Inpatient mother-and-child postpartum psychiatric care: factors associated with improvement in maternal mental health.

International audiencePURPOSE: This study assessed the underexplored factors associated with significant improvement in mothers' mental health during postpartum inpatient psychiatric care. METHODS: This study analyzed clinical improvement in a prospective cohort of 869 women jointly admitted with their infant to 13 psychiatric Mother-Baby Units (MBUs) in France between 2001 and 2007. Predictive variables tested were: maternal mental illness (ICD-10), sociodemographic characteristics, mental illness and childhood abuse history, acute or chronic disorder, pregnancy and birth data, characteristics and mental health of the mother's partner, and MBU characteristics. RESULTS: Two thirds of the women improved significantly by discharge. Admission for 25% was for a first acute episode very early after childbirth. Independent factors associated with marked improvement at discharge were bipolar or depressive disorder, a first acute episode or relapse of such an episode. Schizophrenia, a personality disorder, and poor social integration (as measured by occupational status) were all related to poor clinical outcomes. DISCUSSION: Most women improved significantly while under care in MBUs. Our results emphasize the importance of the type of disease but also its chronicity and the social integration when providing postpartum psychiatric care

Not All Missed Doses Are the Same: Sustained NNRTI Treatment Interruptions Predict HIV Rebound at Low-to-Moderate Adherence Levels

Background: While the relationship between average adherence to HIV potent antiretroviral therapy is well defined, the relationship between patterns of adherence within adherence strata has not been investigated. We examined medication event monitoring system (MEMS) defined adherence patterns and their relation to subsequent virologic rebound. Methods and Results: We selected subjects with at least 3-months of previous virologic suppression on a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen from two prospective cohorts in France and North America. We assessed the risk of virologic rebound, defined as HIV RNA of >400 copies/mL according to several MEMS adherence measurements. Seventy two subjects were studied, five of them experienced virologic rebound. Subjects with and without virologic rebound had similar baseline characteristics including treatment durations, regimen (efavirenz vs nevirapine), and dosing schedule. Each 10% increase in average adherence decreased the risk of virologic rebound (OR = 0.56; 95% confidence interval (CI) [0.37, 0.81], P<0.002). Each additional consecutive day off therapy for the longest treatment interruption (OR = 1.34; 95%CI [1.15, 1.68], P<0.0001) and each additional treatment interruption for more than 2 days (OR = 1.38; 95%CI [1.13, 1.77], P<0.002) increased the risk of virologic rebound. In those with low-to-moderate adherence (i.e. <80%), treatment interruption duration (16.2 days versus 6.1 days in the control group, P<0.02), but not average adherence (53.1% vs 55.9%, respectively, P = 0.65) was significantly associated with virologic rebound. Conclusions: Sustained treatment interruption may pose a greater risk of virologic rebound on NNRTI therapy than the same number of interspersed missed doses at low-to-moderate adherence

Methodological standards in non-inferiority AIDS trials: moving from adherence to compliance

BACKGROUND: The interpretation of the results of active-control trials regarding the efficacy and safety of a new drug is important for drug registration and following clinical use. It has been suggested that non-inferiority and equivalence studies are not reported with the same quantitative rigor as superiority studies. METHODS: Standard methodological criteria for non-inferiority and equivalence trials including design, analysis and interpretation issues were applied to 18 recently conducted large non-inferiority (15) and equivalence (3) randomized trials in the field of AIDS antiretroviral therapy. We used the continuity-corrected non-inferiority chi-square to test 95% confidence interval treatment difference against the predefined non-inferiority margin. RESULTS: The pre-specified non-inferiority margin ranged from 10% to 15%. Only 4 studies provided justification for their choice. 39% of the studies (7/18) reported only intent-to-treat (ITT) analysis for the primary endpoint. When on-treatment (OT) and ITT statistical analyses were provided, ITT was favoured over OT for results interpretation for all but one study, inappropriately in this statistical context. All but two of the studies concluded there was "similar" efficacy of the experimental group. However, 9/18 had inconclusive results for non-inferiority. CONCLUSION: Conclusions about non-inferiority should be drawn on the basis of the confidence interval analysis of an appropriate primary endpoint, using the predefined criteria for non-inferiority, in both OT and ITT, in compliance with the non-inferiority and equivalence CONSORT statement. We suggest that the use of the non-inferiority chi-square test may provide additional useful information

Complications à long terme des traitements antirétroviraux (observance, résistances et troubles métaboliques)

Les progrès thérapeutiques dans le domaine de l infection par le Virus de l Immunodéficience Humaine (VIH) ont transformé le pronostic de cette pathologie. Les personnes séropositives pour le VIH se heurtent aux mêmes difficultés rencontrées dans les autres types de pathologie chroniques : difficultés à suivre un traitement régulièrement, effets secondaires des traitements et perte d efficacité des molécules. Afin d améliorer la prise en charge de ces personnes, de nouvelles molécules comme, par exemple, les analogues non-nucléosidiques (ANN), ont été développées en substitution aux antiprotéases. Notre travail de recherche concerne l évaluation prospective des facteurs prédictifs de l échec virologique des ANN, hors essai thérapeutique. Concernant les complications à long terme, nous avons comparé les modifications lipidiques des deux principales molécules appartenant à la classe des ANN. Considérant qu il n allait pas de soi qu une simplification de posologie de deux à une prise par jour pouvait significativement améliorer l observance, nous avons réalisé un essai randomisé afin de comparer les deux posologies. Enfin, nous avons réalisé une revue de la littérature des essais de non infériorité dans le domaine des traitements du VIH. Nous avons ainsi mis en évidence l impact des interruptions de traitement pendant plus de 48 heures sur le risque de résistance génotypique aux ANN et confirmé le rôle indépendant de la dépression dans le risque d échappement virologique. Le remplacement de l efavirenz par la névirapine réduisait le risque cardiovasculaire à 10 ans de 20%. Le passage à la névirapine en une prise par jour était bien toléré mais l augmentation moyenne du taux d observance mesuré par pilulier électronique était marginale. Enfin, les standards méthodologiques relatifs aux essais de non infériorité étaient rarement respectés, rendant l interprétation de ces études difficile. Notre travail a ainsi contribué à améliorer les connaissances de la prise en charge à long terme des personnes infectées par le VIH en explorant les relations complexes entre les données virologiques, les propriétés pharmacologiques des molécules et les comportements humainsThe therapeutic advance in the field of the Virus of the Human Immunodeficiency (HIV) infection transformed the prognostic of this pathology. The HIV-positive persons experience the same difficulties met in the other chronic diseases: difficulties following a treatment regularly, side effects of treatments and loss of efficiency of drugs. To improve the care of these individuals, new drugs such as non-nucleoside reverse transcriptase inhibitors (NNRTI), have been developed as an alternative to protease inhibitors. We analyzed the predictors of virologic failure and resistance in a prospective cohort of subjects receiving NNRTI based antiretroviral combination. Regarding long term complications, we randomly compared the lipid profile of the two main NNRTI drugs, namely efavirenz and nevirapine. We assessed the effect of once-daily versus twicedaily dosage on electronic monitors defined adherence in a randomized trial. Finally, we conducted a systematic review to assessed the methodologic quality of noninferiority randomized trials in the field of antiretroviral therapy. We identified treatment interruptions for more than 48 hours as an independent risk factor for virologic failure and resistance to NNRTI and confirmed the impact of depression on the risk of virologic failure to NNRTI. The switch from efavirenz to nevirapine was associated with a 20% decrease in the 10-year relative risk for major cardiac events, according to the Framingham equation. The switch from twice to once-daily nevirapine was well tolerated but did not increase adherence significantly compared to twice-a-day. Methodologic standards were scarcely complied with, leaving space for improvements. Overall, our work contributed to improve the knowledge of long term complications associated with HIV by investigating the complex interactions between virologic dynamics, pharmacological properties of drugs and human behavioursPARIS-BIUSJ-Thèses (751052125) / SudocPARIS-BIUSJ-Physique recherche (751052113) / SudocSudocFranceF

Impact of migration origin on individual protection strategies against sexual transmission of HIV in Paris metropolitan area, SIRS cohort study, France.

International audienceThe impact of migration and country or region of origin on sexual behaviours and prevention of the sexual transmission of HIV has been scarcely studied in France. The objective of this study was to evaluate if and how individual attitudes of prevention towards HIV infection are different according to country or region of origins in Paris area, France. 3006 individuals were interviewed in the Paris metropolitan area in 2010. Outcome variables were (i) the intention of the individual to protect oneself against HIV, and (ii) the adoption of a condom-based approach for protection against HIV. To explore factors associated with these outcomes, we constructed multivariate logistic regression models, first taking into account only demographic variables -including country of origin-, then successively adding socioeconomic variables and variables related to sexual behaviour and HIV perception and prevention behaviour. French and foreign people who have origins in Sub-Saharan Africa declared more intentions to protect themselves than French people with French parents (in foreign men, aOR = 3.43 [1.66-7.13]; in foreign women, aOR = 2.94 [1.65-5.23]), but did not declare more recourse to a condom-based approach for protection against HIV (in foreign men, aOR = 1.38 [0.38-4.93]; in foreign women, aOR = 0.93 [0.40-2.18]). Conversely, foreign women and French women from foreign origin, especially from Maghreb (Northern Africa), reported less intention of protection than French women with French parents. These results underline the importance of taking culture and origins of target populations into consideration when designing information, education and communication about HIV and sexually transmitted diseases. These results also draw attention to fractions of the general population that could escape from prevention messages

Les facteurs biographiques et contextuels de la dépression : analyses à partir des données de la cohorte SIRS, agglomération parisienne, 2005.

National audienceIntroduction - Depression, by virtue of its conceptual and/or etiological frameworks, is an emblematic disease of new approaches that have been developed in social epidemiology: life-course epidemiology and contextual epidemiology. The objective of this study is to propose hypotheses for understanding this disease using these two approaches in a complementary way. Its goal is to look for an association between potentially traumatic life events during childhood and the occurrence of a depressive state during adulthood, and if, after adjustment for individual characteristics associated with depression, differences persist according to the type of neighborhood of residence. Methods - The SIRS study has been following a random sample of 3,000 individuals representative of the adult French-speaking population of Paris and its inner suburbs since 2005. The present analysis uses individual baseline data gathered through face-to-face interviews concerning, among other things, the subjects' depressive state, as evaluated by the MINI-Diag, life events and social conditions during childhood. The respondents' type of socioeconomic census block of residence was taken into account as well. The analyses use logistic and multilevel regression models. Results - After adjustment for the subjects' demographic and socioeconomic characteristics, several life-course events during childhood and certain characteristics of family functioning appeared to be strongly and independently associated with depression on the day of the survey, in particular, having been a victim of sexual abuse or having witnessed interparental violence, but also the parents having experienced long periods of unemployment or serious financial difficulties. In addition, after adjustment for these individual characteristics, depression was still more frequent in the neighborhoods considered to be in vulnerable urban areas. Conclusion - Several different life events and conditions during childhood appear to be detrimental to mental health during adulthood, and territorial inequalities persisted after adjustment for these factors

Which adults in the Paris metropolitan area have never been tested for HIV? A 2010 multilevel, cross-sectional, population-based study.

International audienceDespite the widespread offer of free HIV testing in France, the proportion of people who have never been tested remains high. The objective of this study was to identify, in men and women separately, the various factors independently associated with no lifetime HIV testing. We used multilevel logistic regression models on data from the SIRS cohort, which included 3006 French-speaking adults as a representative sample of the adult population in the Paris metropolitan area in 2010. The lifetime absence of any HIV testing was studied in relation to individual demographic and socioeconomic factors, psychosocial characteristics, sexual biographies, HIV prevention behaviors, attitudes towards people living with HIV/AIDS (PLWHA), and certain neighborhood characteristics. In 2010, in the Paris area, men were less likely to have been tested for HIV at least once during their lifetime than women. In multivariate analysis, in both sexes, never having been tested was significantly associated with an age younger or older than the middle-age group (30-44 years), a low education level, a low self-perception of HIV risk, not knowing any PLWHA, a low lifetime number of couple relationships, and the absence of any history of STIs. In women, other associated factors were not having a child < 20 years of age, not having additional health insurance, having had no or only one sexual partner in the previous 5 years, living in a cohabiting couple or having no relationship at the time of the survey, and a feeling of belonging to a community. Men with specific health insurance for low-income individuals were less likely to have never been tested, and those with a high stigma score towards PLWHA were more likely to be never-testers. Our study also found neighborhood differences in the likelihood of men never having been tested, which was, at least partially, explained by the neighborhood proportion of immigrants. In contrast, in women, no contextual variable was significantly associated with never-testing for HIV after adjustment for individual characteristics. Studies such as this one can help target people who have never been tested in the context of recommendations for universal HIV screening in primary care

Time since the last HIV test and migration origin in the Paris metropolitan area, France.

International audienceIn France, the newly diagnosed infection rate was 372/100,000 for African immigrants versus 6/100,000 for the French-born population in 2008. In addition, people from sub-Saharan countries were at higher risk for late diagnosis than native-born French despite their more frequent use of HIV testing. The purpose of this study was to compare the mean time since the last HIV test according to migration origin. This study used data from the SIRS (a French acronym for health, inequalities, and social ruptures) cohort, which, in 2005, included 3023 households representative of the greater Paris area. HIV testing uptake and the time since the last test were studied in relation to socio-economic factors, psychosocial characteristics, and migration origin. Multivariate ANOVA analyses were performed using Stata 10. People from sub-Saharan Africa were more likely to have been tested in their lifetime (78.51%) than those of French (56.19%) or Maghreb (39.74%) origin (p<0.0000). The mean time, in years, since the last HIV test was shorter among sub-Saharan immigrants and Maghreb immigrants (2.15 and 2.53 years, respectively) than among native-born French (4.84 years) (F=12.67; p<0.0000). These differences remained significant even after adjusting for gender, age, number of steady relationships, time lived in France, and difficulty reading and/or writing French (F=5.73; p=0.0007). A gender analysis revealed the same pattern for both sexes, with greater differences in the mean duration by migration origin for women. These results and recent epidemiological data seem to show that since the early 2000s, measures aimed at increasing HIV testing and decreasing late diagnosis in sub-Saharan immigrants have been effective