Clinical trials


FPD established the Ndevana CRS in the Ndevana community in 2021. The Ndevana CRS is conveniently located next to a taxi rank at the main road through the Ndevana, Illitha and Phakamisa villages. 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, STIs and TB. The Ndevana CRS is well-positioned to conduct phase II, III and IV clinical trials.

The community team runs 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.

Facility Layout:
  • Clinical Spaces: 3 clinical rooms, 4 counselling rooms.
  • Laboratory and Pharmacy
  • Additional Rooms: 1 temperature-controlled room, 1 boardroom, 3 offices.
  • Common Areas: Open plan reception/participant waiting area

Utilities and Backup Systems:
  • Two backup generators (20 kVA and 10 kVA) for reliable power supply.
  • Water: Storage drums for emergencies.

Security:
  • Alarm system and 24-Hour on-site security staff.


Our Research Staff




Dr. Joanne Batting

joanneba@foundation.co.za

Principal Investigator


Jacqueline Makowah

jacquelinem@foundation.co.za

Operations Coordinator


Neliswa Swartbooi

neliswas@foundation.co.za

Laboratory manager


Phezukonke Mndebele

phezukonkem@foundation.co.za

Pharmacist


Ms Ayabulelwa Mlati

Ayabulelam@foundation.co.za

Study coordinator


Busi Ngele

busin@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