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NCT ID: NCT06165315 Active, not recruiting - Child Development Clinical Trials

Evaluation of a Group-based Parenting Intervention for Early Childhood Development

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

This implementation research study aims to evaluate the impact and implementation of a group-based parenting program for improving early child development and caregiver outcomes. This study is enrolling primary caregivers with children 0 to 24 months of age to promote caregiver knowledge and skills about nurturing care for young children and support caregiver psychosocial wellbeing. Parenting groups will leverage existing community group networks and be facilitated by trained volunteers for 20 total sessions (groups will meet twice a month for 10 months). ChildFund Kenya and its community partners will implement the program in Busia and Homabay counties. The research study design will involve a cluster-randomized controlled trial and a qualitative implementation evaluation. This research is being led by Emory University with funding from the Conrad N. Hilton Foundation.

NCT ID: NCT06132373 Active, not recruiting - Clinical trials for Mental Disorder of Infancy, Childhood, or Adolescence (Diagnosis)

Assessing Implementation of Delivering Community-based, Peer-led Interventions for Mental Health Problems Among Youth in Eldoret, Kenya

Husisha
Start date: June 27, 2023
Phase: N/A
Study type: Interventional

Introduction: Mental health disorders are a leading cause of disability among youth globally, and this has been worsened by the COVID-19 pandemic. In low and middle-income countries like Kenya and in rural Indiana, there is an enormous treatment gap for youth mental disorders due to limited mental health care resources. Goals: The purpose of this project is to examine the implementation of community-based, peer-led management of mental health care screening, and treatment for adolescents in Eldoret, Kenya using the REAIM framework. Methods: We shall conduct a one-week training to peer-mentors on screening for common mental health problems using the SDQ, PHQ-9, GAD-7, and YTP and treating adolescents who screen positive using a 5 session Problem Solving Treatment (PST), an evidence-based treatment for common youth mental health problems. We will then select five of the peers to deliver the intervention under the supervision of the study team at the largest community-based youth drop-in center, Family Health Options Kenya (FHOK), in Eldoret, where the peers already provide mentorship to adolescents. We will use the REAIM Framework to assess the reach, effectiveness, adoption, implementation, and maintenance of this intervention.

NCT ID: NCT05845619 Active, not recruiting - HIV Infections Clinical Trials

Enhanced Virologic Monitoring for Pregnant and Postpartum Women With HIV

Start date: May 8, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to learn about supporting pregnant and postpartum women living with HIV with treatment adherence. The investigators will conduct a pilot study of an intervention that includes peer counseling about viral load levels and rapid delivery of viral load results. The investigators will evaluate the feasibility of the intervention, and will assess whether it improves viral suppression 6 months following the intervention, compared to historical controls.

NCT ID: NCT05746065 Active, not recruiting - HIV Infections Clinical Trials

A Cohort for Evaluation of Open-label PrEP Use and PreP Preferences Among African Women

INSIGHT
Start date: May 20, 2022
Phase:
Study type: Observational

INSIGHT is a Prospective, Observational, open-label cohort study on women in Sub-Saharan Africa on PrEP screening, informed choice, and compliance. There are no specific intervention arms or comparative treatment plans. We will follow and observe participants taking PrEP, not taking PrEP, as well as those who begin or end PrEP during the course of the observational period.

NCT ID: NCT05561140 Active, not recruiting - Sickle Cell Disease Clinical Trials

Resolution of Sickle Cell Leg Ulcers With Voxelotor

RESOLVE
Start date: May 30, 2022
Phase: Phase 3
Study type: Interventional

This study is a Phase 3, multicenter, randomized, placebo-controlled study to evaluate the efficacy of voxelotor and standard of care for the treatment of leg ulcers in participants with sickle cell disease. The study is divided into a 5 study periods: Screening, Run-in, Randomized Treatment, Open-label Treatment, and Follow-up/End of Study (EOS). The study will be conducted in approximately 80 eligible participants at approximately 20 global clinical trial sites.

NCT ID: NCT05549726 Active, not recruiting - HIV Clinical Trials

SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension

Start date: January 2, 2023
Phase: Phase 4
Study type: Interventional

The overall purpose of this SEARCH CAB-LA (Cabotegravir Injectable Suspension) randomized extension study is to determine if adding the option of CAB-LA as a prevention choice using a person-centered dynamic choice HIV (human immunodeficiency virus) prevention model, with option to switch products over time, compared to the standard of care: 1) increases prevention coverage ; 2) reduces HIV incident infection; and 3) increases prevention coverage during periods of self-assessed risk of HIV infection, in three settings in rural Uganda and Kenya. In addition, this study will describe implementation of a person-centered model for dynamic choice HIV prevention including CAB-LA, using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) evaluation framework among persons randomized to the intervention arm.

NCT ID: NCT05465265 Active, not recruiting - PrEP Uptake Clinical Trials

PrEP for Prevention of HIV Transmission Among People Who Inject Drugs in Nairobi, Kenya

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The investigators broadly aim at determining barriers and facilitators to PrEP uptake and adherence and retention among the study participants. The investigators have the following specific objectives of determining: (1) the PrEP knowledge levels, attitudes, practices, and user experiences among injecting and sexual partners of PWID in Nairobi County (2) the socio-demographic, behavioural, and structural factors hindering the uptake of PrEP among PWID's sexual and injecting partners in Nairobi County; and (3) the effect of a theory-guided behavioural intervention (PrEP-UP) utilizing peer outreach and navigation on the uptake of PrEP by the study participants. The investigators hypothesize that: PWID's injecting and sexual partners in Nairobi City lack PrEP knowledge, and have poor attitudes practices, and user experiences about PrEP; less than 50.0% of the PWID's sexual and injecting partners in Nairobi County have socio-demographic, behavioural and structural factors hindering their uptake of PrEP; and a theory-guided behavioural intervention (PrEP-UP) utilizing peer outreach and navigation has no effect on the uptake of PrEP by the study participants.

NCT ID: NCT05415215 Active, not recruiting - Clinical trials for Locally Advanced Breast Cancer

A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer

ProHer
Start date: July 5, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase IIIb, multinational, multicenter, randomized, open-label study to evaluate patient preference of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) administration in the home setting compared with the hospital setting during the cross-over period of adjuvant treatment in participants with early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer.

NCT ID: NCT05385484 Active, not recruiting - Clinical trials for Human Immunodeficiency Virus

A Savings Intervention to Reduce Men's Engagement in HIV Risk Behaviors

Start date: July 18, 2022
Phase: N/A
Study type: Interventional

This randomized control trial will test an economic intervention to reduce Kenyan men's engagement in behaviors that increase the risk of HIV/STIs. Participants randomized to the intervention group will be able to open accounts with a partner bank and will be incentivized to save with lottery-based rewards.

NCT ID: NCT05362955 Active, not recruiting - HIV Infections Clinical Trials

5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa

Start date: April 26, 2023
Phase: Phase 1
Study type: Interventional

This is a single arm study on the safety, feasibility, and acceptability of adjuvant, self-administered, intravaginal 5-Fluorouracil (5-FU) following treatment for high-grade cervical precancer (CIN2/3) among women living with human immunodeficiency virus (HIV).