View clinical trials related to HIV.
Filter by:In cigarette smokers that are HIV+, one of the most common HIV-associated non-AIDS conditions is the accelerated development of chronic obstructive pulmonary disease (COPD), a disorder associated with significant morbidity and mortality. Based on the knowledge that COPD in smokers starts in the small airway epithelium, this study is focused on examining the hypothesis that the accelerated development of COPD associated with HIV infection results, in part, from an interaction of HIV directly on the small airway epithelium or through infection of cellular components of the immune system, with mediators released by these immune cells evoking premature biologic aging of the small airway epithelium. By identifying the early events in the pathogenesis of the HIV-associated accelerated COPD in smokers, we aim to identify biologic targets to which pharmacologic therapies could be addressed.
The goal of the ACCLAIM (Advancing Community-Level Action for Improving MCH/PMTCT) project is to increase community demand for, uptake of, and retention in Maternal and Child Health (MCH) and/Prevention of Mother-to-child transmission of HIV (PMTCT) services to improve country progress toward elimination of pediatric HIV/AIDS.
Alcohol use among persons with HIV exacerbates health problems and accelerates HIV disease progression. Antiretroviral therapy (ART) is the single most important treatment for people living with HIV. However, ART adherence is suboptimal among adolescents and young adults living with HIV, the age group with the fastest growing rates of HIV infection, and great risk of engaging in risky behaviors such as alcohol use. The proposed study will compare the effectiveness of home-based versus clinic-based "Healthy Choices", a brief, 4- session intervention using Motivational Enhancement Therapy (MET) to address alcohol use, medication adherence, and health outcomes in youth living with HIV (YLH) using a repeated measures design. Unlike previous trials, Healthy Choices will be tested in a "real world" clinical setting and be delivered by community health workers (CHW: already members of the HIV care team). The study population will consist of YLH, ages 16-24, who are current patients at 5 ATN sites. Site staff will recruit potential participants. Youth will be randomized to receive Healthy Choices, either clinic-based or home-based delivered by the same CHW in both conditions. Outcomes are measured at baseline, 4-, 7-, and 13-months. Data collection for biological measures will be through medical record extraction, and self-reported measures will occur using a brief Web-based CASI (computer-administered self-interviewing) survey on an iPad. All intervention sessions will be audio-recorded for MITI fidelity coding, and investigators will support local supervisors during the active intervention phase. We will conduct qualitative interviews with CHWs, supervisors and organization leaders at the end of the trial to obtain information about barriers and facilitators of implementation. Thus, the proposed trial will allow us to use a Type 1 Effectiveness-implementation hybrid design to pilot a sustainable model of MI implementation in real-world youth care settings towards the goals of 1) examining the effectiveness, cost-effectiveness, and scalability of an efficacious behavioral intervention when delivered by CHWs in real-world adolescent HIV care settings; 2) gathering information about who responds under what contexts; and 3) increasing our understanding of the barriers and facilitators for future implementation. The primary hypothesis is that YLH receiving home-based MET will have greater improvements in alcohol use and viral load than YLH receiving clinic-based MET.
This is a two-site, three-arm, open-label, pilot randomized controlled trial of bone anti-resorptive therapy during ART initiation in HIV-infected adults. Thirty (30) treatment-naïve HIV-infected adults initiating eligible first-line ART regimens will be randomized in a 1:1:1 fashion to one of the following three arms: 1. no bone anti-resorptive therapy (standard of care) 2. concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D; 3. a 24 week delay in initiation of a 24 week course of alendronate/vitamin D Assessments (including clinical evaluation, questionnaires, adherence, basic laboratory evaluation, and BMD measurement) will be performed at baseline, 24 and 48 weeks. The primary objective will involve calculation of σ and ρ using all data; δ will be estimated by comparing the two alendronate arms pooled to the no-treatment arm.
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.
In this proposed study with People Living with HIV/AIDS (PLWHA), we will use a stepped care model called a Sequential Multiple Assignment Randomized Trial (SMART) to examine the efficacy of low- and high-intensity smoking cessation treatments for nicotine dependent PLWHA that incorporate the current standard of care and prize-based contingency management. Intervention will be administered in a community-based HIV integrated care clinic in downtown Detroit, which has the highest prevalence rates of HIV/AIDS and smoking in Michigan. Phase 1 will last 4 weeks, and will involve brief intervention to help participants stop smoking. For phase 2, participants will be assigned to different study arms depending on whether they are Responders (reduced their smoking) or Non-responders (continued to smoke). 1. Phase 1: We hypothesize that brief high-magnitude prize contingency management will result in greater reduction in smoking than standard of care alone. 2. Phase 2a: We hypothesize that non-responders who are assigned to contingency management will be more likely to reduce their smoking throughout treatment and to abstain from smoking at all follow-up points. 3. Phase 2b: We hypothesize that responders who are assigned to monitoring and low-magnitude prize contingency management will be more likely to maintain their reduced or abstinent smoking status at all follow-up time-points.
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.