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

National Centre for AIDs and STD Control, Nepal

Status and phase: Completed; Phase 4

Conditions: HIV

Treatments: Combination Product: Standard HIV care; Combination Product: Package of HIV care

Study type: Interventional

Funder types: Other

Identifiers

NCT03723525

NPL-H-SCF (Other Identifier)

525

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,073 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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1,073 participants in 2 patient groups

Package of HIV care

Experimental group

Description:

Screening and management (Preventive / Pre-emptive therapies dosages) of different opportunistic infections (OI), Rapid antiretroviral therapy (ART) initiation and Enhanced adherence support.

Treatment:

Combination Product: Package of HIV care

Standard HIV care

Experimental group

Description:

Screening and management of common OIs, basic health assessment (CD4, viral load and other tests), ARV drugs and follow up.

Treatment:

Combination Product: Standard HIV care