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NCT ID: NCT05168813 Active, not recruiting - HIV Infections Clinical Trials

Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern

CoVPN3008
Start date: December 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The study will evaluate the clinical efficacy of different dosing regimens of the Moderna COVID-19 mRNA vaccine (100 mcg) in preventing COVID-19 disease in people who are living with HIV or have comorbidities associated with elevated risk of severe COVID-19, with the different vaccine regimens assessed determined by whether the participant had evidence of prior SARS-CoV-2 infection at enrollment.

NCT ID: NCT05154513 Recruiting - HIV Infection Clinical Trials

Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV

Start date: February 2, 2022
Phase:
Study type: Observational

IMPAACT 2028 is an observational prospective study to characterize a cohort of early treated children who may participate in future research related to HIV remission or cure. Up to approximately 250 participants will be in the study for approximately seven years. No intervention is provided in the study.

NCT ID: NCT05022277 Recruiting - Pregnancy Related Clinical Trials

Empowering Girls: Health-seeking Behavior, Staying in School, and Preventing Risky Sex

Start date: April 28, 2020
Phase: N/A
Study type: Interventional

This study will test the effectiveness of a phone-based big sister/big brother program designed to provide health information and support, reduce school dropouts, and promote safer relationships. The program's goal is to create a phone-based safe space, to ensure adolescents remained connected with access to support and health information during COVID lockdowns.

NCT ID: NCT05007821 Recruiting - Tuberculosis Clinical Trials

Linezolid Dosing Strategies in Drug-Resistant TB

Start date: August 11, 2022
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy (how well the medicines work) and tolerability (whether participants stop treatment because of side effects from a drug or treatment) of an anti-TB treatment regimen that compares two doses of linezolid (LZD), combined with bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ). This study will also measure the level of these medicines in the participants' blood.

NCT ID: NCT04955717 Completed - Preterm Birth Clinical Trials

Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences

Start date: February 24, 2021
Phase: N/A
Study type: Interventional

To assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on symptoms and signs).

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: NCT04902768 Completed - Clinical trials for Congenital Heart Disease

Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II

APPROACH-IS II
Start date: August 1, 2019
Phase:
Study type: Observational

This is an international, cross-sectional and descriptive study that aims to investigate differences in patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) and that aims to explore the profile and healthcare needs of adults with congenital heart diseases.

NCT ID: NCT04860323 Recruiting - HIV Infection Clinical Trials

Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 703/HPTN 081 AMP Study

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

The purpose of this study is to learn whether having the AMP Study antibody (called VRC01) in a person's body might help their immune system control HIV better, even without HIV medication called antiretroviral therapy or ART, if they get HIV. This study will evaluate the viral and immune system responses in an Analytical Treatment Interruption (ATI), in participants who received VRC01 or placebo and got HIV while enrolled in HVTN 703/HPTN 081 (NCT02568215). Participants in this study will stop taking their HIV medication. They will stay off HIV medication unless and until the HIV levels in their blood show that their immune system is unable to control the HIV or they meet other ART re-start criteria as noted in section "Detailed Description". While they are not taking HIV medication, their HIV levels will be tested frequently, and their health will be monitored closely. This is called an analytical treatment interruption, or an ATI. An ATI is an experimental procedure that is only used in carefully monitored research.

NCT ID: NCT04796610 Completed - HIV Clinical Trials

Mopati: A Pilot Hiv Treatment Partner Intervention In Botswana

Start date: June 17, 2021
Phase: N/A
Study type: Interventional

This study is a pilot test of the Mopati program ("partner" in Setswana), which is a multi-level intervention that guides healthcare providers and patients about treatment partner selection, and trains treatment partners on provision of effective support. The Specific Aims are: (1) To develop a multi-level treatment partner intervention with input from community and healthcare provider stakeholders in Botswana; and (2) To conduct a pilot test of the feasibility, acceptability, and preliminary effects on viral suppression.

NCT ID: NCT04532970 Recruiting - HIV Infections Clinical Trials

BAPS in Botswana: The Thotloetso Trial

BOTS
Start date: May 6, 2021
Phase: N/A
Study type: Interventional

The main purpose of this research study is to compare traditional behavioral smoking cessation therapy with a different type of behavioral therapy-known as behavioral activation problem solving (BAPS)-for smoking cessation. Standard smoking cessation counseling (SC) focuses on self-monitoring, identifying smoking triggers and how to manage them, relaxation and social support for non-smoking, and relapse prevention. BAPS focuses on recognizing he feelings you are having that lead to smoking and how to overcome those feelings and focus on activities that discourage you from smoking and avoid activities that encourage you to smoke. Both counseling types include gathering information about your personal smoking patterns, your likes, dislikes, and other personal characteristics about your lifestyle. Half of participants who enroll in the study will receive standard smoking cessation counseling (SC) and half will receive BAPS counseling. We will compare the rates of quitting smoking across the two groups at the end of treatment (study week 10), and 12 weeks after the end of treatment (study week 26)