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

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

Interventions

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.

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).

Sponsors & Collaborators

• Sukraraj Tropical and Infectious Disease Hospital

  collaborator UNKNOWN

• National Academy of Medical Sciences, Nepal

  collaborator OTHER_GOV

• Tribhuvan University Teaching Hospital, Institute Of Medicine.

  collaborator OTHER

• Rapti Sub-regional Hospital

  collaborator UNKNOWN

• Western Regional Hospital

  collaborator UNKNOWN

• Seti Zonal Hospital

  collaborator UNKNOWN

• Tikapur Hospital

  collaborator UNKNOWN

• Mahakali Zonal Hospital

  collaborator UNKNOWN

• Bharatpur Eye Hospital

  collaborator OTHER

• B.P. Koirala Institute of Health Sciences

  collaborator OTHER

• Expertise France

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• National Centre for AIDs and STD Control, Nepal

  lead OTHER_GOV

Principal Investigators

• Basu Dev Pandey, MD, PhD · National Centre for AIDS and STD Control

• Bir B Rawal, MA · National Centre for AIDS and STD Control

• Rajan K Bhattarai, MPH · Save the Children

• Rajya Shree Nyachhyon Kunwar, MBBS, MPH · National Centre for AIDS and STD Control/ Global Fund Programs

• Upendra Shrestha, MPH · National Centre for AIDS and STD Control/ Global Fund Programs

• Rajesh Khanal, MSc · National Centre for AIDS and STD Control/ Global Fund Programs

• Marie Lagrange-Xelot, MD · Expertise France

• Tristan Delory, MD · Expertise France

• Anna Mia Ekstrom, MD, MPH, PhD · Dept of Infectious Diseases Karolinska University Hospital & Dept of Public Health (Global Health/IHCAR), Karolinska Institutet, Stockholm

• Tara Nath Pokharel, MD, MPH · National Centre for AIDS and STD Control

• Keshab Deuba, MMSc, PhD · National Centre for AIDS and STD Control/ Global Fund Programs

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-22

Primary Completion

2019-12-24

Completion

2019-12-24

Countries

• Nepal

Study Locations