Protocol summary
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Study aim
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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
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Design
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Two arm parallel group randomized unblinded trial
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Settings and conduct
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Eligible Individuals will be randomized to two study arms in Tehran and Isfahan.
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Participants/Inclusion and exclusion criteria
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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 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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Intervention groups
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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
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Main outcome variables
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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.
General information
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Reason for update
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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.
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Acronym
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Selfii
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IRCT registration information
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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
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Registration date
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2017-10-25, 1396/08/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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National Institute for Medical Research Development
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Expected recruitment start date
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2019-01-15, 1397/10/25
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Expected recruitment end date
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2020-09-20, 1399/06/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Monetary incentive effect on HIV self-testing uptake and linkage to care outcomes
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Purpose
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Screening
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Inclusion/Exclusion criteria
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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.
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
1440
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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We will use Respondent-Driven Sampling (RDS) to recruit study participants.
Ethics committees
1
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Ethics committee
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Approval date
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2017-09-15, 1396/06/24
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Ethics committee reference number
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IR.NIMAD.REC.1396.113
2
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Ethics committee
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Approval date
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2017-03-07, 1395/12/17
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Ethics committee reference number
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IR.KMU.REC.1395.982
3
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Ethics committee
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Approval date
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2017-12-26, 1396/10/05
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Ethics committee reference number
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P/12/4/M/99
Health conditions studied
1
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Description of health condition studied
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HIV and High risk behavior
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ICD-10 code
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B24
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ICD-10 code description
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Unspecified human immunodeficiency virus [HIV] disease
Primary outcomes
1
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Description
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Confirmatory HIV test among FSW
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Timepoint
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3 and 6 months after enrollment
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Method of measurement
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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
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Description
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ART initiation among FSW
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Timepoint
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3 and 6 months after enrollment
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Method of measurement
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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
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Description
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Uptake of HIV self-testing among FSW
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Timepoint
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3 and 6 months after enrollment
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Method of measurement
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It will be measured by 1) self-report, 2) tracking system for self-test kits
4
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Description
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HIV self-test results among FSW
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Timepoint
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3 and 6 months after enrollment
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Method of measurement
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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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Description
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Behavioral change among FSW
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Timepoint
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baseline, and 3 and 6 months after enrollment
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Method of measurement
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It will be measured by self-report
6
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Description
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Adverse events among FSW
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Timepoint
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Continuously monitored during the study
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Method of measurement
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It will be measured by self-report
Secondary outcomes
1
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Description
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Confirmatory HIV test among clients, partners and peers
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Timepoint
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3 and 6 months after enrollment
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Method of measurement
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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
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Description
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ART initiation among clients, partners and peers
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Timepoint
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3 and 6 months after enrollment
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Method of measurement
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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
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Description
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Uptake of HIV self-testing among clients, partners and peers
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Timepoint
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3 and 6 months after enrollment
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Method of measurement
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It will be measured by 1) self-report, 2) tracking system for self-test kits
4
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Description
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HIV self-test results among clients, partners and peers
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Timepoint
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3 and 6 months after enrollment
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Method of measurement
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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
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Description
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Behavioral change among clients, partners and peers
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Timepoint
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3 and 6 months after enrollment
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Method of measurement
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It will be measured by self-report
6
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Description
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Adverse events among clients, partners and peers
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Timepoint
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Continuously monitored during the study
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Method of measurement
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It will be measured by self-report
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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Group 2: FSW Participants in the control arm receive no monetary incentive.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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957506
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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National Institute for Medical Research Development
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available