Clinical trial NCT05525533: Supporting Young Women's Reproductive Health by Harnessing Prosociality Among Drug Shopkeepers
Official title: Supporting Young Women's Reproductive Health by Harnessing Prosociality Among Drug Shopkeepers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Contraception
Keywords: Drug shops
Pro-sociality
Adolescent health
HIV self-testing
Contraception
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of California, Berkeley
name: Health for a Prosperous Nation
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-09-01
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 and Private Feedback between 12-18 months; one third of shops (\~N=40) will be assigned to Private Feedback between 6-12 months and Public Feedback between 12-18 months; one third of shops (\~N=40) will be assigned to Public Feedback between 6-18 months.
Primary purpose: HEALTH_SERVICES_RESEARCH

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 18 months.

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.

Eligibility criteria: Inclusion Criteria:

* Shopkeepers enrolled in the parent CRCT

Exclusion Criteria:

* None

Primary outcomes:
measure: Quantity of HIV self-test kits distributed
timeFrame: 12 months
measure: Quantity of HIV self-test kits distributed
timeFrame: 18 months
measure: Quantity of contraceptives distributed
timeFrame: 12 months
measure: Quantity of contraceptives distributed
timeFrame: 18 months
Secondary outcomes:
measure: Quantity of HIV self-test kits stocked
timeFrame: 12 months
measure: Quantity of HIV self-test kits stocked
timeFrame: 18 months
measure: Quantity of contraceptives stocked
timeFrame: 12 months
measure: Quantity of contraceptives stocked
timeFrame: 18 months
Other outcomes:
Locations:
city: Mwanza
country: Tanzania
facility: Mwanza Province
city: Shinyanga
country: Tanzania
facility: Shinyanga
Study officials:
affiliation: University of California, San Francisco
name: Jenny X Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.