NCT05525533

Brief Summary

The goal of the study is to operationalize and test the preliminary impact of providing regular customer feedback from adolescent girls and young women (AGYW) to drug shopkeepers on the distribution of contraceptives and HIV self-testing to AGYW over 12 months.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
144

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 19, 2025

Completed
Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

1.7 years

First QC Date

August 30, 2022

Results QC Date

March 18, 2025

Last Update Submit

June 18, 2025

Conditions

HivContraception

Keywords

Drug shopsPro-socialityAdolescent healthHIV self-testingContraception

Outcome Measures

Primary Outcomes (5)

  • Quantity of HIV Self-test Kits Distributed

    Mean number of HIV self-test kits sold per shop every month

    12 months

  • Quantity of HIV Self-test Kits Distributed

    Mean number of HIV self-test kits distributed per shop every 2 weeks

    18 months

  • Quantity of Sexual and Reproductive Health Products Sold

    Mean number of sexual and reproductive health products sold per shop every month

    12 months

  • Quantity of Contraceptives Distributed

    Mean number of contraceptives distributed per shop every 2 weeks

    18 months

  • Quantity of All Products Sold

    Mean number of all products sold per shop per month

    12 months

Secondary Outcomes (4)

  • Quantity of Condoms Sold

    12 months

  • Quantity of Emergency Contraception Sold

    12 months

  • Quantity of Oral Contraception Sold

    12 months

  • Quantity of Pregnancy Tests Sold

    12 months

Study Arms (3)

No feedback

EXPERIMENTAL

AGYW customer feedback will be collected but not shared with shopkeepers

Behavioral: Harnessing prosocial and social image motivations for behavior change

Private feedback

EXPERIMENTAL

Biweekly summarized reports of AGYW customer feedback will be given directly to shopkeepers

Behavioral: Harnessing prosocial and social image motivations for behavior change

Public feedback

EXPERIMENTAL

Shopkeepers will get biweekly summarized reports of AGYW customer feedback, gold stars reflecting the level of AGYW customer feedback (e.g., 1-5 star rating) will be placed in the shop in a visible location, and shopkeepers will be invited to an awards ceremony every 6 months to recognize shopkeepers who receive high levels of positive AGYW customer feedback

Behavioral: Harnessing prosocial and social image motivations for behavior change

Interventions

Harnessing prosocial and social image motivations for behavior changeBEHAVIORAL

The investigators will collect AGYW customer feedback using a short USSD-based survey and randomize whether shopkeepers receive 1) No feedback; 2) Private feedback; or 3) Public feedback

No feedbackPrivate feedbackPublic feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Shopkeepers enrolled in the parent CRCT

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mwanza Province

Mwanza, Tanzania

Location

Shinyanga

Shinyanga, Tanzania

Location

Related Publications (3)

  • Hunter LA, McCoy SI, Rao A, Mnyippembe A, Hassan K, Njau P, Mfaume R, Liu JX. Designing drug shops for young women in Tanzania: applying human-centred design to facilitate access to HIV self-testing and contraception. Health Policy Plan. 2021 Nov 11;36(10):1562-1573. doi: 10.1093/heapol/czab084.

    PMID: 34313728BACKGROUND

  • Chiu C, Hunter LA, McCoy SI, Mfaume R, Njau P, Liu JX. Sales and pricing decisions for HIV self-test kits among local drug shops in Tanzania: a prospective cohort study. BMC Health Serv Res. 2021 May 6;21(1):434. doi: 10.1186/s12913-021-06432-1.

    PMID: 33957903BACKGROUND

  • Chiu C, Mnyippembe A, Sheira LA, Packel L, Katabaro E, Maokola W, Liu JX. Boosting health provider performance with non-financial incentives: A cluster-randomized controlled trial in Tanzania. PLoS One. 2025 Sep 11;20(9):e0330989. doi: 10.1371/journal.pone.0330989. eCollection 2025.

    PMID: 40934247DERIVED

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

Results Point of Contact

Title
Jenny Liu
Organization
University of California, San Francisco
jenny.liu2@ucsf.edu
6503800762

Study Officials

  • Jenny X Liu, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Randomized controlled trial; the investigators will phase in the 2 interventions (Private and Public Feedback) on a staggered basis. All shops will receive No Feedback during the first 6 months. One third of shops (\~N=40) will be assigned to No Feedback between 6-12 months; one third of shops (\~N=40) will be assigned to Private Feedback between 6-12 months; one third of shops (\~N=40) will be assigned to Public Feedback between 6-12 months.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 1, 2022

Study Start

July 1, 2022

Primary Completion

March 15, 2024

Study Completion

March 15, 2024

Last Updated

June 19, 2025

Results First Posted

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

The investigators will make the data and associated documentation available to users upon request and only under a data-sharing agreement with the study team that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The SP, SAP, and ICF will be made available on the Open Science Framework (OSF) within 12 months recruitment. Study results will be posted to OSF and Clinical Trials within 12 months of completion of data collection.
Access Criteria
Everything posted to OSF and Clinical Trials will be made publicly available.

Locations

TA(2)