Investigating an intervention to improve screening, diagnosis and treatment of persons with very early HIV infection at Indonesian sexual health clinics

1. Approved 02/12/2022, Oxford Tropical Research Ethics Committee (University of Oxford; Research Services, Research Governance, Ethics & Assurance; Wellington Square, Oxford, OX1 4BH, United Kingdom; +44 (0)1865 (2)82106; oxtrec@admin.ox.ac.uk), ref: 565-22

2. Approved 17/11/2022, Atma Jaya Catholic University of Indonesia; Institute of Research and Community Service Ethics Committee (Jendral Sudirman Street, number 51, Jakarta, 12930, Indonesia; +61 (0)21 570-3306; lppm@atmajaya.ac.id), ref: 0009R/III/PPPE.PM.10.05/10/2022

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 cells/mm3, including the complete longitudinal dataset)

2. Evaluation of uptake/adoption, acceptance and feasibility of AHI testing and partner screening and notification, as part of the AHI clinical pathway:
2.1. Number of AHI risk screens conducted (overall and stratified per risk group, including the complete longitudinal dataset)
2.2. Number of individuals who are tested for HIV/STI for the first time ever and at the study clinic; who repeat the HIV/STI test at the study clinic; and the time interval since previous HIV/STI test (median days and number, overall and stratified per risk group, including the complete longitudinal dataset)
2.3. HIV and STI incidence among individuals in follow-up (overall and stratified per risk group, including the complete longitudinal dataset)
2.4. Number of HIV-negative individuals who are eligible for PrEP (according to MOH guidelines) (overall and stratified per risk group, including the complete longitudinal dataset)
2.5. Number of sexual partners of individuals who are newly HIV diagnosed (index clients), who are contacted, tested for HIV, and newly HIV diagnosed (overall and stratified per risk group, including the complete longitudinal dataset)
2.6. Barriers and enablers of implementing the AHI clinical pathway from the participant’s and provider’s perspective (qualitative analysis, including complete study period)
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)

3. Estimation of the potential population impact and cost-effectiveness of an AHI clinical pathway on curbing the HIV epidemic in Indonesia:
3.1. Projections of HIV infections, hospitalizations, and deaths averted and QALYs gained under different intervention scale-up scenarios, including maintenance of the status quo (overall and stratified per risk group, mathematical modelling)
3.2. Cost-effectiveness of different intervention scale-up scenarios, expressed as ICER measured as cost-per QALY gained (overall and stratified per risk group, mathematical modelling)
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. 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)