HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia

NCT03663920 | Completed

• 2 other identifiers: INA104U1111-1263-2484
• Study Type: observational
• Target: 4,336
• Locations: 1 country
• Sites: 19

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.

Conditions

HIV

Keywords

Viral Load; CD4; Mortality; Disease Progression

Outcome Measures

Primary Outcomes (1)

• Incidence of participants achieving viral suppression (HIV RNA Viral Load <1000 copies/mL) in Indonesia.

  Incidence of participants achieving viral suppression with HIV RNA Viral Load \<1000 copies/mL.

  From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years

Secondary Outcomes (6)

• Proportion of participants with HIV RNA Viral Load <1000 copies/mL at baseline and every six-monthly follow-up visit.

  From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years

• Mean change in CD4+ cell count from baseline and every six-monthly follow-up visit.

  From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years

• Proportion of AIDS defining illnesses at baseline and every six-monthly follow-up visit.

  From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years

• Proportion of serious non-AIDS disease at baseline and every six-monthly follow-up visit.

  From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years

• Incidence of AIDS-related deaths at baseline and every six-monthly follow-up visit.

  From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a prospective descriptive study that aims to estimate the characteristics, including among death cases, of people living with HIV in Indonesia. The study population will include people living with HIV at any age, any sex/gender, any HIV-affected key populations, whether ART-naïve or treatment-experienced in Indonesia. To get an estimation with 95% confidence interval (95% CI) that represents the true value in population. We calculated the minimum death cases need to be observed using the proportion of female HIV patients among death cases in Indonesia in 2016 (31%) and case fatality rate for HIV patients in Indonesia, 2016 (1.11%). The minimum number of death to be observed and HIV patients to be enrolled

You may qualify if:

• HIV positive by the Standard of Care.
• 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.
• Willing to comply with the study procedures.
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Ina-Respond: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (19)

Site 520: University of Udayana/Sanglah Hospital

Denpasar, Bali, 80114, Indonesia

Location

Site 560: University of Diponegoro/ Dr. Kariadi Hospital

Semarang, Central of Java, 50244, Indonesia

Location

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

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Site 540: Penyakit Infeksi Sulianti Saroso Hospital

Jakarta, DKI Jakarta, 14340, Indonesia

Location

Site 590: Persahabatan Hospital

Jakarta, DKI Jakarta, 14340, Indonesia

Location

Site 660 RSUD Abdul Wahab Sjahranie

Samarinda, East Kalimantan, 75123, Indonesia

Location

Site 700 - RSUD Dr.TC Hillers

Maumere, East Nusa Tenggara, 86113, Indonesia

Location

Site 570: University of Airlangga/ Dr. Soetomo Hospital

Surabaya, East of Java, 60286, Indonesia

Location

Site 600 : Adam Malik Hospital

Medan, North Sumatra, 20136, Indonesia

Location

Site 650: Budi Kemuliaan Hospital

Batam, Riau Islands, Indonesia

Location

Site 630: M. Ansari Saleh Hospital

Banjarmasin, South Kalimantan, 70125, Indonesia

Location

Site 690 - RSUD Abepura

Jayapura, Special Region of Papua, 99351, Indonesia

Location

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

Bandung, West Java, 40161, Indonesia

Location

Site 610 : RSU Kabupaten Tangerang

Tangerang, West Java, 15111, Indonesia

Location

Site 680 - RSUD dr Soedarso

Pontianak, West Kalimantan, 78111, Indonesia

Location

Site 670 - RSUD Dr. Zainoel Abidin

Banda Aceh, 24415, Indonesia

Location

Site 640: St. Carolus Hospital

Jakarta, 10440, Indonesia

Location

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

Makassar, 90245, Indonesia

Location

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

Yogyakarta, 55284, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 39833697 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Subjects or subject's parent must be willing to allow storage plasma and buffy coat at baseline visit and plasma at every follow up visit. All samples will be stored at the INA-RESPOND Reference laboratory and at each site

MeSH Terms

Conditions

Disease Progression

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

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

  Faculty of Medicine Udayana University-Sanglah Hospital, Denpasar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: September 10, 2018
• Study Start: January 9, 2018
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (19)