Bexsero meningococcal B vaccine for GC prevention among South African women (Biyela study, Celum PI)
The BIYELA trial is a proof-of-concept of the efficacy of the Bexsero 4MenB-4C meningococcal vaccine compared to placebo for gonococcal prevention among 1100 women enrolled from 5 sites in Cape Town, Johannesburg, and Pietermaritzburg, South Africa. The BIYELA trial will also evaluate immune correlates. The BIYELA trial results will add to the evidence base from other trials of Bexsero 4CMenB for gonorrhea prevention which will to inform gonococcal vaccine development
Evaluation of doxycycline post-exposure prophylaxis to reduce sexually transmitted infections in PrEP users and HIV-infected persons (DoxyPEP and DoxyImpact studies, Celum, PI)
The DoxyPEP trial demonstrated that a single dose of the widely available, inexpensive antibiotic doxycycline taken within 72 hours after sex as post-exposure prophylaxis (doxy-PEP) was highly effective with >80% reductions in incident chlamydia and syphilis and 50% reduction in gonorrhea among men at elevated risk of recurrent STIs. The DoxyImpact Study is a longitudinal prospective cohort to evaluate doxy-PEP effectiveness and antimicrobial resistance among persons initiating or using doxy-PEP for STI prevention, which will be conducted in Atlanta, Detroit, Miami, San Francisco and Seattle. The DoxyImpact study will provide evidence about doxycycline for STI prevention during real world implementation in terms of benefits and risks in terms of antimicrobial resistance.
Towards Cervical cancer elimination: Implementation and scale-up of a single-visit, screen-and-treat approach with thermal ablation for sustainable cervical cancer prevention services in Kenya (TIBA Study, Mugo & Gimble MPI)
In low middle income countries, the treatment uptake for women who screen positive for pre-cancerous lesions of the cervix is approximately 30% against a World Health Organization (WHO) cervical cancer elimination target of 90%.
Using a stepped wedge design this study is evaluating implementation of a single-visit-screen and treat approach using thermal ablation for treatment and implementation science methods to evaluate barriers and facilitators to uptake of treatment for women who screen positive for pre-cancer lesions of the cervix. This study will provide a tailored approach for implementation strategies to close the screen to treatment gap for cervical cancer prevention in LMIC similar to Kenya.
A longitudinal cohort study to assess effectiveness and B-memory response to of the quadrivalent HPV vaccine 8 years post vaccination among HIV infected boys and girls ages 9-14 years in Kenya (Merck IV, Mugo PI)
Among a cohort of girls and boys living with HIV vaccinated with three doses of HPV vaccine in 2014, we evaluated for retention of long-term HPV antibody response, protection from acquisition of vaccine HPV serotypes and B memory cells eight years post primary vaccination.
People living with HIV have higher burden of HPV associated morbidities and mortalities. These data will inform on the HPV vaccine efficacy for adolescents living with HIV and the protective impact of a three dose vaccine schedule.