Screening of individuals attending a sexual health clinic at risk of HIV acquisition for acute HIV infection (AHI) Infections and Infestations
Conditions
Interventions
1. Implementing an optimally sensitive AHI screening approach through a client self-completed risk assessment (“AHI Risk Assessment”), coupled with HIV-PCR diagnostic testing (sequential to and additi
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: Individuals are eligible to participate in the INTERACT study if they meet all the following criteria: 1. Aged 18 years or older (or 16-17 years old if deemed mature enough by a clinic doctor/counsellor) 2. Answered "YES" or "I PREFER NOT TO SAY" to at least one of the following: 2.1. Are a man who has sex with men (MSM) 2.2. Are a transgender person 2.3. Have ever injected drugs 2.4. Sell sex or work as a sex worker 2.5. Have sex with a sex worker 2.6. Have sex with a person living with HIV; and/or 2.7. Believe they are at risk of having HIV 3. Provided informed consent by answering "YES" to both: 3.1. Agreement to take part in the study; and 3.2. Agreement to the anonymized use of their medical record and blood sample for the study? For adolescents aged 16-17 years, additional criteria include: A clinic doctor or nurse confirms that: 1. It is in their best interest to access HIV prevention and testing services; 2. They cannot be persuaded to inform their parents/carers; and 3. They understand the study, its risks and benefits, and can make an informed decision?
Exclusion criteria
Exclusion criteria: Individuals are not eligible to participate if they: 1. Are younger than 16 years old 2. Are 16-17 years old but are not deemed mature enough to consent to study participation 3. Have previously tested HIV positive and are already registered in care and/or receiving treatment for HIV?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Evaluation of the effectiveness/yield of an AHI clinical pathway: 1.1. AHI screening outcomes*: 1.1.1. Performance of the Amsterdam screening risk score in diagnosing AHI (sensitivity, specificity and Area Under the Curve [AUC], overall and stratified per risk group, including the complete longitudinal dataset) 1.1.2. Yield of HIV-PCR in diagnosing AHI compared with standard-of-care 4th generation HIV Ag/Ab testing and 3rd generation HIV Ab RDT testing (number and percentage of additional HIV case-detection, overall and stratified per risk group, including the complete longitudinal dataset) 1.1.3. Prevalence of reported symptoms and risk behaviour, and their association with AHI (number and percentage, overall and stratified per risk group, including the complete longitudinal dataset) 1.1.4. Number and proportion of participants who are newly diagnosed with AHI (compared to historical records for all HIV diagnoses) (number and percentage, overall and stratified per risk group, including the complete longitudinal dataset) Analysed with a time-to-event analysis with right censoring, hence the time HIV diagnosis may be between 0 days and 23 months (determined by study recruitment duration) 1.2. HIV care cascade outcomes**: 1.2.1. Proportion of those HIV diagnosed who start ART (compared to historical records) (number and percentage, overall and stratified per risk group, including the complete longitudinal dataset) 1.2.2. Time (days) from confirmed HIV diagnosis to ART initiation (compared to historical records) (median days and number and percentages started on ART at <24 hours, <7 days, <30 days, including the complete longitudinal dataset) 1.2.3. HIV-RNA load levels at the time of HIV diagnosis and after 12 and 24 weeks of ART (compared to historical records for all HIV diagnoses) (mean/median and proportion <50 cps/mL including the complete longitudinal dataset) 1.2.4. CD4 T-cell counts at the time of HIV diagnosis and after 12 and 24 weeks of ART (mean/median | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To improve the implementation of the AHI clinical pathway through a tailored digital behavioural/risk assessment intervention and community outreach: 1.1. Uptake of a tailored digital risk reduction intervention amongst MSM at risk in the local area in all clinical sites (number, including complete study period) 1.2. Usability of the tool via user-centred interaction design methods including focused user questionnaires and remote usability testing (subjective feedback on the interface by users) (qualitative analysis, including complete study period) 1.3. Number of digital engagements and length of digital interaction time spent on the tool, and number of returning digital users (number, including complete study period) 1.4. Number of those engaged enrolling in the INTERACT study (number, including complete longitudinal dataset) Analysed with a time-to-event analysis with right censoring, hence the time HIV diagnosis may be between 0 days and 23 months (determined by study recruitment duration) | — |
Countries
Indonesia
Contacts
Public ContactMargareta Oktaviani
Outcome results
None listed