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.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 1,073
- Locations
- 14
- Primary Endpoint
- Mortality
Study Overview
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.
- 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.
- 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.
- 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,
- 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,
- To assess the cost-effectiveness of this package of care intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Mortality
Time Frame: Week 24
All-cause mortality over the first 24 weeks after starting ART
Secondary Outcomes
- Retention in treatment(Week 48)
- Mortality(Week 48)
- Hospitalization(0-48)
- Adherence to ART(Week 0-48)
- Morbidity(Week 48)
- Viral load suppression(Week 48)
- Cost effectiveness of Package of care(Week 48)
Investigators
Keshab Deuba
Strategic Information Specialist
National Centre for AIDs and STD Control, Nepal