Innovative, enhanced community management of non-hypoxaemic chest-indrawing pneumonia in 2–59-month-old children: a cluster-randomised trial in Africa and Asia

IntroductionThe WHO recommends oral amoxicillin for 2–59-month-old children with chest-indrawing pneumonia presenting at the health facility. Community-level health workers (CLHWs) are not allowed to treat these children when presented at the community level. This study aimed to evaluate whether CLHWs can safely and effectively treat children 2–59 months-old with chest indrawing with a 5-day course of oral amoxicillin in a few selected countries in Africa and Asia, especially when a referral is not feasible.MethodsWe conducted a prospective multicountry cluster-randomised, open-label, non-inferiority trial in rural areas of four countries (Bangladesh, Ethiopia, India and Malawi) from September 2016 to December 2018. Children aged 2–59 months having parents/caregivers reported cough and/or difficult breathing presenting to a CLHW were screened for enrolment. CLHWs in the intervention clusters assessed children for hypoxaemia and treated non-hypoxaemic chest-indrawing pneumonia with two times per day oral amoxicillin (50 mg/kg body weight per dose) for 5 days at the community level. CLHWs in the control clusters identified chest indrawing and referred them to a referral-level health facility for treatment. Study supervisors performed pulse oximetry in the control clusters except in Bangladesh. Children were assessed for the primary outcome (clinical treatment failure) up to day 14 after enrolment. The accuracy and impact of pulse oximetry by CLHWs in the intervention clusters were also assessed.ResultsIn 208 clusters, 1688 CLHWs assessed 62 363 children with cough and/or difficulty breathing. Of these, 4013 non-hypoxaemic 2–59-month-old children with chest-indrawing pneumonia were enrolled. We excluded 116 children from analysis, leaving 3897 for intention-to-treat analysis. In the intervention clusters, 4.3% (90/2081) failed treatment, including five deaths, while in the control clusters, 4.4% (79/1816) failed treatment, including five deaths. The adjusted risk difference was -0.01 (95% CI −1.5% to 1.5%), which satisfied the prespecified non-inferiority criterion. CLHWs correctly performed pulse oximetry in 91.1% (2001/2196) of cases in the intervention clusters.ConclusionsThe community treatment of non-hypoxaemic children with chest-indrawing pneumonia with 5-day oral amoxicillin by trained, equipped and supervised CLHWs is non-inferior to currently recommended facility-based treatment. These findings encourage a review of the existing strategy of community-based management of pneumonia.Trial registrationACTRN12617000857303; The Australian New Zealand Clinical Trials Registry.

Download Full-text

Community-based amoxicillin treatment for fast breathing pneumonia in young infants 7–59 days old: a cluster randomised trial in rural Bangladesh, Ethiopia, India and Malawi

BMJ Global Health ◽

10.1136/bmjgh-2021-006578 ◽

2021 ◽

Vol 6 (8) ◽

pp. e006578

Author(s):

◽

Yasir B Nisar

Keyword(s):

Case Management ◽

Treatment Failure ◽

Pulse Oximetry ◽

Health Facility ◽

Community Level ◽

Secondary Outcome ◽

Control Group ◽

Community Case Management ◽

Young Infants ◽

Cluster Randomised

IntroductionYoung infants 7–59 days old with fast breathing pneumonia presented to a primary level health facility receive a 7-day course of amoxicillin as per the WHO guideline. However, community-level health workers (CLHW) are not allowed to treat these infants. This trial evaluated the community level treatment of non-hypoxaemic young infants with fast breathing pneumonia by CLHWs.MethodsThis cluster-randomised, open-label, non-inferiority trial was conducted in rural areas of Bangladesh, Ethiopia, India and Malawi. We randomly allocated clusters (first-level health facility) 1:1, stratified by the population size, to an intervention group (enhanced community case management) or control group (standard community case management). Infants aged 7–59 days with a respiratory rate of ≥60 breaths/min and oxygen saturation (SpO2) ≥90% were enrolled. In the intervention clusters, these infants were treated with a 7-day course of oral amoxicillin (according to WHO weight bands) and were regularly followed up by CLHWs. In the control clusters, CLHWs continued the standard management (assess and refer after pre-referral antibiotic dose) and followed up according to the national programme guideline. The primary outcome of treatment failure was assessed in both groups by independent outcome assessors on days 6 and 14 after enrolment. Secondary outcomes (accuracy and impact of pulse oximetry) were also assessed.ResultsBetween September 2016 and December 2018, we enrolled 2334 infants (1168 in intervention and 1166 in control clusters) from 208 clusters (104 intervention and 104 control). Of 2334, 22 infants with fast breathing were excluded from analysis, leaving 2312 (1155 in intervention clusters and 1157 in control clusters) for intention-to-treat analysis. The proportion of treatment failure was 5.4% (63/1155) in intervention and 6.3% (73/1157) in the control clusters, including two deaths (0.2%) in each group. The adjusted risk difference for treatment failure between the two groups was −1.0% (95% CI −3.0% to 1.1%). The secondary outcome showed that CLHWs in the intervention clusters performed all recommended steps of pulse oximetry assessment in 94% (1050/1115) of enrolled patients.ConclusionsThe 7-day amoxicillin treatment for 7–59 days old non-hypoxaemic infants with fast breathing pneumonia by CLHWs was non-inferior to the currently recommended referral strategy.Trial registration numbersCTRI/2017/02/007761 and ACTRN12617000857303.

Download Full-text

Saving babies’ lives (SBL) – a programme to reduce neonatal mortality in rural Cambodia: study protocol for a stepped-wedge cluster-randomised trial

BMC Pediatrics ◽

10.1186/s12887-021-02833-7 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Kaajal Patel ◽

Sopheakneary Say ◽

Daly Leng ◽

Manila Prak ◽

Koung Lo ◽

...

Keyword(s):

Data Collection ◽

Neonatal Mortality ◽

Rural Areas ◽

Health Workers ◽

Randomised Trial ◽

Scale Up ◽

Cluster Randomised Trial ◽

Stepped Wedge ◽

Cluster Randomised ◽

The Continuum

Abstract Background Neonatal mortality remains unacceptably high. Many studies successful at reducing neonatal mortality have failed to realise similar gains at scale. Effective implementation and scale-up of interventions designed to tackle neonatal mortality is a global health priority. Multifaceted programmes targeting the continuum of neonatal care, with sustainability and scalability built into the design, can provide practical insights to solve this challenge. Cambodia has amongst the highest neonatal mortality rates in South-East Asia, with rural areas particularly affected. The primary objective of this study is the design, implementation, and assessment of the Saving Babies’ Lives programme, a package of interventions designed to reduce neonatal mortality in rural Cambodia. Methods This study is a five-year stepped-wedge cluster-randomised trial conducted in a rural Cambodian province with an estimated annual delivery rate of 6615. The study is designed to implement and evaluate the Saving Babies’ Lives programme, which is the intervention. The Saving Babies’ Lives programme is an iterative package of neonatal interventions spanning the continuum of care and integrating into the existing health system. The Saving Babies’ Lives programme comprises two major components: participatory learning and action with community health workers, and capacity building of primary care facilities involving facility-based mentorship. Standard government service continues in control arms. Data collection covering the whole study area includes surveillance of all pregnancies, verbal and social autopsies, and quality of care surveys. Mixed methods data collection supports iteration of the complex intervention, and facilitates impact, outcome, process and economic evaluation. Discussion Our study uses a robust study design to evaluate and develop a holistic, innovative, contextually relevant and sustainable programme that can be scaled-up to reduce neonatal mortality. Trial registration ClinicalTrials.gov: NCT04663620. Registered on 11th December 2020, retrospectively registered.

Download Full-text

Effect of self-collection of HPV DNA offered by community health workers at home visits on uptake of screening for cervical cancer (the EMA study): a population-based cluster-randomised trial

The Lancet Global Health ◽

10.1016/s2214-109x(14)70354-7 ◽

2015 ◽

Vol 3 (2) ◽

pp. e85-e94 ◽

Cited By ~ 105

Author(s):

Silvina Arrossi ◽

Laura Thouyaret ◽

Rolando Herrero ◽

Alicia Campanera ◽

Adriana Magdaleno ◽

...

Keyword(s):

Cervical Cancer ◽

Community Health ◽

Community Health Workers ◽

Health Workers ◽

Randomised Trial ◽

Home Visits ◽

Population Based ◽

Cluster Randomised Trial ◽

Hpv Dna ◽

Cluster Randomised

Download Full-text

Effectiveness and cost-effectiveness of group support psychotherapy delivered by trained lay health workers for depression treatment among people with HIV in Uganda: a cluster-randomised trial

The Lancet Global Health ◽

10.1016/s2214-109x(19)30548-0 ◽

2020 ◽

Vol 8 (3) ◽

pp. e387-e398 ◽

Cited By ~ 5

Author(s):

Etheldreda Nakimuli-Mpungu ◽

Seggane Musisi ◽

Kizito Wamala ◽

James Okello ◽

Sheila Ndyanabangi ◽

...

Keyword(s):

Cost Effectiveness ◽

Health Workers ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Depression Treatment ◽

Lay Health Workers ◽

Group Support ◽

Cluster Randomised

Download Full-text

Action leveraging evidence to reduce perinatal mortality and morbidity (ALERT): study protocol for a stepped-wedge cluster-randomised trial in Benin, Malawi, Tanzania and Uganda

BMC Health Services Research ◽

10.1186/s12913-021-07155-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Joseph Akuze ◽

Kristi Sidney Annerstedt ◽

Lenka Benova ◽

Effie Chipeta ◽

Jean-Paul Dossou ◽

...

Keyword(s):

Perinatal Mortality ◽

Process Evaluation ◽

Study Protocol ◽

Health Workers ◽

Randomised Trial ◽

User Participation ◽

Cluster Randomised Trial ◽

Evidence Based ◽

Stepped Wedge ◽

Cluster Randomised

Abstract Background Insufficient reductions in maternal and neonatal deaths and stillbirths in the past decade are a deterrence to achieving the Sustainable Development Goal 3. The majority of deaths occur during the intrapartum and immediate postnatal period. Overcoming the knowledge-do-gap to ensure implementation of known evidence-based interventions during this period has the potential to avert at least 2.5 million deaths in mothers and their offspring annually. This paper describes a study protocol for implementing and evaluating a multi-faceted health care system intervention to strengthen the implementation of evidence-based interventions and responsive care during this crucial period. Methods This is a cluster randomised stepped-wedge trial with a nested realist process evaluation across 16 hospitals in Benin, Malawi, Tanzania and Uganda. The ALERT intervention will include four main components: i) end-user participation through narratives of women, families and midwifery providers to ensure co-design of the intervention; ii) competency-based training; iii) quality improvement supported by data from a clinical perinatal e-registry and iv) empowerment and leadership mentoring of maternity unit leaders complemented by district based bi-annual coordination and accountability meetings. The trial’s primary outcome is in-facility perinatal (stillbirths and early neonatal) mortality, in which we expect a 25% reduction. A perinatal e-registry will be implemented to monitor the trial. Our nested realist process evaluation will help to understand what works, for whom, and under which conditions. We will apply a gender lens to explore constraints to the provision of evidence-based care by health workers providing maternity services. An economic evaluation will assess the scalability and cost-effectiveness of ALERT intervention. Discussion There is evidence that each of the ALERT intervention components improves health providers’ practices and has modest to moderate effects. We aim to test if the innovative packaging, including addressing specific health systems constraints in these settings, will have a synergistic effect and produce more considerable perinatal mortality reductions. Trial registration Pan African Clinical Trial Registry (www.pactr.org): PACTR202006793783148. Registered on 17th June 2020.

Download Full-text

Effect of door-to-door distribution of HIV self-testing kits on HIV testing and antiretroviral therapy initiation: a cluster randomised trial in Malawi

BMJ Global Health ◽

10.1136/bmjgh-2020-004269 ◽

2021 ◽

Vol 6 (Suppl 4) ◽

pp. e004269

Author(s):

Pitchaya P Indravudh ◽

Katherine Fielding ◽

Richard Chilongosi ◽

Rebecca Nzawa ◽

Melissa Neuman ◽

...

Keyword(s):

Antiretroviral Therapy ◽

Hiv Testing ◽

Randomised Trial ◽

Health Facilities ◽

Cluster Randomised Trial ◽

High Coverage ◽

Adjusted Risk ◽

Cluster Randomised ◽

Self Testing ◽

Lifetime Testing

IntroductionReaching high coverage of HIV testing remains essential for HIV diagnosis, treatment and prevention. We evaluated the effectiveness and safety of door-to-door distribution of HIV self-testing (HIVST) kits in rural Malawi.MethodsThis cluster randomised trial, conducted between September 2016 and January 2018, used restricted 1:1 randomisation to allocate 22 health facilities and their defined areas to door-to-door HIVST alongside the standard of care (SOC) or the SOC alone. The study population included residents (≥16 years). HIVST kits were provided door-to-door by community-based distribution agents (CBDAs) for at least 12 months. The primary outcome was recent HIV testing (in the last 12 months) measured through an endline survey. Secondary outcomes were lifetime HIV testing and cumulative 16-month antiretroviral therapy (ART) initiations, which were captured at health facilities. Social harms were reported through community reporting systems. Analysis compared cluster-level outcomes by arm.ResultsOverall, 203 CBDAs distributed 273 729 HIVST kits. The endline survey included 2582 participants in 11 HIVST clusters and 2908 participants in 11 SOC clusters. Recent testing was higher in the HIVST arm (68.5%, 1768/2582) than the SOC arm (48.9%, 1422/2908), with adjusted risk difference (RD) of 16.1% (95% CI 6.5% to 25.7%). Lifetime testing was also higher in the HIVST arm (86.9%, 2243/2582) compared with the SOC arm (78.5%, 2283/2908; adjusted RD 6.3%, 95% CI 2.3% to 10.3%). Differences were most pronounced for adolescents aged 16–19 years (adjusted RD 18.6%, 95% CI 7.3% to 29.9%) and men (adjusted RD 10.2%, 95% CI 3.1% to 17.2%). Cumulative incidence of ART initiation was 1187.2 and 909.0 per 100 000 population in the HIVST and SOC arms, respectively (adjusted RD 309.1, 95% CI −95.5 to 713.7). Self-reported HIVST use was 42.5% (1097/2582), with minimal social harms reported.ConclusionDoor-to-door HIVST increased recent and lifetime testing at population level and showed high safety, underscoring potential for HIVST to contribute to HIV elimination goals in priority settings.Trial registration numberNCT02718274.

Download Full-text

Does community-based distribution of HIV self-tests increase uptake of HIV testing? Results of pair-matched cluster randomised trial in Zambia

BMJ Global Health ◽

10.1136/bmjgh-2020-004543 ◽

2021 ◽

Vol 6 (Suppl 4) ◽

pp. e004543 ◽

Cited By ~ 1

Author(s):

Melissa Neuman ◽

Bernadette Hensen ◽

Alwyn Mwinga ◽

Namwinga Chintu ◽

Katherine L Fielding ◽

...

Keyword(s):

Hiv Testing ◽

Randomised Trial ◽

Population Based ◽

Cluster Randomised Trial ◽

Distribution Models ◽

Community Based ◽

Adjusted Risk ◽

Cluster Randomised ◽

Catchment Areas ◽

The Impact

ObjectivesEnding HIV by 2030 is a global priority. Achieving this requires alternative HIV testing strategies, such as HIV self-testing (HIVST) to reach all individuals with HIV testing services (HTS). We present the results of a trial evaluating the impact of community-based distribution of HIVST in community and facility settings on the uptake of HTS in rural and urban Zambia.DesignPair-matched cluster randomised trial.MethodsIn catchment areas of government health facilities, OraQuick HIVST kits were distributed by community-based distributors (CBDs) over 12 months in 2016–2017. Within matched pairs, clusters were randomised to receive the HIVST intervention or standard of care (SOC). Individuals aged ≥16 years were eligible for HIVST. Within communities, CBDs offered HIVST in high traffic areas, door to door and at healthcare facilities. The primary outcome was self-reported recent testing within the previous 12 months measured using a population-based survey.ResultsIn six intervention clusters (population 148 541), 60 CBDs distributed 65 585 HIVST kits. A recent test was reported by 66% (1622/2465) in the intervention arm compared with 60% (1456/2429) in SOC arm (adjusted risk ratio 1.08, 95% CI 0.94 to 1.24; p=0.15). Uptake of the HIVST intervention was low: 24% of respondents in the intervention arm (585/2493) used an HIVST kit in the previous 12 months. No social harms were identified during implementation.ConclusionDespite distributing a large number of HIVST kits, we found no evidence that this community-based HIVST distribution intervention increased HTS uptake. Other models of HIVST distribution, including secondary distribution and community-designed distribution models, provide alternative strategies to reach target populations.Trial registration numberClinicalTrials.gov Registry (NCT02793804).

Download Full-text