Last updated on September 2018

HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia


Brief description of study

INA-PROACTIVE is a multicenter, prospective, observational cohort study of HIV positive antiretroviral-nave and treatment-experienced individuals. No investigational treatment or intervention will be used by this study. All participants will be managed according to the Indonesian HIV/AIDS Treatment Guideline and/or the Standard of Care (SoC) in local clinical setting, with the addition of rapid HIV viral load, CD4 cell count and syphilis testing.

Detailed Study Description

This study will accept participants meeting the eligibility criteria and data will be collected at baseline visit and 6-monthly regular follow up visits for 3 years (at month 6, 12, 18, 24, 30, and 36). The study will allow a 3-month window period for each scheduled regular follow up visit to minimize loss to follow up. Additional follow up data may be collected between regular follow up visits on certain participants who meet the additional follow up criteria.

During each visit, data collection will include socio-demographics, family history, past and current medical history, clinical assessments, laboratory and/or other supporting diagnosis examination. Blood specimens from each study visits will be collected for future research on immune function, pathogenesis, and genetics or genomics of HIV and risk related coinfections/comorbidities. The stored specimens will be investigated during the study and/or after the study completion.

Based on the highest number of HIV cases in hospitals from the National HIV/AIDS Control Program (MoHRI, 2016), 33 hospitals were identified as the proposed study sites (Appendix B). Ten hospitals are established INA-RESPOND's study sites. They are Dr. Cipto Mangunkusumo Hospital, Prof. Dr. Sulianti Saroso Infectious Diseases Hospital, and Persahabatan Hospital in Jakarta; Dr. Hasan Sadikin Hospital, Bandung; Dr. Kariadi Hospital, Semarang; Dr. Sardjito Hospital, Yogyakarta; Dr. Soetomo Hospital, Surabaya; Sanglah Hospital, Denpasar; Dr. Wahidin Sudirohusodo Hospital, Makassar; and Kab. Tangerang Hospital, Banten.

Ten additional new study sites will be selected from the list (Appendix B) and the INA-RESPOND team will conduct site assessments to determine their willingness and readiness to be INA-PROACTIVE study sites. If site activation is lagging, other hospitals not on the list can also be assessed as a potential study sites.

The total 20 study sites will be activated gradually based on their readiness within 2 years (12 sites on year-1 and additional 8 sites on year-2). It is expected that the additional new sites will expand the network, increase participants' recruitment, and will be able to represent Indonesian situation.

Clinical Study Identifier: NCT03663920

Contact Investigators or Research Sites near you

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Prof. Dr. Ketut Tuti Merati, ...

Site 520: University of Udayana/Sanglah Hospital
Denpasar, Indonesia
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dr. Nur Farhanah Sp.PD, K-PTI, ...

Site 560: University of Diponegoro/ Dr. Kariadi Hospital
Semarang, Indonesia
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Dr. dr. Evy Yunihastuti, Sp.PD-KAI

Site 530: University of Indonesia/ Dr. Cipto Mangunkusumo Hospital
Jakarta, Indonesia
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dr. Pompini Agustina, SpP

Site 540: Penyakit Infeksi Sulianti Saroso Hospital
Jakarta, Indonesia
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dr. Eppy Sp.PD(K)

Site 590: Persahabatan Hospital
Jakarta, Indonesia
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Prof. Dr.Usman Hadi, SpPD, KPTI

Site 570: University of Airlangga/ Dr. Soetomo Hospital
Surabaya, Indonesia
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dr. Tambar Kembaren, SpPD, K-PTI

Site 600 : Adam Malik Hospital
Medan, Indonesia
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Dr. Bratasena, Sp.PD, M.Ked

Site 650: Budi Kemuliaan Hospital
Batam, Indonesia
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Dr. Hj. Wiwit Agung SNC, ...

Site 630: M. Ansari Saleh Hospital
Banjarmasin, Indonesia
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Dr. Rudi Wisaksana, Sp.PD-KPTI, PhD

Site 510: University of Padjajaran/ Dr. Hasan Sadikin Hospital
Bandung, Indonesia
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dr. I Gede Rai Kosa, ...

Site 610 : RSU Kabupaten Tangerang
Tangerang, Indonesia
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dr. Emon Winardi Danudirgo, SpPD

Site 640: St. Carolus Hospital
Jakarta, Indonesia
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dr. Sudirman Katu, SpPD, K-PTI

Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital
Makassar, Indonesia
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Dr. Ida Savitri, Sp.A(K)

Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital
Yogyakarta, Indonesia
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Recruitment Status: Open


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