The cost of the training and supervision of community health workers to improve exclusive breastfeeding amongst mothers in a cluster randomised controlled trial in South Africa

IntroductionA cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks, could increase the uptake of antiretroviral therapy and pre-exposure prophylaxis (PrEP) among young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa.Methods and analysisA three-arm cRCT started mid-March 2019, in 24 areas in rural KwaZulu-Natal. Twenty-four pairs of peer navigators working with ~12 000 young people aged 18 to 30 years over a period of 6 months were randomised to: (1) incentivised-peer-networks: peer-navigators recruited participants ‘seeds’ to distribute up to five HIVST packs and HIV prevention information to peers within their social networks. Seeds receive an incentive (20 Rand = US$1.5) for each respondent who contacts a peer-navigator for additional HIVST packs to distribute; (2) peer-navigator-distribution: peer-navigators distribute HIVST packs and information directly to young people; (3) standard of care: peer-navigators distribute referral slips and information. All arms promote sexual health information and provide barcoded clinic referral slips to facilitate linkage to HIV testing, prevention and care services. The primary outcome is the difference in linkage rate between arms, defined as the number of women (18 to 24 years) per peer-navigators month of outreach work (/pnm) who linked to clinic-based PrEP eligibility screening or started antiretroviral, based on HIV-status, within 90 days of receiving the clinic referral slip.Ethics and disseminationThis study was approved by the Institutional Review Boards at the WHO, Switzerland (Protocol ID: STAR CRT, South Africa), London School of Hygiene and Tropical Medicine, UK (Reference: 15 990–1), University of KwaZulu-Natal (BFC311/18) and the KwaZulu-Natal Department of Health (Reference: KZ_201901_012), South Africa. The findings of this trial will be disseminated at local, regional and international meetings and through peer-reviewed publications.Trial registration numberNCT03751826; Pre-results.

Download Full-text

Effect of community-based promotion of exclusive breastfeeding on diarrhoeal illness and growth: a cluster randomised controlled trial

The Lancet ◽

10.1016/s0140-6736(03)13134-0 ◽

2003 ◽

Vol 361 (9367) ◽

pp. 1418-1423 ◽

Cited By ~ 198

Author(s):

Nita Bhandari ◽

Rajiv Bahl ◽

Sarmila Mazumdar ◽

Jose Martines ◽

Robert E Black ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Exclusive Breastfeeding ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Community Based ◽

Cluster Randomised ◽

Randomised Controlled

Download Full-text

Motivations for, and perceptions and experiences of participating in, a cluster randomised controlled trial of a HIV-behavioural intervention in rural South Africa

Culture Health & Sexuality ◽

10.1080/13691058.2012.717305 ◽

2012 ◽

Vol 14 (10) ◽

pp. 1167-1182 ◽

Cited By ~ 7

Author(s):

Rachel Jewkes ◽

Yandisa Sikweyiya ◽

Mzikazi Nduna ◽

Nwabisa Jama Shai ◽

Kristin Dunkle

Keyword(s):

South Africa ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Behavioural Intervention ◽

Rural South ◽

Cluster Randomised ◽

Randomised Controlled ◽

Rural South Africa

Download Full-text

A cluster-randomised controlled trial of values-based training to promote autonomously held recovery values in mental health workers

Implementation Science ◽

10.1186/s13012-015-0363-5 ◽

2015 ◽

Vol 11 (1) ◽

Cited By ~ 10

Author(s):

Virginia Williams ◽

Frank P. Deane ◽

Lindsay G. Oades ◽

Trevor P. Crowe ◽

Joseph Ciarrochi ◽

...

Keyword(s):

Mental Health ◽

Randomised Controlled Trial ◽

Health Workers ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Mental Health Workers ◽

Cluster Randomised ◽

Randomised Controlled

Download Full-text

A cluster randomised controlled trial to determine the effect of community mobilisation and advocacy on men’s use of violence in periurban South Africa: study protocol

BMJ Open ◽

10.1136/bmjopen-2017-017579 ◽

2018 ◽

Vol 8 (3) ◽

pp. e017579 ◽

Cited By ~ 10

Author(s):

Nicola J Christofides ◽

Abigail M Hatcher ◽

Angelica Pino ◽

Dumisani Rebombo ◽

Ruari Santiago McBride ◽

...

Keyword(s):

South Africa ◽

Randomised Controlled Trial ◽

Alcohol Use ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Computer Assisted ◽

Community Mobilisation ◽

Intention To Treat ◽

Cluster Randomised ◽

Randomised Controlled

ObjectiveThis paper describes the design and methods of a cluster randomised controlled trial (C-RCT) to determine the effectiveness of a community mobilisation intervention that is designed to reduce the perpetration of violence against women (VAW).Methods and analysisA C-RCT of nine intervention and nine control clusters is being carried out in a periurban, semiformal settlement near Johannesburg, South Africa, between 2016 and 2018. A community mobilisation and advocacy intervention, called Sonke CHANGE is being implemented over 18 months. It comprises local advocacy and group activities to engage community members to challenge harmful gender norms and reduce VAW. The intervention is hypothesised to improve equitable masculinities, reduce alcohol use and ultimately, to reduce VAW. Intervention effectiveness will be determined through an audio computer-assisted self-interview questionnaire with behavioural measures among 2600 men aged between 18 and 40 years at baseline, 12 months and 24 months. The primary trial outcome is men’s use of physical and/or sexual VAW. Secondary outcomes include harmful alcohol use, gender attitudes, controlling behaviours, transactional sex and social cohesion. The main analysis will be intention-to-treat based on the randomisation of clusters. A qualitative process evaluation is being conducted alongside the C-RCT. Implementers and men participating in the intervention will be interviewed longitudinally over the period of intervention implementation and observations of the workshops and other intervention activities are being carried out.Ethics and disseminationEthical approval was obtained from the University of the Witwatersrand Human Research Ethics Committee and procedures comply with ethical recommendations of the United Nations Multi-Country Study on Men and Violence. Dissemination of research findings will take place with local stakeholders and through peer-reviewed publications, with data available on request or after 5 years of trial completion.Trial registration numberNCT02823288; Pre-result.

Download Full-text

Task shifting of frontline community health workers for cardiovascular risk reduction: design and rationale of a cluster randomised controlled trial (DISHA study) in India

BMC Public Health ◽

10.1186/s12889-016-2891-6 ◽

2016 ◽

Vol 16 (1) ◽

Cited By ~ 10

Author(s):

Panniyammakal Jeemon ◽

◽

Gitanjali Narayanan ◽

Dimple Kondal ◽

Kashvi Kahol ◽

...

Keyword(s):

Cardiovascular Risk ◽

Randomised Controlled Trial ◽

Community Health ◽

Health Workers ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Task Shifting ◽

Cardiovascular Risk Reduction ◽

Cluster Randomised ◽

Randomised Controlled

Download Full-text

Cost-effectiveness of PoNDER health visitor training for mothers at lower risk of depression: findings on prevention of postnatal depression from a cluster-randomised controlled trial

Psychological Medicine ◽

10.1017/s0033291718001940 ◽

2018 ◽

Vol 49 (08) ◽

pp. 1324-1334 ◽

Cited By ~ 3

Author(s):

Catherine Henderson ◽

Simon Dixon ◽

Annette Bauer ◽

Martin Knapp ◽

C. Jane Morrell ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Postnatal Depression ◽

Lower Risk ◽

Controlled Trial ◽

Cost Effective ◽

Cluster Randomised Controlled Trial ◽

Cluster Randomised ◽

Randomised Controlled ◽

The Cost

AbstractBackgroundThere is evidence for the cost-effectiveness of health visitor (HV) training to assess postnatal depression (PND) and deliver psychological approaches to women at risk of depression. Whether this approach is cost-effective for lower-risk women is unknown. There is a need to know the cost of HV-delivered universal provision, and how much it might cost to improve health-related quality of life for postnatal women. A sub-study of a cluster-randomised controlled trial in the former Trent region (England) previously investigated the effectiveness of PoNDER HV training in mothers at lower risk of PND. We conducted a parallel cost-effectiveness analysis at 6-months postnatal for all mothers with lower-risk status attributed to an Edinburgh Postnatal Depression Scale (EPDS) score <12 at 6-weeks postnatal.MethodsIntervention HVs were trained in assessment and cognitive behavioural or person-centred psychological support techniques to prevent depression. Outcomes examined: quality-adjusted life-year (QALY) gains over the period between 6 weeks and 6 months derived from SF-6D (from SF-36); risk-of-depression at 6 months (dichotomising 6-month EPDS scores into lower risk (<12) and at-risk (⩾12).ResultsIn lower-risk women, 1474 intervention (63 clusters) and 767 control participants (37 clusters) had valid 6-week and 6-month EPDS scores. Costs and outcomes data were available for 1459 participants. 6-month adjusted costs were £82 lower in intervention than control groups, with 0.002 additional QALY gained. The probability of cost-effectiveness at £20 000 was very high (99%).ConclusionsPoNDER HV training was highly cost-effective in preventing symptoms of PND in a population of lower-risk women and cost-reducing over 6 months.

Download Full-text