Clinical trial NCT03723525: Package of Care to Improve Retention in ART and Mortality Among Treatment Naive HIV Infected Individuals
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Keywords: Package of care
Rapid Initiation of antiretroviral therapy
Advanced HIV disease
mHealth
Acquired Immunodeficiency Syndrome
Management of advance HIV disease
Lead sponsor: National Centre for AIDs and STD Control, Nepal
Sponsor class: OTHER_GOV
Collaborators: name: Sukraraj Tropical and Infectious Disease Hospital
name: National Academy of Medical Sciences, Nepal
name: Tribhuvan University Teaching Hospital, Institute Of Medicine.
name: Rapti Sub-regional Hospital
name: Western Regional Hospital
name: Seti Zonal Hospital
name: Tikapur Hospital
name: Mahakali Zonal Hospital
name: Bharatpur Eye Hospital
name: B.P. Koirala Institute of Health Sciences
name: Expertise France
name: Karolinska Institutet
First posted: 2018-10-29
Enrollment: 1073
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: Week 24
Secondary outcomes:
measure: Retention in treatment
timeFrame: Week 48
measure: Adherence to ART
timeFrame: Week 0-48
measure: Morbidity
timeFrame: Week 48
measure: Viral load suppression
timeFrame: Week 48
measure: Cost effectiveness of Package of care
timeFrame: Week 48
measure: Mortality
timeFrame: Week 48
measure: Hospitalization
timeFrame: 0-48
Other outcomes:
measure: Cryptococcal antigen
timeFrame: Week 48
measure: Immune Reconstitution Inflammatory Syndrome (IRIS)
timeFrame: Week 48
measure: CD4 cell count
timeFrame: Week 48
Locations:
city: Kathmandu
country: Nepal
facility: Sukraraj Tropical & Infectious Disease Control Hospital
state: Bagmati
city: Bharatpur
country: Nepal
facility: Bharatpur District Hospital
city: Dang
country: Nepal
facility: Rapti Sub Regional Hospital
city: Kailālī
country: Nepal
facility: Seti Zonal Hospital
city: Kailālī
country: Nepal
facility: Tikapur Hospital
city: Kanchanpur
country: Nepal
facility: Mahakali Zonal Hospital
city: Kathmandu
country: Nepal
facility: National Academy of Medical Science (NAMS), Bir Hospital
city: Kathmandu
country: Nepal
facility: Tribhuvan University Teaching Hospital
city: Pokhara
country: Nepal
facility: Western Regional Hospital
city: Sunsari
country: Nepal
facility: B.P. Koirala Institute of Health Sciences
Study officials:
affiliation: National Centre for AIDS and STD Control
name: Basu Dev Pandey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Centre for AIDS and STD Control
name: Bir B Rawal, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Save the Children
name: Rajan K Bhattarai, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: National Centre for AIDS and STD Control/ Global Fund Programs
name: Rajya Shree Nyachhyon Kunwar, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: National Centre for AIDS and STD Control/ Global Fund Programs
name: Upendra Shrestha, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: National Centre for AIDS and STD Control/ Global Fund Programs
name: Rajesh Khanal, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Expertise France
name: Marie Lagrange-Xelot, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Expertise France
name: Tristan Delory, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Infectious Diseases Karolinska University Hospital & Dept of Public Health (Global Health/IHCAR), Karolinska Institutet, Stockholm
name: Anna Mia Ekstrom, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Centre for AIDS and STD Control
name: Tara Nath Pokharel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: National Centre for AIDS and STD Control/ Global Fund Programs
name: Keshab Deuba, MMSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guidelines for Managing Advanced HIV Disease and Rapid Initiation of Antiretroviral Therapy. Geneva: World Health Organization; 2017. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK475977/
citation: INSIGHT START Study Group; Lundgren JD, Babiker AG, Gordin F, Emery S, Grund B, Sharma S, Avihingsanon A, Cooper DA, Fatkenheuer G, Llibre JM, Molina JM, Munderi P, Schechter M, Wood R, Klingman KL, Collins S, Lane HC, Phillips AN, Neaton JD. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N Engl J Med. 2015 Aug 27;373(9):795-807. doi: 10.1056/NEJMoa1506816. Epub 2015 Jul 20.
citation: Molina JM, Grund B, Gordin F, Williams I, Schechter M, Losso M, Law M, Ekong E, Mwelase N, Skoutelis A, Wiselka MJ, Vandekerckhove L, Benfield T, Munroe D, Lundgren JD, Neaton JD; INSIGHT START study group. Which HIV-infected adults with high CD4 T-cell counts benefit most from immediate initiation of antiretroviral therapy? A post-hoc subgroup analysis of the START trial. Lancet HIV. 2018 Apr;5(4):e172-e180. doi: 10.1016/S2352-3018(18)30003-1. Epub 2018 Jan 16.