Reaching 90 90 90 in Adolescents in Zambia: Using All Our SKILLZ
Phase: NA
Conditions: HIV Infections, Pregnancy Related, STI, Mental Health Wellness 1
Sponsor: University of Alabama at Birmingham

0 
SKILLZ Protocol, v1.2a dated 20 August  2019 
 
 
 
 
Study Title: Reaching 90 90 90 in Adolescents in Zambia: Using all our SKILLZ 
 
Version 1.2a  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Short title:  
 
 
SKILLZ Study 
Protocol version:  
 
1.2a dated 20 August 2019 
Funder:  
 
 
U.S. National Institutes of Health 
Principal Investigator:  
Dr Carolyn Bolton Moore 
Co-Principal Investigator:  
Dr Nancy Padian  
 
 
 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
Table of Contents 
1. 
Introduction .................................................................................................................................. 4 
a. 
General information on the research issue/topic ........................................................................................ 4 
b. Overview of research and research gaps (contribution to policy and practice) ............................................. 4 
c. 
Overall purpose of the research and area/site where the research will be conducted .................................. 5 
2. 
Statement of the problem ............................................................................................................. 5 
a. 
Short summary of the background on the problem ..................................................................................... 5 
b. Importance of relevance of the research ..................................................................................................... 6 
3. 
Rationale/Justification .................................................................................................................. 6 
a. 
Contribution of the study to science or body of knowledge ......................................................................... 6 
b. Changes to be made by the study ............................................................................................................... 7 
c. 
Evidence supporting the justification .......................................................................................................... 7 
4. 
Theoretical/conceptual framework ............................................................................................... 8 
5. 
Literature review ......................................................................................................................... 12 
6. 
Research questions ..................................................................................................................... 13 
7. 
Research aim(s)/General Objective and Specific Objectives ......................................................... 14 
8. 
Methodology .............................................................................................................................. 14 
a. 
Study design ............................................................................................................................................ 14 
b. Study site and population/Research materials .......................................................................................... 16 
c. 
Selection of participants, sampling methods and sample size .................................................................... 17 
d. Data collection plan and tools .................................................................................................................. 19 
e. 
Data management and storage ................................................................................................................ 22 
f. 
Data analysis plan .................................................................................................................................... 23 
9. 
Ethical considerations ................................................................................................................. 25 
10. 
Timelines .................................................................................................................................... 27 
11. 
Budget ........................................................................................................................................ 27 
12. 
Appendices ................................................................................................................................. 28 
a. 
Letter of Permission from MOGE for GRS to continue working in schools in 2019 ...................................... 28 
b. MOU between GRS and MOGE ................................................................................................................. 29 
c. 
Letter of Permission between MOH and GRS ............................................................................................ 38 
13. 
References .................................................................................................................................. 42 
 
 
 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
 
 
 
Investigators and Collaborators  
 
 
Organization 
Role on Project 
FWA/SEV# 
Funding  
Carolyn Bolton Moore, MD, MSc Epi 
CIDRZ 
Principle Investigator  
FWA00005960 
See below  
Nancy Padian, PHD, MPH  
University of 
California, Berkeley 
Co-Principle Investigator  
FWA00006252 
Jenny Liu, PHD, MPP  
University of 
California, San 
Francisco 
Co-Investigator, Scientific 
Lead 
FWA00000068 
Jake Pry, MPH, PhD 
CIDRZ, Washington 
University 
Epidemiologist  
FWA00000338 
Jenala Chipungu, MPH 
CIDRZ 
Qualitative Analyst  
FWA00000338 
Helene Smith, MPH 
CIDRZ 
Implementation Scientist  
FWA00000338 
Taniya Tembo, MSc  
CIDRZ 
Costing Research 
Associate 
FWA00000338 
Boyd Mkandawire, MBA & MPH 
GRS  
Co-Investigator  
FWA002750 
Jeff DeCelles, EdM & DrPH 
GRS  
Co-Investigator  
FWA002750 
 
Chelsea Coakley, MPhil 
GRS  
Co-Investigator  
FWA002750 
 
 
Funding Information 
This work is supported by the US National Institute of Health via Grant Number 1R01MH116789-01A1 
 
Name of Funding Agency: US National Institute of Health (NIH) 
 
Principal Investigators: Dr Carolyn Bolton Moore, MD. MSc & Dr Nancy Padian, PHD, MPH   
 
FAIN #:  R01MH116789 
 
Title of Proposal: Reaching 90 90 90 in Adolescents in Zambia: Using all our SKILLZ (SKILLZ) 
 
Approval period: 25-AUGUST-2018 – 31-MAY-2023 
 
Ethical reviews by other institutions 
The protocol has been submitted for review to the Institutional Review Boards (IRBs) of the University of 
Zambia and the University of Alabama—Birmingham. 
 
 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
Funder’s Role 
The NIH’s role is non-engaged and will not include access to identifiable data. The NIH solely will provide 
funding for the activity. 
 
Acronyms  
AFS 
 
Adolescent Friendly Services 
ART 
 
Antiretroviral Therapy  
ARVs  
Antiretrovirals 
CIDRZ  
Centre for Infectious Disease Research in Zambia  
CRF 
 
Case Reporting Forms  
DHS 
 
Demographic Health Survey 
DMPA-SC 
Depo Medroxyprogesterone Acetate 
EMR 
 
Electronic Management Records 
FGD 
 
Focus Group Discussion  
GRS 
 
Grassroot Soccer 
HIV 
 
Human Immunodeficiency Virus 
HIVST  
HIV Self-Testing  
HTC 
 
HIV Testing & Counselling  
ICER 
 
Incremental Cost-Effectiveness Ratio  
IDI 
 
In-Depth Interview  
LIMS  
Laboratory Information Management System 
MOU  
Memorandum of Understanding 
MOGE  
Ministry of General Education  
MoH  
Ministry of Health 
NHC 
 
Neighborhood Health Committee  
NIH  
 
National Institute of Health 
QALY  
Quality-Adjusted Life Years 
ROI 
 
Return on Investment 
SBHP   
Sports-based HIV prevention programs 
SOC 
 
Standard of Care 
 
SRH 
 
Sexual Reproductive Health  
STI 
 
Sexually Transmitted Infection  
UAB 
 
University of Alabama 
VLS 
 
Viral Load Suppression 
YFHS  
Youth Friendly Health Services 
ZAMPHIA 
Zambia population-based HIV impact assessment 
 
 
 
 
 
 
 
 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
1. Introduction 
 
a. General information on the research issue/topic 
Zambia is struggling to meet the 95-95-95 targets for adolescent women. Despite available public health 
services, including free HIV testing, prevention, care and treatment, uptake of most health services 
amongst adolescents in Zambia remains suboptimal, especially for sexual and reproductive health (SRH).1,2 
HIV testing rates remain low; only 47.5% of girls and 28.5% of boys aged 15-19 years have received an HIV 
test and learned their results, compared to 86.6% of adult women and 69.1% of men.3 Preliminary results 
from the 2015-2016 Zambia population-based HIV impact assessment (ZAMPHIA) study show that 
adolescent girls and young women aged 15-24 years have higher rates of HIV infection compared to their 
male counterparts and that HIV prevalence among 20-24 year-olds is four times higher among females 
(8.6%) than males (2.1%).4 In addition, whereas over 70% of HIV-infected adults have achieved viral load 
suppression (VLS), only 34% of adolescent girls have.  To further support  95-95-95 targets, contraception is 
considered the most cost-effective strategy to reduce the burden of mother-to-child HIV transmission 
among women living with HIV who wish to prevent unintended pregnancy.5 The most recent Demographic 
Health Survey (DHS)  showed that while 73.3% of unmarried, sexually active adolescent girls reported not 
wanting a child in the next two years, only 20.6% were using any contraceptive method to prevent 
pregnancy.3  Further to this, approximately 7.2% of sexually active adolescents (aged 15-19) reported 
having had a sexual partner who was 10 or more years older3, placing them at an increased risk of HIV 
infection and early child-bearing6 and the Ministry Of General Education (MOGE) has recorded a five-fold 
increase in teenage pregnancies among girls in grades 1-12 between 2002 and 20157. The Government of 
Zambia has recognized that this data clearly points to the need to increase adolescents’ awareness and 
utilization of available health services and ensure innovation in the way these messages are delivered.  
 
b. Overview of research and research gaps (contribution to policy and practice) 
 
In a review of adolescent-specific service delivery programs over 2001-2014,8 only 11 studies were 
identified that addressed the HIV treatment cascade among adolescents, none of which met criteria for a 
rigorous, adequately powered, longitudinal program. Although the evidence base is thus weak, programs 
that are easily accessible, and provide integrated services and peer counseling were highlighted as 
promising strategies. Recent research from the Southern African region has shown that effective programs 
for suppressing viral load in adolescents focus on quality of clinical services, including adequate drug 
inventory, dedicated staff time for adolescents, staff who are kind and non-judgmental, funded 
mechanisms for adolescent clinical accompaniment.9 Little research has been done as to what effect these 
programs could have on uptake of contraceptive services and whether a more holistic approach with a 
more integrated program (encompassing contraception, distribution of commodities, and the availability of 
HIV self-testing kits) could provide improved HIV-testing uptake as well as uptake of other contraceptive 
services.   
 
We therefore seek to evaluate an enhanced school-based intervention for girls aged 16 and over that 
combines the innovative demand-generating sports-based program for empowering adolescent girls, 
supported by Grassroot Soccer (GRS) combined with adolescent-friendly clinical services (SKILLZ-girl and 
enhanced SKILLZ-girl) delivered through a combination of community and facility-based approaches. The 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
SKILLZ Package removes barriers to services across multiple levels of influence by creating a fun, interactive 
environment for meaningful discussions and reflection about SRH, future orientation, and goal-setting (see 
Figure 1) using a school-based curriculum, peer mentorship, community soccer events and enhanced 
events, and referrals for and direct service provision. The program also provides opportunity for ongoing 
engagement with all enrolled girls (regardless of HIV status) through the form of school-based clubs that 
provide on-going discussion around positive messages of empowerment, strategies to prevent STI infection 
(including HIV), and direct linkages to access for contraceptives and repeat HIV testing. A rigorous, mixed 
methods evaluation will assess the effectiveness of this intervention following a cohort of enrolled girls 
over two years.   
 
The findings from our research will be shared with both the Ministry of Health (MoH) and MOGE and will 
guide Zambia’s national strategic plan for improved uptake and retention of SRH services by adolescents. 
We are working closely with these partners and Lusaka District Education Board Secretary to pave the way 
for complete integration of the SKILLZ Package into the public education system should this intervention 
prove effective. Our team will work closely with the MOH and MOGE throughout study implementation to 
ensure that services are integrated, streamlined and sustainable as well providing guidance on sustainable 
forms of distribution at the community level.  
 
c. Overall purpose of the research and area/site where the research will be conducted 
 
As part of routine activities, GRS is already implementing an approved, school-based curriculum at the 
majority of secondary schools in Lusaka however, it is unclear as to whether this curriculum, in itself, will 
improve health seeking behaviors and ultimately decrease HIV infection and unintended pregnancies 
amongst this high-risk group.   
 
The overall purpose of the research is to assess the impact of the enhanced SKILLZ GIRL Package, including 
different components of the program aimed at both HIV-infected and uninfected adolescent school girls 
over two years on the outcomes of (1) HIV testing and subsequent retention in care, and (2) contraceptive 
uptake and continuation for pregnancy prevention. We will also assess the impact of school-based SKILLZ 
clubs, on 1) HIV testing and subsequent retention in care, and (2) contraceptive uptake and continuation 
for pregnancy prevention. The study will take place across several high density population areas of Lusaka 
where CIDRZ supports government MoH clinics with ARV services, electronic data management, and 
youth-friendly trained clinical personnel and where GRS has been implementing their basic SKILLZ 
curriculum and events in secondary schools. 
 
2. Statement of the problem 
 
a. Short summary of the background on the problem 
As mentioned above, the ZAMPHIA study showed that adolescent girls and young women have very high, 
disproportionate rates of HIV infection with a prevalence among 20-24 year-olds four times higher than 
that seen in males.4 According to DHS, girls in Zambia have a sexual debut at 13 years of age, highlighting 
the need for early educational and behavioral interventions. Empowering girls and giving them access to 
SRH and broader health related information remains a key strategy to reducing risk of HIV acquisition and 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
encourages more positive health seeking behavior as part of a comprehensive health care package. Whilst 
many adolescent programs are based on the premise that understanding risk and providing adolescent-
friendly services (AFS) translates into participation along all steps in the SRH care cascade, this is not 
always the case. AFS are necessary, but insufficient; furthermore, the link between risk and uptake of AFS 
is tenuous. Compared to individuals at other life stages, adolescents are more likely to engage in novelty-
seeking and risky behaviors and less likely to consider the consequences as they transition to adulthood 
and assume more independence and responsibility.10-15  
b. Importance of relevance of the research 
Strong evidence for what works for improving SRH outcomes among adolescent in resource-poor, but high 
disease burden settings remains poor despite the plethora of studies and investments into SRH 
programming. For example, guidelines in a 2016 WHO review of recommendations for care of HIV-positive 
youth were based on “low” and “very low” quality evidence, strongly suggesting the need for greater 
research.16 Similarly, in a recent report, the Institute of Medicine concluded that there is a lack of evidence 
for effective models of adolescent health care and a need for further research, particularly on how health 
services are delivered and by whom.17 Although a systematic review of sports-based HIV prevention 
programs (SBHP) has found evidence for effects on a range of social and behavioral outcomes (i.e., reduced 
stigma, increased self-efficacy, HIV-related knowledge, uptake of HIV testing a counselling (HTC), and 
condom use)18, rigorous evaluations that can attribute causality and verify pathways for change are 
lacking.18,19 As mentioned previously, GRS has already been rolling out a validated SKILLZ girl curriculum. In 
collaboration with their team, we have developed an enhanced curriculum which includes a 
comprehensive module on HIV self-testing, contraceptive choices and pre-exposure prophylaxis (PrEP) 
combined with increased access to these services through an enhanced soccer event.  
In this study, we are proposing a pragmatic trial (based on real-world implementation) that will provide a 
robust evaluation of effectiveness and cost-effectiveness (CE) between a standard SKILLZ- girl curriculum, 
that has been delivered in many Lusaka secondary schools already, and a more robust, integrated, 
enhanced approach that includes additional SRH service offerings, including HIVST, PrEP and an expanded 
contraceptive method mix.   
3. Rationale/Justification 
a. Contribution of the study to science or body of knowledge 
Few prospective studies have been conducted in sub-Saharan Africa (SSA) among adolescent girls to gauge 
uptake of SRH services, including contraception uptake and continuation and HIV testing, adherence and 
retention in care. Lall et al. reviewed 26 studies on adherence to and retention in care among HIV-positive 
youth and adolescents, but none were conducted in SSA.20 Another review examined data from nine 
studies in SSA, but all were cross sectional and only one used viral load to assess HIV treatment adherence 
(as opposed to self-report).21 Specifically, in Botswana, Lowethal et al. reported that 77% of 692 youth 
were virally suppressed, but again this was cross-sectional.22 Finally, a third review examined data from 53 
countries and reported higher ART adherence rates among African adolescents 84% (95% CI 79–89; I2:93%) 
compared to other regions of the world, but this too used cross-sectional data.23 Furthermore, no studies 
have examined contraceptive continuation among adolescents, despite the burden of early pregnancy 
among young girls during their critical years in the transition to adulthood. 
 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
b. Changes to be made by the study 
In Zambia, SRH services for adolescents remains a challenge with services primarily being provided through 
main-stream, clinic-based services. Uptake of both prevention and curative services remain low. For 
example, adolescents disproportionately contribute to the number of new HIV infections each year3. 
Standard of Care (SOC) for SRH and HIV services designed specifically for adolescents is scant and includes 
provision of basic SRH/HIV education, including HTC in schools by trained health workers and referral for 
other prevention services to general (mainly adult) ART/ SRH clinics. Adolescent girls found to be HIV-
infected are also referred to these clinics for treatment and other services, however adherence and 
retention in care is low with only 34% reported to be virologically suppressed4.   Furthermore, access to 
contraceptive services including long-acting methods is largely limited to clinical settings where 
adolescents face stigma (perceived and actual) from healthcare workers and risk lapses in 
confidentiality24,25.  
 
Our central hypothesis is that an enhanced SRH curriculum (including a comprehensive module on HIVST, 
contraceptives and PrEP) and the additional offering of HIVST and contraceptive services at the event along 
with ongoing engagement the SKILLZ-Club program (Enhanced Arm) , will increase HIV testing and 
contraceptive uptake compared to the standard SKILLZ curriculum & standard event (SOC Arm). 
Furthermore,  supporting subsequent ongoing education as well as linkage to services through SKILLZ 
school clubs in the enhanced arm will improve ongoing uptake of services and retention and will allow us 
the opportunity to measure the effect of the intervention longitudinally. We further hypothesize that our 
intervention will positively and directly affect a number of mediating factors: attendance to soccer events 
where community-based SRH services are offered, SRH knowledge, empowerment, self-confidence, and 
perceptions of gender balance, and (reduced) stigma. For girls found to be HIV-positive, we further expect 
the follow-on SKILLZ intervention (SKILLZ-Plus) aimed at linkage to HIV care and treatment, will reduce HIV-
related stigma, increase disclosure to family and partners, increase feelings of social support, 
empowerment, self-efficacy, and ultimately adherence to ARVs, viral load suppression (VLS) and retention 
in HIV care and treatment.  
 
The SKILLZ program trains young adult mentors (“Coaches”) as community change agents that deliver age-
appropriate, gender-transformative curricula through a pedagogical approach that combines soccer 
metaphors and activities with accurate health information. The aim is to build the health and social assets 
of adolescents, facilitate access to health and social services, and support adherence to medical treatment 
and positive protective behaviors.  
 
c. Evidence supporting the justification 
Adherence to protective behaviors, treatment and psychosocial support for adolescents remains 
inconsistent. Care services are largely inefficient, ineffective and undifferentiated, lack psychosocial 
support elements, and rely on ineffective referral mechanisms between the schools and health facilities.26 
Our soccer-based SKILLZ Package has already demonstrated proof-of-concept, increasing knowledge about 
key risk factors (i.e., age disparate relationships and multiple partners) and changing harmful attitudes 
related to stigma and gender issues.27 In 2010-2012, GRS also analyzed the SKILLZ program compared to 
sub-regional DHS data, showing that among 11,000 youth (males and females) participants in Zambia, 62% 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
tested for HIV, 100% learned their HIV test results, and 95% of those testing positive for HIV were linked to 
care.28 Accompanying qualitative research also revealed high program acceptance by parents, health 
providers and adolescents themselves, although the sentiment to have a girl-only program were salient. At 
that time, the program was linked to only one clinic, no formal evaluation was employed with a meaningful 
clinical outcome (i.e. viral load), and little focus on pregnancy prevention, contraceptive use, and more 
general SRH risks were measured.  
4. Theoretical/conceptual framework for Grassroot Soccer SKILLZ Curriculum 
The SKILLZ Package is based on a multi-level socio-ecological conceptual framework of HIV-related 
behaviors and outcomes among adolescent girls (see Figure 1).29,30  Barriers to accessing services and 
adhering to risk reduction strategies through the continuum of care exist across all levels of influence: 
individuals may hold fears and misconceptions of HIV and suffer from stigma surrounding adolescent 
sexuality; fears and anxiety can lead to a lack of social support from partners and peer groups that would 
otherwise be protective; families and communities are often the source of perceived stigma, and further 
reinforce inequitable gender and social norms that amplify girls’ vulnerability; health systems are often 
inaccessible and unfriendly to young people.31-33 These myriad factors collide to prevent adolescent girls 
from reducing risk, accessing HIV and SRH services, and remain in care over the longer-term.  
Figure 1. To improve HIV testing, linkage to treatment, and retention in care, SKILLZ targets multiple barriers to service utilization based on a 
socio-ecological approach to adolescent health. 
 
The SKILLZ Adolescent SRH program (SKILLZ Package) aims to improve uptake of HIV testing, treatment 
and adherence and SRH services among adolescent girls. The model focuses on removing barriers to critical 
services by creating a fun, interactive environment for meaningful discussions and reflection (see Figure1).  
Designed to be integrated into both secondary school education and clinical services, the SKILLZ Package is 
unique in that it offers holistic and continued support to adolescent girls through several avenues. First, it 
focuses on agency and empowerment by providing mentorship as well as accurate sexual health 
information with a trained age-peer coach. Second, the SKILLZ Package provides direct linkages to facility-
based, youth-friendly care, leveraging existing community- and facility-based resources. Third, the SKILLZ 
Package ensures that comprehensive sexual and reproductive health education and services are 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
continuously given, including a focus on pregnancy and HIV prevention, the two largest risks that 
adolescent girls face in their pursuit of security and independence in adulthood. 
The SKILLZ Package entails three integrated programs that work together to build a continuous support 
system that not only encourages uptake of contraceptive and HIV services, but also adherence and 
continued engagement with health services over the long-term (whether to contraceptive methods, HIV 
repeat testing, preventive services such as PREP and/or HIV treatment and care). 
1. 
SKILLZ-Girl is a school-based program that provides adolescent girls (aged 16 and over 
regardless of HIV status) with a 10-12-week, soccer-based comprehensive sexuality and SRH 
education curriculum; gender and power dynamics in relationships are also addressed. This 
program is run during extra-curricular hours as part of the school syllabus. The program 
culminates in a soccer tournament where girls are provided the opportunity to access 
community-based SRH services offered at mobile clinics, including testing for HIV. The 
program was originally piloted in Zambia in 2015. Permission to continue to run the 
program was most recently granted in 2019 by the MOGE 
2. 
Enhanced SKILLZ-Girl is based on the curriculum described however we have modified the 
regular SKILLZ-Girl curriculum to include a focused module on HIVST, PrEP and 
contraception. In our study we will be comparing the ‘regular’ SKILLZ girl curriculum with 
this ‘enhanced curriculum. The enhanced curriculum is based on the same premises and 
methodology as SKILLZ-girl.  
 
Both SKILLZ-Girl and SKILLZ-Girl enhanced focus on building adolescent girls’ health and social 
assets, culminating in a soccer tournament to address detrimental social norms and attitudes 
towards girls and disrupt traditional service delivery models with several salient features: 
 Building individual self-efficacy, empowerment and future orientation through the 
SKILLZ-Girl and enhanced curriculum: A series of 10-12 x 1.5-hour sessions will be 
delivered by coaches (1 coach for every 25 girls) over approximately 12 weeks at school 
during normal school hours. The curriculum validates experiences of puberty and 
sexuality while building life skills and other critical assets that are broadly applicable to 
many spheres of girls’ lives. It provides a link to a range of behavioral outcomes 
including stigma prevention, SRH and contraception, all designed to create an integrated 
health package for young women. The curriculum culminates in a soccer event where 
participants will be offered an opportunity to either test for HIV at the event or 
(depending on intervention arm) take home a HIVST kit, take up a contraceptive method 
or be assessed for uptake of PREP.   The Permanent Secretary for MOH has provided 
support to conduct this assessment particularly in improving access to PREP for at-risk 
adolescent girls (see Appendix C).   
 
3. 
Following the community soccer event, in the enhanced arm, all girls (regardless of HIV or 
testing status)  will be invited to participate in SKILLZ-Club. These school-based clubs are run 
in the afternoons during extra-curricular hours and provides students with an opportunity to 
continue to engage in a deeper discussion about SRH, empowerment, HIV prevention and 
HIV testing. SKILLZ-Club also focuses on contraception initiation and continuation as a tool 
for future planning, self-care and empowerment. It also includes participation in a 
community change project that continues to build self-efficacy and agency. The club is an 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
ongoing activity that students can participate in until they leave or graduate from school. 
Girls participating in the SOC Arm (SKILLZ-Girl) are able to join any of the other clubs 
currently offered at their school (SOC Clubs). 
 
Clubs have been operating in schools in Zambia since 2017 with the MOGE’s consent as part 
of the Memorandum of Understanding (MOU) signed in 2010 (see Appendix B). The CLUB 
component is currently evolving to include a more formalized education component, and 
will be piloted in Zambia at the same time as this evaluation.  
 
4. 
All girls who test positive for HIV (whether prior to the SKILLZ-Girl event, during the event or 
as part of their participation in SKILLZ-Club) are referred to SKILLZ-Plus, a clinic-based 
initiative which provides HIV-infected girls access to ongoing support through a 12-week 
curriculum. During follow-up in the SOC Club arm, study staff will refer any newly identified 
HIV-positive girls to SKILLZ-Plus. In additional, study staff will refer newly diagnosed girls 
aged 16 years from neighboring clinics to the SKILLZ-Plus intervention.        
For girls who test positive for HIV, either through a:   
1. school referral either at the event, during club participation, are identified during 
follow-up or with a previously known diagnosis or 
2. clinical referral (newly diagnosed only)    
In addition, all girls found to be HIV-positive at any point throughput the SKILLZ-Program will 
be provided with intensive counselling support. Coaches will facilitate a family visit to 
facilitate disclosure and work with CIDRZ networks to provide additional psycho-social 
support as needed on a case-by-case basis by the participant.   
SKILLZ-Plus provides several additional features: 
 Enhanced linkage to care: HIV+ positive girls are matched with trained coaches (~6 girls 
per coach) who use soccer-based activities to guide participants through issues such as 
acceptance, disclosure, healthy living and adherence. The coach will be responsible for 
providing the girl with the support and the guidance she needs to access ART services at 
MoH clinics. This support will include both psychological support and logistical (i.e. 
where to go, who to see, the expected outcome of each visit, etc.) The program consists 
of 12 modules (conducted during intensively over approximately 6 weekends) that 
address different aspects of living with HIV delivered in a private, confidential and non-
judgmental platform at the clinic, to individuals, during regular clinic visits. The 
curriculum for HIV+ girls encourages girls to have discussions about living with HIV, to 
make healthy life decisions, to work to achieve their goals, and to become positive role 
models within their community. SKILLZ-PLUS received written support from MOH in 
2013 (see Appendix C).  
 Ongoing peer support for six months through monthly interactions and virtual forums. 
 After graduation from SKILLZ-Plus, HIV-infected adolescent girls will be linked to support 
groups, which meet twice every month at health facilities when they go for clinical visits 
or drug refills.  
 All SKILLZ-Plus groups are led by GRS trained coaches.  
 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
CIDRZ will work closely with the MOH to ensure adolescent services are available. To accomplish this, 
CIDRZ will support a hybrid model of community-based services and clinic-based adolescent-friendly clinics 
to meet the specific demands of adolescents including HIV testing, SRH services and stigma-reducing 
initiatives. In addition to existing testing venues, HIV testing and mobile SRH services will be offered on site 
during and after the tournament and a trained nurse will available to provide a larger set of SRH services 
including issuing of contraceptives (including injectables, pills, and barrier methods, emergency 
contraception), pregnancy tests, and STI diagnosis and treatment (pending availability of supplies). All 
supplies will be obtained from MoH medical stores, through established mechanisms.  
 
Within SKILLZ-Girl and SKILLZ-Club, our study will examine the additional benefits of offering access to two 
new health service offerings that are expressly designed to overcome barriers to uptake especially difficult 
for adolescents to overcome—HIV self-testing (HIVST) kits and access to an expanded method mix for 
contraceptive methods. Referral for contraceptive and SRH services will be made to the PEPFAR-funded 
DREAMS Houses or youth corners at local government facilities which are located within close distance to 
all schools where the SKILLZ package will be implemented.   
 
Our mixed-methods evaluation will assess the effects of the enhanced SKILLZ offering (SKILLZ-Girl 
Enhanced & SKILLZ Club programs)  compared to the SOC SKILLZ offering of SKILLZ-Girl only. Although the 
SKILLZ Program (Enhanced or SOC pending school allocation) will be offered to all girls enrolled in Grade 10 
at selected study secondary schools, only girls aged 16 and over at the commencement of SKILLZ-Girl will 
be enrolled into the research study.  
 
We will examine outcomes for school girls aged 16 and over enrolled in Grade 10 at the start of the 
intervention in up to 16 schools where the SOC SKILLZ Package is offered, compared to outcomes in up to 
16 schools where the enhanced SKILLZ-Package is offered, including HIVST, the availability of expanded 
contraceptive services and the SKILLZ-Club following completion of SKILLZ-Girl. Therefore, all schools will 
be preassigned prior to the intervention into the following 2 categories (see Figure 3 in Section 8 - 
Methodology below). 
 
1. SOC: SKILLZ-Girl  Club SOC  
2. ENHANCED: SKILLZ-Girl enhanced  SKILLZ-Club  
 
Our central hypothesis is that the additional offering of HIVST and contraceptive services in an enhanced 
SKILLZ-Girl combined with the SKILLZ-Club offering will increase HIV testing and contraceptive uptake and 
continuation.  
In addition to SKILLZ-Girl and SKILLZ-Club, girls testing HIV-positive at any time during the study 
intervention period will be additionally offered to participate in the SKILLZ-Plus facility-based curriculum 
for HIV-infected adolescents. The effect of the SKILLZ-Plus curriculum will be tested using a SmartCare-
derived matched (i.e., on clinic, age, ART start date and gender) population.   
The impact of the SKILLZ Package on our primary outcomes—HIV testing and its care sequelae and 
contraceptive use—is likely to be moderated by girl’s sociodemographic characteristics, such as age, SES 
status, and her home environment (i.e., siblings, parental HIV status).  

12 
SKILLZ Protocol, v1.2a dated 20 August  2019 
5. Literature review 
While historically overlooked, the consequences of neglecting to provide adolescents with strong SRH 
services and potentially causing a painful or damaging transition into adulthood are now well understood. 
For adolescent girls, pregnancies are much more likely to be high risk. Early pregnancies can also 
compromise their ability to complete their education, creating a knock-on effect to their future economic 
earning potential34. They also face an increased risk of exposure to HIV and sexually transmitted infections 
(STIs) as well as being involved in sexual coercion, and acts of gender-based violence35. Obstacles to 
receiving access to AFSRH services include inadequate social support, stigma, and detrimental gender and 
social norms associated with adolescent sexuality including high rates of intergenerational sex and intimate 
partner violence.36-41 Health care workers often judge, reprimand and may also deny SRH services to 
adolescents because they believe they are too young to engage in sexual activity.42 These issues are 
magnified for HIV-infected adolescents, where, unlike other chronic diseases among young people, 
adolescent HIV infection is set apart as a highly stigmatizing disease during a developmentally sensitive 
time when transitions in self, body and health care are at play.43 
The most recent Demographic Health Survey (DHS) showed that while 73.3% of unmarried, sexually active 
adolescent girls reported not wanting a child in the next two years, only 20.6% were using any 
contraceptive method to prevent pregnancy and only 40.4% of sexually active adolescent girls aged 15-17 
had had an HIV-test in the last 12 months3. The report also indicated that by age 19, more than a third of 
Zambian adolescent girls report having experienced sexual violence from a male partner and by age 18, a 
third have been pregnant.3 Furthermore, programmatic data from CIDRZ suggest almost 50% of HIV-
infected adolescents that know their status drop out of care within two years of initiating ART. 
Cultural factors, such as the widespread belief in Zambia that a girl or woman should not say no to sex or 
propose the use of a condom, have obvious consequences to a poor understanding and access to SRH 
services.44 These barriers to accessing services and adhering to risk reduction strategies exist across all 
levels of influence: individuals may hold fears and misconceptions of HIV and suffer from stigma 
surrounding adolescent sexuality; fears and anxiety can lead to a lack of social support from partners and 
peer groups that would otherwise be protective; families and communities are often the source of 
perceived stigma, and further reinforce inequitable gender and social norms that amplify girls’ 
vulnerability; health systems are often inaccessible and unfriendly to young people.31-33  These myriad 
factors collide to prevent adolescent girls from reducing risk, accessing HIV and SRH services, and remain in 
care over the longer-term.  
There is however increasing access to cost-effective and easy to use long-acting methods of contraception 
such as the 3-month intramuscular administrated depo medroxyprogesterone acetate (DMPA-SC). This has 
been specifically designed to overcome some of the major barriers to contraceptive use, including difficulty 
in accessing facility-based SRH services. Research to date has consistently demonstrated its safety, 
effectiveness and acceptability to both users and health care providers45 46,47. Furthermore, use of a 
contraceptive method has been associated with an increased likelihood to be tested for HIV and a decrease 
in high-risk sexual behaviors48.  Unfortunately contraceptive failure and discontinuation is more common 
amongst adolescent girls than among older women49 and only 20.6% of sexually active adolescent girls 
who reported not wanting to become pregnant reported that they were using any contraceptive method 
to prevent pregnancy.3 While DMPA-SC is currently being scaled up in over 22 countries around the world, 
including Zambia, the national strategy for Zambia does not provide specific plans for addressing the SRH 
needs among adolescent girls. Thus, there is an urgent need to fill this gap and identify effective strategies 

13 
SKILLZ Protocol, v1.2a dated 20 August  2019 
for ensuring health equity whereby adolescent girls have access to the same expanded contraceptive 
method mix in Zambia. 
HIVST is another recent technological innovation that has emerged as a promising strategy to provide 
individuals with an opportunity to test while bypassing some of the stigmatizing concerns of the clinical 
environment that are especially salient among adolescents. A pilot study amongst adolescents in South 
Africa using HIVST found fidelity to be very high (96.4%), with participants reporting high rates of  
acceptability and usability50.  
A review of adolescent-specific service delivery programs over 2001-2014,8 only 11 studies were identified 
that addressed the HIV treatment cascade among adolescents, none of which met criteria for a rigorous, 
adequately powered, longitudinal program. Although the evidence base is thus weak, programs that are 
easily accessible, and provide integrated services and peer counseling were highlighted as promising 
strategies. 
Programs integrating contraceptive services and HIV prevention and testing have showed promising results 
for reaching adolescent girls. A recent Teenage Pregnancy Prevention Program in South Africa showed 
improved attitudes amongst its participants, including plans to communicate with partners about teenage 
pregnancy and increased reports of condom use in those that were exposed to the intervention51.  A Youth 
Friendly Health Service (YFHS) model in Malawi offering contraception alongside HIV-testing supplies, and 
using a curriculum based on gender empowerment and self-efficacy, led to higher health services 
utilization, including uptake of HIV testing services, condoms and hormonal contraception52.   
GRS has shown that soccer-based interventions combined with strong school and community partnerships 
and referral networks can change behaviors and make a significant impact on the health of young people.53 
In 2009 in South Africa, GRS piloted the SKILLZ-Girl program which addresses the unique needs of young 
women and adolescent girls. This program was then scaled in South Africa and expanded further into 13 
countries in SSA. A recent evaluation of the SKILLZ-Girl program showed that participants significantly 
improved their knowledge and attitudes surrounding HIV risk for young women, negotiation skills, and 
sense of self-efficacy. In fact, 68.5% of girls that participated in the SKILLZ-Girl program underwent testing 
for HIV at the conclusion of the school-based curriculum.54 Although SKILLZ-Girl has now served over 
26,000 girls in 14 countries, it has never been rigorously evaluated for cost effectiveness and effectiveness. 
6. Research questions 
Our mixed-methods evaluation aims to assess the effect of the enhanced SKILLZ- girl on HIV testing and 
SRH related prevention services uptake (Aim 1), the effect of SKILLZ-Plus on HIV retention to care and VLS 
amongst HIV-infected girls (Aim 2) and identify mediating pathways and moderating factors leading to 
observed effects (Aim 3). Aim 3 will also assess the cost-effectiveness of the SKILLZ Package. 
Our research questions are thus: 
a. What is the impact of enhanced SKILLZ-Girl vs regular SKILL-girl curriculum on HIV testing uptake 
among adolescent girls (aged 16 and over) over a 24-month period? 
b. What is the impact of enhanced SKILLZ-Club on HIV testing uptake among adolescent girls (aged 16 
and over) over a 24-month period? 
c. Among HIV-positive adolescent girls, what is the impact of the SKILLZ-Plus intervention on: 
a. retention in care and treatment at 6, 12, and 24 months  
b. viral load suppression at 12 months? 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
d. What specific barriers to access to services do the SKILLZ interventions (SKILLZ Girl, enhanced 
SKILLZ-girl, SKILLZ-Club & Plus) overcome? 
e. What are the mediators of the observed effects? 
f. What are the moderators of the observed effects? 
g. To what degree was the intervention implemented per protocol (fidelity)? 
h. What is the short- and long-term cost-effectiveness of the SKILLZ Package intervention? 
 
7. Research aim(s)/General Objective and Specific Objectives 
Aim 1: Assess the impact of SKILLZ over two years on:  
(i) (a) HIV testing and (b) SRH-related prevention services uptake among adolescent girls aged 16-19 in 
up to 9 intervention schools (with enhanced HIVST, PrEP, and contraceptive method offerings) 
compared to up to 9 control schools using a quasi-experimental difference-in-difference approach; 
and 
 
(ii) linkage to care and treatment, and viral load suppression and retention at 6, 12, and 24 months 
through a cohort model using pre-existing SmartCare data on HIV+ individuals in care to match to 
adolescent girls aged 16 and over from the same district (Lusaka) who are identified to be HIV+ at any time 
during SKILLZ Girl or SKILLZ Club participation and enrolled in SKILLZ-Plus. 
 
This will be achieved by i) using a quasi-experimental difference-in-difference approach that compares girls 
aged 16 and over in 9 SKILLZ control schools compared to 9 schools where enhanced SKILLZ will be delivered 
with the enhanced HIVST and a variety of contraceptive method offerings; and ii) through a cohort model using 
pre-existing SmartCare data on HIV+ individuals in care to match to adolescent girls aged 16 and over from the 
same district (Lusaka) who are identified to be HIV+ at any time during SKILLZ-Girl or SKILLZ-Club participation. 
 
Aim 2: Examine how the intervention works including lessons learned for future implementation by  
 
(i) conducting a process evaluation to identify mediators, predictors, and barriers to uptake of 
the SKILLZ-Girl, Club, and Plus curricula both quantitatively through mediation and 
moderation analyses and qualitatively through a sequential explanatory approach using 
focus groups discussions, interviews and observation with coaches and girls; and by 
(ii) monitoring fidelity 
 
 
Aim 3: Estimate the short- and long-term cost-effectiveness and return on investment of the SKILLZ Girl, 
Club, and Plus curricula for improving health outcomes for adolescent girls. 
 
8. Methodology 
a. Study design 
We will conduct a mixed-methods evaluation of the SKILLZ intervention using the following approaches: 
A quasi-experimental cohort of school-aged 16-year old and over females to be followed for a two-year 
period will be evaluated with a difference-in-difference (DID) approach to estimate HIV testing uptake and 
sexual/reproductive health services use. Primary and secondary outcomes will be measured at several 

15 
SKILLZ Protocol, v1.2a dated 20 August  2019 
timepoints longitudinally across up to 9 schools offering the enhanced SKILLZ-Girl and SKILLZ-Clubs 
program and up to 9 schools offering the “standard of care” (SOC) SKILLZ-Girl and SOC Clubs (see Figure 3). 
Recruitment will take 12 months on a rolling basis. The order in which schools will be selected will be 
random. Participants will be clustered at the school-level; we will enroll all girls aged 16-years at the 
commencement of SKILLZ-Girl and in Grade 10 from each participating school.  
All enrolled girls will be followed over the two-year time period to assess SRH service uptake, including HIV 
testing. It is estimated that the majority (~98%) of girls testing for HIV will likely be HIV-negative, based on 
estimates from programmatic GRS data. While HIV-positive girls will continue to participate in the school-
based SKILLZ-Girl and Clubs activities and followed for SRH use, they will also be offered contemporaneous 
enrollment into SKILLZ-Plus upon infection; retention in care and Viral Load Suppression (VLS) at 6, 12, and 
24 months will be measured for this subset. See Figure 2 for details of enrolment flow.   
Process evaluation: We will conduct a process evaluation to better understand the casual pathways and 
effect mediators and moderators using mixed methods approaches, including supplemental qualitative 
data collection. To investigate reasons why the program components (SKILLZ-Girl, Club & Plus) might fail or 
succeed in different schools or communities and assess intervention effect mediators and moderators for 
HIV testing and contraceptive use uptake we will use a mixed methods approach involving: (1) quantitative 
analyses of baseline survey data for testing how variables can moderate the observed impact of the 
intervention, and (2) qualitative data collected from a subset of SKILLZ participants in the evaluation cohort 
and their coaches to further understand potential mediating pathways outlined in Figure 1. 
Fidelity monitoring: We will also include measures to monitor fidelity of the intervention implementation, 
including receptivity to and understanding of the intervention amongst participants, the perceived 
appropriateness and relevancy of the intervention for adolescent girls in school, and the extent to which 
the intervention was delivered per protocol in different communities and schools. 
Economic evaluation: We will estimate the short- and long-term cost-effectiveness and return on 
investment of SKILLZ for improving health outcomes for adolescent girls. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
 
 
 
 
Figure 2. Evaluation enrolment flow 
 
  
 
b. Study site and population/Research materials 
Lusaka is the capital and the most inhabited city in Zambia. Home to 2 million people, it has the highest HIV 
prevalence at 14%4. The study will take place across all the highly densely populated areas of Lusaka where 

17 
SKILLZ Protocol, v1.2a dated 20 August  2019 
CIDRZ supports government MoH clinics with ARV services, electronic data management, and youth-
friendly trained clinical personnel, and where GRS has been implementing their basic curriculum and 
events. All schools selected will be secular government schools. Approximately 80% of school-age girls are 
reported to be in school in Lusaka. To facilitate the evaluation of SKILLZ, all girls enrolled in up to 18 
government secondary schools in Urban Lusaka that GRS currently serves will be eligible to participate in 
the SKILLZ program and will be randomly allocated to either the enhanced or SOC SKILLZ implementation. 
For measuring impact, only girls aged 16 and over enrolled in Grade 10 at the start of the intervention 
period will be surveyed and followed because youth aged 16 and over can consent for SRH/HIV services 
without additional parental permission55. (See Section 9: Ethical Considerations for details on waiver of 
parental consent). 
 
c. Selection of participants, sampling methods and sample size 
Study Population: In each school, we will recruit all girls in Grade 10 who are at least 16 years old at the 
start of the intervention period (i.e., the commencement of SKLLZ-Girl). Of the 30,000 youth in Lusaka that 
have benefitted from GRS services to date, GRS has seen HIV testing uptake of 62% as compared to a 
baseline of 13% (internal program data). We have powered the sample for our primary endpoints in Aim 1ii 
to account for attrition anticipated along the cascade (see below). For HIV testing, all eligible girls 
(estimated to be an average of 100 girls per school) in up to 18 schools is large enough to detect a 
significant difference in testing uptake if setting statistical significance at =0.05, =0.2, ICC=0.1, and an 
expected testing uptake of 60% (control) and 80% (intervention).  
 
Cluster randomized controlled trial: We will select up to 18 (2 pilot + 16 for full implementation) schools from the 
Urban District of Lusaka to receive the SKILLZ-Girl curriculum. Of the total (up to 18), half will be randomly 
allocated to host the standard SKILLZ-Girl curriculum, and the remaining half (e.g., up to eight) will be randomized 
to either enhanced SKILLZ-Club. Those schools randomized to standard SKILLZ Girl curriculum will only have access 
to SOC clubs. Those schools selected for enhanced SKILLS Girl curriculum will offer SKILLZ Club. See Figure 3 for 
study allocation flow. 
 
 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
Figure 3. School Selection Flow Chart 
  
 
We anticipate that most of our evaluation cohort will not be HIV-infected. Thus, the retention to SRH 
analysis drives the sample size calculation of 351 girls using contraception at the end of two years, with, 
and risk ratio difference of 0.3 (30%) between the SOC and enhanced SKILLZ-Club schools. To realize the 
351 needed to meet requirements for estimate sensitivity, we augment the initial sample size receiving the 
SKILLZ-Girl curriculum accounting conservatively for 25% uptake of SRH methods and multiplying by two to 
assess the difference within each SKILLZ-Girl model (phase 1) and accounting for attrition across the two 
years of follow-up (12.5%) resulting in a starting sample size of 3159 (((351/0.25)x2)x1.025). SKILLZ-CLUBS 
will act as an extension to the SKILLZ-Girl curriculum enabling participants to seamlessly transition from the 
SKILLZ-Girl curriculum into the SKILLZ-Club. We anticipate minimal attrition (~15-20%). Participants will 
spend the majority of the study window in SKILLZ-Club and it is through the SKILLZ-Club affiliation that we 
will follow-up and ascertain outcomes for those enrolled longitudinally. 
 
For the small minority of girls found to be HIV-infected across all schools where the study will be 
conducted, we will evaluate linkage to care and on treatment, VLS, and retention in care for a period of 
two years. These girls will be encouraged to continue on to the HIV positive-specific SKILLZ-Plus facility-
based curriculum. We will quantitatively measure the impact of SKILLZ-Plus on linkage to care and 
treatment, retention and viral load at 6, 12, and 24 months after diagnosis (or since participant is identified 
by GRS as HIV+) using SmartCare data and compare to an existing matched cohort.  
 

19 
SKILLZ Protocol, v1.2a dated 20 August  2019 
Process evaluation: From 8 purposively selected intervention (n=4) and control schools (n=4), a subset of 
evaluation cohort study participants will be invited to participate in the qualitative research based on their 
HIV and SRH outcomes. In this study, we will use a sequential explanatory mixed method design56 to 
explain the outcomes after each evaluation time point (post-test, 3 mons, 12 mons and 24 mons). This 
means that participants will be selected based on the their SRH and HIV outcomes to join either IDIs, FGDs, 
or narrative interviews in (Figure 4). Six girls from each school (n=36) will be identified for IDIs after each 
survey time-point (n=4). We will select a mix of girls who have either opted to accept, engage with or 
decline the services being offered, in order to understand the drivers and barriers to acceptance of these 
services for the IDIs. We will conduct 1 FGD per school (n=6) each consisting of 8 girls (n=42). Girls enrolled 
in the SKILLZ Package will be selected for the FGDs. In order to gain a deep understanding of the barriers 
and mediators for retention into HIV care for those girls testing HIV positive, 1 HIV+ girl per school (n=6) 
will be invited to participate in narrative interviews. Girls will be chosen from different backgrounds (e.g., 
age, SES, single vs. dual parent homes) as assessed in the survey in order to compare responses between 
cases. For fidelity monitoring, we will verify that all three interventions are delivered as planned (fidelity of 
intervention both in inputs and outputs) and document participants’ reception (understanding and use of 
the interventions), appropriateness of the intervention and equality in reaching all types of girls by 
verifying uptake by risk factors collected at baseline such as SES, sexual activity and HIV knowledge. The 
assessment will be supported by quantitative measurements coming from programmatic data (e.g., 
frequency and attendance at SKILLZ-Plus meetings, frequency of home visits), and from reports and 
interviews of program manager and coordinator, coaches, as well as from the programmatic-level 
information from the qualitative interviews. 
 
 
 
 
 
 
 
 
 
 
 
Economic evaluation. No human subjects will be enrolled for this component. 
 
d. Data collection plan and tools 
SmartCare electronic data: All antiretroviral therapy services offered as part of the study will be captured 
in SmartCare, which permits measuring of utilization and clinical outcomes (i.e., Linkage to Care, VLS) at 
soccer events, mobile clinics, and public clinics in Lusaka. VLS is defined as below detection, i.e. less than 
50 copies/ml. Retention in care will also be measured using SmartCare data on pharmacy visits and defined 
as accessing pharmacy within a 90-day window of visits. Consent will be requested from all participants as 
part of the consent process to access their SmartCare records.  
Figure 4: Sequential Explanatory Study Design

20 
SKILLZ Protocol, v1.2a dated 20 August  2019 
 
Youth-Friendly services electronic data: Depending on the location of the school, the girl’s residential 
address and/or her own personal preferences, participants will be referred to either the PEPFAR Funded 
DREAMS houses or the M.A.C. funded youth-friendly spaces based in local MOH clinics in order to access 
ongoing SRH services after the events (this will include accessing PrEP, STI testing and contraceptive 
methods). All interactions with the DREAMS houses or M.A.C centres (including meeting with counselors, 
referral and uptake of services) are captured in their respective electronic databases. Consent will be 
requested from all participants as part of the consent process to allow researchers to access either 
DREAMS or M.A.C data should they chose to access either of these services.  
 
Survey at baseline: A baseline survey will be administered to all to collect information on school 
characteristics, sexual behavior, age, HIV knowledge, maternal education, baseline HIV status, and 
sexual/reproductive health uptake and retention. These variables will be used as covariates and 
moderators for service uptake and retention. The target sample of 3,200 girls will respond to a survey self-
administered using REDCap software upon informed consent. The survey will be available in English, 
Nyanja and Bemba. Coaches and study staff will on site be help girls navigate the survey. 
 
Survey post-SKILLZ-Girl event, 3-, 12-, and 24 months: All girls (regardless of HIV status) will respond to a 
REDCap survey to collect information on sexual behavior, HIV knowledge, maternal education, 
sexual/reproductive health uptake and retention. Post-SKILLZ-Girl survey data will be used to assess the 
effect of SKILLS Girl and SKILLZ-Club on the outcomes of interest. In schools selected to offer SKILLZ-Club, 
surveys will be conducted during club attendance approximately 3 months after the SKILLZ-Girl community 
soccer event; coaches will help them navigate the survey. If a participant has opted to not attend the clubs 
or has since left or changed schools, the coaches and study staff will attempt to trace participants in the 
community in order to complete the follow-up survey.  
In the schools selected not to offer SKILLZ-Club, GRS will arrange for a 2-hour meeting session with all 
participants still enrolled at that school, where all participants will complete the surveys. If a participant 
opts to not attend the meeting or has since left or changed schools, the coaches and study staff will 
attempt to trace participants in the community in order to complete the follow-up survey.  
 
The survey will record any changes to their home environment from baseline, again ask about self-
reported sexual and risk behaviors and HIV knowledge (i.e., post-test for HIV education curriculum), and 
further quantitatively measure potential mediating pathways.  Based on validated scales, the survey will 
include modules to assess stigma;57  empowerment;58 and self-efficacy59 in general and specific to 
SRH/HIV;60 disclosure, extent of social support from different sources (e.g., family, peers, teachers), and 
trust in health providers.61 Individual lost to follow-up (LTFU) will be traced following standard procedures. 
Active follow up and tracing of late or lost patients enrolled into HIV care or receiving ART is part of the 
National treatment program. We will partner with pre-existing CIDRZ community volunteers responsible 
for follow up to ensure that efforts are synchronized, and that data are shared and entered into SmartCare. 
CIDRZ already has an international reputation leading effort to track those who are lost to ensure 
participants return for visits and viral load testing as per national guidelines.98 
 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
Qualitative methods: Because a number of hypothesized intervening pathway concepts may be difficult to 
quantitatively measure with sufficient precision in the survey (e.g., trust in health providers and facilities,62 
social support, empowerment), particularly for adolescents, we will also collect a variety of qualitative data 
to further investigate factors that SRH uptake and HIV treatment outcomes (see Table 1). Through a 
phenomenological and narrative study approach, we aim to understand factors involved in decision-
making for uptake by learning from girls about how psychological, social and structural factors affected 
their health decisions also including personal beliefs, perceptions and motives. Additionally, we will 
document individual stories (narrative approach) regarding how HIV infected girls experience the 
mediating factors (such as stigma, disclosure, social support and trust in the health facility) and how they 
affect their adherence to care (see Figure 1). These narratives are valuable in revealing the process of 
problem identification to resolution.63 
 
Table 1. Qualitative data collection methods for Aim 2i
Outcome
Research Question
Method
Sample
SRH 
Outcomes 
 
How do psychological, social 
and structural factors affect 
SRH behaviors and the use of 
contraceptives?   
IDIs 
N=36: 6 girls from each of the 6 schools 
selected based on their SRH outcomes. 
How do familial, social, and 
structural factors affect the 
decision access and utilize 
contraception?  
FGDs 
N=6: 1 (8 participants) per purposively selected 
school (intervention and control). Girls enrolled 
in the SKILLZ package will be selected 
HIV 
Outcomes 
 How do psychological, social 
and structural factors affect 
HIV testing behaviors? 
IDIs 
N=36: 6 girls from each of the 6 schools 
selected based on their HIV testing outcomes. 
How has 
stigma/disclosure/social 
support/trust in the health 
providers influenced 
adherence? 
Narrative 
interviews 
 
N=6: HIV-positive girls enrolled in SKILLZ-Plus
 
How do familial, social, 
structural factors affect the 
decision to stay in care? 
Fidelity 
How closely do coaches follow 
the curriculum and how do they 
adapt or modify their delivery 
based on barriers to 
implementation?  
Passive 
Observations 
N = 6: 3 SKILLZ-Girl AND 3 SKLLZ Club sessions 
 
Extraction of programmatic data: Quantitative measurements coming from programmatic data (e.g., 
frequency and attendance at SKILLZ-Plus meetings, frequency of home visits) will be collated from reports, 
supplemented with interviews of implementing staff (e.g., program managers and coordinators, coaches) 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
to track key process indicators. This may also be triangulated with programmatic-level information from 
the qualitative interviews. 
 
 
 
e. Data management and storage 
Quantitative: 
We will collect individual-level data on clinical, laboratory, and demographic characteristics, including 
retention in care and VLS at 6, 12 and 24 months. Using case reporting forms (CRFs), we will collect study-
specific data, including information obtained directly from participants, routine programmatic data from 
GRS and abstract routine clinical data from paper-based medical records, the SmartCare Electronic 
Management Records (EMR), CIDRZ Laboratory Information Management System (LIMS) and DREAMS 
electronic management system. Routinely collected individual-level clinical data are first written onto 
forms in the paper medical record and then entered into the SmartCare EMR. SmartCare serves as a 
repository of clinical data for HIV-infected individuals and includes such data fields as: ART initiation date, 
ART regimen, visit dates, and laboratory data. 
 
GRS will collect programmatic data through a combination of paper and electronic data entry via tablets, 
with all data stored securely in RedCap. Where paper files are used for programmatic management, data 
will be manually entered by study staff directly into the RedCap database. De-identified data will made 
available to GRS co-investigators to allow them to view key fidelity and quality indicators in order to 
monitor implementation in real time. 
 
All paper study files will be stored in secured, locked cabinets located in locked rooms available to study 
staff only. The keys to the locked cabinet will be kept by study staff and not made accessible to non-study 
personnel.  
 
A secure server will be used to store encrypted study data, including the study database.  The research 
database will be developed using REDCap (Research Electronic Data Capture, Nashville, Tennessee, USA) 
and hosted on the secure CIDRZ server. Scheduled backups will be done routinely. A password will be 
required to gain access to the study dataset, and access will be restricted to key study personnel only.  All 
personal identifiers will be removed prior to generating the analytical dataset. 
 
Qualitative: All data will be obtained using digital audio recorders. Recorded data will be transferred on to 
a lockable computer kept by the co-principal investigator leading the qualitative research. Recordings will 
be shared with transcribers who will transcribe the voice recorded data into verbatim. Transcripts will go 
through a QA/QC process where researchers will cross check randomly selected transcribed verbatim with 
the recordings. Where errors are found, changes will be made to reflect the recordings accurately. Once 
this process is done and the quality of transcripts has been assured, recordings will be destroyed. 
Transcripts will be kept by 3 researchers including the Co-PI and stored electronically in a password 
protected computers accessible only to the 3 researchers. Transcripts will also be printed for analysis 
purposes and kept in a designated room in locked cabinets accessible only to the Co-PI. All qualitative data 
will be destroyed after 3 years in line with MOH recommendations.  

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SKILLZ Protocol, v1.2a dated 20 August  2019 
 
f. Data analysis plan 
Difference-in-difference model. The primary outcome is the probability of testing for HIV at any time 
during the period when SKILLZ is delivered through to 24 months after the final soccer event. The primary 
analysis for Aim 1 will follow a difference-in-difference (DID) effect between study arms. The outcome of 
interest will be regressed on an indicator of study arm assignment interacted with a dichotomous variable 
POST which indicates the outcome after the intervention is implemented; this differentiates baseline and 
end-line for each study arm, controls for any time dependent variables that might confound the effect, as 
well as any time-invariant observed or unobserved confounders that might differ between study arm 
schools. Because of this, the DID is robust to time-invariant unobservable confounders (e.g., school quality) 
and time trends (e.g., secular increase in testing). Our estimator relies on the assumption of common time 
trends across intervention and control in absence of the intervention, and of static population. 
Additionally, we control for baseline individual and school-level moderators that may be unbalanced at 
baseline after randomization. School-level controls include size, promotion rates, sex composition and 
repetition and dropout rates (available in the district education office) and individual girls’ controls include 
age, grade, maternal education, HIV knowledge. Clustering by school will be accounted for by a generalized 
estimating equation approach. We will estimate intention-to-treat (ITT) by including all girls in the 
evaluation cohort assigned to each arm rather than all girls who actually participated in SKILLZ. 
 
Individual-level matched cohort analysis for HIV-infected: The analysis will follow an individual ITT 
estimator among individuals found to be HIV-infected, who will then be matched (based on clinic, age, ART 
state date, and gender) to HIV-infected individuals in the SmartCare database. The outcomes are the 
proportion of enrolled HIV+ girls who linked to care, who are virally suppressed and retained in care at 6, 
12, and 24 months after diagnosis of HIV+ (using national electronic HIV medical record data). We will 
conduct an ITT analysis for the logistic probability of being suppressed at 6, 12, and 24 months after HIV+ 
diagnosis, where girl is the unit of analysis. All data will be analyzed using STATA. 
 
Process evaluation: This will involve quantitative and qualitative analyses: 
 
Quantitative analysis: Surveys conducted at baseline will be used to identify differential effects among girls 
who do and do not take up services according to baseline moderating variables as specified in Figure 1 and 
as assessed by previous sexual behavior, HIV testing/status, knowledge, maternal education by interacting 
the main exposure by these indicators. Statistical mediation will be assessed using the causal inference-
based approach of Valeri et al., which yields optimal estimates of indirect effects in the presence of binary 
outcomes and moderator-mediator interactions,64 and robust standard errors to address clustering of 
individuals within facilities, and account for multiple causally depending mediators.65 Significant indirect 
and total effects of integration markers on outcomes accompanied by non-significant direct effects will 
signify mediation. The interplay between exposure, effect modifiers, moderators and outcomes in the 
causal chain is represented in Figure 1. For analyses, we will use mixed effect structural equation models in 
STATA and MPLUS with bootstrapped standard errors to test the contribution of indirect effects.   
 
Qualitative analysis: All interviews will be voice-recorded, transcribed and coded using a thematic analysis 
process66 (e.g. in NVIVO or Atlas.ti). Analysis will begin with familiarization of the data that will involve 

24 
SKILLZ Protocol, v1.2a dated 20 August  2019 
reading and re-reading of the transcripts to understand the data. Notes will be taken down at the point of 
familiarization to guide the development of the codebook. Codes will be extracted both inductively 
(bottom-up) and deductively (top-down). Inductively, open coding will be conducted to identify interesting 
and meaningful text in each line of the transcripts. Each piece of text will be grouped under a specific code 
that describes the meaning of the text. Once all the text has been coded, the researchers will then identify 
themes that tell something significant about the research questions and group a set of codes under each 
related theme. The themes will then be reviewed by reading each code and its associated text and re-
arranged or removed in order to refine the themes and their meaning. Secondary coding will be applied to 
uncover the latent meaning of each of the themes. Themes will then be re-coded to uncover the latent 
meaning of the themes and refine their definitions.  
 
Deductively, attributes from the RE-AIM process evaluation framework will be used to create the themes.67 
These attributes are “reach, effectiveness, adoption, implementation and maintenance.” Transcripts will 
be coded under each of these attributes and subsequently be refined using the same process described 
above.  
 
Fidelity monitoring: Fidelity will be measured by recording number of visits for coaches in the intervention 
and attendance, number of soccer events and attendance, number of home visits by coaches (e.g. for 
missed visits), as well as with key-informant interviews with coaches and with the study coordinator to 
understand how the intervention was implemented and will report in any discrepancy from protocol. 
Reception of the intervention. During the FGDs we will assess how the participants understood and used 
the intervention. Appropriateness and relevancy: During the FGDs to coaches and girls we will inquire 
about appropriateness and relevancy of soccer as a platform for adolescent programs. Reach of program: 
this will be captured by number and proportion of referrals (using SmartCare) to the health facilities that 
were successfully linked, as well as the presence of adolescent friendly corners at facility, number and type 
of adolescent clinical services delivered. 
 
 
 
Economic evaluation: We will assess cost-effectiveness in three steps. First, we will assess the net cost of 
the intervention and its consequences, using micro-costing and modeling techniques. Costs for the 
intervention itself will include mainly personnel to manage the intervention and the financial incentives. 
Costing of the intervention and control models will be captured in costing sheets that will be prepared 
before the start of the intervention aimed at capturing costs as they are spent; we will limit the costing 
from the provider perspective and will only limit costing to programmatic and not research costs. We will 
also cost the change in health care utilization precipitated by the intervention: both increased preventive 
care and decreases in curative care. This will be assessed combining utilization with standard values for 
unit cost (per MOH official records). Together, these generate net costs. Second, we will quantify the 
health benefits of the intervention, including health events (e.g., number and type of opportunistic 
infections, STIs) and Quality-Adjusted Life Years (QALYs) which translate morbidity in the short and long 
term (projected based on published longitudinal clinical studies) into a standard metric of health status. 
Health state utility data (for QALYs) will derive from studies in the literature. The analysis of expected costs 
and QALYs in the intermediate and long-term will be structured using a spreadsheet-based decision 
analysis created for this purpose in consultation with clinical experts. Third, we will calculate the economic 
outcome measures including the Incremental Cost-Effectiveness Ratio (ICER) and Return-on-Investment 
(ROI). The ICER is the ratio of net cost to health gain, comparing the SKILLZ-Plus to control (e.g., ICER for 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
HIV testing = (C_intervention – C_control)/(Testing rate_intervention – Testing rate_control)), and is 
indicated if the intervention has a net cost (i.e., does not save money) while improving health outcomes 
(QALYs gained). All analyses will be repeated for 1, 2, 5, 10, & 20 years, and subjected to extensive 
sensitivity analyses to test the impact of uncertainty on results. 
 
9. Ethical considerations 
 
This study proposes to evaluate the impact of the SKILLZ Package (SKILLZ-Girl, SKILLZ-Club and SKILLZ-Plus) 
on the uptake of HIV and SRH services including uptake and adherence to contraceptive services, HIV 
testing, linkage to care and adherence, VLS and retention in care. This will be done by the review of GRS 
programmatic data, conducting surveys and implementing IDIs and FGDs with adolescent girls aged 16 and 
over as well as program staff involved in the implementation of the SKILLZ package. It will also require 
access to adolescents’ medical records in order to evaluate impact on the HIV outcomes mentioned above. 
 
Parental Consent. Prior to the commencement of the SKILLZ-Girl program, parents of all girls who will be 
aged 16 and 17 years and above and in Grade 10 at the commencement of SKILLZ-Girl, will be invited to 
attend a sensitization session for the study. During this sensitization they will be asked to give consent for 
their children to participate. Parents who do not attend the session, will be visited in their home by a 
member of the study team in order to sensitize participants.  Study staff will only obtain assent from 
participants whose parents or guardians have previously given consent.  Participant information sheets will 
be given to them in a language of their choice between Nyanja, Bemba and English, all common in Lusaka. 
If they are unable to read (i.e. illiterate), a witness aged 18 years and over (not directly involved in the 
study) will be invited to be part of the consent process to verify that the information being given by the 
research assistant is accurate. The information sheet will contain information including the purpose of the 
study, the procedures and risks and benefits. The right to withdraw at any time will also be emphasizes to 
all participants.  
 
Informed Assent. Girls aged 16 and 17 years who plan to participate in the SKILLZ program, and whose 
parents have given prior consent, will be approached by the study team for their assent to participate . The 
same participant information sheets will be given to them in a language of their choice between Nyanja, 
Bemba and English, all common in Lusaka. If they are unable to read (i.e illiterate) , a witness aged 18 years 
and over (not directly involved in the study) or a teacher (only of the adolescent is comfortable) will be 
invited to be part of the consent process to verify that the information being given by the research 
assistant is accurate. The right to withdraw at any time will also be emphasizes to all participants. 
Individuals will be consented privately, in a separate room, to maintain confidentiality.  
 
Informed Consent:  
Girls aged 18 years and above will be approached by the study team without prior consent from their 
parents and will be invited to complete a consent form in a language of their choice (Nyanja, Bemba or 
English). If they are unable to read (i.e. illiterate), a witness aged 18 years and over (not directly involved in 
the study) or a teacher (only of the adolescent is comfortable) will be invited to be part of the consent 
process to verify that the information being given by the research assistant is accurate. The right to 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
withdraw at any time will also be emphasizes to all participants. Individuals will be consented privately, in a 
separate room, to maintain confidentiality. 
 
Involvement of Vulnerable Populations. We are targeting adolescent girls aged 16 years and over. We are 
aware that the population we would like to include in our study are considered a vulnerable population in 
line with the World Health Organization guidelines as well as the Zambian guidelines. The evaluation is 
targeted at this group to see whether the benefits of HIV prevention and treatment services empower girls 
to seek HIV and other family planning services without shame or fear and contribute knowledge that may 
be applicable to countries with similar settings.  
 
Potential Risks and Protection against Risk.  
Psychosocial Distress 
The potential risks to participants of this study are minimal. We are aware that the adolescents targeted 
for this study share unique characteristics from the adult population that need to be considered 
throughout the roll out of the study. Adolescents participating in this study may experience psychological 
distress such as sadness, anxiety, distraction or stress when being surveyed or interviewed. To address this 
all field staff will be trained to offer referral resources and procedures for psychological, social service, and 
other emergency needs. 
 
Stigma  
Stigma may also arise as a result of follow-up visits by research assistants. Due to various HIV related 
studies and programs, follow-up visits in the community by an identifiable clinic staff is usually perceived 
as an adherence visit for one who is HIV positive. Therefore, follow-up visits conducted during the course 
of this study, may be perceived as such and lead to HIV related stigma for any members of a household. To 
avoid this, research assistants will be dressed as regular members of the community with no specific 
identifying information such as T-shirts, ID’s or badges. ID’s will only be shown once inside the home or 
when requested by local authorities.  
 
Loss of Confidential Data:  
It is highly unlikely that confidential data will be lost during this study. However, we know that it is possible 
that other unauthorized personnel may view the data, or the data may be stolen or lost. In such cases, 
measures will be implemented to ensure no harm is posed to pupils. Except for the consent form, no 
identifying information will be collected or documented during assessments, analysis and reporting. 
Teachers and other school staff will not be allowed to see any confidential information unless it is the wish 
of the parent. Only coaches and selected clinical study staff will be allowed to have contact information of 
pupils in order to facilitate HIV testing and adherence counseling services. It will be the responsibility of 
these staff to use their contact information for the purpose of follow-ups only. They will be trained in 
research ethics where confidentiality will be emphasized. All identifying information will be stored in a 
separate password protected database from other project data. Consent forms will be scanned by study 
staff and stored in the password protected database. The original paper copies will be kept in a locked 
cabinet in a secure room at the CIDRZ offices.  
 
 
Potential Benefits.  

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SKILLZ Protocol, v1.2a dated 20 August  2019 
Study participants will receive no direct benefits for participating in the study. They will not be given any 
money for participating in the study. Those pupils invited to attend a focus group discussion will be given 
refreshments during the discussion. In cases where focus group discussions are held on weekends, 
students will be given a transport reimbursement in addition to refreshments. A K100 will be provided for 
transport reimbursements and lunch allowances where necessary. 
10. Timelines 
 
11. Budget 
 
  
Year 1 
Year 2 
Year 3 
Year 4 
Year 5 
Salaries and Wages 
ZMK 235,082
ZMK 235,082
ZMK 235,082
ZMK 262,469
ZMK 262,469 
Fringe Benefits 
ZMK 73,838
ZMK 73,838
ZMK 73,838
ZMK 83,536
ZMK 83,536 
Personnel Costs (Subtotal)  
ZMK 308,920
ZMK 308,920
ZMK 308,920
ZMK 346,006
ZMK 346,006 
Travel  
  
  
  
ZMK 37,624
  
Other  
ZMK 82,163
ZMK 82,163
ZMK 82,163
ZMK 82,163
ZMK 82,163 
Subaward/Consortium/Contractual 
Costs 
ZMK 5,380,354
ZMK 4,901,077
ZMK 4,880,127
ZMK 4,835,098
ZMK 4,629,423 
TOTAL Direct Costs  
ZMK 5,767,853
ZMK 5,292,159
ZMK 5,271,210
ZMK 5,300,891
ZMK 5,057,591 
Facilities and Administrative Costs 
ZMK 423,522
ZMK 101,679
ZMK 101,679
ZMK 121,100
ZMK 111,318 
TOTAL COST  
ZMK 6,191,375
ZMK 5,393,839
ZMK 5,372,889
ZMK 5,421,991
ZMK 5,168,909 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
12. Appendices  
a. Letter of Permission from MOGE for GRS to continue working in schools in 2019 
 

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b. MOU between GRS and MOGE 
 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
c. 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
 
 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
c. Letter of Permission between MOH and GRS  
 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
d. Letter of Support from MOH regarding PREP uptake amongst adolescent girls   
 

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SKILLZ Protocol, v1.2a dated 20 August  2019 
e. Additional Letter of Support from MOH regarding PREP uptake amongst adolescent girls   
 

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