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NCT ID: NCT05393193 Recruiting - HIV Clinical Trials

Point-of-Care HIV Testing and Early Dolutegravir Use for Infants

Moso
Start date: July 4, 2022
Phase: Phase 4
Study type: Interventional

This study is being conducted to explore the feasibility of implementing targeted birth HIV testing of high-risk neonates using facility-based point-of-care (POC) HIV diagnostics, and to improve the ability to implement the best standard-of-care treatment possible. Infants found to be HIV infected will be immediately offered enrollment into a dolutegravir (DTG) antiretroviral treatment study cohort (if maternal consent is granted) or referred for treatment at a government facility. Infants who enter the study treatment cohort will be prospectively followed through 96 weeks of age. ART will follow Botswana guidelines.

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: 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: 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)

NCT ID: NCT04518228 Recruiting - HIV Infections Clinical Trials

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum

Start date: September 1, 2021
Phase:
Study type: Observational

The purpose of this study is to evaluate the pharmacokinetic (PK) properties of antiretroviral (ARV) and anti-tuberculosis (TB) drugs administered during pregnancy and postpartum.

NCT ID: NCT04426448 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Assessment of a Brief Post Traumatic Stress Disorder Intervention for Use in Botswana

Start date: July 8, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to culturally adapt a brief psychological intervention for Post-Traumatic Stress Disorder (PTSD) and assess its efficacy, feasibility, and acceptability in a pilot trial. The intervention has been shown to be efficacious among individuals with comorbid severe mental illness (SMI) and PTSD. The study will be conducted in three phases. The first phase will determine a description of trauma and responses to traumatic experiences among patients with severe mental illness. The first phase of the study will also determine participants' and mental health care providers' perceptions of suitable PTSD interventions in this middle-income context. The findings will then be used to culturally adapt the brief intervention in the second phase. A pilot trial will be conducted in the third phase of the study. Participants with comorbid SMI and PTSD will be randomized into two groups (n= 20 intervention group, n= 20 control group). Outcomes of the intervention such as the severity of PTSD symptoms, knowledge about PTSD will be assessed at baseline and at different timelines during the study. This study will fill the knowledge gap on trauma and its consequences among individuals with severe mental illness in Botswana, it will also contribute to the improvement of clinical practice in the management of PTSD and SMI.

NCT ID: NCT04141449 Recruiting - Breast Cancer Clinical Trials

A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation

Potlako+
Start date: November 18, 2020
Phase: Phase 2
Study type: Interventional

This study evaluates whether the Potlako+ intervention of community education, clinical provider support, and patient navigation can improve access to cancer case for patients presenting with symptoms of cancer. Half of communities will receive the Potlako+ intervention, while the other communities will continue to receive standard programs.

NCT ID: NCT04024488 Recruiting - HIV-1-infection Clinical Trials

Group-Based Intervention to Improve Mental Health and Adherence Among Youth Living With HIV in Low Resource Settings

Start date: November 11, 2023
Phase: N/A
Study type: Interventional

IMPAACT 2016 is a multi-site, two-arm, individually randomized, controlled study to evaluate whether an Indigenous Leader Outreach Model (ILOM) of trauma-informed cognitive behavioral therapy (TI-CBT) delivered by Indigenous Youth Leaders (IYL) is associated with improved mental health outcomes and ART adherence among youth living with HIV in resource-limited settings. The intervention is adapted to the local context through advance conduct of focus groups and pilot testing.