HivNCT05525533

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

A study testing Harnessing prosocial and social image motivations for behavior change in people with Hiv and Contraception, run by University of California, San Francisco at 2 sites in Tanzania.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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 12 months. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Hiv, Contraception
What is being tested?: Harnessing prosocial and social image motivations for behavior change
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 144 participants
Where: 2 sitesTanzania
Study dates: 1 Jul 2022to 15 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Shopkeepers enrolled in the parent CRCT

Who cannot join

None

Trial locations and contacts

2 sites in 1 country.

Tanzania2 sites

Mwanza Province
Mwanza
Shinyanga
Shinyanga

Other trials in Tanzania

About this study

Read the 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.

Conditions: Hiv, Contraception
Being tested: Harnessing prosocial and social image motivations for behavior change
Keywords: Drug shops, Pro-sociality, Adolescent health, HIV self-testing, Contraception
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Harnessing prosocial and social image motivations for behavior changeBehavioural
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

Study groups in NCT05525533
Study group	Role	What they receive
No feedback	Experimental	AGYW customer feedback will be collected but not shared with shopkeepers Receives: 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 Receives: 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 Receives: Behavioral: Harnessing prosocial and social image motivations for behavior change

What is being measured

The primary outcome is the main question the study is designed to answer.

Quantity of HIV Self-test Kits Distributed
Mean number of HIV self-test kits sold per shop every month
Measured: 12 months
Quantity of HIV Self-test Kits Distributed
Mean number of HIV self-test kits distributed per shop every 2 weeks
Measured: 18 months
Quantity of Sexual and Reproductive Health Products Sold
Mean number of sexual and reproductive health products sold per shop every month
Measured: 12 months
Quantity of Contraceptives Distributed
Mean number of contraceptives distributed per shop every 2 weeks
Measured: 18 months
Quantity of All Products Sold
Mean number of all products sold per shop per month
Measured: 12 months

Secondary outcomes (4)

Quantity of Condoms Sold
Mean number of condoms sold per shop every month
Measured: 12 months
Quantity of Emergency Contraception Sold
Mean number of emergency contraception sold per shop every month
Measured: 12 months
Quantity of Oral Contraception Sold
Mean number of oral contraception sold per shop every month
Measured: 12 months
Quantity of Pregnancy Tests Sold
Mean number of pregnancy tests sold per shop every month
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202215 Mar 2024

First posted1 Sep 2022
Study start1 Jul 2022
Primary completion15 Mar 2024
Study completion15 Mar 2024

Why it stopped: This study is linked to a parent study. The parent study was stopped prematurely; as a result this study was also stopped prematurely.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HivStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
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; 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.
Masking: None (open label)
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05525533
Sponsor's protocol ID: R03HD109561-01
Other IDs: R03HD109561-01
Status last verified: Jun 2025
First submitted: 30 Aug 2022
Last updated: 19 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

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.
PubMed 34313728
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.
PubMed 33957903
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.
PubMed 40934247

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hiv trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Supporting Young Women's Reproductive Health by Harnessing Prosociality Among Drug Shopkeepers
ClinicalTrials.gov ID: NCT05525533
Acronym / sponsor ID: R03HD109561-01
Conditions: Hiv, Contraception
Keywords: Drug shops, Pro-sociality, Adolescent health, HIV self-testing, Contraception
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study is linked to a parent study. The parent study was stopped prematurely; as a result this study was also stopped prematurely.
Enrolment: 144 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: University of California, Berkeley, Health for a Prosperous Nation, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 1 Jul 2022 (actual)
Primary completion: 15 Mar 2024 (actual)
Study completion: 15 Mar 2024 (actual)
First posted: 1 Sep 2022 (actual)
Results: Posted 19 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3
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; 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.

Arm	Type	Receives
No feedback	Experimental	Behavioral: Harnessing prosocial and social image motivations for behavior changeAGYW customer feedback will be collected but not shared with shopkeepers
Private feedback	Experimental	Behavioral: Harnessing prosocial and social image motivations for behavior changeBiweekly summarized reports of AGYW customer feedback will be given directly to shopkeepers
Public feedback	Experimental	Behavioral: Harnessing prosocial and social image motivations for behavior changeShopkeepers 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Shopkeepers enrolled in the parent CRCT

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Harnessing prosocial and social image motivations for behavior changeThe 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	Behavioural	No feedback, Private feedback, Public feedback

Primary outcome

Quantity of HIV Self-test Kits Distributed
Time frame: 12 months
Mean number of HIV self-test kits sold per shop every month
Quantity of HIV Self-test Kits Distributed
Time frame: 18 months
Mean number of HIV self-test kits distributed per shop every 2 weeks
Quantity of Sexual and Reproductive Health Products Sold
Time frame: 12 months
Mean number of sexual and reproductive health products sold per shop every month
Quantity of Contraceptives Distributed
Time frame: 18 months
Mean number of contraceptives distributed per shop every 2 weeks
Quantity of All Products Sold
Time frame: 12 months
Mean number of all products sold per shop per month

4 secondary outcomes

Quantity of Condoms Sold
Time frame: 12 months
Quantity of Emergency Contraception Sold
Time frame: 12 months
Quantity of Oral Contraception Sold
Time frame: 12 months
Quantity of Pregnancy Tests Sold
Time frame: 12 months

Results and safety

Results posted to the registry on 19 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No Feedback	44	44
No Feedback (Phase 1) - Private Feedback (Phase 2)	49	49
No Feedback (Phase 1) - Public Feedback (Phase 2)	51	51

Primary outcome: Quantity of HIV Self-test Kits Distributed

Time frame: 12 months. Mean (Standard Deviation). Unit: Items sold

Measure	No Feedback n = 44	Private Feedback n = 49	Public Feedback n = 51
Value	153.53 (203.84)	181.13 (209.49)	239.13 (286.70)

No Feedback vs Private Feedback: Mean Difference (Final Values): 0.17 (95% CI -1.87 to 2.24), Regression, Linear
No Feedback vs Public Feedback: Mean Difference (Final Values): 1.55 (95% CI -0.73 to 3.82), Regression, Linear

Population analysed: It was pre-specified to report this outcome measure at the 12-month time point after all participants received this sequence of interventions.

Primary outcome: Quantity of HIV Self-test Kits Distributed

Time frame: 18 months

Population analysed: 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.

Primary outcome: Quantity of Sexual and Reproductive Health Products Sold

Time frame: 12 months. Mean (Standard Deviation). Unit: Items sold

Measure	No Feedback n = 44	Private Feedback n = 49	Public Feedback n = 51
Value	9.68 (9.38)	9.27 (9.06)	10.70 (9.95)

No Feedback vs Private Feedback: Mean Difference (Final Values): 7.58 (95% CI -2.92 to 18), Regression, Linear
No Feedback vs Public Feedback: Mean Difference (Final Values): 16 (95% CI 0.64 to 31), Regression, Linear

Population analysed: It was pre-specified to report this outcome measure at the 12-month time point after all participants received this sequence of interventions.

Primary outcome: Quantity of Contraceptives Distributed

Time frame: 18 months

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Feedback	0 of 44 (0%)	0 of 44 (0%)	0 of 44
Private Feedback	0 of 49 (0%)	0 of 49 (0%)	0 of 49
Public Feedback	0 of 51 (0%)	0 of 51 (0%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 34313728Hunter 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.
Background: PubMed 33957903Chiu 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.
Derived from this study: PubMed 40934247Chiu 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.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jenny X Liu, PhD principal investigator

University of California, San Francisco

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Harnessing prosocial and social image motivations for behavior change in people with Hiv and Contraception, run by University of California, San Francisco at 2 sites in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantity of HIV Self-test Kits Distributed (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05525533, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.