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Implementing a clinical pathway for diagnosing and treating acute HIV infection
among key populations attending sexual health clinics in Indonesia: cohort profile of
the INTERACT study
Authors
Irwanto1, Nurhayati H. Kawi2, Hendry Luis3, Erik P. Sihotang2, Pande Putu Januraga4,
Margareta Oktaviani5, Suwarti5, Dwi P. Rahmawati5, Evi Sukmaningrum1, Evy Yanihastuti6,
Maartje Dijkstra7, Eduard J. Sanders8,9, F. Stephen Wignall2,3, Keerti Gedela10*, Raph L.
Hamers5,7,11*; INTERACT Study Group**
*KG and RLH are shared last authors
**Members listed at end of paper
Affiliations
1. HIV/AIDS Research Centre, Atma Jaya Catholic University, Jakarta, Indonesia
2. Klinik Utama Globalindo, Jakarta, Indonesia
3. Yayasan Bali Peduli, Denpasar, Indonesia
4. Centre for Public Health Innovation, Udayana University, Denpasar, Indonesia
5. Oxford University Clinical Research Unit Indonesia, Faculty of Medicine Universitas
Indonesia, Jakarta, Indonesia
6. Dr Cipto Mangukusumo Hospital, Faculty of Medicine Universitas Indonesia, Jakarta,
Indonesia
7. Department of Internal Medicine, Amsterdam University Medical Centers, University of
Amsterdam, Amsterdam, The Netherlands
8. The Aurum Institute, Johannesburg, South Africa
9. Sir William Dunn School of Pathology, University of Oxford, Oxford, UK
10. 56 Dean Street clinic, Chelsea & Westminster Hospital NHS Trust, London, UK
11. Centre for Tropical Medicine and Global Health, Nuffield Dept of Medicine, University of
Oxford, Oxford, UK
Correspondence to
Raph L Hamers, MD PhD, Oxford University Clinical Research Unit Indonesia, Faculty of
Medicine Universitas Indonesia, Jalan Salemba Raya No. 6, 10430 Jakarta Pusat, Indonesia
Mobile: +62 811180912; Email: rhamers@oucru.org
Running title: Acute HIV in Indonesia
Word count 3586 Inserts: 2 tables; 4 figures Supplement: 5 tables; 2 figures
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NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
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ABSTRACT
Background
To reduce the high HIV incidence among key populations in Indonesia, we implemented a
clinical pathway for screening, diagnosis and treatment of acute HIV infection (AHI) in sexual
health clinics in Jakarta and Bali. This paper presents a cohort profile and analysis of
baseline data on the study uptake, diagnostic yield, and estimated AHI prevalence and
screening cascade outcomes.
Methods We performed a baseline analysis of 1879 individuals who underwent AHI
screening at three sexual health clinics in Jakarta and Bali between May and December
2023, comprising a risk-score assessment, fourth-generation antibody/p24 antigen-based
rapid diagnostic test (RDT; Abbott Determine HIV Early Detect) and HIV-PCR (Xpert)
testing.
Results Median age was 27 years (IQR24-31), and 75.4% were male. Men who have sex
with men (MSM) accounted for 50.4%, clients of sex workers 20.1%, and sex workers 5.2%.
Of 1866 participants tested at study enrolment, 113 (6.1% [113/1866]) had chronic HIV
(antibody-positive) and 6 (0.34% [6/1748]) had AEHI. HIV-PCR testing led to a 5.3%
(95%CI1.9-11.2) increase in confirmed HIV diagnoses. The number needed to test to detect
one AEHI case was 291 (1748/6) overall and 169 (842/5) among MSM. Overall HIV and AHI
prevalence was 6.4% (95%CI 5.3-7.6; 119/1866) and 0.34% (95%CI0.12-0.74; 6/1748)
overall; and 10.8% (95%CI8.9-13.0; 102/940) and 0.53% (95%CI 0.17-1.2; 5/940) among
MSM. The Abbott Determine HIV Early Detect RDT only detected 2 (18.2%) of 11 AEHI
cases. 113 (95.0%) newly diagnosed individuals were linked to care and started ART, of
whom 75 (66.4%) on the same day and 104 (92.0%) within a week (median 0 days, range 0-
93).
Conclusion AHI screening, diagnosis and prompt treatment is feasible among high-risk
urban MSM in Indonesia. Further evaluations are needed to estimate clinical impact and
cost-effectiveness of AHI screening in this setting. The study continues accrual and follow-
up, and provides a platform for future immuno-virological, social science, and intervention
studies in Indonesia.
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INTRODUCTION
Background
Indonesia is a socio-culturally, economically and geographically diverse, Muslim-majority,
middle-income country with the world’s fourth largest population (275 million), featuring
stark health inequalities across regions and communities. Indonesia has one of the
highest numbers of new HIV infections globally, estimated at 24,000 (95% confidence
interval [CI] 22,000-27,000) in 2022 (1), with an estimated 515,455 persons living with HIV
(PLHIV) by March 2023 (2). Although recent estimates have shown a decreasing trend
overall, numbers of new HIV infections have remained high among vulnerable groups,
specifically men who have sex with men (MSM), transgender women (TGW), and female
sex workers and their sexual partners. The most recent national survey data (2018-2019)
estimated a national HIV prevalence of 17.9% (95%CI 16.8-19.0) for MSM and 11.9%
(95%CI 10.7-13.1) for TGW (3), with province-level estimates for MSM of 23.0% in Jakarta
and 21.2% in Bali (3). A retrospective analysis among MSM and TGW found a very high HIV
incidence of 9.4 per 100 person-years (95%CI7.9-11.2) in Jakarta and 7.2 per 100 person-
years (95%CI5.7-9.1) in Bali (4). Access to oral HIV pre-exposure prophylaxis (PrEP),
currently being rolled out in many other countries (5), remains largely restricted to a pilot
programme in a limited number of government primary health centres (2).
In Indonesia, HIV care cascades for testing, diagnosing, linkage to care and suppressive
treatment are often fractured, particularly for key populations (6,7). By March 2023, national
data estimated that, overall, 85% of PLHIV knew their HIV status, 36% received antiretroviral
therapy (ART), and 10% had viral load suppression on ART (7). In an earlier study in 2015-
2016 among 637 MSM diagnosed with HIV attending non-government sexual health clinics,
83% were linked to care, 73% started ART, 57% were retained in care, 43% had a viral load
test done after six months, and 39% had viral load suppression on ART (6). There are
numerous social, economic and structural factors underlying the fractured HIV care
cascades (8,9). The government prioritises integration of HIV services in general primary
health centres, where high levels of stigma and discrimination against MSM, TGW and
PLHIV have been reported, whereas sexual health services tailored to key populations are
only offered by a few private and non-government clinics. Social stigmatization,
discrimination, economic deprivation and punitive laws further increase the vulnerability to
HIV and hinder public health access in these settings (8,9).
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Acute HIV infection as a driver of epidemics
Acute HIV infection (AHI) is the short phase immediately after viral acquisition, and is
typically characterised by a lack of anti-HIV antibodies and the presence of viremia, which
can be detected by an HIV-RNA or p24 viral antigen test (10). However, clinicians often fail
to recognize AHI because most people experience no or non-specific symptoms. The rate of
sexual transmission has been estimated to be 8-20 times higher during AHI than during
chronic infection (11–13), and phylogenetic and mathematical models, mainly from Europe
and the Americas, have estimated that AHI may account for 10-50% of all new HIV
infections among MSM communities (14,15). Reliable estimates for AHI as a driver of the
HIV epidemic among Asian key populations are lacking, although a modelling study among
MSM in Bangkok estimated that AHI detection and immediate ART initiation could reduce
onward transmissions by 89% (16). To reach the UNAIDS goals towards HIV elimination
(17), it is imperative that all PLHIV are diagnosed early and start ART immediately, to
prevent onward transmission (18,19). Undiagnosed AHI may hinder achieving the desired
population benefits associated with those comprehensive “Treat all” strategies (14).
Study rationale
AHI-centred combined intervention models From a public health perspective, AHI
screening is an important strategy to decrease HIV transmission via viral load reduction and
behavioural interventions, provided that individuals with AHI can be diagnosed, linked to
care and started on same-day or immediate ART (16,17); to improve uptake of pre-exposure
prophylaxis among HIV-negative persons at high risk of HIV acquisition (20,21); and to
enhance partner services via notification of persons recently exposed or likely transmitting
(14,22,23). Moreover, from a clinical perspective, there are substantial immunological and
virological benefits to identifying and treating persons with AHI, evading irreversible damage
to host immune systems (24,25) and seeding of viral reservoirs that occurs during untreated
AHI (14,25,26).
Experiences in urban MSM communities in, for instance, San Francisco (27), British
Columbia (28), London (29) and Amsterdam (30), indicate that combined prevention and
treatment interventions (including for AHI) tailored to key populations with city-specific
strategies to remove structural barriers to access services are most successful in reducing
incident HIV infections and containing HIV epidemics. These experiences create a strong
impetus to tailor such successful models to populations with ongoing HIV transmission in
low- and middle-income countries (LMIC).
Sensitive AHI screening approaches Third-generation HIV antibody rapid diagnostic tests
are the backbone of testing in Indonesia, as in many LMICs, missing the earliest pre-
antibody phase that is AHI. Fourth-generation HIV-antigen/antibody combination tests and
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nucleic acid (HIV-PCR) tests shorten the post-transmission detection window from 2-6
weeks (antibody), to 15-20 days (antigen) or even 7-10 days (HIV-PCR). However, although
fourth-generation antigen/antibody point-of care assays are more straightforward and
cheaper than HIV-PCR, they have shown variable sensitivities for detecting AHI (28-88%
across cohorts) (31–33). Optimal AHI algorithms must balance the consequences of missed
diagnoses and cost, speed and ease-of-use. Many AHI testing algorithms combine third
and/or fourth generation assays with more sensitive HIV-PCR testing technologies. Risk
score algorithms based on symptoms and/or sexual risk behaviour have been developed to
optimize the efficiency and reduce cost of AHI screening approaches, but have been mainly
validated on retrospective datasets from Western and African MSM communities. The
diagnostic yield of targeted HIV-PCR testing has been estimated at 3.3% (95%CI 2.2-4.6%)
across three studies (34). Further prospective studies are needed to assess and optimize
the yield of AHI risk score and testing algorithms in a variety of settings and populations.
Pooled (group) sample testing has been successfully applied to increase testing efficiency
and reduce required resources (31,35,36).
Study objectives
The aim of INTERACT is to assess whether implementing an AHI test and treat clinical
pathway at sexual health clinics serving Indonesian MSM and other key populations,
coupled with a digital community engagement tool tailored to the wider target community,
can strengthen the HIV care cascade in Jakarta and Bali. Specific objectives are:
1. To assess the effectiveness/yield as well as the uptake, acceptability and feasibility, and
barriers and enablers of the AHI test and treat clinical pathway;
2. To assess whether uptake of the intervention can be enhanced through a tailored digital
engagement intervention;
3. To estimate the potential population impact on HIV incidence and cost-effectiveness of
the AHI test and treat clinical pathway in Indonesia.
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METHODS
Design
INTERACT is a prospective cohort study of individuals aged 16 years or older who are
vulnerable to HIV acquisition and are voluntarily attending an open-access sexual health
service in Jakarta or Bali for HIV testing. INTERACT is a collaboration between researchers
and care providers involving several Indonesian and international institutions with track
records in HIV prevention and care models. Study management is done by the Oxford
University Clinical Research Unit (OUCRU) Indonesia, based in Jakarta. Ethics approvals
were obtained from the Atma Jaya Catholic University research ethics committee
(0009R/III/PPPE.PM.10.05/10/2022) and the Oxford Tropical Research Ethics Committee
(565-22). The study enrolment period is from May 2023 through December 2024. This study
is reported as per Strengthening the Reporting of Observational Studies in Epidemiology
guidelines (Table S1).
The central guiding principle for study implementation is that INTERACT procedures are
integrated into the routine client services, compliant with the Ministry of Health HIV
guidelines. The INTERACT AHI test and treat clinical pathway intervention comprises the
following (Figure 1):
• Implementation of an AHI screening approach. A participant-completed AHI risk
assessment (“Risk Checker”), modified from the Amsterdam AHI risk score (37), is
followed by Xpert HIV-PCR diagnostic testing, with same-visit or next-day delivery of
results. Participants are encouraged to return for regular (three-monthly or earlier in case
of AHI risk exposure and/or symptoms) AHI screen visits;
• Offer of immediate, same-visit ART initiation in newly HIV diagnosed persons, and
monitoring HIV-RNA at 3 and 6 months after ART initiation to assess adherence and
virological response;
• Offer of assisted partner notification, to identify and test sexual partners at high risk of
undiagnosed HIV;
• Implementation of a tailored digital engagement intervention, through social media
platforms, which aims to promote uptake of AHI testing at the study clinics
(www.CekUpYuk.id, promoted since March 2024).
Several inter-related quantitative and qualitative outcomes will be measured, related to the
effectiveness/yield, uptake, acceptability, feasibility and potential impact of the AHI clinical
pathway (Table S2). An implementation evaluation, based on stakeholder interviews (38),
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will help identify barriers and enablers. The study data will be used to perform a cost-
effectiveness analysis, estimate the role of AHI as a driver of the local epidemic, and predict
the impact of scalable intervention scenarios on local epidemic. A subset of newly HIV
diagnosed individuals will be enrolled, with written informed consent, in a viro-immunologic
longitudinal sub-study to investigate AHI immune responses, antiretroviral drug resistance
patterns and HIV transmission networks.
Setting and population
INTERACT is implemented at three open-access NGO sexual health clinics providing free or
low-cost HIV and other STI testing and treatment services, predominantly serving MSM,
TGW, and sex workers and their clients. Yayasan Bali Peduli (www.balipeduli.org), operates
clinics in Denpasar and Ubud, Bali, and Klinik Utama Globalindo
(www.yayasankasihglobalindo.org) operates in South Jakarta. DKI Jakarta and Bali are
among the provinces with the highest reported HIV prevalence (Figure S1). All sites offer
point-of-care rapid antigen/antibody HIV testing (Abbott Determine HIV Early Detect) and
HIV-PCR testing (Xpert HIV Viral Load and HIV Qual). Assuming that ~50% of the HIV-
antibody-negative participants classify as AHI high-risk (N~2250) at 3.3% (95%CI 2.2-4.6)
yield for targeted HIV-PCR testing (34), we expect to detect 75 (95%CI 50-104) AHI cases at
an absolute precision of ±4%, given alpha 5%. Assuming that the remaining ~50% of the
HIV-antibody-negative participants classify as non AHI high-risk (N~2250) at a 0.2% (95%CI
0.1-0.3) yield for universal HIV-PCR testing (34), we expect to detect an additional 5 (95%CI
2-7) AHI cases through pooled-sample screening.
Study screening and eligibility assessment
All individuals who attend the clinic for HIV testing, both first-time and returning, are informed
about the ongoing INTERACT project through a participant information sheet and study
banner in the waiting room. Interested individuals are invited to answer study eligibility
questions and provide digital consent into a REDCap electronic data capture on a clinic-
provided or personal mobile device. Eligibility criteria are:
• Aged 16 years or older (individuals aged 16 or 17 years undergo an additional maturity
assessment); AND
• Individuals not known to be living with HIV; AND
• Individual belongs to one or more of the following HIV risk categories:
o Men who have sex with men
o Transgender women
o Persons who inject drugs
o Sex workers
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o Clients of sex workers
o Sexual partners of PLHIV
o Other risk of HIV acquisition (undisclosed category)
Eligible, consenting individuals are consecutively enrolled and proceed to AHI screening
procedures. For individuals who are not eligible or decline participation, the reason is
recorded. All clinic attendees receive services as usual as per standard clinic procedures.
AHI screen visit procedures
At each AHI screen visit, participants are asked to fill out the “AHI Risk Checker”, modified
from the Amsterdam AHI risk score (37): three or more sexual partners, any STI,
condomless receptive anal sex (each within the past six months); weight loss, fever, swollen
lymph nodes, oral thrush (each in the past two weeks). After completion, the client
responses are verified between the client and a counsellor. An AHI risk score is
automatically calculated by summing up the number of risk factors and/or symptoms (range
0-7). Individual HIV-PCR testing is applied to participants classified as “AHI high-risk” based
on their risk score (the initial cutoff >=1 was adjusted to >=2 in October 2024, to strive for
~50% being classified as “AHI high-risk”), whereas all other participants are HIV-PCR tested
using a pooled sampling approach (see below).
Specimens that test HIV-antigen/antibody-positive or indeterminate (i.e. Abbott Determine
HIV Early Detect or equivalent) undergo confirmatory testing with a third-generation HIV-
antibody RDT (i.e. Bioline HIV1/2, or equivalent). The study applies additional HIV-PCR
testing to all specimens that are HIV antigen and antibody negative or
inconclusive/indeterminate, using a study-specific SOP (Figure S2). Participants classified
as AHI high-risk receive an Xpert HIV-1 Qual test on an individual sample; if positive
confirmed with Xpert HIV-1 Viral Load assay (final result reported on the same day, or
<24h). Participants not classified as AHI high-risk receive an Xpert HIV-1 Viral Load on a
pooled sample; if positive, deconvolution testing of the constituent individual samples with
Xpert HIV-1 Viral Load assay; if positive, confirmed with Xpert HIV-1 Qual assay (final result
reported <72h). All positive HIV-PCR results are confirmed on a new specimen. Confirmed
HIV diagnoses are classified as either acute (AHI) (PCR and/or p24 positive, antibody-
negative, including antibody-discordance or early HIV), recent HIV (antibody-positive and
documented negative test <6 months prior), or chronic HIV (antibody-positive and no
documented negative test <6 months prior) (Table S3). Participants who test HIV-negative
are invited (with text message reminders) to regular follow-up AHI screen visits (every three
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months or earlier if they perceive any AHI risk or symptoms). Table S4 summarises the
clinical an lab variables being collected.
Follow-up visit procedures for participants newly diagnosed with HIV.
Participants who are newly diagnosed with HIV (including AHI) receive follow-up visits,
according to existing clinic procedures (Figure 1). During the baseline visit (T0), same-day
ART initiation and assisted partner notification are offered. The standard first-line ART
regimen is emtricitabine 200mg/tenofovir disoproxil fumarate 245 mg/dolutegravir 50
mg
[TLD] once daily. Xpert HIV Viral Load is measured before ART start, and at 3 and 6 months
after ART start. Participants in the immuno-virologic sub-study provide a blood sample for
storage.
Patient and public involvement
The design of the AHI clinical pathway involved clinic staff who are part of or interact closely
with the key populations they serve, including PLHIV. A community advisory board,
consisting of representatives of PLHIV and MSM community organisations, has been
established to help inform and design community engagement tools, share study findings
and identify further research priorities. Knowledge dissemination strategies prioritise sharing
findings with health policymakers and communities and fostering a dialogue that may guide
research direction and further enhance collaboration.
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FINDINGS TO DATE
Study uptake and enrolment
This paper summarises the baseline data of participants enrolled in the first eight months of
the study. From May 12 to December 31, 2023, of overall 5262 individuals seeking HIV
testing across the sites, 1946 (37.0%) were screened for study eligibility (1621 of 3789
[42.8%] in Jakarta and 325 of 1473 [22.1%] in Bali), whereas 3022 refused (most without
providing a reason) and 294 were not offered study eligibility screening (mainly because
research staff were not available or the client came outside of laboratory service hours)
(Figure 2). Of 1946 individuals screened for study eligibility, nearly all (1879, 96.6%) were
eligible and enrolled (1559 in Jakarta and 320 in Bali); the reasons for not enrolling were
previously tested HIV-positive (41), not willing to provide consent (12), and not reporting any
HIV risk (6).
Participant characteristics at enrolment
Table 1 summarises the characteristics of the 1879 participants. 1416 (75.4%) were male,
439 (23.4%) female, 15 (0.8%) transgender women, and 9 (0.5%) identified as other gender.
The median age was 27 years (IQR 24-31). Most participants completed university/higher
education (1335, 71.0%) and were employed (1588, 84.5%). The most reported HIV risk
categories was MSM (947, 50.4%), followed by sex worker client (378, 20.1%), having a
sexual partner living with HIV (143, 7.6%), sex worker (97, 5.2%), transgender woman (15,
0.8%), person who inject drugs (6, 0.3%), and those not disclosing their risk category (296,
15.8%). 1003 (53.4%) participants had a previous negative HIV test result, of whom nearly
half (444, 44.3%) within the past six months. Main reasons for current HIV testing included
feeling at risk (1156, 61.5%), having symptoms (456, 24.3%), retesting because of window
period after possible recent exposure (261, 13.9%), a new sexual relationship (252, 13.4%),
getting married (132, 7.0%), or having a partner who tested HIV positive (77, 4.1%).
Table 2 summarises behavioural risk factors for HIV acquisition among the study population.
Around half of the participants (884, 47.0%) reported to have engaged in anal sex in the past
three months, comprising receptive (306, 34.6%), insertive (316, 35.8%) or both (262,
29.6%). Condomless receptive anal sex was reported by about half of MSM (52.8%,
500/947), 5.2% (49/932) of men who did not identify as MSM, and 10.1% (36/356) of
individuals not disclosing their risk category. The use of recreational drugs before or during
sex (“chemsex”) in the past three months was reported infrequently (33, 1.8%), mostly
“poppers” (inhaled alkyl nitrites). Engaging in group sex and visiting sex parties was reported
by 106 (5.6%) and 41 (2.2%), respectively. PrEP use was reported by 156 (8.3%)
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participants, evenly divided between daily (76, 48.7%) and event-driven dosing (80, 51.3%),
and 63 (40.4%) had last used PrEP more than a month ago. Most participants (113, 72.4%)
sourced their PrEP through a government primary healthcare centre.
AHI Risk Checker and laboratory test results
Figure 3 summarises the AHI screening cascade. All 1879 participants completed the AHI
Risk Checker, within a median of 6.3 minutes (IQR5.0-8.4). The median AHI risk score was
1 (IQR1-2; range 0-7), comprising 906 (48.2%) reporting three or more sex partners, 585
(31.1%) condomless receptive anal sex, 443 (23.6%) STI or STI symptoms (each in the past
six months), 391 (20.8%) fever, 212 (11.3%) oral thrush, 92 (4.9%) weight loss, and 91
(4.8%) enlarged lymph nodes (Table 2).
Of 1879 participants, 1866 (99.3%) underwent an HIV-antigen/antibody screen test. Of 1866
participants tested, 113 (6.1% [113/1866]) had recent/chronic HIV infection (antibody-
positive) and 1753 who tested negative or inconclusive. Of those, 1748 (99.7%) underwent
an Xpert HIV-PCR test, of whom 6 (0.34% [6/1748]) had acute HIV (Xpert HIV-PCR-positive,
antibody-negative; none were antibody-discordant or early HIV). The number needed to test
to detect one case was 17 (1866/113) for recent/chronic HIV infection and 291 (1748/6) for
AHI overall, and, among MSM, 10 (940/97) and 169 (842/5), respectively. Xpert HIV-PCR
testing led to a 5.3% (95%CI 1.9-11.2; 119/113) increase in confirmed HIV diagnoses
overall, and, among MSM, 5.2% (95%CI 1.7-11.6; 102/97). HIV prevalence was 6.4%
(95%CI 5.3-7.6; 119/1866) overall and, among MSM, 10.8% (95%CI 8.9-13.0; 102/940), and
6.2% (95%CI 5.0-7.5; 96/1551) in Jakarta and 7.3% (95%CI 4.7-10.7; 23/315) in Bali. AHI
prevalence was 0.34% (95%CI 0.12-0.74; 6/1748) overall, and 0.53% (95%CI 0.17-1.2;
5/940) among MSM.
All six participants with AHI were below 30 years of age, five were MSM and one did not
disclose their HIV risk category (Table S5). The median AHI risk score was 2 (IQR 1-3;
range 0-6), which was statistically significantly higher than those who tested HIV-negative (1,
IQR1-2; range 0-7; p<0.001), and comprised 4 (66.7%) individuals reporting condomless
receptive anal sex, 4 (66.7%) fever, 2 (33.3%) three or more sexual partners, and 1 (16.7%)
each an STI history, oral thrush or weight loss (Table 2). Assisted partner notification was
only accepted by one participant with AHI, who notified three sexual partners.
Linkage to care and ART initiation
The total time from starting AHI screening to receiving the test results was a median of 2.0
hours (IQR 1.2-2.9) for HIV-antigen/antibody testing, 2.9 (IQR 2.5-3.7) hours for individual
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Xpert HIV-PCR, and 5.4 hours (IQR 3.4-8.5) for pooled Xpert HIV-PCR (p<0.001). Overall,
90.1% (1590/1748) of participants received their Xpert HIV-PCR result on the same day,
96.2% (1681/1748) within 24 hours, and 99.3% (1736/1748) within 72 hours (Figure 4).
Of the 119 individuals newly diagnosed with HIV (including 6 with AHI), 113 (95.0%) were
linked to care and started ART, of whom 92 in the same clinic and 21 in another clinic; 75
(66.4%) started ART on the same day and 104 (92.0%) within one week (median 0 days,
range 0-93), whereas 9 (8.0%) deferred ART because of a concurrent opportunistic infection
(3) or referral elsewhere (6) (Figure 2). Six of the newly HIV-diagnosed individuals (including
3 with AHI) did not return to the clinic and were lost to follow-up.
CONCLUSIONS
This cross-sectional analysis among MSM and other key populations attending sexual health
clinics in Bali and Jakarta, Indonesia, has demonstrated that implementing an AHI risk score
assessment and HIV-PCR-based AHI screening was feasible, and that AHI was highly
prevalent among young urban MSM at 0.53% (95%CI 0.17-1.2). Improved identification of
individuals with AHI, who are most likely to transmit HIV and would have been missed by
standard HIV-antibody testing, provides augmented opportunities for same-day ART
initiation and behavioural interventions (14). Nonetheless, the study experienced challenges
in the uptake and acceptability of the AHI screening and partner notification, as well as the
retention in care of the participants diagnosed with AHI –although it is possible that some of
these individuals linked to care elsewhere without our knowledge. To improve uptake and
retention, we have provided specific training to clinical staff on motivational counselling and
we launched a tailored digital community engagement tool (www.cekupyuk.id). Further
research is needed to determine the yield of the intervention, mitigate any context-specific
implementation barriers, and assess the potential for population impact and cost-
effectiveness in the Indonesian context. This information is needed to determine whether
AHI screening could be a sensible strategy for wider programmatic implementation. The
INTERACT study provides a unique platform to enable future immuno-virological, social
science, and intervention studies in Indonesia.
Data availability statement The INTERACT Study Group welcome feedback and ideas,
including proposals for collaboration on data analyses, new research, or knowledge
translation and exchange activities. Requests for data sharing can be made by submission
of a study concept to the INTERACT Study Group for evaluation of the scientific value,
relevance, design, feasibility, and overlap with existing projects. For more information,
. CC-BY-NC-ND 4.0 International licenseIt is made available under a
is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted June 6, 2024. ; https://doi.org/10.1101/2024.06.06.24307250doi: medRxiv preprint
13
please contact the principal investigators: I (irwanto@atmajaya.ac.id), KG
(k.gedela@nhs.net) or RLH (rhamers@oucru.org).
Ethics approval Ethical approval was obtained from the Catholic University of Atma Jaya
research ethics committee (0009R/III/PPPE.PM.10.05/10/2022) and the Oxford Tropical
Research Ethics Committee (565-22).
Funding declaration This research is jointly funded by the UK Medical Research Council
(MRC) and the Foreign Commonwealth and Development Office (FCDO) under the
MRC/FCDO Concordat agreement (grant no. MR/V035304/1). RLH is supported by the
Wellcome Africa Asia Programme Vietnam (106680/Z/14/Z).
Contributors I is the principal investigator, and KG and RLH are the co-principal
investigators. I, MD, SW, KG and RLH conceptualised the study. I, N, HL, PPJ, FSW, MD,
EJS, KG and RLH designed the study protocol. N, HL, S, DR, MO established the cohort
and collected the study data and samples. S supervised the laboratory assays. N, HL, MO,
DPR managed the clinical database and contributed to data verification. DPR performed the
statistical analyses and data visualisations, under supervision of RLH. DPR, RLH and KG
drafted the manuscript with critical contributions from I, PPJ, MD, EJS, and FSW. DPR and
RLH had full access to all of the study data and take responsibility for the integrity of the
data and the accuracy of the data analysis. All authors provided valuable input to
interpretation of the data and critically reviewed the paper and figures for important
intellectual content. All authors reviewed and approved the final version of the manuscript.
Competing interests None declared
Acknowledgments The INTERACT research team would like to acknowledge the
contribution of all the participants, the clinic staff at the Globalindo and Bali Peduli clinics, the
study support staff at OUCRU Indonesia, and our community partners at Yayasan Inti Muda,
Yayasan Gaya Dewata, Yayasan Inter Medika and Yayasan Kasih Suwitno.
Indonesia Intervention Study to Test & Treat People with Acute HIV Infection
(INTERACT) Study Group:
Prof Irwanto (PI), Ignatius Praptoraharjo, Arie Rahadi, Evi Sukmaningrum (Atma Jaya
Catholic University, Jakarta)
Suwarti, Decy Subekti, Bachtiar Andy Mussafa, Nicolas Tarino, Mutia Rahardjani, Fitri Dewi,
Soraya Weldina Ragil Dien, Margaret Oktavia, Dwi Rahmawati, Raph Hamers (co-PI)
. CC-BY-NC-ND 4.0 International licenseIt is made available under a
is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted June 6, 2024. ; https://doi.org/10.1101/2024.06.06.24307250doi: medRxiv preprint
14
(Oxford University Clinical Research Unit Indonesia, Jakarta)
Keerti Gedela (co-PI) (56 Dean Street, Chelsea & Westminster Hospital, Imperial College
London, UK)
Prof Pande Putu Januraga (Centre for Public Health Innovation, Udayana University, Bali)
Prof Evy Yunihastuti (Dept of Internal Medicine, Dr Cipto Mangukusumo Hospital, Faculty of
Medicine, Universitas Indonesia, Jakarta)
Nurhayati Agus, F. Stephen Wignall (Yayasan Globalindo, Jakarta)
Hendry Luis, F. Stephen Wignall (Yayasan Bali Peduli, Bali)
Godelieve de Bree, Maartje Dijkstra (Amsterdam UMC, location AMC, University of
Amsterdam, Amsterdam, The Netherlands)
Prof Eduard Sanders (The Aurum Institute, Johannesburg, South Africa; and University of
Oxford, Sir William Dunn School of Pathology, Oxford, UK)
Sayem Ahmed (University of Glasgow, Glasgow, UK)
Prof Christophe Fraser, Katrina Lythgoe (Big Data Institute, University of Oxford, Oxford,
UK)
ORCID IDs:
Irwanto 0000-0002-1298-8744
Nurhayati H. Kawi 0000-0002-8018-0528
Hendry Luis 0000-0002-1669-5818
Pande Putu Januraga 0000-0002-2926-0856
Suwarti 0000-0002-4726-7998
Dwi P. Rahmawati 0000-0001-7618-4537
Evi Sukmaningrum 0000-0001-8885-7823
Evy Yanihastuti 0000-0001-6650-0559
Maartje Dijkstra 0000-0003-2561-7659
Eduard J. Sanders 0000-0002-1062-8921
Frank Stephen Wignall 0000-0003-4942-1626
Keerti Gedela 0000-0002-5797-8216
Raph L. Hamers 0000-0002-5007-7896
. CC-BY-NC-ND 4.0 International licenseIt is made available under a
is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted June 6, 2024. ; https://doi.org/10.1101/2024.06.06.24307250doi: medRxiv preprint
15
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Table 1. Participant characteristics at enrolment
Variable
Individuals
screened for
study eligibility
N=1946
Participants
enrolled in
the study
N=1879
P-value1
Participants
who tested
HIV-negative
N=1747
Participants
who tested
HIV-positive
N=119
P-value2
Age (years)
Median (IQR) 27 (24-31) 27 (24-31) 0.900 27 (24-31) 27 (24-30) >0.999
16-19 89 (4.6%) 87 (4.6%)
0.999
573 (32.8%) 5 (4.2%)
0.942
20-24 635 (32.6%) 617 (32.8%) 506 (28.9%) 41 (34.5%)
25-29 573 (29.4%) 548 (29.2%) 369 (21.2%) 37 (31.1%)
30-34 407 (20.9%) 395 (21%) 217 (12.4%) 22 (18.5%)
≥
35 242 (12.4%) 232 (12.3%) 82 (4.7%) 14 (11.8%)
Sex at birth
Male 1509 (77.5%) 1457 (77.5%)
>0.999 1331 (76.2%) 115 (96.6%) <0.001
Female 437 (22.5%) 422 (22.5%) 416 (23.8%) 4 (3.4%)
Gender identity
3
Male 1416 (75.4%) 1416 (75.4%)
<0.001
1294 (74.0%) 111 (93.4%)
<0.001
Female 439 (23.4%) 439 (23.4%) 431 (24.7%) 6 (5.0%)
Transgender 15 (0.8%) 15 (0.8%) 14 (0.8%) 1 (0.8%)
Other
4
9 (0.5%) 9 (0.5%) 8 (0.5%) 1 (0.8%)
Clinic visit status
First-time 966 (49.6%) 925 (49.2%)
0.824 834 (47.8%) 85 (71.4%) <0.001
Returning 980 (50.4%) 954 (50.8%) 913 (52.2%) 34 (28.6%)
Education level
Higher education/University 1381 (71.0%) 1335 (71.0%)
0.962
1251 (71.6%) 76 (63.9%)
0.091
High school completed 507 (26.0%) 487 (25.9%) 449 (25.7%) 36 (30.3%)
Middle school completed 41 (2.1%) 41 (2.3%) 35 (2.0%) 6 (5.0%)
Primary school completed 6 (0.3%) 6 (0.3%) 5 (0.3%) 1 (0.8%)
Primary school incomplete 1 (0.1%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
Not provided 10 (0.5%) 10 (0.5%) 7 (0.4%) 0 (0.0%)
Current occupation
Employed 1645 (84.5%) 1588 (84.5%)
0.999
1487 (85.1%) 92 (77.3%)
0.077
Student 228 (11.7%) 220 (11.7%) 201 (11.5%) 19 (16.0%)
Unemployed 57 (3.0%) 55 (2.9%) 47 (2.7%) 7 (5.9%)
Unspecified 16 (0.8%) 16 (0.9%) 12 (0.7%) 1 (0.8%)
Location
Jakarta 1621 (83.3%) 1559 (83.0%)
0.958 1455 (83.3%) 96 (80.7%) 0.339 Denpasar, Bali 248 (12.7%) 243 (12.9%) 223 (12.7%) 15 (12.6%)
Ubud, Bali 77 (4.0%) 77 (4.1%) 69 (4.0%) 8 (6.7%)
Key population
5
Men who have sex with men 959 (49.3%) 947 (50.4%)
<0.001
838 (48%) 102 (85.7%)
<0.001
Sex worker clients 382 (19.6%) 378 (20.1%) 361 (20.7%) 15 (12.6%)
Sexual partner living with HIV 144 (7.4%) 143 (7.6%) 131 (7.5%) 12 (10.1%)
Sex workers 98 (5.0%) 97 (5.2%) 90 (5.2%) 5 (4.2%)
Transgender women 15 (0.8%) 15 (0.8%) 14 (0.8%) 1 (0.8%)
Persons who inject drugs 6 (0.3%) 6 (0.3%) 6 (0.3%) 0 (0.0%)
Undisclosed risk category 296 (15.2%) 296 (15.8%) 291 (16.7%) 4 (3.4%)
Previous negative HIV test
Ever 1003 (51.5%) 1003 (53.4%)
<0.001 970 (55.5%) 32 (26.9%) <0.001
In the past 6 months 444 (44.3%) 444 (44.3%) 438 (45.2%) 6 (18.8%)
Reason for current HIV
testing5
Feeling at risk - 1156 (61.5%)
<0.001
1056 (60.7%) 85 (71.4%)
<0.001
Having symptoms - 456 (24.3%) 433 (24.9%) 22 (18.5%)
Retest (window period) - 261 (13.9%) 226 (13.0%) 32 (26.9%)
New sexual relationship - 252 (13.4%) 246 (14.1%) 6 (5.0%)
Unspecified - 225 (3.6%) 216 (12.4%) 6 (5.0%)
Getting married - 132 (7.0%) 126 (7.2%) 5 (4.2%)
Partner tested HIV positive - 77 (4.1%) 68 (3.9%) 9 (7.6%)
Partner has STI - 29 (1.5%) 26 (1.5%) 3 (2.5%)
Pregnant or partner pregnant - 7 (0.4%) 7 (0.4%) 0 (0.0%)
Table shows baseline characteristics of those screened and enrolled at Globalindo Jakarta (May 12-December 31,
2023); Bali Peduli Ubud (May 30-December 31, 2023); and Bali Peduli Denpasar (May 31-December 31, 2023)
1 Comparison of individuals screened versus enrolled (Chi2, Kruskall Wallis-H test, and Dunn’s pairwise comparison)
2 Comparison of participants who tested HIV negative versus positive (Chi2, Kruskall Wallis-H test and Dunn’s
pairwise comparison)
3 Gender identity was not recorded for ineligible individuals
4 Includes individuals who identified as non-binary or gender-fluid
5 Individuals could choose more than one category
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Table 2. Sexual practices and other AHI risk factors among participants at enrolment
Variable All study
participants
N=1879
Participants
who tested
HIV-negative
N=1747 1
Participants
who tested
HIV-positive
N=119 2
P value 3
Participants
who tested
AHI-positive
N=6
P value 4
AHI risk score assessment
5
AHI risk score (median, IQR)) 1 (1-2) 1(1-2) 2(1-3) 0.323 2 (1-3) <0.001
Three or more sexual partners in the past 6 months 906 (48.2%) 844 (48.3%) 58 (48.7%) 0.866 2 (33.3%) 0.688
Condomless receptive anal sex in the past 6 months 585 (31.1%) 502 (28.7%) 77 (64.7%) <0.001 4 (66.7%) 0.062
STI and/or STI symptoms in the past 6 months 443 (23.6%) 418 (23.9%) 22 (18.5%) 0.173 1 (16.7%) >0.999
Fever in the past 2 weeks 391 (20.8%) 336 (19.2%) 52 (43.7%) <0.001 4 (66.7%) 0.015
Oral thrush in the past 2 weeks 212 (11.3%) 192 (11.0%) 20 (16.8%) 0.113 1 (16.7%) 0.504
Weight loss in the past 2 weeks 92 (4.9%) 69 (3.9%) 23 (19.3%) <0.001 1 (16.7%) 0.217
Lymph nodes in the past 2 weeks 91 (4.8%) 76 (4.4%) 14 (11.8%) <0.001 0 (0.0%) >0.999
Number of sex partners in the past 6 months (median, IQR) 2 (1-5) 2 (1-5) 2 (1-5) >0.999 2 (2-4) >0.999
Anal sex in the past 3 months 884 (47.0%) 784 (44.9%) 93 (78.2%) <0.001 6 (100.0%) 0.022
Receptive/bottom 306 (34.6%) 262 (33.4%) 41 (44.1%) <0.001 3 (50.0%) 0.009
Insertive/top 316 (35.8%) 299 (38.2%) 16 (17.2%) 2 (33.3%)
Both insertive/top and receptive/bottom 262 (29.6%) 223 (28.4%) 36 (38.7%) 1 (16.7%)
Ever injected drug use 6 (0.3%) 6 (0.3%) 0 (0.0%) 0.690 0 (0.0%) >0.999
Recreational drug use before or during sex in the past 3 months
6
33 (1.8%) 28 (1.6%) 5 (4.2%) 0.079 1 (16.7%) 0.095
Group sex in the past 3 months 106 (5.6%) 98 (5.6%) 8 (6.7%) 0.758 0 (0.0%) >0.999
Visited sex party in the past 3 months 41 (2.2%) 40 (2.3%) 1 (0.8%) 0.344 0 (0.0%) >0.999
PrEP
Ever used PrEP
7
156 (8.3%) 150 (8.6%) 5 (4.2%) 0.209 1 (100.0%) 0.418
More than a month ago 93 (59.6%) 89 (59.3%) 4 (80.0%) 1 (100.0%)
Less than a month ago 63 (40.4%) 61 (40.7%) 1 (20.0%) 0 (0.0%)
PrEP regimen used
Event-driven dosing 80 (51.3%) 70 (46.7%) 3 (60.0%) 0.161 1 (100.0%) 0.243
Daily dosing 76 (48.7%) 80 (53.3%) 2 (40.0%) 0 (0.0%)
Table summarizes the distribution of behavioural risk factors for HIV acquisition in the study population, stratified by those who tested HIV negative versus positive (including
AHI), and those who tested HIV positive versus AHI positive
1 13 of 1879 (0.7%) participants did not receive an HIV-antigen/antibody test
2 Comprises 113 individuals with chronic HIV (antibody positive) and 6 individuals with acute HIV (Xpert HIV-PCR-positive, antibody-negative)
3 Comparison of participants who tested HIV negative versus positive (Chi2 and Kruskall Wallis-H)
4 Comparison of participants who tested HIV-negative versus AHI-positive (Chi2 or Fischer exact and Kruskall Wallis-H)
5 Modified Amsterdam AHI risk score (reference 37)
6 Types of drugs used included poppers (30, 90.9%), GHB and canabis/marijuana (each 3, 9.1%), crystal meth (2, 6.1%), benzodiazepines and ecstasy/MDMA (each 1, 3.0%)
7 Mode of PrEP access included primary health centre (113, 72.4%), private clinic (29, 18.6%), ordered online (5, 3.2%), hospital (3, 1.9%), other (6, 3.8%)
Abbreviations: AHI, acute HIV infection; PrEP, pre-exposure prophylaxis for HIV
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is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted June 6, 2024. ; https://doi.org/10.1101/2024.06.06.24307250doi: medRxiv preprint
Figure 1. Study design overview
Figure shows an overview of the study design and procedures. After the first AHI Screening Visit at study enrolment, participants (who tested AHI-negative) are invited to
regular AHI Screen Visits every 3 months, or earlier if they perceive any AHI risk and/or symptoms. Successive AHI screen visits are denoted as S1, S2, S3, etc.
Participants who are newly diagnosed with HIV are followed up at HIV Baseline (T0) and Follow-Up Visits (T3 and T6 months).
Abbreviations: AHI, acute HIV infection; ART, antiretroviral therapy
S1 S2 S3 S4
Sx
AHI Screen Visits
AHI testing of HIV negative
participants
HIV Baseline and Follow-up Visits
Management of newly HIV diagnosed
participants
Enrolment visit:
Participant Information Sheet
Study Eligibility Screening
Digital consent
Maturity assessment (age 16-17 yrs)
Baseline visit:
Assisted partner notification
Informed consent substudy
Same-day ART start
First and subsequent AHI screen visits:
AHI Risk Checker
Xpert HIV-PCR testing (individual or pooled)
REDCap data capture
T0 T3 T6
Baseline and FU visits for ART monitoring:
Xpert HIV-1 Viral Load testing
REDCap data capture
Sample storage (substudy)
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is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted June 6, 2024. ; https://doi.org/10.1101/2024.06.06.24307250doi: medRxiv preprint
Figure 2. Study flow for the first AHI screen visit (study enrolment)
Figure shows data for the first eight months of study enrolment (May-December 2023).
Abbreviations: ART, antiretroviral therapy; AHI, acute HIV infection
6 lost to follow-up
5262 total HIV tests among clinic attendees
1866 participants underwent
Xpert HIVPCR testing
1946 individuals screened for study eligibility
1879 participants enrolled in study
119 participants newly HIV diagnosed
108 chronic HIV
5 recent HIV
6 acute HIV
113 participants linked to care and started ART
75 on same day
104 within 1 week
9 later than 1 week
13 participants ended study
6 time constraint
4 already known to be living with HIV
2 fear of blood draw
1 unable to obtain a blood sample
67 individuals did not meet eligibility criteria
48 no HIV risk factor reported
13 no informed consent
6 already known to be living with HIV
1747 participants tested HIV negative
1879 participants completed AHI Risk Checker
3316 individuals not screened for study
3022 declined
2245 reason not specified
235 wants standard HIV test only
223 time constraint
180 not interested
139 other
294 not offered
141 research staff not available
99 outside of lab service hours
54 other
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is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted June 6, 2024. ; https://doi.org/10.1101/2024.06.06.24307250doi: medRxiv preprint
Figure 3. AHI screening cascade
Figure shows data for the first eight months of study enrolment (May-December 2023), including clinic attendees
at the three clinics combined. AHI screening comprises the AHI Risk Checker followed by a laboratory test
algorithm of HIV-antigen/antibody and Xpert HIV-PCR (see Figure S2 for further details). Among all clinic
attendees who came for a standard HIV test (n=5262), 1946 (37%) were screened for study eligibility, translating
into a current “AHI screening gap” of 63%. Among those not screened for study eligibility, 3020 declined (most
without providing a reason), and 294 individuals were not offered study eligibility screening (mainly because
research staff were not available or the client came outside of laboratory service hours). See Table S6 for further
details.
“AHI screening gap”
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is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted June 6, 2024. ; https://doi.org/10.1101/2024.06.06.24307250doi: medRxiv preprint
Figure 4. Time to receive HIV-PCR test result
Bart chart showing the proportion of participants who received the Xpert HIV-PCR test result on the same day,
within 24 hours, within 72 hours and within 1 week. The bars represent overall data (N=1748) and divided
between individual (N=995) and pooled HIV-PCR tests (N=753).
Note: 1 participant tested with an Individual Xpert HIV-PCR (Qual) received the result >1 week, and 2 participants
with Individual Xpert HIV-PCR (Qual) have not returned to the clinic to receive their results (all tested HIV-
negative).
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is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted June 6, 2024. ; https://doi.org/10.1101/2024.06.06.24307250doi: medRxiv preprint
