Supporting Young Women's Reproductive Health by Harnessing Prosociality Among Drug Shopkeepers
Phase: NA
Conditions: Hiv, Contraception
Sponsor: University of California, San Francisco

Cover Page 
Results Submission on March 15, 2025 
Study Title: Supporting Young Women's Reproductive Health by Harnessing Prosociality 
Among Drug Shopkeepers 
NIH Grant Number:  R03HD109561 
Clinical Trials Number: NCT05525533 
Documents included: Study Protocol 
Document Date: 03/19/2024 

TITLE: Supporting Young Women's Reproductive Health by Harnessing Prosociality Among 
Drug Shopkeepers 
 
INVESTIGATORS AND INSTITUTIONAL AFFILIATIONS:  
 
Werner Maokola, MD, Msc, PhD, National AIDS Control Program 
Amon Sabasaba, MD, MSc, Health for a Prosperous Nation 
Tracy Kuo Lin, PhD, University of California, San Francisco 
Jenny Liu, PhD, University of California, San Francisco 
 
COLLABORATING INSTITUTIONS: 
 
Health for a Prosperous Nation (HPON) is the local not-for-profit agency that will recruit 
participants and administer the surveys. 
 
 
 

 
2 
Table of Contents 
ABBREVIATIONS .................................................................................................... 3 
SUMMARY .............................................................................................................. 3 
SPECIFIC AIMS: ..................................................................................................... 4 
BACKGROUND: ...................................................................................................... 4 
JUSTIFICATION: .................................................................................................... 4 
HYPOTHESIS: ......................................................................................................... 4 
GENERAL OBJECTIVES: ........................................................................................ 5 
STUDY DESIGN AND METHODOLOGY: ................................................................... 5 
Overview. ......................................................................................................................... 5 
Study populations. ............................................................................................................. 5 
Data collection. ................................................................................................................. 5 
Sampling. ......................................................................................................................... 6 
Recruitment Procedures. .................................................................................................... 6 
Data management. ............................................................................................................ 7 
Potential Risk. .................................................................................................................. 8 
Data analysis. .................................................................................................................... 8 
Study Team. ..................................................................................................................... 9 
TIME FRAME / DURATION OF THE PROJECT ......................................................... 9 
EXPECTED APPLICATION OF RESULTS ................................................................. 9 
REFERENCES ....................................................................................................... 10 
 
 
 
 

 
3 
ABBREVIATIONS 
AGYW: (Adolescent Girls and Young Women) 
CRCT: (Cluster Randomized Control Trial) 
HCD: (Human Centered Design) 
HIV: (Human Immunodeficiency Virus) 
HIVST: (HIV self-testing) 
HPON: (Health For a Prosperous Nation) 
IRB: (Institutional Review Board) 
PrEP: (Pre-exposure Prophylaxis) 
SAE: (Serious Adverse Event) 
SRH: (Sexual and Reproductive Health) 
 
SUMMARY 
In sub-Saharan Africa, adolescent girls and young women (AGYW; ages 15-24) face the dual 
threats of HIV and unintended pregnancy. Despite an urgent need to reach AGYW with sexual 
and reproductive health (SRH) services, and the availability of new technologies to support self-
care (e.g., HIV self-testing (HIVST) kits, pre-exposure prophylaxis (PrEP)), health systems still 
fail to get these critical resources to AGYW in need. With the successful introduction of malaria 
services, Accredited Drug Dispensing Outlets (ADDOs) are already widely recognized as a model 
for building a lower-skilled cadre of health providers and increasing population-wide access to 
other basic health services. However, ADDO owners and dispensers may lack motivation to 
provide high quality of services to AGYW given competing business priorities.  
 
We propose to operationalize and test the preliminary impact of a behavioral economics informed 
intervention involving providing regular customer feedback from AGYW to ADDO shopkeepers 
on ADDO service to AGYW customers. This study uses a randomized controlled trial assigning 
~N=120 ADDOs to one of three initial conditions: 1. No feedback. 2. Private feedback: Feedback 
from AGYW customers will be collected anonymously through USSD-code based surveys. 
Monthly summarized reports of AGYW customer feedback will be given directly to shopkeepers. 
3. Public feedback: Shopkeepers will get monthly summarized reports of AGYW customer 
feedback. In addition, gold stars reflecting the level of AGYW customer feedback (e.g., 1-4 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.  
 
We hypothesize that providing customer feedback to ADDOs will increase provision of services 
to AGYW. Ex ante, we believe that Private feedback will stimulate ADDO owners and dispensers’ 
underlying pro-social motivation towards supporting AGYW, while Public feedback will 
additionally introduce social image considerations as ADDOs will want to signal their pro-
sociality to the community and compete with other ADDOs. We are agnostic regarding whether 
Private or Public feedback will be more effective at increasing ADDO performance. 
 
Our study tests the effectiveness of important non-financial incentives on ADDO performance. 
Should we find evidence of effectiveness, our intervention can be easily scaled across Tanzania to 
stimulate additional effort among ADDOs in serving AGYW at low cost. 
 

 
4 
SPECIFIC AIMS: 
 
Aim 1: Operationalize and test the preliminary impact of providing regular AGYW customer 
feedback to shopkeepers on provision of services to AGYW over 18 months 
 
 
BACKGROUND: 
 
In sub-Saharan Africa, adolescent girls and young women (AGYW; ages 15-24) face the dual 
threats of HIV and unintended pregnancy. AGYW comprise 25% of new HIV infections and 
disproportionately bear 44% of reported unintended births.1–4 Prevention failures are multi-
faceted, including stigma, lack of perceived risk, provider biases, among others.5–10 Despite an 
urgent need to reach AGYW with sexual and reproductive health (SRH) services, and the 
availability of new technologies to support self-care (e.g., HIV self-testing (HIVST) kits, PrEP), 
health systems still fail get these critical resources to AGYW in need.  
 
Our ultimate goal is to reduce HIV incidence and unintended pregnancies by creating a 
sustainable, easily accessible, community-based platform for delivering HIV prevention and 
SRH services to AGYW. Our recent R34MH116804 pilot study in Tanzania showed that 
Accredited Drug Dispensing Outlets (ADDOs) are effective, community-based spaces for 
delivering HIVST and contraceptives to AGYW through our Queen Club intervention, developed 
using human-centered design (HCD) and behavior change tools from behavioral economics.11 
With the successful introduction of malaria services, ADDOs are already widely recognized as a 
model for building a lower-skilled cadre of health providers and increasing population-wide access 
to other basic health services. However, ADDO owners and dispensers may lack motivation to 
provide high quality of services to AGYW given competing business priorities. We propose to 
operationalize and test the preliminary impact of a behavioral economics informed intervention 
involving providing regular customer feedback from AGYW to ADDO shopkeepers on ADDO 
service to AGYW customers. 
 
JUSTIFICATION: 
ADDOs are an accessible and sustainable channel to deliver health services to AGYW but are 
underutilized for HIV prevention. There are over 28,000 new HIV infections among AGYW each 
year and increased access to services is urgently needed. Aligned with Tanzania’s National HIV 
Strategy for >30% of services to be community-based, ADDOs are common, can distribute HIV 
self-tests (HIVST), and are often women’s first stop for drugs, contraceptives, informal 
counseling, and health referrals. Our study tests the effectiveness of important non-financial 
incentives on ADDO performance. Should we find evidence of effectiveness, our intervention can 
be easily scaled across Tanzania to stimulate additional effort among ADDOs in serving AGYW 
at low cost. 
 
HYPOTHESIS: 
We hypothesize that providing customer feedback to ADDOs will increase provision of services 
to AGYW. Ex ante, we believe that Private feedback will stimulate ADDO owners and dispensers’ 
underlying pro-social motivation12 towards supporting AGYW, while Public feedback will 

 
5 
additionally introduce social image13,14 considerations as ADDOs will want to signal their pro-
sociality to the community and compete with other ADDOs. We are agnostic regarding whether 
Private or Public feedback will be more effective at increasing ADDO performance. 
 
GENERAL OBJECTIVES: 
 
1) To operationalize and test the preliminary impact of a behavioral economics informed 
interventions involving providing regular customer feedback from AGYW to ADDO 
shopkeepers 
 
STUDY DESIGN AND METHODOLOGY: 
 
Overview.  
 
We will conduct a randomized controlled trial assigning ~N=120 ADDOs to one of three initial 
conditions:  
 
1. No feedback.  
2. Private feedback: Feedback from AGYW customers will be collected anonymously 
through USSD-code based surveys. Monthly summarized reports of AGYW customer 
feedback will be given directly to shopkeepers.  
3. Public feedback: Shopkeepers will get monthly summarized reports of AGYW customer 
feedback. In addition, gold stars reflecting the level of AGYW customer feedback (e.g., 1-
4 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.  
 
We 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 outcome – number of services 
delivered by ADDOs to AGYW over the 18-month study period. As the gold standard for 
evaluating the effectiveness of interventions, we will provide robust evidence on the effectiveness 
of our behavioral economics informed customer feedback intervention on service distribution to 
AGYW. 
 
Study populations. Our proposed research will recruit ADDOs participating in a parent cluster-
randomized trial evaluating the effectiveness of a girl-friendly loyalty program in the Shinyanga and 
Mwanza regions of Tanzania (NIMR/HQ/R.8a/Vol.IX/3837). In these regions, female HIV 
prevalence is 7.2% and 8.9%, respectively,15 only 19.6% of married women use modern 
contraception, and 34% and 28% of AGYW aged 15-19 have begun childbearing (among the 
highest in Tanzania), respectively.16  
 
Data collection. The primary outcome for this study – the number of services provided by 
ADDOs to AGYW over the study period – will be collected using electronic sales records 
maintained by each ADDO using the Maisha Meds inventory management system as part of their 
participation in the parent trial. As part of the intervention, participating ADDOs will encourage 
AGYW customers to complete anonymous USSD-based short surveys (see attached for 

 
6 
instrument) regarding their shopping experience at the ADDO. Participation is completely 
voluntary and at the discretion of the ADDO owner/dispenser (who decides which customers to 
approach to complete the survey) and the AGYW customer (whose participation in the USSD 
survey is completely voluntary) with no involvement of the research team beyond setting up the 
USSD survey infrastructure. This customer feedback data will be summarized into digestible 
reports and provided to ADDOs monthly to encourage them to increase service provision to 
AGYW and highlight areas for improvement. Among ADDOs assigned to the Public feedback 
arm, the research team will additionally display gold stars reflecting the level of AGYW customer 
feedback (e.g., 1-4 star rating) in a visible location and invite ADDO owners and dispensers to an 
awards ceremony every 6 months to recognize shopkeepers who receive high levels of positive 
AGYW customer feedback. 
 
ADDOs will be assigned to one of three initial conditions:  
 
1. No feedback.  
2. Private feedback  
3. Public feedback  
 
We 
will 
phase 
in 
the 
2 
interventions (Private and Public 
Feedback) on a staggered basis 
(Figure 1) to control for both 
shop-specific and time-specific 
trends for the primary outcome – 
number of services delivered by 
ADDOs to AGYW over the 18-
month study period.  
 
Sampling. All ADDOs participating in the parent trial (~N=120) will be recruited to participate 
in this study. The sample is a convenience sample but gives us power to detect a 20% relative 
increase between Private Feedback and No Feedback, and Public Feedback and No Feedback 
respectively. Minimum detectable effect sizes vary between 15-19%, depending on the treatment 
arm considered and the outcome. Additionally, we are powered to detect a 15% relative increase 
between the pooled Private and Public Feedback arms and No Feedback. The magnitudes of these 
effects are plausible and consistent with estimates from similar interventions in the Behavioral 
Economics literature17. We will potentially not be powered to detect differences between Private 
and Public Feedback if effect differences are small. Similarly, we will not be powered to detect 
differences in the treatment effect by the parent trial treatment arms; thus, we focus our analysis 
on estimating main effects of the proposed interventions. Given the reliance on routinely collected 
data from shops’ electronic inventory management system to measure the primary outcomes, 
attrition is not applicable. 
 
Recruitment Procedures. All ADDOs participating in the parent trial will be invited to 
participate in this ancillary study testing the impact of receiving regular AGYW customer feedback 
on the provision of services to AGYW. Those who are interested in participating will be asked to 
provide written informed consent agreeing to elicit AGYW customer feedback through anonymous 
Figure 1. Treatment assignments for different shops over the study period. The private 
public feedback arms are phased-in across different shops on a staggered basis to 
allow us to analytically control for both shop- and time-specific trends. 
R03 study arm
Phase 0:
Pre-intervention
Phase 1:
Initial condition
Phase 2:
Added condition
0-6 months
6-12 months
12-18 months
Group 1 (N=40)
No feedback
No feedback
Private feedback
Group 2 (N=40)
No feedback
Private feedback
Public feedback
Group 3 (N=40)
No feedback
Public feedback
Public feedback

 
7 
USSD-based short surveys, receive summary reports monthly, and publicly display performance 
scores if randomized to the Public Feedback arm. There are no exclusion criteria. 
 
Upon first contact with a potential participant for the survey, research staff will orally inform the 
potential participant about the purpose and nature of the study. Research staff will then complete 
the informed consent process with individuals who are interested in participating in the study in a 
quiet and private area. As part of the informed consent process, the research staff will explain the 
study and its goals and review all of the elements of informed consent with the individual.  At this 
point, potential participants will be assured that refusing participation will not impact them in any 
way, and that participation is entirely voluntary. In addition, individuals will be reminded that they 
can refuse to answer any question or leave the interview/discussion at any time. 
 
After discussing the consent form with study staff, participants will be quizzed about the nature of 
participation to ensure that they have adequately understood the information. (Note: Consent forms 
will be read aloud to potential participants unless individuals insist that they are comfortable 
reading the form themselves). Individuals who would like to participate can sign the informed 
consent form, or, for participants who feel uncomfortable signing the consent form, they will be 
asked to put a thumbprint (instead of a signature) at the bottom of the document after the 
interviewer has fully read, explained, and answered questions related to the consent form and study 
participation in general. In addition, study staff will sign the two copies of the consent form, noting 
that they have obtained written informed consent. A copy of the signed informed consent form 
will be provided to participants who wish to have a copy. 
 
Data management. Our research team has considerable institutional expertise and well-
established systems for data collection and management. In addition, H-PON has established a 
research site and has hired and trained study personnel in Mwanza and Shinyanga who also adhere 
to these systems. These staff have successfully conducted human subjects research under the 
direction of the PI, and local collaborators Dr. Sabasaba (HPON) on four previous studies 
(including the pilot randomized trial for the parent study and the parent CRCT) and two current 
ongoing studies in the same area. They have undergone training on obtaining informed consent, 
including for the participation of minors, in each of these other projects. A refresher training will 
also be conducted as part of this study in order to ensure that study specific information and 
procedures are followed with fidelity. 
 
A key policy of our collaborative research group is that the fewer individuals handling sensitive 
information, the greater the protection. Thus, project files and databases will only be available to 
research personnel through the authorization of the PI. All staff with access to the data or who 
interact with participants must sign confidentiality agreements and will be informed of their 
responsibility to maintain confidentiality once they have left the study or the study has ended. Staff 
will be trained on the policies and procedures for data management and transmission and will also 
receive instructions on how to report any violations of those policies and procedures. All staff will 
be appropriately trained in the handling of sensitive study data through their employment training 
and annual completion of training in the ethical conduct of research.  
 
The PI will review all procedures for protecting confidentiality with study staff on a bi-monthly 
basis, including storing the data, consents, and questionnaires in secure databases and locked file 

 
8 
cabinets in locked offices, password protection, and procedures for transferring study data to the 
secure password-protected cloud-based folder. In addition, the team has a standard operating 
procedure in place to conduct quality control spot checks and ensure the privacy and confidentiality 
of study participants, data collection forms, and electronic data. 
 
Potential Risk. There are no physical risks associated with this study. This research presents no 
risks of harm greater than the probability and magnitude encountered in daily life. The study 
involves i) asking ADDO owners/dispensers to ask AGYW customers to fill out a quick, 
anonymous USSD survey, ii) receiving summary reports on these surveys, and iii) publicly 
displaying feedback information and participating in awards ceremonies if assigned to the Public 
feedback arm. No personal identifying information will be collected from ADDO owners or 
dispensers. The primary outcomes involve administrative data on sales and services provided to 
AGYW, which is not sensitive. 
 
We believe that the benefits of the study warrant the relatively low risks posed to subjects in the 
study. The results from the study will add to generalizable knowledge about how to increase 
services delivered to AGYW through ADDOs. There are over 28,000 new HIV infections among 
AGYW each year and increased access to services is urgently needed. Aligned with Tanzania’s 
National HIV Strategy for >30% of services to be community-based, ADDOs are common, can 
distribute HIV self-tests (HIVST), and are often women’s first stop for drugs, contraceptives, 
informal counseling, and health referrals. Our study tests the effectiveness of important non-
financial incentives on ADDO performance. Should we find evidence of effectiveness, our 
intervention can be easily scaled across Tanzania to stimulate additional effort among ADDOs in 
serving AGYW at low cost. 
 
All participants will be informed that all data collection activities are confidential (as stated in the 
informed consent process) prior to their agreement to participate. There will be no identifiable 
individual information collected as part of this study. Only study investigators and study personnel 
will have access to the study files. Serious Adverse Events. As all procedures in this study are 
standard survey procedures recommended by the Society of Medical Decision Making and UCSF 
Institutional Review Board. The risks to participation in general are minimal, and this study will 
not monitor or collect data on adverse events. In the unlikely event that a serious adverse event 
(SAE) is considered possibly, probably or definitely related to the study, or in the event of 
unexpected incidents or protocol violations, reporting to UCSF and NIMR IRBs will be made.  
Suspected events will be reviewed by study investigators prior to submission to the IRBs. 
 
Data analysis. Our study team has considerable institutional expertise and well-established 
systems for data collection and management. In addition, our partner in Tanzania, HPON, has 
established a research site and has hired and trained study personnel in Shinyanga and Mwanza 
who also adhere to these systems. A key policy of our collaborative research group is that the fewer 
individuals handling sensitive information, the greater the protection. Thus, project files and 
databases will only be available to research personnel through the authorization of the PI (Dr. Liu). 
All staff with access to the data or who interact with participants must sign confidentiality 
agreements and will be informed of their responsibility to maintain confidentiality once they have 
left the study or the study has ended. Staff will be trained on the policies and procedures for data 
management and transmission and will also receive instructions on how to report any violations 

 
9 
of those policies and procedures. All staff will be appropriately trained in the handling of sensitive 
study data through their employment training and annual completion of training in the ethical 
conduct of research. The PI will review all procedures for protecting confidentiality with study 
staff on a bi-monthly basis, including storing the data, informed consent and assent forms, and 
questionnaires in secure databases and locked file cabinets in locked offices, password protection, 
and procedures for transferring study data to the secure password-protected cloud-based folder. In 
addition, the team has a standard operating procedure in place to conduct quality control spot 
checks and ensure the privacy and confidentiality of study participants, data collection forms, and 
electronic data. 
 
Sales data will be aggregated in monthly increments, mirroring shopkeepers’ receipt of customer 
feedback in intervention groups. We will estimate generalized linear regressions controlling for 
shop- (γi) and time- (dt) specific trends, and parent trial study arm (Mi): Yi,t = α + β1Ti,t + γi + 
Mi + dt + εi,t, where Yi,t is the outcome of interest by shop i in time period t. β1 represents the 
mean change in the outcome between shops receiving Private or Public feedback (Tit) relative to 
No feedback 
 
Study Team. Dr. Werner Maokola will oversee all aspects of recruitment and data collection. Drs. 
Amon Sabasaba and Jenny Liu will oversee data analysis. All investigators will be involved in 
manuscript preparation and dissemination of results. 
 
TIME FRAME / DURATION OF THE PROJECT 
The study will take place over 18 months. Private and Public feedback will be phased in among 
different shops over three 6-month study phases. The study will recruit ADDOs participating in an 
ongoing cluster-randomized trial of a girl-friendly loyalty program in the Shinyanga and Mwanza 
regions of Tanzania (NIMR/HQ/R.8a/Vol.IX/3837). Data analysis will take place in both 
Shinyanga and Mwanza regions of Tanzania, and in California, United States. 
 
EXPECTED APPLICATION OF RESULTS 
ADDOs are an accessible and sustainable channel to deliver health services to AGYW but are 
underutilized for HIV prevention. There are over 28,000 new HIV infections among AGYW each 
year and increased access to services is urgently needed. Aligned with Tanzania’s National HIV 
Strategy for >30% of services to be community-based, ADDOs are common, can distribute HIV 
self-tests (HIVST), and are often women’s first stop for drugs, contraceptives, informal 
counseling, and health referrals. Our study tests the effectiveness of important non-financial 
incentives on ADDO performance. Should we find evidence of effectiveness, our intervention can 
be easily scaled across Tanzania to stimulate additional effort among ADDOs in serving AGYW 
at low cost. Results will be disseminated to relevant stakeholders at the Ministry of Health. 
 
 

 
10 
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