Search

Introduction Index case testing (ICT) is an evidence-based approach that efficiently identifies persons in need of HIV treatment and prevention services. In Malawi, delivery of ICT has faced challenges due to limited technical capacity of healthcare workers (HCWs) and clinical coordination. Digitisation of training and quality improvement processes presents an opportunity to address these challenges. We developed an implementation package that combines digital and face-to-face modalities (blended learning) to strengthen HCWs ICT skills and enhance quality improvement mechanisms. This cluster randomised controlled trial will assess the impact of the blended learning implementation package compared with the standard of care (SOC) on implementation, effectiveness and cost-effectiveness outcomes.Methods and analysis The study was conducted in 33 clusters in Machinga and Balaka districts, in Southern Malawi from November 2021 to November 2023. Clusters are randomised in a 2:1 ratio to the SOC versus blended learning implementation package. The SOC is composed of: brief face-to-face HCW ICT training and routine face-to-face facility mentorship for HCWs. The blended learning implementation package consists of blended teaching, role-modelling, practising, and providing feedback, and blended quality improvement processes. The primary implementation outcome is HCW fidelity to ICT over 1 year of follow-up. Primary service uptake outcomes include (a) index clients who participate in ICT, (b) contacts elicited, (c) HIV self-test kits provided for secondary distribution, (d) contacts tested and (e) contacts identified as HIV-positive. Service uptake analyses will use a negative binomial mixed-effects model to account for repeated measures within each cluster. Cost-effectiveness will be assessed through incremental cost-effectiveness ratios examining the incremental cost of each person tested.Ethics and dissemination The Malawi National Health Science Research Committee, the University of North Carolina and the Baylor College of Medicine Institutional Review Boards approved the trial. Study findings will be disseminated through peer-reviewed journals and conference presentations.Trial registration number NCT05343390.

Introduction To realise the expected gains from prevention of mother-to-child HIV transmission initiatives, adherence to preventative and therapeutic antiretroviral regimens is critical and interventions deployable in busy programmatic settings with a high HIV burden are needed. Based on formative research, we developed an approach that integrates patient-centred counselling and engagement of an adherence supporter for pregnant and breastfeeding women initiating HIV treatment (ie, antiretroviral therapy (ART)) or biomedical HIV prevention (ie, pre-exposure prophylaxis (PrEP)).Methods Tonse Pamodzi 2 is a pilot study designed to provide acceptability, fidelity and clinical outcomes data on a set of behavioural interventions for adherence support. The study comprises two parallel randomised trials, enrolling HIV-positive pregnant women initiating ART (Trial 1, n=100) and HIV-negative pregnant women with risk of HIV acquisition and willing to initiate PrEP (Trial 2, n=200). Within each trial, participants are randomised 1:1 to either the intervention or control group. The Tonse Pamodzi adherence intervention comprises patient-centred counselling (adapted Integrated Next Step Counseling(iNSC)) and external adherence support tailored to the clinical context (ie, for ART or PrEP). Participants randomly assigned to the control group receive standard counselling based on local HIV guidelines. Participants are followed for 6 months. To assess intervention acceptability, we will employ a mixed method approach to describe participant engagement, satisfaction, and discussion content. We will audit and score recorded counselling sessions to evaluate the implementation fidelity of iNSC sessions. We will also assess clinical outcomes at 3 and 6 months for both Trial 1 (retention in care and viral suppression of HIV) and Trial 2 (retention in care, and plasma and intracellular tenofovir drug concentrations).Ethics and dissemination The study protocol was approved by the Malawi National Health Science Research Committee (19/05/2334) and the University of North Carolina at Chapel Hill Institutional Review Board (19-1060).Trial registration number NCT04330989.

Objective This review was conducted to identify interventions effective in improving uptake and retention of HIV-positive mothers and their infants in prevention of mother to child transmission (PMTCT) services in low-income and middle-income countries (LMICs) in order to inform programme planning.Methods We conducted a systematic review of studies comparing usual care with any intervention to improve uptake and retention of HIV-positive pregnant or breastfeeding women and their children from birth to 2 years of age in PMTCT services in LMICs. Twenty-two electronic databases were searched from inception to 15 January 2018, for randomised, quasi-randomised and non-randomised controlled trials, and interrupted time series studies; reference lists of included articles were searched for relevant articles. Risk of bias was assessed using the Cochrane Effective Practice and Organisation of Care group criteria. Random-effects meta-analysis was conducted for studies reporting similar interventions and outcomes.Results We identified 29 837 articles, of which 18 studies were included in our review. Because of heterogeneity in interventions and outcome measures, only one meta-analysis of two studies and one outcome was conducted; we found a statistically significant increase in antiretroviral therapy (ART) use during pregnancy for integration of HIV and antenatal care relative to standard non-integrated care (pooled AOR=2.69; 95% CI 1.25 to 5.78, p=0.0113). The remaining studies assessing other patient, provider or health system interventions were synthesised narratively, with small effects seen across intervention categories for both maternal and infant PMTCT outcomes based predominately on evidence with moderate to high risk of bias.Conclusions Evidence on the effectiveness of interventions to improve uptake and retention of mothers and infants in PMTCT care is lacking. Our findings suggest that integration of HIV and antenatal care may improve ART use during pregnancy. Future studies to replicate promising approaches are needed. Improved reporting of key methodological criteria will facilitate interpretation of findings and improve the utility of evidence to PMTCT programme planners.PROSPERO registration number CRD42015020829.