JMIR Publications

ABSTRACT

Background:

Detection and management of acute HIV infection (AHI) is a clinical and public health emergency, and HIV infections diagnosed among young adults are usually recent. Young adults with recent HIV acquisition frequently seek care for symptoms, and could potentially be diagnosed through the health care system. Early recognition of HIV infection provides considerable individual and public health benefits, including reduction in risk behavior, notification of partners in need of HIV testing, access to counseling and treatment, and viral load suppression, if achieved.

Objective:

The Tambua Mapema Plus study aims to: (1) test 1,500 adults identified by an AHI screening algorithm for acute and prevalent (i.e., seropositive) HIV, linking all newly diagnosed HIV-infected patients to care and offering immediate treatment; (2) offer assisted partner notification services (APNS) to all cases detected, testing partners for acute and prevalent HIV infection and identifying local sexual networks; and (3) model the potential impact of these two interventions on the Kenyan HIV epidemic, estimating incremental costs per HIV infection averted, death averted, and disability-adjusted life-year averted using data on study outcomes.

Methods:

A modified stepped-wedge design is evaluating the yield of this HIV testing intervention at 4 public and 2 private health facilities in coastal Kenya, before and after intervention delivery. The intervention uses point-of-care HIV-1 RNA testing combined with standard rapid antibody tests to diagnose AHI and prevalent HIV among young adults presenting for care; employs APNS to identify linked acute and prevalent infections; and follows all newly diagnosed patients and their partners for 12 months to ascertain clinical outcomes including linkage to care, antiretroviral therapy (ART) initiation and virologic suppression in HIV-infected patients, and pre-exposure prophylaxis (PrEP) uptake in uninfected individuals in discordant partnerships.

Results:

Study enrollment started in December 2017, and will continue over 24 months. As of August 29, 2019, 1,374 participants have been enrolled in the observation period and 1,136 participants have been enrolled in the intervention period. Data on primary outcomes of the HIV-1 RNA testing intervention are accruing, including the proportion of participants in the observation and intervention periods who are: (1) tested for HIV infection; (2) newly diagnosed with prevalent HIV; and (3) newly diagnosed with acute HIV. In addition, data are accruing on secondary endpoints including linkage to care and ART initiation by week 6 following HIV diagnosis, viral suppression by month 6 and month 12 following ART initiation, and partner testing outcomes (i.e., numbers reported, successfully contacted, tested, newly diagnosed, and engaged in care with ART or PrEP as indicated).

Conclusions:

The Tambua Mapema Plus study will provide foundational data on the potential of this novel, combination HIV prevention intervention to reduce ongoing HIV transmission in Kenya and other high-prevalence African settings. Clinical Trial: ClinicalTrials.gov NCT03508908, https://clinicaltrials.gov/ct2/show/NCT03508908