scholarly journals An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: study protocol for the Insika Yomama cluster randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Tamsen J. Rochat ◽  
Samukelisiwe Dube ◽  
Kobus Herbst ◽  
Cecilia A. Hoegfeldt ◽  
Stephanie Redinger ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Child Development ◽  
Perinatal Depression ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Cluster Randomised Controlled Trial ◽  
Perinatal Period ◽  
Hiv Positive ◽  
Hiv Positive Women ◽  
Randomised Controlled

Abstract Background The combination of poverty, HIV and depression in the perinatal period represents a major public health challenge in many Southern African countries. In some areas, up to a third of HIV-positive women experience perinatal depression. Perinatal depression is associated with negative effects on parenting and key domains of child development including cognitive, behavioural and growth, especially in socio-economically disadvantaged communities. Several studies have documented the benefits of psychological interventions for perinatal depression in low- and middle-income countries, but none have evaluated an integrated psychological and parenting intervention for HIV-positive women using task-sharing. This randomised controlled trial aims to evaluate the effect of a home-based intervention, combining a psychological treatment for depression and a parenting programme for perinatally depressed HIV-positive women. Methods This study is a cluster randomised controlled trial, consisting of 48–60 geospatial clusters. A total of 528 pregnant HIV-positive women aged ≥ 16 years who meet the criteria for depression on the Edinburgh Postnatal Depression Scale (EPDS, score ≥ 9)) are recruited from antenatal clinics in rural KwaZulu-Natal, South Africa. The geospatial clusters are randomised on an allocation ratio of 1:1 to either the intervention or Enhanced Standard of Care (ESoC). The intervention group receives 10 home-based counselling sessions by a lay counsellor (4 antenatal and 6 postnatal sessions) and a booster session at 16 months. The intervention combines behavioural activation for depression with a parenting programme, adapted from the UNICEF/WHO Care for Child Development programme. The ESoC group receives two antenatal and two postnatal counselling support and advice telephone calls. In addition, measures have been taken to enhance the routine standard of care. The co-primary outcomes are child cognitive development at 24 months assessed on the cognitive subscale of the Bayley Scales of Infant Development-Third Edition and maternal depression at 12 months measured by the EPDS. Analysis The primary analysis will be a modified intention-to-treat analysis. The primary outcomes will be analysed using mixed-effects linear regression. Discussion If this treatment is successful, policymakers could use this model of mental healthcare delivered by lay counsellors within HIV treatment programmes to provide more comprehensive services for families affected by HIV. Trial registration ISRCTN registry #11284870 (14/11/2017) and SANCTR DOH-27-102020-9097 (17/11/2017).

scholarly journals An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: Study Protocol for the Insika Yomama Cluster Randomised Controlled Trial

2021 ◽  
Author(s):  
Tamsen Rochat ◽  
Sam Dube ◽  
Kobus Herbst ◽  
Cecilia Hoegfeldt ◽  
Stephanie Redinger ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Child Development ◽  
Perinatal Depression ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Perinatal Period ◽  
Hiv Positive ◽  
Hiv Positive Women ◽  
Home Based ◽  
Randomised Controlled

Abstract Background: The combination of poverty, HIV and depression in the perinatal period represents a major public health challenge in many Southern African countries. In some areas, up to a third of HIV-positive women experience perinatal depression. Perinatal depression is associated with negative effects on parenting and key domains of child development including cognitive, behavioural and growth, especially in socio-economically disadvantaged communities. Several studies have documented the benefits of psychological interventions for perinatal depression in low- and middle-income countries, but none have evaluated an integrated psychological and parenting intervention for HIV-positive women using task-sharing. This randomised controlled trial aims to evaluate the effect of a home-based intervention, combining a psychological treatment for depression and a parenting programme for perinatally depressed HIV-positive women. Methods: This study is a cluster-randomised controlled trial, consisting of 48-60 geospatial clusters. A total of 528 pregnant HIV-positive women aged ≥16 years who meet the criteria for depression on the Edinburgh Postnatal Depression Scale (EPDS, score ≥9)) are recruited from antenatal clinics in rural KwaZulu-Natal, South Africa. The geospatial clusters are randomised on an allocation ratio of 1:1 to either the intervention or Enhanced Standard of Care. The intervention group receives 10 home-based counselling sessions by a lay-counsellor (4 antenatal and 6 postnatal sessions) and a booster session at 16 months. The intervention combines Behavioural Activation for depression with a parenting programme, adapted from the UNICEF/WHO Care for Child Development programme. The ESoC group receives two antenatal and two postnatal support and advice telephone calls. The co-primary outcomes are child cognitive development at 24 months assessed on the cognitive sub-scale of the Bayley Scales of Infant Development-Third Edition and maternal depression at 12 months measured by the EPDS. Analysis: The primary analysis will be a modified Intention-to-Treat analysis. The primary outcomes will be analysed using mixed-effects linear regression. Discussion: If this treatment is successful, policymakers could use this model of mental health-care delivered by lay-counsellors within HIV treatment programmes to provide more comprehensive services for families affected by HIV.

scholarly journals High dose oral and intravenous rifampicin for improved survival from adult tuberculous meningitis: a phase II open-label randomised controlled trial (the RifT study)

2018 ◽  
Vol 3 ◽  
pp. 83 ◽  
Author(s):  
Fiona V. Cresswell ◽  
Kenneth Ssebambulidde ◽  
Daniel Grint ◽  
Lindsey te Brake ◽  
Abdul Musabire ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Phase Ii ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Hiv Positive ◽  
Current Standard ◽  
Open Label ◽  
Dose Oral ◽  
Randomised Controlled ◽  
Positive Population

Background: Tuberculous meningitis (TBM) has 44% (95%CI 35-52%) in-hospital mortality with standard therapy in Uganda. Rifampicin, the cornerstone of TB therapy, has 70% oral bioavailability and ~10-20% cerebrospinal fluid (CSF) penetration.  With current WHO-recommended TB treatment containing 8-12mg/kg rifampicin, CSF rifampicin exposures frequently fall below the minimal inhibitory concentration for M. tuberculosis. Two Indonesian phase II studies, the first investigating intravenous rifampicin 600mg and the second oral rifampicin ~30mg/kg, found the interventions were safe and resulted in significantly increased CSF rifampicin exposures and a reduction in 6-month mortality in the investigational arms. Whether such improvements can be replicated in an HIV-positive population remains to be determined. Protocol: We will perform a phase II, open-label randomised controlled trial, comparing higher-dose oral and intravenous rifampicin with current standard of care in a predominantly HIV-positive population. Participants will be allocated to one of three parallel arms (I:I:I): (i) intravenous rifampicin 20mg/kg for 2-weeks followed by oral rifampicin 35mg/kg for 6-weeks; (ii) oral rifampicin 35mg/kg for 8-weeks; (iii) standard of care, oral rifampicin 10mg/kg/day for 8-weeks. Primary endpoints will be: (i) pharmacokinetic parameters in plasma and CSF; (ii) safety. We will also examine the effect of higher-dose rifampicin on survival time, neurological outcomes and incidence of immune reconstitution inflammatory syndrome. We will enrol 60 adults with suspected TBM, from two hospitals in Uganda, with follow-up to 6 months post-enrolment. Discussion: HIV co-infection affects the bioavailability of rifampicin in the initial days of therapy, risk of drug toxicity and drug interactions, and ultimately mortality from TBM. Our study aims to demonstrate, in a predominantly HIV-positive population, the safety and pharmacokinetic superiority of one or both investigational arms compared to current standard of care. The most favourable dose may ultimately be taken forward into an adequately powered phase III trial. Trial registration: ISRCTN42218549 (24th April 2018)

scholarly journals Impact of a community-based package of interventions on child development in Zambia: a cluster-randomised controlled trial

2016 ◽  
Vol 1 (3) ◽  
pp. e000104 ◽  
Author(s):  
Peter C Rockers ◽  
Günther Fink ◽  
Arianna Zanolini ◽  
Bowen Banda ◽  
Godfrey Biemba ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Child Development ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Community Based ◽  
Cluster Randomised ◽  
Randomised Controlled

scholarly journals A factorial cluster-randomised controlled trial combining home-environmental and early child development interventions to improve child health and development: rationale, trial design and baseline findings

2018 ◽  
Author(s):  
Stella M Hartinger ◽  
Nestor Nuño ◽  
Jan Hattendorf ◽  
Hector Verastegui ◽  
Mariela Ortiz ◽  
...  
Keyword(s):  
Risk Factors ◽  
Drinking Water ◽  
Randomised Controlled Trial ◽  
Child Development ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Early Child Development ◽  
Early Child ◽  
Cluster Randomised ◽  
Randomised Controlled

ABSTRACTBackgroundExposure to unhealthy environments and poor cognitive development are the main risk factors that affect children’s health and wellbeing in low- and middle-income countries. Interventions that simultaneously address several risk factors at the household level have great potential to reduce these negative effects. We present the design and baseline findings of a cluster-randomised controlled trial to evaluate the impact of an integrated home-environmental intervention package and an early child development programme to improve diarrhoea, acute respiratory infections and childhood developmental outcomes in children under 36 months of age living in resource-limited rural Andean Peru.MethodsWe collected baseline data on children’s developmental performance, health status and demography as well as microbial contamination in drinking water. In a sub-sample of households, we measured indoor and personal 24-hour air concentration levels of carbon monoxide (CO) and fine particulate matter (PM2.5).ResultsWe recruited and randomised 317 children from 40 community-clusters to four study arms. At baseline, all arms had similar health and demographic characteristics, and the developmental status of children was comparable between arms. The analysis revealed that more than 25% of mothers completed primary education, a large proportion of children were stunted and diarrhoea prevalence was above 18%. Fifty-two percent of drinking water samples tested positive for thermo-tolerant coliforms and the occurrence of E.coli was evenly distributed between arms. The mean levels of kitchen PM2.5 and CO concentrations were 213 μg/m3 and 4.8 ppm, respectively.ConclusionsThe trial arms are balanced with respect to most baseline characteristics, such as household air and water pollution, and child development. These results ensure the possible estimation of the trial effectiveness. This trial will yield valuable information for assessing synergic, rational and cost-effective benefits of the combination of home-based interventions.Trial registrationretrospectively registered on 15th January 2018. SRCTN reference: 26548981

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