Package of Care to Improve Retention in ART and Mortality Among Treatment Naive HIV Infected Individuals (PRAN)
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|ClinicalTrials.gov Identifier: NCT03723525|
Recruitment Status : Active, not recruiting
First Posted : October 29, 2018
Last Update Posted : May 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV||Combination Product: Package of HIV care Combination Product: Standard HIV care||Phase 4|
PRAN is an open-label trial of 1000 Treatment-Naive PLHIV aged 16 years or more.
- 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.
- 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.
- 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,
- 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,
- To assess the cost-effectiveness of this package of care intervention.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1073 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of World Health Organization (WHO) Recommendations on Test and Treat Strategy, Managing Advanced HIV Disease and Rapid Initiation of ART Among People Living With HIV in Nepal: A Cluster Randomized Trial.|
|Actual Study Start Date :||January 22, 2018|
|Estimated Primary Completion Date :||September 22, 2019|
|Estimated Study Completion Date :||November 29, 2019|
Experimental: 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.
Combination Product: 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
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.
Other Name: Screening and management of opportunistic infection, Rapid ART initiation and Enhanced adherence support
Experimental: Standard HIV care
Screening and management of common OIs, basic health assessment (CD4, viral load and other tests), ARV drugs and follow up.
Combination Product: 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).
- Mortality [ Time Frame: Week 24 ]All-cause mortality over the first 24 weeks after starting ART
- Retention in treatment [ Time Frame: Week 48 ]PLHIV alive and on ART over the first 48 weeks after starting ART
- Adherence to ART [ Time Frame: Week 0-48 ]Adherence will be assessed on a monthly basis (total pills taken by patient in last month/ total pills prescribed to patient in last month).
- Morbidity [ Time Frame: Week 48 ]Incidence of opportunistic infection and immune reconstitution inflammatory syndrome (IRIS)
- Viral load suppression [ Time Frame: Week 48 ]PLHIV and on ART who have a suppressed viral load (<1000 copies/mL)
- Cost effectiveness of Package of care [ Time Frame: Week 48 ]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.
- Mortality [ Time Frame: Week 48 ]All-cause mortality over the first 96 weeks after starting ART
- Hospitalization [ Time Frame: 0-48 ]Hospital inpatient episodes and total days admitted
- Cryptococcal antigen [ Time Frame: Week 48 ]Burden of serum cryptococcal antigen positive in PLHIV with CD4 < 100/mL
- Immune Reconstitution Inflammatory Syndrome (IRIS) [ Time Frame: Week 48 ]Burden of IRIS
- CD4 cell count [ Time Frame: Week 48 ]Changes in CD4 cell count
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723525
|Sukraraj Tropical & Infectious Disease Control Hospital|
|Kathmandu, Bagmati, Nepal|
|Bharatpur District Hospital|
|Rapti Sub Regional Hospital|
|Seti Zonal Hospital|
|Mahakali Zonal Hospital|
|National Academy of Medical Science (NAMS), Bir Hospital|
|Tribhuvan University Teaching Hospital|
|Western Regional Hospital|
|B.P. Koirala Institute of Health Sciences|
|Principal Investigator:||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|
|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|