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Clinical Trials/NCT03662165
NCT03662165
Completed
Not Applicable

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

City University of New York, School of Public Health1 site in 1 country4,458 target enrollmentDecember 20, 2016
ConditionsHIV Testing

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Testing
Sponsor
City University of New York, School of Public Health
Enrollment
4458
Locations
1
Primary Endpoint
The Proportion who tested for HIV over 2 months follow-up
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 20, 2016
End Date
April 27, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
City University of New York, School of Public Health
Responsible Party
Principal Investigator
Principal Investigator

Elizabeth Kelvin

Associate Professor

City University of New York, School of Public Health

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Effect Modification of HIV testing outcome by HIV testing history (Had an HIV test in the past year or not)(2 months)
  • Proportion who had any clinic contact over the 2 month follow-up(2 months)

Study Sites (1)

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