BackgroundThere are a number of practical and ethical issues raised in school-based health research, particularly those related to obtaining consent from parents and assent from children. One approach to developing, strengthening, and supporting appropriate consent and assent processes is through community engagement. To date, much of the literature on community engagement in biomedical research has concentrated on community- or hospital-based research, with little documentation, if any, of community engagement in school-based health research. In this paper we discuss our experiences of consent, assent and community engagement in implementing a large school-based cluster randomized trial in rural Kenya.MethodsData collected as part of a qualitative study investigating the acceptability of the main trial, focus group discussions with field staff, observations of practice and authors’ experiences are used to: 1) highlight the challenges faced in obtaining assent/consent; and 2) strategies taken to try to both protect participant rights (including to refuse and to withdraw) and ensure the success of the trial.ResultsEarly meetings with national, district and local level stakeholders were important in establishing their co-operation and support for the project. Despite this support, both practical and ethical challenges were encountered during consenting and assenting procedures. Our strategy for addressing these challenges focused on improving communication and understanding of the trial, and maintaining dialogue with all the relevant stakeholders throughout the study period.ConclusionsA range of stakeholders within and beyond schools play a key role in school based health trials. Community entry and information dissemination strategies need careful planning from the outset, and with on-going consultation and feedback mechanisms established in order to identify and address concerns as they arise. We believe our experiences, and the ethical and practical issues and dilemmas encountered, will be of interest for others planning to conduct school-based research in Africa.Trial registrationNational Institute of Health NCT00878007

The World Health Organization guidelines for treating pregnant HIV-positive women and preventing HIV transmission to infants now recommend lifelong antiretroviral treatment for pregnant and breastfeeding women. We applied quality improvement (QI) methods to support governments and facility staff to address service gaps in 5 countries under the Partnership for HIV-Free Survival (PHFS). We used 3 key strategies: break the complex problem of improving HIV-free survival into more easily implementable phases, support a national management team to oversee the project, and support facility-level staff to learn and apply QI methods to reducing mother-to-child transmission. The key results in each country were increases in data completeness and accuracy, increases in retention in care of mother–baby pairs (MBPs), increase in coverage of MBPs with appropriate services, and reduction in vertical transmission of HIV. The PHFS experience offers a model that other multicountry networks can adopt to improve service delivery and quality of care.

Over half of mother-to-child HIV transmission (MTCT) occurs postdelivery. Keeping mother–infant pairs in care remains challenging. Health workers in 3 countries used quality improvement (QI) approaches to improve data systems, mother–infant retention, and facility-based care delivery. The number and proportion of infants with known HIV status at time of discharge from early infant diagnosis programs increased in Tanzania and Uganda. We analyzed data using statistical process control charts. Mother-to-child HIV transmission did not decrease in 15 Kenyan sites, decreased from 12.7% to 3.8% in 28 Tanzanian sites, and decreased from 17.2% to 1.5% in 10 Ugandan sites with baseline data. This improvement is likely due to the combination of option B+, service delivery improvements, and retention through QI approaches. Reaching the global MTCT elimination target and maximizing infant survival will require health systems to support mother–infant pairs to remain in care and support health workers to deliver care. Quality improvement approaches can support these changes.