HIV/AIDSNCT03559959
A Field Experiment to Assess the Demand for HIV Self-Tests in Zimbabwe
A study testing Vouchers for HIV self-testing kits in people with HIV/AIDS, run by University of Pennsylvania at 1 site in Zimbabwe.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Vouchers for HIV self-testing kits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteZimbabwe
- Study dates
- 15 Feb 2018to 25 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Zimbabwe1 site
Zimbabwe and the Centre for Sexual Health and HIV/AIDS Research (CeSHHAR) Zimbabwe
Harare
About this study
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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- Vouchers for HIV self-testing kits
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vouchers for HIV self-testing kitsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| $0 price | Experimental | 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. Receives: Behavioral: Vouchers for HIV self-testing kits |
| $0.5 price | Experimental | 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. Receives: Behavioral: Vouchers for HIV self-testing kits |
| $1 price | Experimental | 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. Receives: Behavioral: Vouchers for HIV self-testing kits |
| $2 price | Experimental | 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. Receives: Behavioral: Vouchers for HIV self-testing kits |
| $3 price | Experimental | 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. Receives: Behavioral: Vouchers for HIV self-testing kits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voucher redemption
Proportion of individuals that obtained or purchased an HIV self-test
Measured: One month after enrollment
Secondary outcomes (1)
Voucher redemption in key populations
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.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start15 Feb 2018
- Primary completion25 May 2018
- Study completion25 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Sexual Health and HIV/AIDS Research Zimbabwe
- Responsible party
- Principal investigator, Harsha Thirumurthy, University of Pennsylvania
- Investigators
- Harsha Thirumurthy, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559959
- Sponsor's protocol ID
- MRCZ/A/2199
- Status last verified
- Feb 2019
- First submitted
- 5 Jun 2018
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang W, Matambanadzo P, Takaruza A, Hatzold K, Cowan FM, Sibanda E, Thirumurthy H. Effect of Prices, Distribution Strategies, and Marketing on Demand for HIV Self-testing in Zimbabwe: A Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e199818. doi: 10.1001/jamanetworkopen.2019.9818.
PubMed 31461146
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Field Experiment to Assess the Demand for HIV Self-Tests in Zimbabwe
- ClinicalTrials.gov ID
- NCT03559959
- Acronym / sponsor ID
- MRCZ/A/2199
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Centre for Sexual Health and HIV/AIDS Research Zimbabwe
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| $0 price | Experimental | Behavioral: Vouchers for HIV self-testing kitsVouchers for HIV self-testing kits: Individuals will receive a voucher that can be used to redeem an HIV self-testing kit free of charge. |
| $0.5 price | Experimental | Behavioral: Vouchers for HIV self-testing kitsVouchers 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. |
| $1 price | Experimental | Behavioral: Vouchers for HIV self-testing kitsVouchers 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. |
| $2 price | Experimental | Behavioral: Vouchers for HIV self-testing kitsVouchers 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. |
| $3 price | Experimental | Behavioral: Vouchers for HIV self-testing kitsVouchers 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vouchers for HIV self-testing kitsParticipants 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. | Behavioural | $0 price, $0.5 price, $1 price, $2 price, $3 price |
Primary outcome
Voucher redemption
Time frame: One month after enrollment
Proportion of individuals that obtained or purchased an HIV self-test
1 secondary outcome
Voucher redemption in key populations
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Derived from this study: PubMed 31461146Chang W, Matambanadzo P, Takaruza A, Hatzold K, Cowan FM, Sibanda E, Thirumurthy H. Effect of Prices, Distribution Strategies, and Marketing on Demand for HIV Self-testing in Zimbabwe: A Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e199818. doi: 10.1001/jamanetworkopen.2019.9818.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harsha Thirumurthy, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vouchers for HIV self-testing kits in people with HIV/AIDS, run by University of Pennsylvania at 1 site in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voucher redemption (time frame: One month after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03559959, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.