AIDS 2024: Knowledge and experiences of participating in an HIV vaccine efficacy trial with second randomization to oral pre-exposure prophylaxis in South Africa, Tanzania, and Uganda
Rachel Kawuma is a Social Scientist with a research interest in HIV prevention across the life course based at MRC/UVRI & LSHTM Uganda Research Unit. For more than fifteen years, she has worked on several studies, including clinical trials among diverse populations such as adolescents, female sex workers, fisher folk, discordant couples and members of the general population. Her research uses qualitative methods of inquiry to answer questions about trial acceptability, feasibility, adherence and general experiences among trial participants and general populations around the communities where they occur.
In the PrEPVacc study, Rachel coordinated the social science component in the trial across the four participating research sites in Uganda, Tanzania and South Africa. Her roles entailed: Designing the sub-study protocol and data collection tools; working closely with site teams to ensure that data is collected on time, written up and securely deposited on both the site servers and a central server hosted at the London School of Hygiene and Tropical Medicine (LSHTM); supporting site teams in developing data management and analysis plans which included manual coding of the data and identification of areas to write; and writing up and supporting other social scientists to write up findings for possible publication.
For this abstract, Rachel is the lead author and together with all sites social scientists describes research findings from the four PrEPVacc sites in South Africa, Tanzania and Uganda to be reported at the AIDS 2024 conference in July 2024. She answers questions about these findings below:
What was the problem this research was trying to address? Why does it matter?
Sub-Saharan Africa still bears a big burden of the HIV/AIDS epidemic compared to the rest of the world, despite the availability of several safe and effective methods of prevention. There is a need to increase prevention choices, including HIV vaccines, to address end user preferences.
As efforts to develop a safe and effective vaccine for HIV remain an important priority, it should be done in a manner that ensures that people remain protected. To support this goal, the World Health Organisation (WHO) developed guidance that people participating in prevention trials should be provided with and on how they should be helped to access HIV risk reduction services.
The PrEPVacc trial, a phase IIb, double blind, placebo-controlled vaccine study assessed the safety and efficacy of two HIV vaccine regimens, each compared to placebo in preventing acquisition of HIV. Participants were provided with PrEP for the first 6 months in the trial and after that referred to a PrEP provision centre to continue.
We assessed participants’ knowledge and understanding of the design, acceptability and uptake of PrEP and vaccination and their experiences participating in the trial.
How did you address this question?
We used qualitative methods to investigate participants' experiences while participating in the trial, receiving both vaccination and PrEP, as well as disclosure and adherence.
What methods did you use?
We conducted in-depth interviews with 105 participants (81% females) at 2, 6 and 12 months and 15 focus group discussions with 121 (78% females). In addition, regular structured de-briefs were conducted with community engagement and counselling trial staff who were directly involved in recruiting and supporting participants to participate and use trial products.
Sampling characteristics for participants were age, gender, PrEP randomization, and adherence behaviours according to self-report and urine test results
Thematic framework analysis was used to analyse the data.
What did you find?
We found that
Participants understood the process of randomization to both vaccination and PrEP. They were also aware that the vaccine was under trial and only PrEP could protect one from acquiring HIV.
They agreed to participate based on individual perceptions of risk, and health and personal benefits.
Significant others, including partners, family members and peers, discouraged PrEP use and vaccination due to fear of possible side effects.
There was stigma associated with PrEP caused by it being similar to ART drugs taken by people living with HIV.
What does this mean?
Although the trial design was understood and both vaccination and PrEP were accepted, participants preferred vaccination. Therefore, the continuous evaluation and addressing of barriers to product acceptability, recognizing the dynamic nature of trial acceptance and employing participant engagement strategies are all essential for successful trial implementation and product uptake
Are you confident in your conclusions, or are there uncertainties or caveats you would wish people to know?
Our study’s longitudinal design helped in assessing understanding of the trial design. We saw that knowledge about the trial design improved with continued participation. Many participants did not understand the trial design at the time of interview one, but this improved in the subsequent phases after talking with the trial teams. The structured debriefs with trial staff provided a forum to discuss participants’ experiences and how they could be improved.
Were these findings surprising?
Not surprising because mechanisms were put in place to support participants in understanding the trial design. The support offered could have contributed to their overall experience of accepting the trial and products. In addition, the perceptions of PrEP in the trial are not different from those found in previous studies.
What is the message of these findings for different people?
Continous support of trial participants through knowledge sharing can improve overall experiences in participation.
Acceptability of trial participation did not uniformly translate into acceptance of the products offered. This highlights the need for continuous evaluation and addressing barriers to product acceptability.
Significant others and community perceptions greatly influenced participants' decisions regarding participation, thus emphasizing the importance of community engagement.
What question(s) does this research point you (or others) towards addressing next?
These findings point to the ethical dilemmas of positioning standard of care prevention in efficacy trials. Further efforts could aim to design community engagement studies that support participants' adherence to efficacious methods of HIV prevention while they take part in clinical trials. For instance, exploring and addressing individual, relational and structural factors that affect product acceptability and uptake.
Are there any ‘firsts’ that this research can claim?
While the acceptability of trials has previously been assessed, this study points to the notion of ‘conditional trial acceptance’, which means that accepting to take part may not necessarily mean that one is ready to take up all the trial’s products, and this acceptance is a fluid thing, not static.
Any final thoughts?
These qualitative findings offer insight into the acceptance and evaluation of including PrEP as the standard of Prevention in HIV vaccine trials. Continuous education about the study design helped participants in this study, and continuous community engagement helped to support trial and product acceptability. Future clinical trialists and researchers will find them useful as they prepare for their efficacy trials.
Knowledge and experiences of participating in an HIV vaccine efficacy trial with second randomization to oral pre-exposure prophylaxis in South Africa, Tanzania, and Uganda
Rachel Kawuma, Rujeko Samanthia Chimukuche, Sarah Nakamanya, Edith Tarimo, Jane Ambindwile, Janet Seeley on behalf of the PrEPVacc Study Group
WEPED401 at AIDS 2024 | Published 23 July 2024 | Link to abstract in AIDS 2024 programme