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HIV/AIDS clinical trials

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NCT ID: NCT04325438 Completed - Tuberculosis Clinical Trials

The Impact of Pharmacists' Interventions on the Quality of Life of HIV-TB Co-infection Outpatients in Indonesia

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

Rationale: The co-infection of human immunodeficiency virus (HIV) and tuberculosis (TB) diseases presents further problems to patient's adherence due to high pill burden and adverse effects in the drug combination therapy. This situation is also a risk of the increase of multi-drug resistant TB and may affect the quality of life of patients. However, the prevalence of non-adherence has not been studied much in these patients in Indonesia, especially in West Java with several HIV patients who are still struggling with TB as their opportunistic infection. Pharmacist interventions in several studies have resulted in a better outcome of patients' therapy, especially in patients who need long-term adherence and compliance with drug treatment. It is hypothesized that patients' quality of life of HIV-TB co-infection patients will be improved with the intervention conducted by the pharmacist. Objective: In general, the study aimed to evaluate the utility of study participants with specific aims to describe the number of DRP and interventions applied, to describe drug concentration in selected participants (TB drugs: Rifampicin and Pyrazinamide), to compare changes of CD4+ cell counts and plasma HIV RNA (viral load) between baseline and after of intervention, to assess participants compliance and persistence to medication therapy, and descriptive analysis on the direct and indirect costs. Study design: This is a prospective, cluster-randomized study with a stepped-wedge design. Clusters correspond to participating centers. A randomly selected center is crossed-over into the intervention with calculation after the start of inclusions within 6-months follow-up in 3 different clinics in Indonesia (Bekasi City Public Hospital, Persahabatan Public Hospital Jakarta and Cipto Mangunkusumo general hospital). Intervention: Interventions are given by a pharmacist as a drug consultant is an intervention concerning the drug treatment of HAART and anti-TB. Monthly, patients will have a discussion regarding their medication and drug-related problems they experience. The pharmacist will identify drug-related problems before and during treatment and solve the problems. Main study parameters/endpoints: change from baseline utility (quality of life) at 6 months Secondary endpoints: changes from baseline in CD4+, VL, adherence, persistence at 6 months and total costs.

NCT ID: NCT04307433 Completed - HIV/AIDS Clinical Trials

Storytelling Intervention to Promote Cervical Cancer Screening Uptakes Among Malawian Women Living With Human Immunodeficiency Virus

Start date: October 21, 2021
Phase: N/A
Study type: Interventional

To develop a theory-based culturally-grounded storytelling-based intervention to increase cervical cancer screening among Malawian women living with HIV infection. Secondary objectives: To conduct a pilot randomized clinical trial (RCT) to examine the acceptability, feasibility and preliminary effectiveness of narrative intervention on cervical cancer screening prevention behavior.

NCT ID: NCT04296331 Completed - HIV/AIDS Clinical Trials

HIV Jail POC-AgAB Testings

Start date: October 14, 2019
Phase:
Study type: Observational

"Enhancing a universal testing and treatment strategy in jail to promote viral load suppression among justice-involved people living with HIV" is an observational research study led by Dr. Matthew Akiyama, MSc of Albert Einstein College of Medicine and Montefiore Medical Center and Dr. Anne Spaulding, MPH of Emory University's Rollins School of Public Health. Due to the high rates of undiagnosed Human Immunodeficiency Virus (HIV) in the correctional setting and the short length of stay in jails, this study aims to evaluate whether care coordination within the D.C. Central Detention Facility (DC DOC) and upon release, including testing procedures and antiretroviral therapy (ART) initiation, can improve the connection of adults (age 18 and over) living with HIV to care in the community. The researchers will retrospectively look at the aggregate-level de-identified data of roughly 3,000 individuals admitted to the DC DOC over a 6-month period to determine the most effective HIV diagnostic test for routine opt-out testing in the correctional setting. Over the course of these 6 months, the correctional facility will transition from using POC only to POC + antigen/antibody (Ag/Ab), to solely using Ag/Ab, each for a 2-month duration. Individuals from this time period who are identified by corrections staff as HIV-positive either through testing upon admission, their electronic medical record (EMR) or self-report, and have a known release date will be considered eligible for the follow-up study to assess if care coordination is effective in linking others with HIV leaving the DC DOC to care. This follow-up will enroll 100 of these individuals who have consented to participate following their release from the DC DOC, and will consist of a chart review of their DC DOC EMRs and those from their community healthcare provider for up to two years after their release.

NCT ID: NCT04295876 Completed - HIV/AIDS Clinical Trials

The BRIDGES Project: Bridging Resources to Engage Women in Integrated HIV Care and Support Services

BRIDGES
Start date: December 19, 2019
Phase: N/A
Study type: Interventional

The BRIDGES Project seeks to test a program intended to help women living with HIV who face specific barriers due to culture, gender, violence, trauma, adverse mental health, and substance use to be able to better access HIV care. This program was created and tried with women living with HIV, as previously studies have indicated that women with these experiences are less likely to have stable HIV care. The BRIDGES Project will use Peer Navigators, who are other women living with HIV who have had similar experiences and have been successful in accessing care, to help other women living with HIV to access HIV care and stay in HIV care. The BRIDGES Project will also provide support to women through group sessions co-facilitated by a licensed clinical therapist and Peer Navigator. Through participation in BRIDGES, women will: (1) build skills to cope with HIV care and treatment barriers (e.g., violence, trauma, adverse mental health, substance use); (2) be connected to HIV treatment and other support services (e.g., domestic violence, mental health, substance use); and (3) learn interpersonal skills to connect with support (e.g., service providers, peers, friends, family) when faced with new or ongoing barriers.

NCT ID: NCT04289116 Completed - HIV Infections Clinical Trials

Enhancing Sexual Safety: Couples' Communication and HIV Testing Among YMSM

WeTestATN156
Start date: January 20, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to compare different ways to deliver the couples HIV Testing and Counseling (CHTC) intervention that is suited for adolescents and young adults.

NCT ID: NCT04263441 Completed - HIV/AIDS Clinical Trials

Navigating Insurance Coverage Expansion (NICE)

NICE
Start date: October 18, 2018
Phase: N/A
Study type: Interventional

The purpose of this research is to measure the effectiveness of an in-person assistance intervention on successful insurance enrollment, types of insurance coverage, rates of linkage to and retention in HIV-related health care, referrals to other HIV-associated health services, and health outcomes. The study population is Black and Hispanic men who have sex with men (MSM) and transgender persons who are at higher risk for HIV. The study team will be testing the hypotheses that in-person health insurance enrollment assistance results in positive outcomes with regard to linkage to and retention in HIV-related health care. Analyses will be used to assess the efficacy of the intervention as an emerging practice.

NCT ID: NCT04246983 Completed - HIV/AIDS Clinical Trials

Point-of Care Ultrasound for Patients With HIV

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

Rationale: Point-of-care ultrasound (POCUS) is increasingly used by various specialists in the Netherlands, but its role in managing patients with HIV is unclear. In settings endemic for tuberculosis, Fast Assessment with Sonography for HIV/Tuberculosis (FASH) has proven its value to detect extrapulmonary tuberculosis in patients with HIV. However, there is no data to support POCUS for patients with HIV in resource affluent settings. Objective: The investigators aim to determine the feasibility and diagnostic value of POCUS in detecting opportunistic disease in HIV patients with advanced disease stages in the Netherlands. Study design: The investigators will perform a prospective observational pilot study. Study population: The investigators will include new adult patients with HIV presenting with a cluster of differentiation 4 (CD4) T-cell count below 350 cells/mm3, and all adult HIV patients requiring admission to hospital. Intervention (if applicable): The investigators will perform a focused ultrasound examination including FASH, and ultrasound of the lung, liver and kidneys. In case of positive findings additional examinations will be undertaken to determine the underlying pathology and/or treatment started as indicated. In case of negative findings, patients will be followed for 12 months to observe for (possibly missed) opportunistic infections. Main study parameters/endpoints: Our primary outcomes include acceptability of POCUS by patients, interobserver variation in interpretation of POCUS images, and number of diagnosed AIDS and non-AIDS related problems. Secondary outcomes include sensitivity and specificity, negative predictive value and positive predictive value of our POCUS protocol. In addition, incidence rates of opportunistic infections will be compared to a historical matched control group. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The ultrasound examination is painless and without risk to the participants. It will take approximately 30 minutes and will be combined with routine visits to the hospital. Benefits include potential earlier detection of opportunistic disease, while adverse effects may arise from false positive findings requiring further examinations which may cause stress or anxiety. The rate of false positive findings in POCUS has not been formally investigated, but appears low. The effect of POCUS in advanced HIV/AIDS can only be studied in HIV patients.

NCT ID: NCT04224181 Completed - Clinical trials for Myocardial Infarction

Inflammation and Cardiovascular Health in Women

Start date: February 3, 2020
Phase:
Study type: Observational

Systemic immune activation and inflammation are believed to play a significant role in the development and clinical course of myocardial infarction (MI). Among women with HIV (WHIV), heightened systemic immune activation and inflammation persist, even when HIV infection is well-treated with contemporary antiretroviral therapeutic regimens. Moreover, WHIV in high-resource regions face a three-fold increased risk of myocardial infarction as compared with matched non-HIV-infected women. The goals of this study are to better understand ways in which HIV infection-incited systemic immune activation and inflammation augment MI risk among women.

NCT ID: NCT04219878 Completed - HIV/AIDS Clinical Trials

Implementation of Rapid HIV Self-Testing Among MSM Project

iSTAMP
Start date: February 17, 2020
Phase: N/A
Study type: Interventional

This study will use online materials and strategies to recruit 3600 Black and Hispanic men who have sex with men (MSM) and transgender women (TGW) to participate in a study evaluating the effectiveness of the Know@Home mobile app compared to control condition with respect to linkage of participants to appropriate services, as well as cost-effectiveness outcomes.

NCT ID: NCT04206878 Completed - HIV Infections Clinical Trials

Evaluating the Feasibility of Point of Care Birth Testing in Eswatini

Start date: June 1, 2017
Phase:
Study type: Observational

This study aims to assess the feasibility and utility of birth testing using point-of-care (POC) testing in maternity settings in Eswatini.