1005- Malawi- A Cluster-Randomized Trial: Using Implementation Science to Accelerate a Path to Scale for Injectable PrEP in Malawi

This $15 million Gates study will be one of the largest single-country implementation projects evaluating the roll-out of injectable long-acting cabotegravir pre-exposure prophylaxis (PrEP) alongside oral PrEP in real-world conditions. Large clinical trials have demonstrated the superiority of injectable PrEP due to adherence challenges with oral PrEP, however real-world implementation of the roll-out of injectable PrEP is just commencing. This study is being conducted within a consortium of partners, including the Ministry of Health of Malawi, Georgetown University, Johns Hopkins School of Public Health, Johns Hopkins Project Malawi, University of North Carolina (UNC) Project Malawi, Cooper-Smith, CHAI, PEPFAR, and multiple PrEP implementing sites in Malawi. Implementation will be rolled out to 36 clinical sites in Blantyre and Lilongwe starting in January 2024 through a slow lead-in period and scaling up rapidly in July 2024 to reach 9,900 injectable PrEP users by January 2025. *This is a sister project to the implementation evaluation placement, but is a distinct project.* Both will utilize implementation science research methods, however project #1 focuses more on health systems, while this project (#2) focuses on a nested cluster randomized trial that will leverage strategies to affect PrEP client behavior, with a focus on improving PrEP continuation rates. Half of the 36 clinics will be randomized to receive implementation strategies to improve PrEP user persistence and half be usual-care sites.

The student will work collaboratively with partners on this exciting project funded by the Gates Foundation. The position will be based in Blantyre, Malawi at the Johns Hopkins Project (JHP) study site. This project will support the JHP team in the development of study materials including training materials and support implementation research training and database development. The position will support quality control of research data and real-time dissemination of data to study teams – including data review and reporting of client (patient-specific) data that will be collected through the cluster randomized trial, including quantitative surveys among a serial cross-sectional sample of PrEP users and separate qualitative in-depth interviews with users, decliners and people who pause PrEP. The position will also support fidelity monitoring and routine reporting of implementation strategies being executed through the cluster randomized trial, by identifying to what degree they are being implemented as designed, in terms of frequency and quality.
We anticipate that the student will be involved in both quantitative and qualitative study activities, including coding of qualitative data. This project offers an intersection of professional and academic opportunities, including hands-on experience with study implementation, as well as experience working on a pragmatic cluster randomized trial in a low-resource setting. This study is a good fit for someone aiming to gain experience in a behavioral clinical trial at an experienced clinical trials site, as well as implementation science and mixed methods skills development.

The professional work environment at the site is mature and fosters productivity across team members. Attire is professional but comfortable, with a culture of ‘casual Fridays.’ JHP has been a clinical trials site for many years (hosting both NIH and Gates funded research) and has been a site for several landmark HIV prevention trials. The workplace operates in a mature, respectful manner and collaboration and teamwork occurs across the staff. The physical infrastructure includes office space, clean/supplied toilets, kitchen for lunch preparation, vehicles for safe transport to project activities and reliable and secure internet. JHP has monthly team-building activities for staff, such as self-care/mental health seminars, fitness/sports days, annual holiday party, and volunteer blood drives, and the GHEFP student will be warmly welcomed and encouraged to join.

This placement would be a good fit for someone who is motivated and can take the lead on projects. Regular mentoring and supervision will be provided by investigators in Malawi and the US; however, it will be the responsibility of the student to use the ideas and advice provided by the investigative team to move aspects of the project along, requesting additional support along the way when needed. Students with an interest in implementation science, the science of scale-up and working with a diverse set of stakeholders and prioritized populations are encouraged to apply.

Epidemiology and biostats (620 series or above preferred); completion of qualitative series; courses in implementation science preferred, but not required.

Experience working with or sensitivity to marginalized populations and on sensitive topics preferred.
A minimum of 20 weeks is required unless pandemic travel restrictions prohibit this duration. If the student is willing and interested in extending time in-country to work on the project, should express their interest for discussion; if agreed with the faculty and local mentor/collaborator, expenses will be covered to support this. Students who continue to work on the project for longer than 20 weeks will likely have more of an opportunity to assist with data analysis and manuscript development.

Name: Sufia Dadabhai, Department of Epidemiology, sufia@jhu.edu

I would describe my communication and mentorship styles as... 

I am based in Blantyre, Malawi full-time. I prefer short, weekly check-ins with my mentees. I am happy to share my cellphone number with mentees for quick check-ins, course corrections on projects, and to help them feel safe and find their way around Blantyre. As faculty at JHSPH and the Country Director for the Johns Hopkins clinical research site in Malawi, I have a sense of both the academic expectations and needs of students, as well as the local context and cultural picture. I do my best to help students find a manageable number of measurable outputs that they can achieve while in-country, ones that are both important to the study and professionally interesting to the student. I try to make them feel at home with our staff, and integrate them into all team activities and local trainings, for professional development beyond just the assigned project. I seek to promote learning across US and Malawian partners. I have a hands-on style of mentorship, working closely with students to ensure meaningful work and thesis research projects.

A complementary student would have a working style and mentorship expectations that are..

A complementary student will be interested in HIV prevention work and learning about long-acting injectable pre-exposure prophylaxis (PrEP), will show a demonstrated commitment to contributing to the team science approach, is capable of working independently and collaboratively, and proactive with asking questions and creative solutions. We have a large multi-disciplinary team working on multiple projects with various research activities within each project. Students able to take ownership of activities and work independently with weekly, brief mentorship check-ins, and to support creative troubleshooting alongside the investigative team are a good fit for this placement.

$925 to cover housing, food, public transport, communications (phone and internet) and reasonable incidentals. Students wishing to travel internally for personal reasons will incur out of pocket expenses.

We will work with the student to develop a budget to cover monthly expenses including housing, transportation, groceries, and other basic living expenses. Any living expenses not covered by the GHEFP grant plus the flight to and from Malawi will be covered by the project.