NCT03559959

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

June 5, 2018

Last Update Submit

February 27, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Voucher redemption

    Proportion of individuals that obtained or purchased an HIV self-test

    One month after enrollment

Secondary Outcomes (1)

  • Voucher redemption in key populations

    One month

Study Arms (5)

$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.

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.

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.

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.

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.

Behavioral: Vouchers for HIV self-testing kits

Interventions

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.

$0 price$0.5 price$1 price$2 price$3 price

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Harare, Zimbabwe

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Harsha Thirumurthy, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 5, 2018

First Posted

June 18, 2018

Study Start

February 15, 2018

Primary Completion

May 25, 2018

Study Completion

May 25, 2018

Last Updated

February 28, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations