HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia (INAPROACTIVE)

November 9, 2023 updated by: Ina-Respond

A Prospective Observational Cohort Study on HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4336

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Banda Aceh, Indonesia, 24415
        • Site 670 - RSUD Dr. Zainoel Abidin
      • Jakarta, Indonesia, 10440
        • Site 640: St. Carolus Hospital
      • Makassar, Indonesia, 90245
        • Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital
      • Yogyakarta, Indonesia, 55284
        • Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital
    • Bali
      • Denpasar, Bali, Indonesia, 80114
        • Site 520: University of Udayana/Sanglah Hospital
    • Central Of Java
      • Semarang, Central Of Java, Indonesia, 50244
        • Site 560: University of Diponegoro/ Dr. Kariadi Hospital
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Site 530: University of Indonesia/ Dr. Cipto Mangunkusumo Hospital
      • Jakarta, DKI Jakarta, Indonesia, 14340
        • Site 540: Penyakit Infeksi Sulianti Saroso Hospital
      • Jakarta, DKI Jakarta, Indonesia, 14340
        • Site 590: Persahabatan Hospital
    • East Kalimantan
      • Samarinda, East Kalimantan, Indonesia, 75123
        • Site 660 RSUD Abdul Wahab Sjahranie
    • East Nusa Tenggara
      • Maumere, East Nusa Tenggara, Indonesia, 86113
        • Site 700 - RSUD Dr.TC Hillers
    • East Of Java
      • Surabaya, East Of Java, Indonesia, 60286
        • Site 570: University of Airlangga/ Dr. Soetomo Hospital
    • North Sumatra
      • Medan, North Sumatra, Indonesia, 20136
        • Site 600 : Adam Malik Hospital
    • Papua
      • Jayapura, Papua, Indonesia, 99351
        • Site 690 - RSUD Abepura
    • Riau Islands
      • Batam, Riau Islands, Indonesia
        • Site 650: Budi Kemuliaan Hospital
    • South Kalimantan
      • Banjarmasin, South Kalimantan, Indonesia, 70125
        • Site 630: M. Ansari Saleh Hospital
    • West Java
      • Bandung, West Java, Indonesia, 40161
        • Site 510: University of Padjajaran/ Dr. Hasan Sadikin Hospital
      • Tangerang, West Java, Indonesia, 15111
        • Site 610 : RSU Kabupaten Tangerang
    • West Kalimantan
      • Pontianak, West Kalimantan, Indonesia, 78111
        • Site 680 - RSUD dr Soedarso

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of participants achieving viral suppression (HIV RNA Viral Load <1000 copies/mL) in Indonesia.
Time Frame: 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 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of participants with HIV RNA Viral Load <1000 copies/mL at baseline and every six-monthly follow-up visit.
Time Frame: 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 participants with HIV RNA Viral Load <1000 copies/mL at baseline and every six-monthly follow-up visit as virological outcomes
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.
Time Frame: 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
Evaluate the immunologic response by the CD4 measurement from baseline (Mean change in CD4+ cell count) and every six-monthly follow-up visit as immunological outcomes
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.
Time Frame: 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 from baseline and every six-monthly follow-up visit as disease progression outcomes
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.
Time Frame: 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 from baseline and every six-monthly follow-up visit as disease progression outcomes
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.
Time Frame: 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 as the mortality outcomes
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 non-AIDS-related deaths at baseline and every six-monthly follow-up visit.
Time Frame: 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 non-AIDS-related deaths at baseline and every six-monthly follow-up visit as the mortality outcomes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ina-Respond

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Prof. Dr. dr. Tuti Parwati Merati, Sp.PD.KPTI, Faculty of Medicine Udayana University-Sanglah Hospital, Denpasar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INA104
  • U1111-1263-2484 (Other Identifier: WHO UTN Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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