Developing and Testing a Multi-level Package of Interventions for an Integrated Care Delivery Model of HIV Prevention and Treatment Targeting Adolescent Girls in Zambia
Phase: NA
Conditions: HIV
Sponsor: RTI International

1 
 
Title Page 
 
Project Title: 
Developing and Testing a Multi-Level Package of Interventions 
for an Integrated Care Delivery Model of HIV Prevention and 
Treatment Targeting Adolescent Girls in Zambia 
Principal Investigator: 
Sujha Subramanian, PhD 
Implenomics 
8 The Green, Suite 6172, Dover 
United Sates of America 
Email: sujha.subramanian@implenomics.com 
 
Laura Nyblade, PhD 
RTI International 
Research Triangle Park, North Carolina 
United States of America 
Email: lnyablade@rti.org 
 
Co-Investigators: 
Michael T. Mbizvo, DPhil 
Population Council, Zambia Office 
No 8 Nyerere Road, Prospect Hill, Lusaka 
Tel: +260 211 295925 
Email: mmbizvo@popcouncil.org 
 
Nkomba Kayeyi, PhD 
Population Council, Zambia Office 
No 8 Nyerere Road, Prospect Hill, Lusaka 
Tel: +260 211 295925 
Email: nkayeyi@popcouncil.org 
 
 
Carla Chibwesha, MD, MSc 
University of North Carolina at Chapel Hill 
United States of America 
Project Location: 
Lusaka, Zambia 
 
Protocol Version: 
Version 7.0, adapted for ClinicalTrials.gov 
Proposed Project Dates: 
25th October 2018 – 31st August 2024 
  Sujha Subramanian 
 
30th August 2023* 
 
Principal Investigator’s Name 
Date 
*Sections updated July  2025 to clarify intervention components  
Running title: HIV Prevention & Treatment: Adolescent Girls in Zambia 

2 
 
 
 
Table of Contents 
List of Acronyms ............................................................................................................................. 3 
Summary of Proposed Research ...................................................................................................... 4 
1. Background and Introduction ...................................................................................................... 4 
1.1 Background, Rationale and Significance ..................................................................................... 4 
1.2 Study Goal and Objectives ......................................................................................................... 5 
1.3 Ethical Issues ............................................................................................................................ 5 
2.0 Literature Review ...................................................................................................................... 6 
3.0 Methodology ............................................................................................................................ 7 
3.1 Overview of the Intervention Trial ............................................................................................. 7 
3.2 Overview of the interventions ................................................................................................... 7 
3.3 Intervention – Cluster Randomized Trial Protocol ..................................................................... 11 
Research participant population ................................................................................................ 11 
Research Protocol ..................................................................................................................... 12 
Risks and Benefits ..................................................................................................................... 17 
Steps to Minimize Risks ............................................................................................................. 19 
Confidentiality .......................................................................................................................... 20 
Compensation........................................................................................................................... 21 
Informed Consent Process ......................................................................................................... 21 
4.0 Data Management .................................................................................................................. 22 
5.0 Training and Qualifications of Personnel .................................................................................. 23 
6.0 Timeline ................................................................................................................................. 24 

3 
 
List of Acronyms 
AGEP
Adolescent Girl Empowerment Program
AGYW
Adolescent girls and young women
ART
Antiretroviral therapy
CAB
Community advisory board
CFIR
Consolidated Framework for Implementation Research
CFR
Code of Federal Regulations
cRCT
Cluster randomized controlled trial
DCE
Discrete choice experiment
DREAMS 
Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe women
DSMB
Data Safety Monitoring Board
FGD
Focus group discussion
FTP
File transfer protocol 
GCP
Good Clinical Practice
GEE
Generalized estimating equation
GRZ
The Government of the Republic of Zambia
HCT
HIV counselling and testing
HIPAA
Health Insurance Portability and Accountability Act
HPV
Human papillomavirus
ICH
International Council on Harmonization
IDE
Investigational Device Exemption
IDI
In-depth interview
IND
Investigational New Drug Application
IRB
Institutional Review Board
IWC
Integrated wellness care
MOH
Ministry of Health
NAC
National HIV/AIDS/STI/TB Council
NIH
National Institutes of Health
PATC3H 
Prevention and Treatment through a Comprehensive Care Continuum 
for HIV-affected Adolescents in Resource Constrained Settings 
PI
Principal Investigator
PN 
Peer navigator
PopART
Population Effects of Antiretroviral Therapy to Reduce HIV Transmission
PrEP
Pre-Exposure Prophylaxis
PTID
Unique study identification number
SDG
Sustainable Development Goal
SHIELD 
Support for HIV Integrated Education, Linkages to care, and Destigmatization
SOP
Standard Operating Procedure
SRH
Sexual and reproductive health
UNC
University of North Carolina
YAB
Youth advisory board

4 
 
Summary of Proposed Research 
Zambia is among countries in sub-Saharan Africa experiencing one of the highest incidences of HIV, and 
adolescent girls and young women (AGYW)are particularly affected. This has placed priority on 
innovations that are likely to make a positive impact and catalytic in national efforts to curb new infections 
and attain the global 95-95-95 targets. Prior studies and initiatives to provide youth-friendly services 
through adolescent antiretroviral therapy (ART) clinics that offer a range of services, but these clinics have 
faced challenges because of the loss of privacy and the stigma associated with HIV. To address this gap, 
the Zambian Ministry of Health, RTI International, the Population Council, and the University of North 
Carolina are collaborating to develop and test an integrated wellness care (IWC) delivery model that 
targets all HIV-affected AGYW, both those that are HIV negative or do not know their status (HIV-/u) and 
those that are HIV positive (HIV+). 
The proposed study will test a multilevel package of interventions to connect AGYW with a source of 
regular care to provide a sustainable platform for successful implementation of regular HIV testing and 
support for linkage to care and adherence to antiviral treatment. Prior tools will be adapted to create 
the SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization) 
to educate and empower AGYW and their families, and to create community-based youth clubs to foster 
peer support. 
 
 
1. Background and Introduction 
1.1 Background, Rationale and Significance 
Zambia is experiencing one of the highest incidences of HIV in the world, and adolescent girls and young 
women (AGYW) are a particularly affected group because of their social and economic vulnerability.1,2 
Approximately 5% of girls aged 15 to 19 years and 11% of young women aged 20 to 24 are HIV positive in 
Zambia, with about 14,000 new infections among AGYW annually.1,3,4 As part of the DREAMS initiative, 
the Zambian government recognized the importance of addressing the unique needs of AGYW and their 
vulnerability during transition from childhood to adulthood.5,6 Zambia adopted the “test and start” 
approach, which is based on recent evidence on prioritizing treatment to enhance prevention.7 Successful 
implementation requires high levels of adherence along the HIV care continuum, including repeated HIV 
testing and compliance with treatment regimens, which are particularly problematic for AGYW. They face 
multiple barriers, including lack of youth-friendly services, HIV stigma, low levels of self-efficacy, and 
generally weak peer and family support.1 GRZ’s response effort requires complementary research-driven 
innovations that identify and harness opportunities for enhancing prevention and care coverage of AGYW. 
 
Prior studies and initiatives have attempted to provide youth-friendly services through adolescent 
antiretroviral therapy (ART) clinics that offer a range of services, but these clinics have faced challenges 
because of the stigma associated with HIV and loss of privacy.8-10 To address this gap, the Zambian Ministry 
of Health (MOH), RTI International, the Population Council (PC), and the University of North Carolina (UNC) 
are collaborating to test an integrated wellness care (IWC) delivery model that targets all HIV-affected 
AGYW, both those HIV negative or status unknown (HIV-/u) and those HIV positive (HIV+). The study will 
adapt the successful Zambian cervical cancer screening program, which provides a range of services to 
older women who are HIV- and HIV+, to offer tailored services to AGYW.11,12 The availability of the human 
papillomavirus (HPV) vaccine, which is targeted at AGYW (ages 10 to 24 years included in this study) and 
well-accepted in Zambia,13,14 provides an ideal opportunity to address the dual burden of HIV and cervical 

5 
 
cancer. The IWC clinic will provide services related to HIV testing, HIV treatment (in coordination with HIV 
clinic and dispensary in the same facility), HPV vaccination, and other sexual and reproductive health (SRH) 
care needs. 
 
The study team will also include a community-based behavioral intervention for AGYW and their families 
that is specifically tailored to the development stage of the AGYW. The overall goal is to test a multilevel 
package of interventions to connect AGYW with a source of regular care to provide a sustainable platform 
for successful implementation of regular HIV testing and support for linkage to care and adherence to 
antiviral treatment. This approach will avoid siloes and provide a comprehensive HIV care continuum 
with a holistic and integrated health care delivery approach that is recommended by the Zambian HIV 
guidelines.7 
 
 
1.2 Study Goal and Objectives 
Our overall goal of the study is to test a multilevel package of interventions to connect AGYW with a source 
of regular care to provide a sustainable platform for successful implementation of regular HIV testing and 
support for linkage to care and adherence to antiviral treatment. 
 
The objectives of the study are to: 
1. Objective 1: Assess efficacy at 6, and 12 months of a multilevel integration intervention on HIV 
testing and viral load suppression. 
2. Objective 2: Obtain feedback on the integrated care delivery model to assess sustainability, 
document best practices, and update SOPs to support scaling up of integrated services for AGYW. 
3. Objective 3: Perform cost-effectiveness and budget analysis to evaluate and describe impact 
along the HIV care continuum and disseminate findings to national partners and the international 
community. 
1.3 Ethical Issues 
Ethical approval to conduct this study will be sought from ERES Converge IRB, Population Council IRB and 
University of North Carolina at Chapel Hill (UNC) IRB. The final approval will be sought from the Ministry 
of Health, through the National Health Research Authority. All participants will be required to provide 
written informed consent or assent. Before implementation, all informed consent and assent forms will 
be reviewed by the Youth Advisory Board, approved by the study institutional review boards, and field- 
tested to ensure comprehension and completeness. 
In Zambia, the legal age for consent for health research is 18 years. For minors under age 18 who are 
interested in participating in the study, PN will obtain written consent for participation from a parent or 
legal guardian (referred to as “parent” hereafter). After parental permission is obtained, the minor will be 
asked to provide assent for study participation (referred to as “child aged 10–17 years”). Parental consent 
forms will specify that parents may not have access to their children’s study data. 
Separate sets of consent forms will be used for each research activity and each participant population, 
where a “set” of forms includes adult information sheets, informed consent forms plus parental consent 
and child assent forms for AGYW populations. For additional recruitment of any AGYW living with HIV, a 
pre-consent form will be administered by the health facility staff or staff from organizations that provide 
treatment support and care to seek for permission from the parent/guardian/caregiver of adolescent girls 

6 
 
aged 16–17 years or young women aged 18–24 years for Population Council research staff to contact 
them. 
 
2.0 Literature Review 
The proposed study is designed against the following background contexts: 
 
AGYW are less likely to be tested for HIV and less adherent to antiretroviral therapy (ART). HIV 
counseling and testing (HCT) is the key entry point for many HIV prevention interventions and is 
essential for early linkages to HIV treatment.2 With optimal use of ART, early diagnosis can reduce 
transmission to others and improve health outcomes.15-17 Latest estimates indicate that only 42% of 
youth aged 15 to 24 years know their HIV status, 78% of those diagnosed with HIV are in treatment, 
and 71% of those in treatment have achieved viral suppression, resulting in a community viral load 
suppression (at the population level) of less than one-third.18 Evidence indicates that girls have less- 
comprehensive HIV knowledge than boys, face male gender norms that increase their susceptibility, 
and lack access to sexual and reproductive health (SRH) services to support their reproductive 
rights.19,20 Therefore, to decrease the disparities faced by this vulnerable group, the study team will 
focus on interventions to improve HIV testing and treatment adherence among AGYW and on linkages 
to services to reduce HIV risk behaviors (two priority areas addressing the key population of AGYW). 
The planned interventions will be embedded within the broader framework of ongoing studies in 
Zambia, addressing HIV risk and treatment among other populations, including boys and adults. 
 
 
The Zambian government prioritizes HIV services for adolescents and encourages evaluation of new 
models of care delivery to support “test and start” guidelines. Zambia has introduced comprehensive 
sexuality education, which is fully integrated in school curriculums, and is in the early stages of 
initiating facility-based ART adherence clubs. To spearhead further progress, the government is 
interested in evaluating new models of HIV testing and treatment. Under the new “test and treat” 
guidelines,7 linkage to HIV care is crucial to the success of ART treatment. Community-based testing 
approaches, such as the Population Effects of Antiretroviral Therapy to Reduce HIV Transmission 
(PopART) trial in Zambia,21 do face some barriers, including challenges around parents and AGYW 
not being present at home and the high level of resources required in terms of labor hours and 
travel costs. A recent systematic review, investigating acceptability of HCT in children and youth aged 
5 to 19 years in sub-Saharan Africa, reported that provider-initiated testing and counselling achieved 
the highest acceptability (86%), followed by home-based HCT (84.9%) and school-linked HCT 
(60.4%).22 There is also some evidence that locating testing and care services within the same facility 
can improve care linkage and ART initiation.23-25 Additional evidence is required on whether 
provider-initiated HCT in an adolescent-friendly, clinic-based setting that is co-located with HIV 
services can increase HIV testing and improve linkages to HIV treatment among AGYW. 
 
 
Create a Comprehensive Continuum of Care for HIV-affected AGYW by adapting the successful 
Zambian Cervical Cancer Screening Program. The government of Zambia runs a successful cervical 
cancer screening program26 integrated with HIV care that targets women aged 25 to 49 years and was 
selected as a top-10 sustainable solution by Sustainia Award (http://www.sustainia.me/sustainia- 
action-forum). Full countrywide scale-up of the program is in progress. The program began in the 
Lusaka area to address the dual burden of HIV and cervical cancer, as HIV-positive women have up to 
a six-fold higher risk of developing cervical cancer. Women who attend the clinics can request on-site 

7 
 
HIV testing from the program nurses; the nurses are trained to provide holistic care, which include 
comprehensive SRH services. RTI International’s evaluation of the program (1R01CA200845-01A1) 
indicates that because of the stigma associated with HIV, women often prefer to receive testing in the 
privacy of cervical cancer clinics rather than HIV clinics. Program staff also support HIV+ women by 
collecting their ART medication from the HIV dispensary, which protects their privacy, while they 
receive care in the cervical cancer screening clinic. 
 
The successful cervical cancer screening program model will be adapted and create IWC clinics. The 
IWC clinics will offer integrated SRH services along with HPV vaccination. Vaccine implementation 
guidelines support a two-dose schedule for girls before becoming sexually active (generally 9 to 14 
years of age) and a three-dose schedule for the older AGYW cohort (15 to 24 years of age). HPV 
vaccination is well-accepted in Zambia,13,14 and vaccination could serve as one key entry point to 
provide HIV testing in the privacy of the IWC clinics. 
 
 
Individual and interpersonal factors, such as self-efficacy and social support, are key facilitators of 
HIV testing and ART adherence among AGYW. The transitions from being a child, to a teenager, to a 
young adult are crucial developmental phases that require age-appropriate interventions.27 Training 
tools such as the Stepping Stones program and those developed by the study team for the Adolescent 
Girl Empowerment Program (AGEP) are proven to improve self-efficacy and increase HIV 
knowledge.28-31 Additionally, during adolescence, both family support and peer influence are 
important.32,33 Youth clubs are an important venue to help young people establish friendships and 
social bonds to support optimal HIV prevention and treatment behaviors.34 Prior tools will be adapted 
to create the SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and 
Destigmatization) to educate and empower AGYW and their families, and to create community-based 
youth clubs to foster peer support. 
 
 
 
3.0 Methodology 
 
3.1 Overview of the Intervention Trial 
We conducted a cluster randomized trial to assess the efficacy of the multi-level interventions, 
through the measurement of both the primary and secondary endpoints of the intervention. We also 
conducted a post-intervention follow at about 12 months after the end of the intervention. 
3.2 Overview of the interventions 
SHIELD intervention. The SHIELD intervention is based on social cognitive theory, which posits that 
positive behavior change requires knowledge and skills to increase behavioral capability, development of 
self-efficacy to increase the belief that one can achieve the desired outcomes, and social support to 
provide positive reinforcement and develop positive outcomes expectations.46 We developed a modular 
program for AGYW that increases knowledge, skills, and self-efficacy to engage along the HIV prevention 
and care continuum, and a program for family members (up to four participants in addition to the AGYW; 
10 years and older) to increase social support. To reflect AGYW’s evolving cognitive and decisional 
capacity, judgement, emotional development, risk, and health-seeking behaviors, intervention content 
for both AGYW and families were tailored for five distinct groups to reflect development stage and 

8 
 
AGYW’s HIV status. Content areas were adapted from existing evidence-based interventions, such as 
Stepping Stones30,31 and Families Matter!47,48 based on CAB and YAB input and formative research with 
AGYW, caregivers, and community leaders. Modules address HIV prevention and treatment, general 
wellness and SRH, approaches to combat stigma and discrimination, and skills for better communication, 
and include new content on health service availability and access to increase self-efficacy in seeking health 
care services. SHIELD educational materials were pre-tested. The SHIELD sessions will be offered to AGYW 
and their families in the 4 communities randomly assigned to intervention arms. The AGYW in the usual 
care arm will receive one education session focused on stigma and HIV care. SHIELD education session 
content is presented in Exhibit 1 for the AGYW sessions and Exhibit 2 for the family sessions. We have 
noted content that will be included in core sessions along with content that will be included in the basic 
education provided to the control group participants. The core sessions will be provided to all participants 
in the intervention communities while all other sessions will be optional content for future meetings 
within the intervention communities. 

9 
 
Exhibit 1. SHIELD Content Areas for Adolescent Girls and Young Women Program 
 
 
Stigma and discrimination 
around SRH and HIV care 
and treatment 
HIV knowledge, 
prevention, and treatment 
Health service 
availability and access 
Combatting stigma, 
building self-esteem 
 
1. How we are the same, how
1. Taking care of your health
1. Where to access
1. The voice in your head
HIV+ 16+
we are different (all 
when living with HIV*^ 
services* 
(all)* 
 
ages/groups) 
2. Adherence case studies* 
2. Barriers and challenges 
2. Loving me, loving you 
 
2. Naming stigma through 
3. Healthy sexuality* 
to accessing health 
(all)* 
 
pictures (13-24)*^ 
4. Pregnancy prevention 
services* 
3. Introduction to 
 
3. Coping with stigma* 
5. STIs 
3. Claiming rights to quality 
human rights (all)* 
 
 
 
care through assertive 
4. Assertiveness – Be the 
 
 
 
communication* 
change (13+)* 
 
1. How we are the same, how
1. HIV transmission and
1. Where to access
1. The voice in your head
HIV- 10-12
we are different (all 
prevention*^ 
services* 
(all)* 
 
ages/groups) 
2. Living with HIV* 
2. Barriers and challenges 
2. Loving me, loving you 
 
2. Naming stigma through 
3. Good hygiene and 
to accessing health 
(all)* 
 
pictures (10-12)*^ 
managing menstruation 
services* 
3. Introduction to 
 
3. Supporting your friends who 
4. Pregnancy and 
3. Asking adults for 
human rights (all)* 
 
are living with HIV (10-12)* 
menstruation 
information through 
4. Assertiveness – Be the 
 
 
5. Puberty 
assertive communication* 
change (10-12)* 
 
 
6. STIs 
 
 
 
1. How we are the same, how
1. HIV transmission and
1. Where to access
1. The voice in your head
HIV- 13-20
we are different (all 
prevention*^ 
services* 
(all)* 
 
ages/groups) 
2. HIV testing* 
2. Barriers and challenges 
2. Loving me, loving you 
 
2. Naming stigma through 
3. Living with HIV* 
to accessing health 
(all)* 
 
pictures (13-24)*^ 
5. Pregnancy and 
services* 
3. Introduction to 
 
3. Supporting your friends who 
menstruation 
3. Claiming rights to quality 
human rights (all)* 
 
are living with HIV (13-20)* 
6. Pregnancy prevention 
care through assertive 
4. Assertiveness – Be the 
 
 
7. STIs 
communication* 
change (13+)* 
* Indicates core topic area 
^ Indicates inclusion in basic education for control group 

10 
 
Exhibit 2. SHIELD Content Areas for AGYW and Family Program 
 
 
Information on AGYW SRH and 
HIV 
Stigma and Social Support
AGYW and Families 
1. What you see in me (All) 
2. Making puberty easier (parents 
of AGYW ages 10-12) 
3. HIV, AIDS and STIs- Myth or Fact 
(All)* 
4. Helping children express their 
feelings (ages 10-12) 
5. Taking responsibility for 
pregnancy: Community 
responsibility (ages 13-24)* 
1. Non-verbal communication (All) 
2. Sharing information with family 
members: challenges and 
possibilities (HIV+ ages 16-24)* 
3. Providing emotional support 
after a child learns that you or they 
are HIV positive (All) 
4. Analyzing stigma against AGYW 
(All)* 
* Indicates core topic area 
 
 
 
IWC Clinic 
The Integrated Wellness Care (IWC) clinic for AGYW will be established in 2 randomly selected health 
centers participating in this study communities. The clinic will provide integrated HIV and sexual and 
reproductive health services to both participating HIV-/u and HIV+ AGYW facilitated by a trained nurse. 
Specifically, the IWC clinic will offer: 
 
HPV vaccination 
 
HIV testing & counselling 
 
ART adherence counselling (HIV+ AGYW) 
 
STI services information 
 
Family planning, including counselling, initiation of contraception, services related to current 
contraception, and pregnancy testing and counselling. 
 
Information on cervical cancer screening 
 
Referrals for services, such as mental health, gender-based violence, STI testing, cervical 
cancer screening, and other health services as needed 
All services will be provided based on the standard of care guidelines and delivered by a trained nurse. 
IWC components and data collection was tested during the pilot-testing phase. In addition, selected 
staff at the health centers with the IWC clinic will receive stigma training to ensure team-based care is 
available for AGYW who are referred from the IWC clinic to received services in other departments at 
the health center. The training section includes four modules (2-hour session for each) that experienced 
trainers will deliver to give staff the skills to create a stigma-free health facility.29,30 
Caregiver and provider support for AGYW. We will include caregivers who will participate with AGYW in 
the SHIELD family sessions. We will identify one caregiver for each participating AGYW in the 6 

11 
 
Recruitment of AGYW (core intervention recipient) 
intervention communities (approximately 1,125 family members). The AGYW will select their caregiver 
upon enrollment into the intervention. We will also include approximately 60 clinic staff in health centers 
from the 6 communities included in the study. We plan to conduct interviews with these health center 
staff to seek general feedback on barriers and facilitators faced by youth receiving services at their health 
centers. We will include health center staff who have worked at the health center for at least 6 months, 
plan to stay in their current position during the 12-month study implementation period and have some 
interaction with girls and young women who visit the health center. The staff members at health centers 
hosting the IWC clinic will receive stigma training at baseline. The staff at each health center will be 
selected based on their likelihood to interact with AGYW seeking care at their facilities. 
Peer navigators support for AGYW. We selected individuals 18 to 24 years to serve as peer navigators to 
support AGYW enrolled in the study intervention communities/clinics. These navigators were trained to 
deliver the SHIELD education sessions and they also supported the AGYW during IWC clinic visits. 
3.3 Intervention – Cluster Randomized Trial Protocol 
 
 
. In each of the 6 clinic zones, the study team will use stratified random sampling, using age-group strata 
(based on age at cohort enrollment for each study community-clinic zones) drawn from the sampling 
frame recruited for formative research, to select AGYW for the HIV-/u and HIV+ study cohorts (IWC pilot 
study participants will be excluded and higher priority will be given to those who previously indicated 
that they were likely to reside over the long term in the study communities). Zones include the following 
communities and their clinic catchment areas: Chipata, Chawama, Kanyama, Kalingalinga, Mtendere, 
and George. The selection criteria will overall remain the same as the sampling frame recruitment with 
the following exclusions for the intervention: (1) girls and young women who are pregnant at enrollment 
(self-report); (2) young women who are older than 25 as our cohort would have aged; and (3) those not 
planning to live in the study communities or seek care at the study community clinics for at least 24 
months so follow-up data collection can be completed. Those in the HIV- cohort who are diagnosed with 
HIV (self-reported) will be assigned to the HIV+ cohort if they meet the age criteria. The study team will 
oversample from the existing sampling frame cohort in each age subgroup to account for ineligibility. 
Additionally, to maintain balance in enrollment across age groups and communities, we may need to 
recruit few additional AGYW prior to implementing the intervention. As a consequence of the COVID- 
19 pandemic there may have been more dispersal among the already recruited AGYW cohort than 
anticipated. To add new AGYW (if required), we will follow the same procedures as previously approved 
to identify the cohort during formative research. The consent procedures for participation in the 
intervention will be the same for girls identified from the existing cohort or those newly recruited. Our 
overall goal is to select approximately 600 HIV-/u and 525 HIV+ AGYW to test the SHIELD and IWC 
interventions. 
 
The sample size was calculated assuming conventional specifications (power = .80, alpha = .05, two- 
sided tests) and based on the primary endpoints. The sample sizes were determined to allow for the 
detection of a 15–percentage point improvement in the primary endpoints, our minimum threshold to 
consider the intervention to be successful. For the HIV-/u cohort, the current rate of HIV testing is 
estimated to be about 40%. With a sample size of 200 (each of the three cohorts), The study team will 
be able to detect a 13 to 14% difference, and even with a loss of 10% of the cohort during follow-up (the 
grant team achieved a 90% retention rate at 12 months in a recent study of AGYW),28 the study team 

12 
 
Research Protocol 
will still have the statistical power for a minimum detectable difference in HIV testing of 15%. For the 
HIV+ cohort, viral load suppression is estimated to be 70 to 75% among AGYW. With a sample size of 
175 per cohort, the study team will be able to detect a minimum difference of 15% even with a 10% loss 
to follow up. See Exhibit 3 for details on sample size included in the cluster randomized trial. 
 
 
 
 
 
 
 
 
Exhibit 3. Experimental design and sample sizes* 
 
 
 
 
 
Post-intervention data collection: We will conduct one post-intervention survey with AGYW at about 24- 
months from study initiation (approximately 12 months after intervention completion). 
 

13 
 
Assess efficacy of the multilevel interventions (hypothesis testing). Cluster randomization study design 
and interventions. We propose a cluster randomized study implemented in the six selected geographic 
zones in Lusaka, each served by a government-operated clinic providing HIV and cervical cancer 
screening services. Zones, with their respective clinics, will be randomized into three groups (zones with 
IWC clinics and SHIELD intervention, zones with only SHIELD intervention, and control zones with no IWC 
clinic or SHIELD interventions. AGYW in the control zones will be offered one education session on HIV 
prevention and treatment) to assess the impact of offering IWC clinics coupled with the SHIELD 
intervention compared to the standard of care (see Exhibit 1 above). The study team will also evaluate 
whether a similar impact can be achieved with control clinics when the SHIELD intervention is offered in 
the community. The SHIELD intervention, as described in Section 3.2, will begin with training sessions for 
AGYW and their families. This will be followed by PN-facilitated youth clubs that will meet about once a 
month during the 12-month study timeframe. Two-four PNs will be assigned to each clinic zone with the 
SHIELD intervention, and one-two PN each will be assigned to the two control clinic zones to assist with 
data collection and follow-up activities. The PNs in zones with the IWC clinics will also serve as 
community liaisons to support clinic-community linkages. The health centers in which the primary 
endpoint for the HIV-/u cohort is the proportion with any HIV testing at 12 months. For the HIV+ 
cohort, we plan to assess the primary endpoint: viral load suppression, measured as proportion with 
undetectable viral load at 12 months. The secondary endpoints are the proportion with decrease in HIV 
risk behavior, repeat HIV testing (each 6-month period), HIV infections diagnosed through voluntary 
HCT, linkages to HIV care, and adherence to ART. We will also conduct a targeted 6-month post-
intervention data collection after the end of the 12-month intervention period. See Exhibit 4 for 
endpoint definitions and biological, self-report, and clinic audit measures collected at 6- and 12-month 
follow up. To assess the impact of the SHIELD intervention on the medicating outcomes, the study team 
will collect data from AGYWs across all six clinic zones at baseline and at 6- and 12- month follow-up. 
The study team will also track health care service use by conducting clinic audits at all six clinic sites. We 
plan to retain the intervention cohort for a maximum of 24 months total to allow for initiation of the 
intervention and follow-up activities (12 months of intervention and follow-up after intervention 
completion). 
 
Exhibit 4. Tables of measures at baseline, 6 months (6m), and 12 months (12m); few measures also 
collected at about 24 months (24m) during the post intervention period. 
Constructs/Measures
Instrument and Specification
Source
Cohort
Primary and Secondary Endpoints—HIV Care Continuum and HIV Risk Behavior
HIV testing; proportion 
tested for HIV in the past 6 
and 12 months 
Abstraction tool (serologic HCT); and self-report 
confirmed via clinic audit; repeat HCT at 6- 
month intervals will be assessed 
Clinic audit 
Self-report 
HIV-/u 
6m,12m 
Self report only 
at 24m 
HIV early detection; 
proportion with HIV 
identified through 
voluntary testing 
All participants will be tested to determine HIV 
status (rapid finger prick and follow-up per 
Zambian guidelines) 
Biological 
HIV-/u 
12m 
Linkage to care: proportion 
enrolled at an HIV clinic in ≤ 
30 days; ART initiated in ≤ 
90 days 
Measured as days from testing HIV positive or 
from baseline when not on treatment (HIV+ but 
not on ART) 
Clinic audit 
HIV-/u 
HIV+ 
6m & 12m 

14 
 
Adherence to ART; 
proportion filling 
prescriptions at least every 
3 months 
Zambian guidelines recommend dispensing 3- 
month supply of ART medications 
Clinic audit 
 
 
Self-report 
HIV+ 
6m &12m 
Self-report only 
at 24m 
Viral load suppression; 
proportion with 
undetectable viral load 
HIV plasma viral load tests using the Roche 
platform 
Biological 
HIV+ 
6m &12m 
HIV risk behavior: 
proportion with delay in 
first intercourse, reduction 
in sexual partners; 
increases in condom use 
Demographic and Health Survey and AGEP 
instrument (measures will be based on previous 
studies by grant team, including AGEP) 
Self-report 
HIV-/u 
Baseline, 6m, 
12m & 24m 
AGYW (Mediating outcomes, SHIELD intervention dose, and clinic-based services)
Self-efficacy, social support,
HIV stigma & gender roles 
Tailored instrument based on supplemental 
survey completed at cohort recruitment 
Self-report 
HIV-/u & HIV+ 
Baseline, 6m, & 
12m 
 
Self-report at 
24m 
Mental health and 
substance abuse 
Brief assessment based on NICHD consortium 
common data elements 
Self-report 
Unintended pregnancy
Tested at 12m
Urine test
Education modules (AGYW 
& family) 
Number of modules completed 
Study 
database 
Youth club attendance
Number and proportion of meetings attended
HPV vaccination 
Proportion receiving 1, 2, or 3 doses (IWC clinic 
only) 
Clinic audit 
& visit data 
collection 
HIV-/u & 
HIV+; 6m & 12m
Number of clinic visits 
Proportion with visits at 6m and 12m; total 
number of visits 
SRH services provided 
Family planning, sexually transmitted diseases, 
and condoms 
Baseline Data for AGYW
Demographics & socio-
economic status 
AGEP baseline instrument 
Self-report All AGYW 
24m 
 
Trained data abstractors will obtain the information from the clinical records at baseline and during 
the 6- and 12-month follow-up using prespecified abstraction forms. UNC’s Zambia project manager will 
supervise the data collection at the IWC clinics that will manage the pre-screening processes, track visits, 
clinical services provided, and linkages for HIV care. Specially trained staff will perform biological data 
collection, which will include HIV testing at 12 months for the HIV-/u group, viral load testing at 12 
months for the HIV+ group, and pregnancy testing for both groups at 12 months. All data collectors will 
be trained, data collection will undergo continual monitoring, and fidelity to protocol specifications will 
be confirmed by random in-person review of supervisors’ data collection. IWC clinic staff will keep 
detailed records to track patient visits along with information on staff time spent across various clinic 
activities. Data will be stored locally at secure location at Population Council offices and reviewed for 
data completeness. Deidentified data then will be transferred securely to RTI and archived in secure, 

15 
 
password-protected servers. RTI staff will conduct further data quality review, produce reports, and 
develop analytic files. 
SHIELD intervention exposure. Using attendance information entered in the study database, the 
study team will quantify the number of SHIELD education sessions AGYW and family members attend 
and the number of youth clubs AGYW attend. This will allow us to calculate the amount of exposure to 
the intervention (dose) for each participant. This dose estimate will be used as a covariate in sub 
analyses that examine the dose-response of the interventions on outcomes. 
Hypotheses on intervention effect. The study team will test the following hypotheses: (1) HIV-/u 
AGYW from zones with IWC clinics and who receive SHIELD intervention will have higher HIV testing 
than AGYW in zones without the IWC clinics (including those receiving SHIELD intervention with usual 
care clinics); (2a) HIV+ AGYW from zones with IWC clinics and who receive SHIELD intervention will have 
higher viral load suppression (2b) than AGYW in zones without the IWC clinics (including those receiving 
SHIELD intervention with usual care clinics); (3) HIV+ AGYW from zones with IWC clinics will receive 
more-timely linkages to care than AGYW in zones without a IWC clinic; (4) AGYW from zones who 
receive SHIELD intervention will have improved self-efficacy (4a) and social support (4b), and reduced 
HIV risk behaviors (4c) compared to AGYW from zones not receiving the intervention. 
Analysis of hypotheses. The testing of the primary hypotheses will be done by intent to treat, and 
the study team will examine the effects across the three randomization groups. Given the need to 
consider the influence of the cluster randomization by zone, The study team will use generalized 
estimating equation (GEE) models to estimate the effects of the randomization groups and will assess 
the need to apply small sample correction using approaches suggested by the NIH Health Care Systems 
Collaboratory Biostatistics and Design Core.59 If the Hausman assumption of correlation between the 
random and fixed effects is violated, then The study team will include fixed effects representing cluster 
identification. The study team will adjust for baseline covariates, including sociodemographic factors 
and behavioral risks, should the initial descriptive analyses suggest differences in the distribution of 
these factors across study randomization groups. The study team will also explore the use of propensity 
scores to control for systematic differences between the groups. In further analyses, the study team will 
examine the potential mediating and moderating roles of key behavioral, social, and structural factors 
hypothesized to influence HIV testing and adherence along the HIV care continuum (e.g., social support; 
self-efficacy).. The study team will test the “dose” of the SHIELD training received as a covariate in these 
models. Secondary analysis will follow the same approach. As appropriate, the study team will perform 
analyses separately or pooled together for the HIV+ and HIV-/u cohorts. A key aspect of interest in this 
study is the developmental stage of the AGYW; using age as a proxy in our multivariate analysis, the 
study team will determine the differential effect of the IWC clinic and SHIELD intervention on outcomes 
reported by HIV status (see Exhibit 1 for groupings). In subsequent analyses, the study team will also 
consider both medium-term outcomes within the first 6 months after study enrollment and changes at 
any point during the 12-month follow-up period to assess longer-term outcomes. Additionally, for 
measures where we have baseline, 6-month and 12-month follow-up data (for example, self-efficacy, 
and other mediating outcomes for AGYW), the study team will perform difference-in-difference analysis, 
which will allow for comparisons between and across the study arms. The study team will also report all 
mediating factors, and ’IWC clinic utilization metrics stratified by age and HIV status to facilitate 
subgroup analysis. Importantly, the changes along the HIV care cascade, from HIV testing, linkage to 
care, ART adherence, and viral load suppression, will be documented to identify potential differential 
impacts of the interventions. This analysis is critical to assist in further tailoring the SHIELD training and 
IWC clinic services. 
Obtain feedback on the integrated care delivery model and compare with current standard of 
care. Clinic staff and peer navigator data collection. Two complementary data collection approaches, 

16 
 
IDIs (qualitative) and survey (quantitative; see Exhibit 2), will be used to obtain data from about 10 
health center staff (clinical and non-clinical) at each of the six health center sites to assess the impact of 
IWC on HIV care processes, AGYW health seeking behavior, and provider attitudes: The study team will 
develop an interview guide with key questions to explore staff experiences in providing care to AGYW 
and their perception about AGYW’s satisfaction with the services provided. The study team will include a 
specific session for the IWC clinic health center staff on implementation procedures, clinic operations, 
and sustainability. This qualitative information will be supplemented by a survey that will be based on a 
validated instrument by Co-I Dr. Nyblade for measuring attitudes of providers towards those seeking HIV 
services (multiple statements that providers can agree or disagree with). This instrument will be adapted 
for this study and incorporate lessons from an ongoing RTI study in South Africa that is currently 
adapting the same instrument for vulnerable AGYW (1R01HD094629-01). Additionally, we will also 
collect details on the implementation climate using a short, tailored questionnaire. These data will be 
collected at baseline and at 6- and 12-month follow-up to provide a longitudinal assessment of potential 
changes in provider attitudes. 
Furthermore, to assess the implementation of the interventions, we will conduct debrief activities to 
understand barriers and facilitators experienced by AGYW using surveys, interviews and group 
discussions with the study team members implementing the interventions. These activities will involve 
the PNs and the IWC clinic staff who will be working with the AGYW. Furthermore, to understand the 
level of effort required to implement the interventions and to estimate the cost, we will track time spent 
by the PNs, IWC clinic staff and others in implementing the SHIELD and IWC clinic interventions. 
Data analysis and synthesis of findings. The study team will follow the same procedures outlined 
under our formative research to transcribe, code and analyze the qualitative data. The study team will 
identify themes that emerge around barriers to and facilitators of access to and use of HIV and SRH 
services. The study team will generate descriptive statistics based on the survey responses (percentage 
who agree or disagree with statements) and compare the proportions over time to identify patterns in 
health center staff attitude and PN feedback between those in IWC clinic zones and comparison zones 
offering standard-of-care health services. The qualitative analysis will provide contextual information to 
interpret the quantitative findings, and specific feedback provided on the integrated care delivery model 
will be evaluated to assess sustainability, document best practices, and update SOPs to support scaling 
up of integrated services for AGYW. 
Cost-effectiveness, budget impact, and policy implications. The study team will use a previously 
validated instrument, The Cost Assessment Tool.60 to create a tailored data collection approach to 
collect resource use information on the interventions. Our main goal is to estimate the implementation 
cost of the IWC and the SHIELD interventions from the program perspective (which will reflect MOH 
resources needed to sustain interventions), but the study team will also derive the start-up costs related 
to developing the interventions to inform future adaption of these interventions to other settings. The 
study team will estimate labor hours of IWC clinic staff, PN, and other staff by prospectively tracking 
time spent by each project staff member implementing the intervention on a pre-defined set of 
activities and use hourly wage to calculate cost. The study team will also document the expenditure on 
non-labor resources. Using standard economics methodology,61,62 the study team will explore 
economies of scale that can be achieved during scale-up. The cost information, along with the 
effectiveness impact of the IWC and SHIELD interventions, will be used as inputs in previously validated 
models and approaches developed by RTI.63 The study team will evaluate the tradeoff, or return on 
investment, between investing in HIV prevention and lowering HIV treatment cost over the long term. 
The usual care (base case) will be compared to the long-term effectiveness of including the IWC clinic- 
based intervention with and without the SHIELD community-based interventions to address barriers 
along the continuum of care. The study team will report the projected decrease in HIV incidence, 

17 
 
Risks and Benefits 
increase in community-level viral load suppression, and incremental cost per quality-adjusted life years. 
The study team will conduct policy simulations to assess the impact of scaling up the interventions to 
the population level; perform sensitivity analysis, varying the range of effectiveness and cost estimates; 
and generate potential best- and worst-case scenarios. The study team will create tornado and spider 
diagrams to display this uncertainty assessments graphically to policy makers. This cost-effectiveness 
analysis will be complemented by a budget analysis, which will identify the financial outlays that will be 
required annually to implement the intervention during the implementation trial in the scale-up 
process. 
3.3.4 Limitations and approaches to minimize bias. First, although cluster randomization reduces 
contamination across study arms, it increases the risk that clinics and individuals in each arm may differ 
at baseline. The unique feature of this study is that the study team will create a sampling frame and 
therefore will be able to assess individual-level baseline differences before randomization. Additionally, 
through our planned situational analysis, the study team will explore clinic characteristics to select 
clinics that are similar. Second, data could be missing because of nonresponse as well as study attrition. 
All AGYW will be assigned to a PN who will ensure regular contact with the AGYW during the study 
period. The study team will also employ rigorous field data collection practices, including training data 
collectors, developing protocols, and monitoring fidelity on a continual basis. Using this approach, on 
the basis of a recent study among Zambian AGYW by the study team, we expect that retention will be 
90% over the 12-month follow-up period.28 Furthermore, the study team will address any missing data 
by including demographic covariates that will serve as proxies for dropout and conducting sensitivity 
analyses. 
3.3.5 Dissemination, generalizability assessment, and policy forum. In addition to the PATC3H 
consortium meetings, regional conferences, and local YAB and CAB meetings, the study team will plan 
scientific, peer-reviewed journal articles and international conference presentations to disseminate 
formative research findings, interim results, and final results. The study team will involve all government 
partners in the communication plan and ongoing dissemination. The study team will use the PATC3H 
meetings to seek feedback on the extent to which the personal, interpersonal, and structural levels of 
the interventions included in our study are directly transferable to other settings. Key aspects of 
discussion will be differences in AGYW characteristics, community support, and health service delivery 
that may differ between Zambia and other Sub-Saharan African countries. The study team will also 
organize a policy forum in year 5 in Lusaka, Zambia, to present the outcomes to local health department 
and government officials and to share the findings from the modeling work and policy simulations. The 
study’s formative research and hypothesis testing can inform the development of the Zambian 
government’s policy on integrated service delivery and international guidelines regarding health service 
delivery for AGYW. The IWC model, if shown to be successful, will provide a comprehensive and 
sustainable approach to improving health outcomes of AGYW by using low-cost PNs and embedding 
integrated youth-friendly clinics within existing government facilities 
 
 
 
 
 
 
 

18 
 
Although this study presents no greater than minimal risk to participating AGYW, and adequate 
provisions will be made for soliciting the assent of AGYW under age 18, there are some potential risks to 
participating in the proposed study: 
Blood draws for HIV or viral load testing may lead to discomfort, feelings of dizziness or 
faintness, bruising, swelling, or infection. 
Loss of confidentiality. There is a risk of loss of confidentiality for AGYW around study 
participation; HIV status; ART use; or data reported in project questionnaires. The intervention activities 
also carry a risk of participant disclosure of personal information during group activities such as the 
SHIELD intervention youth clubs, and during participant tracking for follow-up. It is also possible that 
other people may find out that participants have taken part in this research, and as a result, participants 
may be treated unfairly, discriminated against, or face problems being accepted by their families, 
communities, or both. 
HPV vaccination. The World Health Organization recommends HPV vaccination. The Global 
Advisory Committee on Vaccine Safety has systematically investigated the HPV vaccine and found it to 
be safe. As with any vaccination, some people may have some side effects. These are usually mild and 
include a sore arm from the shot, fever, headache, or nausea. Brief fainting spells can happen 
immediately after any medical procedure, including vaccination. 
Discomfort with learning HIV status or with interview topics and questionnaires. AGYW 
participants may experience psychological discomfort upon learning their HIV or pregnancy status. 
Sensitive interview topics related to HIV status, ART use, stigma, reproductive health, or sexual behavior 
may make some participants feel uncomfortable, worried, or embarrassed. 
There is little to no risk for other participants, including clinic staff and stakeholders. All of the 
questions we will ask relate to their daily work as clinic staff or community leaders. Additionally, clinic 
staff and other government or private stakeholders who participate in IDIs will not be asked any 
sensitive questions. All responses will be de-identified and only reported in aggregate form. Clinic 
administrators will not have access to individual staff member responses. 
COVID-19-associated risks 
The COVID-19 pandemic may present health risks to both participants and the staff who engage 
with participants in the clinic and community setting. These health risks are significant but are not 
unique to our study. COVID-19 may pose a larger risk during group meetings, such as the SHIELD 
educational sessions, than for one-on-one contact. The project team is closely monitoring COVID trends 
in Zambia and has detailed our risk mitigation strategy in the below section. 
Potential benefits 
Participants may receive no direct benefit from participation in the study. Participants have the 
potential to contribute to and learn from research that will investigate how to improve uptake of HIV 
testing and adherence to ART among AGYW. If the proposed intervention is successful, the participants 
randomized to the interventions in Aim UH3-1 could benefit from improved linkages to services, 
including HPV vaccination and other sexual and reproductive health care. Although these services are 
already available in the public health facilities, proposed interventions may increase demand and 
accessibility. Intervention benefits could also include improved self-efficacy, improved social support, and 
a reduction in stigma. 
Participants and others also may benefit in the future from information learned from these 
studies, if the intervention is scaled up to increase engagement in care in a larger population of AGYW. If 

19 
 
Steps to Minimize Risks 
the intervention is not successful, the information will still be valuable to redirect future efforts toward 
other approaches. 
 
 
 
Risks to participants will be minimized through the following procedures: 
Risks associated with blood draws. The blood draw volume will be the same amount required for clinical 
care. Participants will be offered water, a snack, or both to minimize the risk of dizziness or faintness. 
HPV vaccination. All those who receive the vaccination will be provided with information on how to notify 
the research team if they develop any symptoms, such as nausea, and need follow-up care (details on 
who to contact for care if they have symptoms will be provided). We will also ensure all AGYW sit or lie 
down for about 15 minutes after the vaccination to help prevent fainting and injuries caused by falls. 
Data security to minimize loss of confidentiality. (described in detail in the below section for 
confidentiality) 
Discomfort with interview topics and questionnaires. Procedures for minimizing risk and discomfort for 
participants during the qualitative and quantitative interviews will be monitored closely. Study staff 
interacting with participants will be female, and the interview team will be selected and trained with the 
goal of establishing rapport with the participants’ age group. All study staff will be trained in ethical 
interviewing and discussion of sensitive topics, and staff training and debriefing will be conducted on an 
ongoing basis throughout the study, either weekly or as issues arise. Participants will be advised that they 
are not required to answer any questions, and reminded that they may withdraw from the study at any 
time without losing access to any clinical services. Referrals will be provided to participants who need or 
request clinical or psychosocial care at any point during study participation. In addition, participants will 
be encouraged to contact the peer navigators at any time during the study if they have questions or 
concerns. 
COVID-19-associated risk mitigation 
The study team has developed a detailed COVID-19 risk mitigation plan in conducting research and in the 
training of hired staff. The risk mitigation plan includes specific precautionary measures for all staff during 
trainings, when in contact with participants in the community and in the clinic setting, including wearing 
a mask, sanitizing, social distancing, avoiding crowds, and constant hand washing. Staff temperature will 
be checked prior to performing any fieldwork, and staff will wear a facemask and practice social distancing 
while performing any interviews or participant contacts. Researchers will also sanitize their hands prior to 
giving any materials or compensation to participants and will also ensure participants sanitize their hands 
after signing consent forms or receiving compensation. Research staff will also provide facemasks to 
guardians when obtaining parental permission, as well as for the respondents during consent and 
participation in the study. In addition, the IWC clinic staff will perform COVID-19 risk pre-screening by 
telephone to all participants prior to them coming to the clinic in-person. Staff will also perform an in- 
person COVID-19 screening questionnaire to participants.. Any participant experiencing flu-like symptoms 
will be advised to call the COVID helpline number and will not be interviewed or invited into the clinic. 
The IWC appointment will be scheduled for a later date following successful completion of pre-screening 

20 
 
Confidentiality 
requirements. For risk mitigation within the clinic, we are providing masks to participants, ensuring hand 
washing, providing hand sanitizer, cleaning the clinic space regularly, and keeping windows open to 
ensure air flow in the space. We are also limiting the number of participants per day to make sure that 
social distancing can take place. 
Overall COVID trends in the Lusaka region will be closely monitored by the study team. The study team 
may decide to temporarily halt participant contact activities if the COVID risk level rises in the region or if 
advised by the Zambian Ministry of Health. 
Overall risk mitigation 
All reports of social harms, adverse events, and unanticipated problems will be reported to the Principal 
Investigator, site Lead Investigator, and Field Coordinator within 5 days, and will be reviewed by the Data 
Safety Monitoring Board, who may recommend additional action or modifications to the intervention or 
study protocol to ensure participant safety. 
The knowledge gained in this study will address a critical gap in our understanding of effective public 
health interventions to improve engagement of AGYW along the HIV care continuum. It will test 
community- and clinic-based interventions to address key barriers to engagement in care at the individual, 
interpersonal, and clinic levels, including HIV knowledge, stigma, social support, and the need for youth- 
friendly services. If successful, the proposed interventions will improve HIV testing and treatment 
adherence among AGYW, and will contribute to meeting the 95-95-95 targets, reducing secondary 
transmission, and improving the quality of life of AGYW affected by HIV. If this multilevel intervention is 
successful in establishing a comprehensive care continuum for HIV-affected AGYWs, the Zambian 
Ministry of Health will advocate for expansion to additional settings to support national scale- up. 
Risks to participants are low in this study, and we have designed careful safety reporting and monitoring 
mechanisms to ensure that the proposed intervention does not cause harm. Given the urgency of 
developing interventions that support engagement in care among AGYW, we feel the risks to participants 
are justified in relation to the potential benefits. 
 
 
 
The study team will bring its combined decades of experience working with young women in these settings 
to develop a detailed plan to protect participant confidentiality and minimize harms associated with loss 
of confidentiality. All staff will be trained to manage research with strict attention to appropriate 
counseling, disclosure, confidentiality, and secure storage of data in accordance with ICH-GCP, and these 
principles will be applied in the conduct of this study. Procedures will be documented in detailed standard 
operating procedures, which will be available at the study sites for reference. Staff will also receive 
instructions on how to report any violations of those policies and procedures. 
All study interview and counseling sessions will take place in private rooms with closed doors. For the 
AGYW survey, participants will be offered the option to conduct the visit at a local community center if 
no private space is available at home. At enrollment, study staff will have a discussion with each 
participant about her home and partnership situation to assess the risks of participation. This will include 

21 
 
Compensation 
Informed Consent Process 
helping her make a plan for how she will respond to questions from family members or others about her 
attendance at the clinic or community sessions, to minimize the risk of stigma resulting from study 
participation. 
All consent and data forms will be kept in locked files in the project office, with consent forms and locator 
forms stored separately from paper data collection forms. Data collection forms will be coded only with 
the unique study identification number (PTID) given to each participant. Computer records will be 
password-protected to prohibit illicit access. Audio recordings and interview transcripts from the 
qualitative activities will be labeled only with a PTID. All electronic data will be encrypted and stored on 
password-protected computers in locked rooms. 
There is also risk of loss of confidentiality through participant follow-up procedures. We will minimize risk 
by using only methods of contact that are acceptable to participants, including using an alias or 
pseudonym of the participant’s choosing to protect confidentiality. 
The risk of loss of confidentiality and privacy during group activities such as SHIELD intervention sessions 
and FGDs will be minimized by ensuring that all participants are cognizant of the ground rules of 
participation in a group exercise. These ground rules include the fact that they do not have to reveal their 
full name and should not reveal personal information about others, but rather should talk in general 
terms. Ground rules will be introduced and participants will be asked to take a pledge that they will not 
disclose personal information about other group members to people outside the group. At the beginning 
and end of each session, participants will be reminded that it is essential to respect the confidentiality of 
other members of the group and not discuss other group members’ personal information outside of the 
group meeting. However, participants will be told to keep in mind that the proceedings of the discussion 
may not be kept confidential, although all those present are encouraged to do so. Participants will also be 
reminded on a regular basis that participation in all study activities is voluntary and that withdrawal of 
consent will have no impact on their access to clinical services, including HIV testing and treatment. 
 
 
 
During the cluster randomized study, we will also offer a payment of 80 Kwacha to AGYW for 
transport reimbursement at baseline and at the 6-month, and 12-month. These reimbursement 
amounts are based on standard rates offered to participants in prior studies conducted by the research 
team. 
 
 
 
Study staff will be responsible for obtaining written informed consent or assent from all 
participants. Before implementation, all informed consent forms will be reviewed by the Youth Advisory 
Board, approved by the study institutional review boards, and field-tested to ensure comprehension and 
completeness. 
In Zambia, the legal age for consent for health research is 18 years. For minors under age 18 
who are interested in participating in the study, peer navigators will obtain written consent for 

22 
 
participation from a parent or legal guardian (referred to as “parent” hereafter). After parental 
permission is obtained, the minor will be asked to provide assent for study participation. Parental 
consent forms will specify that parents may not have access to their children’s study data. 
Separate sets of consent forms will be used for each research activity and each participant 
population, where a “set” of forms includes adult consent forms plus parental consent and child assent 
forms for AGYW populations.: 
 
For the implementation trial, consent to participate in the cRCT will be obtained. According to 
national guidelines, those 18 years of age and older will be able to provide written consent for these 
services, and those under 18 years will require their parent’s written consent. 
The consent/assent process will address study procedures, confidentiality and limitations to 
confidentiality, time involved in study participation, risks and potential benefits of participation, the 
right to withdraw from participation, and the rights of research participants. For all activities, AGYW will 
be informed that their participation in the study is voluntary and that their decision will not affect their 
access to routine services at their schools, community agencies, or health clinics. Providers will be 
informed that their choice to participate is entirely voluntary and will not affect their employment 
status. All participants will be advised that they do not have to answer any questions that they do not 
want to and that they can withdraw from the study at any time. The names and telephone numbers of 
the site Field Coordinator and site Lead Investigator (Dr. Michael Mbizvo) will be given verbally to all 
participants and included in all consent or assent forms. 
The staff will be extremely sensitive to issues of confidentiality and risk during all consent 
procedures. They will receive extensive training in ensuring participant confidentiality and 
comprehension of study procedures, and in confidentiality regarding the eligibility criteria when 
discussing the study with parents and other community members. All potential study participants will 
have the opportunity to talk with a member of the research team to clarify the study’s purpose and 
procedures and to discuss the procedures to retain confidentiality during the interview. The informed 
assent and consent procedures will be conducted on a one-to-one basis in a private setting. 
 
 
4.0 Data Management 
Research materials obtained from individuals recruited into this study will include the following: 
 
Consent forms 
 
Contact information sheets (“locator forms” and eligibility assessments) 
 
Audio files and transcripts of interview and focus group sessions 
 
Completed surveys 
 
Clinic data (through clinic data abstractions) 
 
Intervention tracking details on education sessions and services provided 
 
All participant data will be managed according to Zambian and U.S. regulations (45 CFR part 46) and ICH- 
GCP. Participants will receive a unique study identification number (PTID) that will be recorded on all study 
forms and interview transcripts. PTIDs will be maintained by the Population Council Field Coordinator, 
and a Screening and Enrollment Log will provide a link between participant name and PTID. The Screening 
and Enrollment Log will be stored in a secure, double-locked location in the Field Coordinator’s office, 

23 
 
separate from participant data. Hard-copy (paper) consent forms and contact information sheets 
containing personally identifying information will likewise be stored in a secure, limited-access location 
separate from participant data. Personal identifying information will be accessible only to key study 
personnel and will not be transmitted to RTI. 
All other data (transcripts) will be coded by PTID and will not contain any personal identifiers. The 
qualitative transcripts and audio files will be maintained as electronic records, which will be stored in 
encrypted, password-protected files, coded by PTID, and transmitted to RTI using a secure file transfer 
protocol (FTP) server. All electronic data and study databases will be stored on secure, password- 
protected computers in the project office computers, accessible by key study personnel only. 
5.0 Training and Qualifications of Personnel 
The team includes the Principal Investigator (PI) (Subramanian) who has led multiple studies related to 
integrated care delivery and on implementing best practices to scale up cervical cancer prevention for 
HIV- and HIV+ women. Dr. Sujha Subramanian has been working in close collaboration with the Zambian 
MOH to conduct a process evaluation of the Zambian Cervical Cancer Program. The Zambian Co- 
investigators (Co-Is) from the Population Council include Dr. Michael Mbizvo, Country Director, Dr 
Nkomba Kayeyi, an epidemiologist and demographer with extensive experience in managing large scale 
studies and field surveillance work in Zambia and Dr. Maurice Musheke, a social and behavioral scientist, 
who will continue to work on the study in an advisory role, while no longer full-time at the Council. Dr. 
Mbizvo, a professor who has trained public health and medical postgraduates, mentored and published 
in sexual and reproductive health and HIV prevention and care, is an expert in reproductive health, 
epidemiology and linkages between HIV and women’s health services, and Dr. Musheke has extensive 
experience conducting research on HIV testing, ART adherence, key populations and adolescent’s HIV care 
in Zambia. Ms Nachela Chelwa, a senior programme officer and public health specialist with expertise in 
qualitative and quantitative research methodologies and has conducted trainings and deployment of 
several field research assistants. Dr. Carla Chibwesha, Co-I from the University of North Carolina (UNC), 
is a clinician with extensive experience working in Zambia on the intersection of HIV and women’s health. 
Technical Advisors from the Zambia MOH include Dr. Sharon Kapambwe, who was instrumental in 
developing the Zambian cervical cancer screening program, Dr. Tina Chisenga, the Associate Director for 
Infectious Diseases and Dr Matilda Simpungwe, Assistant Director for Adolescents Health. RTI Co-Is are 
Dr. Georgiy Bobashev, who has been a collaborator on modeling projects with the PI for more than 10 
years and brings statistical and HIV modeling expertise; Dr. Sarah Roberts, who has expertise in 
implementing HIV research studies in Zambia; and Dr. Laura Nyblade, an expert in HIV stigma and 
discrimination among vulnerable groups, including AGYW. This team brings an extensive, intersecting, and 
multidisciplinary expertise to design and implement the proposed multilevel interventions to create a 
comprehensive HIV care continuum for AGYW. The team has well-established collaborations on the 
ground, including connections in the government health care sector, community organizations, and 
advocacy groups. To ensure the highest level of fidelity and adherence to the protocol, all data collectors 
will receive in-depth training and monitoring. 
A study coordinator, from among the existing Population Council staff will be in charge of coordinating 
data collection. She will be responsible for the day-to-day supervision of PNs; planning and coordination 
of fieldwork activities. 
Approximately 14 PNs will be recruited to the Population Council staff and will be responsible for leading 
youth club sessions and providing peer navigation across the participating communities. The PNs will have 
skills in conducting in-depth interviews and focus group discussions, and conversant in the two main local 
languages (Bemba and Nyanja) spoken in the study site. While many will have previous research 

24 
 
experience, they undergo a training program on conducting SHIELD sessions, stigma, clinic navigation, and 
research ethics, particularly on research with minors, prior to the start of data collection activities. PNs 
will also under training and receive certification for conducting mobile HIV counseling and testing (HCT) 
along with pregnancy testing. In addition to the PNs, 2 IWC clinic nurses will be hired to the UNC staff and 
will be responsible for facilitating the IWC clinic services, including HIV counseling and testing, HIV 
treatment and adherence counseling, contraception, pregnancy testing, HPV vaccination, along with 
making referrals for other services requested. The IWC clinic nurses will undergo training and will receive 
certification for HCT. 
In addition to study staff, we have also established a data safety monitoring board (DSMB), which includes 
5 Zambian experts or clinicians that work on adolescent health or HIV. The DSMB charter specifies the 
terms for project oversight, establishes regular DSMB meetings, and specifies the role of the DSMB in data 
monitoring. 
6.0 
Timeline 
The study timeline is presented in Exhibit 5. 
Exhibit 5. Project Timeline 

25 
 
 
 
 
 
 
 
 
 
 
References 
1. 
UNAIDS. (2016). HIV prevention among adolescent girls and young women. Retrieved from 
http://www.unaids.org/sites/default/files/media_asset/UNAIDS_HIV_prevention_among_adole 
scent_girls_and_young_women.pdf 
2. 
Wong, V. J., Murray, K. R., Phelps, B. R., Vermund, S. H., & McCarraher, D. R. (2017). 
Adolescents, young people, and the 90-90-90 goals: A call to improve HIV testing and linkage to 
treatment. AIDS (London, England), 31(Suppl 3), S191–S194. 
http://dx.doi.org/10.1097/QAD.0000000000001539 
3. 
Central Statistical Office (CSO) [Zambia], Ministry of Health (MOH) [Zambia], and ICF 
International. 2014. Zambia Demographic and Health Survey 2013-14. Rockville, Maryland, USA: 
Central Statistical Office, Ministry of Health, and ICF International. 
4. 
UNAIDS. (2017, July 19). HIV estimates with uncertainty bounds 1990-2016. Retrieved from 
http://www.unaids.org/en/resources/documents/2017/HIV_estimates_with_uncertainty_boun 
ds_1990-2016 
5. 
UNICEF. (n.d.) A report card of Adolescents in Zambia. Retrieved November 10, 2017, from 
https://www.unicef.org/zambia/A_Report_Card_Of_Adolescents_In_Zambia.pdf 
6. 
Republic of Zambia, Ministry of Health. (2016). Zambia consolidated Guidelines for Prevention 
and Treatment of HIV Infection. Lusaka, Zambia: Author. 
7. 
DREAMS. (n.d.). Zambia DREAMS Overview. Retrieved November 29, 2017, from 
https://www.pepfar.gov/documents/organization/253962.pdf 
8. 
Pediatric AIDS Treatment in Africa and Pride Community Health Organization. (2015, December). 
Promising Practices: One-stop adolescent shop: Delivering adolescent-friendly sexual and 
reproductive health, HIV and TB services. Retrieved from http://teampata.org/wp- 
content/uploads/2017/06/One-stop-adolescent-shop_WEB.pdf 
9. 
Mburu, G., Ram, M., Oxenham, D., Haamujompa, C., Iorpenda, K., & Ferguson, L. (2014). 
Responding to adolescents living with HIV in Zambia: A social–ecological approach. Children and 
Youth Services Review, 45, 9–17. http://dx.doi.org/10.1016/j.childyouth.2014.03.033 
10. 
Fwemba, I., & Musonda, P. (2017). Modelling adverse treatment outcomes of HIV-infected 
adolescents attending public-sector HIV clinics in Lusaka. Public Health, 147, 8–14. 
http://dx.doi.org/10.1016/j.puhe.2017.01.022 
11. 
Parham, G. P., Mwanahamuntu, M. H., Sahasrabuddhe, V. V., Westfall, A. O., King, K. E., 
Chibwesha, C., . . . Chi, B. H. (2010). Implementation of cervical cancer prevention services for 

26 
 
HIV-infected women in Zambia: Measuring program effectiveness. HIV Therapy, 4(6), 703–722. 
12. 
Mwanahamuntu, M. H., Sahasrabuddhe, V. V., Pfaendler, K. S., Mudenda, V., Hicks, M. L., 
Vermund, S. H., . . . Parham, G. P. (2009). Implementation of ‘see-and-treat’ cervical cancer 
prevention services linked to HIV care in Zambia. AIDS, 23(6). 
http://dx.doi.org/10.1097/QAD.0b013e3283236e11 
13. 
Liu, F. W., Vwalika, B., Hacker, M. R., Allen, S., & Awtrey, C. S. (2012). Cervical cancer and HPV 
vaccination: Knowledge and attitudes of adult women in Lusaka, Zambia. Journal of Vaccines & 
Vaccination, 3(138), 6816. 

27 
 
14. 
Subramanian, S., Nyambe, N., Hoover, S., Pender, L., Chibwesha, C., & Parham, G. (2017). 
Insights into the delivery of HPV vaccination, HIV services and cervical cancer screening in 
Zambia (RTI Working Paper). Research Triangle Park, NC: RTI International. 
15. 
WHO. (2016, June). Consolidated guidelines on the use of antiretroviral drugs for treating and 
preventing HIV infection: Recommendations for a public health approach (2nd ed.). Geneva: 
Author. 
16. 
Hudelson, C., & Cluver, L. (2015). Factors associated with adherence to antiretroviral therapy 
among adolescents living with HIV/AIDS in low- and middle-income countries: A systematic 
review. AIDS Care, 27(7), 805–816. http://dx.doi.org/10.1080/09540121.2015.1011073 
17. 
Sam-Agudu, N. A., Folayan, M. O., & Ezeanolue, E. E. (2016). Seeking wider access to HIV testing 
for adolescents in sub-Saharan Africa. [Review]. Pediatric Research, 79(6), 838–845. 
http://dx.doi.org/10.1038/pr.2016.28 
18. 
PEPFAR. (2016). PEPFAR Latest Global Results. Retrieved November 30, 2017, from 
https://www.pepfar.gov/documents/organization/264882.pdf 
19 
Kalibala, S., & Mulenga, D. (2011). Situation assessment of the HIV response among young 
people in Zambia. Geneva: UNAIDS. 
20. 
Abdool Karim, Q., Baxter, C., & Birx, D. (2017). Prevention of HIV in adolescent girls and young 
women: Key to an AIDS-free generation. JAIDS: Journal of Acquired Immune Deficiency 
Syndromes, 75(Suppl 1), S17–S26. http://dx.doi.org/10.1097/QAI.0000000000001316 
21. 
Shanaube, K., Schaap, A., Chaila, M. J., Floyd, S., Mackworth-Young, C., Hoddinott, G., . . . Ayles, 
H., & the HPTN 071 (PopART) Study Team. (2017). Community intervention improves knowledge 
of HIV status of adolescents in Zambia: Findings from HPTN 071-PopART for youth study. AIDS, 
31(Suppl 3), S221–S232. http://dx.doi.org/10.1097/QAD.0000000000001530 
22. 
Govindasamy, D., Ferrand, R. A., Wilmore, S. M. S., Ford, N., Ahmed, S., Afnan-Holmes, H., & 
Kranzer, K. (2015). Uptake and yield of HIV testing and counselling among children and 
adolescents in sub-Saharan Africa: A systematic review. Journal of the International AIDS Society, 
18(1), 20182. http://dx.doi.org/10.7448/IAS.18.1.20182 
23. 
Reddy, E. A., Agala, C. B., Maro, V. P., Ostermann, J., Pence, B. W., Itemba, D. K., . . . Whetten, K. 
(2016). Test site predicts HIV care linkage and antiretroviral therapy initiation: A prospective 
3.5 year cohort study of HIV-positive testers in northern Tanzania. BMC Infectious Diseases, 
16(1), 497. http://dx.doi.org/10.1186/s12879-016-1804-8 
24. 
Bauman, L. J., Braunstein, S., Calderon, Y., Chhabra, R., Cutler, B., Leider, J., . . . Watnick, D. 
(2013). Barriers and facilitators of linkage to HIV primary care in New York City. JAIDS: Journal of 
Acquired Immune Deficiency Syndromes, 64(Suppl 1), S20–S26. 
http://dx.doi.org/10.1097/QAI.0b013e3182a99c19 
25. 
MacPherson, P., Lalloo, D. G., Webb, E. L., Maheswaran, H., Choko, A. T., Makombe, S. D., . . . 
Corbett, E. L. (2014). Effect of optional home initiation of HIV care following HIV self-testing on 
antiretroviral therapy initiation among adults in Malawi: A randomized clinical trial. JAMA, 
312(4), 372–379. http://dx.doi.org/10.1001/jama.2014.6493 
26. 
Mwanahamuntu, M. H., Sahasrabuddhe, V. V., Kapambwe, S., Pfaendler, K. S., Chibwesha, C., 
Mkumba, G., . . . Parham, G. P. (2011). Advancing cervical cancer prevention initiatives in 

28 
 
resource-constrained settings: Insights from the Cervical Cancer Prevention Program in Zambia. 
PLoS Medicine, 8(5), e1001032. http://dx.doi.org/10.1371/journal.pmed.1001032 
27. 
WHO. (2016). Global consultation on lessons from sexual and reproductive health programming 
to catalyse HIV prevention for adolescent girls and young women. Geneva: Author. 
28 
Austrian, K., Hewett, P. C., Soler-Hampejsek, E., Bozzani, F., Behrman, J. R., & Digitale, J. (2016). 
Adolescent Girls Empowerment Programme: Research and evaluation mid-term technical report. 
Lusaka, Zambia: Population Council. 
29 
Hewett, P. C., Austrian, K., Soler-Hampejsek, E., Behrman, J. R., Kelly, C. A., Dela Kusi-Appouh, F. 
B., . . . Maimbolwa, M. (2014). Adolescent Girls Empowerment Programme: Research and 
evaluation baseline technical report. Lusaka, Zambia: Population Council. 
30. 
Welbourn, A. (1995). Stepping stones. A training package on HIV/AIDS, communication and 
relationship skills (Strategies for Hope Training, Series 1). London: ActionAid London. 
31. 
Skevington, S. M., Sovetkina, E. C., & Gillison, F. B. (2013). A systematic review to quantitatively 
evaluate ‘Stepping Stones’: A participatory community-based HIV/AIDS prevention intervention. 
AIDS and Behavior, 17(3), 1025–1039. http://dx.doi.org/10.1007/s10461-012-0327-6 
32. 
Steward, W. T., Sumitani, J., Moran, M. E., Ratlhagana, M. J., Morris, J. L., Isidoro, L., . . . 
Lippman, S. A. (2017). Engaging HIV-positive clients in care: Acceptability and mechanisms of 
action of a peer navigation program in South Africa. AIDS Care, 1–8. 
33. 
Winskell, K., Miller, K. S., Allen, K. A., & Obong’o, C. O. (2016). Guiding and supporting 
adolescents living with HIV in sub-Saharan Africa: The development of a curriculum for family 
and community members. Children and Youth Services Review, 61, 253–260. 
http://dx.doi.org/10.1016/j.childyouth.2015.12.017 
34. 
MacKenzie, R. K., van Lettow, M., Gondwe, C., Nyirongo, J., Singano, V., Banda, V., . . . Chan, A. K. 
(2017). Greater retention in care among adolescents on antiretroviral treatment accessing 
“Teen Club” an adolescent-centred differentiated care model compared with standard of care: A 
nested case-control study at a tertiary referral hospital in Malawi. Journal of the International 
AIDS Society, 20(3), e25028. http://dx.doi.org/10.1002/jia2.25028 
35. 
Kaufman, M. R., Cornish, F., Zimmerman, R. S., & Johnson, B. T. (2014). Health behavior change 
models for HIV prevention and AIDS care: Practical recommendations for a multi-level approach. 
JAIDS: Journal of Acquired Immune Deficiency Syndromes, 66(Suppl 3), S250–S258. 
http://dx.doi.org/10.1097/QAI.0000000000000236 
36. 
Mburu, G., Hodgson, I., Kalibala, S., Haamujompa, C., Cataldo, F., Lowenthal, E. D., & Ross, D. 
(2014). Adolescent HIV disclosure in Zambia: Barriers, facilitators and outcomes. Journal of the 
International AIDS Society, 17, 18866. http://dx.doi.org/10.7448/IAS.17.1.18866 
37. 
Denison, J. A., Banda, H., Dennis, A. C., Packer, C., Nyambe, N., Stalter, R. M., ... McCarraher, D. 
R. (2015). “The sky is the limit": adhering to antiretroviral therapy and HIV self-management 
from the perspectives of adolescents living with HIV and their adult caregivers. Journal of the 
International AIDS Society, 18, 19358. http://dx.doi.org/10.7448/IAS.18.1.19358 
38. 
Reed Johnson, F., Lancsar, E., Marshall, D., Kilambi, V., Mühlbacher, A., Regier, D. A., . . . Bridges, 
J. F. P. (2013). Constructing experimental designs for discrete-choice experiments: Report of the 
ISPOR Conjoint Analysis Experimental Design Good Research Practices Task Force. Value in 
Health, 16(1), 3–13. http://dx.doi.org/10.1016/j.jval.2012.08.2223 

29 
 
39. 
Indravudh, P. P., Sibanda, E. L., d’Elbée, M., Kumwenda, M. K., Ringwald, B., Maringwa, G., . . . 
Taegtmeyer, M. (2017). ‘I will choose when to test, where I want to test’: Investigating young 
people’s preferences for HIV self-testing in Malawi and Zimbabwe. AIDS (London, England), 
31(Suppl 3), S203–S212. http://dx.doi.org/10.1097/QAD.0000000000001516 
40. 
McGrady, M. E., Prosser, L. A., Thompson, A. N., & Pai, A. L. H. (2017). Application of a discrete 
choice experiment to assess adherence-related motivation among adolescents and young adults 
with cancer. Journal of Pediatric Psychology, Epub ahead of print. 
http://dx.doi.org/10.1093/jpepsy/jsx104 
41. 
Quaife, M., Eakle, R., Cabrera, M., Vickerman, P., Tsepe, M., Cianci, F., . . . Terris-Prestholt, F. 
(2016). Preferences for ARV-based HIV prevention methods among men and women, adolescent 
girls and female sex workers in Gauteng Province, South Africa: A protocol for a discrete choice 
experiment. BMJ Open, 6(6), e010682. http://dx.doi.org/10.1136/bmjopen-2015-010682 
42. 
Subramanian, S., Kaganova, Y., Zhang, Y., Hoover, Y., Nyambe, N., Pinder, L., ... Parham G. (2017) 
Patient preferences and willingness to pay for cervical cancer prevention in Zambia: Protocol for 
a multi-cohort discrete choice experiment (RTI Working Paper). Research Triangle Park, NC: RTI 
International. 
43. 
Mburu, G., Hodgson, I., Teltschik, A., Ram, M., Haamujompa, C., Bajpai, D., & Mutali, B. (2013). 
Rights-based services for adolescents living with HIV: Adolescent self-efficacy and implications 
for health systems in Zambia. Reproductive Health Matters, 21(41), 176–185. 
http://dx.doi.org/10.1016/S0968-8080(13)41701-9 
44. 
Bhoobun, S., Jetty, A., Koroma, M. A., Kamara, M. J., Kabia, M., Coulson, R., . . . Jacobsen, K. H. 
(2014). Facilitators and barriers related to voluntary counseling and testing for HIV among young 
adults in Bo, Sierra Leone. Journal of Community Health, 39(3), 514–520. 
http://dx.doi.org/10.1007/s10900-013-9788-4 
45. 
Subramanian, S., Nyambe, N., Hoover, S., Pender, L., Chibwesha, C., & Parham, G. (2017). 
Insights into the delivery of HPV vaccination, HIV services and cervical cancer screening in 
Zambia (RTI Working Paper). Research Triangle Park, NC: RTI International. 
46. 
Bandura, A. (1994). Social cognitive theory and exercise of control over HIV infection, In R. J. 
DiClemente & J. Peterson (Eds.). Preventing AIDS: Theories and Methods of Behavioral 
Interventions (pp. 25–29). New York, NY: Plenum Publishing Corp. 
47. 
Kamala, B. A., Rosecrans, K. D., Shoo, T. A., Al-Alawy, H. Z., Berrier, F., Bwogi, D. F., & Miller, K. S. 
(2017). Evaluation of the Families Matter! program in Tanzania: An intervention to promote 
effective parent-child communication about sex, sexuality, and sexual risk reduction. AIDS 
Education and Prevention, 29(2), 105–120. http://dx.doi.org/10.1521/aeap.2017.29.2.105 
48. 
Miller, K. S. (2013). Families Matter! Presexual risk reduction intervention. American Journal of 
Public Health, 103(11), e16–e20. 
49. 
Johnson R, Orme B. Getting the most from CBC. Sequim: Sawtooth Software Research Paper 
Series, Sawtooth Software. 2003. 
50. 
Hall, J., Kenny, P., King, M., Louviere, J., Viney, R., & Yeoh, A. (2002). Using stated preference 
discrete choice modelling to evaluate the introduction of varicella vaccination. Health 
Economics, 11(5), 457–465. http://dx.doi.org/10.1002/hec.694 

30 
 
51. 
Lancsar, E., & Louviere, J. (2008). Conducting discrete choice experiments to inform healthcare 
decision making: A user’s guide. PharmacoEconomics, 26(8), 661–677. 
http://dx.doi.org/10.2165/00019053-200826080-00004 
52. 
Hauber, A. B., González, J. M., Groothuis-Oudshoorn, C. G., Prior, T., Marshall, D. A., 
Cunningham, C., . . . Bridges, J. F. (2016). Statistical methods for the analysis of discrete choice 
experiments: A Report of the ISPOR Conjoint Analysis Good Research Practices Task Force. Value 
in Health, 19(4), 300–315. http://dx.doi.org/10.1016/j.jval.2016.04.004 
53. 
Goga, A. E., Singh, Y., Singh, M., Noveve, N., Magasana, V., Ramraj, T., . . . Sherman, G. G. (2017). 
Enhancing HIV treatment access and outcomes amongst HIV infected children and adolescents 
in resource limited settings. Maternal and Child Health Journal, 21(1), 1–8. 
http://dx.doi.org/10.1007/s10995-016-2074-1 
54. 
Ng’ambi, K. (2016). Provision of adolescent-friendly sexual and reproductive health (SRH) 
services integrated into HIV treatment and care. Journal of AIDS and HIV Infections, 2(2), 203. 
55. 
Nyblade, L., Stangl, A., Weiss, E., & Ashburn, K. (2009). Combating HIV stigma in health care 
settings: What works? Journal of the International AIDS Society, 12(1), 15. 
http://dx.doi.org/10.1186/1758-2652-12-15 
56 
ICAP at Columbia Mailman School of Public Health. (2012). Adolescent HIV care and treatment, A 
training curriculum for health workers. Retrieved from 
http://icap.columbia.edu/resources/detail/adolescent-hiv-care-and-treatment 
57. 
Menon, A., & Glazebrook, G. (2013, January). Randomized control trial to evaluate yoga-based 
peer support group for human immunodeficiency virus (HIV) positive Zambian adolescents. 
Journal of AIDS and HIV Research, 5(1), 12–19. 
58. 
Menon, A., Glazebrook, C., Campain, N., & Ngoma, M. (2007). Mental health and disclosure of 
HIV status in Zambian adolescents with HIV infection: Implications for peer-support programs. 
JAIDS: Journal of Acquired Immune Deficiency Syndromes, 46(3), 349–354. 
http://dx.doi.org/10.1097/QAI.0b013e3181565df0 
59. 
Cook, A. J., Delong, E., Murray, D. M., Vollmer, W. M., & Heagerty, P. J. (2016). Statistical lessons 
learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care 
Systems Collaboratory Biostatistics and Design Core. Clinical Trials, 13(5), 504–512. 
http://dx.doi.org/10.1177/1740774516646578 
60. 
Subramanian, S., Ekwueme, D., Gardner, J. G., & Trogdon, J. G. (2009). Developing and testing a 
cost-assessment tool for cancer screening programs. American Journal of Preventive Medicine, 
37(3), 242–247. http://dx.doi.org/10.1016/j.amepre.2009.06.002 
61. 
Trogdon, J. G., Ekwueme, D. U., Subramanian, S., & Crouse, W. (2014). Economies of scale in 
federally-funded state-organized public health programs: Results from the National Breast and 
Cervical Cancer Early Detection Programs. Health Care Management Science, 17(4), 321–330. 
http://dx.doi.org/10.1007/s10729-013-9261-z 
62. 
Subramanian, S., Tangka, F. K., Hoover, S., Degroff, A., Royalty, J., & Seeff, L. C. (2011). Clinical 
and programmatic costs of implementing colorectal cancer screening: Evaluation of five 
programs. Evaluation and Program Planning, 34(2), 147–153. 
http://dx.doi.org/10.1016/j.evalprogplan.2010.09.005 

31 
 
63. 
Subramanian, S. (2017). Cost-effectiveness of integrated HPV vaccination and screening: Impact 
on HIV and non-HIV infected women. In 11th International Conference on Cancer in Africa: 
AORTIC 2017 (p. 552). Available at http://aorticconference.org/wp- 
content/uploads/2017/10/2017-AORTIC-Abstracts.pdf