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IRCT201710039506N1 IRCT 2017-10-25 National Institute for Medical Research Development Monetary incentive effect on HIV self-testing uptake and linkage to care outcomes Selfii 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 2019-01-15 anticipated 1440 Complete https://irct.ir/trial/10083 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Screening, Other design features: We will use Respondent-Driven Sampling (RDS) to recruit study participants, 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. N/A HIV and High risk behavior. Intervention 1: 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. Intervention 2: Group 2: FSW Participants in the control arm receive no monetary incentive. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We have not yet decided to do this.
public Ali Mirzazadeh
550 16th St, San Francisco, CA
San Francisco United States of America 94158 +1 0014154765821 Ali.Mirzazadeh@ucsf.edu University of California, San Francisco scientific Ali Mirzazadeh
550 16th Street
San Francisco United States of America 94158 +1 415-476-5821 Ali.Mirzazadeh@ucsf.edu University of California, San Francisco Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 18 years no limit Both if the FSW would not accept to distribute the HIV self- test among her sexual partners. B24 Unspecified human immunodeficiency virus [HIV] disease Treatment - Other N/A 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 2: FSW Participants in the control arm receive no monetary incentive. 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. 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. 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. 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. Behavioral change among FSW. Timepoint: baseline, and 3 and 6 months after enrollment. Method of measurement: It will be measured by self-report. Adverse events among FSW. Timepoint: Continuously monitored during the study. Method of measurement: It will be measured by self-report. 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. 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. 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. 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. Behavioral change among clients, partners and peers. Timepoint: 3 and 6 months after enrollment. Method of measurement: It will be measured by self-report. Adverse events among clients, partners and peers. Timepoint: Continuously monitored during the study. Method of measurement: It will be measured by self-report. National Institute for Medical Research Development Approved 2017-09-15 Ethics in Research Committee of National Institute for Medical Research Development 21 Besat St, West Fatemi Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of) Approved 2017-03-07 Ethics committee of Kerman University of Medical Sciences Ebn-e-Sina St, Jahad Blvd Kerman Kerman Iran (Islamic Republic of) Approved 2017-12-26 Ethics committee of Isfahan University of Medical Sciences 4 Central Building, Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)