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Study Overview

Title:
A Randomised Controlled Trial to Increase HIV Testing Demand Among Truck Drivers and Female Sex Workers Through Offering Self-Administered Oral HIV Testing at North Star Alliance Clinics in Kenya
Study ID:
RIDIE-STUDY-ID-582a2462ae2ab
Initial Registration Date:
11/14/2016
Last Update Date:
11/14/2016
Study Status:
In Development
Location(s):
Kenya
Abstract:
This study aims to assess whether advertising the availability of self-administered oral HIV testing kits increases the number of truck drivers and female sex workers (FSW) who come to North Star Alliance (NSA) roadside wellness clinics for HIV testing in Kenya. Participants will be randomized to one of three study arms stratified on profession (truck driver or FSW): (1) the intervention arm in which participants receive a text message advertising the availability of oral self-testing kits for in-clinic or home use at all NSA clinics in Kenya sent once a week for three weeks (2) the enhanced standard of care arm (SOC) in which participants receive the SOC message reminding them to test for HIV in general sent once a week for three weeks or (3) the traditional SOC arm in which participants receive the SOC message one time. We will compare the proportion of truck drivers and FSW who come to the clinics for HIV testing in the three arms.
Categories:
Health, Nutrition, and Population
Additional Keywords:
HIV, testing, self-test
Secondary ID Number(s):
TW2.2.06

Principal Investigator(s)

Name of First PI:
Elizabeth Kelvin
Affiliation:
CUNY School of Public Health and Health Policy, City University of New York
Name of Second PI:
Affiliation:

Study Sponsor

Name:
International Initiative for Impact Evaluation (3IE)
Study Sponsor Location:
United States
Funding Proposal:

Research Partner

Name of Partner Institution:
North Star Alliance
Type of Organization:
NGO-international
Website:
http://www.northstar-alliance.org/
Location:
Netherlands
Intervention

Intervention Overview

Intervention:
Eligible clients registered in the North Star Alliance electronic medical record system will be randomized to one of three study arms stratified on profession (truck driver or FSW): (1) The Intervention arm in which participants receive a text message advertising the availability of oral self-testing kits for in-clinic or home use at all NSA clinics in Kenya sent once a week for three weeks. The message will 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.” and will be sent in English and Kiswahili. (2) The enhanced standard of care arm (ESOC) in which participants receive the SOC message reminding them to test for HIV in general sent once a week for three weeks. The message will 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.” and will be sent in English and Kiswahili. (3) The traditional standard of care (SOC) arm in which participants receive the SOC message (described under #2) one time.
Multiple Treatment Arms Evaluated?
Yes

Implementing Agency

Name of Organization:
North Star Alliance
Type of Organization:
NGO (International)

Program Funder

Name of Organization:
International Initiative for Impact Evaluation (3IE)
Type of Organization:
NGO (International)

Intervention Timing

Intervention or Program Started at time of Registration?
No
Start Date:
12/01/2016
End Date:
03/31/2017
Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:
Randomized control trial
Other (not Listed) Method:
Additional Evaluation Method (If Any):
Other (not Listed) Method:

Method Details

Details of Evaluation Approach:
eligible North Star Alliance clients registered in the electronic medical record system will be randomized to one of three study arms stratified on profession (truck driver or FSW): (1) The Intervention arm in which participants receive a text message advertising the availability of oral self-testing kits for in-clinic or home use at all NSA clinics in Kenya sent once a week for three weeks. (2) The enhanced standard of care arm (ESOC) in which participants receive the SOC message reminding them to test for HIV in general sent once a week for three weeks. (3) The traditional standard of care (SOC) arm in which participants receive the SOC message one time. We will compare HIV testing rates in the three arms 2 months following the first text message adjusting for strata (truck driver versus female sex worker).
Change History for Details of Evaluation Approach
Changed On Previous Value
11/14/2016 eligible North Star Alliance clients registred in the electronic medical record system will be randomized to one of three study arms stratified on profession (truck driver or FSW): (1) The Intervention arm in which participants receive a text message advertising the availability of oral self-testing kits for in-clinic or home use at all NSA clinics in Kenya sent once a week for three weeks. (2) The enhanced standard of care arm (ESOC) in which participants receive the SOC message reminding them to test for HIV in general sent once a week for three weeks. (3) The traditional standard of care (SOC) arm in which participants receive the SOC message one time. We will compare HIV testing rates in the three arms 2 months following the fist text message adjusting for strate (truck driver versus female sex worker).
Outcomes (Endpoints):
HIV testing in a North Star Alliance clinic in the 2 month period following the first text message as recorded in the North Star Alliance electronic medical record system.
Measurement:
Not applicable
Unit of Analysis:
Individuals
Hypotheses:
Primary null hypothesis: The proportion of clients in the Intervention group who come to North Star Alliance clinics for HIV testing in the 2 months following the first text message is the same as the proportion in the Enhanced Standard Care group. Secondary null hypothesis: The proportion of clients in the Enhanced Standard Care group who come to North Star Alliance clinics for HIV testing in the 2 months following the first text message is the same as the proportion in the Traditional Standard Care Group.
Unit of Intervention or Assignment:
Individuals
Number of Clusters in Sample:
Not applicable
Number of Individuals in Sample:
at least 1600 truck drivers and 1600 female sex workers
Change History for Number of Individuals in Sample
Changed On Previous Value
11/14/2016 at least 1600 truck dfivers and 1600 female sex workers
Size of Treatment, Control, or Comparison Subsamples:
750 truck drivers and 750 female sex workers (FSWs) in each of the Intervention and Enhanced Standard Care arms, at least 100 truck drivers and 1oo FSWs in the Traditional Standard Care Arm
Change History for Size of Treatment, Control, or Comparison Subsamples
Changed On Previous Value
11/14/2016 750 truch drivers and 750 female sex workers (FSWs) in each of the Intervention and Enhanced Standard Care arms, at least 100 truck drivers and 1oo FSWs in the Traditional Standard Care Arm

Supplementary Files

Analysis Plan:
Other Documents:
Data

Outcomes Data

Description:
We will use the data in the North Star Alliance electronic medical record system
Data Already Collected?
No
Survey Name:
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Treatment Assignment Data

Participation or Assignment Information:
Yes
Description:
Data Obtained by the Study Researchers?
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Data Analysis

Data Analysis Status:

Study Materials

Upload Study Materials:

Registration Category

Registration Category:
Prospective, Category 1: Data for measuring impacts have not been collected
Completion

Completion Overview

Intervention Completion Date:
Data Collection Completion Date:
Unit of Analysis:
Clusters in Final Sample:
Total Observations in Final Sample:
Size of Treatment, Control, or Comparison Subsamples:

Findings

Preliminary Report:
Preliminary Report URL:
Summary of Findings:
Paper:
Paper Summary:
Paper Citation:

Data Availability

Data Availability (Primary Data):
Date of Data Availability:
Data URL or Contact:
Access procedure:

Other Materials

Survey:
Survey Instrument Links or Contact:
Program Files:
Program Files Links or Contact:
External Link:
External Link Description:
Description of Changes:

Study Stopped

Date:
Reason: