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.: PACTR201507001178614 Date of Approval: 22/06/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Integration of EPI and Pediatric HIV Services for Improved ART Initiation
Official scientific title Integration of EPI and Pediatric HIV Services for Improved ART Initiation
Brief summary describing the background and objectives of the trial This study on ¿Integration of EPI and Pediatric HIV Services for Improved ART Initiation¿ is a cluster-randomized trial of an intervention at public health facilities in Zimbabwe, conducted collaboratively by Ministry of Health and Child Care (MOHCC) in Zimbabwe and the Clinton Health Access Initiative (CHAI). The facility is the unit of randomization, with facilities randomized to intervention integrating Early Infant Diagnosis (EID) of HIV into the Zimbabwe Expanded Program for Immunization (ZEPI or EPI). Control facilities will maintain the standard of care for EID and EPI. The objective is to evaluate the impact of integrating infant HIV testing and treatment referral into routine EPI services on overall ART initiation by age 16 weeks and average age at ART initiation for infants aged less than two years at public health facilities in Zimbabwe. The primary outcomes for the study are (1) The proportion of infants coming for Penta1 visit who initiate ART by age 16 weeks, and (2) The average age of infants initiating on ART for all infants who initiate ART by age 2 years. Prior to the baseline data collection sample size calculations call for 20 facilities (10 control and 10 intervention), but sample size calculations will be updated once the baseline data collection provides an updated measure of the first primary outcomes and its intracluster correlation coefficient.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 27/07/2015
Actual trial start date
Anticipated date of last follow up 31/01/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 15160
Actual target sample size (number of participants)
Recruitment status Not yet 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 Allocation will be done using a program in Stata with a random seed to improve reproducibility. Randomization will be stratified according to the first primary outcome, and will use the minimum maximum t-statistic method to ensure maximum balance on covariates All allocations to intervention and control will be done simultaneously in Stata Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control (standard of care) group n/a n/a Control facilities will receive the standard of care in Zimbabwe. Staff from control and intervention group facilities will receive a training in the standard of care for Early Infant Diagnosis (EID) for HIV and immunization services at the same time so as not to allow differences within the standard of care training. (Group size below is count of facilities.) 10
Experimental Group Intervention group n/a n/a After receiving same standard of care training as control staff, intervention facility staff will be trained to integrate HIV care into EPI settings at penta1 visit (maternal HTC, ART referral, DBS sample drawn for infant) and at penta2 visit (provision of results, referral to ART if applicable). Group size below is count of facilities. 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All public health facilities across Zimbabwe that provide ART and EPI services will be eligible for the study, provided they do not have active relevant research ongoing at the site; site has provided Penta1 services to at least 500 infants in the previous eight months; and site is reasonably accessible for study staff to visit. Sites within ten kilometers of another eligible facility will be excluded, as will facilities with active research related to EPI services, ART initiation, or other subjects that could directly impact this study. 0 Year(s) 2 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
No 19/03/2015 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Cnr Josiah Tongogara / Mazowe Street Harare Zimbabwe
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 13/04/2015 Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
11 Stafford Road, Mount Pleasant Harare Zimbabwe
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 29/05/2015 Chesapeake Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
6940 COLUMBIA GATEWAY DRIVE, STE 110 Columbia, Maryland 21046 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of infants coming for Penta1 visit who initiate ART by age 16 weeks Facility-level outcome measure continuously from the beginning of the study period (after Standard of Care and Intervention training are completed) through Jan 2016
Primary Outcome The average age of infants initiating on ART for all infants who initiate ART by age 2 years Facility-level outcome measure continuously from the beginning of the study period (after Standard of Care and Intervention training are completed) through Jan 2016
Secondary Outcome the proportion of infants coming for a Penta1 visit who are tested for HIV by age 12 weeks Facility-level outcome measure continuously from the beginning of the study period (after Standard of Care and Intervention training are completed) through Jan 2016
Secondary Outcome the proportion of infants less than two years testing HIV positive who initiate on ART Facility-level outcome measured continuously from the beginning of the study period (after Standard of Care and Intervention training are completed) through Jan 2016
Secondary Outcome the total number of infants less than two years of age tested for HIV Facility-level outcome measured continuously from the beginning of the study period (after Standard of Care and Intervention training are completed) through Jan 2016
Secondary Outcome the total number of infants less than two years of age initiating on ART during the study period; Facility-level outcome measured continuously from the beginning of the study period (after Standard of Care and Intervention training are completed) through Jan 2016
Secondary Outcome the turnaround time between testing and receiving HIV results for infants less than two years Facility-level outcome measured continuously from the beginning of the study period (after Standard of Care and Intervention training are completed) through Jan 2016
Secondary Outcome the proportion of HIV testing results from Penta1 visits available at Penta2 visits Facility-level outcome measured continuously from the beginning of the study period (after Standard of Care and Intervention training are completed) through Jan 2016
Secondary Outcome the total number of infants receiving Penta1 immunizations Facility-level outcome measure continuously from the beginning of the study period (after Standard of Care and Intervention training are completed) through Jan 2016
Secondary Outcome the cost per additional ART initiation by age 16 weeks Facility-level outcome measured continuously from the beginning of the study period (after Standard of Care and Intervention training are completed) through Jan 2016
Secondary Outcome the cost per additional HIV test for children under 12 weeks Facility-level outcome measured continuously from the beginning of the study period (after Standard of Care and Intervention training are completed) through Jan 2016
Secondary Outcome the cost per additional HIV test for children under 12 weeks Facility-level outcome measured continuously from the beginning of the study period (after Standard of Care and Intervention training are completed) through Jan 2016
Secondary Outcome the cost per additional HIV test for children under 12 weeks Facility-level outcome measured continuously from the beginning of the study period (after Standard of Care and Intervention training are completed) through Jan 2016
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Howard Mission Hospital Mazowe Disrict Zimbabwe
Mvurwi Hospital Mazowe Disrict Zimbabwe
Tsungubvi Clinic Mazowe Disrict Zimbabwe
Dotito Rural Health Centre Mt Darwin District Zimbabwe
Mount Darwin District Hospital Mt Darwin District Zimbabwe
Katanga Utano Clinic Chegutu District Zimbabwe
Norton Hospital Chegutu District Zimbabwe
Beitbridge District Hospital Beitbridge District Zimbabwe
Dulibadzimu Clinic Beitbridge District Zimbabwe
Chireya Mission Hospital Gokwe North District Zimbabwe
Gokwe North District Hospital Gokwe North District Zimbabwe
Emakhandeni Clinic Bulawayo Zimbabwe
Chipadze Clinic Bindura District Zimbabwe
Rutope Clinic Bindura District Zimbabwe
David Nelson Clinic Centenary District Zimbabwe
Muzarabani Rural Health Centre Centenary District Zimbabwe
Mzilikazi Clinic Bulawayo Zimbabwe
Nkulumane Clinic Bulawayo Zimbabwe
Tshabalala Clinic Bulawayo Zimbabwe
Budiriro Satellite Clinic Harare Zimbabwe
Glen View PolyClinic Harare Zimbabwe
Hatcliffe PolyClinic Harare Zimbabwe
Mabelreign Satellite Clinic Harare Zimbabwe
Mbare PolyClinic Harare Zimbabwe
Parirenyatwa Clinic Harare Zimbabwe
Tafara FHS Clinic Harare Zimbabwe
Masvingo City Masvingo District Zimbabwe
Runyararo Clinic Masvingo District Zimbabwe
Concession District Hospital Mazowe Disrict Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
International Initiative for Impact Evaluation 1625 Massachusetts Avenue, NW, Suite 450 Washington, DC 20036 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Clinton Health Access Initiative 383 Dorchester Ave, Suite 400 Boston, Massachusetts 02127 United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Brett Keller Clinton Health Access Initaitive Dar es Salaam Tanzania
Elizabeth McCarthy Clinton Health Access Initaitive Lusaka Zambia
Alexio Mangwiro Clinton Health Access Initaitive Harare Zimbabwe
Dr. Owen Mugurungi Ministry of Health and Child Care Harare Zimbabwe
Dr. Angela Mushavi Ministry of Health and Child Care Harare Zimbabwe
Dr. Bernard Madzima Ministry of Health and Child Care Harare Zimbabwe
Dr. Tsitsi Apollo Ministry of Health and Child Care Harare Zimbabwe
Dr. Ngonidzashe Madidi Clinton Health Access Initaitive Harare Zimbabwe
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Brett Keller bkeller@clintonhealthaccess.org +18579390304 Skyways Building, 3rd Floor. Ohio and Sokoine Drive
City Postal code Country Position/Affiliation
Dar es Salaam Tanzania Technical Advisor, Clinton Health Access Initaitive
Role Name Email Phone Street address
Public Enquiries Brett Keller bkeller@clintonhealthaccess.org +18579390304 Skyways Building, 3rd Floor. Ohio and Sokoine Drive
City Postal code Country Position/Affiliation
Dar es Salaam Tanzania Technical Advisor, Clinton Health Access Initaitive
Role Name Email Phone Street address
Scientific Enquiries Brett Keller bkeller@clintonhealthaccess.org +18579390304 Skyways Building, 3rd Floor. Ohio and Sokoine Drive
City Postal code Country Position/Affiliation
Dar es Salaam Tanzania Technical Advisor, Clinton Health Access Initaitive
REPORTING
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