Effect of monetary incentive on HIV self-testing uptake and linkage to care among female sex workers and their clients and partners in Iran: The iTEST study
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Protocol summary
HIV self-testing offers a break-through opportunity for Female sex workers who are a marginalized population to know their serostatus. We propose to assess the feasibility and acceptability of oral fluid- and blood- based HIV self-testing among FSW and their clients and other sexual partners when distribution is initiated by peer leaders and propagated through social networks in Tehran and Isfahan. We will recruit 420 female sex workers who a) are 18 years and older, b) sold sex for money in the past month, c) and have a Telegram account. They will be randomly assigned in two different groups. Randomization sequences will be generated for each study sites separately using a web-based free software (MinimRan). Both groups will receive educational packages during 12 weeks follow up via Telegram messenger. They will be offered to test for HIV and invite three of their friends, partners or clients to do the test using HIV rapid self-test. Group 1 will receive monetary incentives after each step while the second group will not. We will evaluate whether small cash incentives (as intervention) improve the uptake of testing, reporting of results, linkage to care, and onward recruitment of clients, partners, and peers to self-test.
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HIV self-testing offers a break-through opportunity for Female sex workers who are a marginalized population to know their serostatus. We propose to assess the feasibility and acceptability of oral fluid- and blood- based HIV self-testing among FSW and their clients and other sexual partners when distribution is initiated by peer leaders and propagated through social networks in Tehran and Isfahan. We will recruit 420 female sex workers who a) are 18 years and older, b) sold sex for money in the past month, c) and have a Telegram account. They will be randomly assigned in two different groups. Randomization sequences will be generated for each study sites separately using a web-based free software (MinimRan). Both groups will receive educational packages during 12 weeks follow up via Telegram messenger. They will be offered to test for HIV and invite three of their friends, partners or clients to do the test using HIV rapid self-test. Group 1 will receive monetary incentives after each step while the second group will not. We will evaluate whether small cash incentives (as intervention) improve the uptake of testing, reporting of results, linkage to care, and onward recruitment of clients, partners, and peers to self-test.
انجام تست خودآزمایی HIV این امکان را به گروه های درمعرض خطر (از جمله زنان تن فروش) میدهد که به دور از مشکلاتی مانند انگ و تبعیض از وضعیت HIV خود مطلع گردند. هدف این مطالعه بررسی مقبولیت و امکان سنجی انجام خودآزمایی HIV مبتنی بر مایع دهان یا خون در زنان تن فروش و پذیرش انحام تست توسط شرکا جنسی و مشتریان آنها زمانی که آزمایش توسط فردی از گروه همسان ارایه میگردد، میباشد. تعداد 420 زن تن فروش بالای 18 سال که حداقل یک مورد برقراری رابطه جنسی به ازای دریافت پول در یک ماه اخیر داشته اند و نیز دارای اکانت تلگرامی فعال میباشند، وارد مطالعه میشوند. این افراد به صورت تصادفی به دو گروه تقسیم میشوند. توالی تصادفی سازی برای هر یک از سایت های نمونه گیری به صورت جداگانه و توسط نرم افزار رایگان MinimRan تولید میشود. هر دو گروه بسته های آموزشی مرتبط با HIV را در طول 12 هفته پیگیری از طریق تلگرام دریافت مینمایند. در طول این مدت به آنها پیشنهاد انجام تست نیز میشود و همچنین از آنها درخواست میشود که تست خودآزمایی HIV را به سه نفر از دوستان، شرکای جنسی یا مشتریان خود ارایه نمایند. گروه اول در ازای انجام تست و معرفی و ارایه تست به سایر افراد مشوق پولی دریافت خواهند نمود ولی گروه دوم مشوقی دریافت نخواهند کرد. متغیر پیامد اولیه مورد بررسی میزان دریافت و انجام تست، لینک به درمان و میزان پذیرش تست توسط زن تن فروش، مشتریان و شرکا جنسی آنها میباشد.
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انجام تست خودآزمایی HIV این امکان را به گروه های درمعرض خطر (از جمله زنان تن فروش) میدهد که به دور از مشکلاتی مانند انگ و تبعیض از وضعیت HIV خود مطلع گردند. هدف این مطالعه بررسی مقبولیت و امکان سنجی انجام خودآزمایی HIV مبتنی بر مایع دهان یا خون در زنان تن فروش و پذیرش انحام تست توسط شرکا جنسی و مشتریان آنها زمانی که آزمایش توسط فردی از گروه همسان ارایه میگردد، میباشد. تعداد 420 زن تن فروش بالای 18 سال که حداقل یک مورد برقراری رابطه جنسی به ازای دریافت پول در یک ماه اخیر داشته اند و نیز دارای اکانت تلگرامی فعال میباشند، وارد مطالعه میشوند. این افراد به صورت تصادفی به دو گروه تقسیم میشوند. توالی تصادفی سازی برای هر یک از سایت های نمونه گیری به صورت جداگانه و توسط نرم افزار رایگان MinimRan تولید میشود. هر دو گروه بسته های آموزشی مرتبط با HIV را در طول 12 هفته پیگیری از طریق تلگرام دریافت مینمایند. در طول این مدت به آنها پیشنهاد انجام تست نیز میشود و همچنین از آنها درخواست میشود که تست خودآزمایی HIV را به سه نفر از دوستان، شرکای جنسی یا مشتریان خود ارایه نمایند. گروه اول در ازای انجام تست و معرفی و ارایه تست به سایر افراد مشوق پولی دریافت خواهند نمود ولی گروه دوم مشوقی دریافت نخواهند کرد. متغیر پیامد اولیه مورد بررسی میزان دریافت و انجام تست، لینک به درمان و میزان پذیرش تست توسط زن تن فروش، مشتریان و شرکا جنسی آنها میباشد.
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To measure the effect of monetary incentive on HIV self-testing uptake and linkage to care among female sex workers and their clients and partners in Iran
To measure the effect of monetary incentive on HIV self-testing uptake and linkage to care among female sex workers and their clients and partners in Iran
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Two arm parallel group randomized unblinded trial
Two arm parallel group randomized unblinded trial
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Individual will be randomized to two study arms.
Individual will be randomized to two study arms.
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We have four types of participants:
1. Eligible female sex workers (FSW) are a) women age 18 years or older, b) had sex for money in the past month, c) have an active account in Telegram, and d) have never tested for HIV or tested negative not more recently than 3 months prior.
2. Eligible clients are a) men 18 year or older, b) who paid for sex in the past month
3. Eligible partners are a) men 18 year or older, b) who had unpaid sex with the FSW participant in the past month
4. Eligible peers are a) women age 18 years and older, b) had sex for money in the past month
We have four types of participants: 1. Eligible female sex workers (FSW) are a) women age 18 years or older, b) had sex for money in the past month, c) have an active account in Telegram, and d) have never tested for HIV or tested negative not more recently than 3 months prior. 2. Eligible clients are a) men 18 year or older, b) who paid for sex in the past month 3. Eligible partners are a) men 18 year or older, b) who had unpaid sex with the FSW participant in the past month 4. Eligible peers are a) women age 18 years and older, b) had sex for money in the past month
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Study arm 1: FSW participants will join a private Telegram group where peer leaders will post the self-testing guides and videos for 12 weeks and offer participants four free oral HIV self-testing kits for their own use or to give to other clients, partners, or peers.
Study arm 2: The same as arm 1, but in addition, FSW participants will receive monetary incentives.
Study arm 1: FSW participants will join a private Telegram group where peer leaders will post the self-testing guides and videos for 12 weeks and offer participants four free oral HIV self-testing kits for their own use or to give to other clients, partners, or peers. Study arm 2: The same as arm 1, but in addition, FSW participants will receive monetary incentives.
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Uptake of HIV self-testing, self-test results, behavioral change, linkage to care for confirmatory HIV test or ART initiation at 3 and 6 months from enrollment, and adverse events.
Uptake of HIV self-testing, self-test results, behavioral change, linkage to care for confirmatory HIV test or ART initiation at 3 and 6 months from enrollment, and adverse events.
General information
iTEST
iTEST
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18
18
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Year
year
Yes
No
1
Female
Both
femalboth
Other
Screening
otherscree
420
1440
4201440
No
No
2018-07-07, 1397/04/16
2018-09-21, 1397/06/30
2018-0709-0721 00:00:00
Peer-driven HIV self-testing for Iranian female sex workers, their clients,and partners
Monetary incentive effect on HIV self-testing uptake and linkage to care outcomes
Peer-drivenMonetary incentive effect on HIV self-testing for Iranian female sex workers, their clients,and partnersuptake and linkage to care outcomes
Feasibility and acceptability of HIV self-testing following offering of monetary incentive among female sex workers and their clients and partners in two cities in Iran: The iTEST study
Effect of monetary incentive on HIV self-testing uptake and linkage to care among female sex workers and their clients and partners in Iran: The iTEST study
Feasibility and acceptabilityEffect of monetary incentive on HIV self-testing following offering of monetary incentiveuptake and linkage to care among female sex workers and their clients and partners in two cities in Iran: The iTEST study
Eligible female sex workers (FSW) are are a) women age 18 years or older, b) had sex for money in the past month, c) have an active account in Telegram, and d) have never tested for HIV or tested negative not more recently than 3 months prior.
Eligible clients are a) men 18 year or older, b) who paid for sex in the past month.
Eligible partners are a) men 18 year or older, b) who had unpaid sex with the FSW participant in the past month.
Eligible peers are a) women age 18 years and older, b) had sex for money in the past month.
Eligible female sex workers (FSW) are are a) women age 18 years or older, b) had sex for money in the past month, c) have an active account in Telegram, and d) have never tested for HIV or tested negative not more recently than 3 months prior. Eligible clients are a) men 18 year or older, b) who paid for sex in the past month. Eligible partners are a) men 18 year or older, b) who had unpaid sex with the FSW participant in the past month. Eligible peers are a) women age 18 years and older, b) had sex for money in the past month.
We will use Respondent Driven Sampling to recruit the participants.
We will use Respondent-Driven Sampling (RDS) to recruit study participants.
We will use Respondent-Driven Sampling (RDS) to recruit thestudy participants.
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Once 60 female sex workers enrolled and completed the online baseline survey (= one wave), they will be randomly assigned 1:1 to two study arms. The study includes four waves in Tehran and two waves in Isfahan. Random numbers will be generated by a web-based free software, MinimRan software.
Once 60 female sex workers enrolled and completed the online baseline survey (= one wave), they will be randomly assigned 1:1 to two study arms. The study includes four waves in Tehran and two waves in Isfahan. Random numbers will be generated by a web-based free software, MinimRan software.
Ethics committees
#1
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2017-12-26, 1396/10/05
2017-12-26 00:00:00
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P/12/4/M/99
P/12/4/M/99
Primary outcomes
#1
HIV testing uptake
Confirmatory HIV test among FSW
Confirmatory HIV testing uptaketest among FSW
After 12 weeks follow up
3 and 6 months after enrollment
After 12 weeks follow up3 and 6 months after enrollment
By self-report and by review of records at HIV counseling and care sites
It will be measured by 1) participants' self-report using an online form, 2) collecting referral cards from the study collaborating healthcare centers, 3) a health provider at one of the study collaborating healthcare centers reports to us anonymously by completing a paper-based form that has no identifying information and only include the referral card ID.
ByIt will be measured by 1) participants' self-report andusing an online form, 2) collecting referral cards from the study collaborating healthcare centers, 3) a health provider at one of the study collaborating healthcare centers reports to us anonymously by review of records at HIV counselingcompleting a paper-based form that has no identifying information and care sitesonly include the referral card ID.
#2
Linkage of new diagnoses to care
ART initiation among FSW
Linkage of new diagnoses to careART initiation among FSW
At the end of 12 weeks follow up
3 and 6 months after enrollment
At the end of 12 weeks follow up3 and 6 months after enrollment
By self-report and by review of records at HIV counseling and care sites
It will be measured only among those with a confirmed HIV-positive test by 1) participants' self-report using an online form, 2) a health provider at one of the study collaborating healthcare centers reports to us anonymously by completing a form that has no identifying information and only include the referral card ID.
ByIt will be measured only among those with a confirmed HIV-positive test by 1) participants' self-report andusing an online form, 2) a health provider at one of the study collaborating healthcare centers reports to us anonymously by review of records at HIV counselingcompleting a form that has no identifying information and care sitesonly include the referral card ID.
#3
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Uptake of HIV self-testing among FSW
Uptake of HIV self-testing among FSW
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3 and 6 months after enrollment
3 and 6 months after enrollment
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It will be measured by 1) self-report, 2) tracking system for self-test kits
It will be measured by 1) self-report, 2) tracking system for self-test kits
#4
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HIV self-test results among FSW
HIV self-test results among FSW
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3 and 6 months after enrollment
3 and 6 months after enrollment
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It will be measured by 1) self-report, 2) upload a photo of the self-test kit's window results
It will be measured by 1) self-report, 2) upload a photo of the self-test kit's window results
#5
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Behavioral change among FSW
Behavioral change among FSW
empty
baseline, and 3 and 6 months after enrollment
baseline, and 3 and 6 months after enrollment
empty
It will be measured by self-report
It will be measured by self-report
#6
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Adverse events among FSW
Adverse events among FSW
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Continuously monitored during the study
Continuously monitored during the study
empty
It will be measured by self-report
It will be measured by self-report
Secondary outcomes
#1
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Confirmatory HIV test among clients, partners and peers
Confirmatory HIV test among clients, partners and peers
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3 and 6 months after enrollment
3 and 6 months after enrollment
empty
It will be measured by 1) participants' self-report using an online form, 2) collecting referral cards from the study collaborating healthcare centers, 3) a health provider at one of the study collaborating healthcare centers reports to us anonymously by completing a paper-based form that has no identifying information and only include the referral card ID.
It will be measured by 1) participants' self-report using an online form, 2) collecting referral cards from the study collaborating healthcare centers, 3) a health provider at one of the study collaborating healthcare centers reports to us anonymously by completing a paper-based form that has no identifying information and only include the referral card ID.
#2
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ART initiation among clients, partners and peers
ART initiation among clients, partners and peers
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3 and 6 months after enrollment
3 and 6 months after enrollment
empty
It will be measured only among those with a confirmed HIV-positive test by 1) participants' self-report using an online form, 2) a health provider at one of the study collaborating healthcare centers reports to us anonymously by completing a form that has no identifying information and only include the referral card ID.
It will be measured only among those with a confirmed HIV-positive test by 1) participants' self-report using an online form, 2) a health provider at one of the study collaborating healthcare centers reports to us anonymously by completing a form that has no identifying information and only include the referral card ID.
#3
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Uptake of HIV self-testing among clients, partners and peers
Uptake of HIV self-testing among clients, partners and peers
empty
3 and 6 months after enrollment
3 and 6 months after enrollment
empty
It will be measured by 1) self-report, 2) tracking system for self-test kits
It will be measured by 1) self-report, 2) tracking system for self-test kits
#4
empty
HIV self-test results among clients, partners and peers
HIV self-test results among clients, partners and peers
empty
3 and 6 months after enrollment
3 and 6 months after enrollment
empty
It will be measured by 1) self-report, 2) upload a photo of the self-test kit's window results
It will be measured by 1) self-report, 2) upload a photo of the self-test kit's window results
#5
empty
Behavioral change among clients, partners and peers
Behavioral change among clients, partners and peers
empty
3 and 6 months after enrollment
3 and 6 months after enrollment
empty
It will be measured by self-report
It will be measured by self-report
#6
empty
Adverse events among clients, partners and peers
Adverse events among clients, partners and peers
empty
Continuously monitored during the study
Continuously monitored during the study
empty
It will be measured by self-report
It will be measured by self-report
Intervention groups
#1
Group 1 will receive monetary incentives after each of the following steps: using self-test, reporting the result to the research center, linking to care (in positive cases), offering others the self-test and they test themselves.
Group 1: FSW Participants in the monetary incentive arm (intervention arm) will receive monetary incentives for returning their test results, and for every successful invitation of clients, partners, and peers, and for successful linkage to care.
Group 1: FSW Participants in the monetary incentive arm (intervention arm) will receive monetary incentives after eachfor returning their test results, and for every successful invitation of the following steps: using self-testclients, reporting the result to the research centerpartners, linkingand peers, and for successful linkage to care (in positive cases), offering others the self-test and they test themselves.
#2
Group 2: Will not receive any Monetary incentive.
Group 2: FSW Participants in the control arm receive no monetary incentive.
Group 2: Will notFSW Participants in the control arm receive any Monetaryno monetary incentive.
Recruitment centers
#1
Name of recruitment center - English: Iran Research Center for HIV/AIDS (IRCHA)
Name of recruitment center - Persian: مرکز تحقیقات ایدز ایران
Full name of responsible person - English: Dr. Negin Abedinzadeh
Full name of responsible person - Persian: دکتر نگین عابدین زاده
Street address - English: Infectious disease ward, Imam-Khomeini Hospital, Keshavarz Blvd
Street address - Persian: ایران، تهران، انتهای بلوار کشاورز، بیمارستان امام خمینی، پشت بخش عفونی، مرکز تحقیقات ایدز ایران
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Iran Research Center for HIV/AIDS (IRCHA)
Name of recruitment center - Persian: مرکز تحقیقات ایدز ایران
Full name of responsible person - English: Dr. Negin Abedinzadeh
Full name of responsible person - Persian: دکتر نگین عابدین زاده
Street address - English: Infectious disease ward, Imam-Khomeini Hospital, Keshavarz Blvd
Street address - Persian: ایران، تهران، انتهای بلوار کشاورز، بیمارستان امام خمینی، پشت بخش عفونی، مرکز تحقیقات ایدز ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 14197-33141
Phone: +98 21 6658 1583
Fax:
Email: negin.abedinzadeh@gmail.com
Web page address:
Name of recruitment center - English: Iran Research Center for HIV/AIDS (IRCHA) Name of recruitment center - Persian: مرکز تحقیقات ایدز ایران Full name of responsible person - English: Dr. Negin Abedinzadeh Full name of responsible person - Persian: دکتر نگین عابدین زاده Street address - English: Infectious disease ward, Imam-Khomeini Hospital, Keshavarz Blvd Street address - Persian: ایران، تهران، انتهای بلوار کشاورز، بیمارستان امام خمینی، پشت بخش عفونی، مرکز تحقیقات ایدز ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 14197-33141 Phone: +98 21 6658 1583 Fax: Email: negin.abedinzadeh@gmail.com Web page address:
#2
Name of recruitment center - English: Infectious Disease Research Center
Name of recruitment center - Persian: مرکز تحقیقات بیماری های عفونی و گرمسیری اصفهان
Full name of responsible person - English: Dr. Maryam Nasirian
Full name of responsible person - Persian: دکتر مریم نصیریان
Street address - English:
Street address - Persian:
City - English: Isfahan
City - Persian: اصفهان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Infectious Disease Research Center
Name of recruitment center - Persian: مرکز تحقیقات بیماری های عفونی و گرمسیری اصفهان
Full name of responsible person - English: Dr. Maryam Nasirian
Full name of responsible person - Persian: دکتر مریم نصیریان
Street address - English: Isfahan University of Medical Sciences, infectious diseases research center(IDRC)
Street address - Persian:
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81746-73461
Phone: +98 31 1668 5149
Fax:
Email: maryamnasirian17@gmail.com
Web page address:
Name of recruitment center - English: Infectious Disease Research Center Name of recruitment center - Persian: مرکز تحقیقات بیماری های عفونی و گرمسیری اصفهان Full name of responsible person - English: Dr. Maryam Nasirian Full name of responsible person - Persian: دکتر مریم نصیریان Street address - English: Isfahan University of Medical Sciences, infectious diseases research center(IDRC) Street address - Persian: City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81746-73461 Phone: +98 31 1668 5149 Fax: Email: maryamnasirian17@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: National Institute for Medical Research Development
Name of organization / entity - Persian: موسسه ملی توسعه تحقیقات علوم پزشکی ایران (نیماد)
Full name of responsible person - English: Dr. Reza Malekzadeh
Full name of responsible person - Persian: دکتر رضا ملک زاده
Street address - English: 21 Besat St, West Fatemi Ave, Tehran, Iran
Street address - Persian: تهران، خیابان فاطمی غربی، ابتدای خیابان بعثت، پلاک 21، موسسه ملی توسعه تحقیقات پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: National Institute for Medical Research Development
Name of organization / entity - Persian: موسسه ملی توسعه تحقیقات علوم پزشکی ایران (نیماد)
Full name of responsible person - English: Dr. Reza Malekzadeh
Full name of responsible person - Persian: دکتر رضا ملک زاده
Street address - English: 21 Besat St, West Fatemi Ave, Tehran, Iran
Street address - Persian: تهران، خیابان فاطمی غربی، ابتدای خیابان بعثت، پلاک 21، موسسه ملی توسعه تحقیقات پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419693111
Phone: +98 21 6693 8037
Fax:
Email: dr.reza.malekzadeh@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: National Institute for Medical Research Development Name of organization / entity - Persian: موسسه ملی توسعه تحقیقات علوم پزشکی ایران (نیماد) Full name of responsible person - English: Dr. Reza Malekzadeh Full name of responsible person - Persian: دکتر رضا ملک زاده Street address - English: 21 Besat St, West Fatemi Ave, Tehran, Iran Street address - Persian: تهران، خیابان فاطمی غربی، ابتدای خیابان بعثت، پلاک 21، موسسه ملی توسعه تحقیقات پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1419693111 Phone: +98 21 6693 8037 Fax: Email: dr.reza.malekzadeh@gmail.com Web page address:
957506
957506
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Public
public
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Domestic
domestic
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Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: University of California, San Francisco
Name of organization / entity - Persian: دانشگاه کالیفرنیا، سانفرانسیسکو
Full name of responsible person - English: Ali Mirzazadeh
Full name of responsible person - Persian: علی میرزازاده
Position - English: Assistant Professor, MD, PhD
Position - Persian: دکترای تخصصی/ استادیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 550 16th St, San Francisco, CA
Street address - Persian: 550 خیابان شانزدهم
City - English: San Francisco
City - Persian: سانفرانسیسکو
Province: California
Province - English: California
Province - Persian: کالیفرنیا
contact.provinces_available:
Country: United States
Postal code:
Phone: 0014154765821
Mobile: 0014158664234
Fax:
Email: Ali.Mirzazadeh@ucsf.edu
Web page address: https://www.ucsf.edu/
contact.organization_id:
Name of organization / entity - English: University of California, San Francisco
Name of organization / entity - Persian: دانشگاه کالیفرنیا، سانفرانسیسکو
Full name of responsible person - English: Ali Mirzazadeh
Full name of responsible person - Persian: علی میرزازاده
Position - English: Assistant Professor, MD, PhD, MPH
Position - Persian: دکترای تخصصی/ استادیار
Latest degree: phd
Area of specialty/work: 2
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 550 16th St, San Francisco, CA
Street address - Persian: 550 خیابان شانزدهم
City - English: San Francisco
City - Persian: سانفرانسیسکو
Province: California
Province - English: California
Province - Persian: کالیفرنیا
contact.provinces_available:
Country: United States of America
Postal code: 94158
Phone: +1 0014154765821
Mobile: +1 0014158664234
Fax:
Email: Ali.Mirzazadeh@ucsf.edu
Web page address: https://profiles.ucsf.edu/ali.mirzazadeh
contact.organization_id: Name of organization / entity - English: University of California, San Francisco Name of organization / entity - Persian: دانشگاه کالیفرنیا، سانفرانسیسکو Full name of responsible person - English: Ali Mirzazadeh Full name of responsible person - Persian: علی میرزازاده Position - English: Assistant Professor, MD, PhD, MPH Position - Persian: دکترای تخصصی/ استادیار Latest degree: phd Area of specialty/work: 02 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: 550 16th St, San Francisco, CA Street address - Persian: 550 خیابان شانزدهم City - English: San Francisco City - Persian: سانفرانسیسکو Province: California Province - English: California Province - Persian: کالیفرنیا contact.provinces_available: Country: United States of America Postal code: 94158 Phone: +1 0014154765821 Mobile: +1 0014158664234 Fax: Email: Ali.Mirzazadeh@ucsf.edu Web page address: https://www.ucsf.eduprofiles.ucsf.edu/ali.mirzazadeh
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: University of California, San Francisco
Name of organization / entity - Persian: دانشگاه کالیفرنیا، سانفرانسیسکو
Full name of responsible person - English: Ali Mirzazadeh
Full name of responsible person - Persian: علی میرزازاده
Position - English: Assistant Professor, MD. PhD
Position - Persian: دکترای تخصصی/ استادیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 550 16th St
Street address - Persian: 550 خیابان شانزدهم
City - English: San Francisco
City - Persian: سانفرانسیسکو
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +1 415-476-5821
Mobile: +1 415-866-4234
Fax:
Email: Ali.Mirzazadeh@ucsf.edu
Web page address: https://www.ucsf.edu/
contact.organization_id:
Name of organization / entity - English: University of California, San Francisco
Name of organization / entity - Persian: دانشگاه کالیفرنیا، سانفرانسیسکو
Full name of responsible person - English: Ali Mirzazadeh
Full name of responsible person - Persian: علی میرزازاده
Position - English: Assistant Professor, MD. PhD, MPH
Position - Persian: دکترای تخصصی/ استادیار
Latest degree: phd
Area of specialty/work: 2
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 550 16th Street
Street address - Persian: 550 خیابان شانزدهم
City - English: San Francisco
City - Persian: سانفرانسیسکو
Province: California
Province - English: California
Province - Persian:
contact.provinces_available:
Country: United States of America
Postal code: 94158
Phone: +1 415-476-5821
Mobile: +1 415-866-4234
Fax:
Email: Ali.Mirzazadeh@ucsf.edu
Web page address: https://profiles.ucsf.edu/ali.mirzazadeh
contact.organization_id: Name of organization / entity - English: University of California, San Francisco Name of organization / entity - Persian: دانشگاه کالیفرنیا، سانفرانسیسکو Full name of responsible person - English: Ali Mirzazadeh Full name of responsible person - Persian: علی میرزازاده Position - English: Assistant Professor, MD. PhD, MPH Position - Persian: دکترای تخصصی/ استادیار Latest degree: phd Area of specialty/work: 02 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: 550 16th StStreet Street address - Persian: 550 خیابان شانزدهم City - English: San Francisco City - Persian: سانفرانسیسکو Province: California Province - English: California Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic RepublicUnited States of) America Postal code: 94158 Phone: +1 415-476-5821 Mobile: +1 415-866-4234 Fax: Email: Ali.Mirzazadeh@ucsf.edu Web page address: https://www.ucsf.eduprofiles.ucsf.edu/ali.mirzazadeh
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Precision Health Economics
Name of organization / entity - Persian: Precision Health Economics
Full name of responsible person - English: Soodabeh Navadeh
Full name of responsible person - Persian: سودابه نواده
Position - English: Research Scientist, MD, PhD
Position - Persian: دکترای تخصصی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 555 12th St, Suit 250
Street address - Persian: 555 خیابان دوازدهم
City - English: Oakland
City - Persian: اوکلند
Province: California
Province - English: California
Province - Persian: کالیفرنیا
contact.provinces_available:
Country: United States
Postal code: 94607
Phone: 0013109826310
Mobile: 0014152448681
Fax: 0013109826311
Email: soodabeh.navadeh@precisionhealtheconomics.com
Web page address: https://www.precisionhealtheconomics.com/
contact.organization_id:
Name of organization / entity - English: Precision Health Economics
Name of organization / entity - Persian: Precision Health Economics
Full name of responsible person - English: Soodabeh Navadeh
Full name of responsible person - Persian: سودابه نواده
Position - English: Research Scientist, MD, PhD
Position - Persian: دکترای تخصصی
Latest degree: phd
Area of specialty/work: 2
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 555 12th St, Suit 250
Street address - Persian: 555 خیابان دوازدهم
City - English: Oakland
City - Persian: اوکلند
Province: California
Province - English: California
Province - Persian: کالیفرنیا
contact.provinces_available:
Country: United States of America
Postal code: 94607
Phone: +1 0013109826310
Mobile: +1 0014152448681
Fax:
Email: soodabeh.navadeh@precisionhealtheconomics.com
Web page address: https://www.precisionhealtheconomics.com/
contact.organization_id: Name of organization / entity - English: Precision Health Economics Name of organization / entity - Persian: Precision Health Economics Full name of responsible person - English: Soodabeh Navadeh Full name of responsible person - Persian: سودابه نواده Position - English: Research Scientist, MD, PhD Position - Persian: دکترای تخصصی Latest degree: phd Area of specialty/work: 02 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: 555 12th St, Suit 250 Street address - Persian: 555 خیابان دوازدهم City - English: Oakland City - Persian: اوکلند Province: California Province - English: California Province - Persian: کالیفرنیا contact.provinces_available: Country: United States of America Postal code: 94607 Phone: +1 0013109826310 Mobile: +1 0014152448681 Fax: 0013109826311 Email: soodabeh.navadeh@precisionhealtheconomics.com Web page address: https://www.precisionhealtheconomics.com/
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
We have not yet decided to do this.
We have not yet decided to do this.
Protocol summary
Study aim
To measure the effect of monetary incentive on HIV self-testing uptake and linkage to care among female sex workers and their clients and partners in Iran
Design
Two arm parallel group randomized unblinded trial
Settings and conduct
Individual will be randomized to two study arms.
Participants/Inclusion and exclusion criteria
We have four types of participants:
1. Eligible female sex workers (FSW) are a) women age 18 years or older, b) had sex for money in the past month, c) have an active account in Telegram, and d) have never tested for HIV or tested negative not more recently than 3 months prior.
2. Eligible clients are a) men 18 year or older, b) who paid for sex in the past month
3. Eligible partners are a) men 18 year or older, b) who had unpaid sex with the FSW participant in the past month
4. Eligible peers are a) women age 18 years and older, b) had sex for money in the past month
Intervention groups
Study arm 1: FSW participants will join a private Telegram group where peer leaders will post the self-testing guides and videos for 12 weeks and offer participants four free oral HIV self-testing kits for their own use or to give to other clients, partners, or peers.
Study arm 2: The same as arm 1, but in addition, FSW participants will receive monetary incentives.
Main outcome variables
Uptake of HIV self-testing, self-test results, behavioral change, linkage to care for confirmatory HIV test or ART initiation at 3 and 6 months from enrollment, and adverse events.
General information
Reason for update
Acronym
iTEST
IRCT registration information
IRCT registration number:IRCT201710039506N1
Registration date:2017-10-25, 1396/08/03
Registration timing:prospective
Last update:2018-06-08, 1397/03/18
Update count:2
Registration date
2017-10-25, 1396/08/03
Registrant information
Name
Soodabeh Navadeh
Name of organization / entity
Precision Health Economics
Country
United States
Phone
001-310-982-6310
Email address
s.navadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
National Institute for Medical Research Development
Expected recruitment start date
2018-04-14, 1397/01/25
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of monetary incentive on HIV self-testing uptake and linkage to care among female sex workers and their clients and partners in Iran: The iTEST study
Public title
Monetary incentive effect on HIV self-testing uptake and linkage to care outcomes
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
Eligible female sex workers (FSW) are are a) women age 18 years or older, b) had sex for money in the past month, c) have an active account in Telegram, and d) have never tested for HIV or tested negative not more recently than 3 months prior.
Eligible clients are a) men 18 year or older, b) who paid for sex in the past month.
Eligible partners are a) men 18 year or older, b) who had unpaid sex with the FSW participant in the past month.
Eligible peers are a) women age 18 years and older, b) had sex for money in the past month.
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
1440
Randomization (investigator's opinion)
Randomized
Randomization description
Once 60 female sex workers enrolled and completed the online baseline survey (= one wave), they will be randomly assigned 1:1 to two study arms. The study includes four waves in Tehran and two waves in Isfahan. Random numbers will be generated by a web-based free software, MinimRan software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
We will use Respondent-Driven Sampling (RDS) to recruit study participants.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics in Research Committee of National Institute for Medical Research Development
Street address
21 Besat St, West Fatemi Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419693111
Approval date
2017-09-15, 1396/06/24
Ethics committee reference number
IR.NIMAD.REC.1396.113
2
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Ebn-e-Sina St, Jahad Blvd
City
Kerman
Province
Kerman
Postal code
1457886583
Approval date
2017-03-07, 1395/12/17
Ethics committee reference number
IR.KMU.REC.1395.982
3
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
4 Central Building, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81745319
Approval date
2017-12-26, 1396/10/05
Ethics committee reference number
P/12/4/M/99
Health conditions studied
1
Description of health condition studied
HIV and High risk behavior
ICD-10 code
B24
ICD-10 code description
Unspecified human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
Confirmatory HIV test among FSW
Timepoint
3 and 6 months after enrollment
Method of measurement
It will be measured by 1) participants' self-report using an online form, 2) collecting referral cards from the study collaborating healthcare centers, 3) a health provider at one of the study collaborating healthcare centers reports to us anonymously by completing a paper-based form that has no identifying information and only include the referral card ID.
2
Description
ART initiation among FSW
Timepoint
3 and 6 months after enrollment
Method of measurement
It will be measured only among those with a confirmed HIV-positive test by 1) participants' self-report using an online form, 2) a health provider at one of the study collaborating healthcare centers reports to us anonymously by completing a form that has no identifying information and only include the referral card ID.
3
Description
Uptake of HIV self-testing among FSW
Timepoint
3 and 6 months after enrollment
Method of measurement
It will be measured by 1) self-report, 2) tracking system for self-test kits
4
Description
HIV self-test results among FSW
Timepoint
3 and 6 months after enrollment
Method of measurement
It will be measured by 1) self-report, 2) upload a photo of the self-test kit's window results
5
Description
Behavioral change among FSW
Timepoint
baseline, and 3 and 6 months after enrollment
Method of measurement
It will be measured by self-report
6
Description
Adverse events among FSW
Timepoint
Continuously monitored during the study
Method of measurement
It will be measured by self-report
Secondary outcomes
1
Description
Confirmatory HIV test among clients, partners and peers
Timepoint
3 and 6 months after enrollment
Method of measurement
It will be measured by 1) participants' self-report using an online form, 2) collecting referral cards from the study collaborating healthcare centers, 3) a health provider at one of the study collaborating healthcare centers reports to us anonymously by completing a paper-based form that has no identifying information and only include the referral card ID.
2
Description
ART initiation among clients, partners and peers
Timepoint
3 and 6 months after enrollment
Method of measurement
It will be measured only among those with a confirmed HIV-positive test by 1) participants' self-report using an online form, 2) a health provider at one of the study collaborating healthcare centers reports to us anonymously by completing a form that has no identifying information and only include the referral card ID.
3
Description
Uptake of HIV self-testing among clients, partners and peers
Timepoint
3 and 6 months after enrollment
Method of measurement
It will be measured by 1) self-report, 2) tracking system for self-test kits
4
Description
HIV self-test results among clients, partners and peers
Timepoint
3 and 6 months after enrollment
Method of measurement
It will be measured by 1) self-report, 2) upload a photo of the self-test kit's window results
5
Description
Behavioral change among clients, partners and peers
Timepoint
3 and 6 months after enrollment
Method of measurement
It will be measured by self-report
6
Description
Adverse events among clients, partners and peers
Timepoint
Continuously monitored during the study
Method of measurement
It will be measured by self-report
Intervention groups
1
Description
Group 1: FSW Participants in the monetary incentive arm (intervention arm) will receive monetary incentives for returning their test results, and for every successful invitation of clients, partners, and peers, and for successful linkage to care.
Category
Treatment - Other
2
Description
Group 2: FSW Participants in the control arm receive no monetary incentive.