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| ID | Type | Description | Link |
|---|---|---|---|
| NPL-H-SCF | Other Identifier | The Global Fund to Fight AIDS, Tuberculosis and Malaria |
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| Name | Class |
|---|---|
| Sukraraj Tropical and Infectious Disease Hospital | UNKNOWN |
| National Academy of Medical Sciences, Nepal | OTHER_GOV |
| Tribhuvan University Teaching Hospital, Institute Of Medicine. | OTHER |
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This is a cluster randomized trial to determine whether a package of care including rapid antiretroviral therapy (ART) initiation, as compared to standard ART initiation, improves mortality, retention in care and viral suppression among treatment naive people living with HIV (PLHIV) in Nepal. Package of care includes immediate screening and treatment of opportunistic infections (OIs), rapid ART initiation and enhanced retention in care using mobile health (mHealth) and weekly/biweekly home-based adherence/ retention support linked to community care centre. Standard of care includes screening and management of common OIs, baseline assessment (CD4, viral load and other tests), antiretroviral drugs and ART follow up.
PRAN is an open-label trial of 1000 Treatment-Naive PLHIV aged 16 years or more.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Package of HIV care | Experimental | Screening and management (Preventive / Pre-emptive therapies dosages) of different opportunistic infections (OI), Rapid antiretroviral therapy (ART) initiation and Enhanced adherence support. |
|
| Standard HIV care | Experimental | Screening and management of common OIs, basic health assessment (CD4, viral load and other tests), ARV drugs and follow up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Package of HIV care | Combination Product | A. Screening and management (Preventive / Pre-emptive therapies dosages) of different opportunistic infections (OI). Detail information mentioned in the manual (refer to uploaded protocol). B. Rapid ART Initiation
C. Enhanced Adherence/Retention Support: mHealth: Receive text messages in mobile regarding appointment reminder (pill pick up, CD4 test, viral load test, early infant diagnosis (EID) test etc.) and general awareness messages (positive prevention, the importance of regular health check-up etc.). PLHIV with advanced HIV disease will also receive weekly/biweekly home-based adherence/ retention support linked to community care centre and community home-based care. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | All-cause mortality over the first 24 weeks after starting ART | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Retention in treatment | PLHIV alive and on ART over the first 48 weeks after starting ART | Week 48 |
| Adherence to ART | Adherence will be assessed on a monthly basis (total pills taken by patient in last month/ total pills prescribed to patient in last month). |
| Measure | Description | Time Frame |
|---|---|---|
| Cryptococcal antigen | Burden of serum cryptococcal antigen positive in PLHIV with CD4 < 100/mL | Week 48 |
| Immune Reconstitution Inflammatory Syndrome (IRIS) | Burden of IRIS |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Basu Dev Pandey, MD, PhD | National Centre for AIDS and STD Control | Principal Investigator |
| Bir B Rawal, MA | National Centre for AIDS and STD Control | Principal Investigator |
| Rajan K Bhattarai, MPH | Save the Children | Principal Investigator |
| Rajya Shree Nyachhyon Kunwar, MBBS, MPH | National Centre for AIDS and STD Control/ Global Fund Programs | Principal Investigator |
| Upendra Shrestha, MPH | National Centre for AIDS and STD Control/ Global Fund Programs | Principal Investigator |
| Rajesh Khanal, MSc | National Centre for AIDS and STD Control/ Global Fund Programs | Principal Investigator |
| Marie Lagrange-Xelot, MD | Expertise France | Principal Investigator |
| Tristan Delory, MD | Expertise France | Principal Investigator |
| Anna Mia Ekstrom, MD, MPH, PhD | Dept of Infectious Diseases Karolinska University Hospital & Dept of Public Health (Global Health/IHCAR), Karolinska Institutet, Stockholm |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sukraraj Tropical & Infectious Disease Control Hospital | Kathmandu | Bagmati | Nepal | |||
| Bharatpur District Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29341560 | Background | Guidelines for Managing Advanced HIV Disease and Rapid Initiation of Antiretroviral Therapy. Geneva: World Health Organization; 2017. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK475977/ | |
| 26192873 | Background | INSIGHT START Study Group; Lundgren JD, Babiker AG, Gordin F, Emery S, Grund B, Sharma S, Avihingsanon A, Cooper DA, Fatkenheuer G, Llibre JM, Molina JM, Munderi P, Schechter M, Wood R, Klingman KL, Collins S, Lane HC, Phillips AN, Neaton JD. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N Engl J Med. 2015 Aug 27;373(9):795-807. doi: 10.1056/NEJMoa1506816. Epub 2015 Jul 20. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 5, 2017 | Oct 26, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
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| Rapti Sub-regional Hospital | UNKNOWN |
| Western Regional Hospital | UNKNOWN |
| Seti Zonal Hospital | UNKNOWN |
| Tikapur Hospital | UNKNOWN |
| Mahakali Zonal Hospital | UNKNOWN |
| Bharatpur Eye Hospital | OTHER |
| B.P. Koirala Institute of Health Sciences | OTHER |
| Expertise France | OTHER |
| Karolinska Institutet | OTHER |
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|
|
| Standard HIV care | Combination Product | Standard of HIV care includes screening and management of OI (OI- tuberculosis (TB), bacterial pneumonia, herpes, and candidiasis), baseline assessment (CD4 and other blood tests- complete blood count, hemoglobin, platelets, liver function test, renal function test, urine for albumin, chest x-ray), at 6 months CD4 test, viral load (twice a year) and then on a yearly basis, additional lab test at 3 months, 6 months, antiretroviral (ARV) toxicity monitoring like hemoglobin (Zidovudine), Serum Glutamic-Pyruvic Transaminase (Nevirapine/Efavirenz), Creatinine (Tenofovir), prophylaxis (Co-trimoxazole preventive therapy CD4<350 and WHO stage III and IV and Isoniazid preventive therapy if eligible) and ART / follow up (generally monthly/ bimonthly). |
|
| Week 0-48 |
| Morbidity | Incidence of opportunistic infection and immune reconstitution inflammatory syndrome (IRIS) | Week 48 |
| Viral load suppression | PLHIV and on ART who have a suppressed viral load (<1000 copies/mL) | Week 48 |
| Cost effectiveness of Package of care | Intervention cost will be calculated from estimates of the per-patient quantity of services used in delivery of package of care. Cost per death prevented and cost per DALY gained. | Week 48 |
| Mortality | All-cause mortality over the first 96 weeks after starting ART | Week 48 |
| Hospitalization | Hospital inpatient episodes and total days admitted | 0-48 |
| Week 48 |
| CD4 cell count | Changes in CD4 cell count | Week 48 |
| Principal Investigator |
| Tara Nath Pokharel, MD, MPH | National Centre for AIDS and STD Control | Principal Investigator |
| Keshab Deuba, MMSc, PhD | National Centre for AIDS and STD Control/ Global Fund Programs | Principal Investigator |
| Bharatpur |
| Nepal |
| Rapti Sub Regional Hospital | Dāng | Nepal |
| Seti Zonal Hospital | Kailāli̇̄ | Nepal |
| Tikapur Hospital | Kailāli̇̄ | Nepal |
| Mahakali Zonal Hospital | Kañchanpur | Nepal |
| National Academy of Medical Science (NAMS), Bir Hospital | Kathmandu | Nepal |
| Tribhuvan University Teaching Hospital | Kathmandu | Nepal |
| Western Regional Hospital | Pokhara | Nepal |
| B.P. Koirala Institute of Health Sciences | Sunsari | Nepal |
| 29352723 | Background | Molina JM, Grund B, Gordin F, Williams I, Schechter M, Losso M, Law M, Ekong E, Mwelase N, Skoutelis A, Wiselka MJ, Vandekerckhove L, Benfield T, Munroe D, Lundgren JD, Neaton JD; INSIGHT START study group. Which HIV-infected adults with high CD4 T-cell counts benefit most from immediate initiation of antiretroviral therapy? A post-hoc subgroup analysis of the START trial. Lancet HIV. 2018 Apr;5(4):e172-e180. doi: 10.1016/S2352-3018(18)30003-1. Epub 2018 Jan 16. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |