An incentive-based text-messaging intervention to reduce maternal alcohol use during pregnancy and lactation in South Africa (MaRISA study): Findings from a single-arm pilot study.

BACKGROUND: South Africa has the highest rate of fetal alcohol spectrum disorders (FASD) globally. As with alcohol use during pregnancy, alcohol consumption while breastfeeding adversely impacts infant development. We pilot tested an incentive-based text-messaging intervention to reduce alcohol use during pregnancy and lactation in South Africa. METHODS: A single-arm pilot trial was conducted over 3 months in healthcare facilities in Cape Town, South Africa. Pregnant and breastfeeding participants tested positive for recent alcohol use by urinalysis. The three-month intervention had two components, contingency management of alcohol abstinence confirmed by urinalysis twice weekly and weekly health-related text messaging from an evidence-based brief intervention. We collected twice weekly urine samples for measurement of ethyl glucuronide (EtG), an alcohol biomarker, and measures of self-reported alcohol and drug use, violence exposure, and mental health at six weeks and three months post-enrollment. RESULTS: Sixty participants were enrolled, of whom 31 were pregnant and 29 lactating. The number of days with four or more drinks in the past month decreased from 9 days at baseline, on average, to 1-3 days (p-value range: 0.144-0.010) at follow-up timepoints. There were statistically significant increases in the proportions of participants with alcohol-negative urine tests (p < 0.001). The percentages of participants breastfeeding while using alcohol decreased from baseline to the end of 3 months in the overall sample and among those enrolled postpartum, though these were not significant (p-value range: 0.255-0.147). Maternal depression scores also decreased among participants enrolled postpartum (p = 0.054). Emotional abuse by the main partner, but neither physical nor sexual abuse, significantly decreased at both follow-ups in the overall sample (p = 0.032) and among participants enrolled while pregnant (p = 0.015). CONCLUSIONS: This study is among the first to pilot test an incentive-based text-messaging intervention for maternal alcohol use and other outcomes such as depression and violence exposure. Further testing is warranted in a well-powered, randomized controlled trial.

Perceptions of perinatal alcohol use and treatment needs in Cape Town, South Africa: a qualitative study.

Background: South Africa has one of the world's highest rates of foetal alcohol spectrum disorders (FASD). Recent evidence also showed that alcohol use during lactation significantly compromises child development in children exposed to alcohol through breastfeeding, independent of prenatal alcohol exposure. This study explored perceptions of perinatal alcohol use and treatment needs in Cape Town, South Africa, to inform the development of an intervention to encourage alcohol abstinence during pregnancy and breastfeeding. Methods: Individual in-depth interviews (IDIs) were conducted with women who were pregnant with a recent history of alcohol use (n=32) and clinic and community stakeholders (n=16). Interviews were audio recorded and transcribed verbatim. Coding and thematic analyses were conducted in NVivo 12. Results: Results indicate widespread perception that women know the dangers of drinking alcohol while pregnant with much less known about drinking while breastfeeding. Mixed views were shared about whether women who are pregnant or breastfeeding experience alcohol-related stigma. Participants described contextual factors impacting drinking that include interpersonal violence, lack of support, stress, anxiety and poverty, and drinking being normalised. Finally, participants had mixed views and conflicting knowledge of available resources to support alcohol reduction and highlighted a desire for support groups and the involvement of partners in alcohol interventions. Conclusions: Findings from this study highlight the need for an alcohol intervention programme that is innovative and tailored to the needs of women who are pregnant or postpartum. It also highlights the importance of including community-based support and partner involvement in these interventions.

Evaluation of cultural competency in a South African cluster randomised controlled trial: lessons learned for trial reporting standards.

BACKGROUND: Failure to consider relevant cultural, ethnic and diversity parameters (and the intersection between these parameters) during trial protocol development and trial conduct may negatively impact recruitment, intervention development and delivery, and participant adherence and retention, potentially reducing overall internal validity. This case study aimed to evaluate the utility and comparability between the 9-item Gibbs Framework to measure cultural competency and the GRIPP-2(Short Form (SF)) 5-point checklist to assess patient and public involvement in the context of a complex clinical trial conducted in an African setting. METHODS: We identified and collated all relevant publications, source and procedural data related to the trial and integrated the documents into a dynamic trial timeline. Two independent investigators applied and scored the Gibbs Framework and the GRIPP-2(SF) checklist to the four publications arising from the trial, noting functionality and comparability between tools. Where cultural competency was not met, a third investigator screened all procedural and source data and identified if cultural competency had been achieved but not reported in the publications, or if the trial had not met appropriate cultural competency based on the documentation. RESULTS: Application of the Gibbs Framework found that the trial scored '2' for seven of the nine Gibbs items, indicating full cultural competency for those questions. The Framework indicated that the trial research question was not driven by the articulated needs of patients, and neither were patients, caregivers and clinical providers involved in the development of the intervention. Comparability with the GRIPP-2(SF) checklist showed that the Gibbs performed better on evaluation of partnerships with the community, identification of culturally competent data sources and target populations, and appointment of trial staff in an inclusive manner. CONCLUSIONS: Comprehensive evaluation of the trial's cultural competency required scrutiny of both published manuscripts and source and procedural data, suggesting that there is a gap in current trial reporting standards with respect to cultural competence. TRIAL REGISTRATION: PACTR201610001825403. Registered on 17 October 2016.

The Use of Magnetic Resonance Imaging Techniques in Assessing the Effects of Alcohol Consumption and Heavy Drinking on the Adolescent Brain: A Scoping Review Protocol.

Introduction: Alcohol consumption, specifically heavy drinking during adolescence, has been shown to be accompanied by adverse structural brain changes in adolescent drinkers. This scoping review will aim to quantify and evaluate the quality of studies in which magnetic resonance imaging (MRI) techniques are used to assess regional brain deficits among adolescents who consume alcohol. Methods and analysis: This scoping review will be conducted following the Arksey and O'Malley scoping review methodology framework and will be reported using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for Scoping Reviews (PRISMA-ScR) guidelines. Literature will be searched for the period January 1999 to March 2021. Two reviewers will independently screen titles/abstracts and full-texts in two consecutive screening stages. Eligible studies will be independently reviewed to ensure that inclusion criteria are met. Cohen's Kappa (κ) will be used to calculate inter-rater agreement. A third reviewer will resolve any disagreements. The Joanna Briggs Institute (JBI) Appraisal Tools will be used for quality appraisal of the included studies. Findings will be reported by means of a narrative overview, tabular presentation of study characteristics, and quality assessment, and a thematic analysis of major themes. This scoping review has been registered with the Open Science Framework. Ethics and dissemination: Scoping reviews do not require ethical approval, however, this review forms part of a larger study that has obtained approval from the Faculty of Health and Medical Sciences, Health Research Ethics Committee at Stellenbosch University (S20/04/086). Findings will be disseminated by means of peer-reviewed publications and conferences.