Clinical trial NCT03662165: Increase HIV Testing Among Truck Drivers and Female Sex Workers in Kenya Through Offering HIV Self-Testing
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Testing
Keywords: HIV testing
Truck drivers
sex workers
Lead sponsor: City University of New York, School of Public Health
Sponsor class: OTHER
Collaborators: name: International Initiative for Impact Evaluation
name: North Star Alliance
name: University of KwaZulu
name: New York State Psychiatric Institute
First posted: 2018-09-07
Enrollment: 4458
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SCREENING

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.

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:

* None

Primary outcomes:
measure: The Proportion who tested for HIV over 2 months follow-up
timeFrame: 2 months following the first text message
Secondary outcomes:
measure: Proportion who had any clinic contact over the 2 month follow-up
timeFrame: 2 months
measure: Effect Modification of HIV testing outcome by HIV testing history (Had an HIV test in the past year or not)
timeFrame: 2 months
Other outcomes:
Locations:
city: New York
country: United States
facility: CUNY Graduate School of Public Health and Health Policy
state: New York
Study officials:
affiliation: City University of New York
name: Elizabeth A Kelvin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kelvin EA, George G, Mwai E, Kinyanjui S, Romo ML, Odhiambo JO, Oruko F, Nyaga E, Govender K, Mantell JE. A Randomized Controlled Trial to Increase HIV Testing Demand Among Female Sex Workers in Kenya Through Announcing the Availability of HIV Self-testing Via Text Message. AIDS Behav. 2019 Jan;23(1):116-125. doi: 10.1007/s10461-018-2248-5.
citation: Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
citation: Kelvin EA, George G, Kinyanjui S, Mwai E, Romo ML, Oruko F, Odhiambo JO, Nyaga EN, Mantell JE, Govender K. Announcing the availability of oral HIV self-test kits via text message to increase HIV testing among hard-to-reach truckers in Kenya: a randomized controlled trial. BMC Public Health. 2019 Jan 3;19(1):7. doi: 10.1186/s12889-018-6345-1.