History
# Registration date Revision Id
3 2018-06-18, 1397/03/28 117111
2 2018-05-25, 1397/03/04 48434
1 2017-10-25, 1396/08/03 10083
Changes made to previous revision
This is the first revision

Protocol summary

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.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201710039506N1
Registration date: 2017-10-25, 1396/08/03
Registration timing: prospective

Last update:
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
2018-07-07, 1397/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Peer-driven HIV self-testing for Iranian female sex workers, their clients,and partners
Purpose
Other
Inclusion/Exclusion criteria
Female sex workers are eligible to include if they a) are 18 years and older, b) sold sex for money in the past month, c) and have a Telegram account. There is not any exclusion criteria.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 420
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
We will use Respondent Driven Sampling to recruit the 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
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
Postal code
Approval date
2017-03-07, 1395/12/17
Ethics committee reference number
IR.KMU.REC.1395.982

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
HIV testing uptake
Timepoint
After 12 weeks follow up
Method of measurement
By self-report and by review of records at HIV counseling and care sites

2

Description
Linkage of new diagnoses to care
Timepoint
At the end of 12 weeks follow up
Method of measurement
By self-report and by review of records at HIV counseling and care sites

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Other

2

Description
Group 2: Will not receive any Monetary incentive.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran Research Center for HIV/AIDS (IRCHA)
Full name of responsible person
Dr. Negin Abedinzadeh
Street address
Infectious disease ward, Imam-Khomeini Hospital, Keshavarz Blvd
City
Tehran

2

Recruitment center
Name of recruitment center
Infectious Disease Research Center
Full name of responsible person
Dr. Maryam Nasirian
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
National Institute for Medical Research Development
Full name of responsible person
Dr. Reza Malekzadeh
Street address
21 Besat St, West Fatemi Ave, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
University of California, San Francisco
Full name of responsible person
Ali Mirzazadeh
Position
Assistant Professor, MD, PhD
Other areas of specialty/work
Street address
550 16th St, San Francisco, CA
City
San Francisco
Province
California
Postal code
Phone
0014154765821
Fax
Email
Ali.Mirzazadeh@ucsf.edu
Web page address
https://www.ucsf.edu/

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of California, San Francisco
Full name of responsible person
Ali Mirzazadeh
Position
Assistant Professor, MD. PhD
Other areas of specialty/work
Street address
550 16th St
City
San Francisco
Postal code
Phone
+1 415-476-5821
Fax
Email
Ali.Mirzazadeh@ucsf.edu
Web page address
https://www.ucsf.edu/

Person responsible for updating data

Contact
Name of organization / entity
Precision Health Economics
Full name of responsible person
Soodabeh Navadeh
Position
Research Scientist, MD, PhD
Other areas of specialty/work
Street address
555 12th St, Suit 250
City
Oakland
Province
California
Postal code
94607
Phone
0013109826310
Fax
0013109826311
Email
soodabeh.navadeh@precisionhealtheconomics.com
Web page address
https://www.precisionhealtheconomics.com/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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