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.: PACTR201311000675100 Date of Approval: 10/10/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Feasibility of Male Involvement in the Prevention of Mother to Child Transmission of HIV Services in Blantyre, Malawi
Official scientific title The Feasibility of Male Involvement in the Prevention of Mother to Child Transmission of HIV Services in Blantyre, Malaw
Brief summary describing the background and objectives of the trial Despite the scaling up of PMTCT services, they are not fully utilized by the women. One of the reasons for the lack of full utilization of the services is the lack of male involvement in the services. To evaluate the effectiveness and feasibility of an invitation card as a strategy for MI PMTCT services
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MI in PMTCT
Disease(s) or condition(s) being studied Infections and Infestations,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Education /Training
Anticipated trial start date 01/05/2013
Actual trial start date 14/06/2013
Anticipated date of last follow up 31/01/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 462
Actual target sample size (number of participants) 462
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
P02/12/1279 College of Medicine Research and Ethics Committee
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 Computer generated with permuted blocks with variable block size - ratio of 1:1 Opaque sealed envelopes, numbered sequentially and containing a slip of paper with the randomization ID are used to avoid bias during assignment of IDs Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group an invitation Card Given out to the pregnant woman for her to pass on to her male partner. Sealed in an envelope and addressed to the man 231
Control Group Word of mouth invitation Pregnant women delivers word of mouth invite to partners to retrun with them 231 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women, until 30 weeks gestation. Gestation period is limited to 30 weeks to allow room for adequate evaluation of the strategy as they report for antenatal care. Ascertainment of gestational age will be through fundal height assessments and or calculating from the Last Normal Menstrual Period date. Pregnant women aged 16 years or older (and married) will be eligible because according to Malawian law, they are considered emancipated and are able to sign the consent form for themselves without parental consent. If unmarried then they have to be 18 years of age and above in order to be enrolled because 18 is the legal age in Malawi for informed consent Pregnant women must be attending antenatal care without a spouse. Planning to attend antenatal Care at the study clinic. Ability and willingness to provide informed consent before study participation Pregnant women with a male partner responsible for the current pregnancy Women should be willing to pass on the ¿invitation card¿ to the partner. Postpartum women- Postpartum women will be excluded to avoid running the study for a long duration and also because there are only a few postpartum visits that postnatal women attend which may create a potential for loss to follow up in postpartum care. Pregnant women with gestation over 30 weeks. Gestation above 30 weeks will not offer adequate time for follow up to assess uptake of the intervention. Unwillingness to join the study. Unwillingness to comply with study visits. Women without a male partner. Women who attend antenatal care with their spouse. 16 Year(s) 70 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 12/06/2013 College of Medicine Research Ethics Committe
Ethics Committee Address
Street address City Postal code Country
Mahatma Gandhi Road Blantyre NA Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome proportion of pregnant women that are accompanied by their partners at week 2 and week 6 of the study after receipt of an Invitation card from the Health Centre and the non-intervention study arm. 2 and 6 weeks and overall
Secondary Outcome proportion of male partners taking up HIV testing in both study arms at study week 2 and 6. 2 and 6 weeks and overall
Secondary Outcome proportion of women taking up PMTCT services such as HIV testing, Antiretrovirals (ARVs) for PMTCT, Infant feeding Options in both arms at study week 2 and 6. 2 and 6 weeks and overall
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
South Lunzu Health Centre Machinjri Road Blantyre NA Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
National Commission for Science and Terchnology City Centre Lilongwe NA Malawi
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Commission for Science and Terchnology City Centre Lilongwe NA Malawi Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Adamson Muula Mahatma Ghandhi Road Blantyre NA Malawi
Angela Chimwaza Chipatala Avenue Blantyre NA
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alinane Linda Nyondo lindaalinane@gmail.com +265 999 44 12 12 Mahatma Gandhi Road
City Postal code Country Position/Affiliation
Blantyre NA Malawi Doctorate Student
Role Name Email Phone Street address
Public Enquiries Alinane Linda Nyondo lindaalinane@gmail.com +265 999 44 12 12 Mahatma Gandhi Road
City Postal code Country Position/Affiliation
Blantyre NA Malawi Doctorate Student
Role Name Email Phone Street address
Scientific Enquiries Alinane Linda Nyondo lindaalinane@gmail.com +265 999 44 12 12 Mahatma Gandhi Road
City Postal code Country Position/Affiliation
Blantyre NA Malawi Doctorate Student
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information