Science Café; PrEP and Microbicides

Kampala, Uganda

·To provide journalists with updates on the latest developments in research on microbicides and other new or emerging biomedical HIV prevention options

·Help journalists generate story and feature ideas on microbicides and other new oremergingbiomedicalHIV prevention options, critique their work and engage in thought-provoking debate

Several journalists who attended the first café were present as well as new young journalists who are starting to get their feet into health/science reporting.

Many showed enthusiasm in learning and knowing more about the different HIV prevention technologies, especially microbicides and PrEP and the debate that will follow.

Proximity plays a key role in the enthusiasm displayed by the journalists. One of the research studies, the Partners Demonstration Study is being conducted in Uganda and Kenya.

Pre-Exposure Prophylaxis:  What is it in light of the Partners Demo results that were released recently?

Dr. Nulu Bulya from the Infectious Diseases Institute/Partners Demonstration Project took the journalists though this topic, discussing the current status of the research, what has come out of it and the way forward.

Dr. Nulu started her discussion with the definition of PrEP, explaining that it involves the use of antiretroviral medicines to reduce the risk of HIV infection in an HIV negative person, especially those in discordant relationships.

She explained that the Partners Demo Study was undertaken as a result of findings from a 2012 study that found Truvada, an antiretroviral drug was effective in reducing the risk of HIV acquisition by a negative partner.

“When the clinical trial was carried out, it demonstrated that if used consistently, Truvada was 75% against HIV infection,” said Dr. Nulu.

It also sought to demonstrate how PrEP, away from clinical trials could be used in a real world setting.

In Uganda, the number of people getting infected with HIV continues to grow, while many are living in discordant relationships.

The study sought to establish if people in discordant relationships would accept to use the intervention of ART for the positive partner and PrEP for the negative partner in order to reduce the risk of infection for the negative partner.

“So far the results we have is that PrEP can reduce the risk of infection by 90 per cent,” said Dr. Nulu.

The PrEP study was started in 2013, with the first enrolment in November. It has enrolled 1013 people at two sites in Kasangati and Kabwohe Clinical Research Center in Uganda and . There are two other sites in Kenya– Kisumu and Thika.

Civil society perspective on PrEP

Charles Brown, also from the Partners’ PrEP demonstration study gave a civil society perspective, focusing more on advocacy for the establishment of guidelines/policies that ensures that health workers are able to administer PrEP.

“From the recent CROI 2015, we now have more than enough data that PrEP works. What we want is for the government to come up with guidelines that can be used by health workers both in the public and private facilities to prescribe PrEP,” said Mr. Brown.

At the moment, many discordant couples and other key risk groups are missing out on the opportunity to access services because the country does not have these guidelines or policies in place.

He also urged the media to play a leading role in pushing the government to put in place such policies.

 Dr. ClemensiaNakabiito, Makerere University Johns Hopkins University Collaboration (MUJHU) 

Dr. Nakabiito discussed the potential of the vaginal ring, which she said will be a life-changing HIV prevention technology for women if found to be effective at the end of the study.

The dapivirine ring was developed by the International Partnership for Microbicides (IPM) and the active ingredient in it is an antiretroviral (ARV) drug called dapivirine.

The ring is designed in a way that a woman can insert and remove it on her own without a health worker is present.

Explaining to journalists how it works, Dr. Nakabiito said once placed inside the vagina, the ring slowly releases Dapivirine during the four weeks when a woman is wearing it.

According to Dr. Nakabiito, the vaginal ring study is targeting women who are at high risk of contracting HIV.

Uganda has been previously involved in other HIV prevention studies that specifically target women. One example is the trial involving the use of a microbicide gel. However, the trial was discontinued because the women using the gel with the active ingredient under study and those using the placebo were getting infected equally.

The Daprivirin ring study started in 2013 and the site at the Makerere University-Johns Hopkins University Research Collaboration (MUJHU) was the first to enroll women.

The study is being conducted in Uganda, South Africa, Zimbabwe, and Malawi. In total, there are 15 sites across these countries where the trials are being conducted.

A similar study is being conducted at a trial site in Masaka, although the design is different.

Dr. Nakabiito said so far the data from the study shows the ring is safe. As a result, MUJHU was stopped from enrolling more participants.

“After analyzing the available statistics, we found that the 2629 women we had enrolled were enough to give us an endpoint of effectiveness. So far the safety is okay,” said Dr. Nakabiito.

Before enrolment on the study, community sensitization was carried out to inform the women of its intentions and why having an effective method to prevent women from getting HIV/Aids is important. 

After the community sensitization, more information is usually given at the site, where screening is done to ensure those enrolled are from the intended high-risk group of women.

In this case, a high-risk person is defined as someone who has had sex at least once in the last three months, without a condom or a person who has multiple partners.

One of the biggest challenges involving such large-scale and long-term trials is adherence and the ability to remain in the trial to its conclusive stage. “Once a person makes a commitment to take part in the study, they are encouraged to continue with the process to its completion” explained Dr. Nakabiito.

Key questions from journalists

Can we say the vaginal ring is on track as far as protecting women against HIV is concerned?

·We are closing the follow-up of the participants. By July we will have stopped following up all the participants and then the data will be analyzed.

·We expect results in the last quarter of this year or first quarter of next year

·So far it is safe but we have to combine the results of the ring study in SA and Masaka sites.

·At the moment we continue to give the women the ring to wear for one month before returning to the center. Some get the one with the product under trial and others continue to get the placebo.

·When they return every month, we test them for HIV and pregnancy because we don’t want them to become pregnant when they are on the ring.

·When they become pregnant, we discontinue the product.

So will the ring be recommended only after we have the final results? How is this information important at this stage?

• Of course for the community, the information is important. It would mean that women adhered to the ring and when the results turn out to be effective, all those who have been in the trial but taking the placebo will be given the actual product.
• The message for most of the population in the research is adherence, which has been a challenge because if you don’t take the product as prescribed, there is no way you are going to find out if it works or not.
• We shall also combine it with other preventive technologies.
• In Africa what measures can we put in place to ensure adherence
• For every trial we do, we are now attaching a behavioral study to understand the community. -Maybe we are giving them something they do not want. Maybe we are not understanding the community. So we have a behavioral science trial within the trial.

• We ask the women what difficulties they found in using the ring.
• Male involvement is still a challenge. Many women feel if they put on the ring, the men will feel it during sexual intercourse.
• We tell them we are trying to find something for them because they don’t have control of using things like the male condom.
• We also want men to understand that if women find something to prevent HIV, it is also going to benefit them.

In these studies, do you offer incentives for the women to be able to participate?

• We compensate their time and give them transport reimbursement.
• During the consent signing, we explain to them what will happen and how long and how much of their time may be required. At each visit, they may spend almost a whole day.

Do you think the long study period also contributes to the lack of adherence?

• During the VOICE study, we found the non-adherence started at the beginning and not the end. Even for this study, some women would come and tell us they decided to pull out the ring because they had issues. There are several factors that affect adherence which we must address.

Explain what the vaginal ring looks like and what it contains.

• Vaginal rings are flexible products that can be inserted inside the vagina and provide sustained delivery of drugs over a period of time.
• The active ingredient in the ring is an antiretroviral (ARV) drug called Dapivirine.

Why did you target people in discordant relationships?

• The HIV negative partner in a discordant relationship is at high risk especially if their partner has not initiated ARVs or has not used ARVs for 6 months. So if we are able to identify them before the transmission occurs, the negative partner will benefit and may be protected from contracting HIV.

How does PrEP work and when does someone start taking it?

• For the study, we are using PrEP during a time when the HIV infected partner in a discordant relationship has not initiated ARVs and from the time they initiate ARVs, we allow them to use ARVs for at least six months and during this period the viral load will go down and the immunity will be suppressed.
• During this period which may take six months or longer, some people may decline to take the medication because of stigma or other factors so we want to give them support.

How has been the adherence of PrEp by the participants?

• Before we enrolled the participants, we took them through intensive counseling to understand the benefits of the study. While some eventually opt out, our retention rate has been about 85 percent. Others are usually lost to follow up while some may have changed location. Adherence is important and we want people to police themselves. 

Can PrEP be taken like family planning?

• It cannot be taken as an emergency pill. When used by everybody, it may be prone to abuse and resistance just like we have seen with many other drugs. That is why we are pushing for guidelines so that it is only health workers who can administer it.

Does PrEP have side effects?

• It has minor side effects. People who have used it usually report abdominal symptoms like diarrhea. The side effects are minor compared to the benefit a person gets by consuming the drugs.

However, Esther Nakkazi assured her that the journalists would be trusted to be able to write accurate stories as they have always done so. She also encouraged all those journalists to seek any clarifications on things they did not understand with the presenters.

The contact details of the presenters were shared with the journalists

• A fact sheet from the International Partnership for Microbicides: The Dapivirine Ring for HIV Prevention in Women
• Pre-Exposure Prophylaxis for HIV Prevention in Uganda 

http://www.independent.co.ug/features/features/10157-arvs-for-hiv-negative-people

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