Therafirst Medical Center

IntroductionThe prenatal period poses a risk of both onset and relapse of mental health difficulties. Anxiety and depressive symptoms are the most common, with a prevalence of 10-20%. Untreated mental health difficulties can have serious consequences for the child’s development, the quality of the mother-child relationship, and the whole family system. Peer support can be an effective form of care for women at risk.ObjectivesThe aim of the study is to examine the effectivness of remote “Mom Supports Mom” peer support intervention in reducing prenatal anxiety, depression and psychosocial stress levels.MethodsA randomized controlled trial was conducted. The Edinburg Postnatal Depression scale (EPDS) was used to assess the risk of mental health difficulties in pregnant women. Women with EPDS score ≥ 10 were randomized 1:1 to control and intervention groups. The intervention group received the “Mom Supports Mom” peer support intervention. The control group received care as usual. Between group-differences in anxiety, depression and psychosocial stress levels were measured one month after the enrollment/the start of the intervention. The Perinatal Anxiety Screening Scale (PASS), the Edinburg Postnatal Depression Scale (EPDS), and the Prenatal Psychosocial Profile (PPP) were used to assess the mental health difficulties.ResultsThe study involved a total of 67 participants in the intervention group, and 77 participants in the control group. Levels of anxiety (U = 2016, P < 0.05) and psychosocial stress (U = 1862, P = 0.001) were significantly decreased in the intervention group, showing a medium effect size of the intervention (Cliff’s delta= -0.218 and -0.317, respectively). There was no significant difference in depression levels (U = 2288.5, P = 0.243; Cliff’s delta = -0.113); see Table 1.Table 1Between group differences in study outcomes (n=144)Measuring instrumentsIntervention group (n=67) Median (IQR)Intervention group 95% Confidence IntervalControl group (n=77) Median (IQR)Control group 95% Confidence IntervalU value / t valuep-valueEPDS (pre)13 (4)12.513.913 (4)12.814.22429.50.545PASS (pre)36 (17)32.038.036 (15)34.039.50.8460.399PPP (pre)18 (4)17.820.317 (6)16.918.82282.50.233EPDS (dif)-6 (6)-6.7-4.1-5 (6)-5.4-3.02288.50.243PASS (dif)-7 (11)-12.3-6.8-5 (13)-7.3-2.420160.024PPP (dif)-2 (4)-4.0-1.60 (4)-1.20.518620.001EPDS = Edinburg Postnatal Depression ScalePASS = Perinatal Anxiety Screening ScalePPP = Prenatal Psychosocial Profilepre = administered at baselinedif = administered post-interventionIQR = interquartile rangeConclusionsThe remote “Mom Supports Mom” peer support intervention can be effective in reducing anxiety and psychosocial stress levels in at-risk pregnant women. Nevertheless, it didn’t show effectivness in reducing depression levels.Disclosure of InterestNone Declared

Studies of injectable poly-L-lactic acid (PLLA) in human immunodeficiency virus (HIV)-associated facial lipoatrophy have predominantly included male Caucasians. To report cumulative year 2 interim study results examining the safety and efficacy of injectable PLLA in subjects with HIV categorized according to Fitzpatrick skin type and sex. This is an ongoing open-label, multicenter, 5-year study of 290 treated subjects. After correction with injectable PLLA, subjects are being followed annually. Primary end points include incidence and severity of treatment-emergent adverse events (TEAEs). Secondary end points include mean change from baseline of James scale severity grade and treatment satisfaction. At 2 years, TEAE incidences were: potentially related to study product (n = 53,18.3%) or injection procedure (n = 71, 24.5%), injection-site nodules (n = 24, 8.3%) and papules (n = 25, 8.6%). No hypertrophic scars, keloids, or product-related serious TEAEs were reported. Mean improvement in James scale grade for all groups was 1.4 (p < .001), and 89.4% of subjects and 95.5% of physicians rated treatment satisfaction as very good or excellent. At 2 years, injectable PLLA is a safe and effective long-term treatment for HIV-associated facial lipoatrophy regardless of Fitzpatrick skin type; confirmation of these results will be needed at the completion of this 5-year study.

BackgroundTraditional first line regimens containing a non-nucleoside reverse transcriptase inhibitor or protease inhibitor may not be suitable for a subset of antiretroviral-naïve patients such as those with certain co-morbidities, women of child-bearing potential, and intolerability to components of standard first line therapy. This study was conducted to determine if alternate treatment options may meet the needs of both general and special patient populations. The ACTION study was a randomized, open-label, multicenter, 48-week trial that compared the safety and efficacy of a triple nucleoside regimen versus a protease inhibitor plus a dual nucleoside regimen in HIV-1 treatment-naïve subjects.Results279 HIV-infected subjects with HIV-1 RNA (VL) >5000 but < 200,000 copies/mL (c/mL) and CD4+ count ≥ 100 cells/mm3 were randomized (1:1) to receive abacavir sulfate/lamivudine/zidovudine (ABC/3TC/ZDV) twice-daily or atazanavir (ATV) once-daily plus lamivudine/zidovudine (3TC/ZDV) twice-daily. Protocol-defined virologic failure was based on multiple failure criteria.Non-inferiority of ABC/3TC/ZDV to ATV+3TC/ZDV was established with 62% vs. 59% of subjects achieving a VL < 50 c/mL at week 48, [ITT(E), M/S = F, 95% CI: -5.9, 10.4]. Similar results were observed in the 230 (82%) subjects with baseline VL<100,000 c/mL (ABC/3TC/ZDV vs. ATV+3TC/ZDV), 66% vs. 59%; 95% CI: -5.6, 19.5. However, ABC/3TC/ZDV did not meet the non-inferiority criterion compared to ATV+3TC/ZDV in the 48 subjects with baseline VL ≥ 100,000 c/mL, 39% vs. 60%; 95% CI: -49.2, 7.4, respectively. Protocol-defined virologic failure was similar between groups.ConclusionABC/3TC/ZDV demonstrated comparable virologic efficacy to ATV+3TC/ZDV in this population over 48 weeks. In those with a baseline VL ≥ 100,000 c/mL, subjects in the ATV+3TC/ZDV showed better virologic efficacy. Both regimens offer benefits in select therapy-naïve subjects.Trial Registration[Clinical Trials Identifier, NCT00082394].