- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03663920
HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia (INAPROACTIVE)
A Prospective Observational Cohort Study on HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Banda Aceh, Indonesia, 24415
- Site 670 - RSUD Dr. Zainoel Abidin
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Jakarta, Indonesia, 10440
- Site 640: St. Carolus Hospital
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Makassar, Indonesia, 90245
- Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital
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Yogyakarta, Indonesia, 55284
- Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital
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Bali
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Denpasar, Bali, Indonesia, 80114
- Site 520: University of Udayana/Sanglah Hospital
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Central Of Java
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Semarang, Central Of Java, Indonesia, 50244
- Site 560: University of Diponegoro/ Dr. Kariadi Hospital
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DKI Jakarta
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Jakarta, DKI Jakarta, Indonesia, 10430
- Site 530: University of Indonesia/ Dr. Cipto Mangunkusumo Hospital
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Jakarta, DKI Jakarta, Indonesia, 14340
- Site 540: Penyakit Infeksi Sulianti Saroso Hospital
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Jakarta, DKI Jakarta, Indonesia, 14340
- Site 590: Persahabatan Hospital
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East Kalimantan
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Samarinda, East Kalimantan, Indonesia, 75123
- Site 660 RSUD Abdul Wahab Sjahranie
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East Nusa Tenggara
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Maumere, East Nusa Tenggara, Indonesia, 86113
- Site 700 - RSUD Dr.TC Hillers
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East Of Java
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Surabaya, East Of Java, Indonesia, 60286
- Site 570: University of Airlangga/ Dr. Soetomo Hospital
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North Sumatra
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Medan, North Sumatra, Indonesia, 20136
- Site 600 : Adam Malik Hospital
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Papua
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Jayapura, Papua, Indonesia, 99351
- Site 690 - RSUD Abepura
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Riau Islands
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Batam, Riau Islands, Indonesia
- Site 650: Budi Kemuliaan Hospital
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South Kalimantan
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Banjarmasin, South Kalimantan, Indonesia, 70125
- Site 630: M. Ansari Saleh Hospital
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West Java
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Bandung, West Java, Indonesia, 40161
- Site 510: University of Padjajaran/ Dr. Hasan Sadikin Hospital
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Tangerang, West Java, Indonesia, 15111
- Site 610 : RSU Kabupaten Tangerang
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West Kalimantan
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Pontianak, West Kalimantan, Indonesia, 78111
- Site 680 - RSUD dr Soedarso
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- 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).
Exclusion criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
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
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Incidence of participants achieving viral suppression with HIV RNA Viral Load <1000 copies/mL.
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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
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Secondary Outcome Measures
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
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Proportion of participants with HIV RNA Viral Load <1000 copies/mL at baseline and every six-monthly follow-up visit as virological outcomes
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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
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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
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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
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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
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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
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Proportion of AIDS defining illnesses from baseline and every six-monthly follow-up visit as disease progression outcomes
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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
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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
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Proportion of serious non-AIDS disease from baseline and every six-monthly follow-up visit as disease progression outcomes
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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
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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
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Incidence of AIDS-related deaths at baseline and every six-monthly follow-up visit as the mortality outcomes
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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
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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
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Incidence of non-AIDS-related deaths at baseline and every six-monthly follow-up visit as the mortality outcomes
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Prof. Dr. dr. Tuti Parwati Merati, Sp.PD.KPTI, Faculty of Medicine Udayana University-Sanglah Hospital, Denpasar
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
- Coinfection
Other Study ID Numbers
- INA104
- U1111-1263-2484 (Other Identifier: WHO UTN Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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