CARES

Cabotegravir And Rilpivirine: Efficacy and Safety Study

Site 302:  SAMRC

Chatsworth Clinical Research Site

361 RK Khan Circle

Who you are and location of site

Chatsworth

Durban

Kwa-Zulu Natal

South Africa

4092 (GPS coordinators:  29◦55’01.7” S, 030◦ 53’13.9”E).

What you do

The Chatsworth Clinical Research Site is a clinical trial research site which is one of the six clinical research sites of the HIV and Other Infectious Diseases Research Unit if the South African Medical Research Council (SAMRC) which conducts a HIV treatment trial, HIV prevention trials and COVID-19 vaccine trials.

CARES team and role

Management

(L – R) Lakshmi Baboolall (Study Co-ordinator), Logashvari Naidoo (PI), and Nitesha Jeenarain (Clinical Research Site Leader)

Clinical Team

(L – R) Nashaira Ramnanan (Clinician), Ursula Jannsen (Clinician)

(L-R) Sibongile Lorraine Mkhungo (Clinical Trial Nurse), Thabisile Susan Mthembu (Clinical Trial Nurse), Bridget Hlengiwe Phakathi (Clinical Trial Nurse), Ayanda Comfort Mavundla (Clinical Trial Nurse)

Pharmacists

(L-R) Nivriti Hurbans, and Mesuli Philangezwi Mhlongo

Laboratory Staff

(L-R) Keshnee Maharaj, Thobile Bhengu and Ashmintha Ramjeith

Research Assistants

(L-R) Gugu Cleopatra Hlongwane, Ntokozo Zabathethwa Mthethwa, Busisiwe Benedictor Gumede

and Mandisa Clotilda Mchunu

Data Co-ordinator

Bukekile Debra Ndlovu

QA Officer

Nirosha Gokul

Counsellor

Mbongeleni William Buthelezi

Community Liaison Officer

Gerald Thsepo Mphisa

Community Research Assistants

Nondumiso Muthwa and Gugulethu Majozi

Drivers

(l-R) Thulebona Martin Hlela and Vusi Hlambisa

Experience in Research

The site has experience in conducting HIV prevention trials and COVID-19 trials

HIV prevention trials include:

  • HVTN 703/HPTN 081 (AMP)
  • HVTN 705/HPX 2008 (IMBOKODO)
  • MTN 003 (VOICE)
  • MTN 020 (ASPIRE)
  • MTN 025 (HOPE)
  • MK 8591 (IMPOWER)
  • Observational Studies
  • MTN 015
  • MTN 016
  • COVID-19 TRIALS
  • COVPN 3003 (ENSEMBLE)
  • HVTN 405
  • CROWN CORONATION
  • SISONKE

Clientele population/catchment area

The Chatsworth CRS, established in 2003, is located in Chatsworth, KwaZulu-Natal, a province in South Africa with the highest HIV prevalence. Chatsworth is an urban area south of Durban, approximately 14km south-west of the Durban city center. The CRS is located on the property of the RK Khan Hospital, which is a regional and district hospital. The CRS is easily accessible via public transportation including rail, bus and minibus taxis. The participants are recruited from urban and rural areas surrounding the Chatsworth Clinical Research Site.

Figure 4: Map of Recruitment areas

How have you been able to get CARES clients

The main recruitment center is the RK Khan ARV clinic which is located adjacent to the Chatsworth Clinical Research Site, on the premises of R K Khan Hospital. Participants have also been referred to the community team due to knowledge being disseminated in the community regarding the study. Additionally, recruitment is from the support groups for people living with HIV.

Challenges encountered

Initially participants were concerned about potentially changing the treatment that they were stable on. However, with community education and information obtained from previous trials we were able address all queries and concerns. Another challenge was the recruitment from the RK Khan ARV clinic as many of the patients attending the clinic required specialized management and hence were not ideal candidates for the CARES trial. To overcome this, participants are recruited from alternate sources. The Hepatitis B Core Positivity Rate discovered during screening was higher than anticipated and hence resulted in a higher than expected screening to enrolment ratio.

Participants experience and how they have benefited

The participants have expressed that they have benefited from education and sensitization sessions conducted due to the CARES trial. They are pleased to learn that there are potential alternate methods of taking ARVS.

How participants perceive the new treatment

The participants have remarked that injectables are a good alternate to taking ARVs orally and especially assist with adherence to treatment. They feel it will motivate those participant who are not already on treatment.