[BuddyBoss Team]

Law enforcement agents require some updated information to be friendly to the MSM population as well. Doing the above could go a long way.
Issues management team could immediately conduct stakeholder engagement meetings that include the media in the trial community.

[BuddyBoss Team]

Human rights issues usually are viewed as political. The scenario is tricky but clinical trials have to target this key population..
There is need to educate policy makers, religious leaders and community on what really causes one to become homosexual. That piece of education is lacking. There may be some biologic issues I don’t really know.
Stakeholder engagement is the answer. Church,political and community traditional leadership including CAB as society gatekeepers need to be engaged. Making them understand the vulnerability of the MSM community and also breaking down in simple lay terms the rationale behind targeting MSM in clinical trials. This area is sensitive area in most African countries where the bible is usually quoted.
Creating an enabling environment is an important key step before a trial kick off involving MSM in such a community is advisable.
The media needs to also be targeted with education concerning the trial so that they could assist in demystifying the stigma, myths and misconceptions.
I will be happy to learn more on this area for it is an issue in communities around me.

[BuddyBoss Team]

Before the study initiation, the research team/CAB/Advocacy groups musts discuss what social harms could result due to participation. Additionally, there must be a plan to ensure confidentiality and safety to participants. In this case study, it doesn’t appear that law enforcement would be an option for safety because homosexuality is illegal so the advocacy groups would play a vital role to assist with finding options for safety. Maybe a non-publicized safe house where participants can go after initially signing up for the trail.

[BuddyBoss Team]

First we must understand that heterosexism is the belief that was introduced to people and which was the way everyone was expected to live. This kind of attitudes are often communicated unitentionally or without people realizing through assumptions rather than over act of discrimination. As a clinical site what will do is get good social support LGBT people and their family and friends can take steps to reduce the effects of stigma and discrimination and protect their physical and mental health. We believe that LGBT people who have good social support from their loved ones and the wider LGBT community have higher self-esteem, a more positive group identity, and more positive mental health.Education is a key to everything as a clinical site learn as much as we can about the nature of this issue so we can have knowledge to teach others (communities) and have relationship with LGBT communities, Human right organisation and possibly have forums around the communities and engage everyone from the community. We will also try to emphasis the issue of no one can be trained to be gay,people are born this way and we need to accept them as who they are and we do understand the some communities it is a very sensitive issue but such issues need to be address informally or formally even though it is not easy to understand people must know what is going on around their communities.

[BuddyBoss Team]

What implications did the lack of inclusion of clean needles in the prevention package have on trial results?
Not including clean needles to prevent the spread of HIV which is harm reduction at its best was devastating. The HIV outbreak in Austin, IN where two HIV IDU cases increased to almost 200 in this small town. This video clip speaks volumes about harm reduction but only when this small town was in crisis.
https://br.noticias.yahoo.com/video/hiv-heartland-174014869.html

How can researchers engage stakeholders to better negotiate comprehensive prevention packages tailored to the needs of diverse subgroups?
Researchers can better engage stakeholders by providing the full array of items that would or could be part of the prevention package and not to eliminate anything. Each item will be discussed and the stakeholders can then provide their positive or negative feedback. Feedback cannot be provided if something is missing!

[BuddyBoss Team]

The assignment of the research team is identified relevant stakeholder’s for not misconception and also maintain the safety of participants. Having a partnership with LGBT organizations, gays leadership , social rights organizations and LGBT forum, they know the code, the language and its valuable to avoid this episode. I believe its important contacting the donor of the nightclub that most of gay people usually to go for having fun and explain about the upcoming trial.

[BuddyBoss Team]

I would say owner of the nightub instead of donor. I apologize for my idiom mistake.

[BuddyBoss Team]

The research team would immediately refer to the site’s policies on trial-related harms in order to refer attacked trial participants to partnered stakeholders who offer clinical, medical, psycho-social or legal support services as the case may be. If solutions to this sort of problem is not available in the trial-related harm policies, the team would work with the CAB, MSM advocacy groups, legal groups and other relevant stakeholders to discuss the best ways to handle the situation and also in corporate the solutions in the policies.

However, the team and stakeholders should have developed an effective communications plan that would create in depth understanding of the trial research among community members and the public at large.

[BuddyBoss Team]

Lack of inclusion of clean needles in this trial meant that participants were exposed to more risks than the trial was to be of benefit to them, especially in light of the fact that this is a non-negotiable standard that must met if we are to offer responsible HIV prevention options for people who are injecting drugs users. This also questions the intention of “offering safe and respectful research” if that was the case why exclude the insights and concerns raised by the different stakeholders. Inclusion and integration of the suggestions offered by stakeholders is critical because it is not only about the trial but about the ability to have research outcomes that can be integrated in programmes or influence policy changes for example.

The environment and hostility of government and the fact that drug use was illegal and even public campaigns were held to emphasise this point means that participants were not protected should anything wrong happen to them during the trial. The participants were exposed to more risk and the laws of the country in this regards were not supportive to them.

Stakeholders and advocacy groups were right in suggesting that the trial be halted or redesigned.

[BuddyBoss Team]

What implications did the lack of inclusion of clean needles in the prevention package have on trial results?

The failure to provide clean needles obviously influenced the results especially on the placebo arm by heightening the participants risk of HIV infection. The legitimacy of the trial data is indeed questionable as there was no reduction of harm on the participants, the results were therefore obtained in an unethical way and the efficacy of PrEP from the trial results in this case can be challenged.

How can researchers engage stakeholders to better negotiate comprehensive prevention packages tailored to the needs of diverse subgroups?

Researchers can engage stakeholders in negotiating for HIV prevention packages from the protocol development stage. Bringing in the CAB and the local health practitioners can better inform the decisions which researchers can take. The local CAB brings with it the local diversity of the population and hence the various sub groups of the population’s needs will be addressed through the CAB meetings with the researchers.

[BuddyBoss Team]

1. What implications did the lack of inclusion of clean needles in the prevention package have on trial results?
Clean needles not been included in the prevention package might have garbled trial results. Nevertheless, the research team might have engaged in regular HIV prevention counseling for the trial participants especially on the use of clean needles in order to compensate for its non-inclusion in the prevention package. Also, it is important to note that the trial participants who are Injecting drug users were HIV negative as at when been enrolled into the trial therefore it is possible that they had been engaging in the use of clean needles and were aware of the health implication in using unclean needles. Therefore, if pre and post tests on the level of awareness on the importance of using clean needles to inject and prevent HIV were conducted for trial participants, one can use such to determine the authenticity of the trial outcome based on the lack of inclusion of clean needles in the trial’s prevention package.

2. How can researchers engage stakeholders to better negotiate comprehensive prevention packages tailored to the needs of diverse subgroups?

Researchers need to identify and map out a wide range of stakeholders at beginning, during and after the trial. The research team needs to identify stakeholders who have sufficient technical and research expertise and also independent perspective on the research. Stakeholders should be those who can help or harm the trial. The team should invite the CAB, Local Scientific Advisory Board, Local HIV prevention service providers, Civil Society Organizations and other broad national and also global stakeholders in designing prevention packages. In negotiating and deciding on the components of the HIV prevention package, the research team and stakeholders should take into account the available HIV prevention standards at the national and local levels, and the national laws on HIV prevention services. Key policy makers should be properly engaged in trial research.

[BuddyBoss Team]

We would deal with the situation by continuing to educate people about our site and what we offer and also clarify that we do not train people to become gays we could provide this education in the form of media and outreach programs. For our participants we will make sure that we offer them with health and social services such as giving them support and referring them for counselling in order to deal with all the stigma and the negativity. Well in order to avoid this occurrence we need to engage stakeholders in developing plans to address this kind of issues as it would assist in enhancing participants welfare and improve trials;s outcomes. Research teams and stakeholders should also develop policies on how to address all trial related harms.

[BuddyBoss Team]

This was indeed unethical, how can you conduct a trial for HIV prevention and yet you fail to provide clean needles. This actually increases the risk for HIV infection.
Stake holders and research teams have to discuss HIV prevention methods/ packages putting in mind protocol considerations and not for forgetting the ethical requirements.

[BuddyBoss Team]

Also check out this perspective from the community stakeholders
http://www.treatmentactiongroup.org/hiv/Bangkok-prep-statement

[BuddyBoss Team]

Hi Yumeng,
It is possible that the BTS researchers had indeed extensively engaged the Thai government and other national and broader stakeholders but were unable to make inroads into obtaining approval for provision of clean needles for the participants. It’s also possible that engagement o the stakeholders was poor. I found varied accounts about why clean needles were not provided on the web reflecting the differing perspectives of the stakeholders. Here are a few
https://www.cdc.gov/nchhstp/newsroom/docs/factsheets/archive/prep-idu-factsheet-508.pdf
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1261513/

The HIV prevention package contained HIV education and risk-reduction counseling, methadone, HIV counseling and testing, condoms, and bleach with instructions on how to clean needles at monthly study visits. One may argue that providing bleach and teaching participants how to clean their needles for reuse made up for the lack of clean needles in the package but I don’t think so. Frankly, I think the study should have been conducted in another country whose laws would have permitted inclusion of clean needles in the HIV prevention package.