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Human Immunodeficiency Virus clinical trials

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NCT ID: NCT02495779 Completed - Clinical trials for Human Immunodeficiency Virus

Feasibility of Short-Term PrEP Uptake for MSM With Episodic High-Risk for HIV

Start date: July 2015
Phase: N/A
Study type: Interventional

This study is designed to investigate the acceptability, perceived need and uptake of short-term episodic Pre-Exposure Prophylaxis (PrEP) for HIV prevention among men who have sex with men (MSM). The overall objective is to determine the feasibility of a clinic-based Epi-PrEP implementation pilot project for 50 MSM (25/each of the 2 study sites) who report occasional condomless sex and who anticipate a period of high-risk while away from home (e.g. vacation) during the study period.

NCT ID: NCT02491177 Completed - Clinical trials for Human Immunodeficiency Virus

Mother and Infant Visit Adherence and Treatment Engagement Study

MOTIVATE!
Start date: May 2014
Phase: N/A
Study type: Interventional

This is a 2x2 factorial cluster randomized trial of two interventions to improve retention and adherence for women and infants on Option B+. The overall goal is to determine which intervention (or combination of interventions) maximizes antiretroviral therapy (ART) adherence and retention in care in the context of Option B+ and thus improves maternal and infant health outcomes.The proposed study will be conducted in rural Nyanza Province, Kenya at 20 low-resource primary health care facilities and associated communities supported by Family AIDS Care and Education Services (FACES), a President's Emergency Plan for AIDS Relief (PEPFAR)-funded HIV prevention care, and treatment program, ((AIDS) acquired immune deficiency syndrome, (HIV) human immunodeficiency virus) . The investigators will assess both process and outcome indicators using a 2x2 factorial design, in which equal numbers of clusters will be randomized to one of the interventions (community-based mentor mothers or theory-based mobile text messages), both interventions, or standard of care. The interventions will be added to fully integrated high quality HIV and antenatal, maternal, neonatal, and child health (ANC/MNCH) services already offered at these sites.

NCT ID: NCT02481492 Completed - Clinical trials for Human Immunodeficiency Virus

Randomized Controlled Trial of Shang Ring Male Children Circumcision: Comparison Between Flip and No Flip Technique

Start date: June 2015
Phase: N/A
Study type: Interventional

This is a prospect, randomized control trial to evaluate merits between flip and no flip technique in Shang Ring children circumcision.

NCT ID: NCT02464423 Completed - Clinical trials for Human Immunodeficiency Virus

Improving Adherence Among HIV+ Rwandan Youth: A TI-CBTe Indigenous Leader Model

Start date: January 2013
Phase: N/A
Study type: Interventional

Like most of sub-Saharan Africa, Rwandan youth are the epicenter of the AIDS epidemic, accounting for 40% of new infections. Antiretroviral (ART) adherence is a global health priority, but Rwandan youth are more than twice as likely to be on second line therapy than adults, and with a median population age of 18.7 years old, adherence is essential for Rwanda's future. Resources to provide youth-centered medical and psychosocial care are limited in Rwanda, and young people with HIV face many obstacles to adherence, namely the long-term consequences of genocide, depression, and gender-based violence, as well as logistical issues, negative attitudes, and insufficient parent/caregiver support. Preliminary data underscore the utility of culturally-adapted, trauma-informed cognitive behavioral therapy (TI-CBT) in reducing depression and traumatic distress among youth and adults in Rwanda. This project proposes a 2-arm randomized controlled trial (RCT) to test and compare the efficacy of adherence-enhanced Trauma Informed Cognitive Behavioral Therapy (i.e., TI-CBTe) to usual care in increasing ART adherence among Rwandan youth from two clinics caring for the largest number of youth with HIV in Rwanda. This proposal answers a compelling need for innovative programs to increase ART adherence among HIV+ youth. If effective, the study will build Rwanda's capacity to provide much needed services; and, involvement by the Rwanda Biomedical Center will ensure wide dissemination.

NCT ID: NCT02461576 Completed - Clinical trials for Human Immunodeficiency Virus

Clinical Evaluation of the Xpert® HIV-1 VL

Start date: July 2015
Phase: N/A
Study type: Observational

Compare the clinical performance of the Xpert® HIV-1 VL to another FDA approved HIV-1 RNA quantitative assay using frozen and fresh specimens from known HIV-1 positive individuals.

NCT ID: NCT02459678 Completed - Clinical trials for Human Immunodeficiency Virus

ART Readiness in HIV-infected Pregnant Women

Start date: May 2015
Phase: N/A
Study type: Interventional

This study seeks to evaluate the readiness of HIV-infected pregnant women in Zambia to initiate, adhere to, and be retained in care under the Ministry of Health's Option B+ policy. Under a 3-phased research study the investigators will: (1) conduct formative research regarding readiness to start lifelong ART in the pregnant population; (2) translate the results of formative research into a readiness assessment tool and an enhanced adherence package for pregnant women eligible for Option B+ and (3) conduct an individual randomized trial of the enhanced adherence package.

NCT ID: NCT02403583 Completed - Clinical trials for Human Immunodeficiency Virus

Jamii Bora: A Home-Based Couples Intervention

Start date: August 1, 2014
Phase: N/A
Study type: Interventional

The purpose of the study is to develop and pilot-test a home-based intervention to facilitate sate HIV testing and disclosure within pregnant couples in order to increase use of prevention-of-mother-to-child-transmission (PMTCT) and family health services in Kenya.

NCT ID: NCT02402218 Completed - Clinical trials for Human Immunodeficiency Virus

CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS

CHAMPS
Start date: August 2015
Phase: N/A
Study type: Interventional

This study is being done to compare three strategies to deliver HCV treatment with ledipasvir/sofosbuvir which is an approved therapy which is administered as one tablet by mouth daily for 12 weeks. The study population is persons living with HIV and hepatitis C virus (HCV) coinfection who also use drugs. Participants will be randomized into one of three treatment groups: 1. Usual care in the clinic. This treatment group will receive the standard of care for HCV treatment from their health care team. 2. Usual care plus peer-mentors. In addition to the usual care, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection. 3. Usual care plus incentives. In addition to the usual care, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain treatment goals during the course of the study. HCV treatment with ledipasvir/sofosbuvir is considered the standard of care for HCV and is recommended by experts in liver disease and infectious diseases.

NCT ID: NCT02401828 Completed - Clinical trials for Human Immunodeficiency Virus

The Dolutegravir Antiretroviral Mono-Therapy for HIV Trial

DOMONO
Start date: March 2015
Phase: Phase 4
Study type: Interventional

48-week open label randomized phase IV investigator initiated intervention study. The purpose of this study is to evaluate whether HIV-1 suppression can be maintained by DTG monotherapy in HIV-1 infected, virologically suppressed patients on cART. 104 adults fulfilling the in and exclusion criteria and on stable cART will be randomized over 2 investigational arms. The first arm will contain the direct switch population. This population will switch directly from stable cART to Dolutegravir mono-therapy on baseline visit. The second arm will contain the delayed-switch population. This group will switch from stable cART to Dolutegravir monotherapy 24 weeks after baseline visit. The main goal is to investigate if Dolutegravir mono-therapy could be non-inferior to cART in virological suppressed HIV-1 infected adults. If a interim analysis (performed when 40 patients on dolutegravir monotherapy have passed week 12) shows that it is safe to continue the study, an additional 30 patients will be included on top of the 104 patients needed for the primary endpoint analysis. In contrast to the primary endpoint population, these additional 30 patients will have a CD4 nadir <200 but a CD4 >350 at the time of the screening visit. Besides that, these 30 patients will have to fulfill all other in and exclusion criteria of the primary endpoint population (specifically a viral load never >100.000). These 30 patients are part of a pilot study looking at the possibility to broaden the eligible population in a future larger randomized clinical trial.

NCT ID: NCT02396979 Completed - Clinical trials for Human Immunodeficiency Virus

Intervention of HIV, Drug Use and the Criminal Justice System in Malaysia

Harapan
Start date: January 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the relative impact a medical drug (methadone) or behavioral counseling program (Holistic Health Recovery Program) or both (methadone and Holistic Health Recovery Program) has on reducing HIV-related risk behaviors and illicit drug use among opioid-dependent, HIV-infected individuals in prison when given 90 to 180 days prior to leaving prison.