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NCT ID: NCT03498469 Recruiting - Parenting Clinical Trials

Reintegration of Children Into Family-based Care in Uganda

Start date: December 7, 2017
Phase: N/A
Study type: Interventional

The proposed study will be an individually randomized controlled trial with children (age 1 to 13 years at the time of screening for inclusion in the study) living in residential care, reintegrated back into family-based care, in Uganda. It is designed to evaluate the impact of adding a household-based parenting program to a standardized reintegration package that includes individualized case management support and a reunification cash grant, aimed at improving the reintegration of children living in residential care back into family-based care. The study population will include children living in residential care facilities (RCFs) in Mpigi, Mukono, Masaka and Greater Masaka districts in Uganda. Study participants will be randomized to one of two arms of the study: the comparison arm and the intervention arm. The target sample size is 640 children with 320 in each arm of the study. Children assigned to the comparison arm will receive a standard reintegration package that includes individualized case management support and a reunification cash grant. Those in the intervention arm will receive the enhanced reintegration package that includes individualized case management support, reunification cash grant and a parenting intervention. Data will be collected at baseline (while the child is still living in the RCF), 6 months post-placement and 12 months post-placement. Data will be collected in the local language by a project trained local data collection partner on the following six domains of reintegration: Child health and development, Psychosocial health and wellbeing of the child and primary caregiver, Protection and safety of the child, Caregiver-child relationship, Child's and caregiver's sense of social and community belonging, Education access, quality, and achievement (where age-appropriate). The sources of data are a) interviews with primary caregiver, b) interviews with RCF caregiver, c) interviews with older children (8-13 years of age), d) standardized assessments of child cognitive functioning for all the study children, and e) focus groups and interviews with participants, parenting facilitators, and case managers.

NCT ID: NCT03494777 Not yet recruiting - HIV/AIDS Clinical Trials

Behavioral Economics Incentives to Support HIV Treatment Adherence in Sub-Saharan Africa

Start date: April 2018
Phase: N/A
Study type: Interventional

This study will implement an intervention in a two-year randomized controlled trial (RCT) to establish efficacy on viral suppression as a biological endpoint, compare the effectiveness of two different modes of implementation (including one entirely based on readily available clinic data), and investigate cost-effectiveness. Participants in the first intervention group (T1, n=110) will be eligible for small lottery prizes based on timely clinic visits, and qualify for an annual lottery conditional if demonstrating viral suppression; those in the second group (T2, n=110) will draw prizes conditional on electronically measured adherence at each clinic visit, and also participate in an annual lottery that is conditional on high adherence throughout the year. The control group (n=110) will receive the usual standard of care. Assessments will be conducted at baseline and then every six months. Primary outcomes are undetectable viral load and electronically measured adherence.

NCT ID: NCT03492216 Not yet recruiting - Tuberculosis Clinical Trials

Drinkers' Intervention to Prevent Tuberculosis (DIPT Study)

DIPT
Start date: April 2018
Phase: N/A
Study type: Interventional

There is an urgent global need to decrease the high mortality of tuberculosis (TB) in persons with HIV as TB is the leading cause of death among persons with HIV worldwide. The DIPT (Drinkers' Intervention to Prevent TB) study is a randomized, 2x2 factorial trial among HIV/TB co-infected adults in Uganda with heavy alcohol use (n=680 persons, 340 each U01). The goal of the study is to determine whether economic incentive interventions can promote both reduced alcohol use and isoniazid (INH) pill taking among HIV/TB co-infected adult heavy drinkers, during isoniazid preventive therapy (IPT: a six-month course of INH) at HIV clinics in southwestern Uganda. Participants will be randomized to one of four arms: Arm 1: no incentives (control); Arm 2: economic incentives for decreasing alcohol use only; Arm 3: economic incentives for IPT adherence only; Arm 4: economic incentives for decreasing alcohol use and for IPT adherence (rewarded independently).

NCT ID: NCT03486054 Not yet recruiting - Safety Issues Clinical Trials

Pathogen Intercept Inactivation of Whole Blood Transfusions for Sub-Saharan Africa

POINT1africa
Start date: June 2018
Phase: N/A
Study type: Interventional

The pathogen inactivation (PI) system for Whole Blood (WB) using Amustaline (S-303) and Glutathione (GSH) has a potential to decrease transfusion-transmitted infection. There is scientific basis to hypothesize, that cells containing DNA and RNA such as bacteria, viruses and parasites that could be present in blood collected from asymptomatic infected donors are inactivated in the treated whole blood and therefore reduce the risk of transfusion-transmitted infections. The aim of the study is to gather data to support the safety of whole blood products that underwent treatment with amustaline and glutathione and data to support a larger sufficiently powered efficacy study. This study will evaluate the safety of the system for whole blood in adult cancer patients with anemia. This study has a two-stage design. Stage 1 is designed as a randomized, double-blind stage, followed by Stage 2, an open-label, single arm treatment escalation stage. The aim is to explore the safety of the whole blood product treated with a PI system using amustaline and glutathione. The study will enroll 30 patients with anemia due to underlying cancer. In stage1, 20 patients will be randomized either to treated WB (Test) or conventional WB (Control). After safety assessment in Stage 1, Stage 2, a dose escalation stage will follow and enroll additional 10 patients in need of 2 WB products administered successively to correct anemia.

NCT ID: NCT03484533 Not yet recruiting - HIV Clinical Trials

HIV Self Testing of Male Partners of Women in PMTCT

Start date: April 2018
Phase: N/A
Study type: Interventional

The investigators will conduct a randomized trial to evaluate whether provision of oral HIV self-test kits (HIVST) to HIV-positive pregnant women to provide to their male partner, increases the proportion of male partners who test and link to HIV care or prevention, compared to invitation letters for fast track testing. Pregnant women who are randomized to the arm with secondary distribution of HIVST to their male partners will be trained in the use and interpretation of HIVST, and given two oral fluid-based HIVST kits to use with or give to their partners, along with information about HIV testing and prevention and care services. The investigators will offer men confirmatory testing regardless of their HIVST result, counseling, and if negative, pre-exposure prophylaxis (PrEP) and if positive, antiretroviral therapy (ART). The investigators will provide counseling to minimize social harms of HIV self-testing, and additional counseling and referral to social support services when social harms occur. This project will address key challenges in PMTCT B+ programs, by evaluating innovative strategies to increase male partner's knowledge of their HIV status, disclosure, and involvement coupled with offering PrEP to HIV-negative men, ART to HIV-positive men, and encouraging post-partum ART continuation and adherence among HIV-positive women.

NCT ID: NCT03472326 Recruiting - HIV-1-infection Clinical Trials

Efficacy of GS-9131 Functional Monotherapy in HIV-1-Infected Adults Failing a Nucleos(t)Ide Reverse Transcriptase Inhibitor-Containing Regimen

Start date: April 3, 2018
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the short-term antiviral potency of a regimen containing GS-9131 at 30 mg, 60 mg, and 90 mg, compared to placebo-to-match (PTM) GS-9131, each administered once daily with the existing failing antiretroviral therapy (ART) regimen. This is a two-part study. Part 1 consists of two cohorts: a Sentinel Cohort followed by a Randomized Cohort. Eligible participants from Part 1 will proceed to Part 2 followed by an optional open-label extension.

NCT ID: NCT03464266 Not yet recruiting - Clinical trials for Bone Demineralization

The Kampala Women's Bone Study

Start date: March 2018
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to address critical safety questions with concurrent TDF-based PrEP and DMPA use. We hypothesize that young women using TDF-based PrEP and DMPA will have lower bone acquisition and altered bone metabolism. Bone mineral metabolism is in part regulated by the kidney, and we hypothesize that bone effects from concurrent PrEP and DMPA use will be driven by subclinical kidney injury, a known side effect of TDF, as well as DMPA-induced hypoestrogenism. To investigate our hypothesis, we will enroll a prospective cohort of approximately 500 HIV-uninfected women ages 16-25 years in Kampala, Uganda who have substantial HIV risk and are initiating DMPA or barrier method contraception. Over a 24-month period, we will offer TDF-based PrEP. We will use state-of-the-art radiologic, biochemical, and epidemiologic methods to test the hypothesis that concurrent TDF-based PrEP and DMPA use results in compounding adverse effects on bone health.

NCT ID: NCT03453840 Recruiting - Clinical trials for Uncomplicated Plasmodium Falciparum Malaria

Extended Duration Artemether-lumefantrine Treatment for Malaria in Children

EXALT
Start date: February 19, 2018
Phase: Phase 4
Study type: Interventional

This project will determine the pharmacokinetic/pharmacodynamic (PK/PD) of an extended artemether-lumefantrine (AL) dosing regimen in HIV-infected children on efavirenz (EFV)-based antiretroviral therapy (ART) that is designed to improve the PK exposure and treatment efficacy of this artemisinins-based combination therapy (ACT) regimen. Our overarching goal is to inform the best treatment guidelines for young children in Africa. HIV-infected and HIV-uninfected children will be enrolled for intensive PK studies, as well as additional children for population PK studies to enhance association analyses with clinical outcomes.

NCT ID: NCT03435497 Recruiting - HIV Clinical Trials

Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda

Start date: April 16, 2018
Phase: N/A
Study type: Interventional

This randomized controlled pilot study of the "Game Changers" program will: 1. Assess the feasibility and acceptability of implementing an HIV prevention advocacy intervention with people living with HIV who are in HIV care, and who will be trained to be advocates of HIV protective behaviors within their social networks. 2. Assess preliminary intervention effects on a) protective behavior of the HIV-positive clients (condom use, partner concurrency/number of partners, engagement in HIV care, ART adherence); and b) diffusion of prevention messages across the network, as assessed by the content and extent of communication with network members about protective behaviors (condom use, partner concurrency/number of partners, HIV testing, engagement in HIV care, circumcision), HIV disclosure, and HIV stigma. 3. Explore characteristics of HIV-positive clients who more effectively engage in prevention advocacy (in terms of socio-demographics, network characteristics, and network position and type of alters receiving advocacy).

NCT ID: NCT03432039 Recruiting - Malaria Clinical Trials

Preventing Mental Health Problems After Childhood Severe Malaria

Start date: January 9, 2018
Phase: N/A
Study type: Interventional

This is a randomized trial in which caregivers of children suffering from malaria will be assigned to two treatment conditions to prevent mental health problems in the children. A psycho-education arm (control) and a behavioral arm (intervention). Pre- and post-intervention assessments for behavioral problems in the child and mother will be carried out.