Asanda Zondi received an unexpected phone call last Thursday, instructing her to go to a health clinic in Vulindlela, South Africa, where she was participating in a research study testing a new device for preventing pregnancy and HIV infection.
The trial was abruptly halted, a nurse informed her, and the silicone ring inserted into her vagina needed to be removed immediately.
Upon arriving at the clinic, Ms. Zondi learned that the U.S. Agency for International Development (USAID), which funded the study, had withdrawn financial support and issued a stop-work order to all organizations receiving its money. This action followed an executive order by President Trump freezing all foreign aid for at least 90 days, coinciding with steps to dismantle the agency entirely.
Ms. Zondi's trial is one of many that have been abruptly suspended, leaving participants worldwide with experimental drugs and devices in their bodies, cut off from monitoring researchers, and generating widespread suspicion and fear.
The State Department, now overseeing USAID, responded to inquiries by directing reporters to a website that has been stripped of information, stating that all permanent employees are on administrative leave. Secretary of State Marco Rubio has criticized the agency as wasteful and aligned with a liberal agenda contrary to the President's foreign policy.
Scientists, restricted by the terms of the stop-work order from speaking publicly, described the difficult decisions they faced: to either violate the order and continue caring for trial participants or leave them without support, risking potential side effects.
The United States is a signatory to the Declaration of Helsinki, which outlines ethical principles for medical research, mandating that researchers provide care for participants throughout a trial and report findings to the communities involved.
Ms. Zondi expressed confusion and fear, noting that other women involved in the study shared similar concerns about the reasons for the trial's suspension.
The stop-work order was so immediate that research staff could not assist in removing the silicone rings from participants' bodies. However, Dr. Leila Mansoor, a scientist with the Centre for the AIDS Programme of Research in South Africa (CAPRISA), decided to prioritize ethics and participant safety, stating, "There are rings in people’s bodies, and you cannot leave them."
Dr. Mansoor highlighted the trust built over 25 years of volunteer participation in HIV treatment and prevention research, a trust now jeopardized by the abrupt cessation of studies. This history resonates in South Africa, where past medical experiments during apartheid have left lingering fears.
More than 30 studies have been identified as frozen, affecting numerous volunteers. The rapid dismantling of USAID has obscured the total number of affected trials and participants, as the agency's public records have been erased, and its communications department has been disbanded.
In England, approximately 100 individuals inoculated with an experimental malaria vaccine are now without access to clinical trial staff, which could be critical if adverse reactions occur. The trial aimed to develop a more effective malaria vaccine, targeting a disease that claimed 600,000 lives in 2023.
Participants would have typically returned for regular monitoring and sample collection, which is now impossible due to the stop-work order. One scientist, who was recently terminated, expressed concern over the ethical implications of halting studies that involve human subjects.
Dr. Sharon Hillier, a professor of reproductive infectious diseases, described the impact on a $125 million trial testing new HIV prevention products, stating that the suspension prevents the processing of biological samples and data analysis, violating ethical commitments.
The shutdowns have broader implications, affecting trials not directly funded by USAID but reliant on its infrastructure. Millions of taxpayer dollars spent on initiating these trials are now lost.
Additionally, pharmaceutical companies face challenges in conducting research in affected countries, as the sudden halt disrupts ongoing partnerships and studies.
Another HIV trial, CATALYST, with thousands of participants in five countries, has been disrupted, risking the health of those relying on regular injections of an HIV preventive drug.
In the Dominican Republic, a trial testing a biodegradable hormonal implant for pregnancy prevention has also been affected, with participants needing continued care despite the funding cut. A spokesperson for the organization involved stated they are working to provide necessary support to participants.
In Uganda, a trial focused on a new tuberculosis treatment regimen for children has been halted, leaving vulnerable participants without potentially lifesaving medication. A researcher emphasized the ethical obligation to continue care for these children.