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.: PACTR202104622127025 Date of Approval: 21/04/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Anti-Malaria Prophylaxis for Pregnancy (AMPROP) Clinical Trial
Official scientific title Placenta Plasmodium Parasitaemia and Development of Resistance using Sulfadoxine/Pyrimethamine (SP) or Mefluoquine IPT/ITN Intervention among HIV Positive Pregnant Women in Lagos Nigeria: A Randomised Controlled Trial
Brief summary describing the background and objectives of the trial Malaria in pregnancy in the setting of HIV is associated with a poor feto-maternal outcome. Few studies have been done in this area. These studies were also devoid of evaluating SP resistance among individuals with malaria in pregnancy It is therefore pertinent to evaluate the effectiveness of the current intervention to ascertain if there is a need to change the National policy currently in use for the prevention of malaria in pregnancy in the setting of HIV. The objective of this study is to determine placenta parasitaemia and the development of SP and mefloquine resistance among HIV positive pregnant women who received IPT(Using SP or Mefloquine) and ITN The purpose of this research is to determine the most effective medication for the prevention of malaria in pregnancy Study objectives: 1. To compare parasitaemia level in peripheral blood film of pregnant HIV positive and negative women who received IPT (using SP or Mefloquine) and ITN 2. To determine and compare Placenta parasitaemia among HIV positive and negative pregnant women who received IPT (using SP or Mefloquine) and ITN 3. To determine and compare the number of febrile episodes associated with a positive MP test in HIV positive and negative women who received IPT (using SP or Mefloquine) and ITN 4. To determine and compare the pregnancy outcomes in HIV positive and HIV negative women who received IPT (using SP or Mefloquine) and ITN 5. To determine and compare SP or Mefloquine resistance in pregnant HIV positive and Negative patients 6. To determine and compare the frequency of SP resistance versus mefloquine resistance across the study groups
Type of trial RCT
Acronym (If the trial has an acronym then please provide) AMPROP
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 03/05/2021
Actual trial start date
Anticipated date of last follow up 04/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mefloquine Monthly- 2 doses for Mefloquine 16 weeks gestational age to 36 weeks gestational age MEFLOQUINE The pregnant women who are HIV positive will receive the first statim dosage of mefloquine of 15mg/kg body weight at 16wks gestational age and two more doses spaced at least 4wks apart, while they continue with the use of ITN, while the HIV negative women will receive the first statim dosage of mefloquine at 15mg/kg and one additional dosage of mefloquine at least 4wks apart 75
Control Group Sulphadozine Pyrimethamine Combination Monthly- 3 doses of Sulphadozine/Pyrimethamine 16 weeks of gestational age to 36 weeks of gestational age The pregnant women who are HIV positive will receive the first statim dosage of SP at about 16wks gestational age at a dosage of 500mg/25mg (Sulphadozine/pyrimethamine) and then two more doses spaced at least 4 weeks apart, while they continue with the use of their ITN. The pregnant women who are HIV negative will receive the first statim dose of SP at about 16wks gestational age and one additional dosage of SP, spaced at least 4 weeks from the first dose. 150 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
A. HIV POSITIVE POPULATION 1.HIV positive pregnant women 2. Above 13wks gestational age 3. Afebrile at the time of recruitment 4.Not sensitive to sulphadozine 5. Not sensitive to standard ITN 6.Not sensitive to mefloquine B. HIV NEGATIVE POPULATION 1.HIV negative pregnant women 2. Above 13wks gestational age 3. Afebrile at the time of recruitment 4.Not sensitive to sulphadozine 5. Not sensitive to mefloquine 6. Not sensitive to standard ITN A. HIV POSITIVE POPULATION 1. SCD IN PREGNANCY 2. Known febrile illness in the Index pregnancy 3. Known sensitivity to sulphadozine/pyrimethamine combination 4. Known sensitive to mefloquine B. HIV NEGATIVE POPULATION 1. SCD IN PREGNANCY 2. Known febrile illness in the Index pregnancy 3. Known sensitivity to sulphadozine/pyrimethamine 4. Known sensitivity to mefloquine Adult: 19 Year-44 Year 19 Year(s) 40 Year(s) Female
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 09/07/2020 Institutional Review Board of the Nigerian Institute of Medical Research
Ethics Committee Address
Street address City Postal code Country
N0 6, Edmund Crescent, Off Murtala Mohammed Way Lagos 10001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome PRIMARY OUTCOME MEASURES: 1. Placenta parasitaemia 2. Number of episodes of febrile illness associated with a positive malaria parasitaemia 3. Peripheral blood parasitaemia, demonstrable in the third trimester. 4. Number of cases of SP resistance 5. Number of cases of Mefloquine resistance 28-36 weeks gestation and At birth
Secondary Outcome SECONDARY OUTCOME MEASURES: 1. Miscarriages 2. Intra-uterine deaths 3. Hospital admissions 4. Low birth weight 5. Maternal anaemia 6. Side effects and Adverse effect profile of the interventional agents 16 weeks to 36 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos Island Maternity Hospital 10 Campbell Street, Lagos Island Lagos Nigeria
Nigerian Institute of Medical Research No 6, Edmund Crescent Off Murtala Mohammed, Yaba Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nigerian Institute of Medical Research No 6, Edmund Crescent, Yaba, Lagos Lagos Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nigerian Institute of Medical Research No 6, Edmund Crescent, Yaba, Lagos Lagos Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Lagos State Ministry of Health Block 4, The Lagos State Government Secretariat Complex, Alausa, Ikeja, Lagos. Lagos Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aigbe Ohihoin aigbe.ohihoin@nimr.gov.ng +2348035604697 No 6, Edmund Crescent, off Murtala Mohammed Way, Yaba, Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Deputy Director of Maternal and Reproductive Health Research Nigerian Institute of Medical Research
Role Name Email Phone Street address
Public Enquiries Esther Ohihoin ohihoinesther@nimr.gov.ng +2348034057972 No 6, Edmund Crescent, Off Murtala Mohammed Way, Yaba, Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Research Fellow Nigerian Institute of Medical Research
Role Name Email Phone Street address
Scientific Enquiries Ebiere Herbertson echerbertson@nimr.gov.ng +2348134761332 No 6, Edmund Crescent Off Murtala Mohammed Way, Yaba, Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Deputy Director Pharmacy Nigerian Institute of Medical Research
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Publication in peer review journals and update on the trial registration website Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 24-72 weeks On approved request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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