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NCT ID: NCT01854853 Completed - HIV Clinical Trials

Brazilian HIV/Sexually Transmitted Infection (STI) Prevention for Adolescents With Mental Health Disorder

Start date: August 2012
Phase: Phase 1
Study type: Interventional

Adolescents with mental health (MH) disorders (MHD) have higher rates of HIV/STI sexual risk behaviors than those in the general population. In Brazil, among youth seeking HIV testing, those testing positive had more MH problems than HIV-negative youth; HIV/STI sexual risk reduction is not regularly implemented within MH care for adolescents. Our NIMH-funded RCT in Rio de Janeiro (Rio; R01MH065163; PI: Wainberg) promises to provide such intervention for adults with MHD. A comparable evidence-based HIV/STI prevention intervention for adolescents is not available in Brazil; this application targets this need. Using quantitative and qualitative methods we will explore the contextual influences on sexual risk behavior of Brazilian youth ages 13-24 with MHD to inform intervention adaptation. The investigators will then pilot-test the family-based (parent-adolescent dyad) intervention HIV, STI and pregnancy prevention intervention with a sample of male and female youth age 13-24 years (n=144) with MHD who are in MH treatment in four community-based sites in preparation for the RCT.

NCT ID: NCT01854762 Recruiting - HIV Clinical Trials

Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection

PregnantHIV
Start date: March 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The current available antiretroviral (ARV) agents make possible a successful treatment of virtually all HIV-infected patients, even those heavily experienced subjects, with a history of previous failure to ARV drugs of different classes. However, some problems are still present, especially for specific populations, like pregnant women and infants. For these groups, most of currently available drugs are not used, because the lack of information on safety, efficacy, and pharmacokinetic/dynamic behavior of ARVs drugs. The mother to child transmission (MTCT) is still a problem in certain areas of the world, especially in resource-limited settings. In some settings, women often present to their first antenatal care visit late in the pregnancy, posing an additional problem: how to effectively treat these patients to assure they will have an undetectable viral load at the moment of delivering? Depending on the plasma viremia magnitude, and viral susceptibility it can take 6 or more weeks to reduce the viral load to less than the desired 1,000 copies of HIV-1 RNA / ml of plasma. To achieve this goal, it would be necessary the use of a potent, very efficacious ARV regimen that could provide such viral decay in a very short period. Raltegravir (RAL), the first HIV-1 integrase inhibitor, is a potent and safe ARV drug. The available evidence suggest it has no genotoxic potential, and promotes a rapid decline in HIV-1 plasma viremia. In addition, RAL is highly active against viral strains presenting different degree of resistance to other ARV drugs. Thus, RAL could be an ideal candidate to be used for prevention of MTCT for women with detectable viral load, presenting late in the course of pregnancy. Another attractive point is to consider that, due to the similarity between the integrase enzyme of HIV-1 and Human T-cell lymphotropic virus type-1 (HTLV-1); RAL could be active against HTLV-1, blocking its replication. If our hypothesis is correct, the use f RAL-containing ARV regimens would reduce the MTCT of both agents. This study has the objective of evaluating the efficacy of RAL containing ARV regimens in reducing the HIV-1 RNA plasma viral load below 50 copies/ml, at the end of pregnancy, for late-presenters pregnant women and to compare the frequency of adverse events for women using RAL-based ARV regimens and comparators, and for their babies.

NCT ID: NCT01853917 Completed - Pregnancy Clinical Trials

Evaluation of Barriers to Postpartum Care in HIV Infected Women

Start date: January 2012
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate why the majority of HIV infected women in the Harris County Health District system who are pregnant do not come to clinic for their HIV disease after they have a baby through questionaires administered prepartum and questionaires and structured interviews postpartum. The study will ask subjects questions about HIV, drug use, depression and social problems.

NCT ID: NCT01852617 Completed - Pregnancy Clinical Trials

A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay

Start date: October 2011
Phase: N/A
Study type: Interventional

Argentina and Uruguay are among the countries with the highest proportion of pregnant women who smoke. The implementation of an effective smoking cessation intervention would have a significant impact on the health of mothers and children. The "5 A's" (Ask, Advise, Assess, Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5-15 minutes delivered by a trained provider, which is considered the standard of care worldwide. However, it is under used in Argentina and Uruguay. We will conduct a two-arm, parallel cluster randomized controlled trial of an implementation intervention in 20 prenatal clinics in Argentina and Uruguay. Our primary hypothesis is that the intervention is feasible in prenatal clinics in Argentina and Uruguay and will increase the frequency of women receiving tobacco use cessation counseling during pregnancy. Our secondary hypothesis is that the intervention will decrease the frequency of women who smoke by the end of their pregnancies. Prenatal clinics will be randomly allocated to either an intervention or a control group after a baseline data collection period. Midwife facilitators in the ten intervention clinics will be identified and trained to deliver the "5 A's" to pregnant women and will then disseminate and implement the program. The ten clinics in the control group will continue with their standard in-service activities. A follow-up data collection will be conducted immediately after delivery. The intervention will be tailored by formative research to be readily applicable to local prenatal care services at busy maternity hospitals, as well as to be acceptable to local pregnant women and health providers. The study will be conducted in 48 months.

NCT ID: NCT01849900 Active, not recruiting - Pregnancy Clinical Trials

Preconception Reproductive Knowledge Promotion (PREKNOP)

PREKNOP
Start date: February 2013
Phase: N/A
Study type: Interventional

This study examines the efficacy of the "Preconception Reproductive Knowledge Promotion (PREKNOP)" intervention, designed to promote women's reproductive health and positive pregnancy outcomes. The study's goal is to educate low-income women about reproductive changes related to their menstrual cycle. The main hypothesis of the study is that women who receive the PREKNOP intervention will report reduced risk of unplanned pregnancy and increased reproductive knowledge, self-efficacy about that knowledge, and pregnancy planning ability.

NCT ID: NCT01845324 Not yet recruiting - Diabetes Mellitus Clinical Trials

Fetal Heart Interventricular Septum in Fetuses of Diabetic Mothers

Start date: May 2013
Phase: N/A
Study type: Observational

The investigators asume that the measurement of the fetal heart interventricular septum can serve as a good tool to predict glucose control in pregnant patients with diabetes mellitus. The investigators will measure the septum width in patients with Diabetes and will correlate to standard measurements of the glucuse levels.

NCT ID: NCT01844024 Completed - Pregnancy Clinical Trials

Task Sharing to Improve Post Abortion Care at District Health Care Level- Trial in Uganda

Start date: April 2013
Phase: Phase 4
Study type: Interventional

Uganda is one of the countries with highest fertility rate in the world, 6.7 children per women. It is estimated that 56 percent of all pregnancies are unintended and the contraceptive prevalence rate in Uganda is 23 percent. Unwanted pregnancy is common and induced abortion is illegal. Unsafe abortion is responsible for significant morbidity and mortality among women in Uganda. Almost 40% of admissions to emergency obstetric care units in Uganda due to unsafe abortion is reported and considered high in international comparison. Studies have revealed that trained midlevel providers can deliver safe post abortion care (PAC) for incomplete abortion and use manual vacuum aspiration. The prostaglandin E1 analogue misoprostol has been shown to be an effective tool in the treatment of incomplete abortions. This option is so far under-used in developing countries, especially outside the larger hospitals and private clinics. One significant limiting factor in providing safe PAC is the lack of providers. So far technical training has been mainly limited to physicians. The long-term goal of this project is to provide evidence based information that will contribute to the development of strategies to increase women's access to high level post- abortion care at primary health care level provided by midlevel providers in Uganda. A task shift to midlevel provider in providing treatment of incomplete abortion will increase access to safe PAC and is a key to Millenium Development Goal 5. Misoprostol treatment of incomplete abortion remains underused and in accessible to a majority of women in Uganda because national regulations restricts its prescription and supervision to doctors. However, the safety of misoprostol treatment should make it amenable to provision by midlevel providers. Training of midlevel providers in misoprostol treatment of incomplete abortion will support task shifting in places where doctors are costly and scarce. By evaluating the effectiveness of mid-level providers (midwives); administering misoprostol treatment of incomplete abortion the project is attempting to contribute to the reduction of maternal mortality and morbidity and safeguard high quality of post-abortion care. A direct economic impact can also be expected due to reduced treatment costs of complications from unsafely induced abortion and incomplete abortions. The involvement of midlevel providers in medical treatment of incomplete abortion has previously not been systematically evaluated in African primary health care setting.

NCT ID: NCT01842659 Active, not recruiting - Clinical trials for Pregnant Women Requiring Amniocentesis

Prenatal Screening for Imprinting Anomalies Implicated in Beckwith Wiedemann and Silver Russell Syndromes

DASIRUWIBE
Start date: May 2013
Phase: N/A
Study type: Interventional

Losses of imprinting are involved in various syndromes. Those occurring in the 11p15 region lead to Beckwith-Wiedemann and Silver-Russell Syndromes. These losses of imprinting follow a mosaic pattern, rendering their detection difficult, especially given the scarcity of available DNA in amniotic fluid. Thus, in spite of growing demand, prenatal diagnosis (PND) for imprinting abnormalities of the 11p15 region is not available. The recent development of a quantitative PCR method that permits the methylation index (MI) of imprinted regions to be calculated renders PND technically possible. Nevertheless, because of the mosaic nature of these anomalies, it is essential to verify that the methylation pattern of the 11p15 region obtained from the amniotic fluid matches that obtained from the blood.

NCT ID: NCT01841424 Completed - Obesity Clinical Trials

CO-OP Trial: Community-based Outreach on Obesity in Pregnancy

CO-OP
Start date: June 2013
Phase: N/A
Study type: Interventional

Obesity is becoming more common and disproportionately affects the younger generation, the poor and certain ethnic groups. Nearly 50% of reproductive aged women are obese or overweight. Obesity during pregnancy leads to higher rates of hypertensive disorders, stillbirth, less successful breastfeeding, obesity in their offspring, postpartum depression, and higher weight retention postpartum. Dietary counseling can prevent excessive maternal weight gain and is more effective than activity-based interventions. The two objectives of this study are 1) to use community-based techniques to improve dietary counseling for high risk women and 2) to randomize obese women to dietary counseling at Truman Medical Center and measure their success. The hypothesis is that dietary interventions can successfully be tailored for high risk women and that excessive weight gain during pregnancy can be avoided.

NCT ID: NCT01836315 Completed - Obesity Clinical Trials

Inflammation in Obese Parturients: Surgical Outcomes After Elective Caesarean Section

Start date: January 2013
Phase: N/A
Study type: Observational

Hypothesis: The investigators propose that obese parturients will have an increased inflammatory response and a decreased anti-inflammatory response to the surgical and anesthetic insult of caesarean section and that this will be associated with a higher rate of perioperative complications, as compared to non-obese parturients.2 Background: Obese patients exhibit higher levels of inflammatory markers than non-obese patients. Furthermore, obese patients have a higher incidence of perioperative complications, especially wound infections, and this is well documented in the caesarean section population. The pregnant population is unique as a result of the immunologic changes that occur at baseline, and an increase in pro-inflammatory markers is seen in serum and in placental tissue of obese subjects, and has been demonstrated to correlate with adverse fetal outcomes. Specific Objectives: To determine the baseline levels of three established markers of inflammation in term pregnant obese and non-obese patients (defined by a BMI > and < 35 kg/M2 respectively), and examine how they change in response to the stress of surgery/anesthesia. The investigators will correlate the inflammatory response with the incidence of postoperative wound infections. Methods: Patients will be recruited to the study prior to the planned caesarean section. Blood samples for inflammatory marker levels will be performed preoperatively, immediately postoperatively, and at 24 hours postoperatively. Samples will be analyzed for pentraxin-3 (a relatively novel inflammatory marker), C reactive protein (CRP) (a well-known and clinically relevant inflammatory marker), and interleukin-10 (IL-10) (an established anti-inflammatory marker). Plasma will be analyzed by ELISA to determine levels of each biomarker. Patient charts will be reviewed to determine which patients have experienced surgical complications in the 30 days postoperatively. Surgical complications will then be correlated with the measured levels of inflammatory markers. Assuming that the levels of inflammatory cytokines in obese patients will be 15% higher in obese parturients and assuming an alpha error level of 5% and a beta error level of 20%, the investigators would need to study 18 patients per group to prove our hypothesis that inflammatory cytokine levels are correlated with postoperative infections. The investigators plan to study 20 patients per group to account for a potential patient attrition rate of 10% during the study. Significance/Importance: The connection between obesity and dysregulation of the perioperative inflammatory response has not been well established nor has perioperative inflammation in the obese population been linked to the observed increased in perioperative morbidity. The investigators hope to demonstrate these connections and hopefully will be able to identify at risk patients earlier, and in a subsequent study intervene to reduce the risk of postoperative wound infections with pharmacokinetically targeted antimicrobial prophylaxis.