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AzTrials

HIVPhase 4PRANNCT03723525

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

A Phase 4 study testing Package of HIV care and Standard HIV care in people with HIV, run by National Centre for AIDs and STD Control, Nepal at 10 sites in Nepal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
HIV
What is being tested?
Package of HIV care and Standard HIV care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,073 participants
Where
10 sitesNepal
Study dates
22 Jan 2018to 24 Dec 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age greater than or equal to 16 years
  • Diagnosed with HIV-infection
  • ART-naive
  • Consent for study participation

Who cannot join

  • Age less than or equal to 15 years
  • Any previous use of ART

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Nepal10 sites

  • Bharatpur District Hospital

    Bharatpur

  • Rapti Sub Regional Hospital

    Dang

  • Seti Zonal Hospital

    Kailāli̇̄

  • Tikapur Hospital

    Kailāli̇̄

  • Mahakali Zonal Hospital

    Kanchanpur

  • Sukraraj Tropical & Infectious Disease Control Hospital

    Kathmandu, Bagmati

  • National Academy of Medical Science (NAMS), Bir Hospital

    Kathmandu

  • Tribhuvan University Teaching Hospital

    Kathmandu

  • Western Regional Hospital

    Pokhara

  • B.P. Koirala Institute of Health Sciences

    Sunsari

Other trials in Nepal

About this study

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.

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.

Read the 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.
Conditions
HIV
Being tested
Package of HIV care, Standard HIV care
Keywords
Package of care, Rapid Initiation of antiretroviral therapy, Advanced HIV disease, mHealth, Acquired Immunodeficiency Syndrome, Management of advance HIV disease
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Package of HIV careCombination product

    Also called Screening and management of opportunistic infection, Rapid ART initiation and Enhanced adherence support

    1. Screening and management (Preventive / Pre-emptive therapies dosages) of different opportunistic infections (OI). Detail information mentioned in the manual (refer to uploaded protocol).
    2. Rapid ART Initiation
    3. PLHIV without suspicion or active OI: Initiate ART within seven days or same day after HIV serology disclosure
    4. PLHIV with suspicion or active OI: Defer initiation if clinical symptoms suggest tuberculosis or cryptococcal meningitis. Detail information mentioned in the manual (refer to uploaded protocol).
    5. Enhanced Adherence/Retention Support: mHealth: Receive text messages in mobile regarding appointment reminder (pill pick up, CD4 test, viral load test, early infant diagnosis (EID) test etc.) and general awareness messages (positive prevention, the importance of regular health check-up etc.). PLHIV with advanced HIV disease will also receive weekly/biweekly home-based adherence/ retention support linked to community care centre and community home-based care.

  • Standard HIV careCombination product

    Standard of HIV care includes screening and management of OI (OI- tuberculosis (TB), bacterial pneumonia, herpes, and candidiasis), baseline assessment (CD4 and other blood tests- complete blood count, hemoglobin, platelets, liver function test, renal function test, urine for albumin, chest x-ray), at 6 months CD4 test, viral load (twice a year) and then on a yearly basis, additional lab test at 3 months, 6 months, antiretroviral (ARV) toxicity monitoring like hemoglobin (Zidovudine), Serum Glutamic-Pyruvic Transaminase (Nevirapine/Efavirenz), Creatinine (Tenofovir), prophylaxis (Co-trimoxazole preventive therapy CD4<350 and WHO stage III and IV and Isoniazid preventive therapy if eligible) and ART / follow up (generally monthly/ bimonthly).

Study groups in NCT03723525
Study groupRoleWhat they receive
Package of HIV careExperimentalScreening and management (Preventive / Pre-emptive therapies dosages) of different opportunistic infections (OI), Rapid antiretroviral therapy (ART) initiation and Enhanced adherence support.
Receives: Combination Product: Package of HIV care
Standard HIV careExperimentalScreening and management of common OIs, basic health assessment (CD4, viral load and other tests), ARV drugs and follow up.
Receives: Combination Product: Standard HIV care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    All-cause mortality over the first 24 weeks after starting ART

    Measured: Week 24

Secondary outcomes (7)

  1. Retention in treatment

    PLHIV alive and on ART over the first 48 weeks after starting ART

    Measured: Week 48

  2. Adherence to ART

    Adherence will be assessed on a monthly basis (total pills taken by patient in last month/ total pills prescribed to patient in last month).

    Measured: Week 0-48

  3. Morbidity

    Incidence of opportunistic infection and immune reconstitution inflammatory syndrome (IRIS)

    Measured: Week 48

  4. Viral load suppression

    PLHIV and on ART who have a suppressed viral load (<1000 copies/mL)

    Measured: Week 48

  5. Cost effectiveness of Package of care

    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.

    Measured: Week 48

  6. Mortality

    All-cause mortality over the first 96 weeks after starting ART

    Measured: Week 48

  7. Hospitalization

    Hospital inpatient episodes and total days admitted

    Measured: 0-48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2018
  2. Study start22 Jan 2018
  3. Primary completion24 Dec 2019
  4. Study completion24 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
1,073 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03723525
Sponsor's protocol ID
525
Other IDs
NPL-H-SCF
Acronym
PRAN
Status last verified
Sep 2020
First submitted
11 Oct 2018
Last updated
21 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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/

    PubMed 29341560

  • 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.

    PubMed 26192873

  • 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.

    PubMed 29352723

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Package of HIV care and Standard HIV care in people with HIV, run by National Centre for AIDs and STD Control, Nepal at 10 sites in Nepal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03723525, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.

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