Durban, KwaZulu Natal, South Africa is the epicenter of the global HIV pandemic, where a large number of people infected with HIV are also co-infected with TB. The MRC Clinical Trials Unit (MRC CTU) is internationally renowned for conducting large scale trials of HIV prevention including microbicides, vaginal diaphragm, and oral Pre-Exposure Prophylaxis (PrEP); HIV therapeutic trials, and socio-behavioral studies. Six well-established clinical research sites (CRSs) are located in the greater Durban area, where HIV incidence among young women ranges from 5.1/100PY (in earlier research) to 16.4/100PY (in 2012). Lack of effectiveness in earlier trials was due to multiple factors, including poor adherence. The current understanding of the epidemic suggests a need for an integrated approach to HIV and TB prevention, treatment, and linkage to care. The MRC CTU's primary goal is to integrate site operations, community partnerships, and responses to adherence challenges/behavioral research by partnering with 4 Networks to meet the following aims:
AIM 1 : Conduct HIV prevention trials of long-acting microbicides and oral PrEP and HIV vaccines in at-risk populations. We hypothesize that long-acting formulations in this population may circumvent adherence challenges.
AIM 2 : Conduct therapeutic trials of novel, safe, effective, and robust regimens. We hypothesize that cost-effective, third-line treatment regimens will be needed in the foreseeable future in our setting.
AIM 3 : To undertake RCTs of HIV-associated co-morbidities. There are critical gaps in TB treatment that we propose to address by developing and participating in trials using molecular diagnostics to determine treatment duration and optimize drug regimens for multidrug-resistant TB.
AIM 4 : Integrated strategies to address the epidemic. No single HIV prevention option will address the epidemic. We hope to participate in trials testing integrated strategies of HIV prevention, as well as those integrating prevention and treatment of both HIV and TB, with effective linkage to care. The MRC CTU has access to the population at-risk, a well-developed and centralized CRS infrastructure, and the experience and expertise of international consultants to undertake and deliver on the proposed research aims.

Public Health Relevance

This comprehensive attempt to address the dual HIV/TB pandemic in Durban, South Africa through an integrated approach of testing novel HIV prevention strategies, novel HIV therapeutics agents for future options, and addressing HIV co-morbidity with TB with appropriate linkage to care, will provide the empirical data to guide future real-world development and implementation of effective HIV and TB strategies.

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 #
5UM1AI069422-11
Application #
9182812
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Harris, Christina M
Project Start
2007-03-01
Project End
2020-11-30
Budget Start
2016-12-01
Budget End
2017-11-30
Support Year
11
Fiscal Year
2017
Total Cost
Indirect Cost
Name
Medical Research Council of South Africa
Department
Type
DUNS #
635909489
City
Cape Town
State
Country
South Africa
Zip Code
Abbai, Nathlee S; Nyirenda, Makandwe; Naidoo, Sarita et al. (2018) Prevalent Herpes Simplex Virus-2 Increases the Risk of Incident Bacterial Vaginosis in Women from South Africa. AIDS Behav 22:2172-2180
Bekker, Linda-Gail; Moodie, Zoe; Grunenberg, Nicole et al. (2018) Subtype C ALVAC-HIV and bivalent subtype C gp120/MF59 HIV-1 vaccine in low-risk, HIV-uninfected, South African adults: a phase 1/2 trial. Lancet HIV 5:e366-e378
Laborde, Nicole D; Pleasants, Elizabeth; Reddy, Krishnaveni et al. (2018) Impact of the Dapivirine Vaginal Ring on Sexual Experiences and Intimate Partnerships of Women in an HIV Prevention Clinical Trial: Managing Ring Detection and Hot Sex. AIDS Behav 22:437-446
Weintraub, Amy; Mantell, Joanne E; Holt, Kelsey et al. (2018) 'These people who dig roots in the forests cannot treat HIV': Women and men in Durban, South Africa, reflect on traditional medicine and antiretroviral drugs. Glob Public Health 13:115-127
Tariq, Shema; Hoffman, Susie; Ramjee, Gita et al. (2018) ""I did not see a need to get tested before, everything was going well with my health"": a qualitative study of HIV-testing decision-making in KwaZulu-Natal, South Africa. AIDS Care 30:32-39
Riddler, Sharon A; Husnik, Marla; Ramjee, Gita et al. (2017) HIV disease progression among women following seroconversion during a tenofovir-based HIV prevention trial. PLoS One 12:e0178594
Montgomery, Elizabeth T; Mensch, B; Musara, P et al. (2017) Misreporting of Product Adherence in the MTN-003/VOICE Trial for HIV Prevention in Africa: Participants' Explanations for Dishonesty. AIDS Behav 21:481-491
Chirenje, Zvavahera Mike; Gundacker, Holly M; Richardson, Barbra et al. (2017) Risk Factors for Incidence of Sexually Transmitted Infections Among Women in a Human Immunodeficiency Virus Chemoprevention Trial: VOICE (MTN-003). Sex Transm Dis 44:135-140
Kasaro, Margaret P; Husnik, Marla J; Chi, Benjamin H et al. (2017) Impact of targeted counseling on reported vaginal hygiene practices and bacterial vaginosis: the HIV Prevention Trials Network 035 study. Int J STD AIDS 28:467-475
Moodley, Jeeva; Naidoo, Sarita; Moodley, Jayajothi et al. (2016) Sharing of Investigational Drug Among Participants in the Voice Trial. AIDS Behav 20:2709-2714

Showing the most recent 10 out of 20 publications