Tambua Mapema Plus - to Discover HIV Infection Early and Prevent Onward Transmission
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional

Summary: 
      This study will assess the impact of an HIV-1 RNA testing intervention targeting adult
      patients aged 18-39 years who seek urgent care for symptoms at primary care facilities and
      meet specific risk criteria for acute HIV infection. All newly diagnosed HIV-infected
      patients in the intervention arm will be linked to care and offered both immediate treatment
      and assisted partner notification. Partners will also be tested using the HIV testing
      intervention, and pre-exposure prophylaxis will be offered to uninfected individuals with
      HIV-infected partners. The cost-effectiveness of this intervention will be evaluated.
    

Detailed description: 
      This is a proof-of-concept study comparing outcomes of a health facility-based acute HIV
      infection (AHI) and prevalent HIV testing intervention using point of care HIV-1 RNA
      detection, combined with assisted partner services (aPS) and follow-up in an antiretroviral
      therapy (ART) cohort for all newly diagnosed individuals and follow-up in a pre-exposure
      prophylaxis (PrEP) cohort for the uninfected partners of newly diagnosed individuals,
      compared to standard care.

      Study Design: Randomized stepped-wedge study with prospective cohort follow-up of all
      individuals newly diagnosed with acute or prevalent HIV infection and of up to 300 identified
      partners of these persons. Individuals enrolled in the observation phase will be compared to
      those enrolled in the intervention phase at each facility, after undergoing the following
      procedures in each phase.

      Study Population: The study population will be recruited from among male and female adult
      patients who present for care at 6 public or private outpatient clinics in coastal Kenya.
      Eligibility criteria for the HIV-1 RNA testing intervention include: 1) age from 18-39 years;
      2) not previously diagnosed with HIV infection; and 3) a score ≥2 on our AHI risk score
      algorithm. Eligibility criteria for partners of newly diagnosed cases with acute or prevalent
      HIV infection include: 1) age over 18 years; and 2) not previously diagnosed with HIV
      infection.

      Sample Size: 3,175 study participants total, including 2,875 participants in the
      stepped-wedge study (1,375 in the observation period and 1,500 in the intervention period).
      We estimate that approximately 2% of participants in the observation period (n=28) and
      approximately 5% of participants in the intervention period (n=75) will test positive for HIV
      infection and continue in the study. We estimate that up to 300 partners of newly diagnosed
      individuals will be offered enrollment and tested for HIV using standard tests (observation
      period) or HIV-1 RNA testing (intervention period).

      Participating Sites: Kenya Medical Research Institute (KEMRI)-Wellcome Trust Programme,
      Kilifi, Kenya with stepped wedge trial implementation at 6 community health facilities (2-4
      public, 2-4 private) and ART and PrEP cohort follow-up at the KEMRI Research Clinic in
      Mtwapa, Kenya.

      Schedule of Procedures: Individuals eligible for the HIV-1 RNA testing intervention will be
      offered enrollment when they seek care at one of the study facilities, with testing taking
      place on that same day. For individuals with negative test results for both acute and
      prevalent HIV infection, no further follow-up will occur. One 6-week follow-up visit will
      occur after testing for all individuals who are newly diagnosed with HIV. Procedures for the
      aPS intervention, the ART cohort, and the PrEP cohort are detailed in this protocol.

      Study Duration: Study enrollment will occur over 24 months. Following enrollment and study
      procedures (1-2 hours of time), all participants who test negative for HIV infection will
      have no further visits. All participants newly diagnosed with HIV will have a 6-week
      follow-up visit. All participants who enroll in the ART or PrEP cohort will be followed for a
      total of 12 months.

      Intervention: Testing for acute and prevalent HIV infection, followed by partner notification
      services and immediate ART (provided by the Kenyan Ministry of Health) for newly diagnosed
      individuals and PrEP (provided by Gilead) for uninfected partners in serodiscordant
      relationships.
    

Intervention name(s): HIV-1 RNA testing
Intervention type(s): Diagnostic Test
Intervention description(s): During the intervention period, a blood sample will be obtained and tested for AHI using point-of-care Xpert® HIV Qual assay (Cepheid, Sunnyvale, California, USA). Individuals who test positive will undergo rapid tests to differentiate acute from prevalent HIV infection. Newly diagnosed individuals will be offered immediate ART and assisted partner notification with the HIV-1 RNA testing intervention delivered to partners following the same approach.
Other intervention name(s): Xpert HIV-1 RNA testing
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This trial will use a modified stepped wedge design to evaluate the yield of the HIV-1 RNA testing intervention at 6 public or private health facilities in Kenya, before (1,375 patients) and after (1,500 patients) intervention delivery. This study will be conducted in two phases (observation phase and intervention phase) at each site.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV testing; ART; partner notification; PrEP