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NCT ID: NCT03919695 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Development of an Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda

Start date: September 2019
Phase: N/A
Study type: Interventional

Fisherfolk are a high risk population for HIV and are prioritized to receive antiretroviral treatment (ART) in Uganda, but risky alcohol use among fisherfolk is a barrier to HIV care engagement; multilevel factors influence alcohol use and poor access to HIV care in fishing villages, including a lack of motivation, social support, access to savings accounts, and access to HIV clinics. This project aims to address these barriers, and subsequently reduce heavy alcohol use and increase engagement in HIV care, through an intervention in which counselors provide individual and group counseling to increase motivation, while also addressing structural barriers to care through increased opportunities for savings and increased social support. This may be a feasible approach to help this hard-to-reach population reduce drinking and increase access care, which could ultimately reduce mortality rates, improve treatment outcomes, and through its effect on HIV viral load, decrease the likelihood of transmitting HIV to others.

NCT ID: NCT03916783 Not yet recruiting - Cancer Clinical Trials

Suubi4Cancer: Improving Access to Pediatric Cancer Services and Treatment Adherence Among Children Living With HIV/AIDS

Start date: June 2019
Phase: N/A
Study type: Interventional

This study will tailor and explore the short-term preliminary outcomes of an existing evidence-based Economic Empowerment (EE) Intervention, Suubi (Hope in Luganda -local Ugandan language), on access to pediatric cancer diagnosis, care, and treatment adherence among youth living with HIV (YLWHIV) with suspected cancers. The study will specifically address the following aims/research questions: Aim 1. Identify confirmed and suspected cancer cases in a cohort of >3000 HIV+ youth (ages10-24) seen at approximately 39 clinics in seven districts heavily affected by HIV/AIDS in southern Uganda. Aim 2. Enhance the Suubi EE intervention by including an educational component addressing misconceptions about cancer (Suubi4Cancer) and explore the acceptability and preliminary impact of Suubi4Cancer on short-term outcomes. Aim 3. Explore multi-level factors (individual, family, cultural) impacting participants' participation in and experiences withSuubi4Cancer.

NCT ID: NCT03915366 Not yet recruiting - Tuberculosis Clinical Trials

Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia

EMPIRICAL
Start date: January 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This trial will evaluate whether empirical treatment against cytomegalovirus and tuberculosis improves survival of HIV-infected infants with severe pneumonia.

NCT ID: NCT03910972 Not yet recruiting - Schistosomiasis Clinical Trials

Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults

Start date: June 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The study will recruit up to 290 healthy adult males and non-pregnant females into a two-part clinical trial of a vaccine to protect against schistosomiasis caused by infection with S. mansoni. Two formulations of the Sm-TSP-2 vaccine will be tested: one using Alhydrogel® only, and one using Alhydrogel® plus AP 10-701, each at 3 different doses of antigen: 10mcg, 30mcg, and 100mcg. The first part of the study will be a Phase I dose-escalation safety and immunogenicity study followed by a Phase IIb trial in which a larger number of adults will be enrolled to assess the impact of the vaccine on infection with S. mansoni. The impact of the vaccine on infection with S. haematobium will also be assessed although this will be exploratory given that potential cross-protection against this species is only hypothetical at this point.

NCT ID: NCT03900091 Not yet recruiting - Meningitis Clinical Trials

Paediatric Infections Point-Of-Care

PI-POC
Start date: April 1, 2019
Phase:
Study type: Observational

This study aims to identify the aetiology of childhood meningitis in Southwestern Uganda and develop and evaluate new methods for point-of-care diagnosis of childhood meningitis in a low-income setting. A prospective observational study including 600 children aged 0-12 years will be conducted during 1 year in Mbarara, Uganda. We estimate to recruit about 300 children with suspected meningitis (cases), and 300 with non-severe infection age-matched as controls.

NCT ID: NCT03895619 Recruiting - HIV Infections Clinical Trials

Getting to Zero: Safer Conception Programming Among HIV Sero-different Couples in Uganda

G2Z
Start date: November 26, 2018
Phase: N/A
Study type: Interventional

Despite effective strategies to reduce periconception HIV transmission, there are few services to support people living with or affected by HIV to use these methods. In particular, there is a lack of safer conception services focused on engaging men living with HIV. Given known gender inequities in childbearing decision-making and HIV risk, it is critical that safer conception services deliver programming that engages men living with HIV and their HIV sero-different partners. The Healthy Families program, based at the ISS Clinic at Mbarara Regional Referral Hospital, offers client-centered safer conception care to help HIV-affected individuals and couples meet reproductive goals. This care supports clients to leverage personal motivations and partner and social supports to overcome structural barriers and use Antiretroviral Therapy (ART), adopt other HIV-prevention strategies, and remain in care. This pilot study (the 'Getting to Zero' study) will assess uptake and experiences of safer conception care among 50 men living with HIV and their HIV sero-different partners. Investigators will also assess men's retention in HIV care and HIV transmission risk to partners and infants. This is a one-year mixed-methods prospective pilot research study, which will use electronic chart review data, longitudinal survey data (from the male index and female partner participant), and qualitative data from in-depth semi-structured interviews to meet study objectives. By demonstrating safer conception uptake and impact on HIV transmission risks to partners and infants, investigators aim to inform HIV and reproductive health policy in Uganda and globally.

NCT ID: NCT03885492 Not yet recruiting - Birth Asphyxia Clinical Trials

The Baby-Saver Kit: A Novel Device for Affordable Neonatal Resuscitation in Uganda (BabySaver)

BabySaver
Start date: April 1, 2019
Phase:
Study type: Observational

To examine the usability, safety and acceptability of the BabySaver kit: a novel device for neonatal resuscitation in a low-income region in Africa

NCT ID: NCT03877536 Recruiting - HIV Infections Clinical Trials

Antiretroviral Therapy for Acute HIV Infection

Start date: March 17, 2019
Phase: N/A
Study type: Interventional

This study will evaluate the virologic effect, safety and tolerability of Genvoya® in adults during early acute HIV infection.

NCT ID: NCT03848728 Not yet recruiting - HIV Clinical Trials

Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa

Start date: March 2019
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate the effect of a combination intervention on long-term HIV viral load (VL) suppression among HIV-infected adolescents and young adults 15-24 years of age. The study will take place in 28 rural HIV clinics in western Kenya and southwest Uganda. Clinics will be randomly chosen to either continue to provide study participants standard care or to provide the study intervention, which consists of discussion and counseling on major issues or life events, flexible access to the clinic, and rapid turnaround of VL test results. Participants will take part in the study for at least 2 years.

NCT ID: NCT03836833 Not yet recruiting - HIV Clinical Trials

Lopinavir/r/ Lamivudine/ Abacavir as an Easy to Use Paediatric Formulation

LOLIPOP
Start date: April 2019
Phase: Phase 1/Phase 2
Study type: Interventional

A phase I/II, open label, randomized crossover pharmacokinetic, safety and acceptability study of the Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination vs. Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg tablets) in HIV infected Children. The study is intended to support the adoption of the 4-in-1 by healthcare providers and will provide data that may support its registration in certain countries. The study will be carried out in HIV-infected children in Uganda weighing 3 to 25 kg (inclusive) and unable to swallow tablets and will provide supportive clinical data on the pharmacokinetics, safety, tolerability and acceptability of the 4-in-1.