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General

Study Overview

Title:

A Randomized Controlled Trial to Evaluate Adding Self-Administered Oral HIV Testing as a Choice in Clinic and Non-Clinic Settings to Increase HIV Testing Uptake Among Truck Drivers in Kenya

Study is 3ie funded:

No

Study ID:

RIDIE-STUDY-ID-55847d64a454f

Initial Registration Date:

06/19/2015

Last Update Date:

06/19/2015

Study Status:

In Development

Location(s):

Kenya

Abstract:

Truck drivers in Africa are at higher risk for HIV compared to the general population and generally have low HIV testing rates, even when roadside clinics with hours that make them accessible to truck drivers are available. Current HIV testing standard at roadside wellness clinics run by the North Star Alliance is to offer a provider administered rapid blood (finger prick) test. We are conducting a pilot randomized controlled trial to assess the impact offering HIV rapid testing choices (provider-administered finger-prick blood test in the clinic, provider-supervised, self-administered administered oral test in the clinic, or self-administered oral test for unsupervised use outside of the clinic) to truck drivers at two roadside clinics in Kenya compared to the current standard. We will further assess whether allowing those in the intervention arm to obtain a second self-administered oral HIV test kit for home use 3-6 months later increases repeat testing compared to those in the standard care arm who only have access to clinic-based testing. The outcome of interest is HIV test uptake in the clinic and during follow-up.

Registration Citation:

Kelvin, E. and Mwai, E., 2015. A Randomized Controlled Trial to Evaluate Adding Self-Administered Oral HIV Testing as a Choice in Clinic and Non-Clinic Settings to Increase HIV Testing Uptake Among Truck Drivers in Kenya. Registry for International Development for Impact Evaluations (RIDIE). Available at: 10.23846/ridie062

Categories:

Health, Nutrition, and Population

Additional Keywords:

Truck drivers, HIV, HIV testing, Self-administered HIV testing, Kenya, Africa

Secondary ID Number(s):

TW2.2.06

Principal Investigator(s)

Name of First PI:

Elizabeth Kelvin

Affiliation:

Hunter College, City University of New York

Name of Second PI:

Eva Mwai

Affiliation:

North Star Alliance

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:

The intervention being assessed is the offer of HIV rapid testing choices (provider-administered finger-prick blood test in the clinic, provider-supervised, self-administered oral test in the clinic, or self-administered oral test for unsupervised use outside of the clinic) to truck drivers in two roadside wellness clinics in Kenya. The current standard of care in these clinics is to only offer one HIV test option, a provider-administered rapid blood (finger prick) test. We will compare HIV test uptake at baseline and during 6-month follow-up between the group offered HIV test choices and the group offered the standard care.

Theory of Change:

Multiple Treatment Arms Evaluated?

No

Implementing Agency

Name of Organization:

North Stat 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:

07/15/2015

End Date:

04/15/2016

Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:

Randomized control trial

Other (not Listed) Method:

Additional Evaluation Method (If Any):

Regression with controls

Other (not Listed) Method:

Method Details

Details of Evaluation Approach:

Truck driver clients attending the services at one of the participating clinics will be randomized to be offered either only the standard care HIV test or a choice between the standard test or supervised self-administered oral HIV test for use in the clinic. The randomization will be at the individual level and stratified on clinic. Those in the intervention arm who refuse HIV testing in the clinic will then be offered the option to take a self-administered oral HIV test kit for use outside of the clinic. All those in the intervention arm will also be invited to return to a clinic in 3-6 months later to pick-up a second self-administered oral HIV test kit for use outside of the clinic. We will conduct follow-up interviews at 6-months post baseline with those in both arms and ask about any additional HIV tests received post baseline. We will examine differences in uptake of the initial HIV test in the clinic between those randomized to the standard care arm versus the HIV test choice arm. We will also compare HIV test uptake at baseline either in or outside of the clinic, as well as HIV testing during follow-up, between the two study arms.

Outcomes (Endpoints):

The primary outcome of this study is uptake of HIV testing by truck drivers in the clinic. We will examine differences in uptake of the initial HIV test in the clinic between those randomized to the standard care arm versus the HIV test choice arm. We will also compare HIV test uptake at baseline either in or outside of the clinic, as well as HIV testing during follow-up, between the two study arms.

Unit of Analysis:

Individuals

Hypotheses:

Primary Ha: there is a difference in uptake of HIV testing among truck drivers in the clinic between those in the standard care arm versus those in the HIV test choice arm. Secondary: Ha: There is a difference in HIV test uptake among truck drivers at baseline either in or outside of the clinic between those in the standard care arm versus those in the HIV test choice arm. Ha: There is a difference in HIV testing among truck drivers during follow-up between those in the standard care arm and those in the HIV test choice arm.

Unit of Intervention or Assignment:

Individuals (male truck drivers) who agree to participate in the study. All truck drivers who enter the clinic during the recruitment perod will be invited to be screened for the study.

Number of Clusters in Sample:

N/A

Number of Individuals in Sample:

300 total (100-200 per clinic)

Size of Treatment, Control, or Comparison Subsamples:

150 in treatment and 150 in intervention arm

Supplementary Files

Analysis Plan:

Other Documents:

Data

Outcomes Data

Description:

Questionnaire administered to individuals. Baseline data will be collected through in-person interviews. Follow-up data will be collected either through in-person interviews or phone interview, depending on the participant's preference and availability.

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

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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:

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Total Observations in Final Sample:

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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:

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