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Novel Safety Biomarkers for Microbicide trials

ICRH Mombasa coordinates the new EDCTP Project: Novel biomarkers to measure safety of microbicides Products used in a number of recent microbicide trials have turned up unexpected safety results. There is a need for more reliable safety biomarkers for phase I and II vaginal microbicide trials. Better understanding and measurement is needed of the effect of substances introduced in the vaginal environment. The project will study a variety of African female target populations in four African settings to identify and improve both clinical and laboratory methods and findings in search of more reliable safety biomarkers. The consortium offers the combination of multidisciplinary experience and cutting-edge technology to make this possible.

A safety and acceptability study of a vaginal ring microbicide delivery method for the prevention of HIV infection in women

There is an urgent need for female-controlled methods for HIV prevention. To date, candidate vaginal microbicides have been formulated predominantly as gels, films and suppositories. However, data suggests that compliance may be a critical factor in microbicides efficacy due to issues of gel acceptability and the fact that most gels are coital dependant.   The aim of the study is to assess the safety and acceptability of a silicone elastomer vaginal ring intended as a microbicide delivery method for the prevention of HIV infection when inserted in place for a 12 weeks period. .  

An assessment of the contraceptive needs of female sex workers in Kenya

Sex workers are commonly targeted for STI/HIV prevention interventions, but less attention has been directed toward sex workers’ contraceptive needs although they are at high risk of unintended pregnancy.  In addition to the health benefits of preventing unintended pregnancies, provision of contraceptive services to sex workers not desiring pregnancy is a means to reduce the number of unintended HIV positive births. This study identifies the contraceptive needs of Kenyan sex workers and the potential strategies for better meeting those needs.

Family planning needs and consequences of unintended pregnancies in a FSW population in Mombasa

Unsafe abortion remains a significant cause of maternal morbidity and mortality in much of the developing world. Its consequences place great demands on the scarce clinical, material and financial resources of hospitals in many developing countries. Studies have shown that abortion is widely practiced among sex workers which poses great health risks to the mother. In the just concluded Mombasa cohort study for estimation of HIV-1 incidence involving 400 FSW who were not pregnant at baseline, 27% (109/400) conceived within nine months of follow up. Informal discussions with these women revealed that many of these pregnancies were unintended despite continuous counselling and FP provision by the study staff indicating an unmet need for FP. The main aim of the study is assess the family planning needs and the consequences of unintended pregnancies among female sex workers in Mombasa, Kenya.  

Reducing HIV/STI Risks and improving Treatment for Male Sex Workers (MSW) in Mombasa, Kenya.

Men who have sex with men are highly vulnerable to HIV/STI infection. The 2002 formative research by Horizons and ICRH revealed there are active Male sex workers in Mombasa and its environs and are increasing numbers and visibility. A capture- re-capture enumeration carried out early 2006 estimated over 739 MSW in Mombasa. Feedback from MSW indicated MSW are at high risk of HIV/STI infection and transmission due to their risky behaviours of multiple sexual partners, inconsistent condom use, and poor knowledge of STI prevention and high alcohol and drug use. Since the existing HIV/STI prevention programs have failed to reach MSW with information about MSW-specific prevention strategies, the intervention program overall objective was to address the sexual health needs of MSW within a highly stigmatizing and discriminatory environment and promote behaviour change among this population. 

Mombasa Cohort Study for Estimation of HIV-1 Incidence

Topical microbicides are products designed to prevent the sexual transmission of HIV and other disease pathogens. Potentially, they can be applied vaginally to prevent both male-to-female and female-to-male transmission. They may also offer back-up protection in the event that condoms fail. In addition, they may be used by HIV-discordant couples who wish to bear children. Currently, approximately 20 products have been assessed in Phase I clinical studies, and five prod­ucts are being evaluated in large-scale safety and effectiveness studies. The aim of the study was to evaluate the feasibility of establishing a new site for microbicide clinical trials in Mombasa District, Kenya, by conducting a cohort study among women with high risk behaviour for HIV-1 infection. Previous planning efforts have indicated that microbicide effectiveness studies will require the participation of several thousand women at high risk for HIV infection. In addition to accruing large numbers of participants, research centers conducting microbicide effectiveness studies must retain participants for extended periods of follow-up in order to preserve the validity, as well as the statistical power, of the study. Also, to provide evidence that rates of new HIV infection among target populations for future microbicide studies will support the requirements for effec­tiveness trials, one step in site development is the conduct of a cohort study.  

Prevention with Positive People; How do we support them in the community?

This study assessed health-related needs of people living with HIV/AIDS (PLWHA) who are not taking ARVs in Mombasa since there is little clarity on what happens to treatment-naïve HIV positive persons not accessing care and treatment services. This information is needed for the development of effective prevention services with positive people in the community. The study seeks to address the information gap with regard to identifying and accessing treatment-naïve HIV positive persons in the community. It explores attitudes, knowledge and access to prevention messages, sexual risk behaviours, stigma and discrimination amongst the treatment-naïve HIV positive people

Assessment of HIV testing in Europe: from policy to effectiveness.

A large proportion of HIV infected persons - ranging from an estimated 15% to over 50% in EU countries - are unaware of their infection, and therefore do not benefit from treatment and may transmit HIV to others, unknowingly. There is evidence that many opportunities are being missed to diagnose HIV infections in EU countries, particularly in health care settings. ECDC has commissioned ICRH to carry out a study on HIV testing policies, practices and barriers to HIV testing in the EU Member States.