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

NCT03662165 | Completed

• 1 other identifier: 2015-0645
• Study Type: interventional
• Target: 4,458
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Testing

Keywords

HIV testing; Truck drivers; sex workers

Outcome Measures

Primary Outcomes (1)

• The Proportion who tested for HIV over 2 months follow-up

  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.

  2 months following the first text message

Secondary Outcomes (2)

• Proportion who had any clinic contact over the 2 month follow-up

  2 months

• Effect Modification of HIV testing outcome by HIV testing history (Had an HIV test in the past year or not)

  2 months

Study Arms (3)

Intervention

EXPERIMENTAL

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."

Behavioral: Intervention

Enhanced Standard of Care

EXPERIMENTAL

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."

Behavioral: Enhanced Standard of Care

Traditional Standard of Care

ACTIVE COMPARATOR

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."

Behavioral: Traditional Standard of Care

Interventions

Intervention BEHAVIORAL

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.

Intervention

Enhanced Standard of Care BEHAVIORAL

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.

Enhanced Standard of Care

Traditional Standard of Care BEHAVIORAL

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.

Traditional Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• City University of New York, School of Public Health: lead
• International Initiative for Impact Evaluation: collaborator
• North Star Alliance: collaborator
• University of KwaZulu: collaborator
• New York State Psychiatric Institute: collaborator

Study Sites (1)

CUNY Graduate School of Public Health and Health Policy

New York, New York, 10027, United States

Location

Related Publications (3)

• 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.

  PMID: 30109456 RESULT

• 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.

  PMID: 32779730 DERIVED

• 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.

  PMID: 30606161 DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Elizabeth A Kelvin, PhD

  City University of New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 2, 2018
• First Posted: September 7, 2018
• Study Start: December 20, 2016
• Primary Completion: April 27, 2017
• Study Completion: April 27, 2017
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, 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

Locations

US (1)