Dataset Information

Kukaa Salama (Staying Safe): study protocol for a pre/post-trial of an interactive mHealth intervention for increasing COVID-19 prevention practices with urban refugee youth in Kampala, Uganda

ABSTRACT:

Introduction

With over 82.4 million forcibly displaced persons worldwide, there remains an urgent need to better describe culturally, contextually and age-tailored strategies for preventing COVID-19 in humanitarian contexts. Knowledge gaps are particularly pronounced for urban refugees who experience poverty, overcrowded living conditions and poor sanitation access that constrain the ability to practise COVID-19 mitigation strategies such as physical distancing and frequent hand washing. With over 1.4 million refugees, Uganda is sub-Saharan Africa’s largest refugee hosting nation. More than 90 000 of Uganda’s refugees live in Kampala, most in informal settlements, and 27% are aged 15–24 years old. There is an urgent need for tailored COVID-19 responses with urban refugee adolescents and youth. This study aims to evaluate the effectiveness of an 8-week interactive informational mobile health intervention on COVID-19 prevention practices among refugee and displaced youth aged 16–24 years in Kampala, Uganda.

Methods and analysis

We will conduct a pre-test/post-test study nested within a larger cluster randomised trial. Approximately 385 youth participants will be enrolled and followed for 6 months. Data will be collected at three time points: before the intervention (time 1); immediately after the intervention (time 2) and at 16-week follow-up (time 3). The primary outcome (self-efficacy to practise COVID-19 prevention measures) and secondary outcomes (COVID-19 risk awareness, attitudes, norms and self-regulation practices; depression; sexual and reproductive health practices; food and water security; COVID-19 vaccine acceptability) will be evaluated using descriptive statistics and regression analyses.

Ethics and dissemination

This study has been approved by the University of Toronto Research Ethics Board, the Mildmay Uganda Research Ethics Committee, and the Uganda National Council for Science & Technology. The results will be published in peer-reviewed journals, and findings communicated through reports and conference presentations.

Trial registration number

ClinicalTrials.gov Registry (NCT04631367).

SUBMITTER: Logie C

PROVIDER: S-EPMC8609499 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:IntroductionUrban refugee youth remain underserved by current HIV prevention strategies, including HIV self-testing (HIVST). Examining HIVST feasibility with refugees can inform tailored HIV testing strategies. We examined if HIVST and mobile health (mHealth) delivery approaches could increase HIV testing uptake and HIV status knowledge among refugee youth in Kampala, Uganda.MethodsWe conducted a three-arm pragmatic controlled trial across five informal settlements grouped into three sites in Kampala from 2020 to 2021 with peer-recruited refugee youth aged 16-24 years. The intervention was HIVST and HIVST + mHealth (HIVST with bidirectional SMS), compared with standard of care (SOC). Primary outcomes were self-reported HIV testing uptake and correct status knowledge verified by point-of-care testing. Some secondary outcomes included: depression, HIV-related stigma, and adolescent sexual and reproductive health (SRH) stigma at three time points (baseline [T0], 8 months [T1] and 12 months [T2]). We used generalized estimating equation regression models to estimate crude and adjusted odds ratios comparing arms over time, adjusting for age, gender and baseline imbalances. We assessed study pragmatism across PRECIS-2 dimensions.ResultsWe enrolled 450 participants (50.7% cisgender men, 48.7% cisgender women, 0.7% transgender women; mean age: 20.0, standard deviation: 2.4) across three sites. Self-reported HIV testing uptake increased significantly from T0 to T1 in intervention arms: HIVST arm: (27.6% [n = 43] at T0 vs. 91.2% [n = 135] at T1; HIVST + mHealth: 30.9% [n = 47] at T0 vs. 94.2% [n = 113] at T1]) compared with SOC (35.5% [n = 50] at T0 vs. 24.8% [ = 27] at T1) and remained significantly higher than SOC at T2 (p<0.001). HIV status knowledge in intervention arms (HIVST arm: 100% [n = 121], HIVST + mHealth arm: 97.9% [n = 95]) was significantly higher than SOC (61.5% [n = 59]) at T2. There were modest changes in secondary outcomes in intervention arms, including decreased depression alongside increased HIV-related stigma and adolescent SRH stigma. The trial employed both pragmatic (eligibility criteria, setting, organization, outcome, analysis) and explanatory approaches (recruitment path, flexibility of delivery flexibility, adherence flexibility, follow-up).ConclusionsOffering HIVST is a promising approach to increase HIV testing uptake among urban refugee youth in Kampala. We share lessons learned to inform future youth-focused HIVST trials in urban humanitarian settings.

Project 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.