Can Undetectable (Viral Load) = Untransmissible (Virus) Change the Life Course of Adolescents Living the HIV in Africa
Conditions: HIV/AIDS
Sponsor: Centre for Sexual Health and HIV/AIDS Research Zimbabwe

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Title of Proposal 
Can Undetectable (viral load) = Untransmissible (virus) change the life course of 
adolescents living the HIV in Africa? 
 
Acronym 
CUUA 
 
 
Protocol Team  
Dr Zivai Nenguke 
Prof Frances Cowan 
Dr Sarah Bernays  
 
Organization  
Centre for Sexual Health and HIV AIDS Research Zimbabwe (CeSHHAR Zimbabwe) 
4 Bath Road 
Belgravia  
 
Protocol version 2.0 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
Title of Proposal ................................................................................................................................ 1 
Abstract ............................................................................................................................................. 3 
Introduction ....................................................................................................................................... 4 
Background and significance .......................................................................................................... 4 
Research question ......................................................................................................................... 5 
Rationale ....................................................................................................................................... 5 
Aim ................................................................................................................................................ 5 
Methods ............................................................................................................................................ 6 
Study design and setting ................................................................................................................ 6 
Procedures .................................................................................................................................... 8 
Quantitative interviews ................................................................................................................ 8 
Qualitative interviews .................................................................................................................. 9 
Inclusion criteria ............................................................................................................................. 9 
Exclusion criteria ............................................................................................................................ 9 
Data management and analysis procedures ................................................................................... 9 
Quantitative data management ................................................................................................... 9 
Qualitative data management. .................................................................................................... 9 
Managing, storing and curating data. ........................................................................................ 10 
Metadata standards and data documentation. ........................................................................... 10 
Data preservation strategy and standards. ................................................................................ 10 
Data security and confidentiality of potentially disclosive information ......................................... 11 
Main risks to data security ........................................................................................................ 11 
Data sharing and access .......................................................................................................... 11 
Responsibilities......................................................................................................................... 11 
Ethical Considerations ................................................................................................................. 11 
Informed consent ...................................................................................................................... 12 
Voluntary participation .............................................................................................................. 12 
Confidentiality ........................................................................................................................... 12 
Potential Risks to participants ................................................................................................... 12 
Benefits .................................................................................................................................... 12 
Child protection and safeguarding ................................................................................................ 12 
Expected outcomes and impact on programmes and policies........................................................... 13 
Dissemination and exploitation of results ......................................................................................... 13 
REFERENCES ................................................................................................................................ 15 
 
 
 

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Abstract 
Rationale: Adolescents living with HIV (ALHIV) have the worst outcomes of all ages because of sub-
optimal adherence driven by structural factors associated with poverty. This is exacerbated for 
adolescents by the limited opportunities to address mental health problems arising from the intersection 
of growing up in poverty and with HIV. The scientific breakthrough related to Undetectable (viral load) 
= Untransmissible (virus) has had a major impact on motivation to take up and adhere to antiretroviral 
therapy among people living with HIV all over the world. However, the discussion remains remarkably 
silent in high burden, low-income countries (LIC). Very few ALHIV in LIC are aware that having an 
undetectable viral load (VL) substantially reduces the risk of transmitting HIV to their sexual partners 
and children. 
 
Aims: The aim of the study is to work with MoHCC and other stakeholders to explore whether routine 
VL testing using DBS can provide sufficiently robust evidence of ‘undetectability’ to support introduction 
of U=U messaging in ALHIV. 
The specific objectives are: 
1. To determine viral load fluctuation between routine annual VL testing and the extent to which 
annual VL using DBS reflects short term fluctuations that occur in the interim. 
2. To determine what proportion of ALHIV with VL <1000 copies/uL on DBS have a plasma VL 
less than 200 copies/uL  
3. To explore the reasons for and adolescent’s understandings of fluctuations in VL and what a 
VL<1000 copies/mL means to ALHIV 
Methods: This mixed method study will be conducted in conjunction with key stakeholders. We will 
enrol 300 ALHIV with a recent VL<1000 copies/uL in three HIV clinics in Harare and follow them for 12 
months. Of these, 100 will be randomly selected to undergo repeat VL testing, using both DBS and 
plasma samples at enrolment, 6 and 12 months. A purposive sample of twenty will be selected for a 
longitudinal qualitative study. Additionally, up to eight participatory workshops will be conducted with 
key stakeholders over the course of the study to co-develop a ‘safe’ way to message U=U for LIC.    
Potential impact: The study will provide scientific evidence on whether routine VL testing using DBS 
as available in LIC can provide sufficiently robust evidence of ‘undetectability’ and on the variability of 
an individual’s virological response over 12 months. It will provide contextually orientated evidence to 
inform U=U messaging which has the potential to change the motivation of ALHIV to engage with their 
treatment and care. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Introduction  
Background and significance 
 
Adolescents living with HIV (ALHIV) have the highest HIV-related morbidity and mortality of any age 
group as a result of suboptimal adherence to ART (1-4) and are falling far behind the global targets of 
90-90-90 (5, 6). The majority of ALHIV live in East and Southern Africa where poverty is an overarching 
factor that increases vulnerability to, and the impact of, HIV. Poverty includes deprivation, constrained 
choices, and unfulfilled capabilities, and refers to interrelated features of well-being that impact upon 
the standard of living and the quality of life (7). Combined data from East and Southern African countries 
show that only 45% of adolescent girls living with HIV have attained the UNAIDS 90-90-90 virological 
suppression target (73% of those diagnosed and on treatment should be virologically suppressed) (8). 
As a result, they are more vulnerable to antiretroviral resistance, treatment failure and progression to 
expensive second- and third-line regimens than other age groups (9, 10) as well as AIDS related illness 
and death. A major driver of these high rates of morbidity and mortality is suboptimal adherence, which 
is in turn driven by a complex web of social and structural factors. It is the poorest and most vulnerable 
ALHIV who are most at risk of treatment failure (11). 
 
There is now convincing evidence from HIC that people living with HIV who are virologically suppressed 
are at minimal risk of HIV transmission (12, 13), providing PLHIV with added motivation to optimize their 
adherence to antiretroviral therapy and enabling them to have intimate sexual relationships without fear 
of transmitting HIV (13). Despite the transformative effects of U=U, very few ALHIV are aware of the 
clinical relationship between having an undetectable viral load and rendering the virus untransmissible 
(13, 14). 
To date major operational, funding, logistical and developmental concerns have influenced the absence 
of the U=U discussion at a policy level within LIC. There is increasing opportunity for these concerns to 
be overcome, which means that the reticence to explain the implications of viral suppression to 
adolescents needs to be revisited and adjusted. To capitalize on the value of achieving an undetectable 
viral load we need to do much more to explain the benefits of this to adolescents to incentivise optimal 
adherence, but also potentially to support their wellbeing and mental health by highlighting the 
opportunities that accompany viral suppression. We need to do so by discussing virological 
suppression/failure within the context of their personal goals and priorities, which are focused on their 
social and sexual relationships and their capacity for future productivity and reproductivity, goals which 
may seem more achievable in the context of U=U.      
 
Zimbabwe and many other sub-Saharan countries are transitioning to Tenofovir Disoproxil Fumarate, 
Lamivudine and Dolutegravir (TLD) from TLE as a first-line regimen in line with the World Health 
Organization (WHO) recommendation. The transition was due to be completed by December 2020 but 
may be delayed (or possibly accelerated) in light of COVID19. Recent systematic reviews and meta-
analysis conducted have shown that TLD is more potent, suppressing viral load more quickly compared 
to EFV-based regimens (15, 16). Eighty-one percent of individuals who started with a DTG-based 
regimen presented a viral load below 50 copies/ml after 3 months of treatment, compared to 61% for 
those on an EFV-based regimen (15). Furthermore, TLD is more durable, featuring a higher drug-
resistance barrier compared to NNRTIs and older integrase inhibitors and thereby reducing the risk of 
drug resistance (17). Although studies from high income countries have shown an improvement in viral 
suppression, this is not universal and evaluations to determine TLD’s place as first-line and second-line 
therapy in adolescent and paediatric HIV treatment in low-income setting are ongoing. Of relevance is 
that adolescent adherence is often related to wider structural concerns rather than simply forgetting to 
take tablets and so adherence may be poor for prolonged periods of time which TLD may be less able 
to mitigate.  Understanding whether U=U in the context TLD will be critical going forward. 
 
Zimbabwe adopted the WHO guidelines on routine VL testing as standard practice in 2015 amidst 
several resource and logistical challenges (18-20). These include unsuitable laboratory infrastructure, 
complex sample collection procedures, transportation of samples to central laboratories from all over 
the country, unreliable power supply, water supply and air-conditioning; non-adherence to cold chain 
transportation of the reagents, lack of experienced laboratory personnel and the absence of 
maintenance contracts for the equipment (19). Although routine coverage of VL testing and monitoring 
is still erratic the Zimbabwean government has made a commitment to increasing laboratory capacity 
and aggressively scaling-up VL testing to ensure access to VL testing services by at least 90% of people 
living with HIV (PLHIV) receiving ART by December 2020. Through support for universal VL testing 

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from GFATM and PEPFAR, strides have been made in strengthening the laboratory infrastructure, 
sample transportation, data management, procurement and supply chain management, training and 
mentorship, quality assurance and monitoring and evaluation which are crucial areas to the success of 
VL testing scale up (19).    
 
Research question  
The main research question for this study is: 
Can messaging relating to Undetectable (viral load) = Untransmissible (virus) change the motivations 
and adherence of adolescents living the HIV in Africa? 
The study therefore aims to answer three key questions: i) what is the evidentiary robustness of a VL 
1000c/uL measured using a DBS sample to be considered ‘undetectable? ii) what are the perceived 
risks and opportunities of incorporating U=U into routine HIV treatment and care for adolescents in LIC 
and iii) can locally acceptable and appropriate ways to integrate the discussion about undetectability 
into standard of care for ALHIV be developed for Zimbabwe in partnership with stakeholders? 
 
Rationale  
Adolescents living with HIV (ALHIV) have the worst outcomes of all ages because of suboptimal 
adherence driven by structural factors associated with poverty (2, 8). This is exacerbated for 
adolescents by the limited opportunities to address mental health problems arising from the intersection 
of growing up in poverty and with HIV (21). The scientific breakthrough related to Undetectable (viral 
load) = Untransmissible (virus) has had a major impact on motivation to take up and adhere to 
antiretroviral therapy among people living with HIV all over the world (13) although even in high income 
settings the messaging is variable (22). However, the discussion remains remarkably silent in high 
burden, low-income countries (LIC). Very few ALHIV in LIC are aware that having an undetectable viral 
load (VL) substantially reduces the risk of transmitting HIV to their sexual partners and children. The 
study will provide scientific evidence on whether routine VL testing using DBS as available in LIC can 
provide sufficiently robust evidence of ‘undetectability’ and on the variability of an individual’s virological 
response over 12 months and between those considered undetectable (<1000) and those undetectable 
and untransmissible (<200). 
 
U=U messaging has potential enabling effects on adherence and onward disclosure of HIV status but 
there is very little evidence in Zimbabwe or sub-Saharan Africa on how best the importance of viral load 
levels and the message of U=U can be communicated to young people and with what implications. 
There has been limited discussion on whether or how this can be incorporated into routine care in LIC, 
even for adults. This is in part explained by two things. Firstly, the scarce availability of viral load testing 
in LIC, where quality of both sampling and testing may be variable. In HIC the U=U message is 
supported by regular VL testing using plasma samples with a cut off for ‘undetectability’ of 
<200copies/uL (although the PARTNER study which looked at transmission in 551 heterosexual 
partners also found no transmission between partners where the index case had a VL of 200-1000 c/uL 
(14)). 
 
Secondly, the lack of U=U discussions may reflect reticence and possibly stigma among the community 
delivering HIV care and support to ALHIV about whether young people would respond responsibly to 
this information; they are uneasy about the potential disruptive effects of this message (22). Whether it 
is advisable to promote U=U also rests on young people’s likely understanding of the messaging; 
currently there is little knowledge of how an undetectable VL might be interpreted by ALHIV in LIC, what 
it means for them and their futures and whether it motivates or undermines their intention to adhere. 
With limited opportunity for ongoing or more nuanced discussion about their illness, their understanding 
of HIV is often static and may not be updated in response to scientific advances or to meet their evolving 
needs, depriving ALHIV of the opportunity to develop their understanding of the changing nature of the 
management of HIV or the benefit of the changing meanings of HIV. U=U may ameliorate stigma 
associated with it (22). This study will provide contextually orientated evidence to inform U=U 
messaging to guide both policy makers and healthcare workers on how U=U can be integrated in the 
routine care of ALHIV in Zimbabwe. The study will also be relevant to other comparable LIC in the 
region.   
 
Aim  
The study aims to provide scientific evidence on whether routine VL testing using DBS as available in 
LIC can provide sufficiently robust evidence of ‘undetectability’ and on the variability of an individual’s 

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virological response over 12 months and between those considered undetectable (<1000) and those 
undetectable and untransmissible (<200). We therefore propose to conduct a longitudinal study to i) 
determine at what ‘threshold’ U=U might be safely promoted in this setting; ii) explore ALHIV’s 
understanding and or interpretation of the VL results. The study will also explore responsible ways to 
disseminate this message to ALHIV living in Zimbabwe, and across the Southern African region. 
 
Our specific objectives are: 
1. To determine viral load fluctuation between routine annual VL testing and the extent to which 
annual VL using DBS reflects short term fluctuations that occur in the interim. 
2. To determine what proportion of ALHIV with viral load <1000 copies/uL on DBS have a plasma 
VL less than 200 copies/uL  
3. To explore the reasons for and adolescent’s understandings of fluctuations in VL (measured 
using standard of care DBS) and what a VL<1000 copies/mL means to ALHIV 
4. To explore the perceived risks and opportunities of incorporating U=U into routine HIV 
treatment and care for ALHIV in LIC 
5. To explore with key stakeholders the implications of our findings for the feasibility and framing 
of the U=U message in LIC for ALHIV. 
 
Methods  
Study design and setting    
A longitudinal mixed method study will be conducted in Harare City Health Department at three high 
volume clinics (BRIDH, Kuwadzana and Rujeko). All the clinics provide care as part of the Paediatric 
Opportunistic Infection and Antiretroviral Therapy program (OI/ART) and started conducting routine viral 
load testing in 2016. BRIDH has capacity for onsite VL testing. The three clinics are situated in the low-
income and overpopulated residential suburbs which are ranked among the poorest residential areas 
in Harare (Mbare, Kuwadzana and Dzivarasekwa). The clinics mainly serve people from poor 
households. BRIDH is located in Mbare residential suburb which is one of the oldest and most 
impoverished residential suburbs in Zimbabwe. 
 
Aim 1 and 2: To determine viral load fluctuation between routine annual VL testing and the extent 
to which annual VL using DBS reflects short term fluctuations that occur in the interim and to 
determine what proportion of ALHIV with viral load <1000 copies/uL on DBS have a plasma VL 
less than 200 copies/uL   
 
The study will explore the sensitivity of viral load testing so that decisions can be made on the best use 
of resources in optimizing the care and support that can be given to ALHIV in the region. This 
component will utilize primary and secondary data. Three hundred ALHIV with a recent VL<1000 
copies/uL will be randomly selected from clinic registers complete a structured questionnaire. Interviews 
will explore demographic characteristics, self-reported ART adherence and knowledge of U=U.  In depth 
analysis of ALHIV’ VL trajectories will be conducted on a randomly selected sub sample of 100 ALHIV 
using 6 monthly finger prick DBS and plasma VL sampling to provide evidence on the fluctuation in an 
individual’s virological response over 12 months and how this differs between those considered 
virologically suppressed (<1000 copies/uL) and those undetectable and untransmissible (<200 
copies/uL). Secondary data will be collected from clinic records on HIV treatment history, drug 
regimens, VL testing (include VL at enrolment and 12 months). 
 
Aim 3: To explore the reasons for and adolescent’s understandings of fluctuations in VL 
(measured using standard of care DBS) and what a VL<1000 copies/uL means to ALHIV. 
 
A purposive and theoretical subsample of 20 ALHIV will be selected to participate in longitudinal 
qualitative interviews at enrolment, 6 and 12 months after receiving their VL result. The subsample will 
be selected from the quantitative sample. Theoretical sampling is defined as interviewing directed by 
evolving themes rather than focusing on predetermined populations. Purposive and theoretical 
sampling are strategies employed to ensure that the participants involved have a wide range of 
experiences, relevant to answering the research question, but also limit the scale of the data collection 
so that detailed analyses could be conducted. Interesting dynamics such as duration on ART, current 
regimen (first/second line), mode of transmission among other things will be considered among other 
characteristics. 

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Interviews will explore reasons for consistent/fluctuating VL and their understandings of why and what 
is happening. We will explore whether having a VL<1000copies/uL motivates them to adhere and 
whether and how learning that they have a fluctuating or high VL affects their subsequent motivation to 
adhere and or their wellbeing, as well as the influence, if any, on their experience of HIV stigma. The 
interviews will also explore what being undetectable means for ALHIV and what influence it has, if any, 
on their adherence motivation and behaviour alongside developing a broader understanding of the 
effects of social context, including events in their daily life, on their engagement with and adherence to 
ART and their understandings of the social meanings of living with HIV. These in-depth interviews will 
also explore whether and how learning that they have a fluctuating or high VL affects their subsequent 
motivation to adhere and or their wellbeing, as well as the influence, if any, on their experience of HIV 
stigma. Interpretations of how the VL results are described to ALHIV by clinic staff will also be explored. 
Data collection will be an iterative process, where all the interviews will be transcribed and translated in 
order to inform individualized guides for subsequent in-depth interviews. 
 
Aim4: To explore the perceived risks and opportunities of incorporating U=U into routine HIV 
treatment and care for ALHIV in LIC 
 
Up to four participatory workshops will be conducted with healthcare workers and ALHIV to explore 
perceived risks and opportunities of incorporating U=U into routine treatment and care for ALHIV in LIC. 
It is well documented that adolescents’ understanding and acceptance of their HIV status and 
engagement in their treatment is also critical to attaining U=U. The workshops will unpack some of the 
key challenges that undermine ALHIV’s engagement. The first two workshops will be with policy makers 
to discuss the findings and explore their perceptions on the feasibility of implementing policies related 
to U=U in this age group. Additionally, their views will be elicited around whether they consider there is 
‘safe’ U=U messaging for LIC that could be implemented logistically, clinically and socially. The last two 
workshops will include policy makers, healthcare workers and ALHIV to explore the social 
understandings of and the health system response to the role of undetectable VL results in supporting 
care to ALHIV. 
 
Aim 5: To explore with key stakeholders the implications of our findings for the feasibility and 
framing of the U=U message in LIC for ALHIV. 
 
Working with the Ministry of Health and Child Care to develop locally appropriate ways of incorporating 
U=U into routine HIV treatment and care among ALHIV in Zimbabwe. I have already set up a technical 
working group comprising members from the MoHCC, Africaid Zvandiri and UNICEF. This was made 
possible through a UNICEF supported small-scale resource development project which is supporting 
development of resources for ALHIV to improve their HIV literacy and particularly their literacy related 
to viral load testing, which has been relatively recently introduced into routine HIV care in Zimbabwe. 
The UNICEF supported project aims to increase understanding about the importance of achieving, 
monitoring and maintaining viral suppression primarily for prevention of disease progression but also 
for prevention of mother to child transmission and potentially sexual transmission. Although UNICEF is 
supporting the small project viral load data will not be collected so the messaging will largely relate to 
understanding what viral load means rather than whether U=U is a valid message to promote. The study 
proposed here will provide opportunity for more in-depth exploration of issues and generation of 
biological evidence to support or refute perceptions and be integrated into materials so that the 
messaging is clinically sound for what is feasible and deliverable in the Zimbabwean context (and 
potentially other similar settings within the region). 
 
This study will benefit from the technical working group established as part of the UNICEF project. The 
participatory workshops will include members from the technical working group and other key 
stakeholders (policy makers and healthcare workers) to discuss the findings from ALHIV interviews and 
explore their perceptions on the feasibility of implementing policies related to U=U in this age group. 
Additionally, their views will be elicited around whether they consider there is ‘safe’ U=U messaging for 
LIC that could be implemented logistically, clinically and socially. The workshops will explore the social 
understandings of and the health system response to the role of undetectable VL results in supporting 
care to ALHIV, which may or may not include the feasibility of adopting and adapting the U=U message 
in the Zimbabwean context. We aim to establish the implications of the health systems variation in 
provision of VL testing between clinics with or without onsite VL. A range of methodological approaches 
will be used. 

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Procedures  
 
Quantitative interviews 
 
The sample size for ALHIV will be calculated with reference to the total number of ALHIV aged 13-19 
years on ART with a VL <1000copies/uL taken within 6 weeks of study launch from the 3 sampled 
clinics according to the clinic records. A list of all ALHIV aged 13-19 on ART will be drawn from the ART 
registers from this, a systematic random sample will be selected to recruit 300. The sample sizes will 
be calculated using a margin of error of 5 %; confidence interval of 95% and response distribution of 
50% (http://www.raosoft.com/samplesize.html). The figure obtained will be shared among the 3 clinics 
using Probability Proportionate to Size (PPS) sampling. ALHIV taking account age, recency of 
disclosure, duration on ART and current ART regimen and will be shared among the three clinics using 
Probability Proportionate to Size (PPS) as in figure 1 below. 
 
 
Figure 1: Recruitment flow chart 
The quantitative subset of 100 ALHIV who will have intensive follow up and will provide plasma and 
DBS samples VL testing at enrolment, 6 and 12 months will be randomly selected. Ideally, we wanted 
to have intense follow up on all 300 participants however due to limited resources we reduced the 
sample size for intense follow up to 100 participants.  
 
Eligible participants will be drawn from the clinic records with the assistance of the clinic nurses. A list 
of potential eligible participants per clinic containing the residential suburb, name and contact details 
will be given to the Africaid Zvandiri Community Adolescent Treatment Supporters (CATS) working in 
the clinics for recruitment during regular support group meetings or through the phone. CATS are ALHIV 
aged 18-24 years who are trained by Africaid and MOHCC to provide support to other ALHIV. All the 
clinics are supported by Africaid and offer psychosocial support services to ALHIV through a 
combination of home visits and support groups. Willing participants will be invited to the clinic and will 
be introduced to the research team. After being given study information, interested participants who 
met the inclusion criteria and willing to provide written informed consent were recruited. 
 
Subject to feasibility, all interviews will be conducted in ALHIV’s HIV clinics in private and conducive 
interview rooms. In exceptional cases, where the public sector clinics have limited space interviews will 
be conducted at the CeSHHAR office. All participants and their parents/caregivers will be reimbursed 
for their transport costs and given a token of appreciation in line with local ethics committee guidelines 
for participating. Were possible interviews will be scheduled around the same time ALHIV attend their 
routine clinic visits to minimise visits to the clinics. No direct household or community contact will be 

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made by the research team in order to avoid inadvertent disclosure of their HIV status and to prevent 
the risk of stigma and discrimination of participants.     
 
Participants will complete a structured questionnaire using Audio Computer-Assisted Self- Interview 
(ACASI) at enrolment and after 12 months. Interviews will explore demographic characteristics, self-
reported ART adherence, changes in treatment and illness and knowledge of U=U. Data will be 
collected from clinic records on HIV treatment history, drug regimens, routinely collected VL results.  
 
Qualitative interviews  
 
The longitudinal qualitative subsample of 20 participants will be theoretically selected from the baseline 
cohort. As part of the mixed method study design, the quantitative analysis will inform the dimensions 
of the qualitative sample. Key sampling characteristics which emerge as being pertinent for inclusion 
and exploration within the qualitative sample will be identified from the quantitative analysis. Household 
circumstances, duration on ART, current regimen (first/second line), mode of transmission may be 
considered among other characteristics. Theoretical sampling is based on specific characteristics and 
directed by evolving themes rather than focusing on predetermined populations (25). Our sampling will 
ensure participants have a wide range of experiences, relevant to answering the research questions. 
 
A sample of 20 participants for in-depth qualitative studies is anticipated to be large enough to ensure 
a broad coverage of the specific questions and to ensure theme saturation. Given the interview design 
(enrolment, 6 and 12 months), the proposed sample size (20 x 3 phases) will enable the quantity of 
data collected to remain manageable (n=60 interviews) within the timeframe to allow thorough and rich 
analyses. The longitudinal approach will allow the study to capture changes over time with regards to 
how adolescents understand VL testing. Eight (8) participatory workshops will be conducted with 20 
key stakeholders including healthcare workers with direct contact with the ALHIV and have been 
involved in viral loaf results counselling and participating clinics. 
 
Inclusion criteria  
ALHIV aged 13-19 years who are aware of their HIV status for at least six months before enrolment 
(i.e., know the infection by its name and understand some of its implications). 
ART initiation of not less than 6 months. 
Adolescents aged 13-19 with viral load threshold of <1000/uL. 
ALHIV accessing ART within the participating clinics. 
Healthcare workers with direct contact with ALHIV and have been involved in viral load result 
counselling in participating clinics. 
 
Exclusion criteria  
Unable to provide informed assent/ and parental informed consent. 
Requires urgent medical attention or has severe mental health problems that would invalidate the 
informed assent/consent process or else contraindicate participation. 
 
Data management and analysis procedures 
Quantitative data will be collected on password protected and encrypted tablets. Qualitative interviews 
will be audio recorded; hand-written notes will be taken down as back-up. The Principal applicant will 
train, supervise and support data collection. 
Quantitative data management.  
Data management will take place at CeSHHAR Zimbabwe under the direction of Jeffrey Dirawo and 
Zivai Nenguke. JD will be responsible for all data management protocols and quality assurance (QA) 
processes. Most data on this project will be computer-entered, with appropriate consistency and 
completeness checks to minimize errors and missing data. This allows data to be transmitted in real 
time to a central database, thus reducing concerns about data safety and problems with data storage. 
 
Qualitative data management.  
Audio files and notes taken during interviews will be stored securely in a folder on the server. Only 
authorised research team members will have access to this folder. All data will be stored securely in a 
manner proportionate to the volume and the sensitivity of records involved and will ensure compliance 

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with the CeSHHAR General Data Protection Regulation (GDPR), national and EU guidelines. All 
identifiers (address, telephone and names) will be stored separately and linked by a project key. They 
will be archived and released for use only for data linkage that has been approved by the participant 
and relevant ethical bodies (e.g. MRCZ), and for re-contact, where permission has been given. All 
identifiers (such as name, date of birth, location) will be removed from all internal analytical products. 
All identifiers and potentially disclosive information (such as unusual combinations of occupation and 
location) will be removed from external products. We will have written permission from participants to 
collect, store and share all types of data. 
 
Managing, storing and curating data.  
Data will be collected using tablet computers and consecutively uploaded to a cloud. To minimize errors, 
range checks and skip patterns within data entry screens will be used. The computing system is 
password protected, encrypted and only accessible to authorised study team members. Any access to 
the system is automatically recorded. Data will be managed according to International Conference on 
Harmonisation guidelines for Good Clinical Practices. Participants will receive a unique study 
identification number recorded on all forms using a pre-printed bar code and QR code. Numbers will be 
maintained by the data manager on a password protected, secure computer. Data will be uploaded into 
a password-protected database.  
 
Database files will be exported in Stata format for bi-weekly batch error checking, monthly reporting and 
analysis by the data manager. Data will be backed-up daily onto a local machine and on an external 
hard-drive weekly. Audio files will be transcribed into electronic records which will be backed-up on an 
external hard-drive after each session. All data will be kept confidential, under lock-and-key, accessible 
only to trained study staff. Participants’ data will be identified by an ID number/barcode only, and a link 
between names and ID numbers will be kept separately under lock-and-key. Paper copies of locator 
information and consent forms linked to the data through the project-generated identification will be 
stored in locked file cabinets. Participant locator information will be destroyed within 1 year of the 
conclusion of the study unless funding for long-term follow-up is sought, and consent forms within five 
years of the conclusion of the study. 
 
All samples will be labelled by an ID number/barcode that links the samples to the participant’s 
quantitative and qualitative data. Names, contact details, and other personal information will be 
removed. The results of tests will not be included on the participants’ health records. Every effort will 
be made to keep personal information confidential. 
 
All qualitative data will be collected on digital recording devices. Audio-recorded qualitative data will be 
transcribed, including relevant non-verbal communications. The audio files will be stored on the principal 
applicant and research assistant’s password-protected laptop computers. No identifying information will 
be provided to individuals transcribing the data and they will also sign confidentiality agreements. The 
transcripts will be translated verbatim into English. After translation, interview summaries will be written 
for each interview – these will be both a descriptive and analytic synopsis of the interview. Names and 
other personal identifiers will be removed from transcripts before they are entered into NVivo 10, a 
qualitative data storage and retrieval program. Transcripts will then be coded using the modified coding 
framework. Codes will be grouped and emerging themes will be identified. Analytic memos will be 
written for each theme. 
 
Metadata standards and data documentation.  
The database will be available in STATA, and can be exported to other formats. A codebook will 
accompany the data to provide secondary users with any necessary details to prevent misuse, 
misinterpretation or confusion. 
 
Data preservation strategy and standards.  
The database for the study will be maintained on the server at CeSHHAR Zimbabwe. The data manager 
will also have password protected copies of the master database of the quantitative data. The data 
manager and principal applicant (ZN) will have password protected copies of the qualitative data. Data 
will be stored electronically for at least 5 years after the end of the study. 
 

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Data security and confidentiality of potentially disclosive information 
The data will be will be analysed at CeSHHAR Zimbabwe and will adhere to the CeSHHAR Information 
Management and Security Policy which seeks to ensure information security and protect the 
confidentiality, integrity and availability of the data. The database will not store any identifying 
information.  
 
Main risks to data security.  
The main risk to the confidentiality of the information related HIV status and behaviours contained in 
the database. These risks will be managed firstly by ensuring that all copies of the quantitative database 
and qualitative data files are password protected, with access to the password restricted to those trial 
staff who need to work with the data. Secondly the data will not contain any personal identifiers and will 
use anonymised ID numbers as the unique participant identifier. The risks associated with disclosure 
of data are minimal because most data will be collected using tablets in which assessment data are 
only identified by a unique study identifier. Also, we will report study results only at the aggregate level. 
To further minimize the risk of breaching confidentiality, all study staff will be trained and certified using 
the NIH online training course in Protecting Human Subject Research Participants and will be required 
to sign a staff confidentiality agreement form, and Participant confidentiality will be ensured at 
screening, recruitment, follow-up, data entry, storage, retrieval, and analysis stages. 
 
Data sharing and access 
The study data will be suitable for sharing. We will ensure that all publications are open access to 
achieve maximum impact and that our data and dissemination materials are available at a reputable 
online data repository. Potential users will learn about the data on our CeSHHAR website and websites 
of the collaborating institutes. Our intended policy will be to make data available to bona fide 
researchers, within 12 months of completion of the study. This is to make maximum use of data 
collected using public funding while protecting the intellectual property rights of the study team (so 
allowing the study team to publish the main study results paper). We will ensure that the study 
information sheet and participant consent forms contain the information that the study data might later 
be made available to bona fide researchers to maximize the knowledge gained from this study. All 
researchers given access to the data will sign data sharing agreements which will restrict the use to 
answering pre-specified research questions. The steering committee will be responsible for overseeing 
requests for data sharing and that the researchers granted access to the data comply with the terms of 
the data sharing agreement. 
 
Responsibilities 
Data management will take place at CeSHHAR Zimbabwe led by JD under the direction of principal 
applicant. The principal applicant and research team will be responsible for ensuring good quality data 
are collected. 
 
Data analysis: Quantitative data will be analysed using STATA 15.0. Descriptive summaries and 
frequencies of social, clinical and demographic characteristics by different VL trajectories will be 
conducted. All qualitative interviews will be conducted by the PI in Shona, audio-recorded, transcribed 
verbatim, and translated into English. Iterative data collection and analysis will be conducted. Preceding 
interviews will inform subsequent interviews. Data will be uploaded, coded and summarized using a 
qualitative software package (NVivo 9.0, QSR International). Data analysis will be conducted using 
thematic and constant comparison analytical approaches (23). In the initial stages I will adopt a thematic 
approach to explore emerging themes followed by adopting a constant comparison approach within and 
across and between different participants. 
 
Ethical Considerations  
The protocol target ALHIV and healthcare workers and consent procedures will strictly adhere to the 
considerations contained in the principles of good clinical practise (GCP). The study will be conducted 
to the highest ethical standards. Ethical permission will be obtained from Medical Research Council of 
Zimbabwe. All the approvals will be sought prior to the initiation of research.  
 

12 | P a g e  
 
Informed consent  
Participants will be provided with accurate information about the study; its purpose, procedure and 
duration, including known risks and benefits by a research assistant and will have the opportunity to 
ask questions as part of the informed consent/assent process. Participants will be given at least 
72 hours to consider whether they would like to be involved in the study. If the participant is willing to 
take part in the study, researchers will schedule for an interview. Written informed consent/assent will 
be obtained from all participants and all adolescents below age 18 years will also have 
parents/caregivers’ consent. All discussions of VL testing will be based on results of DBS testing which 
is standard of care. Given that plasma VL testing is unlikely to become available it seems potentially 
undermining of existing treatment services to share these results. Ongoing psychological support will 
be available through the Africaid Zvandiri programme including with CATS and clinic-based counsellors 
if any participants get distressed during or after the interviews.  
 
Voluntary participation 
Participation in the study will be voluntary and participants are free to withdraw from the study at any 
given time without giving a reason. If participants decide not to participate or withdraw their participation 
in this study, the decision will not affect their daily life, regular care or future relations with CeSHHAR 
Zimbabwe in any way. 
 
Confidentiality  
Information that obtained from all participants will be stored in a locked filing cabinet and separately 
from any information that identifies them personally (such as consent forms). We will use a unique 
participant identification number instead of names on the study information. Only participants and the 
study team will know this number. A link log, which links the unique ID to name, will be kept in a locked 
and secure place. The information we collect may be shared with other researchers who are involved 
in this study but if shared, it will be shared anonymously. Also, research regulatory bodies (Medical 
Research Council of Zimbabwe and Research Council of Zimbabwe) can have access to research 
records. The information participants tell us will be used to come up with ideas on how to improve viral 
load testing in Zimbabwe especially around incorporating U=U into routine HIV care and support for 
ALHIV. It is anticipated that these ideas will be published and presented to CeSHHAR/EDCTP and their 
partners in order to improve the understanding of the scientific community about these issues. In any 
publication or presentation, information will be presented in such a way that participants cannot be 
identified. After study completion, information collected will be kept securely at the project office for a 
period of 5 years after all analyses and their resulting publications are complete and will then be 
destroyed. Stored blood specimens will also be destroyed then. All staff will undergo Good Clinical 
Practice (GCP) and ethics training. All people working with CeSHHAR sign a confidentiality agreement. 
This Oath requires research teams not to tell people who are not connected with this study, information 
about participants or any other information related to the study. CeSHHAR has very strict confidentiality 
procedures in place. 
 
Potential Risks to participants 
This study has minimal risks associated with participation. Participants will not be exposed to any 
additional risks from this study. Participants may be uncomfortable answering some of the questions 
but can refuse to answer any or all of the questions during the interview at any point and/or can choose 
to stop participating in the study at any time. One possible risk of being in the study could be loss of 
privacy. All the information from participants will be handled with as much privacy as possible.  
 
Benefits 
There are no direct benefits for participating in the study. Information obtained in this study will be used 
to shed more light on the whether the U=U has the potential to change the life course of ALHIV in 
Zimbabwe and on how best to incorporate it into routine HIV treatment and care. Participants will receive 
a token of appreciation valued at USD $5 for their participation in the study. The value of $5 was 
gazetted and approved by the Medical Research Council of Zimbabwe.   
 
Child protection and safeguarding 
CeSHHAR has robust and monitored safeguarding procedures in place (UNICEF and USAID). 
CeSHHAR has a ZERO TOLERANCE policy to cases of sexual exploitation and abuse of beneficiaries, 

13 | P a g e  
 
including children, particularly in the implementation of this research project. The study team and data 
collectors are expected to behave ethically and responsibly at all times and follow the CeSHHAR code 
of conduct. This means that they must not ask participants for any financial, physical or sexual favours 
or child safeguarding violations in return for taking part in this research. Its mandatory for research 
teams to successfully undertake and complete training on prevention of sexual exploitation and abuse 
and safeguarding of children. In addition, regular background checks are conducted on all who work on 
the project. If participants experience any abuse, harassment or neglect by a research team member 
that are free to contact the study Safeguarding Lead. They may also raise a safeguarding concern 
directly with CeSHHAR Designated Safeguarding Officer or with the Medical Research Council of 
Zimbabwe. All the contact details will be provided on the consent/assent forms. Should any illegal or 
reportable activities related or not related to the study be identified during the study period, research 
assistants will be instructed to report these events to the relevant authorities including the Medical 
Research Council of Zimbabwe in accordance with CeSHHAR guidelines and the incidental findings 
policy guidelines. CeSHHAR is ethically obligated to report any instances of child abuse. 
 
Expected outcomes and impact on programmes and policies  
The study will provide scientific evidence on whether routine VL testing using DBS as available in LIC 
can provide sufficiently robust evidence of ‘undetectability’ and on the variability of an individual’s 
virological response over 12 months and between those considered undetectable (<1000) and those 
undetectable and untransmissible (<200). The study will assist in developing an evidence-base to 
support the U=U integration into standard of care and to maximise the opportunities that the investment 
in viral load monitoring could bring for adapting and strengthening care and support to improve 
adolescent HIV outcomes. It will generate peer-reviewed publications and educational resources. 
 
Dissemination and exploitation of results 
The World Health Organization (WHO) and more than 750 other organisations have endorsed the U=U 
message, leading to calls for healthcare providers to routinely talk to their patients about U=U although 
even in high income setting stigma remains a barrier to dissemination. To date very few ALHIV in 
Zimbabwe are aware of the U-U message and very few service providers are confident to routinely 
communicate U=U to their patients. Such widespread unawareness and misinformation surrounding 
U=U makes knowledge dissemination critical and urgent. The findings of this study will be disseminated 
at district, national, regional and international level to health care providers, people including 
adolescents living with HIV and to the broader public. 
 
At district level the findings will be first disseminated through a series of participatory workshops (n= 
maximum of 4), with healthcare workers, policy makers, carers and ALHIV in the study areas. The 
workshops will be facilitated by the research team to present the findings, including diversity and 
disagreement in what would constitute an appropriate approach of sharing the information with a wider 
population. The aim of this stage would be to collaboratively develop a working consensus on how this 
information could be disseminated. The participatory workshops will also explore the format in which 
the findings, for example, whether to produce electronic or hard copies of graphic novels. At national 
level the findings will be disseminated through the existing MoHCC partners’ forum meetings with the 
participation of key stakeholders, including Joint UN Team on HIV/AIDS (JUTA), NAC, MoHCC, and 
NGOs. We will work with MoHCC to get the messaging incorporated into their implementation 
guidelines. The findings will be disseminated to service providers at various medical professional 
societies across the spectrum of care from Nursing (Zimbabwe Nursing Association) to general 
practitioner and specialist medical bodies such as the Zimbabwe Medical Association (ZIMA). This will 
be done through sessions at the annual conferences or presentations during monthly CME meetings.   
 
The findings will also be disseminated to the research community in Zimbabwe using the UNICEF 
supported Brown bag meetings and the Medical Research Council of Zimbabwe annual forum. The 
report of the findings will be shared widely and made available in both soft and hard copies and will be 
produced in diverse versions, fact sheets and briefs to accommodate the needs of diverse audiences. 
Presenting the findings in different formats will help policy makers and program implementers to 
critically analyse and identify potential service delivery needs as well as linkages with other services for 
ALHIV. 

14 | P a g e  
 
 
Central to making U=U a reality for ALHIV the principal applicant will work with the MoHCC AIDS/TB 
technical working group under the mentorship of Dr Sarah Bernays who has considerable expertise in 
translating research findings among young people into relevant and accessible formats to disseminate 
the U=U messages into differentiated models of care (DMOC) for ALHIV. The findings will be 
disseminated to ALHIV countrywide through our partner Africaid Zvandiri’s CATS/YMM programmes. 
Africaid is currently supporting 960 trained, mentored Community Adolescent Treatment Supporters 
(CATS) across 51 districts of Zimbabwe. The CATS are integrated within 613 health facilities and each 
manage a caseload of children, adolescents and young people living with HIV. CATS use a range of 
adolescent-focused IEC materials which have been developed by Africaid in partnership with MoHCC 
and UNICEF and these have now been housed on the newly developed app for CATS, known as The 
Hub. Developed educational resources will be uploaded on the HUB. Africaid currently has active 
relationships with multiple stakeholders at district, provincial, national and regional levels, who will serve 
as strategic partners as the new innovation is rolled out. 
 
CeSHHAR runs the Sisters with a Voice programme, on behalf of National AIDS Council and Ministry 
of Health and Child Care. In 2014, CeSHHAR developed a programme for younger women who sell 
sex (the Young Sisters Programme) up to 40% of who are HIV positive, reaching over 29500 adolescent 
girls and young women by June 2020. The Young Sisters Programme works with younger peer 
educators and has age specific and relevant community mobilization materials to encourage younger 
women to attend services. The findings will also be incorporated into the mobilization materials used by 
the peer educators.  
 
At regional and international level results will be disseminated at regional forums, including making 
publications in recognized international journals and international conferences. Including the biennial 
EDCTP Forum in 2022. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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