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Assisted partner notification services to augment HIV testing and linkage to care in Kenya: study protocol for a cluster randomized trial
Background: HIV case-finding and linkage to care are critical for control of HIV transmission. In Kenya, >50% of seropositive individuals are unaware of their status. Assisted partner notification is a public health strategy that provides HIV testing to individuals with sexual exposure to HIV and are at risk of infection and disease. This parallel, cluster-randomized controlled trial will evaluate the effectiveness, cost-effectiveness, and feasibility of implementing HIV assisted partner notification services at HIV testing sites (clusters) in Kenya. Methods/design Eighteen sites were selected among health facilities in Kenya with well-established, high-volume HIV testing programs, to reflect diverse communities and health-care settings. Restricted randomization was used to balance site characteristics between study arms (n = 9 per arm). Sixty individuals testing HIV positive (‘index partners’) will be enrolled per site (inclusion criteria: ≥18 years, positive HIV test at a study site, willing to disclose sexual partners, and never enrolled for HIV care; exclusion criteria: pregnancy or high risk of intimate partner violence). Index partners provide names and contact information for all sexual partners in the past 3 years. At intervention sites, study staff immediately contact sexual partners to notify them of exposure, offer HIV testing, and link to care if HIV seropositive. At control sites, passive partner referral is performed according to national guidelines, and assisted partner notification is delayed by 6 weeks. Primary outcomes, assessed 6 weeks after index partner enrollment and analyzed at the cluster level, are the number of partners accepting HIV testing and number of HIV infections diagnosed and linked to care per index partner. Secondary outcomes are the incremental cost-effectiveness of partner notification and the costs of identifying >1 partner per index case. Participants are closely monitored for adverse outcomes, particularly intimate partner violence. The study is unblinded due to practical limitations. Discussion This rigorously designed trial will inform policy decisions regarding implementation of HIV partner notification services in Kenya, with possible application to other parts of sub-Saharan Africa. Examination of effectiveness and cost-effectiveness in diverse settings will enable targeted application and define best practices. Trial registration ClinicalTrials.gov NCT01616420
HIV partner services in Kenya: a cost and budget impact analysis study
Abstract Background The elicitation of contact information, notification and testing of sex partners of HIV infected patients (aPS), is an effective HIV testing strategy in low-income settings but may not necessarily be affordable. We applied WHO guidelines and the International Society for Pharmaco-economics and Outcomes Research (ISPOR) guidelines to conduct cost and budget impact analyses, respectively, of aPS compared to current practice of HIV testing services (HTS) in Kisumu County, Kenya. Methods Using study data and time motion studies, we constructed an Excel-based tool to estimate costs and the budget impact of aPS. Cost data were collected from selected facilities in Kisumu County. We report the annual total and unit costs of HTS, incremental total and unit costs for aPS, and the budget impact of scaling up aPS over a 5-year horizon. We also considered a task-shifted scenario that used community health workers (CHWs) rather than facility based health workers and conducted sensitivity analyses assuming different rates of scale up of aPS. Results The average unit costs for HIV testing among HIV-infected index clients was US 17.86 per client using nurses and CHWs, respectively. The average incremental costs for providing enhanced aPS in Kisumu County were US 753,547 per year, using nurses and CHWs, respectively. The average incremental cost of scaling up aPS over a five period was 45% higher when using nurses compared to using CHWs (US 3,767,738 respectively). Over the five years, the upper-bound budget impact of nurse-model was US 1,258,854, which was 71.2% lower than the nurse-based model. The budget impact was sensitive to the level of aPS coverage and ranged from US 1,267,603 for 80% coverage using nurses in 2018. Conclusion Scaling aPS using nurses has minimal budget impact but not cost-saving over a five-year period. Targeting aPS to newly-diagnosed index cases and task-shifting to community health workers is recommended