The majority of patients that are newly diagnosed with HIV in resource-poor settings are lost to care prior to initiation of antiretroviral therapy (ART). Yet current protocols impose delays in therapy by requiring multiple pre-ART visits for ART literacy counseling and medical evaluations to assess for opportunistic infections (OIs). Retention in care would be improved if these services could be provided in one day, as the rate of attrition increases with every additional step between HIV testing and ART initiation. Efforts t implement and evaluate strategies that strengthen linkages between HIV testing and treatment programs, streamline services during the pre-ART period, and improve retention in care are critical to the success of HIV programs worldwide. Such strategies must be considered in the context of constrained financial and human resources. The proposed study is a randomized trial to establish the effectiveness of same-day ART initiation for patients who present for HIV testing with early HIV clinical disease (World Health Organization [WHO] stage 1 or 2) who qualify for ART by immunologic criteria (CD4 cell count d350 cells/mm3) with point-of-care CD4 cell testing at the GHESKIO Center in Port-au-Prince, Haiti. All patients in the intervention group will receive rapid HIV antibody testing, point-of-care CD4 cell testing, clinically relevant testing for OIs, WHO staging, comprehensive counseling and social support, and ART initiation on the day of presentation. The standard group will receive the same services as the same-day ART group (including point-of-care CD4 cell testing) except that instead of same-day ART, they will receive the standard GHESKIO protocol of three sequential visits for ART readiness counseling and testing for OIs prior to ART initiation. For the same-day ART group, these activities will take place on the day of ART initiation and during the subsequent two weeks.
Three specific aims are proposed.
The first aim i s to compare the proportion of patients in the standard and same-day ART groups that are alive and in-care with an undetectable HIV viral load at 12 months after HIV testing.
The second aim i s to compare ART adherence between the two groups using pharmacy refill records.
The third aim i s to compare the cost and cost-effectiveness of standard and same-day ART, where cost is measured by the mean treatment cost and effectiveness is measured by being alive and in care with an undetectable viral load at 12 months after HIV testing. The 2012 Trans-NIH Plan for HIV-Related Research prioritizes investigations that evaluate the clinical impact and cost-effectiveness of innovative approaches to engage and retain individuals in HIV treatment. The results of this study will impact care worldwide, as a substantial proportion of patients with newly diagnosed HIV are lost to follow-up before ART initiation in all settings.

Public Health Relevance

The proposed research is relevant to public health because every study that has evaluated outcomes among HIV-infected patients prior to the initiation of antiretroviral therapy (ART) has documented a high rate of pre- ART attrition. The proposed research is innovative because it studies the impact of the immediate provision of counseling, medical assessments, and ART initiation on the day of HIV testing. This is relevant to the mission of the NIH, because improved retention in care is critical to the success of HIV treatment programs worldwide.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project (R01)
Project #
5R01AI104344-03
Application #
8788800
Study Section
Special Emphasis Panel (ZRG1-AARR-G (92))
Program Officer
Bacon, Melanie C
Project Start
2013-02-19
Project End
2016-01-31
Budget Start
2015-02-01
Budget End
2016-01-31
Support Year
3
Fiscal Year
2015
Total Cost
$609,478
Indirect Cost
$65,866
Name
Brigham and Women's Hospital
Department
Type
DUNS #
030811269
City
Boston
State
MA
Country
United States
Zip Code
02115
Guiteau Moise, Colette; Rivera, Vanessa R; Hennessey, Kelly A et al. (2018) A Successful Model of Expedited Antiretroviral Therapy for Clinically Stable Patients Living With HIV in Haiti. J Acquir Immune Defic Syndr 79:70-76
McNairy, Margaret L; Joseph, Patrice; Unterbrink, Michelle et al. (2017) Outcomes after antiretroviral therapy during the expansion of HIV services in Haiti. PLoS One 12:e0175521
Rivera, V R; Jean-Juste, M-A; Gluck, S C et al. (2017) Diagnostic yield of active case finding for tuberculosis and HIV at the household level in slums in Haiti. Int J Tuberc Lung Dis 21:1140-1146
Koenig, Serena P; Dorvil, Nancy; Dévieux, Jessy G et al. (2017) Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial. PLoS Med 14:e1002357
Esperance, Morgan C; Koenig, Serena P; Guiteau, Colette et al. (2016) A successful model for rapid triage of symptomatic patients at an HIV testing site in Haiti. Int Health 8:96-100
Koenig, Serena P; Bernard, Daphne; Dévieux, Jessy G et al. (2016) Trends in CD4 Count Testing, Retention in Pre-ART Care, and ART Initiation Rates over the First Decade of Expansion of HIV Services in Haiti. PLoS One 11:e0146903
Koenig, Serena P; Bornstein, Alexandra; Severe, Karine et al. (2015) A Second Look at the Association between Gender and Mortality on Antiretroviral Therapy. PLoS One 10:e0142101
Koenig, Serena P; Rouzier, Vanessa; Vilbrun, Stalz Charles et al. (2015) Tuberculosis in the aftermath of the 2010 earthquake in Haiti. Bull World Health Organ 93:498-502
Charles, Macarthur; Vilbrun, Stalz Charles; Koenig, Serena P et al. (2014) Treatment outcomes for patients with multidrug-resistant tuberculosis in post-earthquake Port-au-Prince, Haiti. Am J Trop Med Hyg 91:715-21
Riviere, Cynthia; Faust, Elizabeth; Miller, Thane et al. (2014) Superior outcomes and lower outpatient costs with scale-up of antiretroviral therapy at the GHESKIO clinic in Port-au-Prince, Haiti. J Acquir Immune Defic Syndr 66:e72-9