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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05525533
• Other study ID #: R03HD109561-01
• Secondary ID: R03HD109561-01
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: University of California, San Francisco
• Contact: Jenny X Liu, PhD
• Phone: 4155025200
• Email: jenny.liu2[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 18 months.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Shopkeepers enrolled in the parent CRCT

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Contraception
• Hiv

Intervention

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

Locations

Country	Name	City	State
Tanzania	Mwanza Province	Mwanza
Tanzania	Shinyanga	Shinyanga

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Health for a Prosperous Nation, University of California, Berkeley

Country where clinical trial is conducted

Tanzania, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity of HIV self-test kits distributed	Mean number of HIV self-test kits distributed per shop every 2 weeks	12 months
Primary	Quantity of HIV self-test kits distributed	Mean number of HIV self-test kits distributed per shop every 2 weeks	18 months
Primary	Quantity of contraceptives distributed	Mean number of contraceptives distributed per shop every 2 weeks	12 months
Primary	Quantity of contraceptives distributed	Mean number of contraceptives distributed per shop every 2 weeks	18 months
Secondary	Quantity of HIV self-test kits stocked	Mean number of HIV self-test kits stocked per shop every 2 weeks	12 months
Secondary	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
Secondary	Quantity of contraceptives stocked	Mean number of contraceptives available in the shop to be sold every 2 weeks	12 months
Secondary	Quantity of contraceptives stocked	Mean number of contraceptives available in the shop to be sold every 2 weeks	18 months