View clinical trials related to HIV.
Filter by:The primary objective of this study is to evaluate the efficacy of tenofovir alafenamide (TAF) versus placebo, each administered with the existing, failing antiretroviral (ARV) regimen. There are 2 parts to this study: Part 1 and Part 2. Part 1 consists of 2 cohorts, starting with a sentinel cohort, in which participants will be enrolled to receive open-label TAF in addition to their current failing ARV regimen. This cohort will then be followed by a randomized, double-blind, cohort to compare the addition of TAF or placebo in HIV-1 positive adults who are failing their current ARV regimen. In Part 2, all participants who complete Part 1 of the study will discontinue their failing ARV regimen and TAF or placebo for a 14-day washout period. Following the washout period, all participants who received TAF in Part 1 and have a > 0.5 log10 decline in HIV-1 RNA will receive elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen (STR) plus atazanavir (ATV) once daily for 48 weeks. Participants who received TAF who have a ≤ 0.5 log10 decline in HIV-1 RNA will be discontinued from the study and will not be eligible to continue into Part 2 of the study. All participants who received placebo in Part 1 will be eligible to participate in Part 2 regardless of their viral load change. After completion of Part 2, all participants will be eligible to continue to receive E/C/F/TAF plus ATV in the extension phase until E/C/F/TAF becomes commercially available, or until Gilead Sciences terminates development of E/C/F/TAF in the applicable country.
The BCPP study is designed to test the hypothesis that implementing an enhanced combination prevention package which includes provision of ART to all participants, regardless of CD4 count or HIV disease severity, will impact the HIV/AIDS epidemic by significantly reducing population-level, cumulative HIV incidence in a defined geographic area over a period of 3 years and will be cost-effective.
Implementing a mobile-phone based system for drug use disorders in primary care settings.
The goal of this study is to determine if n-acetylcysteine, given as PharmaNAC, reduces oxidative stress and improves vascular function in HIV-infected older adults already on HIV treatment.
The importance of good nutrition and food security among people living with HIV infection (PLHIV) is widely recognized. In resource-constrained settings, food insecurity is increasingly recognized as an important barrier to retention in care and adherence to antiretroviral therapy (ART). However, there are few studies demonstrating that food and nutrition assistance programs can improve HIV-related outcomes. This study will address this gap by comparing the effectiveness of three models for short-term support for PLHIV. Food insecure women and men on ART will be randomized into one of three groups: 1) nutrition assessment and counseling (NAC) alone, 2) NAC plus food assistance, or 3) NAC plus cash transfers. The investigators will compare the effect of the three approaches on ART adherence and retention in care after 6, 12, and 24-36 months of follow-up. The investigators hypothesize that NAC plus short-term support in the form of food or cash assistance will result in better adherence to ART and retention in care than NAC alone, and that the effects of NAC plus food assistance will be the same as NAC plus cash assistance. The results from the study will provide evidence about which assistance modalities for PLHIV work best to improve ART adherence and retention in care, and under what conditions. This study will be conducted in Shinyanga Region, Tanzania, where approximately 17 percent of households have poor or borderline food consumption and 7.4 percent of people are living with HIV infection.
The protocol, approved by the Medical Research Council, was issued to assess the safety and efficacy of the non-surgical device for applying it to the national scale up of adult male circumcision in Zimbabwe
Validate a promising community survey methodology for evaluating the Prevention of Mother to Child Transmission (PMTCT) program effectiveness against a "gold standard" cohort design and to identify individual- and facility-level characteristics associated with HIV-free survival among HIV-exposed infants.
Despite advances in antiretroviral treatment (ART) over the past 10 years, the incidence of HIV in the United States remains stagnant with over 50,000 new cases annually. HIV-infected individuals inconsistently engaged with care are less likely to receive ART which is associated with correspondingly adverse clinical outcomes in the long term and increased risk of transmission. Mobile health (mHealth) strategies including cell phone and text messaging have shown success in the developing world for medication adherence, yet mHealth interventions have not been developed to improve retention in HIV care. This strategy needs to be tested to demonstrate feasibility, acceptability and preliminary effectiveness in supporting HIV treatment adherence in Rhode Island. The Miriam Hospital Immunology Center is an urban HIV-clinic that provides comprehensive primary and specialty care for over 1400 HIV-infected patients. It is the largest HIV clinic in Rhode Island with patients also referred from eastern Connecticut and southern Massachusetts. In 2010, there were 165 new patients in clinic, 70 of whom were diagnosed within 1 year of entering care. In this environment, we propose a pilot study with the following specific aims: Specific Aim 1: To pilot a bidirectional mHealth intervention among individuals at high risk of loss to follow-up, including those with a recent HIV diagnosis or those re-engaging in HIV care. HIV-infected persons (n=30) with a recent diagnosis or re-engaging in care at the Immunology Center at TMH will be recruited to participate in a bidirectional mHealth intervention that delivers automated, regularly scheduled appointment and medication adherence reminders in an individualized format, and also allows individuals to request motivational enhancement and problem-solving support to address barriers to care. Specific Aim 2: To assess the impact and acceptability of the pilot intervention through qualitative interviews. All participants will also be invited to complete individual in-depth interviews which will assess acceptability and effectiveness of the pilot mHealth intervention, such as content and frequency of automatic messages, for retention and medication adherence for HIV-infected individuals in RI. The results of this study will provide preliminary data to inform an R21 or R34 application to determine efficacy of an mHealth intervention among HIV-infected persons at high-risk for loss to follow-up.
Short courses of drugs can be given to HIV-infected pregnant women to reduce the chance of HIV infection being passed to her child either during pregnancy or during the labour process. However, children can also become infected by drinking the mother's breastmilk which contains the HIV virus. In many poor, developing countries in Africa, breastfeeding is the normal way of infant feeding and is vitally important because of the protection it gives to children from other diseases such as diarrhoea and malnutrition. Ideally there would be a way to make breastfeeding safer from HIV transmission without losing its other advantages. A medical study recently suggested that HIV-infected women who exclusively breastfed their children i.e. gave breastmilk but without any water, tea, formula milk or any solid foods did not pass on the virus to their children to the same degree as women who MBF with these other fluids and foods. It is important to confirm whether this observation is in fact true or not. We hypothesize that exclusive breastfeeding by HIV-infected mothers carries a lower risk of HIV transmission than mixed breastfeeding. We propose to follow 2,100 HIV-infected pregnant women and also some HIV-uninfected women from the time that they book at the clinic until 24 months of age. HIV-infected women who say they intend to breastfeed and all the HIV-uninfected women will be visited at their homes by breastfeeding counsellors both before and after delivery to support exclusive breastfeeding. HIV-infected women who choose not to breastfeed will be helped by clinic staff to safely replace all breastmilk with some other milk. An independent team will visit all mothers at their homes and collect information about the way they feed their children. Blood samples will be collected from the children at different times by a simple heel prick and the blood stored on a piece of filter paper. By testing these samples and comparing with the type of feeding at that time, we will be able to see when a child becomes infected and whether exclusive breastfeeding gives any protection.
In the resource-limited settings where most HIV-infected children live, neither the most effective strategies to inform children of their HIV status, nor the impact of disclosure is well understood. This team's long-term goal is to provide evidence to improve the chronic disease management of HIV-infected children in resource-limited settings. The purpose of this study is to assess the effect of a patient-centered intervention guiding disclosure to HIV-infected Kenyan children using a randomized trial comparing the intervention to routine care. The primary endpoint will be probability of disclosure among children, with secondary endpoints of adherence, clinical outcomes, psychological distress and social outcomes. This work will be done within the Academic Model Providing Access to Healthcare (AMPATH) which currently cares for almost 120,000 adult and pediatric HIV-infected patients in 25 clinics in Kenya. We will utilize the excellent infrastructure of this academic partnership to provide the first comprehensive assessment of the physical, psychological, and social impact of disclosure for HIV-infected children in East Africa. We will evaluate the impact of an intensive disclosure intervention by pursuing these specific aims: Aim 1: Expand and modify an existing pediatric HIV disclosure intervention used in Kenya to include patient-centered components; Aim 2: Perform a randomized trial to compare the impact of clinic implementation of the culturally adapted, pediatric disclosure intervention on the prevalence of disclosure and on the medical, psychological, and social outcomes for HIV-infected Kenyan children ages 10-15 years compared to children exposed to standard clinical care. The usual care control arm will have disclosure training for all clinicians, disclosure chart materials, and an existing protocol to implement disclosure for patients over 10 years. The disclosure intervention will consist of patient-centered materials to guide disclosure, including videotaped narratives; disclosure counselors; post-disclosure child support groups; and the usual care resources. The central hypothesis is that an intensive disclosure intervention based on culture-specific qualitative work and a patient-centered approach will allow for disclosure in which more children know their HIV status at younger ages, and they also have improved medication adherence, improved medical outcomes, unimpaired psychological outcomes, and no increase in experienced stigma over time.