Clinical trials

FPD established the Ndevana Clinical Research Site (CRS) in the Ndevana community in 2021 in collaboration with the Desmond Tutu Health Foundation and following investigator-driven research in HIV prevention conducted in this area. Ndevana CRS aims to ensure that the Eastern Cape community and voices are included in ground-breaking research. Located in Ndevana, the CRS is one of the few clinical trial facilities in South Africa located in a rural area of the country. We work with a highly vulnerable population with high rates of HIV, sexually transmitted infections (STIs) and tuberculosis (TB).

Ndevana CRS is conveniently located next to a taxi rank at the main road through the Ndevana, Illitha and Phakamisa villages. The site has 24-hour security, back-up generators for electricity, and its own water storage. There are consulting rooms for doctors, nurses, and clinical research workers where clinical care, counselling and consent procedures are performed. There is an on-site laboratory with -20 and -80 freezers, centrifuge, incubator and other laboratory equipment and resources. The on-site research pharmacy stores investigational product and ad-hoc medication, has processing and preparation capacity (e.g. for injections) and full-time staff in place.

The community team runs a community programme supporting trial participants and the broader community through awareness events and support. The community advisory board (CAB) is in place and represents the appropriate sectors of the Ndevana community. The community team works closely with the local administrative, regulatory, and community-based partners and organisations to ensure full support and local benefit of the work done in the Ndevana community.

Ndevana CRS is positioned to conduct phase III and phase IV clinical trials with relevance to primary healthcare. The team has a track record and portfolio in clinical trials of novel HIV prevention options and is working in several investigator driven STI projects, with the intention to expand to STI trial research. Given the high burden of TB, and overlap with the HIV programme, infrastructure and resources are in place to participate in any upcoming trial in that field.

Ndevana CRS has successfully completed the INSIGHT study that was funded by the Bill and Melinda Gates Foundation for the International Clinical Research Center at the University of Washington, Seattle, and the NIH-funded Community PrEP study in partnership with the Desmond Tutu Health Foundation (DTHF) in Cape Town. These studies generated valuable scientific data, highlighting the high burden of disease and vulnerability, and provided the team with implementation experience to successfully continue the work in the HIV prevention field at Ndevana CRS.

The Ndevana CRS team has successfully recruited participants in the PURPOSE-1 and PURPOSE-2 clinical trials . These trials evaluate efficacy of long-acting lenacapavir injection for HIV prevention in adolescent girls and young women (AGYW) and in key populations (men who have sex with men (MSM); transgender people (TG) and non-binary people). The site has reached is recruitment targets and has achieved high rates of follow-up visits and retention in these trials to date.