A Randomized Study of Cotrimoxazole Prophylaxis and Longer Breastfeeding Duration to Improve Survival Among HIV-Exposed Infants in Botswana ("Mpepu")
Principal Investigator Initiated

Study Objectives

  • Primary: To determine whether cotrimoxazole offers a survival benefit for HIV-exposed uninfected children
  • Secondary: To evaluate the effect of breastfeeding duration on child mortality

Study Design: Double-blind, randomized, placebo-controlled trial

Study Population: Women living with HIV, age ≥18 years, >26 weeks gestation and < 34 days postpartum, and their infants

Study Duration: 4 years

Acceptability and uptake of HIV self-testing among female sex workers in Botswana: Ikitse Study
Principal Investigator Initiated

Study Objectives

  1. Assess the acceptability of, obstacles to, and preferred approaches to HIV self-testing in FSW, using qualitative methods.
  2. Evaluate the uptake of HIV self-testing among FSW in Botswana, in a pilot study.

Study Design: Mixed methods study.

Study Population: Two hundred and thirty female sex workers and and five non-governmental organization staff directly supporting FSW in Botswana.

Study Duration: Dec 2018- March 2022.

Assessing the potential role of a novel hand-held device (the Intelligent Breast Exam), in breast cancer screening in Botswana: A feasibility pilot study
Principal Investigator Initiated

Study Objectives

  1. To assess barriers and facilitators to prenatal supplementation and preconception fortification through interviews with pregnant women, including the role of side effects, access, knowledge, and beliefs.
  2. To assess barriers and facilitators to prenatal supplementation and preconception fortification through interviews with nurses and midwives, including the role of knowledge, availability of medication, side effects, and adherence.
  3. To assess barriers and facilitators to prenatal supplementation and preconception fortification through interv
Botswana Combination Prevention Project (BCPP) / Ya Tsie Study
Principal Investigator Initiated

Study Objectives

Primary Objectives

Botswana COVID-19 Active Case Finding Pilot Study and Demonstration Project
Principal Investigator Initiated

Study Objectives: The overall aim of this study is to determine the feasibility, utility and yield of COVID-19 case finding strategies in Botswana, and generate data to guide the effective implementation of COVID-19 case finding in Botswana. Specifically we will evaluate three different testing strategies for COVID-19: 

Objective 1: Point of Entry Screening and Testing 
Objective 2: Enhanced Healthcare Facility Based Screening and Testing 
Objective 3: Active Community Case Finding 

Study Design: A pilot surveillance study 

COVID-19: An observational cohort of cases treated in Gaborone, Botswana
Principal Investigator Initiated

Study Objectives

  • To describe the presentation, severity, outcome and persistence of each case of COVID-19 managed in Gaborone.
  • To compare the difference between cases in HIV- infected and HIV-uninfected individuals.
  • To determine if individuals with HIV infection remain infectious for longer than those without HIV infection.
  • To determine the impact of COVID-19 on HIV infection.
  • To establish a bio-repository to conduct future studies on host genetics and COVID-19. 

Study Design: Observational cohort

Effects of HIV and ARV Exposure on Child Health and Neurodevelopment, Botswana (“Tshipidi”)
Principal Investigator Initiated

Study Objectives: to determine if HIV-exposed uninfected (HEU) children had worse neurodevelopmental outcomes at 24 months compared with HIV-unexposed uninfected (HUU) children in Botswana

Study Design: Prospective observational study

Study Population: HIV-infected and –uninfected mothers and their toddlers

Study Duration: 2 years

Sponsor: National Institute of Mental Health (NIMH).

Effects of preterm birth on HIV acquisition risk and antiretroviral prophylaxis in HIV-exposed infants in Botswana (PERHAPS)
Principal Investigator Initiated

Study Objectives

Innovating to save lives: Evaluation of breast cancer care and outcomes in the setting of Breast multidisciplinary clinic in Botswana (Maduo Study)
Principal Investigator Initiated

Study Objectives

  • Aim 1 (Primary): To evaluate if the establishment of a multidisciplinary breast cancer clinic can lead to improved timely quality care. Primary endpoint associated with this aim is shorter time to treatment initiation (time from diagnosis to initiation of cancer treatment).
  • Aim 2: To assess characteristics of breast cancer patients in Botswana, including key risk factors and pathology.
  • Aim 3.
Kgothatso: Male cancer care barriers in Botswana
Principal Investigator Initiated

Study Objectives: 

Optimizing Maternal & Child Health and Development (Monana Ke Isago Study)
Principal Investigator Initiated

Study Objectives 

  • To develop a multi-component intervention program, designed with and for adolescent mothers age 15- to 19-years old. 

The specific objectives of the program are to:

Potlako: A programmatic Multi-Facility Level Intervention to Improve Access to timely Oncology Care in Botswana
Principal Investigator Initiated

Study Objectives

Primary Objectives:  

  • To implement a multicomponent programmatic intervention geared at fostering earlier detection of cancers.
  • To evaluate the impact of the above on cancer stage at diagnosis and time to cancer treatment initiation

Secondary Objectives:

Prevention of Milk-Borne Transmission of HIV-1 in Botswana (“Mashi”)
Principal Investigator Initiated

Study Objectives:

Randomized Trial of LPV/r/ZDV3TC vs. ABC/ZDV/3TC to Prevent MTCT in Pregnant/Breastfeeding Women with CD4>200 (“MmaBana”)
Principal Investigator Initiated

Study Objectives: To determine whether Trizivir (TZV), a single pill containing abacavir sulfate, lamivudine, and zidovudine (ABC/3TC/ZDV), or lopinavir/ritonavir (LPV/r) and lamivudine/zidovudine (3TC/ZDV) is more effective in reducing HIV-1 viral load and preventing MTCT among HIV infected pregnant women in Botswana.

Study Design: Randomized clinical trial

Study Population: Pregnant women living with HIV and their infants

Study Duration: 24 months

The AMBIsome Therapy Induction OptimisatioN (AMBITION-cm)
Principal Investigator Initiated

Study Objectives

Primary Objective:

  • To determine whether short-course high-dose L-AmB is as effective as 7-day amphotericin B deoxycholate-based treatment courses (current standard of care) in averting all-cause mortality in HIV-associated CM patients in a phase-III clinical endpoint trial.

Secondary Objectives:

The Lived Experience of Participants in COVID-19 Clinical Studies in Gaborone– World Health Organisation (WHO)
Principal Investigator Initiated

Study Objective: To document the experience of participants and stakeholders of COVID-19 clinical studies in Botswana and begin to understand how these and similar studies could be improved for the future.

Specific Objectives

Virologic Response to NVP-Containing HAART after Single-DoseNVP vs.Placebo (“Mashi Plus”)
Principal Investigator Initiated

Study Objectives: To assess the virologic responses of women and infants to nevirapine-based antiretroviral treatment after previous exposure to a single dose of nevirapine or placebo in the setting of a short course of zidovudine.

Study Design: prospective observational study nested within a randomized clinical trial

Study Population: Postpartum women living with HIV

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

A5375: An Open-Label, Phase II Pharmacokinetic Study to Evaluate Double-Dose Levonorgestrel Emergency Contraception in Combination with Efavirenz-Based Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis Therapy
Network Studies

Study Objectives

Primary Objectives:

  • To determine if doubling the dose of the LNG EC effectively overcomes the known drug-drug interaction (DDI) with EFV-based ART.
  • To determine if doubling the dose of the LNG EC effectively overcomes the expected DDI with RIF-containing TB therapy.

Secondary Objectives:

IMPAACT 2008: A Phase I/II Multisite, Randomized, Controlled Study of Monoclonal Antibody VRC01 with Combination Antiretroviral Therapy to Promote Clearance of HIV-1-Infected Cells in Infants
Network Studies

Study Objectives

Primary Objectives 

  • To assess the following among HIV-1-infected infants: 
    • Safety of VRC01 administered with Combination Antiretroviral Therapy (cART) (cumulatively through Week 14) .
    • Effect of VRC01 on HIV-1 DNA concentrations in peripheral blood mononuclear cells (change from Week 0 to Week 14) 

Secondary Objectives 

IMPAACT 2010: IMPAACT 2010 Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants
Network Studies

This is a Phase III, three-arm, randomized, open-label study to compare the virologic efficacy and safety of three antiretroviral regimens for HIV-1-infected pregnant women and their infants.

Study Objectives

Primary Objectives