HIV
Conditions
Keywords
Package of care, Rapid Initiation of antiretroviral therapy, Advanced HIV disease, mHealth, Acquired Immunodeficiency Syndrome, Management of advance HIV disease
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.
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.
Interventions
COMBINATION_PRODUCTPackage 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_PRODUCTStandard 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
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
National Centre for AIDs and STD Control, Nepal
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Week 24 | All-cause mortality over the first 24 weeks after starting ART |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | Week 48 | Incidence of opportunistic infection and immune reconstitution inflammatory syndrome (IRIS) |
| Cost effectiveness of Package of care | 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 | Week 48 | All-cause mortality over the first 96 weeks after starting ART |
| Hospitalization | 0-48 | Hospital inpatient episodes and total days admitted |
| Retention in treatment | Week 48 | PLHIV alive and on ART over the first 48 weeks after starting ART |
| Adherence to ART | 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). |
| Viral load suppression | Week 48 | PLHIV and on ART who have a suppressed viral load (\<1000 copies/mL) |
Other
| Measure | Time frame | Description |
|---|---|---|
| CD4 cell count | Week 48 | Changes in CD4 cell count |
| Cryptococcal antigen | Week 48 | Burden of serum cryptococcal antigen positive in PLHIV with CD4 \< 100/mL |
| Immune Reconstitution Inflammatory Syndrome (IRIS) | Week 48 | Burden of IRIS |
Countries
Nepal
Outcome results
None listed