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Introduction There is little consensus and high heterogeneity on the optimal set of relevant clinical outcomes in research studies regarding extubation in neurocritical care patients with brain injury undergoing mechanical ventilation. The aims of this study are to: (1) develop a core outcome set (COS) and (2) reach consensus on a hierarchical composite endpoint for such studies.Methods and analysis The study will include a broadly representative, international panel of stakeholders with research and clinical expertise in this field and will involve four stages: (1) a scoping review to generate an initial list of outcomes represented in the literature, (2) an investigator meeting to review the outcomes for inclusion in the Delphi surveys, (3) four rounds of online Delphi consensus-building surveys and (4) online consensus meetings to finalise the COS and hierarchical composite endpoint.Ethics and dissemination This study received ethical approval from the French Society of Anesthesia and Critical Care Medicine Institutional Review Board (SFAR CERAR-IRB 00010254‐2023-029). The study results will be disseminated through communication to stakeholders, publication in a peer-reviewed journal, and presentations at conferences.Trial registration number This study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) Initiative.

Abstract Background Adolescent girls in Zambia face risks and vulnerabilities that challenge their healthy development into young women: early marriage and childbearing, sexual and gender-based violence, unintended pregnancy and HIV. The Adolescent Girls Empowerment Program (AGEP) was designed to address these challenges by building girls’ social, health and economic assets in the short term and improving sexual behavior, early marriage, pregnancy and education in the longer term. The two-year intervention included weekly, mentor-led, girls group meetings on health, life skills and financial education. Additional intervention components included a health voucher redeemable for general wellness and reproductive health services and an adolescent-friendly savings account. Methods A cluster-randomized-controlled trial with longitudinal observations evaluated the impact of AGEP on key indicators immediately and two years after program end. Baseline data were collected from never-married adolescent girls in 120 intervention clusters (3515 girls) and 40 control clusters (1146 girls) and again two and four years later. An intent-to-treat analysis assessed the impact of AGEP on girls’ social, health and economic assets, sexual behaviors, education and fertility outcomes. A treatment-on-the-treated analysis using two-stage, instrumental variables regression was also conducted to assess program impact for those who participated. Results The intervention had modest, positive impacts on sexual and reproductive health knowledge after two and four years, financial literacy after two years, savings behavior after two and four years, self-efficacy after four years and transactional sex after two and four years. There was no effect of AGEP on the primary education or fertility outcomes, nor on norms regarding gender equity, acceptability of intimate partner violence and HIV knowledge. Conclusions Although the intervention led to sustained change in a small number of individual outcomes, overall, the intervention did not lead to girls acquiring a comprehensive set of social, health and economic assets, or change their educational and fertility outcomes. It is important to explore additional interventions that may be needed for the most vulnerable girls, particularly those that address household economic conditions. Additional attention should be given to the social and economic environment in which girls are living. Trial registration ISRCTN29322231 . Trial Registration Date: March 04, 2016; retrospectively registered.

Abstract Background Provision of HIV prevention and sexual and reproductive health services in Zambia is largely characterized by discrete service provision with weak client referral and linkage. The literature reveals gaps in the continuity of care for HIV and sexual and reproductive health. This study assessed whether improved service delivery models increased the uptake and cost-effectiveness of HIV and sexual and reproductive health services. Methods Adult clients 18+ years of age accessing family planning (females), HIV testing and counseling (females and males), and male circumcision services (males) were recruited, enrolled and individually randomized to one of three study arms: 1) the standard model of service provision at the entry point (N = 1319); 2) an enhanced counseling and referral to add-on service with follow-up (N = 1323); and 3) the components of study arm two, with the additional offer of an escort (N = 1321). Interviews were conducted with the same clients at baseline, six weeks and six months. Uptake of services for HIV, family planning, male circumcision, and cervical cancer screening at six weeks and six months were the primary endpoints. Pairwise chi-square and multivariable logistic regression statistical tests assessed differences across study arms, which were also assessed for incremental cost-efficiency and cost-effectiveness. Results A total of 3963 clients, 1920 males and 2043 females, were enrolled; 82 % of participants at six weeks were tracked and 81 % at six months; follow-up rates did not vary significantly by study arm. The odds of clients accessing HIV testing and counseling, cervical cancer screening services among females, and circumcision services among males varied significantly by study arm at six weeks and six months; less consistent findings were observed for HIV care and treatment. Client uptake of family planning services did not vary significantly by study arm. Integrated services were found to be more efficiently provided than vertical service provision; the cost-effectiveness for HIV/AIDS and cervical cancer was high in the enhanced service models. Conclusions Study results provide evidence for increasing the linkages and integration of a selection of HIV and sexual and reproductive health services. The study provided cost-effective service delivery models that enhanced the likelihood of clients accessing some additional needed health services. Trial registration ISRCTN84228514 Retrospectively registered. The study was retrospectively registered in the ISRCTN clinical trials registry on 06 October 2015. The first recruitment of participants occurred on 17 December 2013.