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.: PACTR201706002322546 Date of Registration: 25/05/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Early Initiation ART Adherence Clubs Versus Standard of Care to Enhance Patient Retention in Care:A Pilot Study
Official scientific title Early Initiation ART Adherence Clubs Versus Standard of Care to Enhance Patient Retention in Care:A Pilot Study
Brief summary describing the background and objectives of the trial In September 2016, the South African Department of Health (SA DoH) implemented the World Health Organization (WHO) ¿test and treat¿ guidelines to provide lifelong antiretroviral treatment (ART) to all people living with HIV, regardless of CD4 count or WHO clinical stage. A recent South African trial of ART initiation at a patient's first clinic visit showed promising results with 36% increased ART uptake and 26% increased viral suppression, suggesting that this intervention could be considered for adoption in routine care in Africa. These developments could greatly contribute towards attainment of the 90-90-90 targets, but will also have important implications for HIV care delivery at already overburdened primary care clinics in South Africa. In 2016, the SA DoH introduced community ART distribution and adherence clubs for people who are stable on ART, based on a body of evidence of improved retention in care when patients receive care in adherence clubs. This study aims to evaluate whether a test and treat strategy coupled with ART initiation at the patient¿s first clinic visit and follow-up at initiation adherence clubs results in improved patient outcomes and greater retention in care compared to standard of care.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EIAC
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 01/03/2017
Actual trial start date 01/04/2017
Anticipated date of last follow up 31/03/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 blinded envelope selection of intervention Allocation codes were prepared by a person separate to that allocating and placed in a sealed opaque envelope. Participants then chose from among the envelopes. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Early ART Initiation Clubs Monthly 6 months Early initiation clubs consist of 20-30 people with HIV who have just been diagnosed and are starting ART. 150
Control Group Standard of care Monthly 6 months Standard of care for ART in South Africa. 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age ¿18 years ART naïve Started ART on the day of HIV diagnosis. CD4 ¿ 200 cells/mm3 Normal baseline bloods (creatinine, Hemoglobin, liver function tests, HBsAg) Age < 18 years Previously on ART Patient with presumed TB or receiving TB treatment Pregnant woman Current comorbidity or chronic illness that is unstable (hypertension, diabetes, epilepsy, cancer, mental illness) or other disease which requires routine and frequent clinical management). Contra-indicated for fixed dose combination ART Refused same-day ART initiation CD4 count < 200 cells/mm3 Anemia Abnormal kidney or liver function tests Severe side effects to ART 18 Year(s) 99 Year(s) Both
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 29/07/2016 Human Research Ethics Committee (Medical), University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
1 Jan Smuts Ave, Braamfontein 2000, Johannesburg, South Africa Johannesburg 2000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of patients retained in care after 6 months following ART initiation Retention in care is measured as attendance at each anticipated monthly clinic or club visit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Witkoppen Health and Welfare Centre 105 William Nicol Drive Fourways, Johannesburg 2055 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
USAID 1300 Pennsylvania Ave Washtington, DC 20004 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Witkoppen Health and Welfare Centre 105 William Nicol Drive Fourways, Johannesburg 2055 South Africa Hospital
Secondary Sponsor Johns Hopkins Bloomberg School of Public Health 615 N Wolfe St Baltimore 21905 United States of America University
COLLABORATORS
Name Street address City Postal code Country
Colleen Hanrahan 615 N Wolfe St, E6031 Baltimore 21205 United States of America
Annelies Van Rie Antwerp Belgium
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joel Steingo joels@witkoppen.co.za +27 11 705 2438 105 William Nicol Drive
City Postal code Country Position/Affiliation
Fourways, Johannesburg 2055 South Africa
Role Name Email Phone Street address
Public Enquiries Joel Steingo joels@witkoppen.co.za +27117052438 105 William Nicol Drive
City Postal code Country Position/Affiliation
Fourways, Johannesburg 2055 South Africa
Role Name Email Phone Street address
Scientific Enquiries Colleen Hanrahan chanrah1@jhu.edu 4105029289 615 N Wolfe St
City Postal code Country Position/Affiliation
Baltimore 21205 United States of America
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information