: The CAPRISA Clinical Trials Unit for AIDS/Tuberculosis Prevention and Treatment (CAPRISA CTU), strategically located in KwaZulu-Natal, South Africa, at the epicenter of one of the world's most severe HIV and tuberculosis (TB) epidemics, has recently made significant scientific contributions on tenofovir gel and pre-exposure prophylaxis, HIV-TB treatment, prevention of breastfeeding transmission, and immunity with broadly neutralizing antibodies. The scientific team includes investigators who have served at the highest levels in Network leadership. During the current funding cycle, 2,854 participants have been enrolled in 25 protocols to date, with retention rates usually exceeding 90% and data quality scores exceeding 95%. The CAPRISA CTU comprises 4 components;firstly, experienced leadership, senior investigators and CTU coordinator;secondly, an administrative and governance component;thirdly, 10 research support cores;and fourthly, 4 Clinical Research Sites (CRSs). The eThekwini CRS for vaccine, microbicide and adult HIV treatment studies, is located in central Durban adjoining a local clinic that annually treats 40,000 patients with sexually transmitted infections (HIV prevalence of 59.3% (CI: 56.5-62.0) and HIV incidence rate of 6.4 per 100 person-years (CI: 2.6-13.2)) as well as 3,500 new TB cases, two thirds of whom are co-infected with HIV. At the rural Vulindlela CRS for integrated prevention, vaccine and microbicide studies, the HIV prevalence among young women is 35.7% (CI: 32.7-38.8) and the HIV incidence rate is 6.5 per 100 person-years (CI: 4.4-9.2). In this community, HIV incidence is 10.2 per 100 person-years (CI: 4.1-20.9) in women under 20 years. The Springfield CRS for adult HIV/TB treatment studies is located at a regional referral hospital that treated 2,359 MDR-TB and 206 XDR-TB patients (71% co-infected with HIV) in 2010. The Umlazi CRS for maternal/pediatric HIV studies is at a 1,200 bed hospital that provides pre-natal services to about 12,000 women annually (HIV prevalence: 39% (CI: 36.7-41.5)). The vertical transmission rate is 2.4% (CI 1.1-4.5) at birth but increases to 6.6% (CI 5.3-8.2) at 6-8 weeks post-partum due to breastfeeding. The CAPRISA CTU headquarters is located at the Nelson R Mandela School of Medicine and houses the Administration as well as the laboratory, pharmacy, data management and IT, community engagement, evaluation and quality assurance, financial management, bioethics, communication, regulatory compliance, and training Cores. The CTU's organizational structures (Leadership Group, Executive Committee and Community Advisory Board) and communication tools (regular meetings, video conferences, monthly newsletters and website) enable effective communication, management and governance in the unit. Overall, the CAPRISA CTU has diverse well-characterized high-risk populations, well established clinical facilities, accredited laboratories, pharmacies, and data management systems, strong community linkages, and extensive experience in conducting clinical trials, together with a track record of scientific innovation available to support the 5 Networks in developing new approaches to HIV and TB prevention and treatment.

Public Health Relevance

The overall goal of the Centre for the AIDS Program of Research in South Africa (CAPRISA) Clinical Trials Unit for AIDS/Tuberculosis Prevention and Treatment (CAPRISA CTU) is to advance the scientific agendas and research contributions of each of the five NIAID Clinical Research Networks (CRNs) focused on 1) adult HIV therapeutic strategies, 2) strategies to address HIV in pediatric and maternal populations, 3) integrated HIV prevention strategies, 4) microbicides. and 5) vaccines

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
2UM1AI069469-08
Application #
8609288
Study Section
Special Emphasis Panel (ZAI1-JBS-A (S1))
Program Officer
Csedrik, Joanne E
Project Start
2007-03-01
Project End
2020-11-30
Budget Start
2013-12-10
Budget End
2014-11-30
Support Year
8
Fiscal Year
2014
Total Cost
$3,228,353
Indirect Cost
$247,455
Name
Centre/AIDS Programme/Research/South Africa
Department
Type
DUNS #
639174239
City
Durban
State
Country
South Africa
Zip Code
4001
Balkus, Jennifer E; Brown, Elizabeth R; Hillier, Sharon L et al. (2016) Oral and injectable contraceptive use and HIV acquisition risk among women in four African countries: a secondary analysis of data from a microbicide trial. Contraception 93:25-31
Hosseinipour, Mina C; Bisson, Gregory P; Miyahara, Sachiko et al. (2016) Empirical tuberculosis therapy versus isoniazid in adult outpatients with advanced HIV initiating antiretroviral therapy (REMEMBER): a multicountry open-label randomised controlled trial. Lancet 387:1198-209
Charalambous, Salome; Grant, Alison D; Churchyard, Gavin J et al. (2016) Clinic-level factors influencing patient outcomes on antiretroviral therapy in primary health clinics in South Africa. AIDS 30:1099-109
Baeten, Jared M; Palanee-Phillips, Thesla; Brown, Elizabeth R et al. (2016) Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women. N Engl J Med 375:2121-2132
Palanee-Phillips, Thesla; Schwartz, Katie; Brown, Elizabeth R et al. (2015) Characteristics of Women Enrolled into a Randomized Clinical Trial of Dapivirine Vaginal Ring for HIV-1 Prevention. PLoS One 10:e0128857
Moodie, Zoe; Metch, Barbara; Bekker, Linda-Gail et al. (2015) Continued Follow-Up of Phambili Phase 2b Randomized HIV-1 Vaccine Trial Participants Supports Increased HIV-1 Acquisition among Vaccinated Men. PLoS One 10:e0137666
Kashuba, Angela D M; Gengiah, Tanuja N; Werner, Lise et al. (2015) Genital Tenofovir Concentrations Correlate With Protection Against HIV Infection in the CAPRISA 004 Trial: Importance of Adherence for Microbicide Effectiveness. J Acquir Immune Defic Syndr 69:264-9
Marrazzo, Jeanne M; Ramjee, Gita; Richardson, Barbra A et al. (2015) Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med 372:509-18
Desmond, Alicia Catherine; Moodley, Dhayendre; Conolly, Catherine A et al. (2015) Evaluation of adherence measures of antiretroviral prophylaxis in HIV exposed infants in the first 6 weeks of life. BMC Pediatr 15:23
Noguchi, Lisa M; Richardson, Barbra A; Baeten, Jared M et al. (2015) Risk of HIV-1 acquisition among women who use diff erent types of injectable progestin contraception in South Africa: a prospective cohort study. Lancet HIV 2:e279-87

Showing the most recent 10 out of 23 publications