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NCT ID: NCT01893112 Completed - HIV Clinical Trials

Reducing HIV Stigma for African American Women

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

African American women account for 66% of HIV infections in women in the U.S., AIDS is a leading cause of death for African American women, and African Americans have the lowest medication adherence rates compared to other groups in the U.S. One of the reasons for low medication adherence among African Americans is fear of stigma. HIV stigma has been linked to depression, psychological distress, poor quality of life, poor medication adherence and service utilization contributing to morbidity and mortality. Research has found that stigma is a moderator to poor adherence via depressive symptoms. The current study is a randomized control trial with a time and attention control group to test the effectiveness of a stigma reduction intervention adapted for use with African American women. A total of 224 African American women will be recruited to participate in the study. Half of the women will be from Chicago, Illinois (112) and the other half will be from Birmingham, Alabama (112). A workshop will be held once a study site has recruited 28 women, half of the women will be in the intervention group (14) and the other half will be in the control group (14). Each study site will have 4 cohorts of 28 women. The main aims of the current study are: 1. to determine the long-term effectiveness of the intervention to reduce stigma for African American women living with HIV in Chicago Illinois and Birmingham, Alabama 2. to examine whether stigma reduction due to the intervention is associated with improved physical health biomarkers (CD4+ T cell count, viral load), mediated by reduced psychological symptoms (depressive symptoms), improved engagement to care, and improved medication adherence 3. to explore whether stigma reduction due to the intervention is moderated by location (Chicago vs. Birmingham), transmission risk factor, time since diagnosis, and perceived social support We expect that the multimedia workshop intervention will demonstrate effectiveness in reducing internalized stigma through an easily-disseminated method, and that it will have a positive impact on medication adherence and engagement in care for African American women living with HIV.

NCT ID: NCT01892358 Completed - HIV Clinical Trials

Preventing Bacterial and Viral Infections Among Injection Drug Users

Start date: September 2013
Phase: N/A
Study type: Interventional

We propose a randomized controlled trial (RCT) of the Skin intervention, compared to an assessment-only condition (both groups receive rapid HIV testing, a review of testing results, and brief HIV prevention counseling) among 350 injection drug users recruited during an acute medical hospitalization at Boston Medical Center. In the general hospital setting, injection drug users who otherwise might not seek care are accessible and teachable, and the presence of a drug-related illness can set the stage for patients to be more receptive to interventions2. We hypothesize that the Skin intervention will produce better outcomes at 1-, 3-, 6-, 9-, and 12-month(s) post-intervention.

NCT ID: NCT01889719 Completed - HIV Clinical Trials

A Phase I Study to Evaluate the Safety and Immunogenicity of Heterologous Boost Immunizations With MVA-CMDR

Start date: January 2014
Phase: Phase 1
Study type: Interventional

This trial will investigate whether immunizations with an MVA recombinant HIV vaccine are safe and whether they will boost immune responses generated by immunizations with a dendritic cell (DC) targeted protein vaccine, DCVax-001, plus poly ICLC in healthy HIV-uninfected volunteers.

NCT ID: NCT01886638 Completed - HIV Clinical Trials

Determining the Effect of Abacavir on Platelet Activation

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

HIV positive patients have a two fold increased risk of developing cardiovascular disease (such as heart attacks and strokes). Cardiovascular disease appears to be due in part to both HIV and the side effects from anti-HIV medications. Abacavir (an important component of current HIV treatment regimens) is one medication shown to be associated with an increase the risk of heart attacks in some studies. The mechanism by which abacavir does this is unknown. We hypothesise that abacavir is leading to heart disease by interacting with platelets, which then form blood clots within the arteries supplying the heart, the subsequent blockage of the artery causing a heart attack. This study aims to determine if abacavir increases the activity (or "stickiness") of platelets, and thus provide evidence as to how it may be promoting heart attacks. It will consist of 23 HIV positive men who currently have well controlled HIV. Participants will take abacavir for 15 days in addition to their usual anti-HIV medications. A blood sample to assess platelet activity will be taken at baseline, following the 15 days of therapy (i.e. at the time of maximal abacavir effect) and again after a 28 day washout period (to determine if any effects are reversible).

NCT ID: NCT01884389 Completed - HIV Clinical Trials

Randomized Trial of an HIV Navigation Program for Early Palliative Care

Start date: June 2013
Phase: Phase 2
Study type: Interventional

This study is testing a navigation program for early palliative care provided in tandem with HIV primary care for persons living with HIV (PLWH) who are at high risk or mortality and morbidity related to their co-morbid chronic conditions. Participants are enrolled for a period of 36 months, with data collection at enrollment and every 9 months after, for a total of 5 data collection time points. Study participants enrolled will be randomized into one of two groups: control or intervention. Control group participants will receive control calls in between survey data collection time points. Intervention group participants will participate in a Navigation Program which includes home visits and phone calls with an advanced practice nurse (APN) and licensed social worker (LSW), as well as visits / calls by a volunteer if desired. The frequency of visits / calls will be determined based on level of need (high, medium or low). The specific aims of the study are to: 1) identify needs and preferences for palliative care and advance care planning for PLWH, in order to tailor an existing Navigation Program for this study; 2) test the effectiveness of an HIV Navigation Program intervention on outcomes of quality of life, symptom burden, coping ability, and advance care planning; and 3) determine if effectiveness of the HIV Navigation Program intervention differs by age, gender, ethnicity, education, income level, and level of palliative care service need.

NCT ID: NCT01884233 Completed - HIV Clinical Trials

Cell Phone Technology Targeting ART Adherence and Drug Use

TXT-CBT
Start date: December 2012
Phase: N/A
Study type: Interventional

The objective of the current research is to improve treatment for injection opioid users by augmenting pharmacotherapy with an innovative text-messaging strategy to promote relapse prevention skills, reduce HIV-risk behaviors, and improve HIV treatment regimen adherence.

NCT ID: NCT01880489 Completed - HIV Clinical Trials

Multicomponent Intervention to Reduce Sexual Risk and Substance Use

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

The objective is to expand and refine an intervention for transgender women (TW) into a 7-session individual- and group-based intervention that is scalable for community settings to reduce sexual risk and substance use and to increase stigma-coping and risk-buffering behaviors among TW in NYC. The investigators will pilot test the intervention with 20 TW and subsequently, conduct a randomized controlled trial with 240 TW to compare the intervention to a wait list control condition.

NCT ID: NCT01878799 Completed - HIV Clinical Trials

Study of A Combination Pill With GS-7977 and GS-5885 for Hepatitis C in People With HIV

Start date: June 2013
Phase: Phase 2
Study type: Interventional

Background: - Present treatment for hepatitis C includes the use of a weekly injection and two different pills. This treatment is associated with serious side effects. Drugs that can be taken by mouth and cure HCV infection without serious side effects would be a great help to the large number of people infected with HCV. GS-7977 and GS-5885 are new medications being developed to treat the hepatitis C virus (HCV) infection. They are still being researched and are not approved by the Food and Drug Administration. They are being developed as treatment for hepatitis C as a single pill taken once a day. Objectives: - To determine whether a combination of the two study drugs can safely and effectively treat HCV infection in people with HIV infection and who do not have cirrhosis of the liver. Eligibility: - Individuals who have HIV infection and have liver disease caused by infection with HCV. Design: - Participants will be screened with a physical exam and medical history. Blood samples will be collected. Urine samples will be collected from participants who might become pregnant. If a participant has not had a liver biopsy in the past 3 years, one will be required. - Participants will take one pill daily for 12 weeks. This pill will be a combination of the two study drugs. - Treatment will be monitored with frequent clinic visits and blood tests over a total of 60 weeks.

NCT ID: NCT01878279 Completed - HIV Clinical Trials

HSV Oral Reactivation in Children

Start date: September 2008
Phase: N/A
Study type: Observational

In the proposed study, the investigators will carry out novel research to evaluate both symptomatic and asymptomatic daily oral herpes simplex virus (HSV) shedding rates and copy number in children with and without HIV. Study Objectives: 1. To evaluate the frequency of oral HSV reactivation in HIV-infected and uninfected children Secondary Objectives: 2. To determine the acceptability of performing daily oral swabs in children age 3-12

NCT ID: NCT01876966 Completed - HIV Clinical Trials

Interaction Between Etravirine or Darunavir/Ritonavir and Artemether / Lumefantrine

DDI Coartem
Start date: March 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the pharmacokinetic interaction between etravirine and artemether/lumefantrine and darunavir/ritonavir and artemether/lumefantrine in healthy Human Immunodeficiency Virus- (HIV-)negative patients. 'Pharmacokinetic interaction' means that one medication can influence the absorption and elimination from the body of the other medication.