By Flavia Nassaka
Woman reveals why she didn’t tell her husband about participation in a research that could finally give women HIV protection they can control
Call her Margret Nakamya. She had nursed a HIV/AIDS patient before. And when the 32-year old describes what she went through taking care of her late aunt, her eyes become teary and she has to pause several times in her story. Finally she bursts out: “I can protect myself but what about the others?”
The mother of four told The Independent that is why she enrolled as a participant in trials to evaluate the safety and efficacy in preventing HIV of a vaginal ring containing the anti-retroviral drug dapivirine that is placed in the vagina. She was of over 4500 women from Uganda, South Africa, Zimbabwe and Malawi who participated in the two trials called `Aspire; and the `ring’ studies.
“Just as I have a story, every woman who participated in the study has a story to tell. My husband is always away. He visits only twice a week. This ring gives me an opportunity to protect myself,” she says when asked about why she decided to take part in the study even when she knew that the device’s effects or degree of protection was unknown. Nakamya did not tell her husband about it. After all, she had been living in fear of HIV ever since she discovered that her husband secretly keeps two other wives.
She was attracted because the ring promised to place the power to protect herself in her hands. She placed the ring in her vagina herself, replaced each month, and her husband was completely unaware that it is there when they had sex.
Meanwhile, throughout the study duration, a HIV blood test was done on her and all participants every month. A cervical cancer test was added after every six months to establish whether there are any side effects. When the results of the trials were released at the Conference on Retroviruses and Opportunistic Infections (CROI) held in the U.S. on Feb. 22, they showed remarkable success of the ring in stopping HIV.
Results found 27% efficacy for the ASPIRE study and 31% for the vaginal ring among women between 18 and 45 years of age.
The ring works as a form of a pre-exposure prophylaxis and protects one from getting infected because small doses of the dapivirine drug are gradually and continuously released into the vaginal area to fight off infections. She says when the ring is inserted, it rests below the cervix and no one can know that you are using the product.
Though the ideal is for the ring to be in place all the time, if someone inserts it eight hours before a sex encounter, it can still offer protection.
In Uganda the trials were conducted by the Makerere University- Johns Hopkins University (MU-JHU) Research Collaboration entity at Mulago National Referral and Teaching Hospital in Kampala.
Dr. Flavia Matovu Kiweewa, the lead researcher for the ASPIRE study in Uganda said 168 acquired HIV during the study duration of which 97 were using a placebo and 71 were using the medicinal ring.
Nakamya is unaware whether she had a placebo or a medicated ring. But she says for the four years she has been using the ring, she has been confident about her health and has learnt to enjoy her marriage once again. In fact, she says, if the device is eventually put on the market, will get it for her teenage daughter.
“I know it doesn’t offer 100% protection. (But) It’s the only method you can control as a woman,” she says.
Tougher hurdle ahead
Though the innovation has been received with excitement especially among women health activists, the device is not landing on pharmacy shelves or at your dispensary any time soon. Dr. Clementia Nakabiito, one of the researchers, says before it can be used massively, the device has to first be approved by the Food and Drug Administration (FDA), an international body that approves all drugs before being used. But the research team is negotiating with the ministry of Health to ease the approval process.
“The US Food and Drug Administration will go to the different countries that got involved for an audit but this will be after the different ministries of health approving,” she said. However, the Ministry appears skeptical about the device. An official who spoke to The Independent said “it’s unreasonable to approve something with such a low efficacy when other researches that have showed better results have not implemented”.
Previous studies that have shown bigger efficacy but remain on paper include PrEP for a HIV negative partner in a discordant relationship yet 60% of new HIV infections are occurring among discordant couples.
Researchers from the Infectious Disease Institute (IDI) came up with a solution of giving the HIV negative partner drugs – Truvada and Viread with recommendation from the World Health Organisation four years ago. While in countries like South Africa and Kenya, PrEP has been massively rolled out, the official Ministry position still remains that it should not be prescribed outside of a clinical trial context. But, the low percentage of protection which is so far the ministry’s main concern should not come up as a reason for delaying approval according to the researchers. They say it could have been low because some of the participants did not adhere.
“This can’t be rated the same as male circumcision, for instance, because some of the women admitted having forgotten to insert the ring. For adhering participants, we saw the protection level going up,” says Kiweewa, “There’s high acceptance and therefore the protection level may increase.”
Kiweewa adds that research shows that methods under clinical trial show lower levels of protection than in bigger demonstrations.
Meanwhile, all the women who participated in the two studies will be initiated on the ring even before approval. The researchers have plans of designing rings that last three months or more to save women the inconvenience of having to change every month. The ring is estimated to cost US$ 5 (Approx. Shs 16,000 or a week’s supply of condoms) once put on the market.