Supporting Young Women's Reproductive Health by Harnessing Prosociality Among Drug Shopkeepers

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 18 months.

Study Overview

• Status: Recruiting
• Conditions: Hiv; Contraception
• Intervention / Treatment: Behavioral: Harnessing prosocial and social image motivations for behavior change

Detailed Description

The investigators will cross-randomize 120 drug shops enrolled in the parent Malkia Klabu effectiveness cluster-randomized controlled trial (CRCT; NCT05357144), stratified by CRCT study arm, to one of three initial conditions: 1. No feedback. AGYW customer feedback will be collected, but not shared with the shopkeeper. 2. Private feedback. Biweekly summarized reports of AGYW customer feedback will be given directly to shopkeepers. 3. Public feedback: 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. The investigators will phase in the 2 interventions (Private and Public Feedback) on a staggered basis to control for both shop-specific and time-specific trends for the primary outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenny X Liu, PhD; Phone Number: 4155025200; Email: jenny.liu2@ucsf.edu
• Study Contact Backup: Name: Calvin Chiu, MA; Email: calvin_chiu@berkeley.edu

Study Locations

• Tanzania
  • Mwanza, Tanzania
    • Recruiting
    • Mwanza Province
    • Contact: Jenny X Liu, PhD; Phone Number: 4155025200; Email: jenny.liu2@ucsf.edu
  • Shinyanga, Tanzania
    • Recruiting
    • Shinyanga
    • Contact: Jenny X Liu, PhD; Phone Number: 4155025200; Email: jenny.liu2@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Shopkeepers enrolled in the parent CRCT

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: No feedback; AGYW customer feedback will be collected but not shared with shopkeepers	Behavioral: Harnessing prosocial and social image motivations for behavior change; 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
Experimental: Private feedback; Biweekly summarized reports of AGYW customer feedback will be given directly to shopkeepers	Behavioral: Harnessing prosocial and social image motivations for behavior change; 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
Experimental: Public feedback; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of HIV self-test kits distributed	Mean number of HIV self-test kits distributed per shop every 2 weeks	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 contraceptives distributed	Mean number of contraceptives distributed per shop every 2 weeks	12 months
Quantity of contraceptives distributed	Mean number of contraceptives distributed per shop every 2 weeks	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of HIV self-test kits stocked	Mean number of HIV self-test kits stocked per shop every 2 weeks	12 months
Quantity of HIV self-test kits stocked	Mean number of HIV self-test kits available in the shop to be sold every 2 weeks	18 months
Quantity of contraceptives stocked	Mean number of contraceptives available in the shop to be sold every 2 weeks	12 months
Quantity of contraceptives stocked	Mean number of contraceptives available in the shop to be sold every 2 weeks	18 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of California, Berkeley; Health for a Prosperous Nation
• Investigators: Principal Investigator: Jenny X Liu, PhD, University of California, San Francisco

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Contraception; HIV self-testing; Drug shops; Pro-sociality; Adolescent health
• Other Study ID Numbers: R03HD109561-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

IPD Sharing 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.

• IPD Sharing Access Criteria: Everything posted to OSF and Clinical Trials will be made publicly available.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No