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

HIV Clinical Trial

Official title:
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.

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03723525
Study type Interventional
Source National Centre for AIDs and STD Control, Nepal
Contact
Status Completed
Phase Phase 4
Start date January 22, 2018
Completion date December 24, 2019
View Details
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