Randomized Community Trial Community Based Screening for HIV Self Testing in Female Sex Workers in 23 Priority Districts in Indonesia (CBS HIVST in FSW)
Phase: NA
Conditions: Human Immunodeficiency Virus (HIV)
Sponsor: Kerti Praja Foundation

 
CBS Protocol Final Version 31 January 2020 
 
1
Study Protocol  
Randomized Community Trial  
Community Based Screening for HIV Self Testing in  
Female Sex Workers in 23 Priority Districts in Indonesia 
(CBS HIVST in FSW) 
Protocol final version: 31th of January 2020 
 
 
 
 
 
 
 
 
 
 
 
 
Developed by: 
Kerti Praja Foundation (Yayasan Kerti Praja) 
Denpasar, Bali, Indonesia 
Supported by: 
United Nations Population Fund 
Jakarta, Indonesia 
 
 
 
 

 
CBS Protocol Final Version 31 January 2020 
 
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Study Title 
Randomized Community Trial Community Based Screening for HIV 
Self Testing in Female Sex Workers in 23 Priority Districts in 
Indonesia 
Protocol Development 
Group 
Prof. dr. D. N. Wirawan, MPH (Chair) 
dr.  Made Ady Wirawan, MPH, PhD  
Dr. dr. Anak Agung Sagung Sawitri, MPH 
dr. Ida Ayu Narayani, M.Sc 
Implementing Institution  
Kerti Praja Foundation (Yayasan Kerti Praja) 
Denpasar, Bali, Indonesia 
Phone: 0361 728 916, 728 917, 4458641 
Email: kertiprajafoundation@gmail.com 
Funding Organization 
United Nations Population Fund (UNFPA) 
Contributors 
dr. Pande Putu Januraga, DrPH 
Dinar SM Lubis, MPH, PhD 
Consultant 
Robert Magnani, DrPH 
Study Initiation Date 
01 February 2020 
Participants Recruitment 
01 April 2020 

 
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ACKNOWLEDGEMENTS 
 
We would like to thank the members of the protocol development group for their 
dedication and hard work throughout the development of this protocol. We would also 
thank Pande Putu Januraga, MD, DrPH and Dinar SM Lubis, MPH, PhD as contributors, and 
Robert Magnani, DrPH as consultant. We would also like to thank the United Nations 
Population Fund (UNFPA) for their support and supervision.  
 
 
 
 
 
Prof. D.N. Wirawan, MD, MPH 
Chair Protocol Development 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Table of Contents 
ABBREVIATIONS 
 
 
 
 
 
 
 
 
 
5 
LIST OF FIGURES AND TABLES 
 
 
 
 
 
 
 
 
6 
 
A. BACKGROUND 
 
 
 
 
 
 
 
 
 
 
7 
1. 
The HIV Epidemic in Indonesia 
 
 
 
 
 
 
 
7 
2. 
HIV Testing Among FSW  
 
 
 
 
 
 
 
9 
3. HIV Self-testing Using Oral Fluid Test 
 
 
 
 
 
 
10 
4. Role of Outreach Worker in HIV Self-testing Using Assisted and Unassisted Method 
 
11 
5. Study Purpose 
 
 
 
 
 
 
 
 
 
11 
6. Study Objectives  
 
 
 
 
 
 
 
 
11 
B. STUDY DESIGN 
 
 
 
 
 
 
 
 
 
12 
1. 
Design Summary  
 
 
 
 
 
 
 
 
12 
2. Study Period 
 
 
 
 
 
 
 
 
 
16 
3. Eligibility Criteria  
 
 
 
 
 
 
 
 
17 
4. Randomization  
 
 
 
 
 
 
 
 
17 
5. Recruitment and Sample Size 
 
 
 
 
 
 
 
19 
C. THE INTERVENTION 
 
 
 
 
 
 
 
 
 
20 
1. 
General Description of The Intervention 
 
 
 
 
 
 
20 
2. Implementation Guidelines: Assisted Community Screening  
 
 
 
20 
3. Implementation Guidelines: Unassisted Community Screening 
 
 
 
21 
4. Implementation Guidelines for Control Group (Standard Program) 
 
 
 
22 
5. Incentives for Participation 
 
 
 
 
 
 
 
23 
D. LINKAGE TO HEALTH SERVICES FOR ARV INITIATION 
 
 
 
 
 
23 
E. DATA COLLECTION PROTOCOLS 
 
 
 
 
 
 
 
 
23 
1. 
Baseline Survey  
 
 
 
 
 
 
 
 
23 
2. Post-test Survey  
 
 
 
 
 
 
 
 
24 
3. Routine Recording 
 
 
 
 
 
 
 
 
24 
4. Numbering System for Test Kit and Other Instruments 
 
 
 
 
26
 
 
 
 
 
 
 
 
 
F. DATA ANALYSES 
 
 
 
 
 
 
 
 
 
26 
G. CONTINGENCY STUDY DESIGN  
 
 
 
 
 
 
 
27 
H. RESEARCH ETHICS 
 
 
 
 
 
 
 
 
 
28 
Annex 1. Flowchart of Routine Data Recording 
 
 
 
 
 
 
29 
Annex 2. Eligibility Form  
 
 
 
 
 
 
 
 
30 
Annex 3. Informed Consent Form  
 
 
 
 
 
 
 
31 
Annex 4. Baseline Survey Questionnaire (VCT) 
 
 
 
 
 
 
37 
Annex 5. VCT Test Confirmation and Result Form  
 
 
 
 
 
42 
Annex 6. Baseline Survey Questionnaire (OFT) 
 
 
 
 
 
 
43 
Annex 7. OFT Result Form 
 
 
 
 
 
 
 
 
47 
Annex 8. Post-test Survey Questionnaire  
 
 
 
 
 
 
48 
Annex 9. Referral Cards to Health Facilities 
 
 
 
 
 
 
50 
Annex 10. ART Initiation Form 
 
 
 
 
 
 
 
 
51 
 
REFERENCES 
 
 
 
 
 
 
 
 
 
 
52
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Abbreviations 
AIDS 
  Acquired Immunodeficiency Syndrome 
ART 
Antiretroviral Therapy  
ARV 
Antiretroviral 
BB 
Beach Boys 
cRCT 
CRF 
Community Randomized Control Trial 
Case Report Form 
FSWs 
Female Sex Workers  
GFATM 
Global Fund to Fight AIDS, Tuberculosis, and Malaria 
GOI 
HIV 
Government of Indonesia 
Human Immunodeficiency Virus 
HIVST 
Human Immunodeficiency Virus Self-Testing 
IRB 
Institutional Review Board 
IU 
Implementing Unit 
KAPs 
Key Affected Populations 
KOLs 
Key Opinion Leaders 
MoH 
Ministry of Health 
MSM 
NGO  
Men who have Sex with Men  
Non-Governmental Organization 
OW 
Outreach Worker 
OFT 
Oral Fluid Test 
PLHIV 
People Living With HIV 
PrEP 
Pre-Exposure Prophylactic 
PWID 
People Who Inject Drugs  
SIHA 
SOP 
Sistem Informasi HIV dan AIDS 
Standard Operating Procedure 
STI 
Sexually Transmitted Infection 
T&T 
Test and Treat 
TB 
Tuberculosis 
UNAIDS 
United Nations Program on HIV and AIDS 
WHO  
World Health Organization 
YKP 
Yayasan Kerti Praja (Kerti Praja Foundation) 
 

 
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List of Figures and Tables 
 
Figure 1. Study Flowchart 
Table 1. Estimated number of female sex workers (2016) 
Table 2. Estimated number of direct (brothel) and indirect female sex workers (2012) 
Table 3. Global Fund HIV testing targets in 23 districts for 2019-2020 
Table 4. Achieved target of HIV testing per semester in 23 priority districts (2018-2019) 
Table 5. Achieved target of outreach per year in 23 priority districts (2018-2019) 
Table 6. Allocated intervention group and comparison group  
Table 7. Allocated intervention districts 
Table 8. Allocated comparison districts  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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A. BACKGROUND 
1. The HIV Epidemic in Indonesia  
Until recently, Indonesia was among the few countries in which annual numbers of new HIV 
infections continued to rise (MoH, 2016). The latest epidemic modeling update indicated that 
except among men who have sex with man (MSM), annual numbers of new HIV infections had 
stabilized and begun to decline. However, with the current epidemic trajectory there would still be 
over 40,000 new HIV infections in the year 2030 (MoH,2016). Indonesia is not yet on course to end 
HIV and AIDS by 2030. 
Although there has been a significant increase in the number of persons being treated for 
HIV/AIDS, the 108,479 people receiving ART as of December 2018 amounts to only 17 percent of 
the estimated number of PLHIV in the country (MoH, 2018). This makes Indonesia a performance 
“outlier” when compared to countries at comparable levels of gross national income (GNI) and 
health system development. The lack of more rapid progress has recently led key development 
partners to question Government of Indonesia (GOI) commitment to meaningfully addressing HIV 
and AIDS. 
Insufficient HIV testing remains a barrier to increasing ART coverage. The number of HIV tests 
performed annually has risen steadily in recent years, reaching 3,077,653 in calendar year 2018 
(MoH, 2018). However, pregnant women account for a sizeable proportion of the increased 
number of persons being tested. While commendable, the case detection “yield” from testing 
pregnant women is relatively low. More effective case finding strategies need to be implemented 
to reach population sub-groups with higher HIV incidence and prevalence, including key affected 
populations (KAPs) such as female sex workers (FSW). Unless Indonesia can significantly increase 
its volume and efficiency of HIV testing, it will not be able to reach the first “95” of the UNAIDS 95-
95-95 framework – that is, 95% of PLHIV know their HIV status. 
The main rationale is Indonesia’s concentrated epidemic transmission of HIV infection among 
KAPs, specifically FSWs. In 2016 it is estimated that there are 226,791 female sex workers 
throughout Indonesia (Table 1) and around 5,254,065 clients access their service per year (MoH, 
2017). This mode of transmission continues to clients’ sexual partner and moreover, their babies. 
Lowering the transmission of HIV infection from FSW to their clients would simultaneously lower 
its transmission to their sexual partners and furthermore their babies.  
In 2012, the estimated number of FSW and distribution FSW by “direct” (i.e., brothel-based) and 
“indirect” status is presented in Tabel-2. In 2016, the estimated number of FSW was not grouped 
into direct and indirect because it was considered that most of FSWs had shifted to becoming 
indirect due to Indonesia’s national policy to close brothels. Due to this policy, most FSWs have 
become hidden and hard to reach, thus increasing the challenge of increasing HIV testing uptake 
among this sub-population. Many commercial sex transactions have become underground, 
especially given the new popularity of digital platforms to sell sexual services. This phenomenon 
has created a new demand to identify alternative strategies for increasing HIV testing uptake 
among FSW. 
 
 
 

 
CBS Protocol Final Version 31 January 2020 
 
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Table 1. Estimated number of female sex workers (2016) 
No 
Province  
Female Sex Workers 
Point Estimate 
Lower Estimate 
Upper Estimate 
1 
Aceh 
2,710 
583 
7,570 
2 
Sumatera Utara 
14,234 
8,079 
21,943 
3 
Sumatera Barat 
12,783 
8,901 
17,797 
4 
Riau 
7,181 
4,569 
9,796 
5 
Jambi 
4,544 
1,986 
7,188 
6 
Sumatera Selatan 
7,630 
4,235 
11,323 
7 
Bengkulu  
1,304 
566 
3,255 
8 
Lampung 
7,532 
4,534 
10,717 
9 
Kep. Bangka Belitung 
3,313 
1,072 
5,645 
10 
Kep. Riau 
4,705 
3,273 
6,664 
11 
DKI Jakarta 
21,405 
17,444 
25,386 
12 
Jawa Barat 
25,281 
17,806 
34,220 
13 
Jawa Tengah 
8,938 
3,566 
18,599 
14 
DI Yogyakarta 
3,511 
1,356 
6,181 
15 
Jawa Timur 
12,672 
6,244 
24,661 
16 
Banten  
5,476 
3,552 
8,012 
17 
Bali 
5,188 
3,431 
6,955 
18 
Nusa Tenggara Barat 
2,127 
1,131 
3,212 
19 
Nusa Tenggara Timur 
1,470 
141 
3,998 
20 
Kalimantan Barat 
11,593 
6,231 
17,316 
21 
Kalimantan Tengah 
5,208 
1,580 
11,181 
22 
Kalimantan Selatan 
9,148 
4,559 
14,662 
23 
Kalimantan Timur  
14,034 
8,879 
19,459 
24 
Kalimantan Utara 
2,219 
1,243 
4,128 
25 
Sulawesi Utara 
3,059 
898 
7,275 
26 
Sulawesi Tengah  
6,052 
1,663 
10,801 
27 
Sulawesi Selatan  
15,303 
7,711 
23,144 
28 
Sulawesi Tenggara 
2,058 
642 
5,400 
29 
Gorontalo  
746 
111 
2,722 
30 
Sulawesi Barat  
1,376 
250 
3,076 
31 
Maluku  
1,741 
846 
3,550 
32 
Maluku Utara 
155 
0 
1,367 
33 
Papua Barat  
542 
326 
1,780 
34 
Papua 
1,553 
706 
5,330 
 
NATIONAL  
226,791 
128,114 
364,313 
Source: Ministry of Health (2016) 
 
 
 
 
 
 

 
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Table 2. Estimated number of direct (brothel) and indirect female sex workers (2012) 
No 
Province 
Direct FSW 
Indirect FSW 
1 
Aceh 
2,179 
929 
2 
Sumatera Utara 
9,032 
5,116 
3 
Sumatera Barat 
3,089 
2,197 
4 
Riau 
3,643 
2,758 
5 
Jambi 
3,937 
1,641 
6 
Sumatera Selatan 
3,740 
1,719 
7 
Bengkulu  
1,235 
1,403 
8 
Lampung 
1,172 
845 
9 
Kep. Bangka Belitung 
481 
472 
10 
Kep. Riau 
1,195 
1,312 
11 
DKI Jakarta 
15,395 
23,386 
12 
Jawa Barat 
18,106 
10,876 
13 
Jawa Tengah 
13,205 
10,023 
14 
DI Yogyakarta 
1,945 
706 
15 
Jawa Timur 
14,381 
10,459 
16 
Banten  
2,798 
1,365 
17 
Bali 
3,378 
3,464 
18 
Nusa Tenggara Barat 
2,888 
4,566 
19 
Nusa Tenggara Timur 
7,245 
6,427 
20 
Kalimantan Barat 
1,695 
2,150 
21 
Kalimantan Tengah 
1,490 
1,071 
22 
Kalimantan Selatan 
845 
1,476 
23 
Kalimantan Timur  
1,041 
759 
24 
Sulawesi Utara 
1,315 
1,360 
25 
Sulawesi Tengah  
983 
776 
26 
Sulawesi Selatan  
1,646 
1,627 
27 
Sulawesi Tenggara 
913 
1,096 
28 
Gorontalo  
486 
373 
29 
Sulawesi Barat  
344 
299 
30 
Maluku  
1,233 
1,082 
31 
Maluku Utara 
535 
635 
32 
Papua Barat  
777 
871 
33 
Papua 
2,199 
1,592 
 
NATIONAL  
124,546 
104,831 
Source: Ministry of Health (2013) 
2. HIV Testing Among FSW 
Getting sufficient numbers of FSW tested for HIV has proven challenging globally (Tokar et al., 
2018). While there is a sizeable literature on the efficacy of HIV prevention interventions for FSW 
(Kerrigan et al., 2015; Shahmanesh et al., 2008; Wariki et al., 2012; Wirtz et al., 2014), there is limited 
global evidence on the question of how best to increase rates of HIV testing among FSW. Although 
the WHO (2015) has recommended community testing approaches to supplement HIV testing at 
health facilities, the available evidence as to efficacy with FSW specifically is quite limited. A recent 
systematic review (Tokar et al., 2018) reported finding of 10 studies that examined recent testing 
in response to FSW HIV promotion interventions. Reported HIV testing uptake were varied, for 
example in Canada it was reported that 76% FSW had HIV test within the last one year (Deering et 
al., 2015), while in China only 22% FSW reported taking HIV test within the last one year (Park et al., 
2011). Some reported barriers for FSW accessing HIV test service were financial, time, stigma, 
discrimination, low-risk perception, fear, lack of accessibility, reluctance from health service 

 
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providers to offer HIV testing and limited human resource. This literature review also showed that 
social support from peers and manager could increase HIV testing uptake in FSW (Tokar et al., 
2018) 
Community based HIV-testing has been implemented in some countries such as Vietnam (Nguyen 
et al., 2019), Uganda (Ortblad et al., 2018), Malawi and Zimbabwe (Napierala et al., 2019). Non-
governmental organizations in Indonesia had conducted study or pilot project on HIV test in men 
who have sex with men (MSM) outside health facility (Hidayat et al., 2019). This study was done to 
find an alternative to facility-based HIV testing, however MoH has been rather conservative in 
supporting non-health facility-based approach outside of mobile clinic testing which involves 
trained healthcare professional to perform HIV testing procedure according to the algorithm 
developed by the government. Mobile clinic testing strategy gave out insufficient result, especially 
in terms of linking those with positive HIV result for further follow-up and initiation of treatment. 
Cost-effectiveness of this approach was also doubted, at least in Jakarta (Cantelmo et al., 2019). 
This study found that the cost needed for mobile testing to identify at least one HIV positive case 
among FSW was almost six-times fold higher compared to finding similar target among 
transgender and MSM, and seventeen-times fold higher than those for identifying one HIV positive 
case among people who inject drugs (PWID). For the effective use of resource, this study 
suggested modification of the test frequency, time, and location for FSWs in Jakarta. In addition, 
this study also recommended the need for alternative strategies to increase HIV test uptake among 
FSW.  
FSWs community are at greater risk of not only HIV infection, but also stigma, discrimination and 
violence. They first face stigma and discrimination due to engaging in sex work itself, or from HIV 
stigma, particularly in contexts of HIV burden, which later affect their access to HIV testing 
(UNAIDS, 2016). The latest WHO guidelines have highlighted HIV self-testing (HIVST) as important 
tool to identify more people with undiagnosed HIV and at high risk of HIV infection. Protection of 
privacy and confidentiality is one of the advantages of this modality which allows for removing 
stigma as barriers to access services. HIVST has been shown to be acceptable across varieties of 
population globally including for FSWs community (King et al, 2013). Oral fluid HIVST is an 
alternative to traditional HIV testing services in the facility or other healthcare provider testing 
(UNAIDS, 2016).  
 
3. HIV Self-testing Using Oral Fluid Test  
One oral fluid test modality (OraQuick
) is currently waiting for the registration approval from 
Ministry of Health and expected to be available by March or April 2020. Evaluation of OraQuick
 
in Thailand showed sensitivity of 90.14% (95%CI 80.74-95.94) and specificity of 99.13% (95%CI 97.78-
99.76) (Rasmi et al., n.d.). A study assessing the acceptability of oral fluid rapid HIV 1 and 2 antibody 
test (OraQuick ) among key populations for HIV infection such as men who have sex with men 
(MSM), beach boys (BB), female sex workers (FSWs), and people who inject drugs (PWID) in Sri 
Lanka showed high level of acceptability for the test (Karawita et al., 2017). In China, most-at-risk 
populations showed high acceptability of oral fluid HIV rapid testing (OraQuick
), with suggestion 
for appropriate pricing and increased public health education through awareness campaigns that 
address concerns about its accuracy and safety (Xun et al., 2013). HIV-self testing kit distribution 
through key opinion leaders (KOLs) was feasible and oral self-testing was highly acceptable among 
urban MSM population in Nigeria (Tun et al., 2018). Linkage to treatment can be achieved with 
active follow-up and access to a trusted community clinic that offers HIV treatment and is MSM 
friendly (Tun et al., 2018). 

 
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4. Role of Outreach Worker in HIV Self-testing Using Assisted and Unassisted Method  
In a study which assessed implementation and scale-up to HIV self-testing programs for female sex 
workers in Malawi and Zimbabwe, there were difference in preferences for how to access HIV self-
testing, depended on how supportive the existing program infrastructure was (Napierala et al., 
2019) In Zimbabwe, where there was a detailed understanding of the context of female sex 
workers and a ready framework to implement and evaluate HIV self-testing strategies, high 
acceptability (76%) and high accuracy of HIV self-testing was reported (Napierala et al., 2019). In 
contrast, peer-distribution models were favored by female sex workers in Malawi and female sex 
workers in Zimbabwe who were not engaged in the program (Napierala et al., 2019). Another study 
in Kampala (Uganda) evaluated HIV self-testing performance and results interpretation among 
FSWs who performed unassisted HIV self-testing, showed that misinterpretation of HIV self-test 
results were common among FSWs: 23% (12/56) of FSWs interpreted HIV-negative self-test results 
as HIV positive and 8% (3/37) of FSWs interpreted HIV-positive self-test results as HIV negative 
(Ortblad et al., 2018). The concordance between FSWs’ instructions was 73% (95%CI 56% to 86%) for 
HIV-positive self-tests and 68% (95%CI 54% to 80%) for HIV-negative self-tests (Ortblad et al., 2018). 
This finding suggested training on use and interpretation of HIV self-test for the unassisted method 
might be necessary to prevent errors and to avoid the negative consequences of false-positive and 
false-negative HIV self-test results among FSWs.  
5. Study Purpose 
The study proposed in this protocol directly addresses the need to get more Indonesian FSW to 
“know their status” by providing an alternative, convenient HIV testing option in non-threatening 
community settings. In the Indonesian context where a reactive HIV test result using the MoH-
mandated triple rapid test algorithm is needed to qualify for GoI-financed ART, community 
screening is seen as a mechanism for enabling FSW to conveniently determine their status and a 
facilitation mechanism for  taking action based upon the community screening result, whether that 
entail going to a health facility for a confirmatory test in the case of a reactive screening result or 
adopting stronger prevention measures in the case of a non-reactive screening result, including 
PrEP as this prevention method is rolled out in Indonesia.  
The study will produce scientifically strong evidence as to whether two alternative models of 
community HIV screening among FSW (assisted and unassisted) result in (1) increased rates of 
formal HIV testing at health facilities and (2) increased rates of treatment initiation in districts in 
which the community screening intervention is added to the existing FSW community outreach 
model.  
Two alternative study protocols are described in this document. The bulk of this document 
presents a protocol for a community randomized controlled trial (cRCT), which is the preferred 
research design option. However, due to a delay in procurement of the OraQuick® rapid HIV test 
kits that are to be used in the study, there may be insufficient time to undertake a full cRCT.1 
Accordingly, a contingency protocol that can be implemented in a shorter period of time is also 
presented.   
6. Study Objectives 
The primary objectives of this study will provide answers to the following five (5) questions: 
1. Does the proportion of FSW who know their HIV status increased? 
 
1 All research activities must be completed by 31 December 2020. 

 
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2. Does the introduction of community HIV screening among FSW increase the rate of HIV testing 
at health facilities? 
3. Does “assisted” or “unassisted” community HIV screening among FSW result in a larger increase 
in the rate of HIV testing at health facilities? 
4. Does “assisted” and “unassisted” community HIV screening among FSW results in a larger 
increase in the rate of HIV positive case finding? 
5. Does the introduction of community HIV screening among FSW increase the rate of initiation of 
ART? 
The secondary objectives of this study will provide answers to the following two (2) questions: 
1. What is the acceptability of community-based self-screening for FSWs participating in this study? 
2. What is the satisfaction of FSWs participating in this study towards delivery of community-based 
self-screening? 
 
B. STUDY DESIGN 
1. Design Summary 
A Community Randomized Controlled Trial (cRCT) will be used for this study to explore in the HIVST 
evidence for FSWs in Indonesia with tests and treatment results in intervention acceleration 
districts compared to control districts with the current standard of care. In the trial, it is 
recommended the candidates will be tested using two approaches (assisted and unassisted), the 
latter via direct, fixed and other means of distribution system. A direct distribution system is where 
and FSW participant is directly given and HIVST by a peer, and a fixed distribution system is where 
the FSW participant collects the HIVST from a fixed point such as health clinic. Other distribution 
system may be implemented using courier services such as GO-JEK, etc. This trial aims to determine 
the acceptability, effectiveness and safety of these HIVST delivery approaches compared with 
standard of care for improving HIV testing coverage and knowledge of HIV status.  
The study will be undertaken in the 23 “acceleration” districts in the National AIDs Program. These 
are: Kota Medan, Deli Serdang, Kota Palembang, Kota Bandar Lampung, Kota Tangerang Selatan, 
Tangerang, Kota Jakarta Selatan, Kota Jakarta Timur, Kota Jakarta Pusat, Kota Jakarta Barat, Kota 
Jakarta Utara, Bogor, Kota Bekasi, Kota Bandung, Kota Depok, Kota Semarang, Kota Surakarta, 
Kota Malang, Kota Surabaya, Kota Denpasar, Kota Makassar, Kota Sorong and Kota Jayapura. 
These are districts with high HIV prevalence among HIV key populations, including FSW, and have 
comprehensive ongoing HIV-TB intervention packages consisting of both health services and 
community prevention and support programs. As for the FSWs program, these 23 priority districts 
already implementing a comprehensive outreach package (reach to test and simplified case 
management for FSWs living with HIV). Table 3 below shows Global Fund targets for FSW HIV 
testing in 23 priority districts for 2019-2020. Table 4 shows achieved target of HIV testing per 
semester in 2018-2019 and estimated numbers of direct and indirect FSW in 2012 (MoH, 2013). Table 
5 shows achieved target of outreach per year in 2018-2019 in 23 priority districts.  
The flowchart of the study is presented in Figure 1. Randomization was carried out among the 23 
priority districts in this study with a ratio of 2:1 (that is, 2 intervention districts per 1 control district). 
The details of randomization are explained in section B.4 of this document. The assigned 15 
intervention districts and 8 comparison districts are described in Table 6. Potential participants in 
the intervention area will be screened through the inclusion and exclusion criteria established for 

 
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this study. The criteria for participants who are eligible for this study are explained in section B.3 
of this document and Annex2.  
According to the Indonesian Ministry of Health’s current recommendation, HIV blood test at an 
authorized health facility is still the current practice for HIV diagnosis. Both participants in the 
intervention and comparison area will be offered for HIV blood test at a health facility. Participants 
in comparison areas and participants in intervention areas who agree to take HIV test at a health 
facility will then be managed further according to the existing guideline or “standard of care.” For 
participants in intervention areas who refuses to have her blood drawn for HIV test at a health 
facility will then be offered self-testing using OraQuick®. Participants will then fill and sign the 
informed consent to participate in CBS study.  
Next, participants will be offered to do the test assisted or unassisted. If the participant chooses 
to perform the test assisted, the PL/PE will help her from filling in a baseline survey, performing 
the test, and filling in a post-test survey. If the participant chooses to perform the test unassisted, 
there will be two options for the participant to get the test kit. First, PL/PE will deliver the test kit 
for the participant, help with filling in the baseline survey on the spot and give information about 
uploading test results and the post-test survey, along with a hotline number to call for any 
questions and concerns, including follow-up steps after participants have received the results. The 
second method, participants will be given a link online which will entitle information of this study, 
eligibility criteria, informed consent, baseline survey, link to order a test kit, link to upload result 
and link to fill in the post-test survey. Participant who chooses this second method will also be 
given hotline number should there be any further inquiries.  
Participants with reactive or indeterminate result resulting from either assisted or unassisted 
methods will be encouraged to get a confirmatory test at a health facility. A confirmatory test will 
also be suggested for participants with non-reactive result. The difference between these two 
result groups will be the level of encouragement given to do the confirmatory test. While 
participant with reactive or indeterminate results will be strongly encouraged, participants with a 
non-reactive result will be suggested for a confirmatory test. These suggestions are derived from 
Indonesia’s current guideline on HIV detection, where the confirmatory test is to be done at the 
health facility using the HIV blood test.  
 
 
 
 
 
 
 
 
 

 
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Assisted 
Unassisted 
• 
PL/PE help FSW filling in 
baseline survey 
• 
PL/PE assisting test  
• 
PL/PE help FSW filling in post-
test survey 
PL/PE deliver  
test kit to FSW 
Routine Data Record 
Self-pick-up at 
fixed point OR 
Delivery by Go-
Send/Grab Send 
Baseline 
survey filled 
at meeting 
place with 
FSW 
FSW 
perform 
self-testing 
and 
complete 
post-test 
survey 
Routine Data Record 
Reactive or 
indeterminate 
Non-reactive 
Suggest for 
confirmatory 
test 
FSW upload or send test results  
FSW fill in 
baseline survey 
online, perform 
self-testing, and 
complete post-
test survey  
Reactive or 
indeterminate 
Non-reactive 
Figure 1. Study Flowchart 
Outreach by PL/PE 
Offer for HIV blood test 
Static 
test 
Mobile 
test 
No 
Test 
Test result 
+ 
- 
Follow-up 
and start 
on ART 
Routine Data Record 
Encourage for 
confirmatory 
test and start 
on ART 
Encourage for 
confirmatory 
test and start 
on ART 
Suggest for 
confirmatory 
test 
FSW order online by 
following the link 
found in broadcast 
message 
Offered for HIV blood 
test 
 agree 
 fill in 
baseline survey 

 
CBS Protocol Final Version 31 January 2020 
 
15
Table 3. Global Fund HIV testing targets in 23 districts for 2019-2020 
No 
Province 
Districts 
Region 
Target of HIV Testing 
P3 
P4 
P5 
P6 
1 
Sumatera Utara 
Kota Medan 
1 
904 
904 
1,002 
1,002 
2 
Sumatera Utara 
Kab. Deli Serdang  
1 
406 
406 
450 
450 
3 
Sumatera Selatan 
Kota Palembang 
1 
1,371 
1,371 
1,520 
1,520 
4 
Lampung 
Kota Bandar Lampung 
1 
393 
393 
435 
435 
5 
Banten  
Kota Tangerang Selatan 
1 
223 
223 
247 
247 
6 
Banten  
Kab. Tangerang  
1 
820 
820 
909 
909 
7 
DKI Jakarta 
Kota Jakarta Selatan  
1 
536 
536 
594 
594 
8 
DKI Jakarta 
Kota Jakarta Timur 
1 
877 
877 
973 
973 
9 
DKI Jakarta 
Kota Jakarta Pusat 
1 
1,341 
1,341 
1,486 
1,486 
10 
DKI Jakarta 
Kota Jakarta Barat 
1 
1,318 
1,318 
1,461 
1,461 
11 
DKI Jakarta 
Kota Jakarta Utara 
1 
1,431 
1,431 
1,586 
1,586 
12 
Jawa Barat 
Kota Bogor 
2 
474 
474 
525 
525 
13 
Jawa Barat 
Kota Bekasi 
2 
248 
248 
275 
275 
14 
Jawa Barat 
Kota Bandung 
2 
582 
582 
645 
645 
15 
Jawa Barat 
Kota Depok 
2 
374 
374 
415 
415 
16 
Jawa Tengah 
Kota Semarang  
2 
510 
510 
565 
565 
17 
Jawa Tengah 
Kota Surakarta 
2 
172 
172 
190 
190 
18 
Jawa Timur  
Kota Malang  
3 
84 
84 
93 
93 
19 
Jawa Timur  
Kota Surabaya 
3 
1,173 
1,173 
1,300 
1,300 
20 
Bali  
Kota Denpasar 
3 
1,407 
1,407 
1,559 
1,559 
21 
Sulawesi Selatan 
Kota Makassar 
3 
1,444 
1,444 
1,600 
1,601 
22 
Papua Barat 
Kota Sorong 
4 
438 
438 
485 
485 
23 
Papua 
Kota Jayapura 
4 
786 
786 
871 
871 
Table 4. Achieved target of HIV testing per semester in 23 priority districts (2018-2019) 
No 
Kab/Kota 
Region 
Achieved target of HIV testing per semester 
1 
Kota Denpasar 
3 
982 
2 
Kota Makassar 
3 
866 
3 
Kota Palembang 
1 
694 
4 
Kota Jakarta Utara 
1 
612 
5 
Kota Medan 
1 
575 
6 
Kota Surabaya 
3 
568 
7 
Kota Jakarta Barat 
1 
544 
8 
Kota Bandung 
2 
487 
9 
Kota Jakarta Timur 
1 
479 
10 
Kota Jakarta Pusat 
1 
473 
11 
Kota Jakarta Selatan 
1 
448 
12 
Kota Sorong 
4 
415 
13 
Kab. Tangerang 
1 
391 
14 
Kota Bogor 
2 
374 
15 
Kota Jayapura 
4 
323 
16 
Kota Bandar Lampung 
1 
319 
17 
Kota Depok 
2 
287 
18 
Kota Malang 
3 
243 
19 
Kota Tangerang Selatan 
1 
184 
20 
Kota Bekasi 
2 
158 
21 
Kota Surakarta 
2 
144 
22 
Kota Semarang 
2 
129 
23 
Kab. Deli Serdang 
1 
80 

 
CBS Protocol Final Version 31 January 2020 
 
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Table 5. Achieved target of outreach per year in 23 priority districts (2018-2019) 
No. 
Kab/Kota 
Region  
Achieved target of outreach per year 
1 
Kota Denpasar 
3 
5100 
2 
Kota Jakarta Barat 
1 
4947 
3 
Kota Jakarta Pusat 
1 
4004 
4 
Kota Palembang 
1 
3741 
5 
Kota Surabaya 
3 
3510 
6 
Kota Jakarta Timur 
1 
3157 
7 
Kota Jakarta Utara 
1 
3129 
8 
Kota Jakarta Selatan 
1 
2905 
9 
Kota Medan 
1 
2858 
10 
Kota Makassar 
3 
2683 
11 
Kota Bandung 
2 
2164 
12 
Kota Bogor 
2 
1961 
13 
Kota Bandar Lampung 
1 
1933 
14 
Kabupaten Tangerang 
1 
1374 
15 
Kota Semarang 
2 
1317 
16 
Kota Sorong 
4 
1220 
17 
Kota Surakarta 
2 
1190 
18 
Kota Depok 
2 
1107 
19 
Kota Tangerang Selatan 
1 
994 
20 
Kota Jayapura 
4 
983 
21 
Kabupaten Deli Serdang 
1 
939 
22 
Kota Bekasi 
2 
879 
23 
Kota Malang 
3 
877 
 
2. Study Period 
The study timeline is presented below. The study will be conducted from February 2020 to 
November 2020 (10 months). The preparatory activities will be conducted in February to March 
2020. The intervention will be implemented from April – October 2020 (7 months), with the last 
one months of 2020 allocated for data analysis, report writing and a workshop presenting study 
findings.  
Study timeline  
Activities  
Month 
Feb  
March 
April 
May 
June 
July 
Aug 
Sept 
Oct 
Nov 
1. Study preparation 
 
 
 
 
 
 
 
 
 
 
1.1 Recruitment of study 
personnel  
 
 
 
 
 
 
 
 
 
 
1.2 Ethics and permit  
 
 
 
 
 
 
 
 
 
 
1.3 Stakeholders mapping 
and engagement strategy  
 
 
 
 
 
 
 
 
 
 
1.4 Procurement of test kit 
 
 
 
 
 
 
 
 
 
 
 
 

 
CBS Protocol Final Version 31 January 2020 
 
17
Activities  
Month 
Feb  
March 
April 
May 
June 
July 
Aug 
Sept 
Oct 
Nov 
1.5 Development of manual 
of operating procedure 
(SOP, questionnaire, study 
media, website, 
WhatsApp center, CRF 
forms) 
 
 
 
 
 
 
 
 
 
 
2.Implementation training 
 
 
 
 
 
 
 
 
 
 
3.Intervention  
 
 
 
 
 
 
 
 
 
 
3.1 Study kick-off  
 
 
 
 
 
 
 
 
 
 
3.2 Data collection 
 
 
 
 
 
 
 
 
 
 
4. Data analysis and report 
writing  
 
 
 
 
 
 
 
 
 
 
5. Workshop for study 
finding dissemination   
 
 
 
 
 
 
 
 
 
 
 
3. Eligibility Criteria 
The target audience for the intervention to be evaluated are FSW in Intervention districts that 
meet the criteria outlined below. 
Inclusion criteria 
• 
Women, 18 years or older at enrolment 
• 
Reports transactional sex (vaginal, oral and/or anal) at least once in the past month 
• 
No HIV test in last 6 months  
• 
Self-reported HIV negative OR HIV status unknown 
Exclusion criteria 
• 
Unwilling to participate for any reason 
• 
Concurrently participating in another HIV prevention study 
 
4. Randomization 
Stratified randomization was carried out for the 23 priority districts involved in this study. First, 
sampling strata were created by sorting the mean average value of achieved HIV testing target per 
semester from 2018-2019 in each district from the largest to the smallest. The second step was to 
sort the districts into eight groups of three districts, except for the last group which will only 
consist of two districts. Randomization for intervention and comparison group were then carried 
out within these groups of eight with 2:1 ratio (2 intervention: 1 comparison).2 The results of 
stratified randomization are presented in Table 6. In separate table, Table 7 contains 15 
intervention districts and Table 8 contains 8 comparison districts.  
 
2 A 2-to-1 intervention to comparison district ratio was chosen in order to increase the likelihood of recruiting 
a sufficient number of FSW for community screening to reach the sample size target considering the relatively 
short time frame available for for study implementation.  

 
CBS Protocol Final Version 31 January 2020 
 
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Table 6. Allocated intervention group and comparison group  
No 
Kab/Kota 
Region 
Achieved target of HIV testing  
per semester (2018-2019) 
Group 
1 
Kota Denpasar 
3 
982 
Intervention 
2 
Kota Makassar 
3 
866 
Comparison 
3 
Kota Palembang 
1 
694 
Intervention 
4 
Kota Jakarta Utara 
1 
612 
Comparison 
5 
Kota Medan 
1 
575 
Intervention 
6 
Kota Surabaya 
3 
568 
Intervention 
7 
Kota Jakarta Barat 
1 
544 
Intervention 
8 
Kota Bandung 
2 
487 
Comparison 
9 
Kota Jakarta Timur 
1 
479 
Intervention 
10 
Kota Jakarta Pusat 
1 
473 
Intervention 
11 
Kota Jakarta Selatan 
1 
448 
Comparison  
12 
Kota Sorong 
4 
415 
Intervention 
13 
Kab. Tangerang 
1 
391 
Intervention 
14 
Kota Bogor 
2 
374 
Intervention 
15 
Kota Jayapura 
4 
323 
Comparison 
16 
Kota Bandar Lampung 
1 
319 
Comparison 
17 
Kota Depok 
2 
287 
Intervention 
18 
Kota Malang 
3 
243 
Intervention 
19 
Kota Tangerang Selatan 
1 
184 
Intervention 
20 
Kota Bekasi 
2 
158 
Comparison 
21 
Kota Surakarta 
2 
144 
Intervention 
22 
Kota Semarang 
2 
129 
Comparison 
23 
Kab. Deli Serdang 
1 
80 
Intervention 
 
Table 7. Allocated intervention districts 
No 
Kab/Kota 
Region 
Achieved target of HIV testing  
per semester (2018-2019) 
Group 
1 
Kab. Deli Serdang  
1 
80 
Intervention 
2 
Kota Medan 
1 
575 
Intervention 
3 
Kota Palembang 
1 
694 
Intervention 
4 
Kab. Tangerang 
1 
391 
Intervention 
5 
Kota Tangerang Selatan 
1 
184 
Intervention 
6 
Kota Jakarta Barat 
1 
544 
Intervention 
7 
Kota Jakarta Pusat 
1 
473 
Intervention 
8 
Kota Jakarta Timur 
1 
479 
Intervention 
9 
Kota Bogor  
2 
374 
Intervention 
10 
Kota Depok 
2 
287 
Intervention 
11 
Kota Surakarta 
2 
144 
Intervention 
12 
Kota Surabaya 
3 
568 
Intervention 
13 
Kota Malang 
3 
243 
Intervention 
14 
Kota Denpasar 
3 
982 
Intervention 
15 
Kota Sorong 
4 
415 
Intervention 
 
 
 
 

 
CBS Protocol Final Version 31 January 2020 
 
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Table 8. Allocated comparison districts 
No 
Kab/Kota 
Region 
Achieved target of HIV testing  
per semester (2018-2019) 
Group 
1 
Kota Bandar Lampung 
1 
319 
Comparison 
2 
Kota Jakarta Utara 
1 
612 
Comparison  
3 
Kota Jakarta Selatan 
1 
448 
Comparison 
4 
Kota Bekasi  
2 
158 
Comparison 
5 
Kota Semarang 
2 
129 
Comparison 
6 
Kota Bandung 
2 
487 
Comparison 
7 
Kota Makassar 
3 
866 
Comparison 
8 
Kota Jayapura 
4 
323 
Comparison 
 
5. Recruitment and Sample Size 
All FSW in intervention districts who meet study eligibility criteria will be offered community 
screening (see Section C below for intervention implementation guidelines). FSW in comparison 
districts will continue to receive the current standard package of interventions.  
In to be able to detect a 10 percentage point difference in the rate of HIV testing at health facilities 
between FSW in intervention vs. comparison districts and have 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 following sample of FSW will be needed 
in intervention and in comparison districts:3 
n ≥ [Z1-α (2P(1-P))1/2 + Z1-β (P1(1-P1) + P2(1-P2)2 / (P1-P2)2] * deft 
 
Where: 
Z1-α = the Z score for the level of statistical confidence, or statistical precision, desired (for 
95%, Z = 1.96) 
 
Z1-β = the Z score for the desired statistical power (for 90% one-sided test, Z = 1.282) 
P1 = the expected population proportion in the comparison group of districts (set = 0.5 – 
this is the worst-case scenario and will produced a sample size that is adequate irrespective 
of the actual proportion 
P2 = the expected population proportion in the intervention group of districts (set = 0.6 – 
assume minimum effect size to be realized of 10 percentages points) 
P = (P1-P2) / 2 
(P1-P2) = the magnitude of comparison-group differences (or change over time) to be 
detected with the specified level of precision and power (assumed to be +/- 10 
percentage points) 
deft = design effect to compensate for clustering at the district level (1.5 assumed). 
 
The required sample size is thus n ≥ 635 per experimental group; ≥ 761 after 20% allowance for 
lost-to-follow up  
 
3 Source: Lwanga SK and Lemeshow S. Sample Size Determination in Health Studies: A Practical Manual. 
Geneva: World Health Organization. 

 
CBS Protocol Final Version 31 January 2020 
 
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Interpretation: we would need to recruit 761 FSW who self-test for HIV testing in the intervention 
districts and 761 FSW for HIV testing at health facilities in comparison districts to be able to detect 
a 10 percentage point difference in the rate of HIV testing at health facilities (intervention vs. 
comparison districts) to have 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 such a 
difference existed.  
In order to assess whether “assisted” or “unassisted” community HIV screening among FSW 
results in a larger increase in the rate of HIV testing at health facilities, we would need samples of 
size n ≥ 761 each of FSW who received assisted and unassisted screening in intervention districts, 
a total of n ≥ 1,522 FSW in intervention districts, plus n ≥ 761 in comparison districts. 
Sample size requirements for the third question measurement pertains to the number of FSW who 
test positive for HIV at a health facility and are thus eligible to initiate treatment. This will depend 
upon (1) the number of FSW presenting at health facilities for testing and (2) the positivity rate 
among those tested. Sample sizes should thus be calculated accordingly. If we assume a testing 
positivity rate of 3%, it is apparent that the expected number of FSWs who would be eligible for 
treatment will be small and we will lack sufficient statistical power to make meaningful 
comparisons with comparison districts. For this reason, it is recommended that the impact of 
community screening among FSW be measured using SIHA data for FSW in both intervention and 
comparison districts. This estimate of impact derived in this way will be confounded if it were to 
be the case that interventions other than HIV self-testing were to be better implemented in 
intervention vs. comparison districts. It might be possible to minimize this potential bias by 
including measures of intervention implementation performance in the intervention and 
comparison districts in multivariable analyses. Thus, a large enough sample size is required to 
ensure sufficient power to determine the difference in the intervention and control districts. 
 
C. THE INTERVENTION 
1. General Description of The Intervention 
FSW who meet the eligibility criteria will be offered for HIV blood test first. Participants who wish 
to take the test will then managed according to the current guideline for standard of care. 
Participants who disagree to take HIV blood test will then be offered screening test with Ora-
Quick®. There will be with two options for community HIV screening by Peer Leaders: (1) in a 
convenient community setting assisted by PL/PE (assisted screening) or (2) in a setting of their own 
choosing without assistance from PL/PE (unassisted screening). FSW will also be able to access a 
community-based screening test by following online link from messages spread through 
WhatsApp number without having to come into contact with outreach workers. The saliva-based 
Ora-Quick® test kit will be used for community screening.  
The community screening intervention will be implemented as an additional component to be 
added in intervention districts to the intervention package currently being implemented by 
UNFPA’s Implementation Units (IUs). In “control districts” implementation of the UNFPA-
supported GFATM will proceed without modification as concerns community screening. 
2. Implementation Guidelines: Assisted Community Screening 
For assisted community screening, which can only be undertaken with FSW with whom outreach 
worker (OW) have established face-to-face contact, the standard outreach process will entail: 
a. For FSW that have not been tested for HIV for at least six (6) months at the time of outreach 
contact, (i) recommend HIV testing at a  health facility, (ii) offer to facilitate making an 
appointment for testing to accompany them to a health facility for testing, and (iii) provide FSW 

 
CBS Protocol Final Version 31 January 2020 
 
21
with a referral card to be submitted to the health facility in order to help track numbers of FSW 
that were tested for HIV. 
b. For those that refuse or decline to go to a health facility for testing, offer community HIV 
screening and explain the process and benefits. 
c. For those who decline community screening, remind them of the need for periodic testing to 
protect their health and offer to assist them with health facility testing and/or community 
screening at a later date. 
d. For those who accept community screening, explain the test procedure and assist the client to 
perform the test providing as much assistance as is needed and/or requested, especially 
regarding interpreting the result. 
e. For clients with reactive community screening results, (i) advise them to get a confirmatory test 
at a health (ii) offer to facilitate making an appointment for testing to accompany them to a 
health facility for testing, and (iii) provide FSW with a referral card to be submitted to the health 
facility. 
f. For clients with non-reactive community screening results, (i) remind them of the need for 
protective behaviors (i.e., condom and lubricant use, periodic STI screening), (ii) remind them of 
the need for periodic HIV testing and reinforce prevention measures and (iii) offer a referral card 
in case FSW want a confirmatory test at a health facility (if there is concern about the accuracy 
of the community screening test). 
g. The current procedures for tracking whether FSW were tested, and if positive for HIV had 
initiated treatment, will be unaffected by the community screening study. 
3. Implementation Guidelines: Unassisted Community Screening 
Because of differences in the structure of sex work and in the enabling environment in different 
districts, it will be necessary to develop the details of unassisted community screening on a district-
by-district basis. Ideally, the same unassisted community screening intervention would be 
implemented in the same way in all intervention districts, but if this is not possible due to the 
factors outlined above, allowing some details to vary across districts is preferable to trying to 
implement a standard protocol that is expected a priori to fail in some locations.  
For unassisted community screening, in which OW don’t have face-to-face contact with FSWs, 
possible mechanisms for distributing Ora-Quick test kits entail:  
a. Trained PE/PL identifying various online networks in which FSWs use to solicit their service.  
b. Trained PE/PL building trust from FSWs to participate in the study. 
c. Trained PE/PL send broadcast message containing brief information of the study, eligibility 
criteria for participation, step-by-step method to order the kit and have it delivered to their 
address, short link for description of how to use the kit (flier or short video), and mandatory 
baseline and post-test survey. Test kit delivery will be done by same-day delivery system (Go-
Send/Grab Send) from selected places where the test kit will be stored (Implementing Unit 
Office or selected health care facilities) to client’s address. Trained peer leader/peer educator 
could also distribute the test kit but not participating in the testing by assisting FSW during the 
test.  

 
CBS Protocol Final Version 31 January 2020 
 
22
d. Trained PE/PL carrying out follow-up for FSWs being previously approached for the test. The 
same trained PE/PL is assigned to be the contact person/hotline for each FSW they approached 
and agreed to take the test.  
e. FSW send/upload results of the test along with a completed post-test survey. Cash (mobile top-
up) incentive will be transferred to FSW who send the test results and post-test survey. Every 
kit distributed will have unique code and FSW will be asked to fill it in both baseline and post-
test survey to ensure one FSW is entitled to only one test kit.  
f. For clients with reactive community screening results, (i) advise them (online) to get a 
confirmatory test at selected health facility (ii) offer to facilitate making an appointment for 
testing to accompany them to a health facility for testing, and (iii) provide FSW with a referral 
card to be submitted to the health facility. Another possible option is to have the referral cards 
within the test kit, therefore when FSW with reactive results do not wish for their result to be 
revealed other than towards the post-test survey platform and health officers, they can access 
health facility for confirmatory test. Information on what’s needed to be done when one finds 
reactive test result has to be mentioned in detail within the instructional fliers or video.  
g. For clients with non-reactive community screening results, (i) again online reinforce prevention 
measures, (ii) remind them of the need for periodic testing and (iii) offer a referral card in case 
FSW want a confirmatory test at a health facility (if there is concern about the accuracy of the 
community screening test). In the case where referral card is included within every box 
containing test kit, FSW with non-reactive result might still be able to bring the card to selected 
health facility to get a confirmatory test. 
4. Implementation Guidelines for Control Group (Standard Program) 
For the control group, there will be no new interventions implemented (that is, they will continue 
with “business as usual”). In each control site, there is an implementing unit (IU) responsible for 
conducting outreach for FSWs. The outreach target is set up for one year, meaning that a sex 
worker will only be outreached once in a year. The outreach packet should include condoms and 
lubricant distribution as well as HIV-AIDS education media distribution. Furthermore, each IU also 
has a certain number of HIV tests to fulfill every six months. To achieve the target, the IU should 
reassure sex workers to do HIV test at least once every six months. While it is possible for a sex 
worker to have HIV test in three months interval, only one test is count for a sex worker every six 
months. The test could be conducted at health facilities or mobile clinics. A mobile clinic could be 
conducted at any place where convenient to the participants, such as workplace or living space. 
For FSWs with reactive test results, they will then be referred to health facility to start on ART.  
Except for outreach, all above mentioned activities are incentivized. Below are details of incentives 
given to PL/PE based on current standard program: 
1. Cash incentive of 70,000 IDR for every client who referred for HIV testing to health facilities. 
2. Cash incentive of 25,000 IDR for every client taking the test after being reached through mobile 
outreach. 
3. Cash incentive of 50,000 IDR for every client with positive confirmatory test starting on ART.  
 
 

 
CBS Protocol Final Version 31 January 2020 
 
23
5. Incentives for Participation  
Incentives will be given for different participation role in this study: 
1. For all eligible FSWs participating in baseline survey will be given 50,000 IDR  
2. For FSWs taking VCT and reporting the results will be given 100,000 IDR 
3. For FSWs doing CBS AND uploading/sending test result will be given 100,000 IDR 
4. For FSWs participating in post-test survey (both assisted and unassisted) will be given 50,000 
IDR 
5. Cash incentive 100,000 IDR for transportation and registration and/or fee for confirmatory test 
for CBS reactive result for FSWs who go to health care facility for confirmatory test (assisted 
and unassisted) 
6. Cash incentive 100,000 IDR for transportation and registration and/or fee for confirmatory test 
for CBS non-reactive result for FSWs who go to health care facility for confirmatory test 
(assisted and unassisted) 
Incentives will be given for different role of PL/PE in this study: 
1. For PL/PE who assists FSWs for taking self-screening (including filling in baseline and post-test) 
will be given 150,000 IDR 
2. For PL/PE who delivers test kit to FSWs who opt for unassisted screening AND obtain baseline 
survey on the spot will be given 100,000 IDR 
 
Incentives will be given for health facility: 
For collecting data on FSWs who do confirmatory test (assisted and unassisted). Funds to cover 
additional operational cost will be given to each implementing unit (IU) for delivering test kit via 
Go-Pay/Grab Pay Top-Up to client’s address. 
 
D. LINKAGE TO HEALTH SERVICES FOR ARV INITIATION  
Outreach workers will navigate clients to health care facilities for confirmatory test and ARV 
initiation if the result is confirmed as positive. Health care facilities in each district will be selected 
by their readiness to offer Test & Treat (T&T). Clients who come for confirmatory test are expected 
to be started for ARV initiation on the same day of confirmatory test.  
E. DATA COLLECTION PROTOCOLS 
1. Baseline survey 
A short baseline survey will be conducted at the time of initial outreach contact with FSW during 
the study period. The purpose of the baseline survey is to collect background information on FSW 
that may be used to assess whether FSW with different characteristics are more or less amenable 
to community HIV screening and HIV testing at health facilities. An application will be developed 
so that the survey can be completed and submitted to a server using mobile phones PL/PE/FSW.  
The following basic information will be gathered (see draft questionnaires for the baseline and 
post-test surveys in the annex of this protocol).  
• 
Name (full name/initial) 
• 
Age 
• 
Date of birth 

 
CBS Protocol Final Version 31 January 2020 
 
24
• 
Test Kit ID Number 
• 
Education 
• 
Marital status 
• 
Age at initiation of sex work 
• 
Number of clients last seven (7) days 
• 
Methods of clients’ recruitment (fixed facility, street, internet, online platform) 
• 
Consistency of condom use 
• 
Ever been tested for HIV 
• 
When last time tested 
• 
Ever been diagnosed with an STI (other than HIV) 
In addition to these questions, FSW will be asked twelve (12) questions in the short version of 
anticipated HIV stigma scale (Reinius et al., 2017) designed to measure the extent to which 
participants anticipated negative intrapersonal and interpersonal consequences were they to 
contract HIV in the future. During data analysis, we will assess the ability of an index constructed 
from the data items collected to predict which FSW presented at health facilities for formal HIV 
testing. This will provide an estimate of the impact of anticipated stigma on HIV testing among 
FSW in Indonesia.  
2. Post-test Survey  
A short post-test survey will be conducted after the test has been taken. The purpose of post-test 
survey is to collect information of the experience of clients using the test kit and to record the test 
result. Some inquiries will be presented on a scale of 1-5, some inquiries will have binary answers 
(Yes/No, Reactive/Non-Reactive). The following inquiries will be made: 
• 
The clarity of information being provided (flier or short video), on a scale of 1-5 
• 
The easiness of test procedure, on a scale of 1-5 
• 
Perceived accuracy of the test result, on a scale of 1-5 
• 
The quality of response by the assigned contact person/hotline, on a scale of 1-5 
• 
Clients’ acceptance/perception towards the study procedure  
• 
The likelihood of clients to recommend their peers to take the test, on a scale of 1-5 
• 
Test result 
• 
How likely is it that the client will get a HIV test at a health facility as a result of the 
community screening test, on a scale of 1-5 
• 
Comments and suggestions. 
3. Routine Recording  
Because of limitations in the data recorded and reported by health facilities, the study will rely 
primarily upon data recorded by IU outreach staff. Modifications will be made to the data 
recording and reporting systems currently being used to facilitate collection of the data needed 
for the study in a manner that minimizes additional recording and reporting burden. The nature of 
the adjustments to be made will be different for “assisted” and “unassisted” community 
screening.  
 
 
 

 
CBS Protocol Final Version 31 January 2020 
 
25
To capture the data needed for of this study, the following data need to be recorded: 
No Data Recorded  
Intervention Group 
Control Group 
1 
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 
Yes 
2 
Numbers of FSW offered for HIV test at 
health facility 
Yes 
Yes 
3 
Numbers agreeing and disagreeing to 
testing at a health facility 
Yes 
Yes 
4 
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 
Yes 
5 
Number of FSW offered for OFT screening 
Yes 
No 
6 
Among FSW not agreeing to be tested at a 
health facility, the numbers that agreed to 
(1) assisted community HIV screening and 
(2) unassisted community HIV screening 
Yes 
No 
7 
Numbers that were actually screened, 
assisted and unassisted 
Yes 
No 
8 
The number of community screening tests 
that were reactive 
Yes 
No 
9 
Among FSW with reactive community 
screening tests, the numbers that were 
subsequently tested at a health facility 
Yes 
No 
10 
Number of FSW initiating ART 
Yes 
Yes 
 
For unassisted approach, additional information will be gathered as indicated below: 
1. Numbers of FSW who access the link online 
2. Numbers of FSW who are deemed eligible 
3. Numbers of FSW who fill in baseline survey and agree to participate 
4. Numbers of FSW who agree to take HIV test at health facility 
5. Numbers of FSW who request the kit being delivered vs picking-up at fixed location 
6. Numbers of FSW who upload the test result 
7. Numbers of reactive vs non-reactive test result 
8. Numbers of FSW who complete the post-test survey 

 
CBS Protocol Final Version 31 January 2020 
 
26
9. Among FSW with community screening tests, the numbers that were subsequently 
tested at a health facility (reactive OR non-reactive) 
10.Number of FSW initiating ART 
4. Numbering System for Test Kit and Other Instruments 
a) Recording Test Kit ID 
Every test kit will have a unique ID number, which will later be referred to as the Kit ID number. 
The Kit ID Number is to be filled in on all instruments and forms that are to be linked to the test 
results (e.g., baseline survey, test results form, post-test survey, routine data record in each IU, 
etc.). This number needs to be identified at all times to make sure that each participant is only 
assigned to one test kit, matching the kit with the results, and to track the stock of the test kit 
remained. The format of this ID kit will be “01-001”, where the first 2 digits are to identify the 
number of the district in which participants take the test, and the last 3 digits are to identify which 
test kit the participant is using. This test kit ID will also be later used for each IU to track the 
distribution of the test kit. Every test kit being distributed, either in a fixed place or delivered 
through same-day delivery services, will be recorded and tracked by each IU. An MS Excel or MS 
Access form will be developed to record and track the Kit ID Number. 
 
b) Recording temporary FSW ID  
On the ground of confidentiality, participants’ full name will not be revealed and used within this 
study. A new system to ensure the reliable yet confidential identification of study participants 
needs to be established. Every participant in the study will be assigned to a temporary FSW ID. The 
format will be the first 4 letters of participants’ names added by the date of birth (yy/mm/dd). For 
example, a participant named “INDRIYANTI” who was born on March 5th, 1976, her temporary FSW 
ID will be “INDR760305”. For FSW whose name contains only 3 letters, the number zero will be 
added after the last letter. For example, an FSW whose name is “AYU” and was born on March 
5th1976, her temporary will be “AYU0760305”. This temporary FSW ID will be used to ensure that 
each participant is only assigned to one test kit, to track test results, and to be filled in the baseline 
and post-test survey.  
 
c) Matching Test Kit ID and temporary FSW ID 
To match the test kit ID and temporary FSW ID, an automatic system needs to be developed to 
detect it precisely. This way, we can be sure that each participant only gets to participate in this 
study once (from receiving the kit, performing the test, and reporting the result). 
 
d) Paper Based Data Collection 
In the event that participants’ data are collected by paper, a procedure to upload the data into the 
established online system will be developed. Each data manager in the IUs needs to conduct the 
procedure regularly. This is to ensure that all data are being captured thoroughly. 
 
F. DATA ANALYSES  
The data analyses to be undertaken will be directed to addressing the research questions laid out 
at the beginning of the protocol and statistical tests appropriate to each specific analysis will be 
performed to inform the interpretation of results.  The specific steps in the data analysis will be as 
follows: 
1. Compare the characteristics of FSWs who receive self-testing and blood testing. 

 
CBS Protocol Final Version 31 January 2020 
 
27
2. Compare the characteristics of FSWs who receive assisted and unassisted self-testing. 
3. Compare proportion of FSWs taking confirmatory test out of those who receive the test in the 
assisted and unassisted self-testing. 
4. Compare the proportion of FSWs who receive HIV test out of those who got offered for the test 
(including self-testing) in the intervention group with proportion of FSWs who receive HIV test 
in the control group. 
5. Compare the proportion of FSWs taking confirmatory test (including self-testing) out of those 
receive the test in intervention groups and control group. 
6. Compare the proportion of HIV positive in the assisted, unassisted (intervention) and HIV 
positive in the control group. 
7. Compare the proportion of ART initiation in the assisted, unassisted (intervention) and the 
control group. 
8. Calculate the cascade of HIV testing and treatment. 
9. Compare stigma scores and FSWs who went to a health facility for HIV testing between assisted, 
unassisted group. 
10. Compare the HIV and STI risk behaviors between assisted and unassisted group.  
G. CONTINGENCY STUDY DESIGN 
Should the OraQuick® test kits not become available in sufficient time to conduct a full-scale cRCT, 
a smaller-scale study will instead be undertaken. The purpose of the smaller study is the same as 
the cRCT described above, and the same protocol described above will be implemented. But the 
comparison is achieved targets between before and after intervention – there will be no 
comparison districts. The study will be undertaken in three (3) districts. The three districts will be 
selected from different parts of Indonesia, and they are: Kota Bandung (west part of Indonesia), 
Kota Denpasar (central part of Indonesia), and Kota Makassar (center-east part of Indonesia). 
The primary limitations of the smaller-scale study are (1) the districts were not randomly chosen 
and (2) the proportion of HIV testing before and after intervention that might not sufficient to 
produce a statistically significant result to prove the success of the intervention. This smaller-scale 
version of the study should be viewed as a demonstration or pilot project leading to a bigger study 
afterwards.  
Data analysis will be done by comparing changes in outcome variables measured against results in 
the four semesters prior to the study in the 3 districts compared to the other 20 acceleration 
districts. 
Analysis of outcome variables are similar with the cRCT approach as below: 
1. Compare the characteristics of FSWs who receive self-testing and blood testing in 3 districts. 
2. Compare the characteristics of FSWs who receive assisted and unassisted self-testing 3 districts. 
3. Compare proportion of FSWs taking confirmatory test in the assisted and unassisted self-testing 
3 districts. 

 
CBS Protocol Final Version 31 January 2020 
 
28
4. Compare the proportion of FSWs who receive HIV test including self-testing in the intervention 
group with proportion of FSW who receive HIV test in the control group (in 3 districts before the 
intervention and other 20 acceleration districts).  
5. Compare the proportion of FSWs taking confirmatory test (including self-testing) in the 
intervention group with proportion of FSW who receive HIV test in the control group (in 3 
districts before the intervention and the other 20 acceleration districts).  
6. Compare the proportion of HIV positive in 3 districts (assisted and unassisted) and HIV positive 
in the control group (in 3 districts before the intervention and other 20 acceleration districts). 
7. Compare the proportion of ART initiation in 3 districts (assisted and unassisted) and the control 
group (in 3 districts before the intervention and other 20 acceleration districts). 
8. Calculate the cascade of HIV testing and treatment. 
9. Compare stigma scores and FSW who went to a health facility for HIV testing. 
10. Compare the HIV and STI risk behaviors. 
 
H. RESEARCH ETHICS AND PERMISSION 
Participation in the study will be entirely voluntary. For the assisted testing, formal signed consent 
or witnessed verbal informed consent will be obtained by outreach workers. Records of informed 
consent will be managed /safeguarded using sealed envelope with unique number. To ensure the 
confidentiality, in the base line data only unique number will be recorded. A draft of the informed 
consent form can be found in Annex-3 of this protocol.  
For unassisted screening, every study participant should fill in the check box of website or 
application to provide consent: “By signing this form/ticking this box, I understand that I am 
thereby agreeing to enroll in this study” and test kit is not sent out if the check box is not checked 
by the user. 
This protocol will be reviewed by the Faculty of Medicine Udayana University Institutional Review 
Board (IRB) prior to study initiation. Approval of the protocol in either its original or modified form 
is required. 
Research permission will be submitted to Department of Internal Affairs Republic of Indonesia, 
which will subsequently be referred to the licensing office in each provinces and priority districts.  
 
 
 
 
 
 
 
 
 
 
 
 
 

 
CBS Protocol Final Version 31 January 2020 
 
29
Annex 1. Flowchart of Routine Data Recording  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FSW Outreach 
Information delivery 
FSW agreed to participate 
FSW perform VCT or CBS 
with OFT 
Completion of baseline 
survey  
Completion of post-test 
survey 
Encourage confirmatory 
test for reactive/ 
indeterminate result OR 
suggest repeating if result 
non-reactive 
 
Routine data recording 
Eligibility Form (Annex 2) 
Information Form for VCT (Annex 3) or Information 
Form for OFT (Annex 6) 
Informed Consent Form for VCT (Annex 3) or for OFT 
(Annex 6) 
Baseline Survey Questionnaire for VCT (Annex 4) or for 
OFT (Annex 7) 
VCT Test Confirmation and Results Form (Annex 5) or 
OFT Result Form (Annex 8) 
Post-test Survey Questionnaire (Annex 9) 
Referral Cards to Health Facilities (Annex 10) 
Referral Return and Confirmatory Test Result Form 
(Annex 11) 
ART Initiation Form (Annex 12) 
Health Facility Record Form (Annex 13) 

 
CBS Protocol Final Version 31 January 2020 
 
30
Annex 2. Eligibility Form 
Eligibility Participants Form for Intervention  
To be completed by PL/PE during FSW outreach 
These checklists are to be completed by PL/PE during FSW outreach to assess the eligibility of FSW to 
participate in this study. If questions number 1-7 is answered “Yes”, then participant is eligible for the 
study. If question number 8 is answered “Yes”, then participant is not eligible for the study, but 
eligible for “blood test study in health facility”. 
No 
Criteria inclusion 
Yes 
No 
1 
Female, aged 18 years old or more 
 
 
2 
Admit having transactional sex (vaginal, oral, or anal) at 
least once within the last one month 
 
 
3 
Have never had any HIV test taken within the last 6 months 
 
 
4 
Self-reported HIV Negative OR HIV status unknown 
 
 
5 
Agreed to participate in this study 
 
 
6 
Not currently participating in any other HIV prevention 
study 
 
 
7 
After being offered for HIV testing in health facility, 
participant stated: 
A. Agree for HIV testing in health facility* 
B. Not agree for HIV testing in health facility** 
 
 
 
 
Note: 
* Use information form for VCT 
** Use information form for OFT 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
CBS Protocol Final Version 31 January 2020 
 
31
 
Annex 3. Informed Consent Form (VCT) 
 
Inform Consent Form  
Community Based Screening for HIV Self-Testing in Female Sex Workers in 
23 Priority Districts in Indonesia 
 
Invitation  
You will be invited to participate in study community-based screening for HIV self-testing in female 
sex workers in 23 priority districts in Indonesia (CBS in FSWs). This study uses a new approach to 
encourage people undertake HIV testing. For those who are detected infected, will get a treatment 
immediately.  
CBS in FSWs conducted by research team in Kerti Praja Foundation (YKP) whereby dr. Pande Putu 
Januraga, M. Kes, DrPH as the principal investigator (PI). 
You have to understand this study deeply before deciding whether you want to take part as a 
participant or not. Please read and grasp the following information and discuss it with somebody 
else if you want. 
1. What is the purpose of this study? 
HIV infection has been more common among FSWs, LSL or shemale. The previous study 
defines that those groups are rarely undergo HIV testing because of many reasons. They, 
accordingly, loss an opportunity to obtain a cure early. Treatment of HIV early is fairly essential 
to prevent the infection become worst. It possibly, furthermore, decreases the transmission 
for their sex partner. 
The purposes of this study that identify some well- approaches to encourage many people 
specifically FSWs to undertake HIV testing, and for those had infected can start the HIV 
treatment immediately and continue to get cure regularly. The outcome of CBS’ study will 
contribute for improving HIV program in Indonesia or even across countries.   
 
2. Why am I invited to participate in this study? 
You qualified to participate in this study because you are a female sex worker (FSWs), your age 
is 18 or over, never been tested to HIV since the 6-last month, never been diagnosed infected 
or do not known the HIV status yet. Moreover, you do not want to take HIV blood-testing. For 
this study, it is expected at least 761 qualified FSWs to be a participant in Indonesia. 
 
3. If I get anxious to take part or if I want to withdraw to participate in this study, what can I do? 
For this study, you never been forced to participate due to it is voluntary. Whatever your 
decision, it never influences your treatment has been received nowadays or later on. It will not 
influence your relationship with those medical staffs who are treating you as well. 
 
You can withdraw from this study after started or whenever without provide a reason.  
 
4. if I become a participant of this study, what will happen? 

 
CBS Protocol Final Version 31 January 2020 
 
32
If you do agree to participate, you need to give a signature or an agreement in inform consent 
form. This study is conducted in 23 districts/cities as the intervention group. 15 districts/cities 
preferred as intervention group while 8 districts/cities have been selected as the control group. 
If you live in those control areas, outreaching procedure and HIV testing will be conducted as 
usual rely on implemented HIV procedure, such as through health services or mobile VCT. If the 
test result is reactive, you will be referenced to health facilities in regard to get treatment 
immediately.  
If you live in those districts/cities who are intervened, and you do not want to undergo the 
conventional test (blood-testing), you will be offered a self-testing which is Ora-Quick®. It is 
recognized as screening test or rapid test whereby its test results can be known between 20-
40 minutes. You can prefer to get screening test, assisted by PL/PE (assisted screening) or 
without assisted (unassisted screening). 
For this study, you are asked to answer some preliminary questions before starting the 
screening test. You undertake the testing and report the test result afterwards. If you prefer 
conducting the test by assisted, they are required to help you to conduct the test completely. 
They assist you to answer the preliminary questions; undertake the screening test; report the 
test result. They help you to take confirmatory test as well and support you in terms of 
continually having HIV treatment. 
On the other hand, there is 3 modes to get the KIT test if you prefer to undertake the test 
without assisted. Firstly, you can ask PL to deliver the KIT devices to your place. You fulfill the 
preliminary questions by your own, then conduct the test without assisted. Secondly, you can 
order it by online. Do not be hesitate because we created a CBS’ website (teman-kita) for you 
that all information has been provided. The test information has been advertised by social 
media (Facebook, Instagram, Twitter) as well. Its information includes Ora-Quick® testing (KIT) 
that encourage you to order it. While you order it, you can prefer the method of KIT delivering. 
You fulfill the preliminary questions and asking to deliver the device through Gosend or 
Grabdelivery without paying. Or you can ask PL/PE which their names have been listed in the 
website to carry out the KIT test for you or you can pick the KIT devices up in the spots which 
set up by the research team. 
Whatever your preferred method, you exactly must report the test result by take the result 
photo and send it to the research team via whats-app (WA) or upload it in the website. You 
asked, subsequently, to complete all questions after the test as well. 
It is important to realize that self-testing (oral fluid test) is only a screening test in which it 
needs an additional test to ensure the result. If the test result is reactive or indeterminate, you 
expectedly must go to health facilities to get a diagnose and treatment. PL/PE can facilitate 
you to access health facilities or if you want, you can go alone. The information of test result 
and references health services can be found in the website.   
As the explanation previously, you will be required to fulfill the question in the early and also 
at the end. In the early before starting the test, you will be asked to give some basic 
information about identity which are name, age, HIV test history, your behavior and your 
outlook of stigmatization. At the end, meanwhile, you should review the performance of Ora-
Quick® test KIT. The reviewing of devices includes clearly information how to use it; the 
confidence of the result; giving recommendation for friends or not; the role of PL/PE while 
conducting the test; ensuring the test result by take confirmatory test in health facilities (for 
the result is reactive or indeterminate) and; your comment in concern to improve a similar 

 
CBS Protocol Final Version 31 January 2020 
 
33
study further. You have to realize that your identity will put in secret whereby we use it only 
for CBS study. Your identity specifically name, even more, will be code during data processing 
to protect your personal privacy. You are freely to refuse to take part in this study or withdraw 
or postpone as a participant.  
5. How is the funding for this study? 
CBS study funded by United Nations for Population Fund (UNFPA).  
6. Is there any risk if I participate in this study further? 
You possibly feel uncomfortable or shameful while you are being interviewed or fulfill the 
questions. However, PL/P who have been known closely will assist you to finalize all steps in 
the study. If you prefer to be counted in unassisted group, all questions can be answered 
privately. Possibly, you are under the pressure, confusion, sad, angry if the test result is 
reactive. Access to health facilities, however, absolutely help you to start HIV treatment. So, 
all negative reaction might be can be overcome. 
7. If I get suffer or injury or HIV complication due to this study, what can I do? 
We do believe that you cannot get suffer or injury or HIV complication because of this study.  
8. Can I get a benefit from this study? 
Being participate, your HIV status will be acknowledged whether you are infected or not. 
Furthermore, if your test result is reactive, it leads you to ensure the diagnose freely without 
paying even If you decided to start the treatment. CBS study, indirectly, aims to increase 
knowledge and contributes to improve HIV program further. 
9. Should I have to pay to take part as participant or will I get paid?  
It is free or not paying anything to participate in this study. Laboratory test and HIV treatment 
provided freely for you. You will receive, furthermore, such amount of money as incentive due 
to your giving time and your participation. For your readiness to fulfill the questionary before 
and after the test, you can receive Rp. 100.000,-. If you conduct the testing and send the result 
for us (reactive, non-reactive or indeterminate) you will also be paid amount Rp. 100.000,-. If 
you decide to conduct the subsequent test in order to ensure the screening test result in clinics 
or another pointed health facilities, you will receive incentive amount Rp. 100.000,-. 
 
10. Is my privacy protected? 
There is only research team; peer leader; peer educator; medical staffs include doctor and 
those staffs who treat you, will know your participation in this study. identified Information as 
a participant will be kept in secret and only released by your permission or if it is required by 
law. Your personal identity will be deleted before sharing to other researchers who get 
involved in this study.  
 
11. How about the result? 
We have a plan to produce an article and published it in peer review journal. Or we precent it 
in the conference and professional forum if we have an opportunity. We are willing to publish 
the result routinely as well in annual report. The data will brighten the perspective of 
stakeholders about HIV among FSWs and leads them to develop a good health policy. Turning 
to the publications, your identity will not be released. The outcome of analysis will give it to 
you, if you want.  
 
12. What will be happen to my treatment after the study? 

 
CBS Protocol Final Version 31 January 2020 
 
34
You can continue to get treatment as usual based on the standard of services of Indonesians 
government even though study has been ended on schedule or not on schedule.  
 
13. What can I do, if I am willing to discuss about this study deeply before I decide to participate 
or not? 
If you want more information, you can discuss it with the principal investigator namely dr. 
Pande Putu Januraga, M.Kes., DrPH. Do not be hesitate to contact him in 081246180389. 
 
14. Who should be contacted if I am worried about the implementation of this study? 
This study has been approved by ethical commission of health-research of Medical faculty in 
Udayana University/ Sanglah hospital. If you are anxious or have a complaint about the 
implementation of CBS study, you can contact researchers’ team or ethical commission of 
health-research of Medical faculty in Udayana University/ Sanglah hospital. 
 
Principal investigator 
dr. Pande Putu Januraga, M. Kes, DrPH.  
(+62 812 4618 0389) 
 
Research coordinator  
I Gusti Agung Agus Mahendra, MPH 
(+62 857 9236 0767) 
 
 
Thank you for your time to consider whether you are going to participate or not 
If you want to take part, please give a signature on the form agreement (next page). 
This information page is given to you to save it. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
CBS Protocol Final Version 31 January 2020 
 
35
 
 
The Agreement to Participate in The Study 
The research of community-based screening HIV self-testing for the female sex workers 
in 23 prioritized districts or cities in Indonesia 
1. I am ................................................................................................................. 
are living in……………………………………………………… 
agree to participate as the participant of the study that is explained on the form 
information participation is explained above (or it is attached on this form) 
2. I acknowledge that I have read the form participants information, who explained 
why I have been chosen, the aim of the study, the nature and the possible risk of 
study, and the information form has given the explanation in detail, so I do 
understand it clearly. 
3. Before signing this agreement, I have been given a chance to ask some questions 
in terms of each mental and physical risk which is possible I suffers as the 
consequence of participating and I have received the satisfied answers.  
4. I understand that I can withdraw from this study anytime without influencing my 
relationship with health services of Non-Government Organization (NGO) who 
accompanied me right now.  
5. I agree that the research data which is collected of this study can be published with 
give protection of my identity. 
6. I agree that If I have questions concern on taking part as participants of this study, 
I can inform dr. Pande Putu Januraga, M. Kes, DrPH in +62 812-4618-0389, which is 
glad to answer my questions. 
7. I acknowledge to receive a copy of the form agreement and the form of participant 
information.  
Complaint can be informed to Kerti Praja Foundation, Phone: (0361) 728916. 
 
 
_______________________________________________________________ 
Canceler signature  
Writing in capital letter   
Date 
 
_______________________________________________________________ 
*only be needed if you cannot read or blind 
Note: directly inputted to the system 
 
 

 
CBS Protocol Final Version 31 January 2020 
 
36
 
The Revocation of Participation on The Study  
Research of Community Based Screening HIV Self-Testing for Female Sex 
Workers in 23 priority regencies/cities in Indonesia 
With this letter, I CANCEL the agreement to participate in the study that has been explained 
above and I understand that this cancellation WILL NOT be dangerous for the treatment or my 
relationship with Kerti Praja Foundation or my medical staffs.  
 
 
___________________________________ 
 
_________________ 
Signature 
 
 
 
 
 
Date 
 
 
___________________________________ 
Writing the name in capital letter 
 
Part of revocation of agreement if forward to: 
dr. Pande Putu Januraga, M.Kes, DrPH 
di Jalan Raya Sesetan No. 270, Denpasar, Bali, Indonesia 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
CBS Protocol Final Version 31 January 2020 
 
37
 
Annex 4. Baseline Survey Questionnaire (VCT) 
 
Baseline Survey Questionnaire 
Introduction 
Thank you for your willingness to participate in this study and to answer this simple questionnaire. 
Your participation is greatly valued. Allow us to provide some more information regarding the 
survey.  
Firstly, this study is part of a national study in evaluating the most appropriate method for HIV 
testing for female sex workers who are at least 18 years of age, have never been tested for HIV and 
have not undergone HIV testing in the last 6 months but would like to receive HIV blood testing at 
this time.  
Secondly, your participation and personal information will be kept confidential. Only the research 
team will know you, and you will not be writing your name or any identifying information explicitly 
on this questionnaire.  
Additionally, only the research team will know your answer. Each questionnaire has been given a 
code, such that your personal details will be safe and can only be accessed by the research team.  
Thirdly, the findings in this study will be presented as a collective result, such that personal 
information will not be presented, including yours.  
Fourthly, you may refuse to answer the questions given, however we will greatly appreciate if you 
answer all the questions, as it will assist us in generating better results.   
Should you have doubts regarding a particular question or certain words in this questionnaire, do 
not hesitate the contact us (at OW/PE’s phone number: ________________________) for further 
explanation. There is no right or wrong answer, please provide that answer that you consider most 
accurate.  
 
Are you ready to begin?  
Note: directly inputted to the system 
 
Baseline Survey for All Participants (Blood testing at healthcare facility and HIV self-testing) 
Participant Code Number 
 
Name of OW/PE (assisted) 
 
1. 
Please write your full name or initials 
 
2. 
What is your date of birth?  
Day: ___Month: __ Year: ____ 
3. 
Your age is  
……years old 
1. Did not attend school 

 
CBS Protocol Final Version 31 January 2020 
 
38
4. 
What was the education level you last 
received? 
2. Did not complete elementary school/ 
equivalent 
3. Completed elementary school/equivalent 
4. Did not complete middle school/equivalent 
5. Completed middle school/equivalent 
6. Did not complete high school/equivalent 
7. Completed high school/equivalent 
8. Ever attended/completed bachelor studies 
5. 
What is your current marital status? 
1. Never married 
 
2. Married (including unofficial marriages) 
 
3. Separated  
 
4. Widowed  
5. Divorced 
6. 
Do you have a consistent partner 
(boyfriend/husband) in the past 
month?  
1. Yes 
2. No 
 
7. 
What was your age when you first 
engaged in sex with a client?  
    ………….. (years of age) 
8. 
What is the approximate number of 
clients you had in the past 7 days?  
    ………….. (people) 
9. 
How often do you use condom when 
engaging in sex with your clients in the 
past month?  
1. Always 
2. Very frequent 
3. Often 
4. Sometimes 
5. Never 
 
10. 
Where do you usually look for or find 
your client (potential client)? 
(CHOOSE ALL THAT APPLY) 
a. Location 
b. Streets 
c. Spa 
d. Café 
e. Karaoke 
f. Salon 
g. Bar  
h. Massage parlour 
i. On-line (web application, SMS, social 
media) 
j. Others, ______________ 

 
CBS Protocol Final Version 31 January 2020 
 
39
11. 
Have you ever experienced symptoms 
such as abnormal vaginal discharge, 
itching, or pain during sexual 
intercourse? 
1. Yes 
2. No 
3. Not sure 
12. 
Have you ever been diagnosed with a 
sexually transmitted infection by a 
doctor in the past six months? 
1. Yes 
2. No 
3. Not sure 
13. 
When was the last time you took an 
HIV test? 
1. Never 
2. 6 to 12 months 
3. more than one year to two years 
4. more than two years 
14. 
In the past one year, have you ever 
received an HIV test offer? 
1. Yes 
P.15 
2. No 
 P.17 
15. 
Did you agree or decline to undergo 
the HIV testing?  
1. Agree 
2. Decline 
 P.16 
16. 
Why did you decline the HIV testing at that time?  
(Choose all that apply) 
a. Afraid to have blood sample taken 
1. Yes 
2. No 
 
b. Fear of needle/injection 
1. Yes 
2. No 
 
c. Afraid of receiving a positive result 
1. Yes 
2. No 
 
d. Afraid that others might know 
about the results 
1.  Yes 
2.  No 
 
e. Uncomfortable while undergoing 
testing (crowd, time, etc)  
1. Yes 
2. No 
 
f. Live far from community health 
centre/hospital/clinic  
1. Yes 
2. No 
 
g. Embarrassed to undergo testing at 
the clinic 
1. Yes 
2. No 
 
h. Perceive to have low risk 
1. Yes 
2. No 
 
i. Other reasons, please mention 
_____________________________ 
 
 
17. 
Where did you hear about HIV self-testing?  
(Choose all that apply) 
a. Staff/NGO/Foundation  
1. Yes 
2. No 
b. Friends 
1. Yes 
2. No 
c. Someone at the workplace 
(madam, security, etc.) 
1. Yes 
2. No 
d. Internet  
1. Yes 
2. No 
e. Social media 
1. Yes 
2. No 

 
CBS Protocol Final Version 31 January 2020 
 
40
f. Chain messages (broadcasted 
messages) 
1. Yes 
2. No 
 
g. Others, __________________ 
1.  Yes 
2.  No 
 
QUESTIONS ON STIGMA 
No 
Question 
Extremely 
Disagree  
Disagree 
Agree 
 
Extremely 
Agree 
 
 
Personalized stigma 
 
 
 
 
1 
Others will avoid touching me if I am infected 
with HIV  
 
 
 
 
2 
I am worried that my 
family/friends/partner/husband/boss will end 
their relationship/contact with me if I am 
infected with HIV  
 
 
 
 
3 
I am worried that I will lose my friends if I am 
infected with HIV  
 
 
 
 
 
Concerns with Revealing Status 
 
 
 
 
4 
Revealing to others that I am infected with HIV 
will pose a risk to me  
 
 
 
 
5 
I have to conceal my status if I am infected 
with HIV  
 
 
 
 
6 
I might have to be extremely careful to whom I 
reveal that I am infected with HIV  
 
 
 
 
 
Concerns regarding public attitude 
 
 
 
 
7 
I am afraid that I will be treated like an 
unwanted person if I am infected with HIV  
 
 
 
 
8 
Most people believe that those infected with 
HIV are dirty  
 
 
 
 
9 
Most people feel uncomfortable being around 
people living with HIV  
 
 
 
 
 
Negative Self Perception 
 
 
 
 
10 
I feel at fault if I am infected with HIV  
 
 
 
 
11 
Others attitude towards HIV will worsen my 
feelings if I am infected with HIV  
 
 
 
 

 
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12 
I feel that I am not as good as others if I live 
with HIV  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Annex 5. VCT Test Confirmation and Result Form 
FOLLOW-UP PARTICIPANT WHO CHOOSE TO PERFORM HIV BLOOD TEST AT HEALTH FACILITY 
1 
If participant agreed to perform HIV blood test in health 
facility, did she really go for it? (Needed to be validated at 
health facility) 
1. Yes 
2. No 
2 
Test result 
1. Reactive 
2. Non-reactive 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Annex 6. Baseline Survey Questionnaire (OFT) 
Introduction 
Thank you for your willingness to participate in this study and to answer this simple questionnaire. 
Your participation is greatly valued. Allow us to provide some more information regarding the 
survey.  
Firstly, this study is part of a national study in evaluating the most appropriate method for HIV 
testing for female sex workers who are at least 18 years of age, have never been tested for HIV and 
have not undergone HIV testing in the last 6 months but would like to receive HIV blood testing at 
this time.  
Secondly, your participation and personal information will be kept confidential. Only the research 
team will know you, and you will not be writing your name or any identifying information explicitly 
on this questionnaire.  
Additionally, only the research team will know your answer. Each questionnaire has been given a 
code, such that your personal details will be safe and can only be accessed by the research team.  
Thirdly, the findings in this study will be presented as a collective result, such that personal 
information will not be presented, including yours.  
Fourthly, you may refuse to answer the questions given, however we will greatly appreciate if you 
answer all the questions, as it will assist us in generating better results.   
Should you have doubts regarding a particular question or certain words in this questionnaire, do 
not hesitate the contact us (at OW/PE’s phone number: ________________________) for further 
explanation. There is no right or wrong answer, please provide that answer that you consider most 
accurate.  
 
Are you ready to begin?  
Note: directly inputted to the system 
 
Baseline Survey for All Participants (Blood testing at healthcare facility and HIV self-testing) 
Participant Code Number 
 
Name of OW/PE (assisted) 
 
1. 
Please write your full name or initials 
 
2. 
What is your date of birth?  
Day: ___Month: __ Year: ____ 
3. 
Your age is  
……years old 
4. 
What was the education level you last 
received? 
9. Did not attend school 
10. Did not complete elementary school/ 
equivalent 
11. Completed elementary school/equivalent 

 
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12. Did not complete middle school/equivalent 
13. Completed middle school/equivalent 
14. Did not complete high school/equivalent 
15. Completed high school/equivalent 
16. Ever attended/completed bachelor studies 
5. 
What is your current marital status? 
6. Never married 
 
7. Married (including unofficial marriages) 
 
8. Separated  
 
9. Widowed  
10. Divorced 
6. 
Do you have a consistent partner 
(boyfriend/husband) in the past 
month?  
3. Yes 
4. No 
 
7. 
What was your age when you first 
engaged in sex with a client?  
    ………….. (years of age) 
8. 
What is the approximate number of 
clients you had in the past 7 days?  
    ………….. (people) 
9. 
How often do you use condom when 
engaging in sex with your clients in the 
past month?  
6. Always 
7. Very frequent 
8. Often 
9. Sometimes 
10. Never 
 
10. 
Where do you usually look for or find 
your client (potential client)? 
(CHOOSE ALL THAT APPLY) 
k. Location 
l. Streets 
m. Spa 
n. Café 
o. Karaoke 
p. Salon 
q. Bar  
r. Massage parlour 
s. On-line (web application, SMS, social 
media) 
t. Others, ______________ 
11. 
Have you ever experienced symptoms 
such as abnormal vaginal discharge, 
4. Yes 
5. No 
6. Not sure 

 
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itching, or pain during sexual 
intercourse? 
12. 
Have you ever been diagnosed with a 
sexually transmitted infection by a 
doctor in the past six months? 
4. Yes 
5. No 
6. Not sure 
13. 
When was the last time you took an 
HIV test? 
5. Never 
6. 6 to 12 months 
7. more than one year to two years 
8. more than two years 
14. 
In the past one year, have you ever 
received an HIV test offer? 
3. Yes 
P.15 
4. No 
 P.17 
15. 
Did you agree or decline to undergo 
the HIV testing?  
3. Agree 
4. Decline 
 P.16 
16. 
Why did you decline the HIV testing at that time?  
(Choose all that apply) 
j. Afraid to have blood sample taken 
3. Yes 
4. No 
 
k. Fear of needle/injection 
3. Yes 
4. No 
 
l. Afraid of receiving a positive result 
3. Yes 
4. No 
 
m. Afraid that others might know 
about the results 
1.  Yes 
2.  No 
 
n. Uncomfortable while undergoing 
testing (crowd, time, etc)  
3. Yes 
4. No 
 
o. Live far from community health 
centre/hospital/clinic  
3. Yes 
4. No 
 
p. Embarrassed to undergo testing at 
the clinic 
3. Yes 
4. No 
 
q. Perceive to have low risk 
3. Yes 
4. No 
 
r. Other reasons, please mention 
_____________________________ 
 
17. 
Where did you hear about HIV self-testing?  
(Choose all that apply) 
h. Staff/NGO/Foundation  
3. Yes 
4. No 
i. 
Friends 
3. Yes 
4. No 
j. 
Someone at the workplace 
(madam, security, etc.) 
3. Yes 
4. No 
k. Internet  
3. Yes 
4. No 
l. 
Social media 
3. Yes 
4. No 
m. Chain messages (broadcasted 
messages) 
3. Yes 
4. No 
 
n. Others, __________________ 
1.  Yes 
2.  No 

 
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STIGMA QUESTION 
No 
Question 
Extremely 
Disagree  
Disagree 
Agree 
 
Extremely 
Agree 
 
 
Personalized stigma 
 
 
 
 
1 
Others will avoid touching me if I am infected 
with HIV  
 
 
 
 
2 
I am worried that my 
family/friends/partner/husband/boss will end 
their relationship/contact with me if I am 
infected with HIV  
 
 
 
 
3 
I am worried that I will lose my friends if I am 
infected with HIV  
 
 
 
 
 
Concerns with Revealing Status 
 
 
 
 
4 
Revealing to others that I am infected with HIV 
will pose a risk to me  
 
 
 
 
5 
I have to conceal my status if I am infected 
with HIV  
 
 
 
 
6 
I might have to be extremely careful to whom I 
reveal that I am infected with HIV  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Annex 7. OFT Result Form 
Number of KIT’s Code 
0 
1 
- 
0 0 1 
Participant’s Code 
 
Test Methods 
1.  assisted 
2.  unassisted 
Test result 
1. Reactive 
2. Non-reactive 
3. Indeterminate 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Annex 8. Post-test Survey Questionnaire 
KIT Code 
0 1 - 
0 0 
1 
Participant Code (First 4 letters, year, month, day) 
 
Name of OW/PE  
 
1. 
Please write your full name or initials 
 
2. 
How was the clarity of the information about 
HIV test kit you received/obtained? (Select one 
answer) 
1. Extremely unclear 
2. Unclear 
3. Fairly clear 
4. Clear 
5. Extremely clear 
3. 
When you performed HIV self-testing, was 
there any person (peer) who assisted you? 
1. Yes 
2. No 
4. 
How easy was performing an HIV test using the 
self-testing kit given? (Select one answer) 
1. Extremely difficult 
2. Difficult 
3. Fairly difficult 
4. Easy 
5. Extremely easy 
5. 
What was the reason that prevented you from 
testing using the test kit provided?  
 
1. 
Extremely difficult 
2. Difficult 
3. Fairly difficult 
4. Easy 
5. Extremely easy 
6. 
This question only applies for those who 
underwent the self-testing assisted by 
OW/PE.  
How would you rate the given support by 
OW/PE /contact people who 
accompanied/contacted you during HIV self-
testing? 
(Select an answer) 
1. Extremely unclear 
2. Unclear 
3. Fairly clear 
4. Clear 
5. Extremely clear 
7. 
This question only applies if your test results 
are negative. How much do you want to take 
an HIV test regularly after taking this test? 
1. Extremely not in favour 
 
2. Less in favour 
3.  Fairly in favour 
 
4.  In favour 
 
5. Very in favour 
 
8. 
How was your experience in performing this 
HIV self-testing (saliva test)? 
1. Extremely unpleasant 
2. Unpleasant 
3. Fairly pleasant 

 
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4. Pleasant 
5. Extremely pleasant 
9. 
How sure are you with the accuracy of this 
test 
1. Very doubt 
2. Less sure 
3. Fairly sure 
4. Sure 
5. Very sure 
10. 
How was your test result? 
 
1. Positive 
2. Negative 
3. Indeterminate 
11. 
How much do you want to confirm your test 
results to the healthcare facilities? 
1. Extremely unlikely 
2. Fairly unlikely 
3. Fairly likely  
4. Likely 
5. Extremely likely 
12. 
How likely are you to recommend your peers 
to undergo the screening test that you just 
performed? 
1. Extremely unpleasant 
2. Unpleasant 
3. Fairly pleasant 
4. Pleasant 
5. Extremely pleasant 
13 
How much do you trust the accuracy of the 
test result  
 
1.  Extremely unsure 
2.  Fairly unsure 
3.  Fairly sure 
4.  Sure 
  5.  Extremely sure 
14. 
What was your test result? 
1. 
Positive 
 P.13 
2. Negative 
 P.14 
15. 
If you are extremely unlikely or unlikely to visit 
a healthcare service, what are the reasons?  
    
 
16. 
What is your opinion regarding this HIV testing 
method? 
 
17. 
What are your suggestions for HIV self-testing?   
18. 
What are your suggestions and comments to 
improve the procedure of this study?  
 
Note: directly inputted to the system 
 
 

 
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Annex 9. Referral Cards to Health Facilities 
 
 
 
 
Annex 11. Referral Return and Confirmatory Test Result Form 
Annex 12. ART Initiation Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Referred Card of Health Services 
Dear …. 
medical staff, 
……………………………………………….. 
 
Name  
: ……………………………………. 
 
 
 
 
 
Age 
 
: ……………………………………. 
Address 
 
: ……………………………………. 
No. Kit code 
: ……………………………………. 
To receive medical treatment of HIV 
IU Organisation: ……………………………………. 
 
                   date ___/___/___ 
 
 
 
Signature PL/PE 
 
 
 
 
Signature client 
 

 
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Annex 10. ART Initiation Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ART Initiation Form 
I hereby provide my signature below to state that I have understood my condition and diagnosis 
given by the physician and I give consent to initiate ARV therapy starting from today and will 
comply with the treatment plan given to me.  
 
                        Date. ____/____/____                                                                          Date. ____/____/____ 
Physician’s name and signature 
 
 
 
      Patient’s name and signature  
 
               
   

 
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