The INA104 (PROACTIVE) study site close-out activity was completed in October 2023, and research documents from the site have been archived with the INDOARSIP vendor. Con-currently, the data management team is undertaking general cleaning of data that has been entered, following thorough quality assurance checks across the site.

The first post-close-out activity involves preparing the final study report. This report, based on an interim report, serves as an attachment for site closure notification to both the central ethics com-mission (FK-UI RSCM Ethics Committee) and local ethics committees. Notifications, along with the interim report, are slated for submission in December 2023. Additionally, if necessary, these will also be sent to the site Director/Education and Research Department.

The second post-close-out activity focuses on writing a scoping review. This review aims to comprehensively understand HIV research conducted in various fields and identify gaps in HIV research in Indonesia. It encompasses a thorough examination of HIV research reports and outcomes in Indonesia, from the early stages of the epidemic to the present. The Secretariat team, along with Re-search Assistants, are currently preparing the protocol scoping review. Simultaneously, they have begun searching and reviewing literature on HIV research in Indonesia using two journal databases:Pubmed and Garuda (Garba Rujukan Digital /Digital Referral Platform:

The third post-close-out activity is the preparation of manuscripts. The secretariat, study core team, and NIAID team, in collaboration with the PI and Co-PI from each site, are developing three main manuscripts. The first manuscript, focusing on baseline characteristics and predictors of mortality within one year (‘Baseline Characteristics and One-Year Mortality’), is in circulation among all teams and is targeted for publication in the Journal of the International AIDS Society.

The other two manuscripts are in the developmental phase. These include an initial analysis of mortality within three years (‘Early Analysis of Three-Years Mortality in People Living with HIV’) and a study on virological, immunological, disease, and clinical progression (‘Clinical, Immunological, and Virological Responses of HIV-infected People with AntiRetroviral Therapy in a Nationwide Indonesian Cohort’). Current efforts include determining the writing team and assigning specific responsibilities for the writing process. The composition of the writing teams for each manuscript is being decided based on the initial concept plans and the enthusiasm shown by the study sites.

Table 1. Ethic Committee List

As of November 13th, 2023, the InVITE study, which initially enrolled 700 participants, has seen a significant portion of its cohort complete their involvement. A total of 617 participants, accounting for 88.14% of the initial group, have concluded their participation, leaving 83 individuals (11.86%) still actively participating in the study. This research is being conducted across three distinct sites, each currently progressing through visit 5. The specific details of these visits, including participant attendance and activities undertaken at each site, are meticulously documented in Table 1.

The study has encountered several issues in maintaining participant retention. Among the 617 participants who have completed their participation:

  • A majority of 555 participants (79.29%) successfully completed the study, fulfilling all requirements and protocols as outlined.
  • 45 participants (6.43%) chose to withdraw from the study, citing various personal reasons such as individual decisions, personal circumstances, or a loss of interest in continuing.
  • 3 participants (0.43%) were excluded from the study as they did not receive the complete vac-cine regimen within the stipulated 12-month period post-enrolment.
  • 2 participants (0.29%) were discontinued from the study as the continuation was deemed not in their best interest, based on medical or other significant considerations.
  • 1 participant (0.14%) displayed non-compliance with the study procedures, leading to their termination from the study.
  • 1 participant (0.14%) passed away during the course of the study.
  • 10 participants (1.43%) had other varied reasons that led to the cessation of their participation in the study.

Furthermore, the study has been tracking symptomatic visits among participants. Table 2 provides the details of these visits as of November 13th, 2023. It is important to note that while some participants have experienced COVID-19 symptoms, this does not necessarily mean that they have contracted the disease.

Table 1. Details of Visits per site per Nov 13, 2023

Table 2. Symptomatic Visit Details per Nov 13, 2023