Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201706002336105 Date of Approval: 02/06/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title INTERVAL: Varying Intervals of ART to Improve Outcomes in HIV
Official scientific title INTERVAL: Varying Intervals of ART to Improve Outcomes in HIV
Brief summary describing the background and objectives of the trial This is an unblinded cluster-randomized study to evaluate the effectiveness of two strategies for scripting/dispensing of antiretroviral therapy (ART) on retention, virologic suppression, and cost compared to the standard of care. The study will be conducted in Malawi and Zambia among approximately 8,200 HIV-1-infected adults (18 years or older) who are stable on ART. Clusters will be randomized to one of three study arms: (1) standard of care (SOC) ART scripting (varies by country, region, clinic, and/or provider), (2) three-month ART scripting, and (3) six-month ART scripting. 30 clusters will be selected for the study, 15 in Malawi and 15 in Zambia, and will be randomized to a study arm.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) INTERVAL
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Other
Anticipated trial start date 31/05/2017
Actual trial start date 31/05/2017
Anticipated date of last follow up 30/09/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 8200
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
16-001652 UCLA IRB
2016-Aug-016 Zambia Excellence in Research Ethics and Science (ERES) Converge IRB
CT 068/17 Zambia Medicines Regulatory Authority (ZAMRA)
1663 Malawi National Health Sciences Research Committee
NCT03101592 ClinicalTrials.gov
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard of care ART dispensing Standard of care ART dispensing 3 years The standard of care arm will allow ART dispensing based on usual practice at the clinic. Standard of care is anticipated to have variability in how ART is dispensed, although the approach should be consistent with applicable country guidelines at the time of study. 2710 Dose Comparison
Experimental Group 3-month ART dispensing 3-month ART dispensing 3 years Providers at facilities randomized to three-month ART dispensing will be expected to provide all enrolled patients with a 90-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic. 2710
Experimental Group 6-month ART dispensing 6-month ART dispensing 3 years Providers at facilities randomized to six-month ART dispensing will be expected to provide all enrolled patients with a 180-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic. 2710
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
At least 18 years of age. Willing and able to provide written informed consent for participation in this study. Confirmed HIV-1 infection based on country standard of care for testing. On antiretroviral treatment (ART) for at least six months. On a first-line ART regimen as defined by country-specific guidelines. No drug toxicity/tolerability issues with ART regimen within the prior six months. No period of more than one month without ART medication possession within the last six months. No active opportunistic infection suspected (including tuberculosis) and not treated for an opportunistic infection in the last 30 days. No active comorbidity (including hypertension) and not treated for a comorbidity in the last 30 days. No viral load of more than 1000 copies/ml (using standard assay) within the last six months. Not currently pregnant. At least six months postpartum if recently delivered a baby. Not currently breastfeeding or planning to breastfeed. Under 18 years of age. Viral load of 1000 copies/ml or greater (using standard assay) within the last six months. On alternative first-line or second-line ART regimen. One month or more without medication possession within the last six months. Experienced an ART toxicity/tolerability issue within the last six months. Currently receiving treatment for tuberculosis or receiving treatment for any other opportunistic infection or comorbidity (including hypertension). Pregnant or less than six months postpartum. Women who are breastfeeding. Unwilling or unable to provide informed consent. Previously enrolled in the study. Currently enrolled in any other research study at the site that involves adherence/retention or alters delivery of HIV care. 18 Year(s) 100 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/04/2017 Zambia Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot No: 6903, Tuleteka Road/ Off Makishi Road Lusaka Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/02/2017 ERES Converge
Ethics Committee Address
Street address City Postal code Country
33 Joseph Mwilwa Road Rhodes Park, Lusaka Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/10/2016 National Health Sciences Research Committee
Ethics Committee Address
Street address City Postal code Country
PO Box 30377 Lilongwe 3 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/12/2016 UCLA Office of the Human Research Protection Program
Ethics Committee Address
Street address City Postal code Country
11000 Kinross Ave, Ste 211 Los Angeles, California 90005 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Retention in care 12 months 24 months 36 months
Secondary Outcome Virologic suppression 12 months 24 months 36 months
Secondary Outcome Cost-effectiveness of ART dipensing 12 months 24 months 36 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
EQUIP Zambia Lusaka Zambia
Partners in Hope Lilongwe Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
U.S. Agency for International Development (USAID) Washington, DC United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor EQUIP, Right to Care 3rd Floor Outspan Building, 1006 Lenchen North Ave. Centurion South Africa Commercial Sector/Industry
Secondary Sponsor Partners in Hope Lilongwe Malawi Hospital
COLLABORATORS
Name Street address City Postal code Country
UCLA 10833 Le Conte Ave., CHS 37-121 Los Angeles, California 90095 United States of America
Boston University 801 Massachusetts Ave Crosstown Center Boston, Massachusetts 02118 United States of America
Malawi Ministry of Health PO Box 30377 Lilongwe 3 Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Risa Hoffman rhoffman@mednet.ucla.edu 1 310 825 7225 10833 Le Conte Ave, CHS 37-121
City Postal code Country Position/Affiliation
Los Angeles, California 90095 United States of America Associate Clinical Professor
Role Name Email Phone Street address
Public Enquiries Ashley Bardon abardon@mednet.ucla.edu 1 310 486 7455 11075 Santa Monica Blvd, Ste 100
City Postal code Country Position/Affiliation
Los Angeles, California 90025 United States of America Research Coordinator
Role Name Email Phone Street address
Scientific Enquiries Risa Hoffman rhoffman@mednet.ucla.edu 1 310 825 7225 10833 Le Conte Ave., CHS 37-121
City Postal code Country Position/Affiliation
Los Angeles, California 90095 United States of America Associate Clinical Professor
REPORTING
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Changes to trial information