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HIV Infections clinical trials

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NCT ID: NCT03824067 Enrolling by invitation - HIV/AIDS Clinical Trials

Impact of Point-of-Care EID for HIV-Exposed Infants

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

This mixed methods study will utilize a randomized step-wedge design to assess the impact of point-of-care (POC) versus conventional early infant diagnosis (EID) on key outcomes including timely return of results to caregivers and time to initiation on treatment for HIV-infected infants. Data will be collected through longitudinal clinical follow-up and medical chart extraction of routine records and lab forms. Feasibility and acceptability data will be collected through interviews with mothers/caregivers of HIV-exposed infants, and community focus groups.

NCT ID: NCT03681912 Enrolling by invitation - HIV Infections Clinical Trials

Tailored Motivational Interviewing Implementation-Effectiveness Trial in Multidisciplinary Adolescent HIV Care Settings

Start date: August 28, 2017
Study type: Observational

The goal of this study is to test a multi-faceted Tailored Motivational Interviewing Implementation intervention (TMI), based on the Dynamic Adaptation Process (DAP) to scale up an Evidence-based Practice (EBP) in multidisciplinary adolescent HIV care settings while balancing flexibility and fidelity. A mixed-methods design will be used, in which the dominant method is quantitative (a dynamic wait-listed design; DWLD) to determine the impact of TMI on the integration of MI with fidelity in 11 adolescent HIV clinics with an average of 15 providers and 100 patients each.

NCT ID: NCT03414411 Enrolling by invitation - HIV Infections Clinical Trials

Boston Alcohol Research Collaboration on HIV/AIDS (ARCH) Cohort: The 4F Study

Start date: February 20, 2018
Study type: Observational

The purpose of this study is to follow a cohort of HIV-infected adults who have alcohol and/or drug use to: 1) test the associations between alcohol (and illicit drugs and polypharmacy (multiple prescribed medications)) and falls (fractures secondarily), and whether frailty mediates these associations; and 2) test the associations between alcohol (and illicit drugs and polypharmacy) and utilization (emergency department use and hospitalization for falls and fractures), and whether frailty mediates them. To achieve the stated aims the investigators will expand (to 400) and continue to follow an existing prospective cohort (The Boston ARCH Cohort) of adults with HIV infection and a high prevalence of exposure to alcohol, other drugs, and polypharmacy. The Boston ARCH Cohort is a longitudinal cohort (1-3.5 years of follow-up) of 250 HIV-infected men and women with current substance dependence or ever injection drug use that have a spectrum of alcohol use.

NCT ID: NCT03388398 Enrolling by invitation - HIV Infections Clinical Trials

Evaluation of the Population-level Impact of PMTCT Option B+ in Zimbabwe

Start date: January 2012
Study type: Observational

This study evaluates the impact of Zimbabwe's program for the prevention of mother-to-child HIV transmission (PMTCT) on vertical transmission of HIV infection and HIV-free survival among infants exposed to HIV. The study will test the hypothesis that the accelerated PMTCT program in Zimbabwe will result in fewer new HIV infections in infants and will increase infant survival.

NCT ID: NCT03369249 Enrolling by invitation - HIV Infections Clinical Trials

Health and Justice: A Continuum of Care for HIV and SU for Justice-Involved Young Adults (PHASE 2)

Start date: December 9, 2017
Phase: N/A
Study type: Interventional

This research study proposes to embed HIV testing outreach workers from a young adult focused medical and HIV treatment program into an alternative sentencing program to deliver a new service delivery model (Link2CARE) that integrates evidence-based protocols for justice-involved young adults to: a) promote HIV and STI testing, and HIV and SU risk screening, b) provide onsite intervention, and c) cross-system linkage to HIV, STI, and SU care. Phase 1 has already been completed. In phase 1, the intervention components were adapted for use among justice involved young adults and the resulting protocols were piloted with justice involved young adults, finalizing the resulting 4-session Link2CARE intervention. In phase 2, we will test Link2CARE among N=450 justice-involved young adults enrolled at the alternative sentencing program and conduct process evaluations with N=15 alternative sentencing program staff.

NCT ID: NCT03275571 Enrolling by invitation - HIV Infections Clinical Trials

HIV, Computerized Depression Therapy & Cognition

Start date: September 6, 2017
Phase: N/A
Study type: Interventional

Among people with HIV, the severity of depressive symptoms has repeatedly been associated with the presence of self-reported cognitive difficulties, even in the absence of impairment on neuropsychological testing. There is uncertainty about the clinical importance of these self-reports, especially when neuropsychological testing is normal. However, there is growing evidence that these self-reports are clinically important. For example, among patients with major depressive disorder (MDD), evidence suggests that functional impairments is mediated by self-reported cognitive dysfunction, rather than objective cognitive dysfunction. Treatment of depression with Cognitive-Behaviour Therapy (CBT) has been shown to improve depressive symptoms and psychosocial functioning in patients with recurrent major depressive disorder, but there are few studies of the impact of psychotherapy on self-reported cognition and cognitive performance. Good Days Ahead (GDA) is a computerized treatment program developed to address symptoms of depression and anxiety. It teaches the basic principles of computerized behavioral therapy (CBT) in nine therapy sessions, each typically taking 30 minutes to complete. GDA has been found to be as effective as face-to-face CBT in decreasing symptoms of depression and anxiety. The hypothesis is that people whose depressive symptoms are reduced following treatment with cCBT will also report fewer cognitive difficulties than before treatment. A second hypothesis is that changes in self-reported cognition will be concordant with changes in cognitive performance, such that people who make no improvement in self-report cognition will also show no improvement in cognitive performance and those who do improve on self-report will improve on cognitive performance.

NCT ID: NCT03157258 Enrolling by invitation - HIV/AIDS Clinical Trials

Social Network Intervention to Engage Community PLH to Engage in HIV Medical Care

Start date: June 8, 2017
Phase: N/A
Study type: Interventional

People living with HIV infection (PLH) are clustered in friendship groups with other HIV+ persons, and an intervention delivered to all members of PLH social networks allows HIV+ people who are friends in day-to-day life to provide one another with support for entering, remaining, and adhering to HIV medical care. Moreover, an intervention delivered to groups attended by HIV+ persons who are friends increases HIV medical care engagement and decreases problem drinking more than individual counseling, probably because the network intervention harnessed mutual peer social support among friends who share the same HIV status, face similar coping issues, and interact together in day-to-day life. The planned research will be conducted in two phases in St. Petersburg, Russia.

NCT ID: NCT03072758 Enrolling by invitation - HIV Infections Clinical Trials

Men's Club: Impact of Male Partner Involvement on Initiation and Sustainment of Exclusive Breastfeeding Among Postpartum Women

Start date: March 30, 2017
Phase: N/A
Study type: Interventional

Breastfeeding remains the optimal mode of feeding for infants younger than six months. Exclusive Breast Feeding (EBF) among HIV-infected mothers has been shown to be associated with a sustained and significant reduction in HIV transmission and has the potential to reduce infant and under-five mortality. Given the considerable authority among men as decision makers in sub-Saharan African, we may be witnessing a missed opportunity to engage men in the education, awareness, and decision-making for EBF. Understanding the role and impact of male partners on this decision-making process require further examination to inform the development of effective and sustainable evidence-based interventions to support the initiation and sustainment of EBF.

NCT ID: NCT02990858 Enrolling by invitation - Hiv Clinical Trials

An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study

Start date: October 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This is an extension study, to provide continued access to PRO 140 to subjects who complete participation in PRO140_CD02 and continue to receive clinical benefit and would require PRO 140 to form a viable regimen, in the opinion of the treating physician. The patient population for this trial are treatment-experienced HIV infected patients with CCR5-tropic virus who demonstrate evidence of HIV-1 suppression after successfully completed 24 weeks of treatment in the PRO140_CD02 study.

NCT ID: NCT02960581 Enrolling by invitation - HIV Infection Clinical Trials

A Clinical Trial of the Safety, Pharmacokinetics and Antiviral Activity of PGT121 Monoclonal Antibody (mAb) in HIV-uninfected and HIV-infected Adults

Start date: November 2016
Phase: Phase 1
Study type: Interventional

This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral efficacy of the PGT121 monoclonal antibody for HIV prevention and therapy.