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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,458
- 试验地点
- 1
- 主要终点
- The Proportion who tested for HIV over 2 months follow-up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
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."
干预措施: Intervention (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."
干预措施: Enhanced Standard of Care (Behavioral)
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."
干预措施: Traditional Standard of Care (Behavioral)
结局指标
主要结局
The Proportion who tested for HIV over 2 months follow-up
时间窗: 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.
次要结局
- 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)
研究者
Elizabeth Kelvin
Associate Professor
City University of New York, School of Public Health