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HIV Infections clinical trials

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NCT ID: NCT04950153 Active, not recruiting - Clinical trials for Adolescent HIV Infection

Intensive Combination Approach to Rollback the Epidemic in Nigerian Adolescents: UH3 Phase

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

Combination interventions with mHealth and Peer Navigation components will be evaluated in a randomized, stepped wedge trial among youth in Ibadan, Lagos, Sagamu, and Jos, Nigeria. Study findings will demonstrate whether or not the combination interventions for HIV testing and linkage to care and for HIV treatment outcomes, which were found to be efficacious in our prior pilot UG3 trial, will remain efficacious if scaled as proposed in this UH3 trial, across multiple sites.

NCT ID: NCT04947475 Active, not recruiting - Depression Clinical Trials

Project MATLINK: Development and Evaluation of a Screening, Brief Intervention, & Referral to Treatment (SBIRT) Program for Opioid Dependent Prisoners and Probationers Transitioning to the Community

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

The purpose of this study is to evaluate the efficacy a Screening, Brief Intervention, and Referral to Treatment (SBIRT) program for linking opioid dependent individuals currently incarcerated or in probation in Moldova, Kyrgyzstan, and Ukraine to opioid substitution therapy in the community after release or during their probation period.

NCT ID: NCT04925752 Active, not recruiting - Clinical trials for Pre-Exposure Prophylaxis of HIV Infection

Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

PURPOSE 2
Start date: June 28, 2021
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to test how well the study drug, lenacapavir (LEN), works in preventing the risk of HIV.

NCT ID: NCT04915768 Active, not recruiting - HIV Infections Clinical Trials

Evaluating the Safety and Immunogenicity of Stabilized CH505 TF chTrimer in Healthy, HIV-uninfected Adult Participants.

Start date: January 23, 2023
Phase: Phase 1
Study type: Interventional

This is an open-label Phase 1 study to examine the safety and immunogenicity of the CH505 TF chTrimer vaccine with 3M-052-AF +/- Alum adjuvant in healthy adults. The primary hypothesis is that the CH505 TF chTrimer will expand CH103-like B-cell precursors. HVTN 300 Part A examines the safety and immunogenicity of the CH505TF chTrimer with 5 mcg 3M-052-AF + 500 mcg Alum. HVTN 300 Part B is being added to this protocol with a goal of assessing the optimal dosing and combination of 3M-052-AF and Alum adjuvant, that can potentially lead to improved neutralizing antibody activity and decreased reactogenicity, compared to Part A. Three groups have been added to Part B (Group 2: 3 mcg 3M-052-AF without Alum, Group 3: 3 mcg 3M-052 with Alum, and Group 4: 5 mcg 3M-052-AF without Alum).

NCT ID: NCT04910711 Active, not recruiting - Contraception Clinical Trials

Investigating the Interaction Between Two Long-acting Reversible Methods of Contraception and Dolutegravir, a Treatment for HIV

CODA
Start date: October 21, 2021
Phase: Phase 4
Study type: Interventional

It is important to make sure that women have access to effective methods of contraception to prevent pregnancy so that they can make choices about when and if they will have their first or next child. Some of the most effective methods of contraception are the long-acting, reversible methods of contraception (LARCS), including the contraceptive implant and the contraceptive injection. In areas of the world where there are high numbers of people living with HIV, providing contraception to women is sometimes complicated, as there are known to be interactions between some of the medications that treat HIV and some hormonal methods of contraception. One medication to treat HIV, dolutegravir, is now one of the first-line treatments for HIV in Botswana, and more and more women of childbearing age are taking dolutegravir to treat HIV. At the moment, there is limited information on whether or not there are interactions between dolutegravir (the HIV medication) and the contraceptive implant or the contraceptive injection, two commonly used methods of contraception in Botswana. The main purpose of this study is to find out if women using contraception and also taking dolutegravir have lower levels of contraceptive hormone in their blood compared to women taking no HIV treatment. The study hypothesis is that there is no interaction between dolutegravir and the contraceptive implant or injection. In this study, levels of hormone from the injection or the implant will be measured in women living with HIV who take dolutegravir and compared to hormone levels in women who do not have HIV and who have never taken any medications to treat HIV. Women will be counselled about all of the possible methods of contraception (including the pill, the injection, the implant and the copper intrauterine device (or coil/loop)) that are available and will be empowered to make their own decision about the method of contraception they feel will be best for them. Women who choose the implant or the injection will be invited to enrol in the study; and will be categorised into one of four groups, based on whether or not they are living with HIV and taking dolutegravir. At several time points, women will have blood tests to check the level of hormone from the implant or the injection, over a course of 12 weeks for women starting the injection and 24 weeks for women starting the implant. Women will also be asked to complete a short questionnaire about any side effects from the contraception including changes to bleeding patterns. At the end of the 12 weeks (for women starting the injection) or 24 weeks (for women starting the implant), the results from these blood samples will be analysed to see how the levels of the hormone in their blood changed over time. The study will also look at whether the levels of dolutegravir (the HIV medication) changed over time. These results will be compared between women living with HIV taking dolutegravir and women without HIV who have never taken dolutegravir to see whether there is any interaction between dolutegravir and the hormonal contraceptive implant or contraceptive injection.

NCT ID: NCT04901728 Active, not recruiting - HIV Infections Clinical Trials

Patients' Experiences and Perceptions of 3TC/DTG Dual Therapy (the PEDAL Study)

PEDAL
Start date: July 1, 2021
Phase:
Study type: Observational

Improvements in health care and antiretroviral treatments have made it possible to turn HIV into a chronic disease leading to longer life expectancies and better quality of life among patients. Dual-drug combinations offer the advantage of a reduced exposure to antiretroviral agents, therefore leading to potential reductions in drug-associated side effects in the long-term. In light of this context, the primary aim of this qualitative study is to investigate patients' perceptions and experiences on the safety, effectiveness, tolerability, and unmet needs of the dolutegravir/lamivudine two-drug regimen. The secondary objective is to conduct a comparative analysis between patients on dolutegravir/lamivudine and patients on other two-drug and three-drug combinations. Lastly, the study aims to provide recommendations that improve doctor-patient communication, knowledge and understanding of the treatment plan, and additional care that ought to be considered in patient-centred, holistic care plans.

NCT ID: NCT04888754 Active, not recruiting - HIV Infections Clinical Trials

A Prospective Cohort for ex Vivo Cure Studies With Chronic HIV Infected Patients in the Netherlands

CHRONO
Start date: May 26, 2021
Phase:
Study type: Observational

A prospective non-interventional cohort study at Erasmus MC of adult chronic HIV infected patients of ≥18 years of age who initiate antiretroviral therapy in routine care.

NCT ID: NCT04833829 Active, not recruiting - HIV Infections Clinical Trials

Cross-disciplinary HIV Integrated Mental Health Support Intervention

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

The proposed project seeks to develop and test an intervention to improve engagement in HIV and mental health care for young Black gay, bisexual and other men who have sex with men (YB-GBMSM) in Ryan White clinics.

NCT ID: NCT04833127 Active, not recruiting - HIV Infections Clinical Trials

A Gender-Enhanced Pre-Exposure Prophylaxis (PrEP) Information-Motivational Workshop for Young South African Women

Masibambane
Start date: March 30, 2021
Phase: Phase 1
Study type: Interventional

This is a phase 1 pilot study to assess feasibility and acceptability and potential for impact of a gender-enhanced virtual group workshop focused on oral Pre-Exposure Prophylaxis (PrEP) as an HIV prevention method for young South African women. It was developed in collaboration with South African adolescent girls and young women (AGYW) aged 18-25. The investigators will compare AGYW (N=100) assigned to the virtual group-based (GE) workshop to those assigned to an Individually Accessed (IA) condition in which women are given access to a PrEP video and to websites that provide information on PrEP and on contraception options. Investigators also are evaluating the acceptability and feasibility of peer-driven recruitment (PDR). AGYW assigned to either intervention condition will be invited to become Peer Health Advocates (PHAs), who are incentivized to talk to social network members and refer up to three to the intervention type the PHA attended. The aim is to assess if PDR is self-sustaining and is effective at reaching women who might not be reached in clinics.

NCT ID: NCT04826562 Active, not recruiting - Clinical trials for Human Immunodeficiency Virus

Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)

Sound
Start date: September 26, 2021
Phase: Phase 4
Study type: Interventional

An open-label, pilot study of switching patients to Dovato who are currently taking Bitarvy who are virological suppressed (HIV-1 < 50 copies/mL