Package of Care to Improve Retention in ART and Mortality Among Treatment Naive HIV Infected Individuals
NCT ID: NCT03723525
Last Updated: 2020-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1073 participants
INTERVENTIONAL
2018-01-22
2019-12-24
Brief Summary
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Detailed Description
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1. To evaluate whether a package of care including rapid ART initiation \[diagnosis and management of opportunistic infection (OI), rapid ART initiation and enhanced adherence support\] is more effective in reducing morbidity and mortality, as compared to standard ART initiation, among ART naïve PLHIV in Nepal.
2. To evaluate whether a package of care including rapid ART initiation is more effective in improving retention in HIV treatment, as compared to standard ART initiation, among ART naïve PLHIV in Nepal.
3. To evaluate whether a package of care including rapid ART initiation improves viral suppression among ART naïve PLHIV in Nepal to a higher extent than standard ART initiation,
4. To evaluate whether the different components of care act synergistically to improve mortality, retention in care and viral suppression among treatment Naive PLHIV, as compared to standard ART initiation,
5. To assess the cost-effectiveness of this package of care intervention.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Package of HIV care
Screening and management (Preventive / Pre-emptive therapies dosages) of different opportunistic infections (OI), Rapid antiretroviral therapy (ART) initiation and Enhanced adherence support.
Package of HIV care
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
1. PLHIV without suspicion or active OI: Initiate ART within seven days or same day after HIV serology disclosure
2. PLHIV with suspicion or active OI: Defer initiation if clinical symptoms suggest tuberculosis or cryptococcal meningitis. Detail information mentioned in the manual (refer to uploaded protocol).
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.
Standard HIV care
Screening and management of common OIs, basic health assessment (CD4, viral load and other tests), ARV drugs and follow up.
Standard HIV care
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).
Interventions
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Package of HIV care
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
1. PLHIV without suspicion or active OI: Initiate ART within seven days or same day after HIV serology disclosure
2. PLHIV with suspicion or active OI: Defer initiation if clinical symptoms suggest tuberculosis or cryptococcal meningitis. Detail information mentioned in the manual (refer to uploaded protocol).
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.
Standard HIV care
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with HIV-infection
* ART-naive
* Consent for study participation
Exclusion Criteria
* Any previous use of ART
16 Years
ALL
No
Sponsors
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Sukraraj Tropical and Infectious Disease Hospital
UNKNOWN
National Academy of Medical Sciences, Nepal
OTHER_GOV
Tribhuvan University Teaching Hospital, Institute Of Medicine.
OTHER
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
National Centre for AIDs and STD Control, Nepal
OTHER_GOV
Responsible Party
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Keshab Deuba
Strategic Information Specialist
Principal Investigators
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Basu Dev Pandey, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Centre for AIDS and STD Control
Bir B Rawal, MA
Role: PRINCIPAL_INVESTIGATOR
National Centre for AIDS and STD Control
Rajan K Bhattarai, MPH
Role: PRINCIPAL_INVESTIGATOR
Save the Children
Rajya Shree Nyachhyon Kunwar, MBBS, MPH
Role: PRINCIPAL_INVESTIGATOR
National Centre for AIDS and STD Control/ Global Fund Programs
Upendra Shrestha, MPH
Role: PRINCIPAL_INVESTIGATOR
National Centre for AIDS and STD Control/ Global Fund Programs
Rajesh Khanal, MSc
Role: PRINCIPAL_INVESTIGATOR
National Centre for AIDS and STD Control/ Global Fund Programs
Marie Lagrange-Xelot, MD
Role: PRINCIPAL_INVESTIGATOR
Expertise France
Tristan Delory, MD
Role: PRINCIPAL_INVESTIGATOR
Expertise France
Anna Mia Ekstrom, MD, MPH, PhD
Role: PRINCIPAL_INVESTIGATOR
Dept of Infectious Diseases Karolinska University Hospital & Dept of Public Health (Global Health/IHCAR), Karolinska Institutet, Stockholm
Tara Nath Pokharel, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
National Centre for AIDS and STD Control
Keshab Deuba, MMSc, PhD
Role: PRINCIPAL_INVESTIGATOR
National Centre for AIDS and STD Control/ Global Fund Programs
Locations
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Western Regional Hospital
Pokhara, , Nepal
Sukraraj Tropical & Infectious Disease Control Hospital
Kathmandu, Bagmati, Nepal
Bharatpur District Hospital
Bharatpur, , Nepal
Rapti Sub Regional Hospital
Dang, , Nepal
Seti Zonal Hospital
Kailāli̇̄, , Nepal
Tikapur Hospital
Kailāli̇̄, , Nepal
Mahakali Zonal Hospital
Kanchanpur, , Nepal
National Academy of Medical Science (NAMS), Bir Hospital
Kathmandu, , Nepal
Tribhuvan University Teaching Hospital
Kathmandu, , Nepal
B.P. Koirala Institute of Health Sciences
Sunsari, , Nepal
Countries
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References
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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/
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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NPL-H-SCF
Identifier Type: OTHER
Identifier Source: secondary_id
525
Identifier Type: -
Identifier Source: org_study_id
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