THIS week, I thought I should reproduce a statement released in the week by Zambian civil society organisations on the Microbicides FACTS001 that coincided with the release of the FACTS001 findings in the USA.
The statement was released during a science café hosted by ZAMCOM in conjunction with the Network of Health and Development journalists at which Dr Margaret Kasaro, a Clinical Scientist from the Centre for Infectious Disease Control in Zambia (CIDRZ) updated media personnel and civil society on microbicides clinical trials.
Worldwide, almost half of all people living with HIV are women. Africa accounts for about two-thirds of women and girls amongst all people infected with HIV; and 76 percent of those who are HIV positive are in the age group of 15 to 24 year olds are young women.
This trend where women continue to bear the burden of the HIV epidemic needs to be urgently addressed and most importantly we need to find a way to protect women against HIV infection.
Contributory factors include gender inequality, access to HIV, sexual health and other health services, community engagement only at early stages, stigma and discrimination. Human rights are fundamental to an effective response, as are new prevention technologies as well as existing prevention efforts.
Therefore, investment into research and development of new HIV prevention technologies, including microbicides, must continue until everyone has access to a method that is both accessible and effective for them as existing prevention methods, remain inadequate.  The availability of condoms does not equate to usage of condoms or negotiation of condom use by women with their partners or husbands. HIV and sexual health must be placed in the context of social attitudes, the impact of inequality and poverty, and the role of health, education and faith in promoting ‘health’ according to its WHO definition.
It is high time to rally behind the development of vaginal microbicides, an initiative that will provide a woman controlled prevention method to prevent more women from becoming infected with HIV.
In the past few years, the microbicides field has learned a great deal, and significant progress has been made in improving the design and conduct of microbicide trials.
Examples of this include evolution in trial design; more and better behavioral science, social science and civil society involvement in the field; and development of innovative solutions to difficult ethical challenges.
The importance of research and clinical trials in making desired products available need not be over-emphasized. Medical research is vital to provide answers to today’s health challenges, the result of which is life-saving products such as Tenofovir 1 per cent gel in preventing the transmission of HIV, a tool that has potential to reduce new HIV infections and free HIV generations. Positive results from Follow-on African Consortium for Tenofovir Studies (FACTS 001) could lead to licensure of first vaginal microbicide and expand women’s options for HIV prevention methods. This is particularly relevant and important for Zambia owing to new HIV infections that occur largely amongst women owing to low condom use negotiation with their sexual partners as well as HIV prevalence rates.
What is FACTS001
Large-scale, double-blinded placebo-controlled trial aimed at confirming and expanding the CAPRISA 004 findings for licensure. Enrolment started Oct 2011 with 2,059 healthy, HIV-negative women, 18 to 30 years, enrolled at 9 sites in South Africa.
Women who were enrolled agreed to be on hormonal contraceptive. However, women WERE still allowed to enroll if they: had genital herpes had Hepatitis B were breastfeeding
Participant follow-up concluded in August 2014 results expected at CROI 2015- Today
The purpose of the study – Is 1 per cent tenofovir gel: safe for women, effective for preventing HIV infection, effective for preventing genital herpes
WHEN USED BEFORE AND AFTER SEX
How to use FACTS 001
A woman must insert the gel vaginally within 12 hours before having sex (this could even be in the few minutes before sex) and then another gel must be inserted as soon as possible and within 12 hours after sex. The sooner she inserts it after sex, the better.
For comments write to knoxngoma@gmail.com or text/call 0955883143