HIV Infections Clinical Trial
— TMPOfficial title:
Impact of a Novel HIV-1 RNA Testing Intervention to Detect Acute and Prevalent HIV Infection and Reduce HIV Transmission - Tambua Mapema Plus
Verified date | November 2023 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 2887 |
Est. completion date | July 31, 2022 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 39 Years |
Eligibility | Inclusion Criteria: - age from 18-39 years; - not previously diagnosed with HIV infection; and - a score =2 on our risk score algorithm to identify persons at higher risk for AHI, with scoring as follows: - age 18-29 years (1), - fever (1), - fatigue (1), - body pains (1), - diarrhea (1), - sore throat (1), and - genital ulcer disease (GUD) (3). Eligibility criteria for partners of newly diagnosed cases with prevalent or acute HIV include: - age over 18 years; and - not previously diagnosed HIV infection. Exclusion Criteria: Patients not meeting inclusion criteria or those who are not willing or able to participate (e.g., due to illness or time constraints, or at the discretion of the study clinician) will be excluded. Individuals at high risk for Intimate Partner Violence (IPV) are excluded from the aPS intervention, but eligible for all other components of the study. |
Country | Name | City | State |
---|---|---|---|
Kenya | KEMRI Mtwapa | Kilifi |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | National Institute of Allergy and Infectious Diseases (NIAID), University of Washington |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Patients With Newly Diagnosed HIV Infection at Care Seeking | Primary endpoints for the HIV-1 RNA testing intervention include the proportion of participants with newly diagnosed prevalent or AHI at care seeking. | 24 months | |
Secondary | Proportion of Newly Diagnosed Patients Linked to Care | Secondary endpoints for the linkage to care intervention include the proportion of newly diagnosed patients captured in the HIV care cascade. | 24 months | |
Secondary | Proportion of Named Partners Tested for HIV | Proportion of named partners tested for HIV in each period | 24 months | |
Secondary | Cost Effectiveness of Novel RNA Testing Intervention: Total Cost (Including Both Testing and HIV-positive Patient Management) Per Participant (Base Case Patient Modeled) | Model outputs will include an analysis of the cost effectiveness of the novel testing intervention assessing several parameters of the HIV prevention and care cascade using stochastic, agent-based mathematical modelling. The population of interest modeled was 18- to 39-year-old heterosexuals in Kenya. The age range coincides with the sampled population in this study (NCT03508908) which provided the majority of the parameters for the networks and behavioral modules in the simulation. The observations from this study were weighted to match the sex and age composition reported in the Kenya Fact and Figures 2015 published by the Kenya National Bureau of Statistics. Additional model parameters were drawn from the literature on HIV infection, prevention, and treatment in Kenya.The analysis was conducted over a time horizon of 10 years, consistent with the mathematical model. 10,000 base-case patients (simulations) were run. | Data collected over 2 years, data is a predicted time point extrapolated to 10 years | |
Secondary | Cost Effectiveness of Novel RNA Testing Intervention: Disability-Adjusted Life Years (Base Case Patient Modeled) | Disability-adjusted Life Year (DALY) is an index calculated as the sum of years of life lost (YLL) plus the years lost due to disability (YLD), where 1 DALY represents one lost year of healthy life. The higher the DALY index value, the worse the outcome, where there is no theoretical minimum ore maximum index value. the sampled population in this study (NCT03508908) which provided the majority of the parameters for the networks and behavioral modules in the simulation. The observations from this study were weighted to match the sex and age composition reported in the Kenya Fact and Figures 2015 published by the Kenya National Bureau of Statistics. Additional model parameters were drawn from the literature on HIV infection, prevention, and treatment in Kenya. The analysis was conducted over a time horizon of 10 years, consistent with the mathematical model. 10,000 base-case patients (simulations) were run. | Data collected over 2 years, data is a predicted time point extrapolated to 10years |
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