implementation strategies (HIV self-testing intervention alone and HIV self-testing combined with an mHealth intervention) in comparison with the HIV testing standard of care in terms of HIV testing outcomes among refugee/displaced youth aged 16 to 24 years in Kampala, Uganda. MethodsA three-arm cluster randomized controlled trial will be implemented across five informal settlements grouped into three sites, based on proximity, and randomization will be performed with a 1:1:1 method. Approximately 450 adolescents (150 per cluster) will be enrolled and followed for 12 months. Data will be collected at the following three time points: baseline enrollment, 8 months after enrollment, and 12 months after enrollment. Primary outcomes (HIV testing frequency, HIV status knowledge, linkage to confirmatory testing, and linkage to HIV care) and secondary outcomes (depression, condom use efficacy, consistent condom use, sexual relationship power, HIV stigma, and adolescent sexual and reproductive health stigma) will be evaluated. ResultsThe study has been conducted in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines. The study has received ethical approval from the University of Toronto (June 14, 2019), Mildmay Uganda (November 11, 2019), and the Uganda National Council for Science and Technology (August 3, 2020). The Tushirikiane trial launched in February 2020, recruiting a total of 452 participants. Data collection was paused for 8 months due to COVID-19. Data collection for wave 2 resumed in November 2020, and as of December 10, 2020, a total of 295 participants have been followed-up. The third, and final, wave of data collection will be conducted between February and March 2021. ConclusionsThis study will contribute to the knowledge of differentiated HIV testing implementation strategies for urban refugee and displaced youth living in informal settlements. We will share the findings in peer-reviewed manuscripts and conference presentations. Trial RegistrationClinicalTrials.gov NCT04504097; https://clinicaltrials.gov/ct2/show/NCT04504097. International Registered Report Identifier (IRRID)DERR1-10.2196/26192https://www.researchprotocols.org/2021/2/e26192
spellingShingle Logie, Carmen
Okumu, Moses
Hakiza, Robert
Kibuuka Musoke, Daniel
Berry, Isha
Mwima, Simon
Kyambadde, Peter
Kiera, Uwase Mimy
Loutet, Miranda
Neema, Stella
Newby, Katie
McNamee, Clara
Baral, Stefan D
Lester, Richard
Musinguzi, Joshua
Mbuagbaw, Lawrence
Mobile Health–Supported HIV Self-Testing Strategy Among Urban Refugee and Displaced Youth in Kampala, Uganda: Protocol for a Cluster Randomized Trial (Tushirikiane, Supporting Each Other)
JMIR Research Protocols
title Mobile Health–Supported HIV Self-Testing Strategy Among Urban Refugee and Displaced Youth in Kampala, Uganda: Protocol for a Cluster Randomized Trial (Tushirikiane, Supporting Each Other)
title_full Mobile Health–Supported HIV Self-Testing Strategy Among Urban Refugee and Displaced Youth in Kampala, Uganda: Protocol for a Cluster Randomized Trial (Tushirikiane, Supporting Each Other)
title_fullStr Mobile Health–Supported HIV Self-Testing Strategy Among Urban Refugee and Displaced Youth in Kampala, Uganda: Protocol for a Cluster Randomized Trial (Tushirikiane, Supporting Each Other)
title_full_unstemmed Mobile Health–Supported HIV Self-Testing Strategy Among Urban Refugee and Displaced Youth in Kampala, Uganda: Protocol for a Cluster Randomized Trial (Tushirikiane, Supporting Each Other)
title_short Mobile Health–Supported HIV Self-Testing Strategy Among Urban Refugee and Displaced Youth in Kampala, Uganda: Protocol for a Cluster Randomized Trial (Tushirikiane, Supporting Each Other)
title_sort mobile health supported hiv self testing strategy among urban refugee and displaced youth in kampala uganda protocol for a cluster randomized trial tushirikiane supporting each other
url https://www.researchprotocols.org/2021/2/e26192
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