Clinical trials: in Botswana
HIV Infections
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN…
- Trial name
- PALISADE (NCT06134362)
- Testing
- CAB LA
- Where
- 33 sites in Argentina, Botswana and 10 more
- Volunteers
- 2,998 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV-1-infection
Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age
The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a long-acting injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to…
- Trial name
- NCT05660980
- Testing
- Once daily CAB tablet + RPV tablet, Long acting CAB injectable + long acting RPV injectable
- Where
- 12 sites in United States, Botswana and 3 more
- Volunteers
- 90 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
This study aims to find the proposed dose of Rifapentine (RPT) taken once daily with Isoniazid (INH) for 28 days to prevent tuberculosis (TB).
- Trial name
- NCT07124559
- Testing
- Rifapentine, Isoniazid, Dolutegravir
- Where
- 11 sites in Botswana, Haiti and 4 more
- Volunteers
- 144 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, MDR
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
The purpose of this study is to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active tuberculosis (TB) during 96 weeks of follow-up among…
- Trial name
- PHOENIx MDR-TB (NCT03568383)
- Testing
- Delamanid (DLM), Isoniazid (INH), Pyridoxine (vitamin B6)
- Where
- 31 sites in Botswana, Brazil and 11 more
- Volunteers
- 5,832 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Antimicrobial Resistance
Surveillance of Healthcare-associated Infections & Antimicrobial Resistance
The aims of this project, called "Surveillance of Healthcare-associated infections \& Antimicrobial Resistance", or "SHARE", are to 1) enhance laboratory capacity to detect emerging AMR patterns; 2) strengthen hospital…
- Trial name
- NCT05734391
- Testing
- Routine Infection control
- Where
- 2 sites in United States, Botswana
- Volunteers
- 642 people
- Sponsor
- University of Pennsylvania
Sexually Transmitted Infection (STI), Gonorrhea
A Clinical Study to Assess the Efficacy of Weekly Doxycycline Prophylaxis to Reduce Bacterial Sexually Transmitted Infections (STI) in Young African Women
This study is for people who may get sexually transmitted infections (STIs). Approximately 580 African adolescent and young adult women ages 13-34 in Africa will be included in this study.
- Conditions
- Sexually Transmitted Infection (STI), Gonorrhea, Syphilis, Chlamydia
- Trial name
- NCT07884240
- Testing
- Doxycycline hyclate, Standard of Care for STI prevention
- Where
- 4 sites in Botswana, Eswatini and 2 more
- Volunteers
- 580 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV, HIV Infections
The Tatelo Plus Study
The purpose of this study is to advance pediatric HIV treatment and cure research by evaluating the impact of a combination of three anti-HIV-1 broadly neutralizing antibodies (bNAbs) or analytic treatment interruption (ATI) on…
- Trial name
- NCT06508749
- Testing
- PGDM1400LS, VRC07-523LS, PGT121.414.LS
- Where
- 2 sites in Botswana
- Volunteers
- 41 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pregnancy Related
Increasing Access to Multiple Micronutrient Supplementation - A Pilot Intervention at up to 15 Clinics in Botswana
The purpose of this study is to pilot a clinic-level supplementation intervention at up to 15 antenatal clinics throughout Botswana.
- Trial name
- NCT05703373
- Testing
- Multiple Micronutrient Supplement
- Where
- 13 sites in Botswana
- Volunteers
- 1,210 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Tuberculosis
A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)
The A5414 study will evaluate whether treatment for drug-susceptible pulmonary tuberculosis (TB) can be tailored according to a participant's risk of an unfavorable outcome.
- Trial name
- NCT07595042
- Testing
- Isoniazid, Rifampin, Pyrazinamide
- Where
- 29 sites in Argentina, Australia and 14 more
- Volunteers
- 900 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
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 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)
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
HIV Infections
More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents
The purpose of this study was to determine the dosage for oral cabotegravir (CAB) and long-acting cabotegravir (CAB LA) and long-acting rilpiverine (RPV LA) and evaluate the safety, acceptability, tolerability, and…
- Trial name
- MOCHA (NCT03497676)
- Testing
- Oral Cabotegravir (CAB), Oral Rilpivirine (RPV), Long-Acting Injectable Cabotegravir (CAB LA)
- Where
- 19 sites in United States, Botswana and 3 more
- Volunteers
- 168 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infection
Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV
IMPAACT 2028 is an observational prospective study to characterize a cohort of early treated children who may participate in future research related to HIV remission or cure.
- Trial name
- NCT05154513
- Testing
- Cohort 1
- Where
- 28 sites in United States, Botswana and 9 more
- Volunteers
- 163 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group