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Increase HIV Testing Among Truck Drivers and Female Sex Workers in Kenya Through Offering HIV Self-Testing

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ClinicalTrials.gov Identifier: NCT03662165
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : September 7, 2018
Sponsor:
Collaborators:
International Initiative for Impact Evaluation
North Star Alliance
University of KwaZulu
New York State Psychiatric Institute
Information provided by (Responsible Party):
Elizabeth Kelvin, City University of New York, School of Public Health

Tracking Information
First Submitted Date  ICMJE September 2, 2018
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date September 7, 2018
Actual Study Start Date  ICMJE December 20, 2016
Actual Primary Completion Date April 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
The Proportion who tested for HIV over 2 months follow-up [ Time Frame: 2 months following the first text message ]
We compared the proportion who tested for HIV during the 2-month follow-up period among participants in the Intervention arm versus those in the Enhanced Standard of Care (SOC) arm (primary comparison) as well as among those in the Enhanced SOC versus those in the Traditional SOC arms (secondary comparison) to look at the impact of the content of the text message (i.e. about self-testing kits or HIV testing in general) and of the number of text messages (3 versus 1) on HIV testing, respectively.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
  • Proportion who had any clinic contact over the 2 month follow-up [ Time Frame: 2 months ]
    We also looked at differences in clinic contact for any reason (i.e., for HIV testing or some other service) between the three groups to see if the text messages brought more clients to the clinic even if some chose not to test for HIV.
  • Effect Modification of HIV testing outcome by HIV testing history (Had an HIV test in the past year or not) [ Time Frame: 2 months ]
    We also looked at whether the differences in HIV testing by study arm were modified by HIV testing history (whether the client had an HIV test at a North Star Alliance clinic in the past year).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Increase HIV Testing Among Truck Drivers and Female Sex Workers in Kenya Through Offering HIV Self-Testing
Official Title  ICMJE A Randomised Controlled Trial to Increase HIV Testing Demand Among Truck Drivers and Sex Workers Through Offering Self-Administered Oral HIV Testing at North Star Alliance Clinics in Kenya
Brief Summary The study aimed to assess whether advertising the availability of self-administered oral HIV testing kits increases the number of truck drivers and female sex workers who come to the North Star Alliance clinics for HIV testing (Demand creation). The investigators sent text messages to eligible truck drivers and female sex workers registered in the North Star Alliance electronic health record system who, based on those records, were not accessing HIV testing regularly and randomized them to receive one of two messaged, (1) the standard message sent to all clients who have not tested for HIV in the past 3 months reminding them of the availability of HIV testing at North Star clinics or (2) a text message announcing the availability of HIV self-testing kits fat all North Star clinics in Kenya. The investigators then compared the number of truck drivers and female sex workers from our samples who came to the clinic for HIV testing over a 2 month period following the first text message in the two study arms.
Detailed Description The study aimed to assess whether advertising the availability of self-administered oral HIV testing kits increases the number of truck drivers and female sex workers who come to the North Star Alliance clinics for HIV testing (Demand creation). The investigators first selected a sample of eligible truck drivers from the electronic health record system of the North Star Alliance who, based on those records, were not accessing HIV testing regularly, sent passive text messages alerting them that The North Star Alliance was planning to use their deidentified electronic health data for program evaluation purposes and gave them the option to opt out of being included. The investigators then randomized those who did not opt-out on a 1:1:1 ratio to receive one of two messages, (1) the standard (SOC) message sent to all clients who have not tested for HIV in the past 3 months reminding them of the availability of HIV testing at North Star clinics sent one time (2) the SOC message sent three times, a week apart (Enhanced SOC) or (2) a text message announcing the availability of HIV self-testing kits fat all North Star clinics in Kenya sent three times, a week apart. The investigators compared the number of truck drivers from our sample who came to the clinic for HIV testing over a 2 month period following the first text message in the three study arms. After completing the study among truck drivers, we followed the same procedures for a sample of female sex workers registered in the electronic health record system who were not accessing HIV testing regularly.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
We selected a sample of eligible truckers and randomized them on a 1:1:1 ratio to the three study arms. After completing the 2 month follow-up, we followed the same procedure with a sample of eligible female sex workers.
Masking: Single (Participant)
Masking Description:
Participants were not informed about the specific research question or the fact that they would be randomized to different HIV testing options in order to avoid bias.
Primary Purpose: Screening
Condition  ICMJE HIV Testing
Intervention  ICMJE
  • Behavioral: Intervention
    A text was sent three times, one week apart, first in Kiswahili, then in English and then again in Kiswahili, and read: "You can now self-test at home or in the clinic for HIV using a new test kit available from all North Star Alliance clinics in Kenya. Your health, our priority." Participants who came to any North Star clinic in Kenya in the intervention arm were given a demonstration of the self-testing kit and then offered a choice among (1) the standard provider-administered blood-based HIV test; (2) the self-administered oral HIV test for use in the clinic with provider supervision; or (3) the self-administered oral HIV test kit for home use with phone-based post-test counseling.
  • Behavioral: Enhanced Standard of Care
    Those randomized to the enhanced Standard of Care (SOC) arm received the SOC message reminding clients about HIV testing sent three times, one week apart first in Kiswahili, then in English and then again in Kiswahili. The message read: "North Star Alliance East Africa would wish to kindly remind you to visit any of our roadside wellness centres for HIV testing. Your health, our priority." Participants who came to any North Star clinic in the enhanced SOC arm only offered the standard provider-administered blood-based HIV test.
  • Behavioral: Traditional Standard of Care
    Those randomized to the traditional Standard of Care (SOC) arm received the SOC message reminding clients about HIV testing sent one time in both Kiswahili, then in English and Kiswahili simultaneously. The message read: "North Star Alliance East Africa would wish to kindly remind you to visit any of our roadside wellness centres for HIV testing. Your health, our priority." Participants who came to any North Star clinic in the traditional SOC arm only offered the standard provider-administered blood-based HIV test.
Study Arms  ICMJE
  • Experimental: Intervention
    The primary intervention consisted of a text message informing participants that HIV self-test kits were available at all North Star Alliance clinics in Kenya. The message was sent three times, one week apart, first in Kiswahili, then in English and then again in Kiswahili, and read: "You can now self-test at home or in the clinic for HIV using a new test kit available from all North Star Alliance clinics in Kenya. Your health, our priority."
    Intervention: Behavioral: Intervention
  • Experimental: Enhanced Standard of Care
    Those randomized to the enhanced Standard of Care (SOC) arm received the SOC message reminding clients about HIV testing sent three times, one week apart first in Kiswahili, then in English and then again in Kiswahili. The message read: "North Star Alliance East Africa would wish to kindly remind you to visit any of our roadside wellness centres for HIV testing. Your health, our priority."
    Intervention: Behavioral: Enhanced Standard of Care
  • Active Comparator: Traditional Standard of Care
    Those randomized to the traditional SOC arm received the SOC message one time sent simultaneously in both Kiswahili and English. The message read: "North Star Alliance East Africa would wish to kindly remind you to visit any of our roadside wellness centres for HIV testing. Your health, our priority."
    Intervention: Behavioral: Traditional Standard of Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2018)
4458
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 27, 2017
Actual Primary Completion Date April 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Truck Drivers or Trucking Assistants (Sample 1) and female sex workers(Sample 2) registered in the North Star Alliance electronic health record system and who
  • had no indication that they were HIV-positive
  • resided in Kenya
  • had a valid mobile phone number listed
  • had fewer than four HIV tests recorded in the system in the past 12 months (indicating that they were not following the recommendation to test every 3 months for 4 tests per year), and
  • had not had an HIV test in the past 3 months.

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03662165
Other Study ID Numbers  ICMJE 2015-0645
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All study deidentified data and documentation (e.g. statistical analysis code, study report) has been provided to the study funder (International Initiative for Impact Evaluation) and they will make it publicly available. We will include instructions abut how to access the study data and documents in all publications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: As soon as the main study papers have been accepted fro publication. We have already posted the data from the sex worker sample and will post the data for the trucker sample once the paper has been accepted for publication
Access Criteria: Open access
URL: https://dataverse.harvard.edu/dataset.xhtml?persistentId=doi:10.7910/DVN/UULS6T
Responsible Party Elizabeth Kelvin, City University of New York, School of Public Health
Study Sponsor  ICMJE City University of New York, School of Public Health
Collaborators  ICMJE
  • International Initiative for Impact Evaluation
  • North Star Alliance
  • University of KwaZulu
  • New York State Psychiatric Institute
Investigators  ICMJE
Principal Investigator: Elizabeth A Kelvin, PhD City University of New York
PRS Account City University of New York, School of Public Health
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP