Innovative Tools to Expand HIV Self-Testing
Phase: EARLY_PHASE1
Conditions: HIV/AIDS, Sexually Transmitted Diseases
Sponsor: Washington University School of Medicine

 
 
COVER PAGE 
Title: Innovative Tools to Expand HIV Self-Testing (I-TEST) 
 
Posting ID: 30347 
 
NCT Number: NCT04070287 
 
Document: Study Protocol and Statistical Analysis Plan 
 
Document Date: July 21th, 2021 Version: 1.0 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Methods 
 
Study aim 
Study objective 1: To evaluate the effectiveness of youth participatory interventions on HIV 
testing and other key prevention services among at-risk, HIV-negative youth (14-24 years old) 
Hypothesis: Youth participatory interventions will increase HIV testing and preventive service 
use 
 
Study objective 2: To train youth-friendly health facilities on how provide youth-friendly health 
services to study participants referred to the facilities for additional sexually transmitted 
infections. For participants in the research study, data collection at the trained youth friendly 
health facilities will be supervised and performed by the Nigerian Institute of Medical Research. 
Youth friendly facilities will be trained using the World Health Organization's guidelines for 
youth-friendly clinics as well as the Nigerian Institute of Medical Research Protocol for 
administrative encounter data.  
 
Study design 
We conducted a pilot, quasi-experimental cohort study to evaluate five different models of 
service delivery across seven sites as part of the Innovative Tools to Expand Youth-friendly HIV 
Self-Testing (I-TEST) study, known locally as 4 Youth by Youth (4YBY). The trial was 
registered with ClinicalTrials.gov (NCT04070287). 
 
Study procedure 
Step 1: Participant enrollment. This will involve recruiting youth to participate in the pilot study. 
Participant recruitment strategies will include: social media, online, event- and venue based, 
participant referral, and walk-ins at study clinics. Participant enrollment will be completed by 
study team. 
 
Step 2: Intervention implementation. Following participant recruitment and enrollment in the 
study. Study participants will be assigned to one of the 5 youth participatory interventions 
focused on expanding the uptake of HIV self-testing and key HIV prevention services. The pilot 
intervention implementation would occur for 6 months. NIMR will provide local training on HIV 
prevention to the five participatory interventions following their existing guidelines. The 
participatory interventions will be conducted in the locations of the five teams who emerged as 
winners from the innovation boot-camp. 
 
• Intervention 1: This involves using “SMART Pack” a HIV self-testing kit to promote 
uptake of HIV self-testing among young people at community centers. The SMART pack 
is a re-branded and repackaged box for HIV self-testing kits. The intervention aims to 
promote distribution of HIVST kits through in institutions, vocational centers, and social 
media platforms. The intervention would also include a referral system, where 
participants provided with the HIV self-testing kits are provided with information with 
youth-friendly health facilities for uptake of testing for sexually transmitted infections. 
The intervention would be promoted using flyers at community events and schools. The 
flyers will provide information on the SMART pack and the location where the pack can 

be obtained for individuals who are interested. For this pilot study, the intervention will 
be implemented in Yaba local government area in Lagos state. 
 
• Intervention 2: The intervention involves using “Luv Box” a box that include personal 
hygiene products and HIV self-testing kit as strategy to promote uptake of HIV testing 
among young people. The Luv box is packaged in two colors: blue and pink. The 
LUVBox would be made available in supermarkets, on-line stores, mini-marts, 
pharmacies, neighborhood stores and markets, for easy accessibility in hard to reach 
areas. The intervention would be promoted using flyers at community events and schools. 
The flyers will provide information on the "Luv Box" and the location where the pack 
can be obtained for individuals who are interested. For this pilot study, the intervention 
will be implemented in Yaba in Lagos state. 
 
• Intervention 3: The intervention involves using a program program called “Bili” that 
leverages community youth events such as football matches as a strategy to promote the 
uptake of HIV self-testing among young people. The HIV self-testing kits will be 
available for interested individuals at the community youth events. These events and 
information the HIV self-testing kits will be on flyers that would be promoted at 
community centers and schools. For this pilot study, the intervention will be implemented 
in Ngenevu/Bunker communities in Enugu state.  
 
• Intervention 4: This intervention involve using “BeterDoc Safety kits” that includes HIV 
self-testing kit, location and phone number to the health centers in the community as a 
strategy to promote update of HIV self-testing among young people. The intervention 
would be promoted using flyers at community events and schools. The flyers will provide 
information on the "BeterDoc Safety Kits" and the location where the pack can be 
obtained for individuals who are interested. For this pilot study, the intervention will be 
implemented in Ibadan, Dugbe and Agbowo in Oyo state. 
 
• Intervention 5: This intervention “IUNGO” involves using a program utilizes community 
vocational skills training centers to promote uptake of HIV self-testing among young 
people. The intervention would be promoted using flyers at community events and 
schools. The flyers will provide information on the HIV self-testing kits and the location 
where the pack can be obtained for individuals who are interested. For this pilot study, 
the intervention will be implemented in Akure South, Orita-Obele, Ipinsa, Ilara Mokin 
and Ijare in Ondo state. 
 
Please note that these participatory interventions will only provide HIV self-testing kits and 
instructions of how to perform the test to participants. They will also provide referral coupons to 
youth friendly centers for sexually transmitted infections (STI) screening and treatment and 
preexposure prophylaxis (PrEP) awareness and referral for at-risk youth. The referral coupons 
are intended to provide study participants information on trained youth friendly centers that are 
involved with the research. The referral coupons give the study participants access to other 
sexually transmitted infections (STI) screening and treatment and pre-exposure prophylaxis 
(PrEP) awareness and referral at these health facilities. The intervention only provide 
participants with the HIV self-testing kits and then refer them to youth-friendly health facilities 

for other testing services. The intervention does not involve monitoring HIV self-testing 
procedure, we will only be asking for self-reported HIV testing and other sexually transmitted 
diseases testing. 
 
These youth friendly centers are currently working in partnership with our local partners, the 
Nigerian Institute of Medical Research to provide youth-friendly health services to young people 
in Nigeria (See Step 4). Trained staff at the centers will record administrative encounter data that 
will capture participants self-reporting of HIV self-testing. Trained staff will also perform STI 
screening and treatment as well as PrEP referral. All individuals diagnosed with HIV, will be 
promptly linked to care with the PEPFAR-supported clinical services provided by the Nigerian 
Institute of Medical Research. Please note the staff will be trained in Step 4 of this study. 
 
Step 3: Baseline data collection. After allocation of participants into the intervention, study 
team will collect baseline data on HIV testing history, sexual behavior history, youth 
participation experience, and other related outcomes will be collected from recruited participants. 
Participants mobile phone numbers will also be collected as tracking information for follow-up 
and retention in a coupon format. The mobile phone numbers would be used to contact study 
participants through text messages and phone calls. These contacts would serve as reminders for 
participants to participate in follow-up data collection. The mobile phone service charge would 
be covered by the research. No other personal identifiers will be collected and no biological 
specimens will be collected at baseline. We will obtain informed consent before proceeding with 
any data collection. 
 
Step 4: Health facilities training. For the purposes of this research study, the Nigerian Institute of 
Medical Research team would provide training to youth-friendly health centers currently 
working with the Nigerian Institute of Medical Research based on the World Health 
Organization guidebook for youth-friendly health services. The training would be to ensure that 
these health facilities are trained to provide youth friendly services to participants who be 
referred to receive STI screening, STI treatment and PrEP awareness and referral. Following the 
training, the NIMR research team would in charge of collecting data to record record participants 
HIV self-testing uptake as well as uptake of STI screening, STI treatment and PrEP awareness 
and referral. 
 
Step 5: Follow up surveys: At 3- and 6-months post intervention implementation, study team will 
collect similar baseline data from study participants. The follow-up survey will assess HIV 
testing, sexual behavior history, youth participation experience 
and other related 
 
Statistical analysis 
1. We will assess the effect of participatory intervention on uptake of testing and prevention 
services using pre-post design. Specifically, baseline and follow-up survey data will be 
compared to assess trends in test uptake and linkage to prevention services. Bi-variate 
analyses will be conducted by comparing proportions of youth reporting a behavior 
between baseline and follow-up, using chi-square statistics. We will also analyze by 
intent to treat; participants who are lost or withdraw from the study will be considered 
failures in analysis of uptake of the particular intervention or service of interest. 

 
2. We will assess factors associated with test uptake and linkage to related preventive 
services. This will be tested as a series of hypotheses using measures related to socio-
demographic variables as well as key variables collected such as sexual behavior history 
and youth participation. A series of logistic regression analyses at baseline will identify 
significant correlates of HIV testing and linkage to prevention, focusing hypothesis 
testing on the measures collected. At completion of the study, the analyses can be 
extended to all data (baseline plus 3- and 6-month follow-ups for HIV-negative 
participants and baseline plus 3 month follow-ups for newly infected participants). The 
basic approach to analyzing longitudinal data will be generalized estimating equations 
(GEE), which accounts for correlation of the data (repeated observations for the same 
individuals) and both time-dependent and time independent Covariates. 
 
Ethical consideration 
Ethical approvals for the study were granted by the Saint Louis University and the NIMR 
Institutional Review Boards.