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)

Abstract

Background HIV 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. Objective This 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. Methods A 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. Results The 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. Conclusions This 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 Registration ClinicalTrials.gov NCT04504097; https://clinicaltrials.gov/ct2/show/NCT04504097. International Registered Report Identifier (IRRID) DERR1-10.2196/26192

“Other risks don't stop”: adapting a youth sexual and reproductive health intervention in Zimbabwe during COVID-19

“…18 The subsequent addition of a mobile-based information text service, which coincided with the COVID-19 pandemic, had a high uptake and supports the success of other programmes which adapted to online delivery. 19 However, the physical service provision was considered essential, both for delivery of commodities and testing, and for face-to-face psychosocial support, and aligns with other studies which show the need for in-person spaces and support for youth. 20 …”

The prevalence and correlates of depression before and after the COVID-19 pandemic declaration among urban refugee adolescents and youth in informal settlements in Kampala, Uganda: A longitudinal cohort study

“…This longitudinal cohort study uses data collected as part of the Tushirikiane cluster randomized control trial among displaced and refugee adolescent youth in Kampala, Uganda. The primary aim of the trial was to assess the effect of HIV testing strategies on HIV testing outcomes; detailed study procedures have been described elsewhere [28] . In brief, displaced and refugee adolescent youth aged 16-24 years, were eligible for inclusion if they lived in one of three clustered informal settlements (Kabalagala/Kansanga, Katwe/Nsambye, and Rubaga) selected for convenience, spoke one of the study languages (English, French, Swahili, Luganda, Kinyarwanda, Kirundi), and had access to a mobile phone.…”

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

“…gov registration NCT04504097), which recently completed data collection in Kampala, Uganda. 38 Findings from this study can be used to inform local and global response efforts with new knowledge of mHealth approaches for COVID-19 prevention with urban refugee youth in humanitarian contexts.…”

“…This study is nested within a cluster randomised trial on HIV self-testing for which the primary outcomes are HIV testing frequency and status knowledge (Tushirikiane; ClinicalTrials.gov registration NCT04504097), which recently completed data collection in Kampala, Uganda. 38 Findings from this study can be used to inform local and global response efforts with new knowledge of mHealth approaches for COVID-19 prevention with urban refugee youth in humanitarian contexts.…”

“…Full details regarding the trial site geography and population have been described elsewhere. 38 Participants and recruitment All participants enrolled in the Tushirikiane trial are eligible for the Kukaa Salama substudy. Tushirikiane participants were recruited using purposive methods, including peer-driven recruitment with the support of 12 peer navigators.…”