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 SELFii study
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Protocol summary
Individual will be randomized to two study arms.
Eligible Individuals will be randomized to two study arms in Tehran and Isfahan.
IndividualEligible Individuals will be randomized to two study arms in Tehran and Isfahan.
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 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
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 who accept to distribute HIV self-test among their clients, partner, or peers.
Study arm 2: The same as arm 1, but in addition, FSW participants will receive monetary incentives for distributing HIV self test among their clients, partner, or peers
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 oralwho accept to distribute HIV self-testing kits fortest among their own use or to give to other clients, partnerspartner, or peers. Study arm 2: The same as arm 1, but in addition, FSW participants will receive monetary incentives. for distributing HIV self test among their clients, partner, or peers
General information
iTEST
Selfii
iTESTSelfii
2018-04-14, 1397/01/25
2019-01-15, 1397/10/25
20182019-0401-1415 00:00:00
2018-09-21, 1397/06/30
2020-09-20, 1399/06/30
20182020-09-2120 00:00:00
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As we planned originally, we have conducted focus group discussion, individual in-depth interviews to adapt the study design and procedures. Then, we run a small pilot phase to ensure the adapted methods work. Based on findings all these formative/pilot steps, we updated part of the methods sections. Eligibility and outcomes were remained the same. We also changed the name of the trail to SELFii as suggested by participants in the formative/pilot phase.
As we planned originally, we have conducted focus group discussion, individual in-depth interviews to adapt the study design and procedures. Then, we run a small pilot phase to ensure the adapted methods work. Based on findings all these formative/pilot steps, we updated part of the methods sections. Eligibility and outcomes were remained the same. We also changed the name of the trail to SELFii as suggested by participants in the formative/pilot phase.
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
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 SELFii 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 iTESTSELFii 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 a) women age 18 years or older, b) had sex for money in the past month, c) 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.
if the FSW would not accept to distribute the HIV self- test among her sexual partners.
if the FSW would not accept to distribute the HIV self- test among her sexual partners.
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.
Eligible female sex workers are being enrolled and complete a self-reported paper-based short survey, and then randomly assigned 1:1 to one of the two study arms (intervention/control). The study is being implemented in Tehran and Isfahan. Random numbers were generated by a web-based free software, MinimRan software.
Once 60Eligible female sex workers are being enrolled and completed the online baselinecomplete a self-reported paper-based short survey (= one wave), they will beand then randomly assigned 1:1 to one of the two study arms (intervention/control). The study includes four wavesis being implemented in Tehran and two waves in Isfahan. Random numbers will bewere generated by a web-based free software, MinimRan software.
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Primary outcomes
#1
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) questionnaires that are designed for participants , 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) questionnaires that are designed for 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
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 , 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.
Secondary outcomes
#1
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 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
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 , 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
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) send the photo of the self-test kit's window results to the study mobile number
It will be measured by 1) self-report, 2) upload asend the photo of the self-test kit's window results to the study mobile number
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
Eligible Individuals will be randomized to two study arms in Tehran and Isfahan.
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 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 who accept to distribute HIV self-test among their clients, partner, or peers.
Study arm 2: The same as arm 1, but in addition, FSW participants will receive monetary incentives for distributing HIV self test among their clients, partner, or peers
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
As we planned originally, we have conducted focus group discussion, individual in-depth interviews to adapt the study design and procedures. Then, we run a small pilot phase to ensure the adapted methods work. Based on findings all these formative/pilot steps, we updated part of the methods sections. Eligibility and outcomes were remained the same. We also changed the name of the trail to SELFii as suggested by participants in the formative/pilot phase.
Acronym
Selfii
IRCT registration information
IRCT registration number:IRCT201710039506N1
Registration date:2017-10-25, 1396/08/03
Registration timing:prospective
Last update:2020-01-07, 1398/10/17
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
2019-01-15, 1397/10/25
Expected recruitment end date
2020-09-20, 1399/06/30
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 SELFii 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 a) women age 18 years or older, b) had sex for money in the past month, c) 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:
if the FSW would not accept to distribute the HIV self- test among her sexual partners.
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
Eligible female sex workers are being enrolled and complete a self-reported paper-based short survey, and then randomly assigned 1:1 to one of the two study arms (intervention/control). The study is being implemented in Tehran and Isfahan. Random numbers were 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
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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) questionnaires that are designed for participants , 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 , 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 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 , 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) send the photo of the self-test kit's window results to the study mobile number
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.