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.: PACTR201702001970148 Date of Approval: 13/01/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of HIV mother-infant pair clinics on 12 month retention
Official scientific title Assessing the impact of clinic days dedicated to providing HIV services for post-partum HIV-positive mothers and their HIV-exposed infants (¿Umoyo¿) on 12 month retention of infants
Brief summary describing the background and objectives of the trial This study will evaluate of the impact of mother-infant pair (MIP) clinics, which is a special type of prevention of mother-to-child transmission (PMTCT) clinic in which groups of HIV-positive mothers and their infants attend follow-up appointments on the same day to receive integrated under five services, health education, HIV testing, TB screening services, and antiretroviral therapy (ART) services for HIV-positive children until the infant is 24 months of age. It is believed that the MIP clinics may be able to improve retention of infants in PMTCT care due to increased peer support among mothers, reduced stigma among mothers and improved HIV-related knowledge of mothers. The proposed evaluation will include a randomized controlled impact evaluation. The impact of the evaluation will be assessed using a difference in difference analysis.
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 Prevention
Anticipated trial start date 23/01/2017
Actual trial start date 20/02/2017
Anticipated date of last follow up 23/04/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 448
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
2016-Nov-001 ERES Converge
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 Facilities were the unit of randomization. We performed covariate-constrained randomization at the facility cluster level. For the randomization we used randomly generated numbers from Stata. In this way, randomization was selected with optimal balance on covariates. Our covariates included Annual expected HEI live births, the 2016 catchment population and district. The code was generated offiste. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Umoyo Mother-Infant Pair (MIP) clinic Once per month Up to duration of study (15 months) Umoyo MIP clinic is unique for the designated clinic day for HIV-positive mothers and their HEIs where they receive routine child healthcare and routine maternal ART services 224
Control Group Standard of Care Once per month or as needed Up to 15 months Standard of care for infants and mothers who will attend child health services along with other non-HIV positive mothers 224 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The following will be used as inclusion criteria for the program: ¿ For the retrospective study, HIV exposed infants (HEI)s will be included if they are 1) over the age of 6 weeks and under 3 months of age at 12 - 9 months before the launch of the MIP clinic program and 2) receiving services from a study facility. ¿ For the prospective study, HEIs will be included if they are 1) over the age of 6 weeks and under 3 months of age at the time of the launch of the MIP clinic and 2) receiving services from a study facility. ¿ For mother¿s questionnaire, women will be eligible for inclusion if they 1) are age 18 years or older, 2) are HIV-positive and 3) are receiving under-five services for their infant from a study site. At baseline, any woman meeting the other criteria and attending the under-five clinic will be eligible. At end line, women who have attended at least three Umoyo clinic days will be eligible. The following will be used as exclusion criteria for the program: ¿ For the retrospective study, any HEI who is under age 6 weeks or over 3 months of age at 12 -9 months before the launch of the MIP program will be excluded. ¿ For the prospective study, any HEI who is under age 6 weeks or over 12 months of age at the time of the Umoyo clinic launch will be excluded. HEIs will also be excluded if they have already tested positive before age 12 months. ¿ For mother¿s exit questionnaire, women will be excluded if they 1) are under 18 years, 2) are not HIV-positive or 3) do not regularly receive under-five services for their infant from a study site. At end line, women will be excluded if they have not attended at least three Umoyo clinic days. 6 Week(s) 12 Week(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 23/11/2016 Chesapeake IRB
Ethics Committee Address
Street address City Postal code Country
6940 Columbia Gateway Dr #110 Columbia 21046 United States of America
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 10/10/2016 ERES Converge IRB
Ethics Committee Address
Street address City Postal code Country
33 Joseph Mwilawa Rd Lusaka Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in the proportion of HIV-exposed infants retained in HIV care and treatment at 12 months of age. Retrospective data on previous 12-month will be collected at baseline Prospective data on proportion of HEI at 12-months after program will be collected at endline
Secondary Outcome Change in the proportion of HEIs with regular attendance as defined by monthly returns up to 6 months of age from 10 weeks to 6 months Previous 6 months collected at baseline Prospective 6 months collected at 6 months into study
Secondary Outcome Change in the proportion of HEIs with regular attendance as defined by monthly returns up to 12 months of age from 10 weeks to 12 months Retropsective data on previous 12 months collected at baseline Prospective data on 12-months after study collected at endline
Secondary Outcome Change in the proportion of HIV-positive children initiated on ART Retrospective data on previous 12 months collected at baseline Prospective data on 12-months of study period collected at endline.
Secondary Outcome Change in the proportion of HIV-positive children retained in care Retrospective data on previous 12 months collected at baseline Prospective data on 12-months of study period collected at endline.
Secondary Outcome 6. Change in the proportion of HIV-positive mothers retained in care Retrospective data on previous 12 months collected at baseline. Prospective data on 12-months of study period collected at endline.
Secondary Outcome Change in the proportion of HIV-Exposed infants initiated on TB Isoniazid (INH) prophylaxis Retrospective data on previous 12 months collected at baseline. Prospective data on 12-months of study period collected at endline.
Secondary Outcome Change in the proportion of HIV positive mothers testing for TB Retrospective data on previous 12 months collected at baseline. Prospective data on 12-months of study period collected at endline.
Secondary Outcome Change in the proportion of HIV positive mothers receiving TB prophylaxis Retrospective data on previous 12 months collected at baseline. Prospective data on 12-months of study period collected at endline.
Secondary Outcome Change in the proportion of HIV positive mothers on TB treatment Retrospective data on previous 12 months collected at baseline. Prospective data on 12-months of study period collected at endline.
Secondary Outcome Difference in perceived social support of HIV-positive mothers among those in the intervention arm vs those in the control arm Retrospective data on previous 12 months collected at baseline. Prospective data on 12-months of study period collected at endline.
Secondary Outcome Difference in perceived stigma of HIV-positive mothers among those in the intervention arm vs those in the control arm Retrospective data on previous 12 months collected at baseline. Prospective data on 12-months of study period collected at endline.
Secondary Outcome Difference in knowledge of mothers on i) importance of retention and adherence ii) family planning among those in the intervention arm vs those in the control arm Retrospective data on previous 12 months collected at baseline. Prospective data on 12-months of study period collected at endline.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kafue DHO Kafue District Health Office Lusaka Province Zambia
Chongwe DHO Chongwe District Health Office Lusaka Province Zambia
Chilanga DHO Chilanga District Health Office Lusaka Province Zambia
Lusaka DHO Lusaka District Health Office Lusaka Province Zambia
Petauke DHO Petauke District Health Office Eastern Province Zambia
Chipata DHO Chipata District Health Office Eastern Province Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Department for International Development 22 Whitehall London SW1A 2EG United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Clinton Health Access Initiative Plot 175 Kudu Rd Lusaka Zambia Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Center for Infectious Disease Zambia Plot 5032 Great North Rd. Lusaka PO Box 34681 Zambia
Zambia Ministry of Health Ndeke House, Haile, Selassie Avenue Lusaka PO. Box 30205 Zambia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sandra Mudhune smudhune@clintonhealthaccess.org +260960349758 175 Kudu Road, Kabulonga
City Postal code Country Position/Affiliation
Lusaka PO Box 51071 Ridgew Zambia
Role Name Email Phone Street address
Public Enquiries Sandra Mudhune smudhune@clintonhealthaccess.org +260960349758 175 Kudu, Kabulonga
City Postal code Country Position/Affiliation
Lusaka PO Box 51071 Ridgew Zambia
Role Name Email Phone Street address
Scientific Enquiries Sandra Mudhune smudhune@clintonhealthaccess.org +260960349758 175 Kudu Road, Kabulonga
City Postal code Country Position/Affiliation
Lusaka PO Box 51071 Ridge Zambia
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
Section Name Field Name Date Reason Old Value Updated Value
SecondaryID SecondaryID List 31/07/2017 New Information SECONDARY_ID SECONDARY_ID
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 31/07/2017 New information 2017-02-20
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 31/07/2017 Modified Not yet recruiting Closed to recruitment: follow up continuing
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 07/02/2017 Edit 300 448
Section Name Field Name Date Reason Old Value Updated Value
Ethics CommitteeName 31/07/2017 New information IssuingAuthority IssuingAuthority
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 05/07/2018 Pactr update Not Applicable