N/A
N=249
Tambua Mapema Plus - to Discover HIV Infection Early and Prevent Onward Transmission
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT03508908 ↗Enrolled (actual)
249
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Proportion of Patients With Newly Diagnosed HIV Infection at Care Seeking — 50; 13; 37; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HIV-1 RNA testing (Diagnostic_test)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Oxford
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Newly Diagnosed HIV Infection at Care Seeking |
50; 13; 37; 2; 0; 2 | — |
| SECONDARY Proportion of Newly Diagnosed Patients Linked to Care |
9; 33 | — |
| SECONDARY Proportion of Named Partners Tested for HIV |
3; 10 | — |
| SECONDARY Cost Effectiveness of Novel RNA Testing Intervention: Total Cost (Including Both Testing and HIV-positive Patient Management) Per Participant (Base Case Patient Modeled) |
47.24; 214.91 | — |
| SECONDARY Cost Effectiveness of Novel RNA Testing Intervention: Disability-Adjusted Life Years (Base Case Patient Modeled) |
0.2140; 0.1598 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03508908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.