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General

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 is 3ie funded:

Yes

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.

Registration Citation:

Kelvin, E., 2016. 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. Registry for International Development for Impact Evaluations (RIDIE). Available at: 10.23846/ridie101

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

Research Partner

Name of Partner Institution:

North Star Alliance

Type of Organization:

NGO-international

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.

Theory of Change:

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.

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

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: