Ongoing Studies – INA-RESPOND

TRIPOD Study

The submitted manuscript of TRIPOD titled “The Character-istics of Drug Sensitive and Drug-Resistant Tuberculosis Cases in Indonesia” was accepted by the American Journal of Tropical Medicine and Hygiene on 18 August 2022, and it has been avail-able online since 17 October 2022 www.ajtmh.org/view/journals/tpmd/aop/article-10.4269-ajtmh.22-0142/article-10.4269-ajtmh.22-0142.xml?rskey=NOzYfd&result=1) This manuscript article will be scheduled to appear in volume 107 issue 5 of AJTMH.

The second paper, “Performance of Xpert TB/RIF and Sputum Microscopy Compared to Sputum Culture for Diagnosis of Tuberculosis in Seven Indonesian Hospi-tals,” was accepted in the Frontiers in Medicine – Infec-tious Diseases – Surveillance, Prevention on 8 Decem-ber 2022. The journal production team is now pro-cessing it before it is published.

In collaboration with the Division of AIDS (DAIDS), NIAID, and NIH, CRDF Global will be coordinating a two-and-a-half-day grantsmanship workshop, in conjunc-tion with the RePORT India annual meeting in India on 5-10 February 2023. dr. Adhela Menur Naysilla from the INA-RESPOND Secretariat has won the opportunity to join as a participant in the RePORT international junior investigator grantsmanship workshop.

PROACTIVE Study

As of 3 January 2023, out of 4,336 subjects enrolled, 4,042 (93.22%) subjects have ended their study, and 294 (6.78%) are still ongoing. For the End-of-Study, 3,313 subjects had already completed the study until the Follow-up Visit Month 36, 405 subjects were lost to follow-up, 247 subjects died, 38 subjects moved to the city without a PROACTIVE Site, 32 subjects withdrew consent, five subjects were HIV negative, and two subjects were suspended (imprisoned). The study progress from each site is described in the Figure on the right, while detailed information on the End-of-Study participants is available in Table 1.

Table 1. Subject’s end of study reasons

After the completion of the follow-up at site 610 – RSU Kabupaten Tangerang in September 2022, sites 510, 550, 560, 580, 590, 600, 630, 640, 650, and 660 also completed the follow-up for all their subjects. The previously mentioned sites will have a site monitoring visit by appointment and site closeout visits within six months from the last follow-up before archiving the documents the following month. For the monitoring activity, two on-site monitoring visits are scheduled for early 2023, namely site 600 – Adam Malik Hospital on 17-20 Jan 2023, site 510 – Hasan Sadikin Hospital on 28-20 Jan 2023, site 590 – Persahabatan Hospital in Feb 2023, Site 560 – Kariadi Hospital in Feb 2023, Site 670 – Zainoel Abidin Hospital in Feb 2023 and Site 540 in March 2023.

The last monitoring visit dates that have been conducted for some sites

ORCHID Study

The data management team have completed the data au-dit for random sample subject in all sites. Meanwhile, the data audit for the critical data field on all subjects for site 521 is already done, while site 610 is still ongoing. All the study process close out at site RS Universitas Udayana has already finished since the site close-out visit (SCV) on 22 and 23 September 2022. The screenshot of the remote SCV is shown in Figure 1. The SCV of site RSU Kabupaten Tangerang was arranged on 13 and 14 October 2022. The site is still preparing the pending/incomplete documents to be filed in the study’s regulatory binders before archiving. Figure 2 shows the study team at RSU Kabupaten Tangerang preparing for the SCV. We express our deepest gratitude for the efforts and good cooperation of the two sites during the research. We hope to continue to collaborate on INA-RESPOND research in the future.

Figure 1. Remote Site Close-Out Visit ar RS. Universitas Udayana

Currently, the reference laboratory team is doing PCR SARS-CoV-2 test on all collected specimens (saliva, nasopharyngeal swab, oro-pharyngeal swab, urine, feces, and serum) from all COVID-19 cases. Some specimens that were positive SARS COV-2 at visit 1 (enrolment) will continue for another PCR SARS-CoV-2 testing on samples collected at follow-up visit 2 (7- 14 days after enrolment). Meanwhile, the study team will determine the target pathogen to do molecular and serology testing for non-COVID-19 cases based on clinical symptoms.

Figure 2. Study Team at RSU Kabupaten Tangerang

Moreover, the study team is preparing two manuscripts (Overall study result and FLU PRO data), and it is discussing the tables and figures for the manuscript’s overall study results.