Clinical trials: in Botswana
RSV
Stakeholder-Informed RSV Prevention Economic Model in Botswana
The goal of this mixed methods study is to engage stakeholders to develop a health economic model to estimate the costs, health benefits, and value of respiratory syncytial virus (RSV) prevention strategies.
- Trial name
- NCT07756528
- Where
- Botswana
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
HIV Infections
Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants
The purpose of this study was to compare the virologic efficacy and safety of three antiretroviral (ARV) regimens, dolutegravir plus emtricitabine/tenofovir alafenamide, dolutegravir plus emtricitabine/tenofovir disoproxil…
- Trial name
- VESTED (NCT03048422)
- Testing
- Dolutegravir, Emtricitabine/tenofovir alafenamide, Emtricitabine/tenofovir disoproxil fumarate
- Where
- 21 sites in United States, Botswana and 7 more
- Volunteers
- 643 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pre-Exposure Prophylaxis (PrEP), Breast Feeding
Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana
The goal of this this hybrid safety/implementation study is to evaluate whether using long-acting cabotegravir (CAB-LA) for HIV prevention (PrEP) is acceptable, feasible and safe in post-partum people who are breastfeeding.
- Trial name
- Tshireletso (NCT05986084)
- Testing
- Cabotegravir Injection [Apretude]
- Where
- 2 sites in United States, Botswana
- Volunteers
- 500 people
- Sponsor
- Beth Israel Deaconess Medical Center
Cervical Cancer
Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana
Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a pragmatic trial design.
- Trial name
- NCT05952141
- Testing
- Clinic Outreach, Enhanced Outreach, Low-Touch Strategy
- Where
- 3 sites in United States, Botswana
- Volunteers
- 610 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Major Depressive Disorder, Mild Neurocognitive Disorder
Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV
A phase II, randomized, open-label, two-arm clinical trial evaluating the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and comorbid MDD with…
- Conditions
- Major Depressive Disorder, Mild Neurocognitive Disorder, HIV
- Trial name
- NCT06705478
- Testing
- Pramipexole ER, Escitalopram
- Where
- 41 sites in United States, Botswana and 12 more
- Volunteers
- 186 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Obstructive Pulmonary Disease, Restrictive Pulmonary Disease
Lung Health and the Microbiome Among Adults in Botswana: the Go-hema Cohort
Chronic respiratory diseases like chronic obstructive pulmonary disease (COPD) are responsible for millions of deaths each year, the majority of which occur in low- and middle-income countries (LMICs).
- Trial name
- NCT07699614
- Where
- Botswana
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Duke University
HIV
POC HIV Testing and Early DTG Use for Infants
This study is being conducted to explore the feasibility of implementing targeted birth HIV testing of high-risk neonates using facility-based point-of-care (POC) HIV diagnostics, and to improve the ability to implement the best…
- Trial name
- NCT05393193
- Testing
- Point-of-Care Cepheid Xpert HIV-1, DTG/ABC/3TC
- Where
- Botswana
- Volunteers
- 900 people
- Sponsor
- Harvard School of Public Health (HSPH)
Antenatal Health, Antenatal Care
Healthy Expectancy Through Routine Antenatal STI Screening
This study will evaluate whether routine screening and treatment for two common sexually transmitted infections, chlamydia and gonorrhoea, during pregnancy can reduce preterm birth and other poor birth outcomes in Botswana, and…
- Conditions
- Antenatal Health, Antenatal Care, STI, Chlamydia Trachomatis Infection in Pregnancy
- Trial name
- HERA (NCT07458802)
- Testing
- Chlamydia trachomatis and Neisseria gonorrhoeae screening
- Where
- Botswana
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Adriane Wynn
PrEP Adherence, Sexually Transmitted Infections (STIs)
STI Testing to Enhance PrEP Use in Pregnancy
The investigators are conducting a study in Botswana to see if offering STI testing along with expanded HIV prevention options (PrEP) helps more pregnant women start and continue using PrEP during and after pregnancy.
- Conditions
- PrEP Adherence, Sexually Transmitted Infections (STIs), Pregnancy
- Trial name
- STEP-UP (NCT06919614)
- Testing
- Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing
- Where
- Botswana
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Botswana Harvard AIDS Institute Partnership
Tuberculosis, HIV Infections
Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
This is a randomized, blinded, two-arm comparative trial of continued versus limited isoniazid (INH) tuberculosis (TB) preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana.
- Trial name
- NCT00164281
- Testing
- Isoniazid
- Where
- Botswana
- Volunteers
- 1,995 people
- Sponsor
- Centers for Disease Control and Prevention
HIV-1-infection
Group-Based Intervention to Improve Mental Health and Adherence Among Youth Living With HIV in Low Resource Settings
IMPAACT 2016 was a multi-site, two-arm, individually randomized, controlled study to evaluate whether an Indigenous Leader Outreach Model (ILOM) of trauma-informed cognitive behavioral therapy (TI-CBT) delivered by Indigenous…
- Trial name
- NCT04024488
- Testing
- Youth TI-CBT Intervention Arm, Youth Discussion Control Arm, Caregiver TI-CBT Intervention Arm
- Where
- 8 sites in Botswana, Malawi and 2 more
- Volunteers
- 484 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
HIV Infections, Hypertension
Integrating Hypertension and Cardiovascular Diseases Care Into Existing HIV Services Package in Botswana (InterCARE)
The InterCARE research project proposes to leverage a successful national ART program to develop an effective package to improve the uptake of established effective hypertension and CVD risk factors management interventions among…
- Trial name
- InterCARE (NCT05414526)
- Testing
- InterCARE package
- Where
- 3 sites in Botswana
- Volunteers
- 4,655 people
- Sponsor
- University of Botswana
HIV Infection
Dual bNAb Treatment in Children
The purpose of this study is to evaluate the impact of two broadly neutralizing antibodies, VRC01LS and 10-1074, on the maintenance of HIV suppression in a cohort of early-treated children in Botswana.
- Trial name
- NCT03707977
- Testing
- ART, VRC01LS, 10-1074
- Where
- 2 sites in Botswana
- Volunteers
- 30 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cervical Cancer, Prevention
Primary HPV-based Cervical Cancer Screening Algorithms in Botswana
Primary high-risk human papillomavirus (HPV) testing has become first line screening for cervical cancer in high-income countries.
- Trial name
- NCT04242823
- Testing
- 8-type HPV genotype restriction
- Where
- Botswana
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Hiv, Serious Mental Illness
RCT of an Intersectional Stigma Intervention to Sustain Viral Suppression Among Women Living With Serious Mental Illness and HIV in Botswana
The study goal is to promote viral load suppression among women with serious mental illness (SMI) and HIV in Botswana, given that these women are especially vulnerable to psychiatric medication nonadherence and symptom…
- Trial name
- NCT05807867
- Testing
- WMM-based intersectional stigma intervention
- Where
- Botswana
- Volunteers
- 360 people
- Sponsor
- New York University
SARS-CoV-2 Infection, HIV Infections
Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern
The study will evaluate the clinical efficacy of different dosing regimens of the Moderna COVID-19 mRNA vaccine (100 mcg) in preventing COVID-19 disease in people who are living with HIV or have comorbidities associated with…
- Conditions
- SARS-CoV-2 Infection, HIV Infections, COVID-19
- Trial name
- CoVPN3008 (NCT05168813)
- Testing
- Moderna mRNA-1273, Moderna mRNA-1273.222, Vaccine 3 Dose
- Where
- 47 sites in Botswana, Eswatini and 5 more
- Volunteers
- 14,237 people
- Sponsor
- COVID-19 Prevention Network
HIV Infection
Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 703/HPTN 081 AMP Study
The purpose of this study is to learn whether having the AMP Study antibody (called VRC01) in a person's body might help their immune system control HIV better, even without HIV medication called antiretroviral therapy or ART, if…
- Trial name
- NCT04860323
- Testing
- Analytical Treatment Interruption
- Where
- 11 sites in Botswana, Malawi and 2 more
- Volunteers
- 13 people
- Sponsor
- HIV Vaccine Trials Network
HIV, Pediatric AIDS
Early Infant HIV Treatment in Botswana
The overall objective of this study is to determine whether very early antiretroviral treatment (ART) initiation in HIV-infected infants limits the seeding of viral reservoirs and maintains immune responses, potentially allowing…
- Trial name
- EIT (NCT02369406)
- Testing
- Nevirapine, Kaletra, Lamivudine
- Where
- Botswana
- Volunteers
- 67 people
- Sponsor
- Harvard School of Public Health (HSPH)
HIV Infections
Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019
Dolutegravir is a potent integrase strand transfer inhibitor. Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) is a fixed dose combination regimen containing two nucleoside reverse transcriptase inhibitors and dolutegravir.
- Trial name
- NCT03016533
- Testing
- Dolutegravir film-coated tablets, Dolutegravir film-coated dispersible tablets, ABC/DTG/3TC immediate release tablets
- Where
- 17 sites in United States, Botswana and 5 more
- Volunteers
- 100 people
- Sponsor
- ViiV Healthcare
Lymph Node Excision Biopsy
Prevalence of Epstein-Barr Virus Infection
This will be a cross sectional, pilot study to determine the burden of EBV related lymphomas in this population. Patient information including demographics and HIV status, history of HIV infection, HIV viral load and CD4 counts…
- Trial name
- NCT06444152
- Testing
- Sample analysis
- Where
- Botswana
- Volunteers
- 100 people
- Sponsor
- University of Pennsylvania