HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia

NCT ID: NCT03663920

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4336 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-09
• Study Completion Date: 2023-09-30

Brief Summary

INA-PROACTIVE is a multicenter, prospective, observational cohort study of HIV positive antiretroviral-naïve 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 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.

Conditions

HIV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. HIV positive by the Standard of Care.

2. Documented informed consent for participants' ≥18 years old or informed consent by parents/legally accepted representative (LAR) or assent for minor participants prior to study procedures.

3. Willing to comply with the study procedures.

4. Agrees to the collection and storage of specimens for use in future research on immune function, pathogenesis, and/or genetics/genomics of HIV and opportunistic infections. (The participant may decline participation in genetic or genomics research and will still be eligible for the study).

Exclusion Criteria

1. Plans to move away to an area where the participant will not be able to complete the study visits in 3 years.

2. Is currently imprisoned.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Ina-Respond

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Dr. dr. Tuti Parwati Merati, Sp.PD.KPTI

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Udayana University-Sanglah Hospital, Denpasar

Locations

Site 520: University of Udayana/Sanglah Hospital

Denpasar, Bali, Indonesia

Site 560: University of Diponegoro/ Dr. Kariadi Hospital

Semarang, Central of Java, Indonesia

Site 530: University of Indonesia/ Dr. Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, Indonesia

Site 540: Penyakit Infeksi Sulianti Saroso Hospital

Jakarta, DKI Jakarta, Indonesia

Site 590: Persahabatan Hospital

Jakarta, DKI Jakarta, Indonesia

Site 660 RSUD Abdul Wahab Sjahranie

Samarinda, East Kalimantan, Indonesia

Site 700 - RSUD Dr.TC Hillers

Maumere, East Nusa Tenggara, Indonesia

Site 570: University of Airlangga/ Dr. Soetomo Hospital

Surabaya, East of Java, Indonesia

Site 600 : Adam Malik Hospital

Medan, North Sumatra, Indonesia

Site 650: Budi Kemuliaan Hospital

Batam, Riau Islands, Indonesia

Site 630: M. Ansari Saleh Hospital

Banjarmasin, South Kalimantan, Indonesia

Site 690 - RSUD Abepura

Jayapura, Special Region of Papua, Indonesia

Site 510: University of Padjajaran/ Dr. Hasan Sadikin Hospital

Bandung, West Java, Indonesia

Site 610 : RSU Kabupaten Tangerang

Tangerang, West Java, Indonesia

Site 680 - RSUD dr Soedarso

Pontianak, West Kalimantan, Indonesia

Site 670 - RSUD Dr. Zainoel Abidin

Banda Aceh, , Indonesia

Site 640: St. Carolus Hospital

Jakarta, , Indonesia

Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital

Makassar, , Indonesia

Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital

Yogyakarta, , Indonesia

Countries

Indonesia

References

Merati TP, Yunihastuti E, Wisaksana R, Kurniati N, Arlinda D, Karyana M, Susanto NH, Lokida D, Kosasih H, Diana A, Bang LE, Setiyaningrum M, Amin DM, Eppy E, Cahyawati WASN, Danudirgo EW, Darmaja IMG, Farhanah N, Gunawan CA, Hadi U, Jamil KF, Katu S, Kembaren T, Kosa IGR, Norosingomurti DL, Purnama A, Laksanawati IS, Rusli A, Somia IKA, Subronto YW, Toruan IL, Ridzon R, Liang CJ, Neal AT, Chen RY; INA-PROACTIVE Study Group. A prospective observational cohort study of HIV infection in Indonesia: baseline characteristics and one-year mortality. BMC Infect Dis. 2025 Jan 20;25(1):87. doi: 10.1186/s12879-024-10354-8.

Reference Type: DERIVED

PMID: 39833697 (View on PubMed)

Other Identifiers

U1111-1263-2484

Identifier Type: OTHER

Identifier Source: secondary_id

INA104

Identifier Type: -

Identifier Source: org_study_id