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

Phase 4

Completed

• Conditions: HIV
• Interventions: Combination Product: Package of HIV care; Combination Product: Standard HIV care

• Registration Number: NCT03723525
• Lead Sponsor: National Centre for AIDs and STD Control, Nepal

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.

Study Timeline

• Study Start: 2018-01-22
• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-26
• Study First Posted: 2018-10-29
• Primary Completion: 2019-12-24
• Study Completion: 2019-12-24
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-18
• Last Update Posted: 2020-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1073

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Package of HIV care	Package of HIV care	Screening and management (Preventive / Pre-emptive therapies dosages) of different opportunistic infections (OI), Rapid antiretroviral therapy (ART) initiation and Enhanced adherence support.
Standard HIV care	Standard HIV care	Screening and management of common OIs, basic health assessment (CD4, viral load and other tests), ARV drugs and follow up.

Primary Outcome Measures

Name	Time	Method
Mortality	Week 24	All-cause mortality over the first 24 weeks after starting ART

Secondary Outcome Measures

Name	Time	Method
Retention in treatment	Week 48	PLHIV alive and on ART over the first 48 weeks after starting ART
Mortality	Week 48	All-cause mortality over the first 96 weeks after starting ART
Hospitalization	0-48	Hospital inpatient episodes and total days admitted
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).
Morbidity	Week 48	Incidence of opportunistic infection and immune reconstitution inflammatory syndrome (IRIS)
Viral load suppression	Week 48	PLHIV and on ART who have a suppressed viral load (\<1000 copies/mL)
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.

Trial Locations

Locations (10)

Mahakali Zonal Hospital; 🇳🇵 Kanchanpur, Nepal

Rapti Sub Regional Hospital; 🇳🇵 Dang, Nepal

Tikapur Hospital; 🇳🇵 Kailālī, Nepal

Sukraraj Tropical & Infectious Disease Control Hospital; 🇳🇵 Kathmandu, Bagmati, Nepal

Seti Zonal Hospital; 🇳🇵 Kailālī, Nepal

National Academy of Medical Science (NAMS), Bir Hospital; 🇳🇵 Kathmandu, Nepal

Bharatpur District Hospital; 🇳🇵 Bharatpur, Nepal

Tribhuvan University Teaching Hospital; 🇳🇵 Kathmandu, Nepal

B.P. Koirala Institute of Health Sciences; 🇳🇵 Sunsari, Nepal

Western Regional Hospital; 🇳🇵 Pokhara, Nepal