Package of Care to Improve Retention in ART and Mortality Among Treatment Naive HIV Infected Individuals

NCT03723525 | Completed Phase 4 DMC

• 2 other identifiers: 525NPL-H-SCF
• Study Type: interventional
• Target: 1,073
• Locations: 1 country
• Sites: 10

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.

Conditions

HIV

Keywords

Package of care; Rapid Initiation of antiretroviral therapy; Advanced HIV disease; mHealth; Acquired Immunodeficiency Syndrome; Management of advance HIV disease

Outcome Measures

Primary Outcomes (1)

• Mortality

  All-cause mortality over the first 24 weeks after starting ART

  Week 24

Secondary Outcomes (7)

• Retention in treatment

  Week 48

• Adherence to ART

  Week 0-48

• Morbidity

  Week 48

• Viral load suppression

  Week 48

• Cost effectiveness of Package of care

  Week 48

Other Outcomes (3)

• Cryptococcal antigen

  Week 48

• Immune Reconstitution Inflammatory Syndrome (IRIS)

  Week 48

• CD4 cell count

  Week 48

Study Arms (2)

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.

Combination Product: Package of HIV care

Standard HIV care

EXPERIMENTAL

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

Interventions

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 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.

Also known as: Screening and management of opportunistic infection, Rapid ART initiation and Enhanced adherence support

Package of HIV care

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).

Standard HIV care

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Centre for AIDs and STD Control, Nepal: lead
• Sukraraj Tropical and Infectious Disease Hospital: collaborator
• National Academy of Medical Sciences, Nepal: collaborator
• Tribhuvan University Teaching Hospital, Institute Of Medicine.: collaborator
• Rapti Sub-regional Hospital: collaborator
• Western Regional Hospital: collaborator
• Seti Zonal Hospital: collaborator
• Tikapur Hospital: collaborator
• Mahakali Zonal Hospital: collaborator
• Bharatpur Eye Hospital: collaborator
• B.P. Koirala Institute of Health Sciences: collaborator
• Expertise France: collaborator
• Karolinska Institutet: collaborator

Study Sites (10)

Sukraraj Tropical & Infectious Disease Control Hospital

Kathmandu, Bagmati, Nepal

Location

Bharatpur District Hospital

Bharatpur, Nepal

Location

Rapti Sub Regional Hospital

Dāng, Nepal

Location

Seti Zonal Hospital

Kailāli̇̄, Nepal

Location

Tikapur Hospital

Kailāli̇̄, Nepal

Location

Mahakali Zonal Hospital

Kañchanpur, Nepal

Location

National Academy of Medical Science (NAMS), Bir Hospital

Kathmandu, Nepal

Location

Tribhuvan University Teaching Hospital

Kathmandu, Nepal

Location

Western Regional Hospital

Pokhara, Nepal

Location

B.P. Koirala Institute of Health Sciences

Sunsari, Nepal

Location

Related Publications (3)

• 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/

  PMID: 29341560 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.

  PMID: 26192873 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.

  PMID: 29352723 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Strategic Information Specialist

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 29, 2018
• Study Start: January 22, 2018
• Primary Completion: December 24, 2019
• Study Completion: December 24, 2019
• Last Updated: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

NE (10)