Suzen Maonera

Suzen Maonera has been an IMPAACT Network CRS Coordinator for 16 years. She assess site capacity for upcoming protocols, identifying necessary facility upgrades and personnel training needs, and oversees the crafting of recruitment and retention strategies. She also monitors data performance and departures from protocols, identifying root cause of errors and institutes remedial action. Finally, Suzen oversees protocol document translation to local languages.

Please describe your role within the IMPAACT Network.

I hold a Master of Science in Nursing with a specialization in Maternal and Child Health and I have been a CRS Coordinator for 16 years. I am the shop-floor manager, driving the IMPAACT agenda by supervising the day-to-day implementation of several concurrent Phase IIb-IV, IND clinical trials in compliance with Sponsor, Network and local regulatory requirements.  I have acquired the experience of coordinating clinical research site activities in a high-volume setting, ensuring that the IMPAACT/HPTN/HVTN clinical trials are implemented in accordance with International Council of Harmonization (ICH) and Good Clinical Practice (GCP) guidelines that guarantee participant safety and wellbeing as well as collection of complete and accurate data.  I assess site capacity for upcoming protocols, identifying necessary facility upgrades and personnel training needs. I oversee the crafting of recruitment and retention strategies, and monitor data performance and departures from protocols, identifying root cause of errors and instituting remedial action. I also oversee protocol document translation to the local languages.

Under my coordination, the site has managed to efficiently enroll participants to protocols completing enrollment before the Network timelines. The site I oversee has also maintained excellent participant retention rates of above 95 percent for all protocols executed, as well as excellent data quality as per the site monitoring and data reports. To this end, the site has been recognized by IMPAACT for excellence in data quality for the PROMISE and P1078 studies.  In 2019, the site was recognized by the IMPAACT Network as first to be activated, highest enrolling and almost 100 percent observation of daily dosing (DOTs) for the IMPAACT 2009 PK Component.

My experience as a nurse practitioner and nurse educator has served me well in my role of trainer within the program where I manage various training activities that include GCP, Ethics, protocol training and CQMP training for all research personnel within the IMPAACT projects. The experience has also equipped me with the skills in the domain of monitoring, evaluation and report writing which are integral components of my function as CRS coordinator that requires me to write weekly, monthly, and quarterly updates on study progress for the Site Leader and IoRs for escalation to the sponsor. To strengthen my capacity, I successfully completed the PERC on-line Clinical Research Site Coordinators Course with the University of Alabama at Birmingham and Certificate in Monitoring and Evaluation offered by the University of Zimbabwe (2014). I have also had training in Bioethics, GCP, PMTCT, Rapid HIV Testing, HIV Management and Infant Feeding Counseling. I am a very good staff motivator and manage both the human and material resources judiciously, creating an enabling environment for the young investigators.

What have you enjoyed most about working with the IMPAACT Network?

What I have enjoyed most is implementing protocols that have given children exposed to HIV a lifeline. I have participated in protocols where the children of the study cohort have survived while other children exposed to HIV did not survive to see the fifth year of life. I have participated in interventions that have made breastfeeding safe for the infants in resource-limited settings where to not breastfeed would have deleterious effects. Finally, I have seen scientifically proven interventions influencing national PMTCT policies and the WHO guidelines. To summarize, I have enjoyed participating in clinical trials that have had an impact on the health of mothers and their children internationally.

Two of the studies you have worked on, IMPAACT 2009 and IMPAACT 2010, both released results this year (at CROI 2020). Explain how that felt and what these results could mean for the future of HIV research in pregnant women and their infants.

The IMPAACT 2009 experience was a first for me to participate in a PrEP study, which is a very new concept in my country. The site study team was not sure how it was going to turn out. I was not convinced the site was going to pull this one off. The idea of helping women realize they are vulnerable to HIV, convincing them to take pills when they are not sick and directly observing the swallowing of 84 doses for each one of them appeared to be an insurmountable task. It turned out the site performance was exceptional with high recruitment and excellent conduct of directly observed therapy. This was a perfect performance that surpassed all expectations and I was thrilled. The results, which showed that concentrations were lower in the pregnant women, points to the need for further studies to establish the appropriate dose for women or novel administration routes to help women take charge of HIV prevention and in the process, protect the unborn child. 

The IMPAACT 2010 results showed superiority of the DTG-containing regimen, a finding that will promise women a more efficacious, safe, well-tolerated and cost-effective intervention in resource-limited settings like my country. These qualities make it affordable and acceptable to the women, which promotes good adherence and protection of infants exposed to HIV peripartum and during breastfeeding, promising an AIDS-free generation.

What has been the most defining experience so far in your career?

I am passionate about participating in programs that target the health and welfare of mothers and children, and my participation in the HPTN 046 did it for me. I have that fulfilling experience of seeing infants exposed to HIV surviving and going into secondary school.

What do you enjoy doing when you’re not working?

Reading novels, walking, gardening and playing with my two grandchildren.