Prevention of Mother-to-child Transmission of HIVNCT01774136
Effectiveness of an HIV-adapted IMCI Training and Supervision Programme for Community Health Workers
A study testing Enhanced HIV and MCH training for CHW in people with Prevention of Mother-to-child Transmission of HIV and Antenatal Health Care Utilization, run by University of KwaZulu at 1 site in South Africa.
Trial summary
This is a cluster randomized controlled trial (C-RCT) to evaluate the effectiveness of a Community-Integrated Management of Childhood Illness (C-IMCI) training for community caregivers (CCGs), adapted to include HIV-related interventions, on the delivery of maternal, newborn and child health interventions within… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevention of Mother-to-child Transmission of HIV, Antenatal Health Care Utilization, Postnatal Health Care Utilization
- What is being tested?
- Enhanced HIV and MCH training for CHW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,342 participants
- Where
- 1 siteSouth Africa
- Study dates
- Apr 2012to Apr 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community caregivers
- CCGs who work in Ugu District
- age 18 years or older
- with grade 9 education or greater
- Mothers
- Mothers age 18 years and older who delivered a live-born infant within the prior 12 months
- Reside in households served by participating CCGs.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of an HIV-adapted IMCI Training and Supervision Programme of Community Caregivers to Support Interventions That Will Reduce MTCT and Improve Delivery of Other Essential Newborn and Child Survival Interventions
This is a cluster randomized controlled trial (C-RCT) to evaluate the effectiveness of a Community-Integrated Management of Childhood Illness (C-IMCI) training for community caregivers (CCGs), adapted to include HIV-related interventions, on the delivery of maternal, newborn and child health interventions within households in rural communities in Ugu District, KwaZulu-Natal (KZN) Province, South Africa. The intervention includes two components: (1) a 2-week HIV/C-IMCI training for CCGs and their associated facilitators and supervisors, and (2) continuous support and supervision following the continuous quality improvement (CQI) framework, a low-technology approach to management and supervision of health programs. The primary objectives of the proposed evaluation are to measure the effect of the intervention on key outcomes, including early uptake of antenatal care, facility based delivery, postnatal visits, coverage of exclusive breastfeeding, and uptake of HIV PCR testing in infants at 6 weeks. We will also examine the effects of the intervention on immunization uptake up to 12 months and knowledge and practices of CCGs and mothers pertaining to maternal, newborn and child health.
- Conditions
- Prevention of Mother-to-child Transmission of HIV, Antenatal Health Care Utilization, Postnatal Health Care Utilization, Infant Feeding Practices
- Being tested
- Enhanced HIV and MCH training for CHW
- Keywords
- community health workers, HIV, PMTCT, antenatal, postnatal, breastfeeding, South Africa
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced HIV and MCH training for CHWBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Enhanced HIV and MCH training for CHW | Experimental | The intervention includes two components: (1) a 2-week HIV/C-IMCI training for CCGs and their associated facilitators and supervisors, and (2) continuous support and supervision following the continuous quality improvement (CQI) framework, a low-technology approach to management and supervision of health programs. Receives: Behavioral: Enhanced HIV and MCH training for CHW |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of antenatal booking before 20 weeks gestation
Measured: 1 year
Prevalence of presentation for post-natal care within 7 days of delivery
Measured: 1 year
Prevalence of exclusive breast-feeding practice at 14 weeks
Measured: 1 year
Coverage of HIV PCR testing at 6 weeks
Measured: 1 year
Secondary outcomes (12)
Proportion of women who attended for antenatal care at least 4 times in pregnancy
Measured: 1 year
Proportion of deliveries by skilled birth attendant at a health facility
Measured: 1 year
Proportion of age-eligible infants who received recommended immunizations at 6, 10, and 14 weeks and 9 and 12 months
Measured: 1 year
Proportion of children whose growth was monitored by CCG at home
Measured: 1 year
Prevalence of exclusive breast-feeding practice at 6 months
Measured: 1 year
Proportion of women without known HIV-positive status who received HIV test in pregnancy
Measured: 1 year
Proportion of women without known HIV-positive status who received HIV test result in pregnancy
Measured: 1 year
Proportion of HIV-positive women who received CD4 test results
Measured: 1 year
Proportion of HIV-positive women who received ARV prophylaxis in pregnancy and during delivery
Measured: 1 year
Proportion of infants born to HIV-positive mothers who received ARV prophylaxis following birth (including during breastfeeding where appropriate)
Measured: 1 year
Knowledge and practices of mothers in the community regarding: infant feeding, HIV, availability of interventions to reduce HIV transmission, newborn care practices and recognition of serious illness in children and management of childhood illnesses
Measured: 1 year
Knowledge and practices of CCGs with regards to: HIV-specific interventions to improve maternal health, reduce HIV transmission and improve child survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startApr 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prevention of Mother-to-child Transmission of 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,342 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of KwaZulu
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, World Health Organization, Institute for Healthcare Improvement, University of California, San Francisco
- Responsible party
- Principal investigator, Dr. Jennifer Reddy, University of KwaZulu
- Investigators
- Jennifer Reddy, MBChB, Principal investigator, 20,000+ Partnership, University of KwaZulu-Natal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774136
- Sponsor's protocol ID
- Nompilo
- Status last verified
- Apr 2019
- First submitted
- 20 Jan 2013
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Horwood C, Butler L, Barker P, Phakathi S, Haskins L, Grant M, Mntambo N, Rollins N. A continuous quality improvement intervention to improve the effectiveness of community health workers providing care to mothers and children: a cluster randomised controlled trial in South Africa. Hum Resour Health. 2017 Jun 13;15(1):39. doi: 10.1186/s12960-017-0210-7.
PubMed 28610590
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an HIV-adapted IMCI Training and Supervision Programme of Community Caregivers to Support Interventions That Will Reduce MTCT and Improve Delivery of Other Essential Newborn and Child Survival Interventions
- ClinicalTrials.gov ID
- NCT01774136
- Acronym / sponsor ID
- Nompilo
- Conditions
- Prevention of Mother-to-child Transmission of HIV, Antenatal Health Care Utilization, Postnatal Health Care Utilization, Infant Feeding Practices
- Keywords
- community health workers, HIV, PMTCT, antenatal, postnatal, breastfeeding, South Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,342 participants (actual)
- Lead sponsor
- University of KwaZuluUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, World Health Organization, Institute for Healthcare Improvement, University of California, San Francisco
- Study start
- Apr 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 23 Jan 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.
This is a cluster randomized controlled trial (C-RCT) to evaluate the effectiveness of a Community-Integrated Management of Childhood Illness (C-IMCI) training for community caregivers (CCGs), adapted to include HIV-related interventions, on the delivery of maternal, newborn and child health interventions within households in rural communities in Ugu District, KwaZulu-Natal (KZN) Province, South Africa. The intervention includes two components: (1) a 2-week HIV/C-IMCI training for CCGs and their associated facilitators and supervisors, and (2) continuous support and supervision following the continuous quality improvement (CQI) framework, a low-technology approach to management and supervision of health programs. The primary objectives of the proposed evaluation are to measure the effect of the intervention on key outcomes, including early uptake of antenatal care, facility based delivery, postnatal visits, coverage of exclusive breastfeeding, and uptake of HIV PCR testing in infants at 6 weeks. We will also examine the effects of the intervention on immunization uptake up to 12 months and knowledge and practices of CCGs and mothers pertaining to maternal, newborn and child health.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced HIV and MCH training for CHW | Experimental | Behavioral: Enhanced HIV and MCH training for CHWThe intervention includes two components: (1) a 2-week HIV/C-IMCI training for CCGs and their associated facilitators and supervisors, and (2) continuous support and supervision following the continuous quality improvement (CQI) framework, a low-technology approach to management and supervision of health programs. |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Community caregivers
- CCGs who work in Ugu District
- age 18 years or older
- with grade 9 education or greater
- Mothers
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Enhanced HIV and MCH training for CHW | Behavioural | Enhanced HIV and MCH training for CHW |
Primary outcome
Prevalence of antenatal booking before 20 weeks gestation
Time frame: 1 year
Prevalence of presentation for post-natal care within 7 days of delivery
Time frame: 1 year
Prevalence of exclusive breast-feeding practice at 14 weeks
Time frame: 1 year
Coverage of HIV PCR testing at 6 weeks
Time frame: 1 year
12 secondary outcomes
Proportion of women who attended for antenatal care at least 4 times in pregnancy
Time frame: 1 year
Proportion of deliveries by skilled birth attendant at a health facility
Time frame: 1 year
Proportion of age-eligible infants who received recommended immunizations at 6, 10, and 14 weeks and 9 and 12 months
Time frame: 1 year
Proportion of children whose growth was monitored by CCG at home
Time frame: 1 year
Prevalence of exclusive breast-feeding practice at 6 months
Time frame: 1 year
Proportion of women without known HIV-positive status who received HIV test in pregnancy
Time frame: 1 year
Proportion of women without known HIV-positive status who received HIV test result in pregnancy
Time frame: 1 year
Proportion of HIV-positive women who received CD4 test results
Time frame: 1 year
Proportion of HIV-positive women who received ARV prophylaxis in pregnancy and during delivery
Time frame: 1 year
Proportion of infants born to HIV-positive mothers who received ARV prophylaxis following birth (including during breastfeeding where appropriate)
Time frame: 1 year
Knowledge and practices of mothers in the community regarding: infant feeding, HIV, availability of interventions to reduce HIV transmission, newborn care practices and recognition of serious illness in children and management of childhood illnesses
Time frame: 1 year
Knowledge and practices of CCGs with regards to: HIV-specific interventions to improve maternal health, reduce HIV transmission and improve child survival
Time frame: 1 year
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 17 Apr 2019.
- Derived from this study: PubMed 28610590Horwood C, Butler L, Barker P, Phakathi S, Haskins L, Grant M, Mntambo N, Rollins N. A continuous quality improvement intervention to improve the effectiveness of community health workers providing care to mothers and children: a cluster randomised controlled trial in South Africa. Hum Resour Health. 2017 Jun 13;15(1):39. doi: 10.1186/s12960-017-0210-7.
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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.
Jennifer Reddy, MBChB principal investigator
20,000+ Partnership, University of KwaZulu-Natal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced HIV and MCH training for CHW in people with Prevention of Mother-to-child Transmission of HIV and Antenatal Health Care Utilization, run by University of KwaZulu at 1 site 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 7 inclusion and 1 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 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Prevalence of antenatal booking before 20 weeks gestation (time frame: 1 year). The study lists 4 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 NCT01774136, which also lists 1 linked publication.
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 17 Apr 2019.