PrEPVacc Vaccine Trial Results Dissemination to participants in Masaka, Uganda
By Vincent Basajja, Community Liaison Officer, MRC UVRI & LSHTM, Uganda
Results from the PrEPVacc trial were disseminated to study participants between 23 July and 22 October 2024 at the MRC/UVRI & LSHTM Masaka Field Station. Dissemination sessions followed immediately after the release of the trial results at the AIDS 2024 Conference in Munich, Germany, on 23 July 2024.
389 (78% of the site total) participants received the results between July and October through face-to-face dissemination sessions designed to ensure thorough discussions. The site purposefully started by inviting participants to attend in small groups to ensure that everyone fully understood the results and was given an opportunity to be heard.
After 22 October 2024, efforts to reach out to as many participants as possible have continued, using alternative outreach mechanisms such as phone calls to ensure the site meets its ethical obligation towards all participants.
Participants were welcomed by the site staff and informed about the main reason for their visit (dissemination/sharing of the PrEPVacc trial vaccine results). The engagement began with a review of the trial objectives, design, and procedures, conducted in a Q&A format to involve participants and actively identify any information gaps. It was very encouraging to note that, among Masaka participants who responded to questions about the key trial information areas, they demonstrated a high level of information retention, recalling key details about the trial, such as the double-blind design, the testing of vaccine safety, and the comparison of vaccine efficacy to a placebo.
Dissemination outcomes I
Questions and concerns arising from participants at Masaka
1. You told us not to go for HIV testing from any other facility besides this research site. Now that you have told us about the trial vaccine results, and we are not likely be coming here for HIV counselling and testing, how shall we access such services?
2. How come some people on the active vaccine developed HIV antibodies but could not get total protection from HIV infection?
3. When shall we get to know who was on the active arm or the placebo arm?
4. I may still have the antibodies in me, if I go for check-up elsewhere (where they use the widely available HIV testing kits, won’t they right away conclude that I am HV infected even when I am not?
5. You said that the results on PrEP are not yet out, when do you think this will be? And how do you plan to make them known to us and other people like the case is with the trial vaccine results?
6. During the trial, you told us that you did tests on our kidneys, liver and other body organs to monitor for safety. If I now need such tests since I do not yet know what I received during the trial, can you do this for me?
7. Now that the trial has ended, if I want to travel abroad and I am required to undertake HIV tests, how will the cards help me explain medical tests in case of VISP?
8. Did you keep on following up with participants who were seroconverters to ensure that they are on care and treatment?
9. One challenge I foresee is that you might not be able to reach out to all the people who participated in this trial to share these important results with them. Can you tell us what you plan to do to ensure that everyone gets to know about the results?
10. Assuming you unblind us and you find that some of us developed VISP, how long will the research site provide specialised HIV testing services to participants with this condition?
11. Are there any other HIV vaccines being tested in Uganda or elsewhere in the world? You know, at first, some people were so sceptical about clinical trial participation. With time, you hear them ask if they too, can participate in a trial like PrEPVacc. I am ready to recommend them if you have another clinical trial planned in the near future.
12. Even when these results have disappointed me, I strongly believe that, for us to end this epidemic, there must be an effective HIV vaccine. You can imagine how intensively you promoted PrEP, correct and consistent condom use and other available prevention strategies, but we still registered some HIV infections during the trial.
The vaccine trial results were then shared and followed by an open Q&A session, during which participants expressed their concerns and observations. Many were disappointed but not surprised by the lack of efficacy of the trial vaccines, as they recalled the news that vaccinations had been stopped in December 2023 following the trial Independent Data Monitoring Committee (IDMC) recommendation based on the evidence that neither of the trial vaccines had demonstrated ability to reduce HIV infection.
“I am disappointed but not surprised by the fact that the trial vaccines were not able to reduce HIV risk. We were told this last year when you shared some updates with us. What is very disturbing is the difference in the number of infections in the vaccine arms being slightly higher compared to those among participants who received normal saline (placebo).” – Masaka participant during dissemination event
However, they were pleased to learn that the vaccines were safe, which they felt would encourage continued support for HIV vaccine research.
“We are very happy to confirm this finding again. Even if the vaccines were not protective against HIV infection, we are very happy to learn they were safe. We would be very scared if it was the other way. This finding will give courage to people and communities to continue supporting HIV vaccine research in future.” – Masaka participant during dissemination event
Participants noted the lower-than-expected HIV incidence across the whole trial, and they attributed this to the comprehensive HIV prevention options they were exposed to during the trial.
“From the time we got into contact with the research teams, we were told that HIV/AIDS was still a very big health problem in Uganda. The first HIV counselling and testing was a wakeup call for me. I was very surprised that up to then, I was still HIV-. We got exposed to a number of HIV prevention options that were not so much known to us such as PrEP, PEP and SMMC in addition to correct and consistent condom use. I strongly believe this helped many of us to use some of these preventive strategies during our trial participation” – Masaka participant during dissemination event
Overall, they appreciated the researchers' openness and the benefits they received from the trial, including health education and STI diagnosis and treatment.
“It is unfortunate that a total of 32 participants got infected with the HIV virus at all trial sites and eight were from Masaka-Uganda. We are happy that you are very open about these findings. One thing that I would like to say is that such cases could have been far higher if we never got the research tailored IEC and HIV prevention packages. I remember very well how I was always reminded about taking care of my life since the trial vaccines were not yet proven to protect me. I guess even our wider communities must have benefited from the sensitization outreaches you exposed them to. How I wish these could continue even when the trial ended. People need constant reminders about this epidemic.” – Masaka participant during dissemination event
Each dissemination session concluded with reminders about the importance of continued HIV prevention efforts and the availability of one-on-one sessions for unblinding.
Participants and study teams acknowledged that the PrEPVacc partnerships (between the research teams, trial participants, general communities and other trial stakeholders) contributed a lot to the global fight against HIV.
Participants were thanked once again for their contribution to the PrEPVacc trial, which, despite the disappointing results, provided valuable knowledge and research capacity for future HIV vaccine research.
Dissemination outcomes II
All participants’ concerns and questions were addressed during the dissemination sessions, and each engagement ended with these key reminders:
· Vaccines do not cause HIV infection.
· Infections are acquired when prevention is not used properly.
· The study objectives, vaccine pause, and the finding of lower HIV infections in the trial compared to the cohort and similar populations.
· Encourage participants to engage with staff for any concerns or personal queries
· One-on-one sessions would occur for individual participants unblinding, counselling and guidance.
· Participants should return for future testing and receipt of PrEP results.
· Continue to use available HIV prevention options correctly and consistently to protect themselves from HIV.
· Those who Sero-converted during the trial and those that might sero-convert post trial participation should be encouraged as much as possible to access treatment and care to protect themselves and others.