Reaching Adolescent Girls and Young Women Through Girl-Friendly Drug Vendors
Phase: NA
Conditions: HIV, Contraception
Sponsor: University of California, San Francisco

 
1 
STUDY PROTOCOL 
 
 
 
Reaching Adolescent Girls and Young Women (AGYW) Through 
Girl-Friendly Drug Vendors 
 
 
 
ClinicalTrials.gov Identifier: 
 
 
NCT04045912 
Brief Title:  
 
 
 
 
 
AmbassADDOrs for Health  
Protocol Version & Date: 
 
 
 
Version 2.0 (9 May 2019) 
 
 
 
 
 
 
 
►Revised 23 November 2022◄ 
Sponsor: 
 
 
 
 
 
U.S. National Institutes of Health 
  
Lead Principal Investigators:  
Jenny Liu 
Sandra McCoy 
Local Principal Investigator: 
  
 
Prosper Njau  
                                                                         
Angela Ramadhani 
                                                                           
Elizabeth Shekalaghe 
                                                                           
Peri Urassa 
 
 
 
 
 
 

 
2 
Protocol Table of Contents 
1. Contact Details of Investigators.......................................................................................................... 3 
2. List of Abbreviations ........................................................................................................................... 4 
3. Protocol Summary ............................................................................................................................. 5 
4. Background and Rationale ................................................................................................................. 6 
5. Study Objectives ................................................................................................................................ 8 
M6. Methodology ................................................................................................................................... 9 
6.1 Study Setting................................................................................................................................ 9 
6.2 Study Design................................................................................................................................ 9 
6.3 Study Population and Sample Size .............................................................................................. 9 
6.4 Eligibility and Screening ............................................................................................................... 9 
6.5 Recruitment ................................................................................................................................. 9 
6.6 Informed Consent ...................................................................................................................... 10 
6.7 Intervention Procedures ............................................................................................................. 10 
6.8 Data Collection ........................................................................................................................... 13 
6.9 Study Compensation .................................................................................................................. 13 
6.10 Data Analysis ........................................................................................................................... 14 
6.11 Data Management.................................................................................................................... 14 
7. Ethical Considerations ..................................................................................................................... 14 
7.1 Alternatives to Participation ........................................................................................................ 14 
7.2 Risks and Benefits ..................................................................................................................... 14 
7.3 Confidentiality of Study Participants ........................................................................................... 16 
7.4 Vulnerable Populations .............................................................................................................. 17 
8. Qualifications of Key Study Personnel ............................................................................................. 17 
9. Study Sponsor and Management ..................................................................................................... 19 
9.1 Stakeholder Engagement and Dissemination Plan ..................................................................... 20 
10. Limitations ..................................................................................................................................... 20 
11. Future Directions ........................................................................................................................... 20 
 
 

 
3 
1. Contact Details of Investigators 
 
Principal Investigators 
Name 
Contact Information 
Dr. Jenny Liu 
Assistant Professor of Health Economics  
UC San Francisco 
 
Dr. Sandra McCoy 
Associate Adjunct Professor of Epidemiology 
UC Berkeley School of Public Health  
 
Dr. Prosper Njau 
 
Program Officer for the Prevention of Mother to 
Child Transmission of HIV  
Ministry of Health, Community Development, 
Gender, Elderly, and Children  
Executive Secretary 
Health for a Prosperous Nation (H-PON) 
 
Dr. Angela Ramadhani 
Program Manager 
National AIDS Control Program (NACP) 
Ministry of Health, Community Development 
Gender, Elderly, and Children 
 
Ms. Peris Urasa 
National HIV Testing Coordinator 
National AIDS Control Program (NACP) 
Ministry of Health, Community Development, 
Gender, Elders and Children 
 
Ms. Elizabeth Shekalaghe 
Registrar 
Tanzania Pharmacy Council 
 
 
 
Co-Investigator 
Name  
Contact Information 
Dr. Sue Mavedzenge 
 
 
Research Scientist 
RTI International 
 
 

 
4 
2. List of Abbreviations 
 
ADDO…….Accredited Drug Dispensing Outlet 
 
AGYW……Adolescent girls and young women 
 
HCD………Human-centered design 
 
HIVST…….HIV self-testing 
 
H-PON........Health for a Prosperous Nation 
 
SRH……….Sexual and reproductive health 
 
PMTCT……Prevention of mother-to-child transmission 
 
TSH............Tanzanian Shillings 
 

 
5 
3. Protocol Summary 
Title 
Reaching Adolescent Girls and Young Women (AGYW) Through  
Girl-Friendly Drug Vendors 
Study Objective 
Pilot the intervention to deliver AGYW-friendly SRH services at ADDOs and 
determine the intervention’s acceptability, feasibility, and preliminary impact on 
AGYW patronage and SRH product distribution. 
Study Design 
We will implement a 4-month randomized pilot study of the intervention (the 
Queen Club) to deliver AGYW-friendly SRH services, including HIVST and 
contraception, at ADDOs. We will compare mediating outcomes (AGYW 
patronage, SRH product distribution) between ►10 intervention and 10 
comparison ADDOs, randomized into study arms. 
 
Our proposed data collection strategy involves three main activities: 
1. Surveys with ADDO owners and/or employees 
2. Time-location surveys of ADDO customers 
3. Shop records kept by ADDO owners and/or employees◄ 
Study Site 
This study will take place in Shinyanga Region, Tanzania. 
Study Populations 
►Participants in the randomized trial will meet the following criteria: 
a. Owner or employee of a registered ADDO in Shinyanga, Tanzania 
b. At least 18 years old 
c. Provides informed consent◄ 
Sample Size 
►20 ADDO owners/employees◄ 
Duration 
►Data collection for the randomized trial will take place over a 6-month period, 
including 4 months of intervention implementation.◄ 
 
 

 
6 
4. Background and Rationale 
Adolescent girls and young women (AGYW; ages 15-24) in sub-Saharan Africa face the dual threats of 
HIV infection and unintended pregnancy that severely undermine their long-term well-being. AGYW 
comprise 25% of new adult infections in SSA, are more than twice as likely to acquire HIV as their male 
peers in many countries, and disproportionately bear 44% of all reported unintended births.1–4 Reasons 
for prevention failures are multi-faceted, including stigma, lack of perceived risk, and challenges 
accessing available health services.5–10 In particular, biases against sexuality among AGYW by many 
health providers greatly discourages care-seeking.11–15 Thus, despite the urgent need to reach AGYW 
with sexual and reproductive health (SRH) services, health systems are ill-equipped to overcome 
myriad access barriers alone.  
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. We hypothesize that this can be achieved through privately owned drug 
shops where AGYW already go to buy contraception and other hygiene/beauty products. This 
implementation science-focused R34 proposal will develop and pilot mechanisms to increase demand 
for the mediating outcomes of HIV self-testing (HIVST) and contraception at community drug shops in 
Tanzania, in preparation for a future study of effectiveness and sustainability (e.g., pricing, quality). 
Privately owned drug shops, such as Accredited Drug Dispensing Outlets (ADDOs) in Tanzania, can 
promote beneficial health behaviors and bridge gaps in health services, but are often underutilized in 
health systems.16–22 ADDOs (mostly operated by women) are often women’s first point of access for 
drugs, contraceptives, pregnancy tests, and informal counseling and referral.23–25 AGYW are twice as 
likely as older women to obtain contraception from ADDOs26, but demand remains suboptimal, partly 
due to discriminatory attitudes toward AGYW sexuality among some shop owners.24 Thus, reducing 
stigma and stimulating demand at drug shops is an untapped opportunity to amplify distribution of SRH 
services, including HIV prevention, to AGYW.  
Building on our team’s experience with human-centered design (HCD) methods and behavioral 
economics theories, we will develop an intervention to develop AGYW-friendly drug shops 
where we will introduce HIVST alongside contraceptives and linkages to care. We hypothesize 
that creative strategies led by ADDO owners (e.g., selling AGYW-relevant products, creating AGYW-
welcoming environments) can attract more AGYW and bolster uptake of SRH services/products, 
including HIV testing, the gateway to HIV prevention and care services. Our study will be the first to 
examine HIVST distribution targeting AGYW in Tanzania, doing so with special permission from the 
Ministry of Health (MOH) to add HIVST kits (recommended by WHO27,28) to the ADDO inventory. 
Working closely with the existing health system, we will conduct the study in Shinyanga, a region with 
high (23%) unmet need for contraception26 and a generalized HIV epidemic (7.4% overall prevalence, 
5.1% among AGYW).29 We will identify ways to stimulate AGYW demand at ADDOs using HCD 
methods30, a creative and empathetic intervention design approach, combined with insights from 
behavioral economics theoretical constructs. Our multidisciplinary team will leverage our collective 
experiences in health service delivery through drug shops; HIVST and uptake among adolescents; and 
designing and evaluating creative, theoretically-driven interventions for priority public health problems.   
Our past studies on drug shops in sub-Saharan Africa show that these providers can effectively 
increase broad access to basic health services. Numerous studies on drug shops in Nigeria led by 
Dr. Liu show that they are often the first point of care, give treatment and care advice if requested (e.g., 
prescribe antibiotics, give injections), stock essential health commodities for common conditions (i.e., 
diarrhea, malaria, pneumonia, contraceptives), are owned and run by respected members of the 
community (in some areas, up to 75% were health professionals, e.g., nurses/midwives, community 

 
7 
health workers), and view themselves as fulfilling an essential public service role.22,31–33 Moreover, drug 
shops vastly outnumber health facilities (up to 4:1), offering unparalleled reach of health services to 
underserved populations22,34, including AGYW.  Several previous studies led by our team show that 
introducing new products at drug shops can substantially improve access to and proper use of 
products.21 For example, similar to the successful malaria initiative at ADDOs35,36, we found that 
introducing malaria rapid diagnostic tests to customers seeking antimalarials in Nigeria increased 
appropriate treatment by over 60%37–40, evidence that led to nationwide allowance of such testing at all 
licensed drug shops. We are also examining the delivery of Sayana Press, the hormonal contraceptive 
formulated for self-injection, through community-based distribution points, including drug shops, in 
efforts to reduce unmet need. Initial results suggest that specific AGYW-focused outreach strategies, 
including specific training on counseling for AGYW, led to higher contraceptive uptake among AGYW. 
Together, our past studies underpin our central hypothesis that ADDOs can be an effective platform for 
reaching AGYW with HIV and SRH services, provided they are supported with training, commodities, 
and tools for demand-creation. 
Our studies also show that interest in HIVST among AGYW is high, suggesting that distributing 
HIVST kits at ADDOs may successfully increase testing and linkage to care. Our research on 
barriers and facilitators to HIV testing and linkage among AGYW in sub-Saharan Africa and the U.S. has 
shown that clinic access issues, lack of youth-friendly services, and provider bias against AGYW sexuality 
are significant barriers to seeking services.41 In contrast, being offered HIV testing while engaging in other 
health services (e.g., antenatal care) motivated testing access in other settings.41 Dr. Mavedzenge’s 
extensive research on HIVST has shown acceptability and demand for HIVST using oral fluid across a 
range of populations and settings, including AGYW in sub-Saharan Africa41–44, and that HIVST in the 
hands of lay users can be highly accurate.43,45 Study participants also report that self-testing would 
reduce stigma around HIV testing and increase convenience and confidentiality, critically important 
factors for AGYW.41,44,45 Recent Tanzania policy allows HIVST46 but there is no evidence on how best to 
deploy HIVST so as to ensure access and support for vulnerable individuals, such as AGYW. We 
hypothesize that uptake of HIVST by AGYW can be enhanced if made available at more AGYW-friendly 
community-based locations, such as ADDOs—a strategy that has never been tried but that has excellent 
potential for meeting the needs of this population. In this study, we will take the critical first step and focus 
on demand, in preparation for a later study of effectiveness and sustainability. 
However, merely making new health services available will not engender uptake; rather, our 
studies show that interventions designed with HCD methods and built on theoretical principles 
from behavioral economics can effectively complement product introduction to spur demand. 
We have a track record of developing and evaluating innovative interventions to stimulate demand, 
including those developed with HCD methods and incorporating constructs from behavioral economics, 
several of which were conducted in Tanzania. Drs. McCoy, Njau, and Ms. Rao recently used HCD to 
create and evaluate an intervention using the behavioral economics constructs of priming and social 
influence to address poor retention in HIV primary care among PLHIV in Tanzania. The novel, low cost-
intervention bolstered social support at the clinic, provided patients with useful items (e.g., a discreet 
pillbox to aid their adherence), and resulted in increased retention in care at 6 months (87% vs. 79%, 
adjusted odds ratio = 1.73, 95% CI: 1.08, 2.78, p<0.05).47–49 In addition, our team has evaluated the 
effectiveness of cash and in-kind incentives to stimulate demand for ART adherence and HIV testing in 
Tanzania and the U.S. (McCoy, Njau, Padian)50,51, cash incentives for preventing mother-to-child HIV 
transmission in Nigeria (Liu, Padian)52,53, non-financial incentives delivered in game-like environment 
for HIV/STI screening (McCoy)54, non-financial incentives for increasing couples HIV testing and 
counseling in Zimbabwe (McCoy, Mavedzenge, Padian)55, financial and non-financial incentives for 
improving oral health behaviors (Liu; UH2/UH3DE025514), and text message reminders for increasing 
antimalarial drug adherence (Liu)39,40. Thus, across a number of health behaviors and contexts, we are 

 
8 
observing that behavioral economics constructs of incentives, priming, social norms, and saliency can 
effectively overcome barriers to uptake for both one-time actions (e.g., HIV testing, clinic visits) and 
those requiring longer fidelity (e.g. drug adherence, PMTCT care). We will leverage this collective 
insight on how to effectively change behavior by applying these behavioral economics tools to increase 
demand for HIVST and contraception at drug shops. 
To develop acceptable and applicable interventions for demand-creation, our past experiences 
suggest that the HCD methodological process yields solutions that are highly-tailored and thus 
effective. From a life course perspective, we have found that AGYW are particularly motivated to 
achieve important milestones in the transition to adulthood (e.g., schooling, marriage, family formation), 
but may under-invest in the routes to success due to immediate influences and risks faced 
everyday.48,56 Rapidly changing social relations, including premarital sex, make contraception and HIV 
prevention imperative57–60, but fears, misconceptions, and stigma61, among other barriers, obstruct their 
uptake. Thus, services need to address the specific day-to-day interests and concerns of girls in order 
to effectively reach AGYW. Our team has experience addressing complex public health problems by in-
depth learning about the subject population: In our study of ART adherence in Tanzania, we employed 
HCD to identify patient segments and insights, map patient “health journeys” from diagnosis to long-
term adherence, and develop and iteratively test potential solutions.47,48,56 Similarly, in an ongoing study 
in Zambia, Dr. Padian and colleagues are directly soliciting user and patient feedback to shape HIV 
service delivery across the continuum of community- to clinic-based care, for which the resulting 
models of care will be evaluated.62 Both of these experiences revealed the limitations of narrow 
research approaches that ignore an individual’s lived experience, and highlight the potential for private-
sector design strategies to tap into novel and unexpected strategies to improve health and well-being. 
5. Study Objectives 
The overarching goal of the proposed study is to create a sustainable, community-based platform to 
deliver HIV prevention and other reproductive health services to adolescent girls and young women 
(AGYW) in Tanzania through drug shops.  
►In the previous phase of research (Phase 1), we conducted diverse formative research activities (i.e., 
ADDO observations; AGYW shadowing; interviews with AGYW, ADDO staff, and stakeholders) and 
followed the established, iterative HCD process to develop intervention components informed by 
behavioral economics tenets (e.g., messenger, defaults) and iteratively test them for acceptability, 
feasibility, and cultural sensitivity in focus groups with AGYW. Now, in Phase 2, we will pilot the 
resulting intervention at ADDOs in Shinyanga.◄ 
Based on our team’s formative work using HCD methods and behavioral economics theories in Phase 
1, we have designed a thoughtful, focused pilot study to supply contraception and free HIVST in 
Shinyanga ADDOs to maximize learning about which demand-creation strategies resonate with AGYW. 
Our objective in Phase 2 is to pilot the intervention to deliver AGYW-friendly SRH services at ADDOs 
and determine the intervention’s acceptability, feasibility, and preliminary impact on AGYW patronage 
and SRH product distribution.  
This strategy has a high potential for impact because it is increasingly recognized that “drug shops”, 
such as Accredited Drug Dispensing Outlets (ADDOs) in Tanzania, can promote beneficial health 
behaviors, bridge gaps in health services, and mitigate health workforce shortages.  

 
9 
M6. Methodology  
6.1 Study Setting 
This study will be conducted in Shinyanga Region, Tanzania.  
6.2 Study Design  
During Phase 2, we will pilot the intervention designed in Phase 1 (entitled the “Queen Club”) to create 
AGYW-friendly drug shops where we will introduce HIVST alongside contraception and linkages to 
care. The components of the intervention are described in detail in Section 6.7. 
In a 4-month randomized pilot study, we will introduce the intervention in ADDOs and determine its 
preliminary impact on the mediating outcomes of AGYW patronage and distribution of HIVST kits and 
contraception to AGYW. We will compare mediating outcomes between ►10 intervention and 10 
comparison ADDOs, randomized into study arms and included in primary analyses. 
 
Our proposed data collection strategy involves three main activities: 
1. Surveys with ADDO owners and/or employees 
2. Time-location surveys of ADDO customers 
3. Shop records kept by ADDO owners and/or employees◄ 
 
6.3 Study Population and Sample Size  
Given the pilot nature of this study, we have not conducted formal power calculations. The sample size 
of ►randomized ADDOs (n=20)◄ was selected to ensure we had a diversity of ADDO shops in the 
study, including various geographic areas, shop sizes, and types of owner.  
 
6.4 Eligibility and Screening  
With the Regional and Municipal Pharmacists and using their established communication channels with 
ADDOs and local pharmacies, we will identify ►20 new ADDO owners who meet the eligibility criteria: 
• 
Accredited ADDO shop in Shinyanga Region 
• 
Owner is ≥18 years of age 
• 
Interested in participating in the pilot program, and thereby willing to distribute HIVST and, if 
randomized to the intervention arm, willing to implement the intervention in their shops.◄ 
 
Eligibility of ADDO owners/shops for the study will be verified when H-PON makes the initial visit to the 
ADDO (after the ADDO owner has expressed initial interest). At that time, the H-PON team will verify 
that the shop is accredited and that the owner is at least 18 years of age. (Operation of the shop in 
Shinyanga Region will be determined based on physical location of the shop.) Should any ADDO 
employees fill out the baseline survey (i.e., at the owner’s suggestion), eligibility (≥18 years) will be 
verified at the beginning of the survey.  
 
6.5 Recruitment  
►Recruitment will be conducted by the local implementing partner, H-PON. 
 
We will randomly select drug shops from four administrative wards in the Shinyanga Region using a 
registry of ADDOs provided by the Municipal Pharmacist. The Municipal Pharmacist will contact shop 

 
10
owners using phone numbers from the registry and inform them that they are invited to participate in a 
study. After this first contact, trained staff members from H-PON will call drug shop owners to provide 
information about the study and, if interested, arrange to meet to obtain informed consent. H-PON staff 
members will meet one-on-one with every interested ADDO owner to discuss the study, to answer 
questions, and if the ADOO owner is interested, to obtain informed consent to participate as a study 
shop. Shop owners who sign informed consent will be invited to a future 2-day training event and asked 
to complete a short baseline survey about their background and shop operations. If the shop owner has 
limited involvement in the daily operations of the shop, an employee suggested by the owner may 
instead be invited to complete the baseline survey after providing informed consent.◄  
 
6.6 Informed Consent 
In a one-on-one meeting with interested ADDOs owners at the ADDO shop or at another location 
selected by the owner, a trained member of the research staff who is hired by the research team 
through H-PON specifically for this research study will outline the overall purpose of the study, as well 
as risks and benefits of study participation. This will include a discussion about: 
• 
Their willingness to learn about and distribute HIVST, and to instruct customers about its use 
when appropriate; 
• 
The possibility of the ADDO being randomly assigned to the intervention group, in which case 
the owner would be asked to implement the intervention (described above); 
• 
Their willingness to participate in a survey about daily operations and products and services 
available at their shop; 
• 
Their willingness to allow ADDO shop observations in the future; and 
• 
Maintenance of paper records of product distribution and referrals.  
 
The ADDO owner will be told that s/he can choose to leave the study at any point without penalty, 
including no implications on their role as an accredited ADDO in the community. After the research staff 
member thoroughly explains the consent form and answers any questions related to the study or 
participation, ADDO owners will be given the opportunity to join the study by signing the informed 
consent form. The informed consent form includes consent for participation in the baseline survey. 
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. 
 
If the ADDO owner has limited involvement in the daily operations of the shop, an employee suggested 
by the owner may instead be invited to complete the baseline survey, after the employee completes 
informed consent procedures (described in the previous paragraph). 
 
6.7 Intervention Procedures 
We will use stratified randomization by ward to assign 20 ADDOs 1:1 into the study groups, an 
intervention arm and a comparison arm. ►We will do this through a participatory randomization process 
at the HIVST training that representatives of all participating shops will attend. Specifically, shopkeepers 
will draw colored balls from an opaque bag in front of all attendees to obtain their study arm 
assignment.◄  
 
Regardless of intervention arm, we will conduct the following activities in all ADDOs: 
 
1. HIVST Trainings and HIVST Supply: In-person trainings of ADDO owners and staff on HIVST 
kits will involve: 1) hands-on demonstrations of the FDA-approved Orasure Oraquick ADVANCE 

 
11
rapid HIV ½ oral fluid test, 2) review of the Kiswahili package insert, 3) review of the Orasure 
instructional video in Kiswahili which can be sent via SMS or Whatsapp to interested customers, 
4) a comprehension quiz, and 5) a certificate of competency for public display.  
 
Each ADDO (regardless of study arm) will be given a starting supply of approximately 30 HIVST 
kits, with resupply conditional on presentation of satisfactory distribution records. Adolescents at 
least 16 years of age and those <16 who are sexually active can legally consent to an HIV test 
in Tanzania.   
 
We will instruct all ADDO owners and staff that HIVST kits will be provided free to all AGYW 
who request the kit; we will measure the relative distribution of AGYW HIVST recipients versus 
non-AGYW as a mediating outcome. Half of each bundle of kits distributed to the ADDOs will be 
explicitly earmarked for AGYW only; supplies will be verified against tallies of distribution to 
various age and sex groups (no names will be collected, only tallies within approximate age 
groups collected on a paper record keeping form). However, ADDOs will be told that kits for 
adults and other groups (young men) can be sold to those groups. (We will measure whether 
ADDOs sold the kit to other groups and for how much at the conclusion of the study.)  
 
Every HIVST will be pre-packaged with cards with referral information for HIV confirmatory 
testing and HIV care affixed to the HIVST kit. For the kits designated for AGYW (with a specific 
color), this referral card will include the specific contact information for a referral facility staff 
member designated as the local youth-friendly contact for HIVST customers at a local hospital.  
 
2. An HIV Care Referral Plan: Given that one of the benefits of HIV self-testing is its anonymous 
nature, we do not expect that many people will share the results of their HIVST kit with ADDO 
owners and staff; we have nevertheless prepared for this possibility with a plan to make 
referrals to local facilities for free confirmatory testing and HIV care. In addition to the pre-
packaged referral card presented above, all ADOO shops will be given the contact information 
and procedures for confidential referral of individuals with a reactive HIVST result to the HIV 
care and treatment facility for confirmatory testing at a local hospital. ADDOs will track referrals 
on a standardized form, including age of the patron.  
 
3. Shop Record Tracking: At the initial meeting with the ADDO owner and after informed 
consent, we will introduce a simple paper record system for participating ADDOs in order to 
collect data on the following outcomes:  
a. AGYW patronage: number of visits by AGYW, collected in a simple tally system (no 
names or contact information collected); 
b. Contraceptive distribution: number and types of contraceptives (i.e., condoms, oral pills, 
emergency contraceptive pills) distributed to AGYW per month;  
c. Health facility referrals: number of referrals for AGYW made for ►family planning, 
pregnancy, or HIV-related services;◄ 
d. HIVST kit distribution: number and proportion of kits distributed to AGYW per month. 
ADDOs in the intervention arm will also track customers’ engagement with intervention 
activities, described below. 
Monthly reviews of inventory by the local team will include review of shop records to determine 
AGYW patronage (for any service) and the volume and types of contraception and HIVST kits 
distributed to AGYW.  
 
ADDOs in the intervention arm will be trained to implement the “Queen Club” intervention. The Queen 
Club intervention was developed through a year-long human-centered design process with AGYW and 

 
12
other stakeholders and is informed by behavioral economic theory and game-design. It is intended to 
partially mitigate to the physical, economic, and social constraints faced by AGYW in Shinyanga, as 
revealed in the formative research, and motivate them to discreetly seek HIVST and contraceptives at 
local drug shops, while in a context of fun.  
 
The Queen Club is a loyalty program that builds on multiple formative research insights, including that 
AGYW often make purchases at ADDOs throughout the course of their day, often at the behest of 
parents and other adults, but rarely feel empowered or comfortable asking for contraception given a 
perceived lack of privacy and expectation of judgment by ADDO owners and staff. In addition, we found 
that while HIVST was perceived as exciting and useful to AGYW, there were information gaps about 
how to use the product. The Queen Club ties these insights together, in a fun program that has been 
developed in close consultation with stakeholders and the Youth Advisory Board.  
 
We will conduct the following activities in ADDOs assigned to the intervention arm: 
 
1. Loyalty Program: In brief, the Queen Club involves distribution of membership cards to AGYW 
who would like to join. The card includes a space for the AGYW’s name but no other identifying 
information and no text that could reveal what the program is about. A simple “road” displays 
spaces where AGYW will receive a stamp/punch each time they visit the ADDO and make any 
purchase. This is intended to build loyalty and trust with an ADDO shop, and also build the 
customer base for the ADDO owner. After every one to two spaces on the card are complete, 
the AGYW will have the option to select an item from the mystery box. Mystery boxes are 
intended to be fun rewards for loyalty and include a variety of items of interest for AGYW, 
including inexpensive (<2,000 TSH) beauty items, pads, apparel, school supplies, and snacks. 
Girls who ‘complete’ their card before the end of the study can turn their completed card into the 
ADDO shop and can re-start with a fresh card.  
 
Note that because only tallies of products distributed will be kept that are not tied to individuals, 
and the loyalty program contains no personal data, we will not be requesting informed consent 
from club members.  
 
2. Symbol Card: While the Queen Club loyalty program motivates AGYW to attend the shop, 
there are several elements of the program to increase the likelihood that AGYW will be access 
to HIVST and contraception. First, the back of the Queen Club card includes symbols, selected 
by AGYW, that represent the following health products: oral contraceptives, HIVST, emergency 
contraception, condoms and pregnancy tests. These are products routinely available at ADDOs 
but which AGYW do not feel comfortable asking for, especially in busy shops. With the symbol 
portion of the card, AGYW can discreetly point to their desired product and receive it (for free) 
without questioning.  
 
3. SRH Product Supply: In addition to HIVST, we will reimburse intervention ADDOs for the oral 
contraception, condoms, emergency contraception, and pregnancy tests provided to AGYW 
customers for free upon request (e.g., when using the symbol card). 
 
4. HIVST Display and Instruction: At every intervention ADDO, we will provide a wall display with 
a HIVST for demonstration (if desired by any customer) including a tablet computer with the pre-
loaded Oraquick Kiswahili video and videos about various contraceptive products (videos 
developed by PSI or other local organizations). We will also provide headphones for discreet 
listening to the videos. Note that the Oraquick HIVST has been distributed in numerous 
countries, including to AGYW in eastern Africa, and the package insert is intended to contain all 

 
13
necessary information to successfully perform the test. Nevertheless, we will provide additional 
opportunities to learn about the test via the in-store displays and videos to ensure that AGYW 
have numerous ways to answer all of their questions.  
 
5. Refresher ADDO Training on Contraceptive Counseling and Girl-Friendly Services: In a 
one-day training with ADDO owners and/or employees, we will review contraceptive methods 
and counseling techniques using training materials adapted from the Ministry of Health, 
Community Development, Gender, Elderly, and Children. This will ensure that AGYW are given 
a choice of methods available at the ADDO as well as referral for longer-acting methods (e.g., 
intrauterine devices, implants) at nearby facilities. Training will focus on communicating 
information in ways that AGYW can understand using tailored job aids that have been used 
previously by the Government of Tanzania and adapted from our current study on injectable 
contraceptives. 
 
6.8 Data Collection  
We will monitor mediating outcomes and assess acceptability and feasibility of the intervention using 
the data collection activities detailed below. 
 
1. Surveys with ADDO Owners and/or Employees (up to ►20◄)  
Immediately after informed consent, a short in-person survey will be conducted with the owner or a 
designated employee at the shop about their background (e.g., age, education, experience with AGYW) 
and shop (e.g., size, location, years of operation, products and services offered). 
 
2. Time-location Surveys of ADDO Customers 
We will discreetly observe ADDOs, with their permission, during randomly selected ►3-hour◄ intervals 
to document the number of customers, their sex, and approximate age and products and services 
received. These data are complimentary to the paper-based records collected by ADDO staff. ►We will 
select observation day/time blocks at baseline (0-4 weeks prior to intervention), midline (after 2-3 
months), and endline (after 3-4 months). We will randomly select 5 blocks per shop per time point, 
corresponding to up to 15 time-location surveys per ADDO.◄ 
 
3. Shop Records 
At the initial meeting with the ADDO owner and after informed consent, we will introduce a simple paper 
record system for participating ADDOs in order to collect data on AGYW patronage, HIVST and 
contraceptive distribution, and health facility referrals (previously described in detail in Section 6.7). 
ADDOs in the intervention arm will also track engagement with intervention components (e.g., 
participation in the Queen Club). 
 
6.9 Study Compensation 
ADDO owners and employees will not be directly compensated for their shop’s participation in the 
intervention, including their completion of the baseline survey and shop records. However, as part of 
the intervention procedures, we will provide ADDOs in both study arms with a four-month supply of HIV 
self-test kits for free (~30 kits per month, each valued at $4 USD), and ADDO owners will be able to sell 
half of these kits to shop customers and keep the profits.  
 

 
14
6.10 Data Analysis 
We will compare AGYW patronage, referrals to health facilities, and ►HIVST kit and contraception 
provision between the 20 randomized intervention and comparison ADDOs over the 4-month pilot 
period using: (1) statistical tests of means (t-tests) and medians (Kruskal-Wallis tests) and (2) a 
negative binomial regression model (for counts of AGYW customers)◄ to estimate rate ratios and 
confidence intervals controlling for baseline levels of AGYW patronage using a “difference-in-
differences” approach. Results will be used to understand the potential effectiveness of AGYW-friendly 
ADDO environments on AGYW visits and demand generation for HIV prevention and SRH services, a 
basis for power calculations to determine the sample size needed for the future study of effectiveness 
and sustainability.   
 
6.11 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 Shinyanga 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 PIs (Dr. Liu & Dr. McCoy (UCB)). 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 (UCSF and UC Berkeley staff and students). The PIs 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 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. Additional protections against risks specific to each data collection activity 
are outlined in Section 7.2 and 7.3. 
 
All study forms, including the signed informed consent forms and field notes from the shadowing 
exercise, will be placed in a locked file cabinet in the locked study office and will be available only to 
study investigators and key study personnel. 
 
7. Ethical Considerations 
7.1 Alternatives to Participation 
ADDO shops, owners, and employees and referral facility staff who decline to participate as a site can 
do so without consequence. The identities of ADDO shops and their participation status will not be 
revealed publicly in this phase of the research to preclude any impact on their business or reputation. 
 
7.2 Risks and Benefits 
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.  

 
15
 
A year-long formative research process with AGYW and numerous community stakeholder groups 
(e.g., parents, community leaders, ADDO owners) led to the development of the Queen Club 
intervention, which is intended to leverage known motivational strategies from behavioral economics to 
motivate AGYW to visit ADDO shops – a behavior they already engage in – in order to receive fun 
rewards. The symbol portion of the club is intended to protect their privacy and allow them to obtain 
sensitive products like HIVST and contraception in a discreet way. Contraception is already legally 
allowed for AGYW in Tanzania but social mores prohibit them from accessing it in a way where they 
feel safe and comfortable.  
 
HIVST is a new product in Tanzania but country-wide rollout of HIV self-testing globally, including 
elsewhere in the region (e.g., Kenya) indicate that this product can be safely used by a variety of 
vulnerable groups, including AGYW. We have a robust training plan for ADDO staff and a referral plan 
for confidential confirmatory HIV testing and linkage to care. The HIVST involves an oral swab and no 
blood draws, and is intended to be self-administered.  
 
In the surveys, the primary risks are psychological distress or loss of confidentiality. For example, 
participants may experience discomfort or anxiety when discussing their perspectives on adolescent 
sexuality, HIV self-testing, access to health services, HIV-related risk behavior, gender biases, and/or 
HIV/AIDS in their community. However, it is very unlikely that sharing their viewpoints and opinions or 
answering survey questions about these issues will result in long-term or severe distress. In addition, 
loss of confidentiality resulting from personal information inadvertently being shared with outside 
individuals may have repercussions, including anger from family members or friends. All participants 
will be informed that the surveys and observations are confidential (as stated in the informed consent 
process) prior to their agreement to participate. We have outlined our plan to minimize any risk of loss 
of confidentiality in Section 7.3. The consent process will also inform participants that they may refuse 
to answer any question or leave the survey or study at any time.  
 
We believe that the benefits of the study warrant the relatively low risks posed to subjects in the study. 
Customers at ADDOs, including AGYW, may benefit from the product and services offered at ADDOs 
as part of the pilot study. The ADDO program in Tanzania is already widely recognized as a model for 
building a lower-skilled cadre of health providers, and the successful introduction of malaria services at 
ADDOs suggests that population-wide access to other basic health services can similarly be achieved. 
Thus, by providing HIVST at trained ADDOs, customers may gain knowledge about their HIV status 
and (if needed) be referred to confirmatory testing and treatment during this study. Moreover, the 
intervention may increase access to contraception and SRH services among AGYW customers through 
several targeted components of the intervention (i.e., free contraceptive provision, informational videos, 
the loyalty/symbol card, training of ADDOs), with potential impacts on their health and health behaviors. 
 
ADDO owners/employees who participate in the pilot study may benefit from their participation in 
several ways. ADDOs will be able to sell for a profit half of the HIVST which we distribute to them for 
free during the study period. Additionally, by providing ADDOs with HIVST and (in the intervention arm) 
girl-friendly marketing strategies, this study may increase profitability by driving business to participating 
shops.  
 
We believe that ADDOs are well positioned within local communities and health systems to offer girl-
friendly services to AGYW that simultaneously achieve public health goals. In Tanzania, ADDOs are 
located in nearly every community and are tasked with improving access to quality-assured 
pharmaceuticals, including oral contraceptives, pregnancy tests, and malaria testing and treatment. It is 
possible that the addition of HIV prevention services, including HIV self-test kits per the WHO 
guidelines, could greatly benefit AGYW who often face barriers to services in more traditional clinic-

 
16
based environments. ADDOs therefore are a prime opportunity to target AGYW with underutilized HIV 
prevention services. We hypothesize that creative strategies led by ADDO owners can attract more 
AGYW and will bolster uptake of HIV self-test kits and contraception. In this way, the current study to 
develop the ADDO platform to focus on AGYW-specific challenges could pave the way for more 
efficient community-based delivery of other high priority AGYW health initiatives. The results from the 
study will add to generalizable knowledge about how to deliver HIV prevention services to AGYW 
through an existing network of community-based drug shops. Young women elsewhere in Tanzania 
and in sub-Saharan Africa more broadly could potentially benefit if the strategy of reaching AGYW with 
HIV prevention services at ADDOs proves effective.  
 
7.3 Confidentiality of Study Participants  
All HPON staff who will have contact with human subjects will be trained on data collection instruments, 
confidentiality, and informed consent procedures in English and Swahili. Therefore, consistent 
translation during survey administration will be emphasized during training. All interviewers hired will be 
bilingual. All data collection activities will be conducted in a private location that preserves the 
confidentiality of the participant. Study participants will be provided with local study contact phone 
number that they can contact with any questions or concerns. The study protocol and all instruments 
will be submitted for approval to the Committee for Protection of Human Subjects to ensure compliance 
with local ethical standards. 
 
As described in Section 6.11, 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 PIs (Dr. Liu & Dr. McCoy 
(UCB)). We will also implement the following measures: 
• 
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 (UCSF 
and UC Berkeley staff and students).  
• 
All data collected will be anonymized prior to sharing with the PIs and the research team, except 
for video files from video shadowing which may potentially contain identifying content. The de-
identified data cannot be linked back to individual participants; identifiable video files will be 
securely stored in an encrypted and protected cloud-based server. 
• 
The data will be housed in a secure password-protected cloud-based folder. Only the PIs can 
grant access to the folder and access is limited to key personnel only. During data analysis, a 
local copy of the de-identified data may be housed on the PI’s computer which is securely 
stored and password protected at all times. 
• 
Access to any of the data is limited to the PI and other key personnel and requires a password 
at all times. 
• 
No subjects will be identified in any report or publication of the study or its results. 
• 
The PIs 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 cabinets in locked offices, password protection, and procedures for transferring study data to 
the secure password-protected cloud-based folder.  

 
17
• 
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.  
 
Additional protections against risk specific to certain data collection activities are outlined below. 
 
Time-location surveys: 
Observations of ADDO customers will be conducted by trained local researchers who speak Kiswahili 
and English. Observations will be recorded following a structured form and identified only by a unique 
ID for the ADDO shop. All collected forms will be stored in locked file cabinets and transcribed into 
electronic files housed in the same secure password-protected cloud-based storage folder described 
above.  
 
Shop records and referral records: 
ADDO owners/employees and referral facility staff will keep records following a structured form. The 
forms do not ask for any identifying information about ADDO customers and/or facility patients, and we 
will explicitly instruct those who complete these forms not to record identifying information. The ADDO 
shop record forms will identify ADDOs only by a unique ID for the ADDO shop, and the referral record 
forms will identify referral facility staff only by a unique ID. All collected forms will be stored in locked file 
cabinets and transcribed into electronic files housed in the same secure password-protected cloud-
based storage folder described above. 
 
7.4 Vulnerable Populations 
Some of the women in various target groups (e.g., AGYW, ADDO owners and employees, referral 
facility staff) may be pregnant at the time of the study, and if they meet the inclusion criteria, they will 
eligible for inclusion. It is likely that we will have pregnant women in our study considering the age 
range of participants (≥18 years for ADDO owners and employees and referral facility staff) and the 
high fertility rate in Tanzania. This study involves only minimal risk and our study team can make 
appropriate referrals to antenatal care at nearby healthcare facilities, if necessary. The research team 
has substantial experience conducting research on sensitive topics such as sexual risk behavior among 
young women and men; this experience is reflected in our plans to minimize research participation-
related risks. 
All research members who will interact with potential subjects will be bilingual (Swahili and English) and 
will be trained on consistent translation of data collection instruments and informed consent documents 
during training. They will be instructed to read the consent form out loud to the potential participant. 
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. 
 
8. Qualifications of Key Study Personnel 
Prosper Njau, MD 
Local Principal Investigator 
Health for a Prosperous Nation 
• 
Responsibilities: Oversees the implementation of the intervention and evaluation data collection 
in Tanzania through H-PON.  
• 
Qualifications: Dr. Njau has collaborated and locally lead more than five research projects, 
providing leadership and technical oversight as part of my role as Executive Secretary of the 

 
18
Tanzanian NGO Health for a Prosperous Nation. He has focused his research on HIV and the 
intersection between HIV and sexual and reproductive health through programing for the 
prevention of mother-to-child transmission (PMTCT) of HIV infection. 
 
Jenny Liu, PhD 
Co-Principal Investigator 
University of California, San Francisco  
• 
Responsibilities: Oversees all aspects of the proposed study, including design, data collection, 
analysis, recruitment, informed consent, and reporting of results.   
• 
Qualifications: Dr. Liu is a health economist and Assistant Professor at the University of 
California, San Francisco’s School of Nursing. She has been conducting research in Sub-
Saharan Africa for over 8 years, studying market penetration and uptake of health commodities 
for priority global health initiatives. 
 
Sandra McCoy, PhD 
Co-Principal Investigator 
University of California, Berkeley 
• 
Responsibilities: As Co-Principal Investigator, oversee all aspects of the proposed study, 
including design, data collection, analysis, recruitment, informed consent, and reporting of 
results.   
• 
Qualifications: Dr. McCoy is an Associate Professor in Residence in Epidemiology at the 
University of California, Berkeley School of Public Health with expertise in HIV prevention and 
care, including the use of incentives, the intersection of food insecurity and HIV, family planning 
and HIV, and impact evaluation and implementation science. This study builds off of her 
ongoing research program in Shinyanga, Tanzania. 
 
Sue Mavedzenge, PhD 
Co-Investigator 
RTI International 
• 
Responsibilities: Advise on the implementation of HIVST kits. 
• 
Qualifications: Dr Mavdzenge is a Research Scientist at RTI International. She has conducted 
HIV/STI and reproductive health research among high risk AGYW and other populations 
disproportionately affected by health disparities. She has been at the forefront of research on 
HIV self-testing since 2008, exploring the feasibility, accuracy, and acceptability of HIV self-
testing, strategies to promote linkage to onward services, potential cost-effectiveness, and 
shaping the policy environment around self-testing. 
 
Aarthi Rao, MBA 
Independent Consultant 
CVS Pharmacy 
• 
Responsibilities: Advise on the application of human-centered design methods to develop the 
intervention being piloted. 
• 
Qualifications: Ms. Rao completed her MBA at the University of California, Berkeley Haas 
School of Business concentrating on how to use tools from design thinking and marketing 
research to drive behavior change. She has a background in global health and development 
with the Results for Development Institute and has collaborated with the University of California, 
Berkeley School of Public Health on adherence programs in Tanzania. 
 
Lauren Hunter, MPH 
Project Manager 

 
19
University of California, Berkeley 
• 
Responsibilities: On behalf of the UCSF/UCB PIs, manage the project and coordinate activities 
with Tanzanian collaborators, and contribute to research data collection and analysis. 
• 
Qualifications: Ms. Hunter is a doctoral student in Epidemiology at the University of California, 
Berkeley School of Public Health, studying under the direction of Co-Principal Investigator, Dr. 
McCoy. She has been leading the formative research data collection work under this project, 
and will assist in all aspects of the pilot study and evaluation. 
 
Agatha Mnyippembe, BA 
Project Manager 
Health for a Prosperous Nation 
• 
Responsibilities: Oversee the field activities in Shinyanga, Tanzania and manage the field team 
operations.  
• 
Qualifications: Ms. Mnyippembe has over 8 years of experience managing research projects in 
Shinyanga as part of Dr. McCoy’s Tanzania research program. She has been trained in human 
subjects research, qualitative research methods, and human-centered design, and has 
managed large-scale randomized controlled trials. 
 
Kassim Hassan, BA 
Project Staff 
Health for a Prosperous Nation 
• 
Responsibilities: Implement study activities and participate in research synthesis under the 
direction of the project managers. 
• 
Qualifications: Mr. Hassan has over 4 years of experience carrying out research projects in 
Shinyanga as part of Dr. McCoy’s Tanzania research program. He has been trained in human 
subjects research, qualitative research methods, and human-centered design.  
 
Moza Chitela, BA 
Project Staff 
Health for a Prosperous Nation 
• 
Responsibilities: Implement study activities and participate in research synthesis under the 
direction of the project managers. 
• 
Qualifications: Ms. Chitela has previous experience implementing research projects in 
Tanzania. She has been trained in human subjects research, qualitative research methods, and 
human-centered design.  
 
Atuganile Kalinjila, BA 
Project Staff 
Health for a Prosperous Nation 
• 
Responsibilities: Implement study activities and participate in research synthesis under the 
direction of the project managers. 
• 
Qualifications: Ms. Kalinjila has previous experience implementing SRH programs in Tanzania, 
and has been trained in human subjects research and research methods.  
 
9. Study Sponsor and Management 
The study is sponsored by the National Institutes of Health. 
 

 
20
9.1 Stakeholder Engagement and Dissemination Plan 
A strong research collaboration has already been established between H-PON, the University of 
California, and the Shinyanga Regional Medical Officer. This link will facilitate the incorporation of the 
study findings into national health policy and HIV care practices. Results from the study will be 
presented at conferences and in peer-reviewed journals and will be local stakeholders at the end of the 
study. 
 
10. Limitations 
Our intervention to create girl-friendly ADDO shops is designed to build on the extensive network of 
ADDOs in Tanzania, has government support, and fits into the national HIV, SRH, and task-shifting 
strategic goals—all of which pave the way for adoption and scale-up should results show it to be 
feasible, acceptable, and, later, effective. To our knowledge, this is the first time such a community-
based program has been developed to address the ultimate goals of reducing AGYW HIV incidence 
and prevention of unintended pregnancy using innovative HCD methodological approaches to ensure 
applicability. Although we cannot test the delivery of a comprehensive package of HIV (beyond HIVST 
kits) and SRH services through ADDOs in this initial phase, we plan to do so in the next study.  
 
11. Future Directions 
A fully self-sustaining program through privately owned ADDOs will need to develop a more 
comprehensive business line for HIV and SRH services to match demand with sufficient supply, 
including sourcing, to maintain profitability incentives. If we can demonstrate that demand can be 
effectively generated for AGYW to seek products and services at ADDOs, including for HIVST kits and 
contraceptives when given for free, then we plan to incorporate several additional intervention features 
in the future: additional essential health commodities (e.g., PrEP, injectable contraceptives) that 
similarly can be accessed more easily from a community-based portal; enhanced demand generation 
capabilities (e.g., technologies to enable direct-to-consumer communications; social networking 
interfaces and apps) and recognition (e.g., specialized branding for AGYW-friendly shops); pricing 
schemes to may enable some cost recovery but that do not inhibit AGYW demand; supply-side factors, 
including more comprehensive training and licensing, mechanisms for monitoring quality assurance, 
and other non-monetary incentives needed for ADDO continued participation and engagement (e.g. 
community recognition, legitimacy); and robust linkages between ADDOs and health facilities to enable 
case management. This may potentially be achieved in partnership with public sector support and 
collaboration in order to create market structures that enable long-run sustainability. 
 

 
21
References 
 
1.  
Fleischman J, Peck K. Addressing HIV Risk in Adolescent Girls and Young Women [Internet]. 
Washington, D.C.: Center for Strategic & International Studies; 2015 Apr. Available from: https://csis-
prod.s3.amazonaws.com/s3fs-
public/legacy_files/files/publication/150410_Fleischman_HIVAdolescentGirls_Web.pdf 
2.  
UNAIDS. HIV Prevention among Adolescent Girls and Young Women [Internet]. Geneva, 
Switzerland: Joint United Nations Programme on HIV/AIDS (UNAIDS); 2016. Available from: 
http://www.unaids.org/sites/default/files/media_asset/UNAIDS_HIV_prevention_among_adolescent_girl
s_and_young_women.pdf 
3.  
UNAIDS, The African Union. Empower Young Women and Adolescent Girls: Fast-tracking the 
End of the AIDS Epidemic in Africa [Internet]. Joint United Nations Programme on HIV/AIDS (UNAIDS); 
2015. Report No.: JC2746. Available from: 
http://www.unaids.org/sites/default/files/media_asset/JC2746_en.pdf 
4.  
Hubacher D, Mavranezouli I, McGinn E. Unintended pregnancy in sub-Saharan Africa: 
magnitude of the problem and potential role of contraceptive implants to alleviate it. Contraception. 
2008 Jul;78(1):73–78. PMID: 18555821 
5.  
Napierala Mavedzenge SM, Doyle AM, Ross DA. HIV Prevention in Young People in Sub-
Saharan Africa: A Systematic Review. J Adolesc Health. 2011 Dec;49(6):568–586. PMID: 22098767 
6.  
Michielsen K, Chersich MF, Luchters S, De Koker P, Van Rossem R, Temmerman M. 
Effectiveness of HIV prevention for youth in sub-Saharan Africa: systematic review and meta-analysis 
of randomized and nonrandomized trials. Aids. 2010;24(8):1193–1202. PMID: 20375876 
7.  
McCoy SI, Kangwende RA, Padian NS. Behavior Change Interventions to Prevent HIV Infection 
among Women Living in Low and Middle Income Countries: A Systematic Review. AIDS Behav. 2009 
Dec 1;14(3):469–482. PMID: 19949847 
8.  
McCoy SI, Ralph LJ, Njau PF, Msolla MM, Padian NS. Food Insecurity, Socioeconomic Status, 
and HIV-Related Risk Behavior Among Women in Farming Households in Tanzania. AIDS Behav. 2013 
Oct 6;18(7):1224–1236. PMID: 24097335; PMCID: PMC3977025 
9.  
Dunbar MS, Kang Dufour M-S, Lambdin B, Mudekunye-Mahaka I, Nhamo D, Padian NS. The 
SHAZ! project: results from a pilot randomized trial of a structural intervention to prevent HIV among 
adolescent women in Zimbabwe. PloS One. 2014;9(11):e113621. PMID: 25415455; PMCID: 
PMC4240618 
10.  
Dunbar MS, Maternowska MC, Kang M-SJ, Laver SM, Mudekunye-Mahaka I, Padian NS. 
Findings from SHAZ!: a feasibility study of a microcredit and life-skills HIV prevention intervention to 
reduce risk among adolescent female orphans in Zimbabwe. J Prev Interv Community. 
2010;38(2):147–161. PMID: 20391061; PMCID: PMC4578719 
11.  
Nalwadda G, Mirembe F, Tumwesigye NM, Byamugisha J, Faxelid E. Constraints and 
prospects for contraceptive service provision to young people in Uganda: providers’ perspectives. BMC 
Health Serv Res. 2011;11:220. PMID: 21923927; PMCID: PMC3181204 
12.  
Sidze EM, Lardoux S, Speizer IS, Faye CM, Mutua MM, Badji F. Young women’s access to and 
use of contraceptives: the role of providers’ restrictions in urban Senegal. Int Perspect Sex Reprod 
Health. 2014 Dec;40(4):176–183. PMID: 25565345 
13.  
Tumlinson K, Okigbo CC, Speizer IS. Provider barriers to family planning access in urban 
Kenya. Contraception. 2015 Aug;92(2):143–151. PMID: 25869629; PMCID: PMC4506861 
14.  
Wood K, Jewkes R. Blood Blockages and Scolding Nurses: Barriers to Adolescent 
Contraceptive Use in South Africa. Reprod Health Matters. 2006 May;14(27):109–118. PMID: 
16713885 
15.  
Minnis AM, Mavedzenge SN, Luecke E, Dehlendorf C. Provider counseling to young women 
seeking family planning services. Perspect Sex Reprod Health. 2014 Dec;46(4):223–231. PMID: 
24786186; PMCID: PMC4269332 

 
22
16.  
Awor P, Wamani H, Bwire G, Jagoe G, Peterson S. Private sector drug shops in integrated 
community case management of malaria, pneumonia, and diarrhea in children in Uganda. Am J Trop 
Med Hyg. 2012 Nov;87(5 Suppl):92–96. PMID: 23136283; PMCID: PMC3748528 
17.  
Awor P, Wamani H, Tylleskar T, Jagoe G, Peterson S. Increased Access to Care and 
Appropriateness of Treatment at Private Sector Drug Shops with Integrated Management of Malaria, 
Pneumonia and Diarrhoea: A Quasi-Experimental Study in Uganda. PLoS ONE. 2014 Dec 
26;9(12):e115440. PMID: 25541703; PMCID: PMC4277343 
18.  
Rutebemberwa E, Kadobera D, Katureebe S, Kalyango JN, Mworozi E, Pariyo G. Use of 
community health workers for management of malaria and pneumonia in urban and rural areas in 
Eastern Uganda. Am J Trop Med Hyg. 2012 Nov 7;87(5 Suppl):30–35. PMID: 23136275 
19.  
Goodman C, Brieger W, Unwin A, Mills A, Meek S, Greer G. Medicine sellers and malaria 
treatment in Sub-Saharan Africa: What do they do and how can their practice be improved? Am J Trop 
Med Hyg. 2007 Dec 1;77(6 Suppl):203–218. PMID: 18165494 
20.  
Ajayi IO, Falade CO, Adeniyi JD, Bolaji MO. The role of patent medicine sellers in home 
management of childhood malaria: A situational analysis of experience in rural Nigeria. Int Q 
Community Health Educ. 2002;21(3):271–281.  
21.  
Treleaven E, Liu J, Prach LM, Isiguzo C. Management of paediatric illnesses by patent and 
proprietary medicine vendors in Nigeria. Malar J. 2015;14(1):232. PMID: 26041654; PMCID: 
PMC4465720 
22.  
Liu J, Prach LM, Treleaven E, Hansen M, Anyanti J, Jagha T, Seaman V, Ajumobi O, Isiguzo C. 
The role of drug vendors in improving basic health-care services in Nigeria. Bull World Health Organ. 
2016 Apr 1;94(4):267–275. PMID: 27034520; PMCID: PMC4794299 
23.  
Kagashe GAB, Minzi O, Matowe L. An assessment of dispensing practices in private 
pharmacies in Dar-es-Salaam, Tanzania. Int J Pharm Pract. 2011 Feb 1;19(1):30–35. PMID: 21235657 
24.  
Dusabe J, Mchome Z, Nnko S, Changalucha J, Obasi A. “There are bugs in condoms”: 
Tanzanian close-to-community providers’ ability to offer effective adolescent reproductive health 
services. J Fam Plann Reprod Health Care. 2014 Nov 28;jfprhc-2014-100915. PMID: 25432866 
25.  
Rutta E, Liana J, Embrey M, Johnson K, Kimatta S, Valimba R, Lieber R, Shekalaghe E, Sillo H. 
Accrediting retail drug shops to strengthen Tanzania’s public health system: an ADDO case study. J 
Pharm Policy Pract. 2015;8:23. PMID: 26413304; PMCID: PMC4582893 
26.  
Ministry of Health, Community Development, Gender, Elderly and Children (MoHCDGEC) 
[Tanzania Mainland], Ministry of Health (MoH) [Zanzibar], National Bureau of Statistics (NBS), Office of 
the Chief Government Statistician (OCGS), ICF International. Tanzania Demographic and Health 
Survey and Malaria Indicator Survey (TDHS-MIS) 2015-16 [Internet]. Dar es Salaam, Tanzania, and 
Rockville, Maryland, USA: MoHSW, MoH, OCGS, and ICF International; 2016. Report No.: PR74. 
Available from: http://dhsprogram.com/pubs/pdf/PR74/PR74.pdf 
27.  
World Health Organization. WHO Recommends HIV Self-Testing [Internet]. Geneva, 
Switzerland: World Health Organization; 2016 Dec. Report No.: WHO/HIV/2016.21. Available from: 
http://www.who.int/hiv/pub/vct/who-recommends-hiv-self-testing/en/ 
28.  
World Health Organization. Guidelines on HIV Self-Testing and Partner Notification: 
Supplement to Consolidated Guidelines on HIV Testing Services [Internet]. Geneva, Switzerland; [cited 
2016 Nov 29]. Available from: http://www.who.int/hiv/pub/vct/hiv-self-testing-guidelines/en/ 
29.  
Tanzania Commission for AIDS (TACAIDS), Zanzibar AIDS Commission (ZAC), National 
Bureau of Statistics (NBS), Office of the Chief Government Statistician (OCGS), ICF International. 
Tanzania HIV/AIDS and Malaria Indicator Survey 2011-12: Key Findings [Internet]. Dar es Salaam, 
Tanzania: TACAIDS, ZAC, NBS, OCGS, and ICF International; 2013. Report No.: SR196. Available 
from: http://www.dhsprogram.com/pubs/pdf/SR196/SR196.pdf 
30.  
IDEO.org. Field Guide to Human-Centered Design. IDEO.org; 2015.  
31.  
Beyeler N, Liu J, Sieverding M. A systematic review of the role of proprietary and patent 
medicine vendors in healthcare provision in Nigeria. PLoS ONE. 2015 Jan 28;10(1):e0117165. PMID: 
25629900; PMCID: PMC4309565 

 
23
32.  
Sieverding M, Liu J, Beyeler N. Social support in the practices of informal providers: The case of 
patent and proprietary medicine vendors in Nigeria. Soc Sci Med. 2015 Oct;143:17–25. PMID: 
26331864 
33.  
Prach LM, Treleaven E, Isiguzo C, Liu J. Care-seeking at patent and proprietary medicine 
vendors in Nigeria. BMC Health Serv Res. 2015;15:231. PMID: 26067426; PMCID: PMC4465150 
34.  
Liu J, Beyeler N, Prach L, Sieverding M, Isiguzo C, Nwokolo E, Anyanti J. The Landscape of 
Patent and Proprietary Medicine Vendors in 16 States of Nigeria. Abuja, Nigeria: Sociey for Family 
Health, Nigeria; 2015.  
35.  
Simba D, Kakoko D, Semali I, Kessy A, Embrey M. Household Knowledge of Antimicrobials and 
Antimicrobial Resistance in the Wake of an Accredited Drug Dispensing Outlet (ADDO) Program 
Rollout in Tanzania. PLOS ONE. 2016 Sep 29;11(9):e0163246. PMID: 27684066; PMCID: 
PMC5042404 
36.  
Alba S, Dillip A, Hetzel MW, Mayumana I, Mshana C, Makemba A, Alexander M, Obrist B, 
Schulze A, Kessy F, Mshinda H, Lengeler C. Improvements in access to malaria treatment in Tanzania 
following community, retail sector and health facility interventions - a user perspective. Malar J. 
2010;9:163. PMID: 20550653 
37.  
Liu J, Isiguzo C, Sieverding M. Differences in malaria care seeking and dispensing outcomes for 
adults and children attending drug vendors in Nasarawa, Nigeria. Trop Med Int Health TM IH. 2015 
Aug;20(8):1081–1092. PMID: 25877471; PMCID: PMC4696411 
38.  
Isiguzo C, Anyanti J, Ujuju C, Nwokolo E, De La Cruz A, Schatzkin E, Modrek S, Montagu D, 
Liu J. Presumptive treatment of malaria from formal and informal drug vendors in Nigeria. PLoS ONE. 
2014 Oct 21;9(10):e110361. PMID: 25333909; PMCID: PMC4204870 
39.  
Liu JX, Modrek S. Evaluation of SMS reminder messages for altering treatment adherence and 
health seeking perceptions among malaria care-seekers in Nigeria. Health Policy Plan. 2016 
Dec;31(10):1374–1383. PMID: 27315831; PMCID: PMC5091342 
40.  
Modrek S, Schatzkin E, Cruz ADL, Isiguzo C, Nwokolo E, Anyanti J, Ujuju C, Montagu D, Liu J. 
SMS messages increase adherence to rapid diagnostic test results among malaria patients: Results 
from a pilot study in Nigeria. Malar J. 2014 Dec 1;13(1):1–8. PMID: 24564925; PMCID: PMC3943452 
41.  
Napierala Mavdzenge S, Luecke E, Lopez A, Wagner D, Hartmann M, Lutnick A, Lambdin B. 
HIV Testing among Key Populations, Adolescent Girls and Men in Eastern and Southern Africa: A 
Review of Research, Policy and Programming. Research Triangle Park, NC: RTI International; 2016 
Jul.  
42.  
Choko AT, Desmond N, Webb EL, Chavula K, Napierala-Mavedzenge S, Gaydos CA, 
Makombe SD, Chunda T, Squire SB, French N, Mwapasa V, Corbett EL. The uptake and accuracy of 
oral kits for HIV self-testing in high HIV prevalence setting: a cross-sectional feasibility study in 
Blantyre, Malawi. PLoS Med. 2011 Oct;8(10):e1001102. PMCID: PMC3186813 
43.  
Napierala Mavedzenge S, Baggaley R, Corbett EL. A review of self-testing for HIV: research 
and policy priorities in a new era of HIV prevention. Clin Infect Dis Off Publ Infect Dis Soc Am. 2013 
Jul;57(1):126–138. PMID: 23487385; PMCID: PMC3669524 
44.  
Napierala Mavdzenge S, Sibanda E, Mavengere Y, Dirawo J, Hatzold K, Mugurungi O, Padian 
N, Cowan F. Acceptability, feasibility, and preference for HIV self-testing in Zimbabwe. Abstr Book. 
Durban, South Africa: IAS 2016; 2016.  
45.  
Naperiela Mavedzenge S. Supervised HIV self-testing to inform implementation and scale-up of 
self-testing in Zimbabwe. Abstr Book. Vancouver, Canada: IAS 2015; 2015.  
46.  
Tanzania | HIVST.org [Internet]. [cited 2016 Dec 17]. Available from: 
http://hivst.org/policy/tanzania 
47.  
McCoy SI, Fahey C, Rao A, Kapologwe N, Njau PF, Bautista-Arredondo S. Pilot study of a 
multi-pronged intervention using social norms and priming to improve adherence to antiretroviral 
therapy and retention in care among adults living with HIV in Tanzania. PLOS ONE. 2017 May 
9;12(5):e0177394. PMID: 28486553; PMCID: PMC5423659 

 
24
48.  
Rao A, McCoy S. Fostering behavior change for better health. Stanf Soc Innov Rev [Internet]. 
2015 Aug 17 [cited 2016 Dec 9]; Available from: 
https://ssir.org/articles/entry/fostering_behavior_change_for_better_health 
49.  
Rao A, McCoy S. Optimizing on the Edges. Stanf Soc Innov Rev [Internet]. 2017 Jun 23 [cited 
2017 Aug 16]; Available from: https://ssir.org/articles/entry/optimizing_on_the_edges 
50.  
McCoy SI, Shiu K, Martz TE, Smith CD, Mattox L, R. Gluth D, Murgai N, Martin M, Padian NS. 
Improving the Efficiency of HIV Testing With Peer Recruitment, Financial Incentives, and the 
Involvement of Persons Living With HIV Infection. JAIDS J Acquir Immune Defic Syndr. 2013 
Jun;63(2):e56–e63. PMID: 23403860 
51.  
McCoy SI, Njau PF, Czaicki NL, Kadiyala S, Jewell NP, Dow WH, Padian NS. Rationale and 
design of a randomized study of short-term food and cash assistance to improve adherence to 
antiretroviral therapy among food insecure HIV-infected adults in Tanzania. BMC Infect Dis. 2015 Oct 
28;15:490. PMID: 26520572; PMCID: PMC4628274 
52.  
Liu J, Wilson N, Padian N. Evaluation of a Conditional Cash Transfer Program for Preventing 
Mother-to-child Transmission [PMTCT] of HIV in NIgeria. Abstr Book [Internet]. Durban, South Africa: 
IAS 2016; 2016 [cited 2016 Dec 11]. Available from: 
http://www.aids2016.org/Portals/0/File/AIDS2016_Abstracts_LOW.pdf?ver=2016-08-10-154247-087 
53.  
Liu J, Falahati V, Stadler P, Janumpalli S, Padian N. Randomized controlled trial of a conditional 
cash transfer program to prevent mother-to-child transmission of HIV and increase facility delivery in 
Nigeria. San Francisco, CA: New Incentives; 2016 Jun.  
54.  
Mejia CM, Acland D, Buzdugan R, Grimball R, Natoli L, McGrath MR, Klausner JD, McCoy SI. 
An Intervention Using Gamification to Increase Human Immunodeficiency Virus and Sexually 
Transmitted Infection Screening Among Young Men Who Have Sex With Men in California: Rationale 
and Design of Stick To It. JMIR Res Protoc. 2017 Jul 17;6(7):e140. PMID: 28716771 
55.  
Sibanda EL, Tumushime M, Mufuka J, Mavedzenge SN, Gudukeya S, Bautista-Arredondo S, 
Hatzold K, Thirumurthy H, McCoy SI, Padian N, Copas A, Cowan FM. Effect of non-monetary 
incentives on uptake of couples’ counselling and testing among clients attending mobile HIV services in 
rural Zimbabwe: a cluster-randomised trial. Lancet Glob Health. 2017 Sep;5(9):e907–e915. PMID: 
28807189 
56.  
Rao A, Njau PF, Mnyippembe A, Hassan K, Czaicki NL, Kapologwe N, Bautista-Arredondo S, 
McCoy S. Application of tools from marketing research, design thinking, and behavioral priming to 
understand variation in patient experiences and opportunities for improving adherence among adults 
living with HIV in Tanzania. Abstr Book. Durban, South Africa: IAS 2016; 2016.  
57.  
Mavedzenge SN, Weiss HA, Montgomery ET, Blanchard K, de Bruyn G, Ramjee G, Chipato T, 
Padian NS, Van Der Straten A. Determinants of differential HIV incidence among women in three 
southern African locations. J Acquir Immune Defic Syndr 1999. 2011 Sep 1;58(1):89–99. PMID: 
21654502 
58.  
Napierala Mavedzenge S, Olson R, Doyle AM, Changalucha J, Ross DA. The epidemiology of 
HIV among young people in sub-Saharan Africa: know your local epidemic and its implications for 
prevention. J Adolesc Health Off Publ Soc Adolesc Med. 2011 Dec;49(6):559–567. PMID: 22098766 
59.  
Doyle AM, Mavedzenge SN, Plummer ML, Ross DA. The sexual behaviour of adolescents in 
sub-Saharan Africa: patterns and trends from national surveys. Trop Med Int Health TM IH. 2012 
Jul;17(7):796–807. PMID: 22594660 
60.  
Mavedzenge SN, Luecke E, Ross DA. Effective approaches for programming to reduce 
adolescent vulnerability to HIV infection, HIV risk, and HIV-related morbidity and mortality: a systematic 
review of systematic reviews. J Acquir Immune Defic Syndr 1999. 2014 Jul 1;66 Suppl 2:S154-169. 
PMID: 24918591 
61.  
MacPherson P, Webb EL, Choko AT, Desmond N, Chavula K, Napierala Mavedzenge S, 
Makombe SD, Chunda T, Squire SB, Corbett EL. Stigmatising attitudes among people offered home-
based HIV testing and counselling in Blantyre, Malawi: construction and analysis of a stigma scale. 
PloS One. 2011;6(10):e26814. PMID: 22046367; PMCID: PMC3202579 

 
25
62.  
Roy M, Holmes CB, Sikazwe I, Savory T, Mwanza M, Moore C, Mulenga K, Czaicki NL, Padian 
N, Geng E. Evaluating appointment patterns to improve sustainability of HIV treatment in Zambia. Abstr 
Book. Boston, MA: CROI 2016; 2016.  
63. 
Delbecq AL, Van DV. A Group Process Model for Problem Identification and Program Planning. 
J Appl Behav Sci. 1971;  
64. 
Dolan P, Hallsworth M, Halpern D, King D, Metcalfe R, Vlaev I. Influencing behaviour: The 
mindspace way. J Econ Psychol. 2012 Feb;33(1):264–277.