Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04578145
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2020-09-13
Brief Title:
Community Based Screening for HIV Self Testing in FSW in 23 Priority Districts in Indonesia
Sponsor:
Kerti Praja Foundation
Organization:
Kerti Praja Foundation
Study Overview
Official Title:
Randomized Community Trial Community Based Screening for HIV Self Testing in Female Sex Workers in 23 Priority Districts in Indonesia CBS HIVST in FSW
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CBS-FSW
Brief Summary:
Indonesia is not yet on course to end HIV and AIDS by 2030 Epidemic transmission of HIV infection among key affected populations KAPs specifically FSWs crucially has contributed to not achieving the target Although the number of HIV tests performed annually has grown steadily in recent years reaching 3077653 in calendar year 2018 pregnant women is accounted for a fairly large proportion of an increased number of persons being tested MoH 2018
Regarding the FSWs it has been a significant challenge to increase HIV testing uptake among this population The challenge has been affected by Indonesias national policy to close brothels As consequence many FSWs have become hidden and hard to reach The implementation national policy also impacts on the way of commercial sex transactions in which it becomes underground especially many FSWs utilize the new popularity of digital platforms to sell sexual services It needs more effective case finding strategies to be implemented to reach them accordingly
If it is considered from the FSWs side there are some barriers to access HIV test services according to several reports They consist of lack of money time stigma discrimination low-risk perception fear lack of accessibility reluctance of health service providers to offer HIV testing and limited human resources Oral fluid HIVST using is an alternative to traditional HIV testing services in the facility or other healthcare provider testing UNAIDS 2016 For this study OraQuick is used as an alternative strategy for HIV testing among FSWs
The primary objectives of this study are to assess whether proportion of FSW who know their HIV status increases or not whether introduction of Oral fluid test increases the number of HIV testing at health facilities or not and whether assisted or unassisted community HIV screening have a result to an increasing proportion of HIV testing at health facilities or not Furthermore CBS study aims to assess whether assisted and unassisted community HIV screening results to an increasing number of HIV positive case finding or not and whether community HIV screening increases proportion of initiation of antiretroviral therapy ART or not The secondary objectives of this study meanwhile are to measure acceptability of community-based self-screening in participation and to measure satisfaction of FSWs who has participated towards the delivery of community-based self-screening
Regarding the inclusion criteria of this study participant must be women 18 years old or older at enrollment has a transactional sex vaginal oral andor anal at least once in the past month does not uptake HIV test in the last 6 months and acknowledges her HIV status negative or unknown There are several exclusion criteria which are FSW does not able to fulfill one of inclusion criteria that has been explained above FSW does not has desire to participate due to several reasons and she is currently participating in another HIV prevention study
Outcome variables of this study are to compare the characteristic FSWs who receive self-testing and blood testing who receive assisted and unassisted self-testing Moreover it compares the proportion of taking confirmatory test out of those who receive the test in the assisted and unassisted self-testing 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 the proportion of FSWs taking confirmatory test including self-testing out of those receive the test in intervention groups and control group It compares furthermore the proportion of HIV positive in the assisted unassisted intervention and HIV positive in the control group This study also compares ART initiation in the assisted unassisted intervention and the control group Additionally it compares stigma scores and FSWs who went to a health facility for HIV testing between assisted unassisted group and compares the HIV and STI risk behaviors between assisted and unassisted group It calculates lastly the cascade of HIV testing and treatment
Regarding the FSWs it has been a significant challenge to increase HIV testing uptake among this population The challenge has been affected by Indonesias national policy to close brothels As consequence many FSWs have become hidden and hard to reach The implementation national policy also impacts on the way of commercial sex transactions in which it becomes underground especially many FSWs utilize the new popularity of digital platforms to sell sexual services It needs more effective case finding strategies to be implemented to reach them accordingly
If it is considered from the FSWs side there are some barriers to access HIV test services according to several reports They consist of lack of money time stigma discrimination low-risk perception fear lack of accessibility reluctance of health service providers to offer HIV testing and limited human resources Oral fluid HIVST using is an alternative to traditional HIV testing services in the facility or other healthcare provider testing UNAIDS 2016 For this study OraQuick is used as an alternative strategy for HIV testing among FSWs
The primary objectives of this study are to assess whether proportion of FSW who know their HIV status increases or not whether introduction of Oral fluid test increases the number of HIV testing at health facilities or not and whether assisted or unassisted community HIV screening have a result to an increasing proportion of HIV testing at health facilities or not Furthermore CBS study aims to assess whether assisted and unassisted community HIV screening results to an increasing number of HIV positive case finding or not and whether community HIV screening increases proportion of initiation of antiretroviral therapy ART or not The secondary objectives of this study meanwhile are to measure acceptability of community-based self-screening in participation and to measure satisfaction of FSWs who has participated towards the delivery of community-based self-screening
Regarding the inclusion criteria of this study participant must be women 18 years old or older at enrollment has a transactional sex vaginal oral andor anal at least once in the past month does not uptake HIV test in the last 6 months and acknowledges her HIV status negative or unknown There are several exclusion criteria which are FSW does not able to fulfill one of inclusion criteria that has been explained above FSW does not has desire to participate due to several reasons and she is currently participating in another HIV prevention study
Outcome variables of this study are to compare the characteristic FSWs who receive self-testing and blood testing who receive assisted and unassisted self-testing Moreover it compares the proportion of taking confirmatory test out of those who receive the test in the assisted and unassisted self-testing 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 the proportion of FSWs taking confirmatory test including self-testing out of those receive the test in intervention groups and control group It compares furthermore the proportion of HIV positive in the assisted unassisted intervention and HIV positive in the control group This study also compares ART initiation in the assisted unassisted intervention and the control group Additionally it compares stigma scores and FSWs who went to a health facility for HIV testing between assisted unassisted group and compares the HIV and STI risk behaviors between assisted and unassisted group It calculates lastly the cascade of HIV testing and treatment
Detailed Description:
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 40000 new HIV infections in the year 2030 MoH2016 Therefore 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 HIVAIDS the 108479 people receiving ART as of December 2018 amounts to only 17 percent of the estimated number of people live with HIV 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 3077653 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 Indonesias concentrated epidemic transmission of HIV infection among KAPs specifically FSWs In 2016 it is estimated that there are 226791 female sex workers and around 5254065 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
FSW can be grouped by direct ie brothel-based and indirect status with regard to way of selling their sex services In 2016 however 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 Indonesias 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
2 HIV Testing Among FSW
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 World Health Organization 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 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 1256 of FSWs interpreted HIV-negative self-test results as HIV positive and 8 337 of FSWs interpreted HIV-positive self-test results as HIV negative Ortblad et al 2018 The concordance between FSWs instructions was 73 95CI 56 to 86 for HIV-positive self-tests and 68 95CI 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
4 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 Pre-Exposure Prophylactic 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 Accordingly a contingency protocol that can be implemented in a shorter period of time is also presented
B Study Design
1 Design Summary
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
2 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 21 ratio 2 intervention 1 comparison
3 Recruitment and Sample Size
All FSW in intervention districts who meet study eligibility criteria will be offered community screening 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 realthe truth the following sample of FSW will be needed in intervention and in comparison districts
n Z1-α 2P1-P12 Z1-β P11-P1 P21-P22 P1-P22 deft
Where
Z1-α the Z score for the level of statistical confidence or statistical precision desired for 95 Z 196 Z1-β the Z score for the desired statistical power for 90 one-sided test Z 1282 P1 the expected population proportion in the comparison group of districts set 05 - 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 06 - 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 15 assumed
The required sample size is thus n 635 per experimental group 761 after 20 allowance for lost-to-follow up 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 1522 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 system information HIV and AIDS data SIHA 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
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 UNFPAs Implementation Units IUs In control districts implementation of the UNFPA-supported GFATM will proceed without modification as concerns community screening
D Data Collection Protocols
1 Baseline survey
An application will be developed so that the survey can be completed and submitted to a server using mobile phones Outreach worker OWPeer educator PEFemale sex worker 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 nameinitial
Age
Date of birth
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 sexually transmitted infectionsSTI other than HIV
2 Post-test Survey
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 personhotline on a scale of 1-5
Clients acceptanceperception 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
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
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
1 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 eg 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
2 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 yymmdd 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
3 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
4 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
E 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 formticking 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
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 40000 new HIV infections in the year 2030 MoH2016 Therefore 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 HIVAIDS the 108479 people receiving ART as of December 2018 amounts to only 17 percent of the estimated number of people live with HIV 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 3077653 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 Indonesias concentrated epidemic transmission of HIV infection among KAPs specifically FSWs In 2016 it is estimated that there are 226791 female sex workers and around 5254065 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
FSW can be grouped by direct ie brothel-based and indirect status with regard to way of selling their sex services In 2016 however 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 Indonesias 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
2 HIV Testing Among FSW
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 World Health Organization 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 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 1256 of FSWs interpreted HIV-negative self-test results as HIV positive and 8 337 of FSWs interpreted HIV-positive self-test results as HIV negative Ortblad et al 2018 The concordance between FSWs instructions was 73 95CI 56 to 86 for HIV-positive self-tests and 68 95CI 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
4 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 Pre-Exposure Prophylactic 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 Accordingly a contingency protocol that can be implemented in a shorter period of time is also presented
B Study Design
1 Design Summary
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
2 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 21 ratio 2 intervention 1 comparison
3 Recruitment and Sample Size
All FSW in intervention districts who meet study eligibility criteria will be offered community screening 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 realthe truth the following sample of FSW will be needed in intervention and in comparison districts
n Z1-α 2P1-P12 Z1-β P11-P1 P21-P22 P1-P22 deft
Where
Z1-α the Z score for the level of statistical confidence or statistical precision desired for 95 Z 196 Z1-β the Z score for the desired statistical power for 90 one-sided test Z 1282 P1 the expected population proportion in the comparison group of districts set 05 - 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 06 - 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 15 assumed
The required sample size is thus n 635 per experimental group 761 after 20 allowance for lost-to-follow up 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 1522 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 system information HIV and AIDS data SIHA 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
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 UNFPAs Implementation Units IUs In control districts implementation of the UNFPA-supported GFATM will proceed without modification as concerns community screening
D Data Collection Protocols
1 Baseline survey
An application will be developed so that the survey can be completed and submitted to a server using mobile phones Outreach worker OWPeer educator PEFemale sex worker 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 nameinitial
Age
Date of birth
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 sexually transmitted infectionsSTI other than HIV
2 Post-test Survey
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 personhotline on a scale of 1-5
Clients acceptanceperception 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
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
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
1 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 eg 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
2 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 yymmdd 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
3 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
4 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
E 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 formticking 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None