Suchergebnisse

Background Child marriage (<18 years) and school drop-out disproportionately affect girls living in impoverished households in rural areas, with long-term economic and health consequences. Improving retention in education, and delaying age at marriage and first pregnancy have received substantial attention at the national and global level, in line with the Millennium Development Goals and the Sustainable Development Goals (SDGs) (2015-2030). Methods We examined changes over time in economic, education and child marriage indicators among adolescents from rural households in (i) Northern Karnataka (the most deprived region of Karnataka), (ii) Karnataka state, and (iii) all India, using individualized data from four pre-existing, nationally-representative datasets (District Level Household and Facility Surveys (DLHS 2-4) (2002/4–2012/3) and the National Family Health Survey (NFHS-4) (2015-16)). Results At the national and state level, we found large improvements in secondary educational attainment among girls and boys living in rural settings (proportion of adolescents completing age-appropriate secondary school education (all India): girls 12.4% 2002/3 vs. 31.6% 2015/6; boys 18.9% 2002/4 vs. 36.8% 2015/6). We also observed large reductions in child marriage and early child-bearing rates (proportion of married women aged 18-24 years married <18 years: 62.4% 2002/4 vs. 23.8% 2015/6; proportion of married girls aged <19 years who are pregnant or have children: 62.4% 2002/4 vs. 21.9% 2015/6). In addition, we found evidence of "clustered deprivations", whereby girls in rural areas from the poorest families and lowest castes continue to experience multiple forms of disadvantage, with child marriage significantly associated with scheduled caste / scheduled tribe (SC/ST) caste (odds ratio (OR)=1.25, 95% confidence interval (CI)=1.18-1.32), poorest quintile (OR=2.38, 95% CI=2.21-2.55) and illiteracy (OR=2.09, 95% CI=1.95-2.23); and not completing secondary education significantly associated with SC/ST caste (OR=1.52, 95% CI=1.45-1.59), poorest quintile (OR=4.17, 95% CI=3.90-4.46), and child marriage (OR=2.05, 95% CI=1.85-2.26). Conclusions The results show substantial improvements in economic, educational and child marriage indicators at the state and national level over the past 14 years. The government has implemented multiple programmes and policies to address child marriage and school drop-out, and these trends suggest such efforts may be having a positive impact. If India is to achieve the SDGs, designing targeted interventions to reach those who continue to be left furthest behind is going to be key.

BACKGROUND: Child marriage (<18 years) and school drop-out disproportionately affect girls living in impoverished households in rural areas, with long-term economic and health consequences. Improving retention in education, and delaying age at marriage and first pregnancy have received substantial attention at the national and global level, in line with the Millennium Development Goals and the Sustainable Development Goals (SDGs) (2015-2030). METHODS: We examined changes over time in economic, education and child marriage indicators among adolescents from rural households in (i) Northern Karnataka (the most deprived region of Karnataka), (ii) Karnataka state, and (iii) all India, using individualized data from four pre-existing, nationally-representative datasets (District Level Household and Facility Surveys (DLHS 2-4) (2002/4–2012/3) and the National Family Health Survey (NFHS-4) (2015-16)). RESULTS: At the national and state level, we found large improvements in secondary educational attainment among girls and boys living in rural settings (proportion of adolescents completing age-appropriate secondary school education (all India): girls 12.4% 2002/3 vs. 31.6% 2015/6; boys 18.9% 2002/4 vs. 36.8% 2015/6). We also observed large reductions in child marriage and early child-bearing rates (proportion of married women aged 18-24 years married <18 years: 62.4% 2002/4 vs. 23.8% 2015/6; proportion of married girls aged <19 years who are pregnant or have children: 62.4% 2002/4 vs. 21.9% 2015/6). In addition, we found evidence of "clustered deprivations", whereby girls in rural areas from the poorest families and lowest castes continue to experience multiple forms of disadvantage, with child marriage significantly associated with scheduled caste / scheduled tribe (SC/ST) caste (odds ratio (OR)=1.25, 95% confidence interval (CI)=1.18-1.32), poorest quintile (OR=2.38, 95% CI=2.21-2.55) and illiteracy (OR=2.09, 95% CI=1.95-2.23); and not completing secondary education significantly associated with SC/ST caste (OR=1.52, 95% CI=1.45-1.59), poorest quintile (OR=4.17, 95% CI=3.90-4.46), and child marriage (OR=2.05, 95% CI=1.85-2.26). CONCLUSIONS: The results show substantial improvements in economic, educational and child marriage indicators at the state and national level over the past 14 years. The government has implemented multiple programmes and policies to address child marriage and school drop-out, and these trends suggest such efforts may be having a positive impact. If India is to achieve the SDGs, designing targeted interventions to reach those who continue to be left furthest behind is going to be key.

IntroductionMicrobicides were conceptualized as a product that could give women increased agency over HIV prevention. However, gender‐related norms and inequalities that place women and girls at risk of acquiring HIV are also likely to affect their ability to use microbicides. Understanding how gendered norms and inequalities may pose obstacles to women's microbicide use is important to inform product design, microbicide trial implementation and eventually microbicide and other antiretroviral‐based prevention programmes. We reviewed published vaginal microbicide studies to identify gender‐related factors that are likely to affect microbicide acceptability, access and adherence. We make recommendations on product design, trial implementation, positioning, marketing and delivery of microbicides in a way that takes into account the gender‐related norms and inequalities identified in the review.MethodsWe conducted PubMed searches for microbicide studies published in journals between 2000 and 2013. Search terms included trial names (e.g. "MDP301"), microbicide product names (e.g. "BufferGel"), researchers' names (e.g. "van der Straten") and other relevant terms (e.g. "microbicide"). We included microbicide clinical trials; surrogate studies in which a vaginal gel, ring or diaphragm was used without an active ingredient; and hypothetical studies in which no product was used. Social and behavioural studies implemented in conjunction with clinical trials and surrogate studies were also included. Although we recognize the importance of rectal microbicides to women, we did not include studies of rectal microbicides, as most of them focused on men who have sex with men. Using a standardized review template, three reviewers read the articles and looked for gender‐related findings in key domains (e.g. product acceptability, sexual pleasure, partner communication, microbicide access and adherence).Results and discussionThe gendered norms, roles and relations that will likely affect women's ability to access and use microbicides are related to two broad categories: norms regulating women's and men's sexuality and power dynamics within intimate relationships. Though norms about women's and men's sexuality vary among cultural contexts, women's sexual behaviour and pleasure are typically less socially acceptable and more restricted than men's. These norms drive the need for woman‐initiated HIV prevention, but also have implications for microbicide acceptability and how they are likely to be used by women of different ages and relationship types. Women's limited power to negotiate the circumstances of their intimate relationships and sex lives will impact their ability to access and use microbicides. Men's role in women's effective microbicide use can range from opposition to non‐interference to active support.ConclusionsIdentifying an effective microbicide that women can use consistently is vital to the future of HIV prevention for women. Once such a microbicide is identified and licensed, positioning, marketing and delivering microbicides in a way that takes into account the gendered norms and inequalities we have identified would help maximize access and adherence. It also has the potential to improve communication about sexuality, strengthen relationships between women and men and increase women's agency over their bodies and their health.

After two decades of microbicide clinical trials it remains uncertain if vaginally‐ delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre‐licensure implementation trials, Phase IV post‐marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large‐scale microbicide efficacy trials completed to‐date, the paper identifies six broad areas of adherence lessons learned: (1) Adherence measurement in clinical trials, (2) Comprehension of use instructions/Instructions for use, (3) Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4) Partner influence on use, (5) Retention and continuation and (6) Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post‐marketing research, and microbicide introduction and delivery programs.

STUDY QUESTION: Do injectable and oral contraceptives increase the risk of human immunodeficiency virus (HIV) acquisition in women? SUMMARY ANSWER: After adjusting for confounders, evidence of a significantly increased risk of HIV remained for women using injectable depo-medroxyprogesterone (DMPA) (hazard ratio = 1.49, 95% confidence interval (1.06-2.08)) but not for injectable norethisterone-enanthate (Net-En) or oral contraceptive pills (OC). WHAT IS KNOWN ALREADY: An association between the use of some types of hormonal contraception (HC) methods and an increased risk of HIV, possibly through changes in the genital tract environment and alterations in the immune response, has been previously observed, although not consistently. A recent systematic review of these studies has highlighted the need for more definitive evidence. STUDY DESIGN, SIZE, DURATION: A secondary data analysis of the MDP301 phase 3 microbicide trial was conducted to estimate the effects of use of different methods of HC on the risk of HIV acquisition in women. HIV-negative women (n = 8663) with a median age of 28 years were included in the analysis; 382 HIV seroconverted by 52 weeks follow-up; 10% of women-years were lost to follow-up before 52 weeks. PARTICIPANTS/MATERIALS, SETTING, METHODS: Contraceptive use was reported at each 4-weekly visit. Cox proportional hazards (PH) models were used to estimate the effects of baseline and current use of injectable DMPA, injectable Net-En and OC compared with no HC, on the risk of HIV, adjusting for baseline and time-updated covariates. Causal effects for 52 weeks of HC use compared with no HC were estimated in a weighted Cox model, censoring women at deviation from baseline HC use (or non-use) or pregnancy. MAIN RESULTS AND THE ROLE OF CHANCE: At baseline, 2499 (29%) women were on DMPA, 1180 (14%) on Net-En, and 1410 (16%) on OC; 3574 (40%) not on HC, started HC in follow-up. Adjusted hazard ratios (HR) for baseline HC use, compared with no HC, were 1.38 (95% confidence interval (CI) 1.07-1.78) for DMPA; 1.18 (0.86-1.62) for Net-En and 0.97 (0.68-1.38) for OC. The estimated causal effects of DMPA and Net-En over 52 weeks were: HR = 1.49 (95% CI 1.06-2.08) and HR = 1.31 (95% CI 0.62-1.61), respectively. LIMITATIONS, REASONS FOR CAUTION: A main limitation of the study was that it was a secondary analysis of data from a study that was not designed to investigate this question. Despite our best efforts, we cannot exclude residual confounding to explain the effect of DMPA. WIDER IMPLICATIONS OF THE FINDINGS: The results of this study should be reviewed by the World Health Organization to determine whether current recommendations on the use of DMPA in settings with high HIV prevalence require modification. STUDY FUNDING/COMPETING INTERESTS: MDP is a partnership of African and European academic/government institutions with commercial organizations, which is funded by the UK Government (DFID and MRC), with support from IPM and EDCTP. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Competing interests: None.

BACKGROUND: The collection of accurate data on adherence and sexual behaviour is crucial in microbicide (and other HIV-related) research. In the absence of a "gold standard" the collection of such data relies largely on participant self-reporting. After reviewing available methods, this paper describes a mixed method/triangulation model for generating more accurate data on adherence and sexual behaviour in a multi-centre vaginal microbicide clinical trial. In a companion paper some of the results from this model are presented [1]. METHODOLOGY/PRINCIPAL FINDINGS: Data were collected from a random subsample of 725 women (7.7% of the trial population) using structured interviews, coital diaries, in-depth interviews, counting returned gel applicators, focus group discussions, and ethnography. The core of the model was a customised, semi-structured in-depth interview. There were two levels of triangulation: first, discrepancies between data from the questionnaires, diaries, in-depth interviews and applicator returns were identified, discussed with participants and, to a large extent, resolved; second, results from individual participants were related to more general data emerging from the focus group discussions and ethnography. A democratic and equitable collaboration between clinical trialists and qualitative social scientists facilitated the success of the model, as did the preparatory studies preceding the trial. The process revealed some of the underlying assumptions and routinised practices in "clinical trial culture" that are potentially detrimental to the collection of accurate data, as well as some of the shortcomings of large qualitative studies, and pointed to some potential solutions. CONCLUSIONS/SIGNIFICANCE: The integration of qualitative social science and the use of mixed methods and triangulation in clinical trials are feasible, and can reveal (and resolve) inaccuracies in data on adherence and sensitive behaviours, as well as illuminating aspects of "trial culture" that may also affect data accuracy.

Gender norms serve to normalise gender inequalities and constrain girls' agency. This paper examines how girls' agency, along a continuum, is influenced by the interplay between constraining and enabling influences in the girls' environments. We analyse data from a qualitative study nested within a cluster randomised evaluation of Samata, a multi-layered programme supporting adolescent girls to stay in school and delay marriage in Karnataka, South India. Specifically, we compare agency among 22 girls from intervention communities and 9 girls in control communities using data from the final round of interviews in a qualitative cohort. Using the concept of 'thin' and 'thick' agency on a continuum, we identified shocks like mothers' death or illness, poverty stress, gender norms and poor school performance as thinning influences. Good school examination results; norms in support of education; established educational aspirations; supportive parents, siblings and teachers; and strategic government and Samata resources enabled thicker agency. The intervention programme's effect increased in parallel to the gradient from thin to thicker agency among girls in progressively supportive family contexts. Engagement with the programme was however selective; families adhering to harmful gender norms were not receptive to outreach. In line with diffusion theory, late adopters required additional peer encouragement to change norms.

Background: Secondary education and delayed marriage provide long-term socio-economic and health benefits to adolescent girls. We tested whether a structural and norms-based intervention, which worked with adolescent girls, their families, communities, and secondary schools to address poverty, schooling quality and gender norms, could reduce secondary school drop-out and child marriage among scheduled-caste/scheduled-tribe (SC/ST) adolescent girls in rural settings of southern India. Methods: 80 of 121 villages in Vijayapura and Bagalkote districts, Karnataka State, were randomly selected (control = 40; intervention = 40). All 12-13 year-old SC/ST girls in final year of primary school (standard 7th) were enrolled and followed for 3 years (2014-2017) until the end of secondary school (standard 10th). Primary trial outcomes were proportion of girls who completed secondary school and were married, by trial end-line (15-16 years). Analyses were intention-to-treat and used individual-level girl data. Results: 92.6% (2275/2457) girls at baseline and 72.8% (1788/2457) at end-line were interviewed. At end-line, one-fourth had not completed secondary school (control = 24.9%; intervention = 25.4%), and one in ten reported being married (control = 9.6%; intervention = 10.1%). These were lower than expected based on district-level data available before the trial, with no difference between these, or other schooling or sexual and reproductive outcomes, by trial arm. There was a small but significant increase in secondary school entry (adjusted odds ratio AOR = 3.58, 95% confidence interval CI = 1.36-9.44) and completion (AOR=1.54, 95%CI = 1.02-2.34) in Vijayapura district. The sensitivity and attrition analyses did not impact the overall result indicating that attrition of girls at end-line was random without much bearing on overall result. Conclusions: Samata intervention had no overall impact, however, it added value in one of the two implementation districts- increasing secondary school entry and completion. Lower than expected school drop-out and child marriage rates at end-line reflect strong secular changes, likely due to large-scale government initiatives to keep girls in school and delay marriage. Although government programmes may be sufficient to reach most girls in these settings, a substantial proportion of SC/ST girls remain at-risk of early marriage and school drop-out, and require targeted programming. Addressing multiple forms of clustered disadvantage among hardest to reach will be key to ensuring India "leaves no-one behind" and achieves its gender, health and education Sustainable Development Goal aspirations. Trial registration: ClinicalTrials.gov registration number NCT01996241.