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.


Current projects



PURPOSE 1

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

Site : Ndevana Clinical Research Site

Donor: Gilead

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

Donor: Gilead

A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People older than 16 Years of Age Who Have Sex With Male Partners and Are at Risk for HIV Infection.

ClinicalTrials.govID NCT04925752



Wonders 2

Start Date : 2025-02-10 End Date : Depending on enrolment

Site : Ndevana Clinical Research Site

Donor: Gilead

An Operationally Seamless Phase 2/3, Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination with GS-4182 Versus Biktarvy in Treatment Naive People with HIV-1

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