INGABO: A Phase 3 Open-label Randomized Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of a 2-dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed by MVA-BN-Filo in Healthy Pregnant Women. This clinical trial will enroll 2000 pregnant women in Rwanda. The purpose of this study is: a) to assess adverse maternal/fetal outcomes in pregnant women randomized to receive the 2-dose Ebola vaccine regimen (Group A) and in unvaccinated pregnant women controls (Group B); and b) to assess adverse neonatal/infant outcomes in neonates/infants born to women randomized to Group A and in neonates/infants born to women randomized to Group B. This study is funded by Coalition for Epidemic Preparedness Innovations (CEPI), and sponsored by Janssen Vaccines & Prevention B.V. PI: Etienne Karita, Susan Allen.
Umurinzi Ebola Vaccination Campaign in Rwanda. Umurinzi is an implementation program to vaccinate 200,000 non-pregnant Rwandan adults and children near the Congolese border. This program is funded by Wellcome Trust and the UK Department for International Development, and sponsored by the Rwanda Ministry of Health. PI: Etienne Karita.
HIV Vaccine Preparedness and Clinical Trials in Rwanda and Zambia. Funded by the International AIDS Vaccine Initiative since 2003, activities include longitudinal studies of HIV-negative high risk women; clinical and laboratory studies of acute HIV infection in high risk women; research training, advanced degree support, and capacity building; and clinical site preparation for future HIV vaccine clinical trials. PI: Etienne Karita, William Kilembe, Mubiana Inambao, Susan Allen.
HVTN705 in Zambia. The primary purpose is to assess the efficacy, safety, and tolerability of a heterologous prime/boost regimen utilizing Ad26.Mos4.HIV and aluminum-phosphate adjuvanted Clade C gp 140 for the prevention of HIV infection in HIV-seronegative women residing in sub-Saharan Africa. This trial is funded by the HIV Vaccine Trials Network. PI: William Kilembe, Mubiana Inambao.
CoVPN 5001: A Prospective Study of Acute Immune Responses to SARS-CoV-2 Infection. The purpose of this study is to learn more about the acute response to infection with and recovery from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The information gained from the study can be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines, other prevention strategies, and treatments. This study is funded by the HIV Vaccine Trials Network. PI: William Kilembe, Mubiana Inambao.
Natural History of SARS-CoV-2 in comparison in influenza A virus: a multi-site study focused in the Southern Hemisphere and equatorial regions. This study aims to document clinical outcomes and risk factors for severe disease in individuals with SARS-CoV-2 infection, define virologic features of SARS-CoV-2 infection, and define the magnitude, quality and longevity of immune responses to SARS-CoV-2. This study is funded by the National Institutes of Allergies and Infectious Disease Centers of Excellence for Influenza Research and Surveillance (CEIRS). PI: Walter Orienstein
Improving female genital schistosomiasis diagnosis within comprehensive reproductive health services in Zambia. The goal of this study is to develop and pilot test an innovative standardized diagnostic algorithm for female genital schistosomiasis and other common causes of genital ulcerative and inflammatory disease that is feasible to use in Zambian government clinics. This study is funded by the UK Department for International Development. PI: Kristin Wall
HPX2004 in Rwanda. Funded by Janssen Pharmaceuticals, this is a randomized, parallel-group, placebo-controlled, double-blind Phase 1/2a study in healthy HIV uninfected adults to assess the safety/tolerability and immunogenicity of 2 Different Prime/Boost Regimens: Priming With Trivalent Ad26.Mos.HIV and Boosting With Trivalent Ad26.Mos.HIV And Clade C Gp140 Plus Adjuvant, or Priming With Tetravalent Ad26.Mos4.HIV and Boosting With Tetravalent Ad26.Mos4.HIV and Clade C Gp140 Plus Adjuvant. PI: Susan Allen.
HPX2003 in Rwanda. Funded by Janssen Pharmaceuticals, this is a randomized, parallel-group, placebo-controlled, double-blind Phase 1/2a study in healthy HIV uninfected adults to assess the safety/tolerability and immunogenicity of 2 Different Prime/Boost Regimens: Priming With Tetravalent Ad26.Mos4.HIV and Boosting With Tetravalent Ad26.Mos4.HIV and Either Clade C gp140 Plus Adjuvant, Or a Combination of Mosaic and Clade C gp140 Plus Adjuvant. PI: Susan Allen.
Virologic Correlates of Heterosexual Transmission in Rwanda and Zambia. The major goals of this NIH-funded project are to determine whether sequence variants within gp120 are selected during transmission; if these variants reflect the population of virus present in the genital fluids of the donor transmitted and what the functional properties of viral variants are; and the virological, immunological and clinical consequences of superinfection. PI: Eric Hunter.
CTL and HIV Polymorphisms in Heterosexual Transmission in Rwanda and Zambia. The goal of this NIH-funded study is to understand the role of CTL escape in HIV transmission and disease pathogenesis. PI: Eric Hunter.
GREAT in Zambia. The Globally Relevant AIDS Vaccine Europe-Africa Trials Partnership is a collaboration between Oxford University, the International AIDS Vaccine Initiative, the Imperial College London, and research centers in three African countries (Zambia, Kenya, and Uganda). This collaboration will ensure the development of a cross-clade preventive HIV-1 vaccine strategy, by engaging at-risk populations from diverse clade regions, and by conducting a phase IIa clinical trial in these populations to assess the feasibility, safety, and immunogenicity of the tHIVconsvX. GREAT is funded through the European and Developing Countries Clinical Trials Partnership (EDCTP). PI: William Kilembe, Mubiana Inambao.
SANTHE in Rwanda and Zambia. The Sub-Saharan African Network for TB/HIV Research Excellence aims to strengthen South-South partnerships, create enabling environments for excellence in research in Africa, and train the next-generation leaders of African science. This consortium is specifically focused on HIV and TB as this ‘syndemic’ is a public health crisis in Africa that requires the full weight of basic science, translational/clinical research, and political and social mobilization. SANTHE is funded through Wellcome Trust. PI: Etienne Karita, William Kilembe, Mubiana Inambao.
CKAE609A2202 Malaria Therapy in Rwanda (2019-2020). This study funded by Novartis was a phase 2, multi-center, randomized, open-label, dose-escalation study to determine safety of single (QD) and multiple (3 QD) doses of KAE609, given to adults with uncomplicated Plasmodium falciparum malaria. PI: Etienne Karita.
Improving Allocation of Limited HIV Prevention and Treatment Resources in Zambia (2016-2020). This NIMH-funded project (1K01MH107320) used disease modeling, optimization modeling, and quantitative and qualitative health policy methodologies to determine a rational and realistic approach to better allocate HIV prevention and treatment resources in Zambia. PI: Kristin Wall.
Evidence-Based Prevention Interventions for Key Populations in the Republic of Rwanda (2015-2019). The major goal of this CDC and PEPFAR funded project (5NU2GGH001443) was to implement evidence-based HIV prevention interventions in key populations, including female sex workers, men who have sex with men, and other priority populations, including adolescent girls, young women, and clients of sex workers. PI: Susan Allen.
Interdisciplinary Development of an intervention to improve postpartum IUD/implant services in Rwanda (2017-2018). This Emory University Research Council Grant (URCGA16872456) evaluated knowledge, attitudes, and practices related to postpartum implant at the systems-level and the client-level in Rwanda. PI: Kristin Wall.
Improving Post-Partum Intrauterine Device Services in Rwanda (2016-2018). The major goal of this Bill & Melinda Gates Foundation project was to develop and pilot test a multi-level intervention to improve post-partum intrauterine device (IUD) services in Rwanda and lay the groundwork for a large, randomized controlled trial of the intervention. PI: Kristin Wall.
IUD, Implant, and Condoms: Sexual and Perinatal HIV Prevention in Rwandan Couples (2012-2017). The goal of this NIH study (R01 HD072659) was to optimize the integration of family planning services to prevent unplanned pregnancy and perinatal HIV, with CVCT, the only behavioral intervention proven to reduce HIV infection in couples. PI: Susan Allen.
VCT with Primary and Concurrent Partners to Prevent HIV Transmission in Zambia (2011-2016). The goal of this NIH funded study (R01 MH095503) was to develop and test the efficacy of concurrent partnership counseling modules when used in addition to standard marital couples’ HIV counseling. PI: Susan Allen.
Integrating CVCT with Family Planning Services in Zambia (2013-2016). The major goal of this project funded by the UK Department for International Development (UK202340-102) was to integrate Couples Family Planning Counseling and long-acting reversible contraception services with Couples Voluntary HIV Counseling Testing and a nutritional Good Health Package in Zambian government clinics. PI: Susan Allen.
Rwanda Zambia HIV Research Group Center of Excellence for the Expansion of CVCT (2009-2015). The goal of this CDC-funded activity (CDC PS1904) was to establish the sites in Rwanda and Zambia as Centers of Excellence to provide regional and global training and technical assistance in couples’ HIV counseling and testing. PI: Susan Allen.
Emory AIDS International Training and Research Program (1999-2015). The goal of this NIH funded grant (TW001042) was to produce highly qualified HIV/AIDS researchers with training in public health and clinical science. PI: Carlos del Rio.
Center of Excellence for the Expansion of Couples’ HIV Counseling and Testing in Rwanda (2009-2014). The goal of this funding from CDC (CDC PS1839) was to train staff in Rwandan health facilities to disseminate CVCT nationwide. PI: Susan Allen.
Expansion of CVCT in the Copperbelt of Zambia (2010-2014). The goal of this study funded by the Canada International Development Agency and PATH Arise (CID.1450-08863) was twofold: expand CVCT in the Copperbelt of Zambia, and conduct a study to compare risk factors in HIV seroconverters vs. nonseroconverters. PI: Susan Allen.
Host Genetic Epidemiology in HIV-1 Discordant African Couples (2008-2014). The goal of this NIH study (R01 AI071906) was to investigate the role of host genetics on HIV-1 transmission and disease progression in HIV discordant couples. PI: Jianming Tang.
Rapid Expansion of CVCT in Lusaka, Zambia (2007-2013). The goal of this CDC funded project (CDC PS0758) was to rapidly scale up availability of Couples VCT services in Lusaka and Southern Province, Zambia. PI: Susan Allen.
Botswana Strategy for Couples Voluntary HIV Counseling and Testing (2012-2013). The main goal of this project, funded by CDC, was to develop a CVCT strategy for Botswana. The strategy aimed to address, from a multi-sectorial perspective, gaps and challenges related to Couples Voluntary HIV Counseling and Testing. PI: Susan Allen.
Schistosomiasis and HIV in Zambia (2009-2011). Funded by the Bill & Melinda Gates Foundation (09073109), the goal of this retrospective study was to assess schistosomiasis antibody status of HIV-positive and HIV-negative Zambian men and women, and to correlate antibody positivity with genital abnormalities and prevalent and incident HIV. PI: Susan Allen.
Molecular Analysis and Modeling of HIV-1 Transmission, Containment and Escape (2005-2010). This Bill & Melinda Gates Foundation Grand Challenge was a consortium of investigators from clinical and laboratory research sites in Africa conducting a comprehensive, integrated analysis of humoral and cellular responses to HIV-1 in people in early and acute stages of infection. Sites included Rwanda and Zambia. PI: George Shaw.
CTL and HIV Polymorphisms in Heterosexual Transmission (2004-2010). A major goal of this NIH study (R01 AI64060) was to understand the role that cytotoxic T lymphocyte (CTL) escape plays in HIV transmission and disease pathogenesis. PI: Eric Hunter.
Couples HIV Counseling and Testing in Two African Capitals (2002-2009). Funded by NIH (R01 MH066767), this two-city, neighborhood randomized control study compared two interventions to promote Couples’ Voluntary HIV Counseling and Testing (CVCT) in Kigali, Rwanda and Lusaka, Zambia. The interventions were “promote demand” through influence network agents, and “enhance supply” through mobile testing units. PI: Susan Allen.
Partners in Prevention HIV-HSV Transmission Clinical Trial (2004-2009). The Partners in Prevention trial enrolled over 3400 HIV discordant couples in 7 countries, including Rwanda and Zambia. The Phase 3 trial was randomized, double-blinded, and placebo-controlled, to determine whether the use of acyclovir by people who are infected with both HSV-2 and HIV can reduce transmission of HIV to their HIV uninfected sexual partners. This study was funded by the Bill & Melinda Gates Foundation through the University of Washington. PI: Susan Allen.
Community Influences on Young People's HIV/AIDS Knowledge, Attitudes & Practices (2007-2008). The main objective of this NIH study (R03 HD053226) was to estimate the influence of several dimensions of the community environment on the sexual behavior of heterosexual males in four countries: Ghana, Nigeria, Zambia, and Zimbabwe. PI: Rob Stephenson.
DNA Methylation as an Epigenetic Host Factor in HIV/AIDS (2003-2007). NIH funded this study (R01 AI51173) to define DNA methylation profiles at seven human loci that encode key molecules involved in HIV-1 transmission, pathogenesis and response to antiretroviral therapy. PI: Jianming Tang.
Child Sexual Abuse in Zambia: Epidemiology and Prevention (2003-2005). This FIRCA (R03 TW006305) expanded the research agenda of NICHD R01 40125-01AI “Family planning promotion in HIV infected Zambian couples” through the addition of research on child sexual abuse. PI: Susan Allen.
Implementing Voluntary HIV Counseling and Testing in Belize (2002-2003). This NIH/NIAID supplemental grant aimed to implement a voluntary HIV counseling and testing program in Belize. PI: Susan Allen.
Preventing Unplanned Pregnancies in HIV Infected Zambian Couples (2001-2008). The goal of this randomized control trial (NIH R01 HD040125) was to evaluate two interventions to reduce unplanned pregnancies in Zambian couples with HIV. The first intervention promoted more effective contraception by placing user-independent methods (IUD and Implant) first in the educational message hierarchy instead of oral contraceptives and employing positive message framing. The second intervention helped couples plan by assisting couples to prepare a will, choose a guardian, and make a financial plan including the cost of educating and taking care of existing children. The interventions were compared with a standard family planning program with respect to impact on incident pregnancy, contraceptive choice and pattern of use, psychosocial and behavioral variables, and future planning actions. PI: Susan Allen.
Rapid HIV Testing and Counseling for Couples in Kigali and Lusaka (2001-2002). The goal of this World AIDS Foundation program was to provide technology transfer of rapid HIV testing and couples’ specific counseling programs into antenatal clinics for mutual reinforcement of heterosexual transmission prevention and prevention of mother-to-child transmission. PI: Susan Allen.
Acute Infection and Early Disease Research Network (1997-2004). This study (NIAID U01 AI41530) used a network of three (Alabama, Florida, Zambia) cohorts to study elucidation of HIV-1 pathogenesis in acute and early infection, and aimed to develop and evaluate a therapeutic intervention. PI: Michael Kilby.
Heterosexual Transmission and the Natural History of HIV (1996-2003). This project was a competitive NIH supplement (NIAID R01 AI040951) to add studies of virologic, immunologic, and host genetic correlates of HIV transmission to the heterosexual transmission observational cohort study in Rwanda. PI: Susan Allen.
The HIV Network for Prevention Trials (1997-2000). This funding through NIH was for a network of clinical sites to prepare and conduct studies to prevent perinatal HIV in developing countries, and for vaccine clinical trials. Zambia PI: Susan Allen.
Center for AIDS Research International Core (1998-1999). This project (NIAID P30 AI027767) proposed to provide liaison and support services to facilitate UAB-Zambia collaborative studies, including practical assistance, facilitation of IRB clearance and approvals from relevant authorities, handling of samples, and logistics of communications and travel. Rwanda and Zambia Director: Susan Allen.
Voluntary HIV Testing and Counseling, Syphilis Screening, and Family Planning (1996-1999): With funding from the United Nations Populations Fund, we supported an integrated model for reproductive health in Rwanda. PI: Susan Allen.
Development of a Specimen Repository for Zambian Samples (1996). Pilot study grant from the University of Alabama at Birmingham Center for AIDS Research. PI: Susan Allen.
Expansion of an HIV Virology and Immunology Site in Zambia (1996). University of Alabama at Birmingham Health Services Foundation Grant. PI: Susan Allen.
Preparation for AIDS Vaccine Evaluation in Rwanda (1992-1994). PAVE (NIAID R21 AI033863) prepared for AIDS/HIV vaccine immunogenicity and efficacy evaluations in Rwanda by promoting HIV education, strengthening laboratory capabilities, and training health professionals. As a simulation, a study was conducted using Hepatitis B vaccine to demonstrate site capabilities. PI: Susan Allen.
Contraception in HIV-Positive Rwandan Women (1992-1993). A UNICEF grant to assess the impact of an educational program and free provision of contraceptive methods on uptake rates among HIV-positive women in Rwanda. PI: Susan Allen.
The Relationship of HIV Infection to Tuberculosis in Rwanda (1990-1991). World Health Organization. PI: Susan Allen.
HIV, HPV, and Cancer in Rwanda (1989-1994). This project (NCI R01 CA050847) studied the incidence and natural history of HIV, HPV, and tumors, including cervical intraepithelial neoplasia in Kigali, as well as a case-control analysis of tumor diagnoses in HIV-positive and HIV-negative samples. PI: Susan Allen.
Epidemiology of HIV Risk Behavior in Rwandan Men (1989-1991). Funded by NIH (R01 MH046571), this study added men (husbands) to the cohort of women (wives) being followed in the earliest Rwanda HIV studies.
Transmission of HIV in Discordant Couples in Kigali, Rwanda (1988-1992). American Foundation for AIDS. PI: Susan Allen.
African AIDS: Risk Factors, Virology and Pathology (1987-1999). This project (NIAID R01 AI023980) included expansion and continuation of studies evaluating the natural history of HIV infection and identification of clinical and laboratory parameters with prognostic significance, development and evaluation of an algorithm to allow the earliest possible diagnosis and treatment of tuberculosis among HIV infected adults. PI: Susan Allen.
HIV Epidemiology in Rwanda (1987-1992). The original funding for HIV studies for Rwanda was an NIMH grant to the Prevention Sciences Center of the Department of Epidemiology at the University of California San Francisco. PI: Stephen Hulley. CoI and Rwanda Director: Susan Allen.
