An observational study in HIV, sponsored by Ina-Respond. Completed at 19 sites in Indonesia. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Ina-Respond · Observational
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.
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 4,336 is above the median of 200 across 713 observational studies indexed under HIV Infections.
Browse HIV Infections studies →Ina-Respond is the lead sponsor of 9 studies on the registry; none are open to participants now.
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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
Exclusion criteria:
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.
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.
Proportion of participants with HIV RNA Viral Load \<1000 copies/mL at baseline and every six-monthly follow-up visit as virological outcomes
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
Mean change in CD4+ cell count from baseline and every six-monthly follow-up visit.
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
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 at baseline and every six-monthly follow-up visit.
Proportion of AIDS defining illnesses from baseline and every six-monthly follow-up visit as disease progression outcomes
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 at baseline and every six-monthly follow-up visit.
Proportion of serious non-AIDS disease from baseline and every six-monthly follow-up visit as disease progression outcomes
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.
Incidence of AIDS-related deaths at baseline and every six-monthly follow-up visit as the mortality outcomes
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.
Incidence of non-AIDS-related deaths at baseline and every six-monthly follow-up visit as the mortality outcomes
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
Plan to share: No
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