View clinical trials related to HIV Prevention.
Filter by:Despite all prevention efforts, many people in Australia continue to be infected with HIV. The Seventh National HIV Strategy 2014-2017 in Australia aims to work towards the elimination of HIV transmission by the year 2020. This project will evaluate a new additional way to lower people's chances of getting HIV. It will provide pre-exposure prophylaxis (PrEP) to people who are at high risk for HIV and evaluate what impact this new prevention approach will have on HIV in WA at the community level. The drug used in PREPIT-WA is called generic TDF/FTC (made by Mylan Laboratories Ltd.). The generic TDF/FTC is a single tablet made up of two HIV medications: tenofovir disoproxil fumarate and emtricitabine (a combination known as TDF/FTC). TDF and FTC have been widely used for many years to treat HIV. When used with other medicines in people who already have HIV, TDF/FTC reduces the amount of HIV virus in the blood. TDF/FTC does not cure HIV or AIDS, and it is not an HIV vaccine. As a treatment for people who already have HIV, TDF/FTC is approved for use in most of the world, including Australia. As a medicine for PrEP, to lower chances of HIV in those who are not infected, TDF/FTC has been approved in the US, and Truvada® (which contains TDF/FTC made by Gilead Sciences Inc.) was approved for PrEP in Australia in May 2016. At the start of the project, the generic TDF/FTC is not approved in Australia for the use as PrEP but it may become registered for use and more freely available in Australia in the future.
The investigators aim to pilot-test a novel social and structural-level HIV intervention for YMSM and YTW of color ages 16-24.
Pre-exposure prophylaxis, or PrEP, is a relatively new HIV prevention method where individuals who are at risk for HIV but do not currently have it take a daily pill (Truvada). PrEP has been proven medically effective and could help to reduce the rate of new HIV incidence in the United States, but in five large, randomized and controlled studies, many prospective PrEP patients chose not to take PrEP, and those that did often did not adhere to it consistently. How do we increase PrEP uptake and adherence amongst those most at risk for HIV? Also, will taking PrEP increase or decrease high-risk individual sexual behavior and HIV incidence? Here, the investigators propose a parallel group randomized, controlled clinical trial to test the effectiveness of a behavioral intervention designed to buffer individuals against stigma-related feelings, and to increase their connection to their selves twenty years in the future. The primary objective of the study is to increase PrEP adherence, as measured by the concentration of tenofovir diphosphate (TFV-DP) in dried blood spot samples (DBS). The secondary objectives are to decrease the incidence of STIs and increase safe sexual practices, as measured by clinic diagnoses and self-reported practices at 3, 6, 9 and 12 months. This 12-month outpatient study will take place at four PrEP clinics in Pittsburgh and will enroll 170 subjects across 4 sites, with an expectation of retaining 80%, or 135 subjects. Eligibility includes male and female adults, ages 18-65, who are at risk of contracting HIV. Efforts will be made to recruit 33% of subjects from each of the following strata: 1) young, minority LGBT adults age 18-30 years of age; 2) Caucasian adults (MSM and heterosexual females) age 18-65 years of age; and 3) IDU adults, age 18-65, of any ethnic background.
Human immunodeficiency virus (HIV) persists worldwide as an immense health burden among vulnerable populations. HIV pre-exposure prophylaxis (PrEP) has offered the promise of limiting the global burden of HIV. The objective of this proposal is to conduct a pharmacokinetic (PK) study in transgender women to describe the pharmacokinetics of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as PrEP within this population.
Participants will have a 28-day pre-ring baseline assessment period (Stage 1) followed by randomization to order with 5 participants per study arm. All participants will sequentially receive both study products for 28-days with at least a 2-week washout period between products. Arm 1 will receive the TDF-FTC pod-IVR for Stage 2 followed by the placebo pod-IVR during Stage 3. Arm 2 will receive the placebo pod-IVR for Stage 2 followed by the TDF-FTC pod-IVR during Stage 3. During Stages 2 & 3 participants will also complete brief phone surveys (<3 min), computer-assisted self-interviews (CASIs), and in-depth interviews (IDIs) regarding perceptibility and acceptability. If willing, participants' male sexual partners will be invited to complete IDIs as well.
Subjects preliminarily eligible who choose to receive PrEP will be included after obtaining the informed consent and confirmation of eligibility within 45 days after the screening visit. Once included, participants will be examined in a follow-up visit performed four weeks later and evaluated for evidence of seroconversion to HIV, medication compliance and clinical toxicity. The second follow-up visit will occur at 12th week and every 12 weeks successively (quarterly). Quarterly visits include HIV testing, serum creatinine and counseling on medication compliance and risk reduction. The study has a total of 6 visits plus 2 extra visits for those participants enrolled in the PK study. In all visits will be assessed the risks, HIV testing will be performed, monitoring of renal function and dispensing of the drug Truvada [emtricitabine 1 tablet (FTC) / tenofovir (TDF) (200/300 mg) once a day orally for 12 months]. Participants who have completed 48 weeks of follow-up or prematurely discontinue a PrEP will be encouraged to return for a follow-up visit after discontinuation of medication for monitoring of the status and evaluation of HIV as the resolution of side effects.
The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of E-PrEP on reaching young men of color who have sex with men (YMCSM) at high-risk of HIV infection to reduce HIV acquisition. E-PrEP is a peer-designed social media-based health intervention to increase PrEP awareness, knowledge, and motivation as a tool for HIV prevention and to increase linkage to primary care.
Women who choose to conceive with an infected or unknown serostatus partner in HIV-endemic settings need prevention strategies to reduce periconception HIV acquisition risk. Women at high risk for acquiring HIV during pregnancy need risk reduction strategies to protect themselves and their babies. Evaluating uptake of and adherence to antiretrovirals as pre-exposure prophylaxis in this population is crucial to understanding whether and how this novel prevention strategy should be incorporated into HIV-risk reduction packages for at- risk women planning or with pregnancy.
This study seeks primarily to test, in a two-arm randomized controlled trial (RCT), the efficacy of Project IMPACT, an intervention that integrates Behavioral Activation (BA) with HIV risk reduction (RR) counseling for HIV-uninfected men who have sex with men (MSM) with stimulant use disorder at risk for HIV via sexual behavior. HIV-uninfected MSM with a diagnosis of stimulant use disorder will be equally randomized to one of two study arms: (1) the Project IMPACT intervention, BA-RR counseling, which lasts ten sessions; and (2) the standard of care (SOC) comparison condition, including two equivalent sexual risk-reduction counseling sessions. Participants will be followed for one year post-randomization, with assessments at months four, eight, and 12.
The Project WERK intervention is a brief, theory based and culturally sensitive intervention designed to capitalize on organic yet underutilized social support networks in the lives of young black men who have sex with men (YBMSM). The intervention has been developed with input from clients and their support network members, case managers, social workers, primary care providers. The goal of the intervention is to improve retention in PrEP care for young Black MSM.