Clinical trial NCT03663920: HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia
Official title: A Prospective Observational Cohort Study on HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: Viral Load
CD4
Mortality
Disease Progression
Lead sponsor: Ina-Respond
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2018-09-10
Enrollment: 4336
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of participants achieving viral suppression (HIV RNA Viral Load <1000 copies/mL) in Indonesia.
timeFrame: 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:
measure: Proportion of participants with HIV RNA Viral Load <1000 copies/mL at baseline and every six-monthly follow-up visit.
timeFrame: 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
measure: Mean change in CD4+ cell count from baseline and every six-monthly follow-up visit.
timeFrame: 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
measure: Proportion of AIDS defining illnesses at baseline and every six-monthly follow-up visit.
timeFrame: 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
measure: Proportion of serious non-AIDS disease at baseline and every six-monthly follow-up visit.
timeFrame: 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
measure: Incidence of AIDS-related deaths at baseline and every six-monthly follow-up visit.
timeFrame: 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
measure: Incidence of non-AIDS-related deaths at baseline and every six-monthly follow-up visit.
timeFrame: 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
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Site 520: University of Udayana/Sanglah Hospital
state: Bali
city: Semarang
country: Indonesia
facility: Site 560: University of Diponegoro/ Dr. Kariadi Hospital
state: Central Of Java
city: Jakarta
country: Indonesia
facility: Site 530: University of Indonesia/ Dr. Cipto Mangunkusumo Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Site 540: Penyakit Infeksi Sulianti Saroso Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Site 590: Persahabatan Hospital
state: DKI Jakarta
city: Samarinda
country: Indonesia
facility: Site 660 RSUD Abdul Wahab Sjahranie
state: East Kalimantan
city: Maumere
country: Indonesia
facility: Site 700 - RSUD Dr.TC Hillers
state: East Nusa Tenggara
city: Surabaya
country: Indonesia
facility: Site 570: University of Airlangga/ Dr. Soetomo Hospital
state: East Of Java
city: Medan
country: Indonesia
facility: Site 600 : Adam Malik Hospital
state: North Sumatra
city: Jayapura
country: Indonesia
facility: Site 690 - RSUD Abepura
state: Papua
city: Batam
country: Indonesia
facility: Site 650: Budi Kemuliaan Hospital
state: Riau Islands
city: Banjarmasin
country: Indonesia
facility: Site 630: M. Ansari Saleh Hospital
state: South Kalimantan
city: Bandung
country: Indonesia
facility: Site 510: University of Padjajaran/ Dr. Hasan Sadikin Hospital
state: West Java
city: Tangerang
country: Indonesia
facility: Site 610 : RSU Kabupaten Tangerang
state: West Java
city: Pontianak
country: Indonesia
facility: Site 680 - RSUD dr Soedarso
state: West Kalimantan
city: Banda Aceh
country: Indonesia
facility: Site 670 - RSUD Dr. Zainoel Abidin
city: Jakarta
country: Indonesia
facility: Site 640: St. Carolus Hospital
city: Makassar
country: Indonesia
facility: Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital
city: Yogyakarta
country: Indonesia
facility: Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital
Study officials:
affiliation: Faculty of Medicine Udayana University-Sanglah Hospital, Denpasar
name: Prof. Dr. dr. Tuti Parwati Merati, Sp.PD.KPTI
role: PRINCIPAL_INVESTIGATOR
References: