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Improving the effectiveness of public health interventions relies as much on the attention paid to their design and feasibility as to their evaluation. Yet, compared to the vast literature on how to evaluate interventions, there is little to guide researchers or practitioners on how best to develop such interventions in practical, logical, evidence based ways to maximise likely effectiveness. Existing models for the development of public health interventions tend to have a strong social-psychological, individual behaviour change orientation and some take years to implement. This paper presents a pragmatic guide to six essential Steps for Quality Intervention Development (6SQuID). The focus is on public health interventions but the model should have wider applicability. Once a problem has been identified as needing intervention, the process of designing an intervention can be broken down into six crucial steps: (1) defining and understanding the problem and its causes; (2) identifying which causal or contextual factors are modifiable: which have the greatest scope for change and who would benefit most; (3) deciding on the mechanisms of change; (4) clarifying how these will be delivered; (5) testing and adapting the intervention; and (6) collecting sufficient evidence of effectiveness to proceed to a rigorous evaluation. If each of these steps is carefully addressed, better use will be made of scarce public resources by avoiding the costly evaluation, or implementation, of unpromising interventions.

There is a growing need for interventions that reduce both violence against children and intimate partner violence in low- and middle-income countries. However, few parenting interventions deliberately address this link. We tested the feasibility of a 16-session group-based parenting programme, Parenting for Respectability, in semi-rural Ugandan communities. This was a pre-post study with parents and their children (N = 484 parents; 212 children). Pre-post comparisons found large effects for parent-reported reduced harsh parenting (Cohen's f2 = 0.41 overall; f2 = 0.47 (among session attendees); with an overall reduction of 26% for harsh parenting. Session attendees reported higher reductions than non-attendees (p = 0.014), and male caregivers reported higher reductions than female caregivers (p<0.001). Children also reported reduced harsh parenting by attending fathers (f2 = 0.64 overall; f2 = 0.60) and attending mothers (f2 = 0.56 overall; f2 = 0.51); with reduction in harsh parenting ranging between 27% to 29% in the various categories. Overall, spousal violence reduced by 27% (f2 = 0.19 overall; f2 = 0.26 (among session attendees). Both parents and children reported reduced dysfunctional parent relationships; parents: f2 = 0.19 overall; f2 = 0.26 (among session attendees); and children: f2 = 0.35 overall; f2 = 0.32 (for attending parents); with reductions ranging between 22% to 28%. Parents who attended more than 50% of the program reported greater effects on reduced dysfunctional relationships than those who attended less than half of the program (B = -0.74, p = 0.013). All secondary outcomes were improved with f2 ranging between 0.08 and 0.39; and improvements ranging between 6% and 28%. Results suggest the importance of more rigorous testing to determine program effectiveness.

Understanding why parenting programmes work or do not work, and for whom, is crucial for development of more effective parenting interventions. In this paper we focus on a specific component of Mellow Bumps: reflection on one's own childhood/past/life. We explore how this component was implemented, how participants engaged with it, the facilitating and constraining factors shaping this, whether and how it appeared to work, or not, and for whom. The paper analyses data from the Process Evaluation of the Trial of Healthy Relationships Initiatives for the Very Early years, which is evaluating two antenatal interventions delivered to vulnerable women, one of which is Mellow Bumps. Data were collected from January 2014 to June 2018 for 28 groups, 108 participants and 24 facilitators in a comprehensive and rigorous Process Evaluation designed to complement the Outcome Evaluation. Data were gathered at various time points using multiple methods, and were synthesised to triangulate findings. The reflective component was implemented with fidelity and participants engaged with it to varying degrees, dependent largely on the coherence of the group. Patchy attendance compromised the coherence of some groups, with the development of rapport, which is key to delivering reflective exercises, more difficult when group composition varied from week to week. Where there was a coherent group, powerful mechanisms of change, leading to stress reduction, included: relief through unburdening, empowerment through support given and received, reduced isolation through sharing anxieties, and control through self-care advice. A minority of highly vulnerable mothers seemed not to benefit from the reflective exercises and were marginalised within their groups. In order to minimise potential harmful effects of such exercises, allocation of participants to groups should strive to maximise group homogeneity. More research is needed to explore how very vulnerable parents can be supported in attending parenting interventions from start to finish.

Interventions tackling zoonoses require an understanding of healthcare patterns related to both human and animal hosts. The control of dog-mediated rabies is a good example. Despite the availability of effective control measures, 59,000 people die of rabies every year worldwide. In Tanzania, children are most at risk, contributing ~40% of deaths. Mass dog vaccination can break the transmission cycle, but reaching the recommended 70% coverage is challenging where vaccination depends on willingness to vaccinate dogs. Awareness campaigns in communities often target children, but do not consider other key individuals in the prevention chain. Understanding factors related to dog ownership and household-level responsibility for dog vaccination and child health is critical to the design of vaccination strategies. We investigated who makes household decisions about dogs and on health care for children in rural Tanzania. In the Kilosa district, in-depth interviews with 10 key informants were conducted to inform analysis of data from a household survey of 799 households and a survey on Knowledge Attitudes and Practices of 417 households. The in-depth interviews were analysed using framework analysis. Descriptive analysis showed responsibilities for household decisions on dogs’ and children’s health. Multivariate analysis determined factors associated with the probability of dogs being owned and the number of dogs owned, as well as factors associated with the responsibility for child health. Dog ownership varied considerably between villages and even households. The number of dogs per household was associated with the size of a household and the presence of livestock. Children are not directly involved in the decision to vaccinate a dog, which is largely made by the father, while responsibility for seeking health care if a child is bitten lies with the mother. These novel results are relevant for the design and implementation of rabies interventions. Specifically, awareness campaigns should focus on decision-makers in households to improve rabies prevention practices and on the understanding of processes critical to the control of zoonoses more broadly.

Background Evaluations of complex interventions in public health are frequently undermined by problems that can be identified before the effectiveness study stage. Exploratory studies, often termed pilot and feasibility studies, are a key step in assessing the feasibility and value of progressing to an effectiveness study. Such studies can provide vital information to support more robust evaluations, thereby reducing costs and minimising potential harms of the intervention. This systematic review forms the first phase of a wider project to address the need for stand-alone guidance for public health researchers on designing and conducting exploratory studies. The review objectives were to identify and examine existing recommendations concerning when such studies should be undertaken, questions they should answer, suitable methods, criteria for deciding whether to progress to an effectiveness study and appropriate reporting. Methods We searched for published and unpublished guidance reported between January 2000 and November 2016 via bibliographic databases, websites, citation tracking and expert recommendations. Included papers were thematically synthesized. Results The search retrieved 4095 unique records. Thirty papers were included, representing 25 unique sources of guidance/recommendations. Eight themes were identified: pre-requisites for conducting an exploratory study, nomenclature, guidance for intervention assessment, guidance surrounding any future evaluation study design, flexible versus fixed design, progression criteria to a future evaluation study, stakeholder involvement and reporting of exploratory studies. Exploratory studies were described as being concerned with the intervention content, the future evaluation design or both. However, the nomenclature and endorsed methods underpinning these aims were inconsistent across papers. There was little guidance on what should precede or follow an exploratory study and decision-making surrounding this. Conclusions Existing recommendations are inconsistent concerning the aims, designs and conduct of exploratory studies, and guidance is lacking on the evidence needed to inform when to proceed to an effectiveness study. Trial registration PROSPERO 2016, CRD42016047843

Background Few of the many behavioral sexual health interventions in Africa have been rigorously evaluated. Where biological outcomes have been measured, improvements have rarely been found. One of the most rigorous trials was of the multi-component MEMA kwa Vijana adolescent sexual health programme, which showed improvements in knowledge and reported attitudes and behaviour, but none in biological outcomes. This paper attempts to explain these outcomes by reviewing the process evaluation findings, particularly in terms of contextual factors. Methods A large-scale, primarily qualitative process evaluation based mainly on participant observation identified the principal contextual barriers and facilitators of behavioural change. Results The contextual barriers involved four interrelated socio-structural factors: culture (i.e. shared practices and systems of belief), economic circumstances, social status, and gender. At an individual level they appeared to operate through the constructs of the theories underlying MEMA kwa Vijana - Social Cognitive Theory and the Theory of Reasoned Action – but the intervention was unable to substantially modify these individual-level constructs, apart from knowledge. Conclusion The process evaluation suggests that one important reason for this failure is that the intervention did not operate sufficiently at a structural level, particularly in regard to culture. Recently most structural interventions have focused on gender or/and economics. Complementing these with a cultural approach could address the belief systems that justify and perpetuate gender and economic inequalities, as well as other barriers to behaviour change.

IntroductionParenting programmes may reduce the risk of violence against children and improve child well-being. However, additional economic support may be necessary in highly deprived rural communities in sub-Saharan Africa. Furthermore, delivering programmes within farmer groups may increase male caregiver recruitment and engagement.MethodsA parallel cluster randomised controlled trial examined the combined and separate effects of parenting and economic strengthening programmes on reducing violence against children aged 0–18 years in farming communities in Tanzania (n=248 families; 63% male caregivers). Eight villages were randomly assigned to four conditions (2:2:2:2): (1) 12-session parenting programme (n=60); (2) agribusiness training (n=56); (3) parenting and agribusiness combined (n=72); (4) control (n=60). Parent-report, child-report and early childhood observation assessments were conducted at baseline, mid-treatment and post-treatment. Primary outcomes were child maltreatment and parenting behaviour. Secondary outcomes included corporal punishment endorsement, parenting stress, parent/child depression, child behaviour, economic well-being and child development.ResultsAt post-treatment, parents and children receiving the combined interventions reported less maltreatment (parents: incidence rate ratio (IRR=0.40, 95% CI 0.24 to 0.65; children: IRR=0.40, 95% CI 0.17 to 0.92). Parents reported reduced endorsement of corporal punishment (Dw=−0.43, 95% CI −0.79 to 0.07) and fewer child behaviour problems (Dw=−0.41, 95% CI −0.77 to 0.05). Parents in parenting-only villages reported less abuse (IRR=0.36, 95% CI 0.21 to 0.63) and fewer child behaviour problems (Dw=−0.47, 95% CI −0.84 to 0.11). Parents in agribusiness-only villages reported fewer child behaviour problems (Dw=−0.43, 95% CI −0.77 to 0.08) and greater household wealth (Dw=0.57, 95% CI 0.08 to 1.06). However, children in agribusiness-only villages reported increased physical abuse (IRR=2.26, 95% CI 1.00 to 5.12) and less positive parenting (Dw=−0.50, 95% CI −0.91 to 0.10). There were no other adverse effects.ConclusionParent training may be the active ingredient in reducing maltreatment in farmer groups with majority male caregivers, while agribusiness training programmes may have unintended negative consequences on children when delivered alone. Locating parenting support in existing farmer groups can engage much higher proportions of fathers than stand-alone programmes.ClinicalTrials.gov: NCT02633319

Background Material exchange for sex (transactional sex) may be important to sexual relationships and health in certain cultures, yet the motivations for transactional sex, its scale and consequences are still little understood. The aim of this paper is to examine young women's motivations to exchange sex for gifts or money, the way in which they negotiate transactional sex throughout their relationships, and the implications of these negotiations for the HIV epidemic. Method An ethnographic research design was used, with information collected primarily using participant observation and in-depth interviews in a rural community in North Western Tanzania. The qualitative approach was complemented by an innovative assisted self-completion questionnaire. Findings Transactional sex underlay most non-marital relationships and was not, per se , perceived as immoral. However, women's motivations varied, for instance: escaping intense poverty, seeking beauty products or accumulating business capital. There was also strong pressure from peers to engage in transactional sex, in particular to consume like others and avoid ridicule for inadequate remuneration. Macro-level factors shaping transactional sex (e.g. economic, kinship and normative factors) overwhelmingly benefited men, but at a micro-level there were different dimensions of power, stemming from individual attributes and immediate circumstances, some of which benefited women. Young women actively used their sexuality as an economic resource, often entering into relationships primarily for economic gain. Conclusion Transactional sex is likely to increase the risk of HIV by providing a dynamic for partner change, making more affluent, higher risk men more desirable, and creating further barriers to condom use. Behavioural interventions should directly address how embedded transactional sex is in sexual culture.

Background Surveys of young people under-represent those in alternative education settings (AES), potentially disguising health inequalities. We present the first quantitative UK evidence of health inequalities between AES and mainstream education school (MES) pupils, assessing whether observed inequalities are attributable to socioeconomic, familial, educational and peer factors. Methods Cross-sectional, self-reported data on individual- and poly-substance use (PSU: combined tobacco, alcohol and cannabis use) and sexual risk-taking from 219 pupils in AES (mean age 15.9 years) were compared with data from 4024 pupils in MES (mean age 15.5 years). Data were collected from 2008 to 2009 as part of the quasi-experimental evaluation of Healthy Respect 2 (HR2). Results AES pupils reported higher levels of substance use, including tobacco use, weekly drunkenness, using cannabis at least once a week and engaging in PSU at least once a week. AES pupils also reported higher levels of sexual health risk behaviours than their MES counterparts, including: earlier sexual activity; less protection against sexually transmitted infections (STIs); and having 3+ lifetime sexual partners. In multivariate analyses, inequalities in sexual risk-taking were fully explained after adjusting for higher deprivation, lower parental monitoring, lower parent-child connectedness, school disengagement and heightened intentions towards early parenthood among AES vs MES pupils. However, an increased risk (OR = 1.73, 95% CI 1.15, 2.60) of weekly PSU was found for AES vs MES pupils after adjusting for these factors and the influence of peer behaviours. Conclusion AES pupils are more likely to engage in health risk behaviours, including PSU and sexual risk-taking, compared with MES pupils. AES pupils are a vulnerable group who may not be easily targeted by conventional population-level public health programmes. Health promotion interventions need to be tailored and contextualised for AES pupils, in particular for sexual health and PSU. These could be included within interventions designed to promote broader outcomes such as mental wellbeing, educational engagement, raise future aspirations and promote resilience.

Background Improving the reproductive health of young women in developing countries requires access to safe and effective methods of fertility control, but most rely on traditional rather than modern contraceptives such as condoms or oral/injectable hormonal methods. We conducted a systematic review of qualitative research to examine the limits to modern contraceptive use identified by young women in developing countries. Focusing on qualitative research allows the assessment of complex processes often missed in quantitative analyses. Methods Literature searches of 23 databases, including Medline, Embase and POPLINE ® , were conducted. Literature from 1970–2006 concerning the 11–24 years age group was included. Studies were critically appraised and meta-ethnography was used to synthesise the data. Results Of the 12 studies which met the inclusion criteria, seven met the quality criteria and are included in the synthesis (six from sub-Saharan Africa; one from South-East Asia). Sample sizes ranged from 16 to 149 young women (age range 13–19 years). Four of the studies were urban based, one was rural, one semi-rural, and one mixed (predominantly rural). Use of hormonal methods was limited by lack of knowledge, obstacles to access and concern over side effects, especially fear of infertility. Although often more accessible, and sometimes more attractive than hormonal methods, condom use was limited by association with disease and promiscuity, together with greater male control. As a result young women often relied on traditional methods or abortion. Although the review was limited to five countries and conditions are not homogenous for all young women in all developing countries, the overarching themes were common across different settings and contexts, supporting the potential transferability of interventions to improve reproductive health. Conclusion Increasing modern contraceptive method use requires community-wide, multifaceted interventions and the combined provision of information, life skills, support and access to youth-friendly services. Interventions should aim to counter negative perceptions of modern contraceptive methods and the dual role of condoms for contraception and STI prevention should be exploited, despite the challenges involved.