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Protocol Community HIV Self Testing

Study protocol for Tes Mandiri Berbasis Komunitas (Teman Kita) randomized community trial among female sex workers in Indonesia


Indonesia is among one of the few countries which has continued rise in annual HIV infections in recent years (Ministry of Health, 2017). Although overall HIV prevalence is projected to decline between 2019 and 2024, the number of AIDS-related death is projected to increase (Ministry of Health of the Republic of Indonesia, 2020).

The HIV epidemic in Indonesia is concentrated among key population groups, especially female sex workers (FSW). FSWs have also become harder to reach, as many commercial sex transactions have become hidden, especially as digital platforms gain popularity to facilitate transactions.

In 2019 it is estimated that there were 277,624 FSWs throughout Indonesia receiving around 4,688,216 clients annually (Ministry of Health of the Republic of Indonesia, 2020). This mode of transmission continues to their clients’ other sexual partners and their babies. Lowering HIV transmission between FSW and clients will lower subsequent transmissions. In order to increase the number ART coverage, more PLHIVs need to know their status. Given the increasingly challenging landscape in Indonesia’s sex work, a new demand to identify alternative strategies for increasing HIV testing uptake among FSW (Cantelmo, Soehoed, Lee, & Ross, 2019).

The latest WHO guidelines highlighted community-based testing through HIV self-testing (HIVST) as a tool to identify more people with undiagnosed HIV and at high risk of HIV infection. Privacy, confidentiality, and elimination of stigma are some of the advantages offered by this method in removing barriers to service access. UNAIDS (2014) also suggested that HIVST, including oral fluid test (OFT) kits has a potential to increase access to HIV testing especially among PLHIV who do not yet know their status, including key population groups.

Few studies on HIVST that are specifically designed to reach or include female sex workers have been performed. Studies in Malawi and Zimbabwe (Napierala et al., 2019), Vietnam  (Nguyen et al., 2019), Uganda (Ortblad et al., 2018), Botswana (Shava et al., 2020), and Zambia (Chanda et al., 2017) have indicated HIVST as a highly accepted strategy.


To date, the OFT strategy has not been employed to increase testing among FSW in Indonesia, a key population group that have become increasingly hidden due to persistent police harassment (Fielding, McCallum, Sebayang, Burrows, & Parsons, 2018). For this reason, this randomized community trial, from here on referred as CBS, aims to examine if shifting screening to the community setting using non-invasive OFT HIVST can increase the number of FSW who know their HIV status, and subsequently increase treatment uptake for those who test positive.  Furthermore, the acceptability and potential differences between assisted and unassisted testing can also be evaluated, as was observed in Nguyen et al’s (2019) study where case finding was lower among participants lay-provider testing as opposed to self-testing.


Study Design and procedures

The study consists of an intervention and control arm. Districts that were randomized into the control arm implements the standard of care (SOC) whereby the implementing units (IU) are responsible for reaching FSWs once a year. The SOC outreach packets include educational media on HIV and AIDS, condoms and lubricants, as well as encourage FSWs to receive HIV tests at healthcare facilities or through mobile VCT. Each IU was given a target number of HIV tests that renews every six months. FSWs with positive test results were also referred to initial ART. For the intervention arm, in addition to SOC, the FSWs who refuse to undergo facility-based HIV blood test were given the additional option to undergo OFT. Should their OFT result be reactive or indeterminate, participants were then referred for confirmatory testing through facility-based HIV testing.

The initial study protocol which was developed prior to the COVID-19 outbreak, utilized in-person outreach, OW trainings, as well as in-person monitoring to study sites. However, in light of the spread of COVID-19 and impacts from PSBB policies across Indonesia, most activities within the study protocol were shifted to be performed virtually, including outreach to FSW. In conjunction with the study protocol, a manual of operating procedure (MoOP) outlines operational components within the study was compiled through stakeholder consultation. The MoOP was also modified accordingly to maintain the integrity of the study protocol within the evolving situation.

Initiation of the study was planned to commence simultaneously throughout all districts in April 2020. However, due to staggered dates of virtual OW training, the initiation of the study staggered through the 15 intervention districts from April 2020 – May 2020, while data collection in the 8 control districts commence in April 2020. Data collection was set to take place until October 31, 2020 or until the OFT kit supplies have been exhausted.


This trial is implemented in 23 priority districts across Indonesia using stratified randomization.  First, sampling strata were created by sorting from largest to smallest the mean average value of achieved HIV testing target per semester from 2018-2019 in each district. The 23 districts were then sorted into seven groups of three districts and one group two districts. Randomization for intervention and comparison group was performed with 2:1 ratio (2 intervention: 1 comparison) as presented in table below:

Sumatera UtaraKota MedanIntervention
Kabupaten Deli SerdangIntervention
Sumatera SelatanKota PalembangIntervention
LampungKota Bandar LampungControl
BantenKota Tangerang SelatanIntervention
Kabupaten TangerangIntervention
DKI JakartaKota Jakarta SelatanControl
Kota Jakarta TimurIntervention
Kota Jakarta PusatIntervention
Kota Jakarta BaratIntervention
Kota Jakarta UtaraControl
Jawa BaratKabupaten BogorIntervention
Kota BekasiControl
Kota BandungControl
Kota DepokIntervention
Jawa TengahKota SemarangControl
Kota SurakartaIntervention
Jawa TimurKota MalangIntervention
Kota SurabayaIntervention
BaliKota DenpasarIntervention
Sulawesi SelatanKota MakassarControl
Papua BaratKota SorongIntervention
PapuaKota JayapuraControl


Eligible participants fulfill the following characteristics:

  • Female aged 18 and above
  • Has had sex (vaginal, anal, or oral) at least once within the last month with reward (gifts, money, items, etc)
  • At least six months since the last HIV test
  • Is not currently planning or receiving HIV-related care at a health service
  • Reports being HIV negative or not knowing their HIV status
  • Is not currently participating in another HIV-related study
  • Agrees to participate in the study


Participants were recruited via outreach workers (OW) and social media platforms. Those recruited through OWs and eligible were offered blood testing again after signing the informed consent. Conversely, FSWs who were recruited independently through social media are only given the option of OFT. Both those who are recruited through OW and through social media will be given the option of performing OFT unassisted or with assistance by an OW. FSW reached through OW will receive their OFT kits from the OWs while those who registered independently will receive their kits through courier services (unassisted) or OWs (assisted). Baseline surveys will be performed for all participants regardless of choice of testing, and post-test surveys will be performed only for OFT testers.

Participants with an indeterminate or reactive OFT result will be encouraged to access health services for their confirmatory blood test and proceed to initiate ARV if the confirmatory test is be reactive. Subsequently, participants whose data have been verified will be compensated for their time according to the data completed and uploaded to the website. OWs will also be compensated for their involvement in facilitating testing for each eligible FSW.


In order to detect a 10 percentage point difference in the rate of facility-based HIV testing between FSWs in the intervention and comparison districts, achieve 95% certainty that a difference of that magnitude would not have occurred by chance, and 90% certainty of detecting a difference of this magnitude if the difference was real/”the truth”.

The required sample size is n ≥ 635 per arm but increased to n≥ 761 to allow for 20% loss to follow up. Hence, in the intervention arm, 761 participants choosing OFT in the control arm, 761 participants attending facility-based HIV testing must be recruited. Subsequently, to assess whether “assisted” or “unassisted” OFT resulted in a larger increase in the rate of facility-based HIV testing, a sample size of n ≥ 761 each receiving assisted and unassisted OFT is necessary, a total of n ≥ 1,522 participants in the intervention districts and n ≥ 761 participants in the control districts are required.


Data was entered and stored in web-based system, which can also be downloaded as Excel spreadsheets by principal investigators and research staff for analysis purposes. A cascade was compiled based on table below to monitor data collection progress and aid the analysis process.

Data RecordedIntervention Group Control Group
Number of FSW contacted via outreach that were at least 6 months since their last HIV test for whom testing at a health facility was recommendedYesNoYes
Numbers of FSW offered for HIV test at health facilityYesNoYes
Numbers agreeing and disagreeing to testing at a health facilityYesNoYes
Of those agreeing to getting tested at a health facility, the numbers that actually went to a health facility and were tested for HIVYesNoYes
Number of FSW accessing website independentlyNoYesNo
Number of FSW offered for OFT screeningYesNoNo
Number of FSW eligible for CBSYesYesNo
Number of FSW receiving HIVSTYesYesNo
Number of eligible FSW receiving blood testYesNoNo
Number of FSW screenedYesYesNo
Number of reactive HIVSTYesYesNo
Number of confirmatory tests among FSW with reactive HIVST resultsYesYesNo
Number of FSW initiating ARTYesYesYes


To measure the differences between control and intervention districts, two proportion t-tests will be performed to compare proportions of data collected in previous table to generate outcome measures as presented in table below:

Primary Outcomes Description
HIV case findingProportion of those tested positive
HIV testing uptakeProportion of those who receive both OFT and facility-based HIV testing
Facility-based HIV testing uptakeProportion of those who receive facility-based HIV testing, including post-OFT confirmatory tests
ARV initiationProportion of those confirmed positive who initiate ARV
Secondary Outcomes Description
Characteristics (baseline survey)DemographicsAge, education, marital status, place of recruitment
Sexual behaviorAge of first sexual transaction, condom use, number of clients in the past 7 days, stable partner
History of HIV testEver undergone HIV testing, last HIV testing, ever offered HIV testing within the past year, whether or not accepted HIV testing, reason for not accepting HIV testing
History of sexually transmissible infectionsHistory of discomfort during sex or around genitalia, ever diagnosed with STI by a doctor within the past six months
Client baseInternet or social media, lokalisasi, karaoke, bar, massage parlor, friends, etc.
Knowledge of OFTPrior knowledge of OFT and perception of OFT promotion
Stigma scoreAdapted from stigma scale
Perception on OFT (only for FSW receiving OFT)Clarity of OFT informationScale of 1-5, 1 being very unclear and 5 being very clear
Peer or OW assistanceYes/No
Difficulty of useScale of 1-5, 1 being very difficult and 5 being very easy
Difficulty of interpreting resultsScale of 1-5, 1 being very difficult and 5 being very easy
Perceived support (only for assisted OFT)Scale of 1-5, 1 being very unsupportive and 5 being very supportive
Willingness to receive routine testing after OFT (only for negative OFT)Scale of 1-5, 1 being very unwilling and 5 being very willing
Experience of testingScale of 1-5, 1 being very unpleasant and 5 being very pleasant
Certainty of resultScale of 1-5, 1 being very uncertain and 5 being very certain
OFT resultPositive, negative, or indeterminate
Desire to confirm OFT resultScale of 1-5, 1 being very weak desire and 5 being very strong desire
Desire to recommend OFT testing to peersScale of 1-5, 1 being very weak desire and 5 being very strong desire
Reason for lack of or wear desire to receive facility-based testingMultiple answers with free-text option
Suggestions for OFTMultiple answers with free-text option
Comments to improve study procedureMultiple answers with free-text option

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