The Effect of Undetectable Equals Untransmittable (U=U) Messaging on HIV Testing Uptake Among South African Men: a Randomized Trial.
Phase: NA
Conditions: HIV/AIDS
Sponsor: University of Pennsylvania

 
 
 
 
 
 
 
 
 
The effect of undetectable equals untransmittable (U=U) messaging on HIV testing uptake among South 
African men: a randomized trial.  
[Short title: U=U] 
 
 
 
 
 
Protocol Version: 1.0 
Version Date: October 31, 2019 
NCT04364165 
 
 
 
 
Study Sponsors 
Bill and Melinda Gates Foundation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Question: 
Can messaging about being undetectable equals untransmittable (U=U) increase HIV 
testing uptake in men? 
Purpose: 
HIV testing is the gateway to HIV prevention, treatment and HIV control, but uptake is 
suboptimal in South African men. Consequently, men have poor HIV outcomes including 
lower HIV testing uptake, lower ART initiation and a lower proportion achieving viral 
suppression. This study will investigate the effect of participatory, user-designed 
messaging to increase knowledge about U=U on HIV testing uptake in men in the 
Klipfontein Mitchells Plain (KMP) district in Cape Town, through a randomized trial design.  
Primary 
objectives: 
1) To develop U=U messaging that encourages HIV testing uptake in men using a 
participatory, user-centered design. Messaging will seek to assuage the fears of testing 
HIV positive by conveying the message that HIV treatment makes it possible for HIV 
positive people to be untransmittable and to live normal lives. 
 
2) To investigate the effect of U=U messaging on HIV testing uptake in men compared 
with the standard of care messaging.   
Design: 
The study will be conducted in two phases:  
 
Phase 1 is a participatory, human-centered design framework that will be used to develop 
U=U messages to increase HIV testing uptake in men.  
 
Phase 2 is a cluster randomized trial that will determine the effect of U=U messaging on 
HIV testing uptake. Men in the intervention group will receive invitation cards for mobile 
HIV testing that contain U=U messages. Men in the control group will receive invitation 
cards for mobile HIV testing that contain standard messaging. Mobile clinic days (i.e. 
clusters of men receiving invitation cards at one site on one day) will be the unit of 
randomization. 
 
The primary outcome will be HIV testing uptake at a community-based mobile clinic. 
Secondary outcomes will include the proportion of males tested who are HIV-positive and 
newly HIV positive. 
Study 
setting and 
population: 
KMP is a resource-limited, densely populated, high HIV disease burden area in Cape Town, 
where the use of health services among men is sub-optimal. Recruitment will be 
conducted by trained mobile clinic staff at high foot-traffic sites in the KMP community. 
Recruitment efforts will focus on young men in multiple mobile testing sites that are 
located in areas within KMP where there is a high burden of HIV.  
Study size: 
In phase 1, approximately 20 men will be invited to participate in formative research 
through insight workshops for U=U message development. After the initial message 
development, about 20 more men will be invited to give feedback and suggest 
improvements to ensure understanding and acceptability of the messaging.  
 
In phase 2, 40 clinic days will be randomized to intervention or control, with 100 men in 
the vicinity of the Tutu Tester receiving invitation cards for testing on each day (N=4,000). 
Process: 
In phase 1, mobile clinic staff will invite men to participate in an insight workshop at a 
community location. Men who agree to participate will respond to questions and take 
part in group brainstorming activities that will inform development of U=U messaging. 

 
 
The research team will map the ideas and themes and use these to create an invitation to 
men. Their feedback will be used to calibrate the messages for the phase 2 trial.  
 
In phase 2, a trained recruiter will deliver a U=U invitation message on intervention days 
and standard HIV testing messaging on control days to encourage HIV testing at a mobile 
clinic. On each day, recruiters will deliver about 100 invitation cards to young men in the 
vicinity of the mobile testing van where free HIV testing will be available. 
Duration: 
Phase 1 will run for one month. Phase 2 will run for 3 months. 
Analysis: 
In phase 1, acceptability will be measured through workshop feedback. In phase 2, a chi-
squared test will estimate the effect of U=U messaging on HIV testing uptake compared 
with standard of care. We will also compare HIV positivity by study arm. Logistic 
regression analysis will model the effects of participant demographics, binary line of sight 
of mobile clinic, and time of day on testing uptake and time to presentation at the clinic.  
Abstract:  
HIV testing is the gateway to HIV prevention, treatment and HIV control, but uptake is 
suboptimal in South African men. Consequently, men have poor HIV outcomes including 
lower HIV testing uptake, lower ART initiation and a lower proportion achieving viral 
suppression. This study will investigate the effect of participatory, user-designed 
messaging to increase knowledge about U=U on HIV testing uptake in men in a high HIV 
disease burden area in Cape Town, through a clustered experimental design. This project 
has two main objectives. The first is to develop a U=U message that encourages HIV 
testing uptake in men using a participatory, user-centered workshops. Messages will seek 
to assuage the fears of testing HIV positive by conveying the message that HIV treatment 
makes it possible for HIV positive people to be untransmittable and to live normal lives. 
Second, the study will investigate the effect of U=U messaging on HIV testing uptake in 
men compared with the standard of care messaging. This study will utilize the DTHF Tutu 
Tester program, a mobile HIV clinic, to trial this new messaging intervention.     
 
 
 

 
 
1. Introduction 
South African men have suboptimal levels of HIV testing, antiretroviral therapy (ART) initiation, retention and 
survival on treatment and have poorer HIV outcomes than their female counterparts, suggesting that these 
men remain underserved in the context of the HIV response (Cornell, Cox, & Wilkinson, 2015; Cornell et al., 
2012; Cornell & Myer, 2013; Johnson et al., 2017). Only 78% of men living with HIV know their status, 67% of 
those men are on ART and 82% were virally suppressed in 2017 (HSRC, 2018). While the increased focus on 
key populations, pediatrics, girls and young women has produced a better understanding of their sexual 
health needs and improved HIV related outcomes (Haal, Smith, & van Doorslaer, 2018), the needs of men in 
South Africa remain understudied.  
 
ART-based interventions have consistent efficacy and effectiveness data and represent the standard of care 
for both HIV prevention and treatment in recommendations by UNAIDS, WHO, and the Ministry of Health in 
South Africa (Bekker et al., 2016; Meintjes et al., 2017). Taking daily ART eliminates enough of the virus so 
that HIV cannot be detected via viral load testing (Eisinger, Dieffenbach, & Fauci, 2019). Those who have an 
undetectable viral load cannot transmit the virus to sexual partners or through giving birth (Davies et al., 
2018; Eisinger et al., 2019), commonly referred to as U=U (undetectable viral load equals untransmittable 
virus). Typical communication about and delivery of HIV testing and ART in South Africa has primarily focused 
on "access" (Sharma, Barnabas, & Celum, 2017) as opposed to promoting uptake and adherence as a 
rewarding experience. U=U is a message that promotes the reward of knowing one’s status (peace of mind) 
and starting on treatment if diagnosed with HIV to remain healthy and alleviate the stress of HIV transmission 
to sex partners. The U=U message has been effectively promoted in Europe and North America where people 
living with HIV describe feeling free of internal and external stigma as a result (The Lancet HIV, 2017). 
However, awareness of the large prevention effects of ART remains low in many parts of sub-Saharan Africa. 
Recent studies have shown that many men are unaware that ART can dramatically reduce the likelihood of 
HIV transmission.  
 
While ART-based interventions are efficacious, the ongoing adverse outcomes among men suggest 
implementation challenges, including adoption and adherence. Findings from implementation research have 
recommended differentiated services, focused on dedicated testing and treatment programs tailored to the 
needs of men, to improve care outcomes (Fakoya, Dybul, & Sands, 2019; Sharma et al., 2017). Yet, there are 
few rigorous evaluations on the impact of services targeting men, particularly in HIV endemic, low- and 
middle-income countries. 
 
The behavioral economics (BE) health model (Rice, 2013) suggests that the context in which decisions are 
made influence those decisions. Health messaging frequently fails to adequately influence behavior because 
it appeals to dread, which can thwart adaptive health-seeking behavior and lead to vulnerability denial 
instead (Arndt & Goldenberg, 2017; Millar & Millar, 1995). The BE health model proposes reframing the 
message to align with desirable outcomes, which eases the decision making context (Rice, 2013). By 
reframing the message to align with reward-seeking behavior instead of disease detection, the decision and 
resultant behavior is simplified. Since the U=U message complements this theoretical framework, the 
overarching goal of the proposed project is to design and adapt a U=U message and to describe its impact on 
improving HIV testing uptake among men 15 to 39 years old in a high HIV disease burden community in Cape 
Town, South Africa. 

 
 
 
2. Methods 
2.1. Objectives – HIV testing is the gateway to HIV prevention, treatment and HIV control, but uptake is 
suboptimal in South African men. Consequently, men have poor HIV outcomes including lower HIV testing 
uptake, lower ART initiation and a lower proportion achieving viral suppression. This study will investigate 
the effect of a participatory, user designed message to increase knowledge about U=U on HIV testing uptake 
in men in the Klipfontein Mitchells Plain (KMP) district in Cape Town, through a randomized trial design. The 
primary objectives of this study are 1) to develop a U=U message that encourages HIV testing uptake in men 
using a participatory, user-centered workshop, and 2) to investigate the effect of U=U messaging on HIV 
uptake in men. The primary outcome will be HIV testing uptake at a community-based mobile clinic. 
Secondary outcomes will include the proportion of males tested who are HIV-positive (and newly HIV 
positive).  
 
2.2. Study Duration and Setting – The study will be 12 months in duration including the preparation period, 
Phase 1, Phase 2 and analysis. The study will take place in KMP, a resource-limited, densely populated, high 
HIV disease burden area in Cape Town, where the use of health services among men is sub-optimal. The 
DTHF Tutu Tester offers mobile HIV testing clinic days in various locations in the region, including KMP. 
Trained recruiters stationed at the Tutu Tester mobile clinic sites distribute invitation cards inviting men to 
visit the mobile clinic for a voluntary HIV test. The intervention will utilize the Tutu Tester to trial a new 
messaging intervention. DTHF will build upon their existing activities and relationship with the local 
community to implement this study in KMP. DTHF will complete all data collection. Penn will not take part in 
data collection, nor will Penn interact with the subjects.  
 
2.3 Inclusion criteria and recruitment – Recruitment will be conducted by trained mobile clinic staff at 
selected high foot-traffic sites in the KMP community. Men in high HIV disease burden areas in KMP will also 
be recruited through community outreach activities to participate in the study. Inclusion criteria for the study 
will be males at least 18 years of age within the vicinity of the mobile Tutu Tester HIV testing van. 
The study will consist of two phases: 
 
2.4. Phase 1  
2.4.a. Design – In phase 1, we will develop a U=U message using a participatory, human-centered design 
framework. There is increasing recognition that intervention design should incorporate viewpoints from 
the target audience to enhance collaboration, improve acceptability, and increase uptake (Byrne & 
Sahay, 2007; Mabunda, Khoza, Van den Borne, & Lebese, 2016). Thus, this participatory research will 
include workshops of approximately 40 men from a population that may potentially be recipients of the 
intervention.  
 
2.4.b Process – Mobile clinic staff will invite approximately 20 men from high traffic locations in the KMP 
region to participate in design workshops for the development of a U=U message, that even if HIV 
positive they can be untransmittable, to normalize HIV and mitigate the fears of testing HIV positive. 
Each workshop participant will be asked to give informed consent, and then a trained facilitator will 
present the U=U message to the participants and facilitate the group to develop a message that 
resonates with them in language that is sufficiently colloquial to enable easy understanding among local 

 
 
men. Their suggestions and statements will be recorded in written form verbatim and used to generate 
the invitation message. Once developed, the message will be presented to approximately 5-10 more men 
from within the community who will be invited to rate and suggest improvements to the acceptability of 
the prototype message. Following this exercise, the message will be fine-tuned and the final message 
will be printed on invitation cards for the phase 2 randomized trial.  
 
2.5. Phase 2  
2.5.a. Design – In phase 2, a cluster randomized trial will be conducted to determine the effect of the 
U=U message on HIV testing uptake. Individual mobile clinic days (i.e., the tester being parked at one site 
for one day) will serve as the unit of randomization, with each site day being assigned to the treatment 
or control condition via a computer-generated randomization process. Randomization will be stratified 
by testing location so that an equal number of clinic days at each location within KMP are assigned to 
each study group. On each mobile clinic day during the study, men in the vicinity of the mobile clinic will 
be offered invitation cards for same-day testing. Invitation cards will have unique identification codes. 
The information content on the referral cards and the mobilization approach will vary depending on 
condition. 
 
2.5.b. Intervention group – Following phase 1, the final U=U messages will be printed on invitation cards 
to be distributed at mobile testing sites. Messages will seek to assuage the fears of testing HIV positive 
by conveying the message that HIV treatment makes it possible for HIV positive people to be 
untransmittable and to live normal lives. Messages will encourage men to come in for HIV testing at the 
mobile clinic on the same day. A mobile clinic recruiter will deliver the invitation and share a brief script 
explaining U=U.  
 
2.5.c. Control group – The standard invitation cards used at the Tutu Tester contain basic information 
encouraging HIV testing. Messages will encourage men to come in for HIV testing at the mobile clinic on 
the same day. A mobile clinic recruiter will deliver the invitation and share a brief script including the 
standard Tutu Tester message.  
 
2.5.d. Study Instruments: Invitation cards – After mobile clinic recruiters deliver the invitation card and 
scripted verbal message, they will request the participant bring the card with them if they return to test. 
The card will contain the distribution date and time and recruiter information. The recruiter will also 
separately record the date and time the invitation was delivered, and whether the mobile clinic was 
visible on the card. When the participant returns to visit the mobile clinic, the recruiter will request the 
card and record the date and time of presentation as well as the unique identification code on the card. 
The participant will then be invited by a counsellor into a cubicle in the mobile clinic to complete a rapid 
HIV test after the counsellor consents the participant.  
 
2.5.e. Study Instruments: Questionnaire – Key information will be collected from participants who come 
for testing via tablet. This intake will be completed immediately after an individual arrives at the Tutu 
Tester and presents their card. This will include a confirmation of inclusion criteria to ensure that the 
men are at least 18 years old. Other key information will include: type of message (intervention or 
control), line of sight, date and time of message delivery, date and time of presentation for HIV testing, 

 
 
time taken to get tested, age, whether the participant brought a peer or partner, whether the person 
stayed for an HIV test or not and HIV status. Several open-ended questions to learn about men’s 
perceptions of the U=U messaging may also be asked including: if they had any previous understanding 
of U=U, what they think about the message and how this might change their behavior. The DTHF team 
will translate and validate the questionnaire and confirm its cultural appropriateness. As per standard 
operating procedure, those who test HIV positive will receive post-test counselling and assessment by a 
nurse and will be referred to their preferred clinic facility for HIV treatment.  
 
2.5.f. Sample size and power calculations – In phase 2, the DTHF Tutu Tester will circulate between 
approximately four different locations within KMP. The Tutu Tester will be based in only one location on 
any given day. Clusters will comprise men who receive invitation cards on the same clinic day. Power 
calculations assumed 8 percent HIV testing uptake among men in the control group (based on two 
operational pilots conducted by our team) and an intraclass correlation of 0.02. With 40 clinic days in the 
study and 100 men within the vicinity of the Tutu Tester receiving invitation cards on each clinic day, we 
will have 80 percent power to detect a difference in HIV testing between groups of at least 5 percentage 
points.  
 
2.5.g. Outcomes and analysis – The primary outcome will be HIV testing uptake, measured at the Tutu 
Tester based on presentation of the invitation cards. A chi-squared test will be conducted to estimate 
the effect of the intervention on HIV testing uptake. Logistic regression models will also be estimated to 
control for location, time of day, and distributor effects.  Additional outcomes examined will include the 
proportion of males tested who are HIV-positive (and newly HIV positive). 
 
3. Protection of Human Subjects   
3.1. Ethics – The study will be reviewed and approved by the University of Cape Town Health Science 
Research Ethics Committee (HREC). The protocol meets the Common Rule criteria as the research study is 
expected to pose no more than minimal risk to subjects AND the procedures fall within “category 7” outlined 
by the Office for Human Research Protections (OHRP) and in compliance with 45 CFR 46.110(b)(1). Our 
research focuses on assessing the uptake of HIV testing at a mobile clinic. The overall methodology of the 
protocol is the employment of workshops and a randomized trial of two HIV testing invitations. This type of 
behavioral study is best grouped or otherwise described as being “category 7” using the OHRP designation 
system. There are support services for participants at the site, including staff who are able to counsel 
participants on site, or telephonically, as well as established referrals to external counselling resources. 
Participation in the study is voluntary.  
 
Participants who present for an HIV test will sign individual voluntary written informed consent form before 
enrolling. This consent will invite them to participate in the study, complete the questionnaire and complete 
an HIV test. Each participant will have time to ask any questions or raise any concerns they might have. 
Participants may refuse participation, which will not affect further treatment and any reasons for non-
participation will be recorded. Participants will have the option to choose not to participate in the study at 
any time. All information is anonymous and will be kept confidential. The name of investigators who are 
responsible for conducting the study and direct contact details (telephone, address, e-mail) will be made 
available on the informed consent forms. The Site Investigator or designee will maintain, and store securely, 

 
 
complete, accurate, and current study records throughout the study, in accordance with local regulations. 
All records will be stored for five years from the beginning of the study. 
 
3.2. Risks – There are minimal risks to study participants. The primary risks involved in study participation are 
inadvertent loss of confidentiality. Procedures will be implemented to ensure maintenance of privacy, 
confidentiality, and security of the data obtained. Although the study site will make every effort to protect 
participant privacy and confidentiality, including conducting interviews in a private space, it is possible that 
participants’ involvement in the study could become known to others. Social harms will be monitored and 
documented throughout the duration of the study. Should additional support be required for some 
participants due to study-related harms, referrals will be made to community-based services as needed.  
 
3.3 Benefits – Participants will benefit from the hearing a U=U message adapted for the context. Participants 
and others may benefit in the future from information learned from this study. Participants may appreciate 
the opportunity to collaboratively contribute to the field of HIV research. Information learned in this study 
may lead to the development of effective messaging interventions to prevent onward HIV transmission in an 
HIV endemic community. Participants who test HIV positive will be referred to the nearest clinic for rapid 
ART start. We will follow up participants to ensure they seek referral and start ART.  
 
3.4. Study Discontinuation – The study may be discontinued at any time by DTHF and/or the local Ethics 
Committees, as part of their duties to ensure that study participants are protected. 
 
3.5. Data Security, Storage and Management – Information about study subjects will be kept confidential and 
all men who choose to participate will complete an informed consent form. DTHF and UPenn will jointly 
create standard operating procedures for electronic and paper data security and confidentiality procedures 
at collection, transfer, entry and storage levels, and will only release this information to study team members 
who have IRB approval. All study data will remain securely stored by DTHF for the duration of the study. 
University of Pennsylvania investigators and managers listed on the UPenn IRB application will have access 
to de-identified data only. No participant identifiers will included on any data forms; names and signatures 
will only be on the consent forms, which will be kept under lock and key by the DTHF study. At the end of the 
study, data will be kept for up to 5 years for electronic version, and up to 2 years for paper forms, including 
consent forms at the DTHF office.  
 
3.6. Resources Necessary for Human Research Protection – The DTHF Tutu Tester will utilize their staff of 
trained recruiters to implement the study. No data collection will occur prior to appropriate human subjects 
training sessions and competency assessments of all involved research staff. UPenn and DTHF will work 
jointly to ensure that available resources, including funding and timeline, are commensurate with research 
objectives. Not only does UPenn have excellent facilities for research, but DTHF has a positive track record 
of conducting rigorous evaluations in South Africa.  
 
4. Limitations  
Stigma and denial remain significant problems in HIV endemic communities in South Africa. People are often 
willing to receive STI tests and screens as well as testing and screening for other chronic health conditions. 
However, people are less inclined to test for illnesses associated with death because of the possible 

 
 
implications, that is, finding out that one is dying. Counterintuitively, discovering that one has a potentially 
life-threatening condition may actually save one’s life because of the medico-technical advances aimed at 
intervening in life threatening situations. The medico-technological advancements help people to live full 
and healthy lives where in decades previous, they would have faced significantly reduced life expectancy. 
Tailored messaging aimed at supporting desirable outcomes may circumvent the stigma and denial 
associated with testing and initiating ART. The sampling of the study is biased because the mobile clinic 
actively targets men in high disease burden communities in Cape Town. Furthermore, while the services are 
provided in communities with high HIV prevalence, it is difficult to access those who chronically avoid 
diagnostic services, or who are unwilling to acknowledge their risk. It’s possible that this intervention will not 
reach the most vulnerable men, given these access behaviors and therefore be somewhat biased as a result. 
However, the mobile clinic was developed in response to men’s recommendations to increase access and 
acceptability of sexual health services for men.  
 
5. Conclusion 
Reversing and eradicating the HIV epidemic is dependent upon a treatment cascade that identifies and tests 
at-risk populations, linkage into care, adherence to treatment and consequent undetectable viral loads. If 
U=U messaging increases HIV testing over standard messaging, U=U should be used as part of a multi-
pronged intervention package to improve men’s entry into the prevention and treatment cascade. 
Considering multiple level interventions is imperative because they have been found to significantly increase 
rates of earlier testing, linkage to care and drug adherence when compared to single mode interventions. 
Tailored messaging, mobile clinics, and early ART initiation may be a valuable addition to primary healthcare 
as they reach people earlier on in their infection, decongest conventional healthcare facilities, encourage 
healthy behavior, and facilitate retaining clients over time.  

 
 
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