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 Utara||Kota Medan||Intervention|
|Kabupaten Deli Serdang||Intervention|
|Sumatera Selatan||Kota Palembang||Intervention|
|Lampung||Kota Bandar Lampung||Control|
|Banten||Kota Tangerang Selatan||Intervention|
|DKI Jakarta||Kota Jakarta Selatan||Control|
|Kota Jakarta Timur||Intervention|
|Kota Jakarta Pusat||Intervention|
|Kota Jakarta Barat||Intervention|
|Kota Jakarta Utara||Control|
|Jawa Barat||Kabupaten Bogor||Intervention|
|Jawa Tengah||Kota Semarang||Control|
|Jawa Timur||Kota Malang||Intervention|
|Sulawesi Selatan||Kota Makassar||Control|
|Papua Barat||Kota Sorong||Intervention|
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 Recorded||Intervention 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 recommended||Yes||No||Yes|
|Numbers of FSW offered for HIV test at health facility||Yes||No||Yes|
|Numbers agreeing and disagreeing to testing at a health facility||Yes||No||Yes|
|Of those agreeing to getting tested at a health facility, the numbers that actually went to a health facility and were tested for HIV||Yes||No||Yes|
|Number of FSW accessing website independently||No||Yes||No|
|Number of FSW offered for OFT screening||Yes||No||No|
|Number of FSW eligible for CBS||Yes||Yes||No|
|Number of FSW receiving HIVST||Yes||Yes||No|
|Number of eligible FSW receiving blood test||Yes||No||No|
|Number of FSW screened||Yes||Yes||No|
|Number of reactive HIVST||Yes||Yes||No|
|Number of confirmatory tests among FSW with reactive HIVST results||Yes||Yes||No|
|Number of FSW initiating ART||Yes||Yes||Yes|
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:
|HIV case finding||Proportion of those tested positive|
|HIV testing uptake||Proportion of those who receive both OFT and facility-based HIV testing|
|Facility-based HIV testing uptake||Proportion of those who receive facility-based HIV testing, including post-OFT confirmatory tests|
|ARV initiation||Proportion of those confirmed positive who initiate ARV|
|Characteristics (baseline survey)||Demographics||Age, education, marital status, place of recruitment|
|Sexual behavior||Age of first sexual transaction, condom use, number of clients in the past 7 days, stable partner|
|History of HIV test||Ever 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 infections||History of discomfort during sex or around genitalia, ever diagnosed with STI by a doctor within the past six months|
|Client base||Internet or social media, lokalisasi, karaoke, bar, massage parlor, friends, etc.|
|Knowledge of OFT||Prior knowledge of OFT and perception of OFT promotion|
|Stigma score||Adapted from stigma scale|
|Perception on OFT (only for FSW receiving OFT)||Clarity of OFT information||Scale of 1-5, 1 being very unclear and 5 being very clear|
|Peer or OW assistance||Yes/No|
|Difficulty of use||Scale of 1-5, 1 being very difficult and 5 being very easy|
|Difficulty of interpreting results||Scale 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 testing||Scale of 1-5, 1 being very unpleasant and 5 being very pleasant|
|Certainty of result||Scale of 1-5, 1 being very uncertain and 5 being very certain|
|OFT result||Positive, negative, or indeterminate|
|Desire to confirm OFT result||Scale of 1-5, 1 being very weak desire and 5 being very strong desire|
|Desire to recommend OFT testing to peers||Scale 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 testing||Multiple answers with free-text option|
|Suggestions for OFT||Multiple answers with free-text option|
|Comments to improve study procedure||Multiple answers with free-text option|
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