HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia
- Conditions
- HIV
- Registration Number
- NCT03663920
- Lead Sponsor
- Ina-Respond
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4336
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of participants achieving viral suppression (HIV RNA Viral Load <1000 copies/mL) in Indonesia. 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.
- Secondary Outcome Measures
Name Time Method 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 AIDS defining illnesses from baseline and every six-monthly follow-up visit as disease progression outcomes
Incidence of non-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 Incidence of non-AIDS-related deaths at baseline and every six-monthly follow-up visit as the mortality outcomes
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 Proportion of participants with HIV RNA Viral Load \<1000 copies/mL at baseline and every six-monthly follow-up visit as virological outcomes
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 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
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 Proportion of serious non-AIDS disease from baseline and every six-monthly follow-up visit as disease progression outcomes
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 Incidence of AIDS-related deaths at baseline and every six-monthly follow-up visit as the mortality outcomes
Trial Locations
- Locations (19)
Site 540: Penyakit Infeksi Sulianti Saroso Hospital
🇮🇩Jakarta, DKI Jakarta, Indonesia
Site 590: Persahabatan Hospital
🇮🇩Jakarta, DKI Jakarta, Indonesia
Site 630: M. Ansari Saleh Hospital
🇮🇩Banjarmasin, South Kalimantan, Indonesia
Site 670 - RSUD Dr. Zainoel Abidin
🇮🇩Banda Aceh, Indonesia
Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital
🇮🇩Yogyakarta, Indonesia
Site 600 : Adam Malik Hospital
🇮🇩Medan, North Sumatra, Indonesia
Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital
🇮🇩Makassar, 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 650: Budi Kemuliaan Hospital
🇮🇩Batam, Riau Islands, Indonesia
Site 680 - RSUD dr Soedarso
🇮🇩Pontianak, West Kalimantan, Indonesia
Site 640: St. Carolus Hospital
🇮🇩Jakarta, 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 610 : RSU Kabupaten Tangerang
🇮🇩Tangerang, West Java, Indonesia
Site 690 - RSUD Abepura
🇮🇩Jayapura, Papua, Indonesia
Site 510: University of Padjajaran/ Dr. Hasan Sadikin Hospital
🇮🇩Bandung, West Java, Indonesia
Site 520: University of Udayana/Sanglah Hospital
🇮🇩Denpasar, Bali, Indonesia