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

PHASE4CompletedINTERVENTIONAL
Enrollment

1,073

Participants

Timeline

Start Date

January 22, 2018

Primary Completion Date

December 24, 2019

Study Completion Date

December 24, 2019

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).

Trial Locations (10)

Unknown

Sukraraj Tropical & Infectious Disease Control Hospital, Kathmandu

Bharatpur District Hospital, Bharatpur

Rapti Sub Regional Hospital, Dang

Seti Zonal Hospital, Kailāli̇̄

Tikapur Hospital, Kailāli̇̄

Mahakali Zonal Hospital, Kanchanpur

National Academy of Medical Science (NAMS), Bir Hospital, Kathmandu

Tribhuvan University Teaching Hospital, Kathmandu

Western Regional Hospital, Pokhara

B.P. Koirala Institute of Health Sciences, Sunsari

All Listed Sponsors
collaborator

Sukraraj Tropical and Infectious Disease Hospital

UNKNOWN

collaborator

National Academy of Medical Sciences, Nepal

OTHER_GOV

collaborator

Tribhuvan University Teaching Hospital, Institute Of Medicine.

OTHER

collaborator

Rapti Sub-regional Hospital

UNKNOWN

collaborator

Western Regional Hospital

UNKNOWN

collaborator

Seti Zonal Hospital

UNKNOWN

collaborator

Tikapur Hospital

UNKNOWN

collaborator

Mahakali Zonal Hospital

UNKNOWN

collaborator

Bharatpur Eye Hospital

OTHER

collaborator

B.P. Koirala Institute of Health Sciences

OTHER

collaborator

Expertise France

OTHER

collaborator

Karolinska Institutet

OTHER

lead

National Centre for AIDs and STD Control, Nepal

OTHER_GOV

NCT03723525 - Package of Care to Improve Retention in ART and Mortality Among Treatment Naive HIV Infected Individuals | Biotech Hunter | Biotech Hunter