Is it possible to develop a home based package of interventions delivered by community based women that will improve levels of maternal, newborn, child and HIV care in a disadvantaged community in South Africa?
| ISRCTN | ISRCTN41046462 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41046462 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/11/2009
- Registration date
- 04/01/2010
- Last edited
- 01/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Mark Tomlinson
Scientific
Scientific
Department of Psychology
Stellenbosch University
Private Bag X1
Matieland
7602
South Africa
Stellenbosch
7602
South Africa
| markt@sun.ac.za |
Study information
| Study design | Cluster randomised unblinded active controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | An effectiveness study of an integrated, community based package for maternal, newborn, child and HIV care in a disadvantaged community in South Africa |
| Study objectives | This study aims to test the hypothesis that infants in clusters receiving a home based package of interventions, will have significantly improved HIV free survival and higher levels of exclusive appropriate feeding at 12 weeks postnatally, relative to control clusters receiving improved health facility care and key information to the mother and family on available social grants and the processes for gaining access to these grants. |
| Ethics approval(s) | The Medical Research Council (South Africa) Ethics Committee approved on the 5th of May 2008 (Protocol ID: EC08-002) |
| Health condition(s) or problem(s) studied | Mother to child transmission of HIV; neonatal health |
| Intervention | 1. Antenatal visit 1 at home Content in this visit will include: 1.1. Antenatal care action immunisations/micronutrient supplementation 1.2. Focus on the importance of VCT (linking this with the PMTCT programme and the benefits of testing to the mother) 1.3. Emphasise the importance of antenatal care 1.4. Key messages on appropriate infant feeding 1.5. Encourage exclusive breastfeeding in HIV negative women or women of unknown HIV status. 1.6. For HIV positive women, assist with thinking about infant feeding options 1.7. Input regarding infant communication and the mother-infant relationship 2. Antenatal visit 2 at home Content in this visit will include: 2.1. Birth plans place of birth, support during labour, care plans if returning to work 2.3. Danger signs and emergency plans this will be done, if possible together with other family members in order to elicit their input regarding possible plans in the event of an emergency, including recognition of danger signs, emergency transport plan and emergency funds if needed 2.4. Homecoming arrangements 2.5. Follow up and re-emphasis on VCT, PMTCT, the key messages on appropriate infant feeding that were provided in antenatal visit 1; further discussion in terms of assisting with the implementation of chosen feeding option 2.6. Additional input on infant communication and the warning signs of postnatal depression 3. Postnatal visit 1 at home (24-48hrs) Content in this visit will include: 3.1. Assessment of newborn breathing, thermal care, colour, bleeding, neonatal eye care, checklist of danger signs 3.2. Assessment of mother - bleeding, signs for infection, mastitis 3.3. Early recognition of illness (superficial or systemic) and help seeking 3.4. Exclusive breastfeeding or appropriate infant feeding support 3.5. Hygienic cord care and what to expect regarding when the cord will drop off 3.6. Thermal care, skin to skin care and Kangaroo care if needed for preterm babies 3.7. Ensure that babies of HIV positive women have received Nevirapine 3.8. Information about warning signs for mother or baby and what to do 3.9. Support for women who have the blues 4. Postnatal visit 2 at home (3-4 days) Content in this visit will include: 4.1. Assessment of the mother and the newborn, Further input on the early recognition of illness (superficial or systemic) and help seeking 4.2. Monitoring and follow up of breastfeeding or appropriate feeding and possible feeding problems 4.3. Further support for hygiene, thermal care and cord care, with Kangaroo care input if needed for preterm babies 4.4. 1st week clinic visit reminder 4.5. Information about warning signs for mother or baby and what to do 4.6. Newborn Interactive Assessment - demonstration of the abilities of infants and infant communication and social responsiveness. Sleeping, crying, consolability and wider concerns 5. Postnatal visit 3 at home (10-14 days) Content in this visit will include: 5.1. Early recognition of illness (superficial or systemic) and help seeking 5.2. Ongoing monitoring of breastfeeding or other appropriate feeding 5.3. Information about warning signs for mother or baby and what to do 5.4. Promote attendance at clinic for 6 week visit for mother to have access to family planning and baby to receive immunisations and the babies of HIV+ women been given bactrim and HIV testing 5.5. Mother infant interaction modelling and communication input 5.6. Assess for signs of postnatal depression 6. Postnatal visit 4 at home (3-4 weeks) Content in this visit will include: 6.1. Early recognition of illness (superficial or systemic) and help seeking 6.2. Ongoing monitoring of breastfeeding or other appropriate feeding 6.3. Information about warning signs for mother or baby and what to do 6.4. Promote attendance at clinic for 6 week visit for mother to have access to family planning and baby to receive immunisations and the babies of HIV+ women been given bactrim and HIV testing 6.5. Mother infant interaction modelling and communication input 6.6. Assess for signs of postnatal depression 7. Postnatal visit 5 at home (7-8 weeks) Content in this visit will include: 7.1. Further input on feeding including advice regarding weaning 7.2. Infant weight from clinic card (6 week visit) 7.3. Mother infant attachment 7.4. Checklist of signs of postnatal depression 7.5. Has the child been tested for HIV at six weeks and receiving cotrimoxazole 7.6. Formula sustainability for HIV positive women using formula milk 7.7. Family planning and counselling 7.8. Input on milestones and information and specific skills about the stimulation of infants All intervention visits will be delivered by community health workers targeting pregnant women and postnatal women and their newborns to provide essential maternal and newborn care. All visits will take place in the home |
| Intervention type | Other |
| Primary outcome measure | 1. HIV free infant survival at 12 weeks postpartum 2. Levels of exclusive and appropriate infant feeding at 12 weeks postpartum |
| Secondary outcome measures | 1. Better uptake of a postnatal clinic visit within 7 days of life 2. Coverage of care and behavioural indicators (antenatal HIV testing, uptake of cotrimoxazole amongst HIV exposed infants at 6 weeks, family planning uptake at 6 weeks) 3. Levels of maternal depression at 12 weeks postpartum 4. To assess whether the intervention is cost-effective compared to improved health facility care alone. This will be evaluated in terms of cost per HIV infection averted and disability-adjusted life years (DALYs) saved |
| Overall study start date | 17/06/2008 |
| Completion date | 31/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | A total of 3600 pregnant women will be recruited |
| Key inclusion criteria | All pregnant women aged 16-49 years who give informed consent for study participation |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 17/06/2008 |
| Date of final enrolment | 31/10/2010 |
Locations
Countries of recruitment
- South Africa
Study participating centre
Department of Psychology
Stellenbosch
7602
South Africa
7602
South Africa
Sponsor information
Saving Newborn Lives (Save the Children) (USA)
Charity
Charity
2000 L Street NW, Suite 500
Washington, DC 20036
Washington
20036
United States of America
| joylawn@yahoo.co.uk | |
| Website | http://www.savethechildren.org |
"ROR" |
https://ror.org/036jr6x18 |
Funders
Funder type
Other
Center for Disease Control (CDC) (USA)
No information available
Saving Newborn Lives (Save the Children) (USA)
No information available
World Health Organization (WHO)
Private sector organisation / International organizations
Private sector organisation / International organizations
- Alternative name(s)
- منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
- Location
- Switzerland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | study protocol | 01/11/2011 | Yes | No | |
| Results article | results | 06/02/2013 | Yes | No |
