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| ID | Type | Description | Link |
|---|---|---|---|
| R03HD109561-01 | U.S. NIH Grant/Contract | View source |
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This study is linked to a parent study. The parent study was stopped prematurely; as a result this study was also stopped prematurely.
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| Name | Class |
|---|---|
| University of California, Berkeley | OTHER |
| Health for a Prosperous Nation | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No feedback | Experimental | AGYW customer feedback will be collected but not shared with shopkeepers |
|
| Private feedback | Experimental | Biweekly summarized reports of AGYW customer feedback will be given directly to shopkeepers |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harnessing prosocial and social image motivations for behavior change | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantity of Condoms Sold | Mean number of condoms sold per shop every month | 12 months |
| Quantity of Emergency Contraception Sold | Mean number of emergency contraception sold per shop every month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jenny X Liu, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mwanza Province | Mwanza | Tanzania | ||||
| Shinyanga |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34313728 | Background | 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. | |
| 33957903 | Background | 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. |
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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.
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.
Everything posted to OSF and Clinical Trials will be made publicly available.
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Please note that for the purposes of this study, "participants" refer to each drug shop owner or representative enrolled in the study. Each drug shop enrolled one participant. There are no other participants in this study. Shops were recruited on a rolling basis within each arm. The wards are geographical units that were the unit of randomization (cluster). All shops within each ward had the same treatment assignment.
| ID | Title | Description |
|---|---|---|
| FG000 | No Feedback | Participants will receive no feedback for 12 months. No feedback: AGYW customer feedback will be collected but not shared with shopkeepers 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 |
| FG001 | No Feedback (Phase 1) - Private Feedback (Phase 2) | Participants will receive no feedback for 6 months and then private feedback for 6 months. Private feedback: Biweekly summarized reports of AGYW customer feedback will be given directly to shopkeepers 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 |
| FG002 | No Feedback (Phase 1) - Public Feedback (Phase 2) | Participants will receive no feedback for 6 months, then public feedback for 6 months. 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 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 - No Feedback |
| |||||||||||||
| Phase 2 - No, Private or Public Feedback |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Feedback | No feedback for 12 months. No feedback: AGYW customer feedback will be collected but not shared with shopkeepers 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quantity of HIV Self-test Kits Distributed | Mean number of HIV self-test kits sold per shop every month | It was pre-specified to report this outcome measure at the 12-month time point after all participants received this sequence of interventions. | Posted | Mean | Standard Deviation | Items sold | 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Feedback | AGYW customer feedback will be collected but not shared with shopkeepers 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jenny Liu | University of California, San Francisco | 6503800762 | jenny.liu2@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 19, 2024 | Mar 18, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 19, 2024 | Mar 18, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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.
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| 12 months |
| Quantity of Oral Contraception Sold | Mean number of oral contraception sold per shop every month | 12 months |
| Quantity of Pregnancy Tests Sold | Mean number of pregnancy tests sold per shop every month | 12 months |
| Shinyanga |
| Tanzania |
| 40934247 | Derived | 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. |
| NOT COMPLETED |
|
| BG001 | No Feedback - Private Feedback | No feedback for 6 months, private feedback for 6 months. Private feedback: Biweekly summarized reports of AGYW customer feedback will be given directly to shopkeepers 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 |
| BG002 | No Feedback - Public Feedback | No feedback for 6 months, public feedback for 6 months. 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 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Sex unknown for 2 participants | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Biweekly summarized reports of AGYW customer feedback will be given directly to shopkeepers 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 |
| OG002 | 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 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 |
|
|
|
| Primary | Quantity of HIV Self-test Kits Distributed | Mean number of HIV self-test kits distributed per shop every 2 weeks | The customer feedback intervention ended due to the early termination of the parent study. As a result, these data were not collected beyond 12 months, therefore we cannot report on this 18 month outcome. The 12-month outcome is reported under Outcome 1. This study used the same participants as as the parent study and when the parent study terminated so did this study. All data collection ceased when the parent study terminated, after 12 months of this study. | Posted | 18 months |
|
|
| Primary | Quantity of Sexual and Reproductive Health Products Sold | Mean number of sexual and reproductive health products sold per shop every month | It was pre-specified to report this outcome measure at the 12-month time point after all participants received this sequence of interventions. | Posted | Mean | Standard Deviation | Items sold | 12 months |
|
|
|
|
| Primary | Quantity of Contraceptives Distributed | Mean number of contraceptives distributed per shop every 2 weeks | The customer feedback intervention ended due to the early termination of the parent study. As a result, these data were not collected beyond 12 months, therefore we cannot report on this 18 month outcome. The 12-month outcome is reported under Outcome 3. This study used the same participants as as the parent study and when the parent study terminated so did this study. All data collection ceased when the parent study terminated, after 12 months of this study. | Posted | 18 months |
|
|
| Primary | Quantity of All Products Sold | Mean number of all products sold per shop per month | It was pre-specified to report this outcome measure at the 12-month time point after all participants received this sequence of interventions. | Posted | Mean | Standard Deviation | items sold | 12 months |
|
|
|
|
| Secondary | Quantity of Condoms Sold | Mean number of condoms sold per shop every month | It was pre-specified to report this outcome measure at the 12-month time point after all participants received this sequence of interventions. | Posted | Mean | Standard Deviation | items sold | 12 months |
|
|
|
|
| Secondary | Quantity of Emergency Contraception Sold | Mean number of emergency contraception sold per shop every month | It was pre-specified to report this outcome measure at the 12-month time point after all participants received this sequence of interventions. | Posted | Mean | Standard Deviation | items sold | 12 months |
|
|
|
|
| Secondary | Quantity of Oral Contraception Sold | Mean number of oral contraception sold per shop every month | It was pre-specified to report this outcome measure at the 12-month time point after all participants received this sequence of interventions. | Posted | Mean | Standard Deviation | items sold | 12 months |
|
|
|
|
| Secondary | Quantity of Pregnancy Tests Sold | Mean number of pregnancy tests sold per shop every month | It was pre-specified to report this outcome measure at the 12-month time point after all participants received this sequence of interventions. | Posted | Mean | Standard Deviation | items sold | 12 months |
|
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Private Feedback | Biweekly summarized reports of AGYW customer feedback will be given directly to shopkeepers 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 | 0 | 49 | 0 | 49 | 0 | 49 |
| EG002 | 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 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 | 0 | 51 | 0 | 51 | 0 | 51 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Male |
|
| Mean Difference (Final Values) |
| 16 |
| 2-Sided |
| 95 |
| 0.64 |
| 31 |
| Superiority |
| Mean Difference (Final Values) |
| 113 |
| 2-Sided |
| 95 |
| 38 |
| 189 |
| Superiority |
| Mean Difference (Final Values) |
| 1.50 |
| 2-Sided |
| 95 |
| -1.50 |
| 4.50 |
| Superiority |
| Mean Difference (Final Values) |
| 3.38 |
| 2-Sided |
| 95 |
| -0.54 |
| 7.30 |
| Superiority |
| Mean Difference (Final Values) |
| 7.57 |
| 2-Sided |
| 95 |
| 0.42 |
| 15 |
| Superiority |
| Mean Difference (Final Values) |
| 3.29 |
| 2-Sided |
| 95 |
| 0.33 |
| 6.25 |
| Superiority |