HIVVTSNCT01948557
Vertical Transmission Study
A study testing Infant feeding counselling and support in people with HIV, run by University of KwaZulu at 2 sites in South Africa.
Trial summary
Short courses of drugs can be given to HIV-infected pregnant women to reduce the chance of HIV infection being passed to her child either during pregnancy or during the labour process. However, children can also become infected by drinking the mother's breastmilk which contains the HIV virus. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Infant feeding counselling and support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,465 participants
- Where
- 2 sitesSouth Africa
- Study dates
- Oct 2001to Oct 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All pregnant women attending antenatal clinics in the Mpukunyoni and Hlabisa Tribal Areas of Hlabisa District or at Kwadabeka clinic or St Mary's hospital, Mariannhilll Hospital who offer consent to participate in the study
Who cannot join
- Intention to leave Hlabisa District or Kwadabeka community within 3 months of delivery.
- Failure to give consent.
- Less than 16 years of age.
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Kwadabeka health centre
Durban, KwaZulu-Natal
Africa Centre for Health and Population Studies
Somkele, KwaZulu-Natal
About this study
Official title: A Cohort Study To Assess The Impact Of A Breastfeeding Counselling And Support Strategy To Promote Exclusive Breastfeeding On Post-Natal Transmission Of HIV In African Women
Short courses of drugs can be given to HIV-infected pregnant women to reduce the chance of HIV infection being passed to her child either during pregnancy or during the labour process. However, children can also become infected by drinking the mother's breastmilk which contains the HIV virus. In many poor, developing countries in Africa, breastfeeding is the normal way of infant feeding and is vitally important because of the protection it gives to children from other diseases such as diarrhoea and malnutrition. Ideally there would be a way to make breastfeeding safer from HIV transmission without losing its other advantages.
A medical study recently suggested that HIV-infected women who exclusively breastfed their children i.e. gave breastmilk but without any water, tea, formula milk or any solid foods did not pass on the virus to their children to the same degree as women who MBF with these other fluids and foods. It is important to confirm whether this observation is in fact true or not. We hypothesize that exclusive breastfeeding by HIV-infected mothers carries a lower risk of HIV transmission than mixed breastfeeding.
We propose to follow 2,100 HIV-infected pregnant women and also some HIV-uninfected women from the time that they book at the clinic until 24 months of age. HIV-infected women who say they intend to breastfeed and all the HIV-uninfected women will be visited at their homes by breastfeeding counsellors both before and after delivery to support exclusive breastfeeding. HIV-infected women who choose not to breastfeed will be helped by clinic staff to safely replace all breastmilk with some other milk. An independent team will visit all mothers at their homes and collect information about the way they feed their children. Blood samples will be collected from the children at different times by a simple heel prick and the blood stored on a piece of filter paper. By testing these samples and comparing with the type of feeding at that time, we will be able to see when a child becomes infected and whether exclusive breastfeeding gives any protection.
Read the detailed description
Short course antiretroviral regimens such as AZT (Thai regimen), or nevirapine (Uganda HIVNET 012 regimen) given to HIV-infected women in pregnancy can reduce in utero and intrapartum transmission to their child by 40-50%. However, these gains are threatened by the continued transmission of HIV through breast milk of poor HIV-infected women in Africa who have no realistic choice but to breastfeed. A recent study from Durban compared for the first time, Mother-to-child transmission of HIV (MTCT) rates in each of the 3 feeding groups viz. exclusive breastfeeding (EBF), mixed breastfeeding (MBF) and formula feeding. The results of this study showed that at 3 months the MTCT in EBF mothers was similar to that in mothers giving only formula feeds, and the MTCT in EBF mothers was significantly lower than in those MBF (14.6% vs. 24.1%). This suggested that EBF may carry no additional risk of MTCT of HIV1 over formula feeding. A prospective study is required to verify these findings.
We propose a cohort study of HIV-infected mothers and their infants, to examine the risk of post-natal transmission of HIV in relation to infant feeding practices after mothers receive intensive breastfeeding counselling and support to practise EBF until about 6 months of age (the optimal duration for EBF).
The hypothesis being tested is: Exclusive breastfeeding by HIV-infected women carries no additional risk of post-natal transmission of HIV than exclusive formula feeding.
The primary objectives of the study are to determine the effect of infant feeding practices on HIV infection rates of infants at 6 and 22 weeks of age, and secondly to to determine the infant survival rate at 24 months of age according to feeding practices and HIV status.
Secondary objectives are:
- To determine the HIV infection rate of infants as measured of a sample collected within 72 hours of birth; ii) To determine the HIV transmission incidence attributable to the duration of different feeding practices; iii) To determine the cumulative incidence of vertical transmission in EBF, MBF and EFF infants; iv) To describe risk factors, other than feeding practice, for post-natal transmission of HIV, including maternal and infant morbidity and breast health; v) To assess the determinants of transmission in MBF adjusting for exposure factors e.g. type and age of introduction of other food/milk; vi) To describe the morbidity and growth of infants in relation to feeding practices and HIV status; and vii) To describe adherence rates to EBF following a breastfeeding support intervention.
HIV infected women will be counselled according to the WHO/UNICEF/UNAIDS infant feeding guidelines. All HIV-infected women and a random sub-sample of HIV-uninfected women will be recruited antenatally. Those who choose to breastfeed will be visited frequently at home by a team of breastfeeding counsellors before and after delivery to promote and support EBF. HIV-infected mothers who choose not to breastfeed will be supported in their choice by clinic-based staff. An independent team of field monitors will collect data weekly on feeding practices and morbidity of all infants at home visits. Blood samples will be collected by finger/heel prick and stored on filter paper prior to qualitative and quantitative estimation of HIV viral content to determine the timing of transmission.
- Conditions
- HIV
- Being tested
- Infant feeding counselling and support
- Keywords
- Breastfeeding, Infants, Mother to child transmission of HIV, Survival
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant feeding counselling and supportBehavioural
Counselling of appropriate feeding practices as recommended in WHO/UNICEF/UNAIDS guidelines on HIV and infant feeding. Subsequent intensive, home-based support of exclusive breastfeeding or safe replacement feeding according to mothers' selection of feeding practice. Counselling contacts with mothers varied over time. 1-2 antenatal contacts. After delivery, home visits by infant feeding counsellors 3-4 times in first 2 weeks then every 2 weeks until 6 months.
Outcome data collected by separate field based team who were blinded to mothers HIV status and infant feeding practice.
| Study group | Role | What they receive |
|---|---|---|
| Infant feeding counselling and support | Other | All mothers provided with counselling. Subsequent support interventions depended on mothers' selection of feeding practice Receives: Behavioral: Infant feeding counselling and support |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV infection rates of infants who are Exclusively breastfed, Mixed Breastfed or Exclusive Formula Feeding as determined by HIV RNA PCR analysis of a blood sample at that time
Measured: 6 weeks of age
HIV infection rates of infants who are Exclusively breastfed, Mixed Breastfed or Exclusive Formula Feeding as determined by HIV RNA PCR analysis of a blood sample at that time
Measured: 22 weeks of age
Infant/child survival
Measured: 24 months of age
Secondary outcomes (9)
HIV infection rates of infants as determined by HIV RNA PCR analysis of a blood sample obtained in that time period
Measured: Within 72 hours of birth
Difference between intrauterine and intrapartum HIV infection rates in women and neonates receiving NVP as determined by HIV RNA PCR analysis of blood samples collected within 72 hours of birth and at 6 weeks
Measured: 72 hours and 6 weeks
HIV infection rates of infants at various time points between 6 and 26 weeks, in relation to the type and duration of infant feeding practices i.e. EBF, MBF and EFF (+/- an initial period of EBF)
Measured: 6 weeks of age and 26 weeks of age
HIV infection rates of infants 4 weeks after cessation of EBF as determined by HIV RNA PCR analysis of blood samples collected at that time
Measured: 4 weeks post cessation of breastfeeding
Prevalent days of diarrhoea
Measured: Weekly from birth to 9 months of age
Prevalent days of respiratory distress
Measured: Weekly from birth to 9 months of age
Changes in weight, length and head circumference
Measured: From birth to 18 months of age
Maternal morbidity
Measured: Monthly until 18 months post partum
Percentage of women who adhere to EBF
Measured: Until 6 months post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startOct 2001
- Primary completionSep 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,465 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of KwaZulu
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Hoosen M Coovadia, MB, Principal investigator, University of KwaZulu-Natal, and University of the Witwatersand, South AfricaMarie Louise Newell, PhD, Study chair, University of KwaZulu-Natal and Institute for Child Health, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948557
- Sponsor's protocol ID
- WT063009
- Acronym
- VTS
- Status last verified
- Sep 2013
- First submitted
- 18 Sep 2013
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bland R, Coovadia H, Coutsoudis A, Rollins N, Newell M. Cohort profile: mamanengane or the Africa centre vertical transmission study. Int J Epidemiol. 2010 Apr;39(2):351-60. doi: 10.1093/ije/dyp165. Epub 2009 Mar 31. No abstract available.
PubMed 19336438Neveu D, Viljoen J, Bland RM, Nagot N, Danaviah S, Coutsoudis A, Rollins NC, Coovadia HM, Van de Perre P, Newell ML. Cumulative exposure to cell-free HIV in breast milk, rather than feeding pattern per se, identifies postnatally infected infants. Clin Infect Dis. 2011 Mar 15;52(6):819-25. doi: 10.1093/cid/ciq203.
PubMed 21367736Patel D, Bland R, Coovadia H, Rollins N, Coutsoudis A, Newell ML. Breastfeeding, HIV status and weights in South African children: a comparison of HIV-exposed and unexposed children. AIDS. 2010 Jan 28;24(3):437-45. doi: 10.1097/QAD.0b013e3283345f91.
PubMed 19915445Becquet R, Bland R, Leroy V, Rollins NC, Ekouevi DK, Coutsoudis A, Dabis F, Coovadia HM, Salamon R, Newell ML. Duration, pattern of breastfeeding and postnatal transmission of HIV: pooled analysis of individual data from West and South African cohorts. PLoS One. 2009 Oct 16;4(10):e7397. doi: 10.1371/journal.pone.0007397.
PubMed 19834601Rollins NC, Becquet R, Bland RM, Coutsoudis A, Coovadia HM, Newell ML. Infant feeding, HIV transmission and mortality at 18 months: the need for appropriate choices by mothers and prioritization within programmes. AIDS. 2008 Nov 12;22(17):2349-57. doi: 10.1097/QAD.0b013e328312c740.
PubMed 18981775Desmond C, Bland RM, Boyce G, Coovadia HM, Coutsoudis A, Rollins N, Newell ML. Scaling-up exclusive breastfeeding support programmes: the example of KwaZulu-Natal. PLoS One. 2008 Jun 18;3(6):e2454. doi: 10.1371/journal.pone.0002454.
PubMed 18560596Bland RM, Little KE, Coovadia HM, Coutsoudis A, Rollins NC, Newell ML. Intervention to promote exclusive breast-feeding for the first 6 months of life in a high HIV prevalence area. AIDS. 2008 Apr 23;22(7):883-91. doi: 10.1097/QAD.0b013e3282f768de.
PubMed 18427207Lebon A, Bland RM, Rollins NC, Coutsoudis A, Coovadia H, Newell ML. Short communication: CD4 counts of HIV-infected pregnant women and their infected children--implications for PMTCT and treatment programmes. Trop Med Int Health. 2007 Dec;12(12):1472-4. doi: 10.1111/j.1365-3156.2007.01954.x.
PubMed 18076554Bland RM, Becquet R, Rollins NC, Coutsoudis A, Coovadia HM, Newell ML. Breast health problems are rare in both HIV-infected and HIV-uninfected women who receive counseling and support for breast-feeding in South Africa. Clin Infect Dis. 2007 Dec 1;45(11):1502-10. doi: 10.1086/523320. Epub 2007 Oct 22.
PubMed 17990235Bland RM, Rollins NC, Coovadia HM, Coutsoudis A, Newell ML. Infant feeding counselling for HIV-infected and uninfected women: appropriateness of choice and practice. Bull World Health Organ. 2007 Apr;85(4):289-96. doi: 10.2471/blt.06.032441.
PubMed 17546310Coovadia HM, Rollins NC, Bland RM, Little K, Coutsoudis A, Bennish ML, Newell ML. Mother-to-child transmission of HIV-1 infection during exclusive breastfeeding in the first 6 months of life: an intervention cohort study. Lancet. 2007 Mar 31;369(9567):1107-16. doi: 10.1016/S0140-6736(07)60283-9.
PubMed 17398310Rollins NC, Coovadia HM, Bland RM, Coutsoudis A, Bennish ML, Patel D, Newell ML. Pregnancy outcomes in HIV-infected and uninfected women in rural and urban South Africa. J Acquir Immune Defic Syndr. 2007 Mar 1;44(3):321-8. doi: 10.1097/QAI.0b013e31802ea4b0.
PubMed 17195768Thairu LN, Pelto GH, Rollins NC, Bland RM, Ntshangase N. Sociocultural influences on infant feeding decisions among HIV-infected women in rural Kwa-Zulu Natal, South Africa. Matern Child Nutr. 2005 Jan;1(1):2-10. doi: 10.1111/j.1740-8709.2004.00001.x.
PubMed 16881874Shah S, Rollins NC, Bland R; Child Health Group. Breastfeeding knowledge among health workers in rural South Africa. J Trop Pediatr. 2005 Feb;51(1):33-8. doi: 10.1093/tropej/fmh071. Epub 2004 Dec 15.
PubMed 15601651Bland RM, Rollins NC, Van den Broeck J, Coovadia HM; Child Health Group. The use of non-prescribed medication in the first 3 months of life in rural South Africa. Trop Med Int Health. 2004 Jan;9(1):118-24. doi: 10.1046/j.1365-3156.2003.01148.x.
PubMed 14728615
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study To Assess The Impact Of A Breastfeeding Counselling And Support Strategy To Promote Exclusive Breastfeeding On Post-Natal Transmission Of HIV In African Women
- ClinicalTrials.gov ID
- NCT01948557
- Acronym / sponsor ID
- VTS / WT063009
- Conditions
- HIV
- Keywords
- Breastfeeding, Infants, Mother to child transmission of HIV, Survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,465 participants (actual)
- Lead sponsor
- University of KwaZuluUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- Oct 2001
- Primary completion
- Sep 2005 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 23 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Short courses of drugs can be given to HIV-infected pregnant women to reduce the chance of HIV infection being passed to her child either during pregnancy or during the labour process. However, children can also become infected by drinking the mother's breastmilk which contains the HIV virus. In many poor, developing countries in Africa, breastfeeding is the normal way of infant feeding and is vitally important because of the protection it gives to children from other diseases such as diarrhoea and malnutrition. Ideally there would be a way to make breastfeeding safer from HIV transmission without losing its other advantages.
A medical study recently suggested that HIV-infected women who exclusively breastfed their children i.e. gave breastmilk but without any water, tea, formula milk or any solid foods did not pass on the virus to their children to the same degree as women who MBF with these other fluids and foods. It is important to confirm whether this observation is in fact true or not. We hypothesize that exclusive breastfeeding by HIV-infected mothers carries a lower risk of HIV transmission than mixed breastfeeding.
We propose to follow 2,100 HIV-infected pregnant women and also some HIV-uninfected women from the time that they book at the clinic until 24 months of age. HIV-infected women who say they intend to breastfeed and all the HIV-uninfected women will be visited at their homes by breastfeeding counsellors both before and after delivery to support exclusive breastfeeding. HIV-infected women who choose not to breastfeed will be helped by clinic staff to safely replace all breastmilk with some other milk. An independent team will visit all mothers at their homes and collect information about the way they feed their children. Blood samples will be collected from the children at different times by a simple heel prick and the blood stored on a piece of filter paper. By testing these samples and comparing with the type of feeding at that time, we will be able to see when a child becomes infected and whether exclusive breastfeeding gives any protection.
Detailed description
Short course antiretroviral regimens such as AZT (Thai regimen), or nevirapine (Uganda HIVNET 012 regimen) given to HIV-infected women in pregnancy can reduce in utero and intrapartum transmission to their child by 40-50%. However, these gains are threatened by the continued transmission of HIV through breast milk of poor HIV-infected women in Africa who have no realistic choice but to breastfeed. A recent study from Durban compared for the first time, Mother-to-child transmission of HIV (MTCT) rates in each of the 3 feeding groups viz. exclusive breastfeeding (EBF), mixed breastfeeding (MBF) and formula feeding. The results of this study showed that at 3 months the MTCT in EBF mothers was similar to that in mothers giving only formula feeds, and the MTCT in EBF mothers was significantly lower than in those MBF (14.6% vs. 24.1%). This suggested that EBF may carry no additional risk of MTCT of HIV1 over formula feeding. A prospective study is required to verify these findings.
We propose a cohort study of HIV-infected mothers and their infants, to examine the risk of post-natal transmission of HIV in relation to infant feeding practices after mothers receive intensive breastfeeding counselling and support to practise EBF until about 6 months of age (the optimal duration for EBF).
The hypothesis being tested is: Exclusive breastfeeding by HIV-infected women carries no additional risk of post-natal transmission of HIV than exclusive formula feeding.
The primary objectives of the study are to determine the effect of infant feeding practices on HIV infection rates of infants at 6 and 22 weeks of age, and secondly to to determine the infant survival rate at 24 months of age according to feeding practices and HIV status.
Secondary objectives are:
- To determine the HIV infection rate of infants as measured of a sample collected within 72 hours of birth; ii) To determine the HIV transmission incidence attributable to the duration of different feeding practices; iii) To determine the cumulative incidence of vertical transmission in EBF, MBF and EFF infants; iv) To describe risk factors, other than feeding practice, for post-natal transmission of HIV, including maternal and infant morbidity and breast health; v) To assess the determinants of transmission in MBF adjusting for exposure factors e.g. type and age of introduction of other food/milk; vi) To describe the morbidity and growth of infants in relation to feeding practices and HIV status; and vii) To describe adherence rates to EBF following a breastfeeding support intervention.
HIV infected women will be counselled according to the WHO/UNICEF/UNAIDS infant feeding guidelines. All HIV-infected women and a random sub-sample of HIV-uninfected women will be recruited antenatally. Those who choose to breastfeed will be visited frequently at home by a team of breastfeeding counsellors before and after delivery to promote and support EBF. HIV-infected mothers who choose not to breastfeed will be supported in their choice by clinic-based staff. An independent team of field monitors will collect data weekly on feeding practices and morbidity of all infants at home visits. Blood samples will be collected by finger/heel prick and stored on filter paper prior to qualitative and quantitative estimation of HIV viral content to determine the timing of transmission.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infant feeding counselling and support | Other | Behavioral: Infant feeding counselling and supportAll mothers provided with counselling. Subsequent support interventions depended on mothers' selection of feeding practice |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All pregnant women attending antenatal clinics in the Mpukunyoni and Hlabisa Tribal Areas of Hlabisa District or at Kwadabeka clinic or St Mary's hospital, Mariannhilll Hospital who offer consent to participate in the study
Key exclusion criteria (3 listed)
- Intention to leave Hlabisa District or Kwadabeka community within 3 months of delivery.
- Failure to give consent.
- Less than 16 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant feeding counselling and supportCounselling of appropriate feeding practices as recommended in WHO/UNICEF/UNAIDS guidelines on HIV and infant feeding. Subsequent intensive, home-based support of exclusive breastfeeding or safe replacement feeding according to mothers' selection of feeding practice. Counselling contacts with mothers varied over time. 1-2 antenatal contacts. After delivery, home visits by infant feeding counsellors 3-4 times in first 2 weeks then every 2 weeks until 6 months. Outcome data collected by separate field based team who were blinded to mothers HIV status and infant feeding practice. | Behavioural | Infant feeding counselling and support |
Primary outcome
HIV infection rates of infants who are Exclusively breastfed, Mixed Breastfed or Exclusive Formula Feeding as determined by HIV RNA PCR analysis of a blood sample at that time
Time frame: 6 weeks of age
HIV infection rates of infants who are Exclusively breastfed, Mixed Breastfed or Exclusive Formula Feeding as determined by HIV RNA PCR analysis of a blood sample at that time
Time frame: 22 weeks of age
Infant/child survival
Time frame: 24 months of age
9 secondary outcomes
HIV infection rates of infants as determined by HIV RNA PCR analysis of a blood sample obtained in that time period
Time frame: Within 72 hours of birth
Difference between intrauterine and intrapartum HIV infection rates in women and neonates receiving NVP as determined by HIV RNA PCR analysis of blood samples collected within 72 hours of birth and at 6 weeks
Time frame: 72 hours and 6 weeks
HIV infection rates of infants at various time points between 6 and 26 weeks, in relation to the type and duration of infant feeding practices i.e. EBF, MBF and EFF (+/- an initial period of EBF)
Time frame: 6 weeks of age and 26 weeks of age
HIV infection rates of infants 4 weeks after cessation of EBF as determined by HIV RNA PCR analysis of blood samples collected at that time
Time frame: 4 weeks post cessation of breastfeeding
Prevalent days of diarrhoea
Time frame: Weekly from birth to 9 months of age
Prevalent days of respiratory distress
Time frame: Weekly from birth to 9 months of age
Changes in weight, length and head circumference
Time frame: From birth to 18 months of age
Maternal morbidity
Time frame: Monthly until 18 months post partum
Percentage of women who adhere to EBF
Time frame: Until 6 months post partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2013.
- Background: PubMed 19336438Bland R, Coovadia H, Coutsoudis A, Rollins N, Newell M. Cohort profile: mamanengane or the Africa centre vertical transmission study. Int J Epidemiol. 2010 Apr;39(2):351-60. doi: 10.1093/ije/dyp165. Epub 2009 Mar 31. No abstract available.
- Results publication: PubMed 21367736Neveu D, Viljoen J, Bland RM, Nagot N, Danaviah S, Coutsoudis A, Rollins NC, Coovadia HM, Van de Perre P, Newell ML. Cumulative exposure to cell-free HIV in breast milk, rather than feeding pattern per se, identifies postnatally infected infants. Clin Infect Dis. 2011 Mar 15;52(6):819-25. doi: 10.1093/cid/ciq203.
- Results publication: PubMed 19915445Patel D, Bland R, Coovadia H, Rollins N, Coutsoudis A, Newell ML. Breastfeeding, HIV status and weights in South African children: a comparison of HIV-exposed and unexposed children. AIDS. 2010 Jan 28;24(3):437-45. doi: 10.1097/QAD.0b013e3283345f91.
- Results publication: PubMed 19834601Becquet R, Bland R, Leroy V, Rollins NC, Ekouevi DK, Coutsoudis A, Dabis F, Coovadia HM, Salamon R, Newell ML. Duration, pattern of breastfeeding and postnatal transmission of HIV: pooled analysis of individual data from West and South African cohorts. PLoS One. 2009 Oct 16;4(10):e7397. doi: 10.1371/journal.pone.0007397.
- Results publication: PubMed 18981775Rollins NC, Becquet R, Bland RM, Coutsoudis A, Coovadia HM, Newell ML. Infant feeding, HIV transmission and mortality at 18 months: the need for appropriate choices by mothers and prioritization within programmes. AIDS. 2008 Nov 12;22(17):2349-57. doi: 10.1097/QAD.0b013e328312c740.
- Results publication: PubMed 18560596Desmond C, Bland RM, Boyce G, Coovadia HM, Coutsoudis A, Rollins N, Newell ML. Scaling-up exclusive breastfeeding support programmes: the example of KwaZulu-Natal. PLoS One. 2008 Jun 18;3(6):e2454. doi: 10.1371/journal.pone.0002454.
- Results publication: PubMed 18427207Bland RM, Little KE, Coovadia HM, Coutsoudis A, Rollins NC, Newell ML. Intervention to promote exclusive breast-feeding for the first 6 months of life in a high HIV prevalence area. AIDS. 2008 Apr 23;22(7):883-91. doi: 10.1097/QAD.0b013e3282f768de.
- Results publication: PubMed 18076554Lebon A, Bland RM, Rollins NC, Coutsoudis A, Coovadia H, Newell ML. Short communication: CD4 counts of HIV-infected pregnant women and their infected children--implications for PMTCT and treatment programmes. Trop Med Int Health. 2007 Dec;12(12):1472-4. doi: 10.1111/j.1365-3156.2007.01954.x.
- Results publication: PubMed 17990235Bland RM, Becquet R, Rollins NC, Coutsoudis A, Coovadia HM, Newell ML. Breast health problems are rare in both HIV-infected and HIV-uninfected women who receive counseling and support for breast-feeding in South Africa. Clin Infect Dis. 2007 Dec 1;45(11):1502-10. doi: 10.1086/523320. Epub 2007 Oct 22.
- Results publication: PubMed 17546310Bland RM, Rollins NC, Coovadia HM, Coutsoudis A, Newell ML. Infant feeding counselling for HIV-infected and uninfected women: appropriateness of choice and practice. Bull World Health Organ. 2007 Apr;85(4):289-96. doi: 10.2471/blt.06.032441.
- Results publication: PubMed 17398310Coovadia HM, Rollins NC, Bland RM, Little K, Coutsoudis A, Bennish ML, Newell ML. Mother-to-child transmission of HIV-1 infection during exclusive breastfeeding in the first 6 months of life: an intervention cohort study. Lancet. 2007 Mar 31;369(9567):1107-16. doi: 10.1016/S0140-6736(07)60283-9.
- Results publication: PubMed 17195768Rollins NC, Coovadia HM, Bland RM, Coutsoudis A, Bennish ML, Patel D, Newell ML. Pregnancy outcomes in HIV-infected and uninfected women in rural and urban South Africa. J Acquir Immune Defic Syndr. 2007 Mar 1;44(3):321-8. doi: 10.1097/QAI.0b013e31802ea4b0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hoosen M Coovadia, MB principal investigator
University of KwaZulu-Natal, and University of the Witwatersand, South Africa
Marie Louise Newell, PhD study chair
University of KwaZulu-Natal and Institute for Child Health, University College, London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant feeding counselling and support in people with HIV, run by University of KwaZulu at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV infection rates of infants who are Exclusively breastfed, Mixed Breastfed or Exclusive Formula Feeding as determined by HIV RNA PCR analysis of a blood sample at that time (time frame: 6 weeks of age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01948557, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2013.