The case of the Vaginal Ring Study underway in Malawi where female participants are inserted with 25mg dapivirine vaginal matrix ring for a month to determine the effectiveness of the drug over the investigational product use period in preventing HIV-1 infection among healthy sexually active HIV-uninfected women. The outcome of the study by 2016 will see women being protected from catching the deadly HIV and AIDS pandemic
The 2009 UNAIDS report revealed that 1.8 million people became newly infected with HIV that two million lost their lives to AIDS as over 33.3 million individuals are living with the virus that out of this figure 22.5 million reside in sub-Saharan Africa countries including Malawi.
The report showed that women and girls continue to be affected disproportionately by HIV in these nations whereby they (women) are accounted for approximately 60% of people living with HIV.1 which ignited researchers, scientists to develop safety and effective HIV prevention technologies that can be made easily accessible to them in a developing country which remains as a public health priority.
Why the need for new prevention measures among women on HIV and AIDS
Consequently, of the 2009 UNAIDS/WHO report, other researches recommended the need to develop prevention measures specifically for women as unprotected heterosexual intercourse is currently the leading mode of HIV transmission among them, condoms are widely regarded as inadequate prevention options for , many of them are unable to negotiate condom use with their partners and women do not have the social or economic power to insist on condom use they require the consent of the male partner hence microbicides would not require a partner’s cooperation as they would put the power to protection into their hands.
Microbicides, a new prevention measure among women
With decades of research into microbicides, this resulted in proof-of-concept that antiretroviral (ARV)-such that the outcome of various studies revealed microbicides as alternative notion which can offer women protection against HIV infection and potentially save millions of lives.
In July 2010, the results announced from CAPRISA 004, a clinical trial in South Africa, showed that a vaginal gel containing the ARV tenofovir used around the time of sex offered women 39 percent protection against HIV.
Therefore, microbicides are gels, films, rings or suppositories that are mainly used to neutralize viruses and bacteria and are both vaginal and rectal.
Microbicides vaginal microbicides are antiretroviral (ARV)-based products being developed to reduce the transmission of HIV to women during sex with an HIV-positive male partner.
The active ingredients in the products (ring) are based on the same types of ARV drugs used successfully to prolong the lives of HIV-positive individuals and to prevent mother-to-child transmission of the virus.
Actually, the microbicides in the vaginal ring releases pathogens aimed at killing or inactivating, strengthening the body’s normal defenses (maintaining vaginal pH) and blocking infection by creating a barrier between the pathogen and target cells of the virus which end up preventing infection from spreading to other cells
Acceptability of microbicides-vaginal ring among women
The vaginal ring would address a critical gap in current prevention strategies by offering long-acting female-initiated protection against HIV with consistently use among them (women).
This is particularly important for women in developing countries, where the epidemic has hit hardest, mainly young women who are at least twice as likely to be infected as young men.
Thus, to ensure that the ring would meet the needs of women who are greatly risked to HIV, International Partnership for Microbicides (IPM), a global organization behind the discovery of this notion, conducted a study to assess the acceptability and safety of a placebo ring (containing no active drug) among women in South Africa and Tanzania, the results from this study showed that the ring is acceptable to women and nearly all women expressed an interest in using the ring if proven effective against HIV.
While some women indicated interest in using it discreetly, the majority of them preferred to involve their partners and even male partners interviewed also supported use of the ring. So, no matter how well-designed a product may be, it is essential that it fits women’s needs and lifestyles so it is used consistently and IPM takes women’s preferences into account from the earliest stages of product development.
Vaginal ring study in Malawi
The 2014 National Aids Commission (NAC)’s mid-year review report has revealed that the nation is making head way in combating the deadly HIV/AIDS pandemic with the prevalence rate of 10.6% as 34,000 people are infected yearly.
With the country’s current response to HIV/AIDS, the report shows that incidences of the pandemic has been reduced from 66,000 in 2012 to 34,000 in 2014 representing 50% with 521,139 people on Antiretroviral Therapy (ART) treatment in 2014 from 3,000 in 2004.
The study revealed that pregnant women on ART treatment have increased from 32% in 2011 to 73% in 2014 with 13% reduction of Prevention of Mother-to-Child Transmission (PMTCT) from 50% in 2011.
In this regard, confirmatory trials underway, and if the results are confirmed, tenofovir gel could become the first microbicide approved for use around 2015 which will continue reducing the prevalence rate especially among women.
With funding from the US National Institutes of Health, Microbicide Trials Network (MTN) partnered with IPM to advance this important product into parallel late-stage clinical trials in three developing countries in Africa where HIV and AIDS’s prevalence rate is high namely Zimbabwe ( 3 sites), South Africa (9 sites), Uganda (1 site) and Malawi (2 sites).
In, Malawi the vaginal ring study which was launched in 2012, Microbicides Trials Network (MTN) has partnered with the University of North Carolina (UNC) Project, located at Kamuzu Central Hospital campus and Johns Hopkins University (JHU), situated at Queen Elizabeth Central Hospital campus in Lilongwe and Blantyre respectively.
About 2629 women in Africa are participating in the clinical trial such that Blantyre site has 130 and Lilongwe enrolled 142 with follow ups which is to be finalized by June 25, 2015 whose results are expected to be out end 2015 or early 2016.
Enrollment and the magic behind the vaginal ring in women
The primary aim of a clinical trial is to provide reliable evidence of treatment efficacy or effectiveness and safety such that 25 mg dapivirine vaginal matrix ring is inserted once every 4 weeks over the investigational product use period among women.
So, enrollment criteria for participants safety in this trial is based on age between 18 – 45, willing to provide informed consent, able to provide locator information, HIV uninfected, sexually active, using effective contraceptive method, not pregnant and breastfeeding.
In an exclusive interview with Maravi Post, Tchangani Tembo, Malawi’s UNC Microbicides Project Study Coordinator expressed optimistic of the positive outcome of the study saying all stages of the study have been passed through citing consenting, screening, enrollment, follow ups while remaining with endpoints and termination of the study.
“This is critical study the UNC Project assigned to conduct as its results will be a milestone in preventing women from being the victims of the deadly HIV and AIDS as the macrobicides will empower them to care of their own health particularly protecting themselves from catching the virus.
“We are very optimistic of the outcome of the study which has passed almost critical stages since it’s our first time to carry such trial. Malawian women are a credit towards this study’s stage whose participation has been encouraging”, delighted Tembo.
Although the study’s progress was promising, Tembo noted some challenges hampering the trial including an ability for communities to understand the principles of research, rumors, misconceptions retention, relocations and social and cultural beliefs, norms and customs of participants taking part in the study.
In an effort to complement the success of the trial’s outcome, Journalist Association Against Aids in Malawi, (Journaids) with funding from Bill and Melinda Gates Foundation through International Partnership for Microbicides (IPM) is engaging Malawi’s media, print and electronic by sensitizing them on context and innovations around new HIV prevention technologies and microbicides that right information was delivered to general public specifically to preventing women from HIV/AIDS.
“The role of the media is to inform the public on new innovations that uptake of such measures are highly supported and patronized hence the training to journalists. The capacity building on microbicides will generate interest in the local media on the need to scale up reporting on microbicides and HIV prevention from a policy research perspective in Malawi”, said Dingaan Minthi, Journaids Programs officer upon training Malawi’s media on microbicides on Wednesday, May 13, 2015 in Dowa as part of activities in complementing the ring vaginal clinical trial.
Malawi is yet to experience another down turn of HIV prevalence rate after successfully done well with ARVs such the outcome of the microbicides study will be another milestone in combating the pandemic especially in women are vulnerable