Tushirikiane-4-Uthabiti (Supporting Each Other For Resilience): study protocol of a mental health, HIV self-testing and livelihoods randomised controlled trial for advancing HIV prevention outcomes among urban refugee youth in Kampala, Uganda

Introduction
Research with urban refugee youth in Uganda has documented co-occurring social (e.g., poverty) and health (e.g., depression) disparities associated with HIV vulnerabilities. Benefits of HIV self-testing (HIVST) in increasing HIV testing uptake among youth are well established, yet limited interventions have examined if combining HIVST with mental health promotion, or with mental health promotion alongside poverty reduction, is associated with greater improvements in HIV prevention and testing outcomes.

Methods and analysis
The aim is to evaluate the effectiveness of: (1) HIVST alone (standard of care); (2) mobile health (mHealth) and graphic medicine (comic) programme for mental health alongside HIVST; and (3) the combination of HIVST, a livelihoods programme, and mHealth mental health programme, in advancing the primary outcome of HIV testing uptake and secondary outcomes (HIV status knowledge, linkage to confirmatory testing and HIV care, HIV knowledge, consistent condom use, condom use self-efficacy, sexual risk) with urban refugee youth in Kampala, Uganda. A three-arm randomised controlled trial will be implemented from 8 April 2024 to 31 October 2024 with youth across five informal settlements in Kampala, grouped into three sites based on proximity, and randomised in a 1:1:1 design. Approximately 330 participants (110 per arm) are enrolled and data collection will occur at three time points (baseline enrolment, 3-month follow-up and 6-month follow-up).

Ethics and dissemination
The study received ethical approval from the University of Toronto (#37496), Mildmay Uganda Research Ethics Committee (#MUREC-2021-41) and Uganda National Council for Science & Technology (#SS1021ES). The trial is registered at ClinicalTrials.gov (NCT06270160). Study findings will produce new knowledge of the impacts of a mental health programme, and a combined mental health and livelihoods programme, on improving HIV prevention outcomes among urban refugee youth in Kampala. Findings will be shared in peer-reviewed publications, conference presentations and in community dissemination.

Trial registration number
NCT06270160 (date of registration: 13 February 2024).

Trial sponsor
Dr. Carmen Logie, carmen.logie@utoronto.ca.

Leggi
Novembre 2024

Booster-free anti-retroviral therapy for persons living with HIV and multidrug resistance (B-Free): protocol for a multicentre, multistage, randomised, controlled, non-inferiority trial

Introduction
Anti-retroviral therapy (ART) simplification strategies are needed for treatment-experienced people with HIV (PWH) and multidrug-resistant viruses. These individuals are commonly treated with boosted ART regimens and are thereby at risk for harmful drug-drug interactions (DDI). In this trial, we aim to assess the efficacy of the combination doravirine, dolutegravir and lamivudine (DOR/DTG/3TC) among people with a history of virological failure who receive boosted ART.

Methods and analysis
B-Free is a multistage, randomised, multicentre, open-label, non-inferiority trial, embedded within the Swiss HIV Cohort Study and conducted in collaboration with cohorts of PWH in the Netherlands and France. Cohort participants with a history of ART change due to virologic failure and who maintain HIV virologic suppression with an ART regimen consisting of a pharmacological booster and at least two drugs from classes other than nucleoside reverse transcriptase inhibitors are included. Patients with major drug resistance mutations against DTG or DOR and individuals with chronic hepatitis B virus infection are not eligible for the study. Individuals are randomised 1:1 to either receiving co-formulated DTG/3TC and DOR once daily or continuing their boosted ART regimen. The primary outcome is the proportion of individuals lacking virologic control (HIV-RNA ≥50 cp/mL) at 48 weeks, according to the Food and Drug Administration snapshot algorithm. Changes in DDI burden (assessed using a DDI score), treatment satisfaction (assessed using the HIV Treatment Satisfaction Questionnaire), quality of life and mental health represent key secondary outcomes. Additional secondary outcomes include the proportion of individuals developing new resistance-associated mutations and changes in quality of life and mental health. In a qualitative substudy, we will conduct semistructured interviews with a subset of participants to assess their expectations and experiences towards HIV treatment and clinical research in general. Enrolling 210 individuals will provide 80% power to demonstrate non-inferiority, defined as less than 8% absolute increase in loss of viral suppression in individuals randomised to DOR/DTG/3TC (one-sided type I error rate of 0.025).

Ethics and dissemination
The study was approved by the competent ethics committees (reference number BASEC 2023–01060) and the regulatory authority Swissmedic (reference number 701655) in Switzerland before the enrolment of the first participant. Approval by the European Medicines Agency and local ethical committees in the Netherlands and France will be obtained prior to including participants in these countries. Participant’s written informed consent is obtained by the investigators before enrolment. The results of all major B-Free study outcomes will be submitted to peer-reviewed journals that enable Open Access publication.

Trial registration number
Swiss National Clinical Trials Portal (SNCTP000005686, registered on 06 November 2023) and Clinicaltrials.gov (NCT06037564, registered on 07 September 2023).

Leggi
Novembre 2024

Exploring the barriers and facilitators to HIV information and health services among youth in NDjamena, Chad: a qualitative descriptive study

Objectives
Identifying the barriers and facilitators for Chadian youth (aged 15–24 years) along the pathway of access to HIV information and health services.

Study design
Qualitative descriptive study.

Study setting
The study was conducted in N’Djamena, Chad, with 20 high schools purposefully selected based on participation in a Blue Cross Chad (BCC) peer-to-peer education programme.

Participants
A total of four focus groups, each consisting of 12 participants, stratified by gender and BCC programme participation (two each among participating and non-participating high schools), were conducted.

Methods
A descriptive qualitative study using thematic analysis of content was conducted. The qualitative software ATLAS.ti V.22 was used to organise and code the data.

Results
Five main categories of barriers and facilitators for HIV information and health services were identified, including (1) societal expectations and norms; (2) power dynamics; (3) social networks; (4) peer-education programmes; and (5) bypassing the system. Barriers and facilitators to information information-seeking and access to health services were observed at individual, community and system levels. High school students expressed that access to information and health services were important when it comes to HIV and AIDS prevention and treatment. Societal expectations and power dynamics were identified as key barriers, while trust through social networks and peer-education programmes were key facilitators to accessing information and health services.

Conclusion
This study allowed for the identification of both barriers and facilitators of HIV information and health-seeking in the context of N’Djamena, Chad. Our findings highlight the importance of comprehensive community- and youth-led approaches that are youth-friendly and youth-centric and are needed to effectively communicate HIV information.

Leggi
Novembre 2024

Effectiveness of HIV prevention interventions targeting long-distance truck drivers: protocol for a systematic review and meta-analysis of global evidence

Introduction
Globally, long-distance truck drivers’ (LDTDs) risk of exposure to HIV infections is higher compared with other populations in transit. Thus, several HIV prevention interventions have been implemented, though to a narrower extent compared with other most at-risk populations. Consequently, the effectiveness of such interventions is not well understood. Therefore, a review is warranted to inform policymakers on the most effective HIV prevention interventions targeted for LDTDs.

Methods and analysis
The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines were followed. Original peer-reviewed interventional studies involving LDTDs of either gender aged above 18 years, and reporting findings on HIV prevention interventions from any part of the world will be included. Non-empirical research studies like systematic reviews, literature reviews and scoping reviews will be excluded. A comprehensive search will be done from PubMed, Cumulated Index to Nursing and Allied Health Literature and other five databases to identify eligible studies. The Rayyan online platform will be used for the screening of titles and abstracts. For the meta-analysis, a random-effects meta-analysis using the ‘metafor’ package in R software will be done. Where specific studies may not report adequate data for meta-analysis, their findings will be presented qualitatively. The Cochrane Collaboration tool and Joanna Brigs Checklist will be used to assess the quality and risk of bias in the included studies.

Ethics and dissemination
A formal ethical approval is not required for this systematic review and meta-analysis. The findings will be presented at scientific conferences and published in open-access peer-reviewed journals to reach policymakers, stakeholders and the scientific community.

PROSPERO registration number
CRD42024505542.

Leggi
Novembre 2024