HIV/AIDS
Conditions
Interventions
HIV testing per Kenyan guidelines and clinician judgment
HIV 1 RNA testing intervention
Sponsors
Division of AIDS DAIDS National Institute of Allergy and Infectious Diseases NIAID National Institutes of Health NIH
Eligibility
Sex/Gender
All
Inclusion 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: o age 18-29 years (1), o fever (1), o fatigue (1), o body pains (1), o diarrhea (1), o sore throat (1), and o 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
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 IPV are excluded from the aPS intervention, but eligible for all other components of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To conduct a proof-of-concept study to determine outcomes of a health facility-based HIV-1 RNA testing intervention to identify acute (i.e., RNA-positive, seronegative or discordant rapid test results) and prevalent (i.e., RNA-positive, seropositive) HIV infection, compared to standard care. | — |
Secondary
| Measure | Time frame |
|---|---|
| Linkage to care: To determine the feasibility, acceptability, and uptake of offering immediate linkage and treatment to all newly diagnosed HIV-infected patients in the intervention period, comparing this approach to standard care.;Partner testing: To determine the feasibility, acceptability, and uptake of aPS for partner identification and testing, comparing enhanced aPS with HIV-1 RNA testing in the intervention period to passive referral followed by delayed aPS with standard HIV testing in the observation period.;Impact and cost-effectiveness: To model the potential impact of the HIV-1 RNA testing, linkage, immediate treatment, and aPS interventions on the Kenyan HIV epidemic, in terms of incremental costs per HIV infection averted, death averted, and disability-adjusted life-year (DALY) averted, using data on standard care outcomes from the observation period and data on intervention outcomes from the intervention period.;Barriers and facilitators: To conduct qualitative in-depth interviews with up to 60 newly diagnosed prevalent and AHI patients and seronegative partners in discordant relationships to gain insights into intervention uptake, including barriers and facilitators to ART or PrEP uptake and adherence in these groups.;Staff views: To conduct interviews or focus groups with up to 60 individuals who work in the 6 health facilities where the trial will take place (up to 10 participants per facility), to obtain their views on HIV-1 RNA testing and the research carried out at the facility, including challenges to intervention scale-up. | — |
Countries
Kenya
Contacts
Public ContactClara Agutu
Project Manager
Outcome results
None listed