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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 : Recruiting
First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Collaborators:
Sukraraj Tropical and Infectious Disease Hospital
National Academy of Medical Sciences, Nepal
Tribhuvan University Teaching Hospital, Institute Of Medicine.
Rapti Sub-regional Hospital
Western Regional Hospital
Seti Zonal Hospital
Tikapur Hospital
Mahakali Zonal Hospital
Bharatpur Eye Hospital
B.P. Koirala Institute of Health Sciences
Expertise France
Karolinska Institutet
Information provided by (Responsible Party):
Keshab Deuba, National Centre for AIDs and STD Control, Nepal

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Combination Product: Package of HIV care Combination Product: Standard HIV care Phase 4

Detailed Description:

PRAN is an open-label trial of 1000 Treatment-Naive PLHIV aged 16 years or more.

  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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : March 1, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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

  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.

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).




Primary Outcome Measures :
  1. Mortality [ Time Frame: Week 24 ]
    All-cause mortality over the first 24 weeks after starting ART


Secondary Outcome Measures :
  1. Retention in treatment [ Time Frame: Week 48 ]
    PLHIV alive and on ART over the first 48 weeks after starting ART

  2. 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).

  3. Morbidity [ Time Frame: Week 48 ]
    Incidence of opportunistic infection and immune reconstitution inflammatory syndrome (IRIS)

  4. Viral load suppression [ Time Frame: Week 48 ]
    PLHIV and on ART who have a suppressed viral load (<1000 copies/mL)

  5. 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.

  6. Mortality [ Time Frame: Week 48 ]
    All-cause mortality over the first 96 weeks after starting ART

  7. Hospitalization [ Time Frame: 0-48 ]
    Hospital inpatient episodes and total days admitted


Other Outcome Measures:
  1. Cryptococcal antigen [ Time Frame: Week 48 ]
    Burden of serum cryptococcal antigen positive in PLHIV with CD4 < 100/mL

  2. Immune Reconstitution Inflammatory Syndrome (IRIS) [ Time Frame: Week 48 ]
    Burden of IRIS

  3. CD4 cell count [ Time Frame: Week 48 ]
    Changes in CD4 cell count



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than or equal to 16 years
  • Diagnosed with HIV-infection
  • ART-naive
  • Consent for study participation

Exclusion Criteria:

  • Age less than or equal to 15 years
  • Any previous use of ART

Information from the National Library of Medicine

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


Contacts
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Contact: Keshab Deuba, MMSc, PhD 9779843064279 deuba4k@gmail.com
Contact: Rajya S Nyachhyon Kunwar, MBBS, MPH 9779849208499 rajyashreekunwar@gmail.com

Locations
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Nepal
Sukraraj Tropical & Infectious Disease Control Hospital Recruiting
Kathmandu, Bagmati, Nepal
Contact: Dr Anup Bastola, MD         
Contact: Dr Bimal Chalise, MD         
Principal Investigator: Dr Abdesh Mishra, MD         
Principal Investigator: Dr Parmeshwori Shrestha, MBBS         
Sub-Investigator: Sabitra Dhakal, PCL Nursing         
Sub-Investigator: Amee Thapaliya, PCL Nursing         
Sub-Investigator: Surakshya Ghimire, BIM         
Principal Investigator: Dr Manisha Rawal, MDGP         
Principal Investigator: Dr Bimal Chalise, MD         
Principal Investigator: Dr Anup Bastola, MD         
Bharatpur District Hospital Recruiting
Bharatpur, Nepal
Contact: Dr Unnat Shrestha, MD         
Contact: Babita Ranabhat, Bachelor in Nursing         
Principal Investigator: Dr Unnat Shrestha, MD         
Sub-Investigator: Babita Ranabhat, Bachelor in Nursing         
Principal Investigator: Dr Sanjay Shrestha, MD         
Rapti Sub Regional Hospital Recruiting
Dang, Nepal
Contact: Dr Gagan Neupane, MBBS         
Contact: Shova Kunwar, PCL Nursing         
Principal Investigator: Dr Gagan Neupane, MBBS         
Sub-Investigator: Shova Kunwar, BSc Nursing         
Seti Zonal Hospital Recruiting
Kailālī, Nepal
Contact: Dr Aashika Singh, MBBS         
Contact: Puja Bhatt, PCL in General Medicine         
Principal Investigator: Dr Aashika Singh, MBBS         
Sub-Investigator: Puja Bhatt, PCL in General Medicine         
Tikapur Hospital Recruiting
Kailālī, Nepal
Contact: Dr Rakesh Jha, MBBS         
Contact: Anu Danuwar, PCL Nursing         
Principal Investigator: Dr Rakesh Jha, MBBS         
Sub-Investigator: Anu Danuwar, PCL Nursing         
Mahakali Zonal Hospital Recruiting
Kanchanpur, Nepal
Contact: Dr Hari K Shrestha, MD         
Contact: Bimala Bhatta, PCL Nursing         
Principal Investigator: Dr Hari K Shrestha, MD         
Sub-Investigator: Bimala Bhatta, PCL Nursing         
National Academy of Medical Science (NAMS), Bir Hospital Recruiting
Kathmandu, Nepal
Contact: Dr Sushil Shakya, MD         
Principal Investigator: Dr Sushil Shakya, MD         
Sub-Investigator: Kamala Subedi, PCL Nursing         
Tribhuvan University Teaching Hospital Recruiting
Kathmandu, Nepal
Contact: Dr. Rakshya Shrestha, MD         
Principal Investigator: Dr Rakshya Shrestha, MD         
Sub-Investigator: Bijyashree Singh, PCL Nursing         
Principal Investigator: Dr Prem Khadga, MD         
Western Regional Hospital Recruiting
Pokhara, Nepal
Contact: Dr Manoj Koirala, MD         
Principal Investigator: Dr Manoj Koirala, MD         
Sub-Investigator: Mangala Sinjali, PCL Nursing         
B.P. Koirala Institute of Health Sciences Recruiting
Sunsari, Nepal
Contact: Dr Roshan Chhetri, MD         
Contact: Pabitra Limbu, PCL Nursing         
Principal Investigator: Dr Roshan Chhetri, MD         
Sub-Investigator: Pabitra Limbu, PCL Nursing         
Sub-Investigator: Renu Yadav, PCL Nursing         
Principal Investigator: Dr Vivek Kattel, MD         
Sponsors and Collaborators
National Centre for AIDs and STD Control, Nepal
Sukraraj Tropical and Infectious Disease Hospital
National Academy of Medical Sciences, Nepal
Tribhuvan University Teaching Hospital, Institute Of Medicine.
Rapti Sub-regional Hospital
Western Regional Hospital
Seti Zonal Hospital
Tikapur Hospital
Mahakali Zonal Hospital
Bharatpur Eye Hospital
B.P. Koirala Institute of Health Sciences
Expertise France
Karolinska Institutet
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Keshab Deuba, National Centre for AIDs and STD Control, Nepal:
Study Protocol  [PDF] December 5, 2017


Publications:
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Responsible Party: Keshab Deuba, Strategic Information Specialist, National Centre for AIDs and STD Control, Nepal
ClinicalTrials.gov Identifier: NCT03723525     History of Changes
Other Study ID Numbers: 525
NPL-H-SCF ( Other Identifier: The Global Fund to Fight AIDS, Tuberculosis and Malaria )
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Keshab Deuba, National Centre for AIDs and STD Control, Nepal:
Package of care
Rapid Initiation of antiretroviral therapy
Advanced HIV disease
mHealth
Acquired Immunodeficiency Syndrome
Management of advance HIV disease

Additional relevant MeSH terms:
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Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents