A Field Experiment to Assess the Demand for HIV Self-Tests in Zimbabwe

February 27, 2019 updated by: Harsha Thirumurthy, University of Pennsylvania
This study is a field experiment in peri-urban and rural communities near Harare, Zimbabwe, that seeks to estimate the likelihood that individuals will purchase HIV self-tests under various pricing and distribution strategies. About 4,000 adults will be randomly selected, administered a short questionnaire, and given vouchers that will offer them HIV self-tests at randomly allocated prices and distribution sites. The study will also test whether the provision of HIV self-tests can be targeted more cost-effectively to reach high-risk persons and non- recent testers. Last, the study will explore whether demand for repeated HIV self-testing is contingent on the price offered initially.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a field experiment that seeks to obtain "revealed preference" estimates of the likelihood that individuals will purchase oral fluid-based HIV self-tests at alternative prices. Such an approach is useful for estimating the price sensitivity (or elasticity) of demand for HIV self-tests. The study will also estimate the extent to which demand for self-tests differs by certain distribution channels such as retail outlets, public sector health facilities, and other community-based venues. Importantly, the experiment will also test whether the provision of HIV self-tests can be targeted more cost-effectively to reach high-risk persons and non-recent testers by examining the demand for self-tests in these populations in responses to various prices and distribution strategies. The results of the study will provide vital information required by policy makers and implementers on the optical pricing and distribution strategies for introducing HIV self-tests and scaling up HIVST in resource-limited settings. In a subsequent study with additional funding, the study will also seek to determine the long-term implications of offering self-tests at very low prices initially; specifically, it will assess whether free distribution initially suppresses individuals' willingness to pay for self-tests in the future. Roughly 12 months after the initial voucher offer, participants who provided a mobile phone number they can access within their household will be contacted via phone-based text messages and offered the same HIV self-tests again at one common non-zero price. The purchases at 12 months will once again be monitored and linked to participants via a unique identifier that is included in the text messages.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zimbabwe
      • Harare, Zimbabwe
        • Zimbabwe and the Centre for Sexual Health and HIV/AIDS Research (CeSHHAR) Zimbabwe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 16 years or older
  • Willing and able to provide written informed consent for participation
  • Intends to stay in the study area for at least 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: $0 price
Vouchers for HIV self-testing kits: Individuals will receive a voucher that can be used to redeem an HIV self-testing kit free of charge.
Behavioral: Vouchers for HIV self-testing kits
Participants will be given one referral voucher that offers a self-test kit at a randomly selected price point and distribution site. The vouchers will be valid for one month after the enrollment date. The other household members above 16 years of age will also be offered one voucher per person. Vouchers for the same household will have the same price, distributor, and promotion messages.
Experimental: $0.5 price
Vouchers for HIV self-testing kits: Individuals will receive a voucher that can be used to purchase an HIV self-testing kit at the price of $0.5.
Behavioral: Vouchers for HIV self-testing kits
Participants will be given one referral voucher that offers a self-test kit at a randomly selected price point and distribution site. The vouchers will be valid for one month after the enrollment date. The other household members above 16 years of age will also be offered one voucher per person. Vouchers for the same household will have the same price, distributor, and promotion messages.
Experimental: $1 price
Vouchers for HIV self-testing kits: Individuals will receive a voucher that can be used to purchase an HIV self-testing kit at the price of $1.
Behavioral: Vouchers for HIV self-testing kits
Participants will be given one referral voucher that offers a self-test kit at a randomly selected price point and distribution site. The vouchers will be valid for one month after the enrollment date. The other household members above 16 years of age will also be offered one voucher per person. Vouchers for the same household will have the same price, distributor, and promotion messages.
Experimental: $2 price
Vouchers for HIV self-testing kits: Individuals will receive a voucher that can be used to purchase an HIV self-testing kit at the price of $2.
Behavioral: Vouchers for HIV self-testing kits
Participants will be given one referral voucher that offers a self-test kit at a randomly selected price point and distribution site. The vouchers will be valid for one month after the enrollment date. The other household members above 16 years of age will also be offered one voucher per person. Vouchers for the same household will have the same price, distributor, and promotion messages.
Experimental: $3 price
Vouchers for HIV self-testing kits: Individuals will receive a voucher that can be used to purchase an HIV self-testing kit at the price of $3.
Behavioral: Vouchers for HIV self-testing kits
Participants will be given one referral voucher that offers a self-test kit at a randomly selected price point and distribution site. The vouchers will be valid for one month after the enrollment date. The other household members above 16 years of age will also be offered one voucher per person. Vouchers for the same household will have the same price, distributor, and promotion messages.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Voucher redemption
Time Frame: One month after enrollment
Proportion of individuals that obtained or purchased an HIV self-test
One month after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Voucher redemption in key populations
Time Frame: One month
Proportion of individuals that obtained or purchased an HIV self-test in key segments of the populations, including individuals who have never tested for HIV in the past or not tested recently, individuals with high risk of HIV infection based on self-reported sexual behavior, and individuals with low and high income.
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre for Sexual Health and HIV/AIDS Research Zimbabwe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MRCZ/A/2199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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