The diagnosis and treatment of Chlamydia Trachomatis and Neisseria Gonorrhea in Woman to prevent adverse neonatal consequences (Maduo/STI Study)
Principal Investigator Initiated
Principal Investigator - Dr. Chelsea Morroni, MD, MPH, PhD
Name of the study: The diagnosis and treatment of Chlamydia trachomatis and Neisseria gonorrhoeae in pregnant women to prevent adverse neonatal consequences (Maduo Study).
Study Status: Recruiting
Study Objectives
The diagnosis and treatment of Chlamydia trachomatis and Neisseria gonorrhoeae in pregnant women to prevent adverse neonatal consequences.
Principal Investigator Initiated
The FACET Study: Family Dynamics and Child Neurodevelopment in Botswana
Principal Investigator Initiated
Principal Investigator - Kathleen Powis, MD, MPH, MBA | Michelle Bulterys PhD
Study Objectives:
Tshilo Dikotla Study: Metabolic Outcomes of Children HIV/ARV- Exposed Uninfected in Botswana
Principal Investigator Initiated
Principal Investigator - Dr. Jennifer Jao, MD, MPH
Study Objectives
Primary Objectives
- To assess the early longitudinal metabolic effects including insulin sensitivity in HIV-exposed uninfected (HEU) children compared to HIV-unexposed uninfected (HUU) children.
- To determine differences in the effects of neonatal zidovudine (AZT) vs. nevirapine (NVP) prophylaxis on early longitudinal changes in insulin sensitivity in the first 3 years of life.
Secondary Objectives
Understanding the Mechanisms of Adverse Birth Outcomes in Botswana
Principal Investigator Initiated
Principal Investigator - Dr. Rebecca Zash, MD
Study Objectives: General and Specific
Virologic and Molecular characterization of HIV-1Strains in non-citizens in Botswana
Principal Investigator Initiated
Principal Investigator: Patrick T Mokgethi Bsc
Study Objectives:
Virologic responses among people with HIV on dolutegravir-based first line therapy in Botswana
Principal Investigator Initiated
Principal Investigator: Ontlametse T Bareng Bsc
Study Objectives:
The aim of the study is to:
Assessing barriers and facilitators to improving prenatal supplementation and preconception fortification in Botswana – a qualitative study
CoVPN 5001: A Prospective Study of Acute Immune Responses to SARS-CoV-2 Infection.
Principal Investigator - Dr. Joseph Makhema MB.ChB, FRCP
Study Objectives
Primary Objectives
Evaluating a Group-Based Intervention to Improve Mental Health and ART Adherence Among Youth Living with HIV in Low Resource Settings (IMPAACT 2016)
HPTN 084: A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women
Principal Investigator - Dr. Shahin Lockman MD, MPH
Study Objectives
Primary Objectives
- Efficacy: To evaluate the relative efficacy of oral CAB/CAB LA (oral run-in and injections, Steps 1 and 2) vs. daily oral TDF/FTC for HIV prevention (Steps 1 and 2).
- Safety: To evaluate the relative safety of oral CAB/CAB LA (oral run-in and injections, Steps 1 and 2) vs. daily oral TDF/FTC for HIV prevention (Steps 1 and 2).
Secondary Objectives
HVTN 703/HPTN 081 (AMP Study): A phase 2b study to evaluate the efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection in women in Sub- Saharan Africa.
Principal Investigator - Dr. Shahin Lockman MD, MPH
Study Objectives
Primary Objectives
- To evaluate the safety and tolerability of VRC01 mAb administered through IV infusion in sub-Saharan African women.
- To determine if the VRC01 mAb prevents HIV-1 infection and to estimate the level of efficacy in sub-Saharan African women.
Study Design: Multicenter, randomized, controlled, double-blind trial.
HVTN805/HPTN093: Antiretroviral analytical treatment interruption (ATI) to assess immunologic and virologic responses in participants who initiated ART in early HIV infection after having received VRC01 or placebo in HVTN 703/HPTN 081.
Principal Investigator - Dr. Shahin Lockman MD, MPH
Study Objectives
Primary Objectives
- To evaluate the effect of early ART initiation, with or without having received VRC01 in the immediate pre-HIV acquisition period and/or during early infection, on the time to meeting ART re-initiation criteria in participants undergoing ATI.
- To evaluate the safety of ATI among HVTN 805/HPTN 093 participants.
Secondary Objectives
IMPAACT 2005
Principal Investigator - Dr. Shahin Lockman MD, MPH
Study Title: IMPAACT 2005 - Phase I/II Open-label, Single-Arm Study to Evaluate Pharmacokinetics (PK), Safety, and Tolerability of Delamanid (DLM) in Combination with Optimized Multidrug Background Regimen (OBR) for Multidrug Resistance-Tuberculosis (MDR-TB) in HIV-infected and HIV-uninfected Children with MDR-TB
Study Objectives
Primary Objectives
IMPAACT 2017 - Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents
Principal Investigator - Dr. Shahin Lockman MD, MPH
Study Objectives
Primary Objectives
Cohort 1 (continuing a background cART regimen)
IMPAACT 2019 – Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less than 12 Years of Age
Principal Investigator - Dr. Shahin Lockman MD, MPH
Study Objectives
Primary Objectives
IMPAACT 2042: Phase I/II Trial to Evaluate the Impact of Three Broadly Neutralizing Antibodies or Analytic Treatment Interruption on Viral Reservoir, Immune Function, and Maintenance of HIV Suppression in Early-Treated Children in Botswana
Principal Investigator: Roger Shapiro, MD,MPH
Study Objectives:
Primary Objectives
Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern: CoVPN 3008
Principal Investigator - Dr. Joseph Moeketsi Makhema MB.ChB, FRCP
Study Objectives
Primary Objectives:
Open-Label, Single-Arm, Phase 3B Study of the Incidence of Severe COVID-19 and Adverse Events Following AZD1222 COVID-19 Vaccination in Botswana Against SARS-CoV-2
Principal Investigator - Dr. Joseph Moeketsi Makhema, MB.ChB, FRCP
P1093 - Phase I/II, Multi-Centre, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents
Principal Investigator - Dr. Shahin Lockman MD, MPH
Study Objectives
Primary Objectives
