The early years of the combination antiretroviral therapy (ART) era have brought about dramatic reductions in the morbidity and mortality associatedwith HIV infection in industrialized countries and recently, international and local initiative have allow access to HAART in the developing world. Preliminary data from my prior work and other have shown that good adherence is feasible in resource-limited settings, but it is unclear whether these results are reproducible in scaled ART programs and what interventions would likely be effective at maximizing adherence in such settings. Peer advocates have been used to improve adherence with medical therapies in a variety of settings. In order to investigate the potential utility of peer- advocates in South Africa, I propose to conduct a randomized trial in which 300 patients will be assigned to either peer-DOT-HAART or self-administration of a twice daily combination of Stavudine, Lamivudine and Efavirenz for 24 months.
The specific aims of this study are: 1) to evaluate the impact of peer-DOT HAART on control of viral burden and immune restoration as measured by viral load and CD4 T cell counts;2) to evaluate the impact of DOT-HAART on treatment adherence;3) the determination the proportion of genotypic HAART resistance in the peer-DOT vs. self-administered HAART arms;4) to compare the incidence of new or recurrent opportunistic infection in the peer-DOT vs. self-administered HAART. My hypothesis is that the patients in the peer-DOT-HAART arm will have high levels of treatment adherence and hence more effective in controlling viral burden, thereby limiting the likelihood of virologic failure, drug resistance, and disease progression. This study will generate critical data on an alternative community- based approach of delivering HAART which may become a standard of care throughout sub-Saharan Africa and the developing world. My career development plan is based on a post-graduate training program, which includes comprehensive coursework at the Johns Hopkins University and University of Cape Town, structured mentoring, and guidance from a thesis committee. My career plan and research proposal are consistent with my long-term goals of becoming an effective independent investigator, and optimizing treatment outcomes in HIV-infected in sub-Saharan Africa.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23AI068582-05
Application #
7774326
Study Section
Acquired Immunodeficiency Syndrome Research Review Committee (AIDS)
Program Officer
Livnat, Daniella
Project Start
2006-03-15
Project End
2011-02-28
Budget Start
2010-03-01
Budget End
2011-02-28
Support Year
5
Fiscal Year
2010
Total Cost
$129,060
Indirect Cost
Name
Johns Hopkins University
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Zeier, Michèle D; Botha, Matthys H; Engelbrecht, Susan et al. (2015) Combination antiretroviral therapy reduces the detection risk of cervical human papilloma virus infection in women living with HIV. AIDS 29:59-66
Nachega, Jean B; Uthman, Olalekan A; Mills, Edward J et al. (2013) Adherence to Antiretroviral Therapy for the Success of Emerging Interventions to Prevent HIV Transmission: A Wake up Call. J AIDS Clin Res 2012:
Duwell, Monique M; Knowlton, Amy R; Nachega, Jean B et al. (2013) Patient-nominated, community-based HIV treatment supporters: patient perspectives, feasibility, challenges, and factors for success in HIV-infected South African adults. AIDS Patient Care STDS 27:96-102
Zeier, Michele Desire; Botha, Matthys Hendrik; van der Merwe, Frederick Haynes et al. (2012) Progression and persistence of low-grade cervical squamous intraepithelial lesions in women living with human immunodeficiency virus. J Low Genit Tract Dis 16:243-50
Nachega, Jean B; Uthman, Olalekan A; Anderson, Jean et al. (2012) Adherence to antiretroviral therapy during and after pregnancy in low-income, middle-income, and high-income countries: a systematic review and meta-analysis. AIDS 26:2039-52
Svensson, Elin; van der Walt, Jan-Stefan; Barnes, Karen I et al. (2012) Integration of data from multiple sources for simultaneous modelling analysis: experience from nevirapine population pharmacokinetics. Br J Clin Pharmacol 74:465-76
Nachega, Jean B; Uthman, Olalekan A; Ho, Yuh-Shan et al. (2012) Current status and future prospects of epidemiology and public health training and research in the WHO African region. Int J Epidemiol 41:1829-46
Eshun-Wilson, Ingrid; Taljaard, Jantjie J; Nachega, Jean B (2012) Sub-optimal CD4 T-lymphocyte responses among HIV infected patients who develop TB during the first year of ART. J AIDS Clin Res 3:
Nakimuli-Mpungu, Etheldreda; Bass, Judith K; Alexandre, Pierre et al. (2012) Depression, alcohol use and adherence to antiretroviral therapy in sub-Saharan Africa: a systematic review. AIDS Behav 16:2101-18
Zeier, M D; Nachega, J B; Van Der Merwe, F H et al. (2012) Impact of timing of antiretroviral therapy initiation on survival of cervical squamous intraepithelial lesions: a cohort analysis from South Africa. Int J STD AIDS 23:890-6

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