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Trial no.:
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PACTR201802003137364 |
Date of Approval:
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22/02/2018 |
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Trial Status:
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Registered in accordance with WHO and ICMJE standards |
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| TRIAL DESCRIPTION |
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Public title
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Determining the Effects of layered multi-component interventions on the Early Childhood Stimulation (ECS) among PMTCT mother baby pairs |
| Official scientific title |
Determining the Effects of layered multi-component interventions on the Early Childhood Stimulation (ECS) among PMTCT mother baby pairs |
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Brief summary describing the background
and objectives of the trial
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In Swaziland, 63% of the population lives below the poverty line and chronic food insecurity has left one in four children suffering from stunted growth (WHO, 2010). The nutrition challenges in the general population of below 5 children is at 25.5% stunting (MICS, 2014). With HIV prevalence of 27.2% among adults 15-29 years and peaking at 54.2% among women 35-39 years (SHIMS 2, 2016) the chances of mother to child transmission becomes very high. Also, the incidence of reductions in adherence to ARV among persons living with HIV in food insecure households is high. According to the Socio-Economic Impacts of the 2015/16 El Nino Induced Drought report, drought impact affected patients¿ access to health facilities and increased vulnerabilities as some are unable to make the journey to the health facilities due to illness, weakness or lack of finances. Vulnerable women possess very few resources, services, inputs or information to keep themselves and their babies healthy and well nourished. These challenges negatively impact the development of an infant particularly in the first 1,000 days, which will impair the future, health, economic, social outcomes and general wellbeing at adulthood.
Thus the study aims to determine the possibility of increasing Early Childhood Stimulation (ECS) skills and knowledge, nutrition through permaculture, economic resilience through groups savings and lending schemes and care outcomes among 235 HIV exposed and infected infants aged 0-2 years and retention in PMTCT care amongst their mothers using a comprehensive, community-based intervention. Specific objectives include, first, pilot a community-based multi-component intervention (ECS+ parenting, permaculture gardening, economic strengthening and ECS re-enforced Interactive Voice Messaging) aimed at improving ECS practices, and second, assess changes in uptake of PMTCT and other health services amongst caregivers and their HIV exposed children in the first 1,000 days. |
| Type of trial |
CCT |
| Acronym (If the trial has an acronym then please provide) |
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| Disease(s) or condition(s) being studied |
Infections and Infestations |
| Sub-Disease(s) or condition(s) being studied |
HIV/AIDS |
| Purpose of the trial |
Prevention |
| Anticipated trial start date |
01/01/2018 |
| Actual trial start date |
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| Anticipated date of last follow up |
31/10/2018 |
| Actual Last follow-up date |
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| Anticipated target sample size (number of participants) |
470 |
| Actual target sample size (number of participants) |
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| Recruitment status |
Recruiting |
| Publication URL |
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