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NCT ID: NCT04799483 Active, not recruiting - HIV Clinical Trials

Safety and Survival of Genetically Modified White Blood Cells in HIV-infected Twins The Gemini Study

Start date: January 5, 2001
Phase:
Study type: Observational

This study will consolidate under one umbrella protocol all NIH studies of the safety and survival of gene-modified lymphocytes in HIV-infected twins. The major purposes of the current study are to: - place subjects from the various identical twin cell transfer/gene therapy studies on a single, more uniform schedule of visits; - examine the long-term safety of apheresis procedures in non-HIV-infected lymphocyte donor twins; - examine the long-term safety of lymphocytes in HIV-infected lymphocyte recipient twins. Identical twins enrolled in NIH protocols 93-I-0110, 94-I-0206, 96-HG-0051, and 97-I-0165 involving the transfer of lymphocytes for the treatment of HIV infection are eligible to continue their research participation under the current protocol, 02-I-0080. Participants will not undergo any additional research procedures in this study. They will continue to take their antiretroviral therapy and will be followed at least once a year, or more often if medically indicated, with a medical history, physical examination and blood tests for routine studies and to determine the number of lymphocytes in the blood. Recipient twins will also have blood levels of gene-modified lymphocytes checked. Recipient twins will have some blood stored for RCR (replication competent retrovirus) testing, should it become necessary. A special virus was used to insert genes into the donated lymphocytes and, although the virus was rendered incapable of growing in the body, a theoretical risk exists that the virus could mix with other viruses and possibly begin growing or reproducing. If a participant subsequently develops medical problems, the stored blood samples can be checked for RCR to see if it may be a cause of the problem.

NCT ID: NCT04794543 Active, not recruiting - Hiv Clinical Trials

Effects of Using E-Cigarettes on Lungs in People With HIV (HBS Ancillary)

HBS Ancillary
Start date: April 1, 2022
Phase:
Study type: Observational

This is an ancillary study, thus participants will be recruited from participants in the HBS Study. This project acutely assesses the role of the e-cigarettes and vaping on lung health. The proposed work will inform the design of future studies to better understand vaping's health consequences and to test novel interventions to mitigate vaping's contribution to acute and/or chronic lung injury.

NCT ID: NCT04791865 Active, not recruiting - HIV Clinical Trials

Pediatric HIV Disclosure Benefits Study (PhD-BS) - Sankofa 2

Start date: June 15, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to conduct a pragmatic, stepped wedge cluster randomized trial in 12 HIV pediatric clinics in Ghana to determine effectiveness, health benefits, cost and implementation to inform scale-up and sustainability of pediatric disclosure.

NCT ID: NCT04782180 Active, not recruiting - Hiv Clinical Trials

PrEP at a Syringe Services Program

Start date: February 1, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to see if providing participants with pre-exposure prophylaxis (PrEP) medicine right away at the IDEA Exchange will help participants remain in HIV negative.

NCT ID: NCT04711954 Active, not recruiting - Covid19 Clinical Trials

HIV/COV in Ukraine-NL

Start date: November 1, 2020
Phase:
Study type: Observational [Patient Registry]

Contradicting preliminary results are available on the impact of COVID-19 in people with HIV (PWH). How achieving goals of the HIV 90-90-90 cascade of care influences the risk of COVID-19 in PWH is unclear. The primary objective is to determine the impact of COVID-19 in PWH cohorts from Ukraine and the Netherlands.

NCT ID: NCT04624061 Active, not recruiting - Hypertension Clinical Trials

Leveraging the HIV Platform for Hypertension Control in Uganda (INTEGRATED HIV/HTN) STUDY

Start date: November 16, 2020
Phase: N/A
Study type: Interventional

The INTEGRATED HIV/HTN is a hybrid type-1 effectiveness/implementation cluster randomised trial evaluating the introduction of a multi-component integrated HIV/HTN care model intervention, randomised to 13 districts in the intervention arm compared to 13 districts in the control. Selected health facilities within the 13 intervention districts will receive the intervention while those in the 13 control districts will continue implementing the standard of care as per the Ministry of Health (MoH) guidelines. All the participating facilities will receive blood pressure (BP) machines, and Non- communicable diseases (NCDs) registers as a standard of care.

NCT ID: NCT04616963 Active, not recruiting - Hiv Clinical Trials

Emtricitabine/Tenofovir Alafenamide Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis

TAF4TRANS
Start date: October 24, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate Pre-Exposure Prophylaxis (PrEP) levels in transgender-identifying or gender non-binary individuals taking versus not taking gender affirming hormone therapy. Subjects who have previously taken F/TDF as PrEP will continue with a fixed dose combination of daily oral F/TAF substituting for F/TDF. Subjects will receive the iTAB text messaging adherence reminders to provide personalized, automated text messages to support and monitor adherence that will vary by participant choice until 12 weeks after switching medication. This study will enroll 60 individuals to take F/TAF as PrEP for 48 weeks.

NCT ID: NCT04588883 Active, not recruiting - Hiv Clinical Trials

Strengthening Families Living With HIV in Kenya

Start date: September 28, 2021
Phase: N/A
Study type: Interventional

This study seeks to use a group-based microfinance/internal lending model to develop social capital among people with HIV in Kenya. This will create a context to deliver validated curriculum targeting intimate partner violence, positive parenting, agriculture, small business entrepreneurship, group-interpersonal therapy, and other determinants of well-being and ART adherence among people with HIV. The primary outcomes are viral suppression, ART adherence, and common mental disorders.

NCT ID: NCT04571684 Active, not recruiting - HIV Clinical Trials

Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya

Start date: October 5, 2020
Phase: N/A
Study type: Interventional

The goal of this project is to rigorously evaluate the efficacy of HIV Infant Tracking System 2.1 (HITSystem, an eHealth intervention that uses short message service (SMS) texts to patients and algorithm-driven electronic alerts for providers) to increase retention in guideline-adherent prevention of mother-to-child transmission of HIV services (PMTCT) and to increase viral suppression and appropriate clinical action through the extended period of 6 months postpartum, compared to standard of care PMTCT services in a matched, cluster randomized controlled trial.

NCT ID: NCT04568460 Active, not recruiting - HIV Clinical Trials

Standing Tall (Yima Nkqo)

Start date: November 25, 2020
Phase: Phase 2
Study type: Interventional

The investigators propose the Standing Tall study, a prospective randomised study of strategy to optimize community-based ART initiation in South Africa. Investigators will work closely with community members to integrate community-based ART. One hundred participants will be enrolled and followed for a total of up to 6 months. Those in the intervention arm will be provided with the ST intervention which includes a behavioral component and access to ART. The intervention will be linked to a clinic through a "Nurse Initiated Management of ART."