International Journal of Scientific and Research Publications, Volume 6, Issue 6, June 2016 477 ISSN 2250-3153 www.ijsrp.org A step-wedge simple randomized trial to assess the use of Case Managers to Increase Linkage to HIV Care and Early retention of Newly Diagnosed HIV-positive Persons at a regional Referral Hospital in Western, Kenya Burmen B, Mutai K Kenya Medical Research Institute Center for Global Health Research Abstract- Linkage of newly diagnosed HIV positive individuals to HIV care and treatment services is essential to initiate lifesaving antiretroviral therapy and thereby reduce HIV transmission. However, program data has shown that only 38% of newly diagnosed HIV patients in Kenya are linked to care. Case management model, a model with proven efficacy, uses case managers to provide strength based counseling that enable individuals identify their internal strengths and assets needed to facilitate linkage and enhance retention. This evaluation seeks to test the efficacy of using case managers in increasing linkage and early retention to HIV care among newly diagnosed HIV positive individuals at a referral hospital in Western Kenya within one year and including a six month follow up period by comparing linkage and retention rates among HIV infected persons who receive case managers to those who did not. A step-wedged design will be employed at 12 of the 24 hospital departments. This will be done by introducing the intervention in a phased approach by testing site. A minimum of 672 HIV infected persons will be recruited. Linkage to care will be defined as a recorded encounter at the HIV clinic’s enrolment registry. Participants will be considered retained in care after attending two or more visits over a six month period. Data on participant characteristics, linkage and retention proportions and their associated factors will be analyzed in the early and late intervention groups. Results from this evaluation will provide information on improving linkage and retention rates among HIV infected patients. Index Terms- HIV, Phased-approach, engagement in HIV care I. BACKGROUND A. Introduction n 2014, 36.9 million people were living with HIV globally; there were 2.0 million new infectiosn and 1.2 million deaths [1]. In 2015, 2009 indicated that only around 49% of PLHIV in low and middle income coutnries who are in need of ART are actually on ART [2]. According to the Kenya Demographic and Health Survey of 2012, the national HIV prevalence among persons aged 15-64 years was 5.6%. In the same survey, Kisumu County of Kenya had a HIV prevalence of 18% [3]. In Africa, linkages rates among newly diagnosed HIV patients range from 23%-50% [4-6]. HIV treatment programs from Low and Middle Income Countries have an attrition rate of 21% six months after enrolment into HIV care [7]. In Kenya, 53% of HIV infected persons are not aware of their HIV infection. About 89% persons country-wide aged 15-64 years who were aware of their HIV infection were on care, 88% of those eligible for Antiretroviral Therapy (ART) were on ART; only 43% of those who initiated care remained in care [8]. At the Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH), a regional referral hospital in Western Kenya, only 38% of HIV infected persons are linked HIV care, and 83% of them are retained in care within 1-2 months, 76% within 3-4 months, and 61% within a one year period (L.Nguti, personal communication, October 22, 2014). HIV test and treat strategies aim to mitigate the effects of HIV by increasing the coverage of HIV testing services, linking those tested to relevant HIV prevention, care and treatment services and ensure those linked to these services are managed appropriately [9]. This has been emphasized in UNAIDS’ recent 90-90-90 treatment targets that aims to eliminate HIV by 2030 [10]. HIV testing is postulated to decrease HIV transmission by decreasing risky sexual behavior among all persons tested and decrease viral load among those who test HIV positive after ART initiation [11]. Delayed presentation or non-retention in HIV care places HIV-infected clients at risk for elevated morbidity and mortality [12] and reduces the long term benefits of ART as prevention [13]. Linkage to care has been defined as ‘attending one or more clinic visits’ [14], “documented CD4 T- cell counts results’ or [15] or ‘a scheduled visit with a health care provider who can manage ART’ [16, 17] all within 6 months of HIV diagnosis. HIV biomarkers (CD4 count and plasma HIV viral load) are often evidence of a completed visit at a HIV clinic [18] . Other measures include, records of missed visits [17, 19], appointment adherence [20], visit constancy [19] and gaps in care [21]. Strength-based counseling, a strategy that includes building patient-provider relationships, improving family-patient relationships, identifying clients strengths, providing information and education, [22] and use of patient navigators [23], has been successfully used to improve linkage to HIV care after diagnoses [24]. JOOTRH which has low linkage and retention rates does not routinely use case managers. There is a need to test the efficacy of using case managers to improve linkage and early retention of newly diagnosed HIV-infected patients at JOOTRH. B. Study Objectives General objectives I