Adults 18 to 39, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Patients With Newly Diagnosed HIV Infection at Care SeekingPrimary· 24 months
Primary endpoints for the HIV-1 RNA testing intervention include the proportion of participants with newly diagnosed prevalent or AHI at care seeking.
Group
Value
95% CI
Adult Outpatients With Symptoms of Acute HIV Infection
50
Observation Phase
13
Intervention Phase
37
Adult Outpatients With Symptoms of Acute HIV Infection
2
Observation Phase
0
Intervention Phase
2
Adult Outpatients With Symptoms of Acute HIV Infection
2822
Observation Phase
1361
Intervention Phase
1461
Proportion of Newly Diagnosed Patients Linked to CareSecondary· 24 months
Secondary endpoints for the linkage to care intervention include the proportion of newly diagnosed patients captured in the HIV care cascade.
Group
Value
95% CI
Observation Period
9
Intervention Period
33
Proportion of Named Partners Tested for HIVSecondary· 24 months
Proportion of named partners tested for HIV in each period
Group
Value
95% CI
Observation Period
3
Intervention Period
10
Cost Effectiveness of Novel RNA Testing Intervention: Total Cost (Including Both Testing and HIV-positive Patient Management) Per Participant (Base Case Patient Modeled)Secondary· Data collected over 2 years, data is a predicted time point extrapolated to 10 years
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 a
Group
Value
95% CI
Observation Phase
47.24
Intervention Phase
214.91
Cost Effectiveness of Novel RNA Testing Intervention: Disability-Adjusted Life Years (Base Case Patient Modeled)Secondary· Data collected over 2 years, data is a predicted time point extrapolated to 10years
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 201
Group
Value
95% CI
Observation Phase
0.2140
Intervention Phase
0.1598
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Oxford
Last refreshed: 13 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03508908.