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)

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

The team is cross-national and multidisciplinary (Social Work, Nursing, Medicine, Biostatistics, Medical Anthropology), which is very important for the proposed study given the topic and population to be studied. Included is a knowledge user representative from the Ugandan Ministry of Health.
The applicant has a track record in publishing and success in obtaining grants for her research.
The budget appears realistic and well-justified, and it is recommended that it be accepted as described.

Review Type / Type d'évaluation:
Reviewer The proposal addresses a significant and urgent health need of a vulnerable population (HIV among displaced and refugee adolescent girls in Uganda). The researchers make a compelling case for the importance of the research, including a detailed analysis of the HIV risk of the target group, the value of HIV self-testing and the use of mobile health approach.
The mixed methods approach effectively integrates both qualitative and quantitative approaches to program design and evaluation. The initial year of development work, with meaningful engagement of the community (forming an advisory team, training peer navigators, conducting youth focus groups and key informant interviews) will be integral to understanding the individual issues and the broader social context in order to design an acceptable, feasible, culturally relevant approach to empower girls to engage in HIV self-testing. The clustered RCT approach makes sense given the social context of the slums and there was a good description of the intervention and analysis approaches. Sample size justification was provided, although a 3-4 month recruitment period for 144 participants and 10% drop-out rate is quite ambitious given the many complex challenges faced by the displaced young women. It will be interesting to see if the strategy of maintaining weekly contact is effective in maintaining engagement. It will be important to be clear about how responses to problems identified in these check-ins will be handled, since this may add an additional layer of complexity to the role of those who are responding to the text messages. It was good to see that the study incorporates not only self-testing, but also promotes linkages to additional community supports for HIV intervention. The researchers have done a good job of considering how to manage social desirability bias. The effectiveness implementation hybrid design to simultaneously collect data on the intervention and the implementation process will yield important implementation data that will inform interpretation of the outcomes and recommendations for implementation and evaluation. The proposal integrated a clear sex/gender based framework throughout the study, including theoretical and scientific understanding of gender issues, approach to data collection, analysis and knowledge translation. The researchers have also done a good job of considering how to track process as well as outcome data. Since participation in the intervention is over a 6 month period, are there plans to ensure sustainability once the project is complete? Since you will have invested a lot of time in training and establishing processes of implementation, it will be important to ensure that the work continues beyond the data collection period.
This is an ambitious, but important project that has the potential to make a significant difference in the lives of a group of vulnerable young women. The proposed intervention could have a significant impact on the community since HIV testing can be a key entry point for HIV prevention and antiretroviral therapy-preventing onward HIV transmission. The research team has established a clear foundation of support from the community with letters of support from 10 Uganda-based organisations, including high level decision makers as well as front-line champions. The primary investigator has done similar research in Haiti, therefore will be able to transfer some of this knowledge to this research in Uganda. As noted in the proposal, the project will build on the team's CIHR Planning Grant and collective expertise in global HIV research with adolescents, displaced people, and m-health. Overall, the proposal was thoughtfully prepared and well-written.