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.


Our Research Staff




Dr. Joanne Batting

joanneba@foundation.co.za

Principal Investigator


Ms Dalene Blom

daleneb@foundation.co.za

Site Manager


Neliswa Swartbooi

neliswas@foundation.co.za

Laboratory manager


Sisipo Ndzamela

sisipond@foundation.co.za

Pharmacist


Ms Ayabulelwa Mlati

Ayabulelam@foundation.co.za

Study coordinator


Ms Amanda Mzamo

amandamz@foundation.co.za

Community Liaison Officer


Current projects



PURPOSE 1

Start Date : 2022-10-30 End Date : 2027-08-31

Site : Ndevana Clinical Research Site

A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice-Yearly Long Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection.

ClinicalTrials.gov ID NCT04994509



PURPOSE 2

Start Date : 2023-08-01 End Date : 2027-12-31

Site : Ndevana Clinical Research Site

A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice-Yearly Long Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection.

ClinicalTrials.gov ID NCT04994509


Past projects



INSIGHT study

Partner:International Clinical Research Center, University of Washington

Start Date: 2022-09-08 End Date : 2023-07-27

Site: Ndevana Clinical Research Site

Donor: Bill and Melinda Gates Foundation

A cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women



Community PrEP study.

Start Date: 2017-06-01 End Date : 2023-05-31

Site: Ndevana Clinical Research Site

Donor: National Institute of Mental Health (NIMH) of the U.S. National Institutes of Health (award number R01MH114648).

A cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women


Publications



De Vos L, Mudzingwa EK, Fynn L, et al. Factors that influence adolescent girls and young women’s re-initiation or complete discontinuation from daily oral PrEP use: a qualitative study from Eastern Cape Province, South Africa. J Int AIDS Soc 2023; 26(9): e26175. Access


Daniels J, de Vos L, Bezuidenhout D, et al. “I know why I am taking this pill”: young women navigation of disclosure and support for PrEP uptake and adherence in Eastern Cape Province, South Africa. PLOS Glob Public Health 2023; 3(1): e0000636. Access


Medina-Marino A, Bezuidenhout D, Ngwepe P, et al. Acceptability and feasibility of leveraging community-based HIV counselling and testing platforms for same-day oral PrEP initiation among adolescent girls and young women in Eastern Cape, South Africa. J Int AIDS Soc 2022; 25(7): e25968. Access


Mudzingwa EK, de Vos L, Atujuna M, et al. Factors influencing adolescent girls and young women’s uptake of community-based PrEP services following home-based HIV testing in the Eastern Cape, South Africa: a qualitative study. AIDS Behav 2022; 26(11): 3726-3739. Access


Mudimu E, Sardinia J, Momin S, et al. Incremental costs of integrated PrEP provision and effective use counselling in community-based platforms for adolescent girls and young women in South Africa: an observational study. J Int AIDS Soc 2022; 25(2): e25875. Access


Medina-Marino A, Bezuidenhout D, Hosek S, et al. The Community PrEP Study: a randomized controlled trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa – a study protocol. Trials 2021; 22(1): 489. Access