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NCT ID: NCT03315962 Not yet recruiting - Tuberculosis Clinical Trials

Simplified Isoniazid Preventive Therapy Strategy to Reduce TB Burden

SEARCH-IPT
Start date: October 2017
Phase: N/A
Study type: Interventional

The failure to use isoniazid (INH) preventative therapy (IPT) in HIV-infected individuals in Sub-Saharan Africa represents one of the single biggest implementation gaps between evidence and practice in today's response to the HIV epidemic. The proposed study will evaluate the effectiveness of a multi-component intervention to improve IPT uptake across the country of Uganda. The overall objective of this study is to determine if a multi-component implementation intervention (SPIRIT) that targets District Health Officers (DHOs) can increase IPT initiation and completion among HIV-infected persons, and decrease tuberculosis (TB) incidence, as compared to country standard practices, in a cluster randomized trial in Uganda.

NCT ID: NCT03307226 Not yet recruiting - HIV/AIDS Clinical Trials

Suubi4Her: A Combination Intervention Addressing HIV Risk Behaviors Among Older Adolescent Girls Transitioning Into Adulthood in Uganda

Start date: October 15, 2017
Phase: N/A
Study type: Interventional

This study examines the impact and cost associated with Suubi4Her, an innovative combination intervention that aims to prevent HIV risk behaviors among 15-17 year-old girls living in communities heavily affected by poverty and HIV/AIDS in Uganda. Participants will be randomly assigned at the school level into one of three study conditions: 1) Savings (Youth Development Accounts - YDA) - with a 1:1 incentive match rate - for education and microenterprise development; 2) Savings (YDA) + Multiple Family Groups intervention; 3) Control condition receiving standard health and sex education provided in schools. The intervention will last for 24 months. Assessments will be conducted at baseline, 12, 24 and 36 months. Assessments will include biologically confirmed STIs, proportion of HIV infections during the study period, and for HIV+ participants markers for ART adherence. The study aims to examine the impact of the Suubi4Her intervention on behavioral health functioning, and protecting adolescent girls against known HIV risk factors. The study will also examine the cost-effectiveness of each intervention condition.

NCT ID: NCT03302299 Recruiting - Tuberculosis Clinical Trials

Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT)

ADEPTT
Start date: April 7, 2017
Phase: Phase 4
Study type: Interventional

The Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT) will examine the safety and tolerability of, and adherence to, 6 months of daily INH (6H) in 300 TB and HIV-infected persons (200 drinkers and 100 non-drinkers) in Uganda. The first aim is to evaluate the safety and tolerability of 6H overall and by level of alcohol use. The second aim is to estimate adherence and compare adherence by level of alcohol use and at 3 and 6 months. Self-reported measures of alcohol use will be augmented by phosphatidylethanol (PEth), an established biomarker of alcohol use. Objective measures of adherence will include electronic pill bottle monitoring and a novel measure of INH exposure, INH concentration in hair. The study will actively monitor for hepatotoxicity using the U.S. standard of care for TB preventive therapy for heavy drinkers and discontinue if any Grade 3/4 toxicities are detected. The investigators will use the safety, tolerability, and adherence results, together with the known efficacy and mortality benefit of TB preventive therapy in HIV-infected persons in SSA, and an established decision analytic model of TB preventive therapy to conduct the third aim: to determine whether the benefits of TB preventive therapy outweigh the toxicity risks for HIV-infected drinkers in resource limited settings. The study will additionally follow the cohort every 6 months after completing INH to monitor drinking and the development of active TB.

NCT ID: NCT03284866 Not yet recruiting - HIV Infection Clinical Trials

HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV

COVENANT
Start date: October 2017
Phase: Phase 3
Study type: Interventional

This randomized phase III trial studies how well human papillomavirus (HPV) vaccine therapy works in reducing high-grade cervical lesions in patients with human immunodeficiency virus (HIV) and HPV. Vaccines made from HPV peptides or antigens may help the body build an effective immune response to kill the HPV virus and prevent cervical lesions from developing or coming back after being removed.

NCT ID: NCT03282799 Not yet recruiting - Contraception Clinical Trials

Pharmacologic Strategies for the Etonogestrel Implant in HIV-Infected Women

Start date: January 2018
Phase: Phase 2
Study type: Interventional

This study will evaluate the frequency of ovulation and cervical mucus quality of HIV-infected women on efavirenz (EFV)-based antiretroviral therapy (ART) using either a single etonogestrel (ENG) implant or two ENG implants for at least one year.

NCT ID: NCT03249181 Not yet recruiting - Pregnancy Related Clinical Trials

Dolutegravir in Pregnant HIV Mothers and Their Neonates

DolPHIN-2
Start date: September 2017
Phase: Phase 3
Study type: Interventional

To evaluate dolutegravir (DTG) efficacy in women who present with untreated HIV in late pregnancy. An open-label, multi-centre randomised controlled trial of DTG vs efavirenz-based regimens for women commencing cART in late pregnancy. HIV positive pregnant women presenting with untreated HIV infection in late (≥28 weeks gestation) pregnancy will be randomised 1:1 to receive DTG (50mg once daily) + 2 nucleoside reverse transcriptase inhibitors (NRTIs) or EFV + 2 NRTIs (SoC)

NCT ID: NCT03208725 Recruiting - Sepsis Clinical Trials

Childhood Acute Illness and Nutrition Network

CHAIN
Start date: November 2016
Phase: N/A
Study type: Observational

The CHAIN Network aims to identify modifiable biomedical and social factors driving the greatly increased risk of mortality among young undernourished children admitted to hospital with acute illness, as inpatients and after discharge. The study will inform priorities, risks and targeting for multi-faceted interventional trials. CHAIN is a multi-centre cohort study with a nested case control analysis of stored biological samples. Study sites are located in Africa and South Asia. Children will be recruited at admission to hospital, stratified by nutritional status. Exposures will be assessed at admission, during hospitalisation, at discharge, and at two time points after discharge. The main outcomes of interest are mortality, re-admission to hospital and failure of nutritional recovery up to 180 days after discharge. To determine community health norms, an additional sample of children living in the same communities will be enrolled and assessed at one time point only.

NCT ID: NCT03203200 Recruiting - Clinical trials for Sexually Transmitted Infection

A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Sex Workers

ZETRA
Start date: August 2015
Phase: N/A
Study type: Interventional

This study develops and tests a behavioural and structural intervention to prevent unprotected sex among young female sex workers. Half the participants will receive the intervention and half will receive the standard of care.

NCT ID: NCT03179059 Active, not recruiting - Pregnancy Tests Clinical Trials

Resolution of Uncertainty Through Testing

Start date: September 28, 2017
Phase: N/A
Study type: Interventional

Given the high rate of delayed adoption of antenatal care (ANC), and high rates of unintended pregnancy and unsafe abortion in Uganda, research on the period of time before confirmation of pregnancy is critical to understand underlying beliefs that guide behaviors ultimately important for maternal and neonatal health (UDHS, 2011; Hussain, 2013). Home pregnancy tests - which now cost less than 10 cents each - have the potential to facilitate FP uptake and significantly improve reproductive, maternal and child health outcomes in sub-Saharan Africa, including Uganda. These tests are easy to administer, disposable, inexpensive, and have a low false positive rate. Yet, for women living in rural areas in sub-Saharan countries, these tests are typically unavailable outside of health centers or they are prohibitively expensive. This study will investigate women's underlying beliefs about pregnancy status and examine how providing access to home-based pregnancy tests - thus facilitating earlier resolution of uncertainty of pregnancy status - influences such beliefs and decisions to take up family planning (FP) or seek appropriate pregnancy services. The results will inform the design of a larger study in the future.

NCT ID: NCT03174236 Not yet recruiting - Clinical trials for Antibiotic Resistance

First Line Antimicrobials in Children With Complicated Severe Acute Malnutrition

FLACSAM
Start date: June 5, 2017
Phase: Phase 3
Study type: Interventional

Children with severe malnutrition who are admitted sick to hospitals have a high mortality(death rate), usually because of infection. All children with severe malnutrition admitted to hospitals are treated with antibiotics(medication used to kill bacteria). However, the current antibiotics used in hospitals may not be the most effective. It is possible that the antibiotics that are currently used after initial antibiotics should be used first. No studies have been carried out to determine if the current antibiotics used for treating malnourished children who are sick and admitted in hospital are the most appropriate. The aim of this study is to find out if a changed antibiotic system for children with malnutrition is safe, reduces the risk of death and improves nutritional recovery.