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HIV Infections clinical trials

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NCT ID: NCT03153709 Completed - HIV Infections Clinical Trials

Prospective Cohort Evaluating Pregnancy Rates, PK Interactions Among HIV+ Women on EFV Initiating LNG Implant or DMPA

FP-ART
Start date: August 17, 2017
Phase:
Study type: Observational

The purpose of this study is to compare the pregnancy rates among women who are using the HIV drug Efavirenz and either the birth control injection or implant.

NCT ID: NCT03149848 Completed - HIV Infections Clinical Trials

Effect of Rifabutin on the Pharmacokinetics of Oral Cabotegravir in Healthy Subjects

Start date: June 6, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase I, single-center, open-label, fixed-sequence, 2-period crossover study in healthy adults to evaluate the effect of oral rifabutin (RBT) 300 milligram (mg) on the pharmacokinetics of oral cabotegravir (CAB) 30 milligram ( mg). This study will evaluate the drug-drug interaction (DDI) potential between CAB and RBT to inform dosing strategies for tuberculosis in subjects receiving CAB for human immunodeficiency virus (HIV) treatment or prevention. In Treatment Period 1 (Treatment A) participants will receive CAB 30 mg once daily for 14 days, followed by Treatment Period 2 (Treatment B) where participants will receive RBT 300 mg once daily with CAB 30 mg once daily for 14 days. The total study duration will be approximately for 10 weeks. Approximately 15 healthy subjects will be enrolled to ensure that 12 subjects complete dosing and critical assessments.

NCT ID: NCT03149757 Completed - HIV Infections Clinical Trials

Connecting Youth and Young Adults to Optimize ART Adherence: YouTHrive Efficacy Trial

Start date: May 16, 2017
Phase: N/A
Study type: Interventional

YouTHrive (YT) is a two-arm randomized control trial (RCT) to test the efficacy of an adapted version of the Thrive With Me (TWM) intervention for youth living with HIV (YLWH). In the RCT, intervention participants will have access to the full YouTHrive (YT) website- a mobile-enhanced private social networking website aimed at improving medication adherence for YLWH. The investigators will enroll up to 60 YLWH for formative work on YT, and 300 YLWH (15-24 years old) of all genders living in eight cities and randomize them to either the intervention condition or control condition. Assessments will be collected at baseline and 5-month follow-up.

NCT ID: NCT03149237 Completed - Clinical trials for Human Immunodeficiency Virus

Partners-based HIV Treatment for Couples Attending Antenatal Care

Start date: November 16, 2017
Phase: N/A
Study type: Interventional

The purpose of this R01 proposal is to evaluate the clinical impact, hypothesized mechanisms of behavior change, and cost-effectiveness of a partners-focused integrated elimination of mother-to-child transmission of HIV (EMTCT) package comprised of: 1) antenatal care-based couples HIV testing, ART enrollment, and care for sero-concordant HIV+ expectant couples; (2) Couples-based treatment in the post-partum period; (3) Couple-based education and skills building; and (4) Treatment continuity with the support of expert-patient (peer) supporters from couples who have successfully navigated EMTCT. This innovative approach to scaling up EMTCT services, if proven feasible and effective, will be adopted in President's Emergency Plan for AIDS Relief (PEPFAR) programs to accelerate progress toward EMTCT and helping families with HIV infection live long, healthy lives.

NCT ID: NCT03149094 Completed - HIV Clinical Trials

CBSM Intervention Via mHealth to Ameliorate HIV-related Fatigue

Start date: April 27, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to create a smartphone, tablet and web-based application to help people deal with stress. Stress often increases fatigue in people with HIV infection, so successfully dealing with stress could help reduce HIV-related fatigue. The study is being done at one site, the Medical University of South Carolina. Approximately 30 people will take part in this portion of the study.

NCT ID: NCT03145753 Completed - HIV Infection Clinical Trials

Education vs Education Plus Intervention in HIV/HCV Diagnosis (DRIVE 03)

DRIVE
Start date: November 18, 2016
Phase: N/A
Study type: Interventional

Objectives: A targeted HIV testing strategy (TTS) through an HIV risk of exposure and indicator conditions (RE&IC) questionnaire resulted in same rate of new HIV infection diagnosis (NHID), coverage and even reduced costs compared with a universal non targeted (Non TSS) HIV testing strategy in a prior study (DRIVE 01). To compare number of New HIV/HCV Infection Diagnoses (NHID HIV/HCV) and costs two HIV/HCV testing programs in the Primary Health Care: an educational and support only initiative to enhance HIV /HCV testing (EDSUP) or EDSUP plus a resourced external program (DRIVE 03). Methodology: Prospective, randomized 1:1, clustered, crossover study, in one Health Care Area of Madrid, Spain, comparing the implementation of two HIV testing programs, EDSUP only vs. EDSUP plus DRIVE 03 program in 4 Primary Care Centers (PCC´s). People randomized to EDSUP plus DRIVE 03 program, non HIV infected, between 18-65 years, attending to any of the 4 PCC´s, not previously included in the study will be offered to participate. HIV testing program will be evaluated by measuring absolute number of new diagnosed infections (NDI) HIV/HCV and costs. Other outcomes considered will be people assigned and offered to participate, number of HIV tests performed, coverage (HIV /HCV tests/assigned population ratio), and rate of NDI HIV/HCV per ‰ tests performed. Six months prior to randomization main outcome variables will be recorded in the 4 PPC´s. Before randomization, EDSUP will be equally implemented in the 4 PCC´s. After randomization, first six months, DRIVE 03 program will be implemented in 2 PCC´s and in the other 2 observation of interest variables will be conducted. After first 6 month study period, PCC´s will be crossover to the opposite arm of randomization. DRIVE 03 program will offer rapid HIV tests, and testing staff to conduct all study procedures. For NDI HIV/HCV, molecular epidemiology, delayed diagnosis, retention in care, HIV/HCV treatment and control/eradication will be also monitored.

NCT ID: NCT03144336 Completed - HIV Infections Clinical Trials

Using Mobile Technology and Incentives With Men Who Have Sex With Men and Transgender Women for HIV Prevention

MOTIVES
Start date: May 24, 2017
Phase: N/A
Study type: Interventional

This project called Mobile Technology and Incentives (MOTIVES) aims to increase engagement with HIV prevention information and improve testing frequency among Latino/a men who have sex with men (MSM) and transgender women (TGW). Its primary goal is to develop and test the feasibility and acceptability of an HIV prevention intervention that uses text messages in combination with prizes to improve HIV prevention information retention and HIV testing frequency. The project will be conducted in collaboration with Bienestar Human Services, Inc. (Bienestar) in Los Angeles County. Phase 1 consists of formative research (focus groups n=9) with MSM (n=52) and TGW (n=39) to complement the previously collected pilot data (2014-2015) to finalize the planned intervention. In Phase 2, the intervention will be piloted among 5 individuals, implemented, and tested in a small, randomized controlled trial (RCT) among 200 Latino MSM and TGW from Bienestar's HIV testing sites. Interested individuals will be screened for eligibility upon testing HIV-negative (those testing positive will be linked to HIV services as required by Bienestar's standard of care). Eligible participants will be randomized into either the intervention or control group that will both receive study information weekly and will be invited to get tested for HIV every three months. Participants in the intervention group will be able to accumulate rewards points for correctly answering weekly quizzes regarding the HIV prevention information; these reward incentives aim to encourage retention in the study and improve HIV prevention knowledge engagement and recollection. Every three months those in the intervention group can win a prize based on testing HIV-negative at least once during that time period. The chance of winning will increase based on the number of reward points a participant accumulates by correctly answering questions on the weekly quizzes. The primary outcome measures will include HIV-preventive knowledge and frequency of HIV testing (at least once every 3 months). In Phase 3 of the study, the investigators will conduct 6 focus groups with approximately 5-8 participants each among MSM (n=3) and TGW (n=1) study participants, testing site staff (n=1), and administrative staff (n=1) to identify implementation challenges and areas for improvement; and estimate mission-critical design parameters with point and confidence interval estimates to inform a subsequent, fully-powered R01 application.

NCT ID: NCT03143205 Completed - Inflammation Clinical Trials

Gene Expression Outcomes in Interventions for Substance Using HIV+ Minority Men

Start date: May 5, 2017
Phase: N/A
Study type: Interventional

This is a pilot study of a new 9-session individually delivered cognitive behavioral intervention targeting sexual minority stress. In this study, 40 HIV+ men sexual minority men will be recruited for the study then will be randomly assigned to either the new 9 session intervention or a writing task condition.

NCT ID: NCT03141918 Completed - HIV Infections Clinical Trials

Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS

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

Among the many changes associated with the impact of HIV and the long-term use of antiretroviral therapy, metabolics are important because they are important risk factors for the development of cardiovascular diseases. The objective of the present study is to evaluate the effect of the supplementation of curcumin, on the oxidation of resting energetic substrates in HIV / AIDS patients. The sample will be composed of adults living with HIV / AIDS on antiretroviral therapy for at least 6 months. Supplements will be made separately for 30 days and will be evaluated before and after the intervention the following parameters: body composition, energy metabolism, biochemical parameters and a structured anamnesis. Food consumption and the level of physical activity of the volunteers will be controlled.

NCT ID: NCT03137797 Completed - HIV Infection Clinical Trials

Cohort of Patients Naive of Antiretroviral Treatment at Enrollment

COPANA
Start date: February 2004
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the short, medium and long-term prognosis for newly diagnosed HIV patients.