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Completed

NCT Number: NCT03723525

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

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sukraraj Tropical & Infectious Disease Control Hospital, Kathmandu, Bagmati, Nepal

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About this study

PRAN is an open-label trial of 1000 Treatment-Naive PLHIV aged 16 years or more.

  • 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.
  • 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.
  • 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,
  • 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,
  • To assess the cost-effectiveness of this package of care intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Package of HIV care

Combination Product

A. Screening and management (Preventive / Pre-emptive therapies dosages) of different opportunistic infections (OI). Detail information mentioned in the manual (refer to uploaded protocol).

B. Rapid ART Initiation

  • PLHIV without suspicion or active OI: Initiate ART within seven days or same day after HIV serology disclosure
  • 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).

C. 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.

Other names: Screening and management of opportunistic infection, Rapid ART initiation and Enhanced adherence support

Standard HIV care

Combination 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).

Primary outcomes

  1. Mortality

    Time frame: Week 24

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

Secondary outcomes

  1. Retention in treatment

    Time frame: Week 48

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

  2. Adherence to ART

    Time frame: 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).

  3. Morbidity

    Time frame: Week 48

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

  4. Viral load suppression

    Time frame: Week 48

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

  5. Cost effectiveness of Package of care

    Time frame: 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.

  6. Mortality

    Time frame: Week 48

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

  7. Hospitalization

    Time frame: 0-48

    Hospital inpatient episodes and total days admitted

Other outcomes

  1. Cryptococcal antigen

    Time frame: Week 48

    Burden of serum cryptococcal antigen positive in PLHIV with CD4 < 100/mL

  2. Immune Reconstitution Inflammatory Syndrome (IRIS)

    Time frame: Week 48

    Burden of IRIS

  3. CD4 cell count

    Time frame: Week 48

    Changes in CD4 cell count

Sponsors and collaborators

Lead sponsor

National Centre for AIDs and STD Control, Nepal

Other Gov

Collaborators

  • B.P. Koirala Institute of Health Sciences
  • Bharatpur Eye Hospital
  • Expertise France
  • Karolinska Institutet
  • Mahakali Zonal Hospital
  • National Academy of Medical Sciences, Nepal
  • Rapti Sub-regional Hospital
  • Seti Zonal Hospital
  • Sukraraj Tropical and Infectious Disease Hospital
  • Tikapur Hospital
  • Tribhuvan University Teaching Hospital, Institute Of Medicine.
  • Western Regional Hospital

Registry information

Official study 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.

Acronym: PRAN

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 29, 2018
Registry last updated
Sep 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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