View clinical trials related to HIV.
Filter by:The purpose of the study is to look at the levels of three HIV medications: tenofovir, emtricitabine, and rilpivirine in blood after the drug intake has been stopped in order to understand how long these drugs persist in the blood. The study will specifically look at blood levels of these three drugs (taken as a 3-in-1 tablet) after taking them every day for 14 days. The duration of the subjects involvement in the study will be up to 23 days plus a screening visit which will take place up to 4 weeks prior to the start of the study, and a follow up visit which takes place 16-22 days after the last dose of study medication. This study is not randomised which means that all participants will receive all study medications in the same order. The participant and the study doctor will know which study medications you are taking at all times during the study.
The overall goal of this project is to implement and evaluate a community-level, structured approach to enhance HIV care access and retention for drug users in San Juan, Puerto Rico. The "Enhanced HIV Care Access and Retention Intervention" will: 1) identify drug users living with HIV who either do not know their HIV status and/or are not engaged in HIV care; 2) provide direct HIV care services through a mobile health van; and 3) support identified HIV-infected drug users with patient navigators to enhance their ability to engage in HIV care and substance abuse treatment, to initiate antiretroviral therapy, and maintain adherence to their treatment regimens. The structural enhanced care approach will be evaluated through a randomized roll-out design, a refinement of the stepped-wedge design. The community-level success of the intervention will be assessed by evaluating virologic suppression (primary biological outcome), increased attendance to HIV care visits, uptake of antiretroviral therapy, adherence to HIV treatment regimens, and decreased substance use (as secondary behavioral outcomes) in an independent cohort of HIV-positive individuals drawn from each of the neighborhoods included in the intervention. The investigators will also evaluate the implementation process and cost of the enhanced care approach including implications for cost-effectiveness, feasibility of expansion, and sustainability.
Substance abuse is highly prevalent among individuals with HIV and associated with negative outcomes including poorer medication adherence and HIV risk behavior. The primary aim of this project is to address substance abuse among individuals with or at high-risk for HIV by enhancing and expanding the substance abuse services provided in the formerly Substance Abuse and Mental Health Services Administration (SAMHSA) funded Carolinas Alcohol and Drug Expansion Team (CADET) program, which offered comprehensive substance abuse care for individuals with HIV living primarily in the Durham NC area. Services will be enhanced by adding peer outreach and navigation services to improve treatment engagement and participation and expanded to replicate the enhanced CADET service model in Charlotte NC. The target population for this project is minority individuals, primarily African-Americans, with HIV or at high-risk for HIV with a particular focus on minority men who have sex with men (MSM)s. The program will provide up to 18 months of comprehensive services for approximately 315 individuals and will include: 1) peer outreach to facilitate and enhance treatment engagement 2) individual and group substance abuse treatment using evidence-based models 3) ongoing recovery groups for individuals who have completed the intensive substance abuse treatment phase and 4) linkage to needed services such as case management, psychiatric care, and HIV/Hepatitis medical care. We will also target HIV and Hepatitis C testing and treatment services for minority MSM of unknown HIV status to increase access and utilization of substance use services and identify HIV and Hepatitis status. The study evaluation will involve analysis of participant survey data gathered at baseline, 6, 12, 18 months of study participation to determine the effect of the comprehensive substance abuse care services on outcomes for individuals with HIV including substance use, mental health, HIV treatment adherence, HIV risk behavior, and access and utilization of HIV services. The study will also determine the effect of the comprehensive substance use program on substance abuse, mental health, and risk behavior outcomes for minority MSM who are not HIV-positive.
The use of hormone contraception poses a significant challenge for the estimated 16 million HIV-infected women of childbearing age. This is due to known drug interactions with antiretroviral therapy (medicines used to treat HIV) that may jeopardize contraception effectiveness. By evaluating the impact of antiretroviral therapy on a levonorgestrel subdermal implant, the most widely available hormone implant in low and middle-income countries, this study will translate its findings into an evidence-based approach to co-manage these important medications. The investigators hypothesize that women receiving nevirapine or efavirenz-based antiretroviral therapy will have a significant decrease in the mean levonorgestrel plasma concentration measured six months after the implant's insertion as compared to those women who are not taking antiretroviral therapy. Although the implant's efficacy may be retained initially, the investigators propose that a decrease in levonorgestrel concentrations in women receiving antiretroviral therapy may jeopardize the implant's effectiveness near the end of its intended duration of use (5 years).
The specific aim of the study is to assess antiretroviral therapy adherence and evaluate the impact of a situated treatment adherence intervention program among persons living with HIV/AIDS on antiretroviral therapy in Estonia.
This is an open label, dual cohort study evaluating safety, tolerability and immunogenicity of redirected CD4+ T cells in HIV subjects.
The proposed study addresses a significant public health threat of Human immunodeficiency virus (HIV) and sexually transmitted infections (STIs) among drug involved women on probation, parole or other community supervision. This randomized controlled trial aims to test the efficacy of a multimedia version of a 4-session, gender-specific, integrated drug use and HIV/STI prevention intervention (Multimedia Women On the Road To Health (WORTH)) in increasing condom use and decreasing the incidence of sexually transmitted infections (STIs) among 420 drug-involved, female offenders in a large community court setting in New York City, compared to a non-media version of the same intervention (Traditional WORTH) and to a 4-session Wellness Promotion condition.
The purpose of this study is to investigate the impacts of home-based couple HIV-testing and counseling and male partner education on partner HIV testing and other critical maternal and infant health outcomes during pregnancy and the postpartum period. Additionally, the study seeks to assess the cost-effectiveness of this approach. Involvement of men during the antenatal and postpartum period, including HIV testing of male partners, can have substantial benefits for women and infants. In observational studies, male participation in antenatal care has been associated with increased uptake of prevention of mother-to-child transmission (PMTCT) interventions, and more recently, a study in Kenya found a significant HIV-free survival benefit for children of HIV-infected women whose male partners attended antenatal care where couple HIV testing was offered. In this study only 31% of ~450 men invited for counseling and testing came to clinic, highlighting the challenges faced across sub-Saharan Africa when trying to access male partners of pregnant women. In areas of high HIV-1 prevalence, high levels of male involvement may be readily achievable because home-based counseling and testing is highly acceptable and the benefits of male participation and HIV testing extend to HIV-uninfected pregnant and postpartum women and infants. Reaching out to men during pregnancy may reduce incident HIV infection and vertical transmission among these women, but efforts to engage men in antenatal care in Western Kenya have thus far achieved limited success. This intervention may achieve gains beyond prevention of maternal and infant HIV-1 acquisition through identification of HIV-infected men who would otherwise not learn their status or delay treatment, and by improving child health through targeted education of male partners. When administered in a home-based setting simple, established interventions such as the promotion of exclusive breastfeeding have been shown to be associated with significant reductions in child mortality. Home-based approaches also lend themselves to integration with targeted interventions such as promotion of HIV testing among male partners of at-risk pregnant women. Furthermore, a successful HIV testing program for male partners of pregnant women has potential to reach a large number of men who may be unaware of their HIV status or who are HIV-infected but not in care, providing linkages to treatment clinics and promoting prevention interventions, such as safe sex and voluntary male circumcision for those who are uninfected. In this randomized clinical trial up to 600 couples (300 in each treatment arm) will be randomized to standard antenatal care or home-based partner education and HIV testing (HOPE) as part of routine pregnancy services. Women will be enrolled at the antenatal clinic in Kisumu District Hospital, Kisumu, Kenya. Couples in the control group will receive the HOPE Intervention, featuring home-based couple counseling and HIV testing as well as key educational messages concerning HIV prevention behaviors, facility delivery, exclusive breastfeeding, and post-partum family planning. Women in the control arm will be invited to bring their male partners to the antenatal clinic for voluntary clinic testing and counseling. Women will be followed up at clinic visits 6-weeks and 14-weeks postpartum and again with their male partner 6-months post-partum. These follow-up visits will include questionnaires to measure uptake of HIV testing, facility delivery, exclusive breastfeeding and postpartum contraceptive use as well as linkage to HIV care. Cost-effectiveness of the intervention will also be evaluated in order to inform future scale-up. First, the investigators hypothesize that successful implementation of HOPE will result in higher uptake of male partner HIV testing, couple testing and disclosure of HIV status. The investigators also hypothesize that there will be benefits to HIV-infected and HIV-uninfected women and their children who will have improved uptake of interventions to improve maternal and child health. Specifically, the investigators anticipate higher levels of facility delivery, optimal breastfeeding practices, and post-partum contraceptive use, as well as increased uptake of antiretroviral treatment for HIV+ women in the intervention arm, relative to the control arm. Second, the investigators hypothesize that greater than 85% of HIV-1-infected men identified through home-based partner education and testing (HOPE) will access care and treatment services, and, overall, more women in the HOPE arm will know their partners' status at each time point and more partners will be in care and treatment. Third, the investigators predict that uptake of counseling and testing and HIV prevalence among male partners and family members will be high enough to make this approach cost-effective from both payer and societal perspectives.
This study seeks to address the question of whether antacids or multivitamins influence the pharmacokinetics of raltegravir when co-administered. The aim of this study is to optimise the dosing of raltegravir when co-administered with antacids or multivitamins.
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatment-naive adults.