HIV Self-Testing to Improve the Efficiency of PrEP Delivery
Phase: NA
Conditions: HIV-1-infection
Sponsor: University of Washington

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STUDY PROTOCOL  
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HIV self-testing to improve the efficiency of PrEP delivery 
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Version 1.7 
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April 18th 2019 
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Funding: 
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United States National Institutes of Health 
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PROTOCOL TEAM 
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University of Washington, Seattle, USA 
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Jared Baeten, MD, PhD (Co-PI) 
 
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Ruanne Barnabas, MBChB, DPhil 
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Deborah Donnell, PhD 
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Katrina Ortblad, ScD, MPH 
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Kenneth Mugwanya, MBChB, PhD, MS 
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Jomo Kenyatta University of Agriculture and Technology Nairobi, Kenya 
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Kenneth Ngure, PhD, MPH (Co-PI) 
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Elizabeth Irungu, MBChB, MPH 
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Kenya Medical Research Institute, Nairobi, Kenya 
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Nelly Rwamba Mugo, MBChB, MMed, MPH 
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Massachusetts General Hospital and Harvard Medical School, Boston, USA 
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Jessica Haberer, MD, MPH  
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Table of Contents 
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PROTOCOL  SUMMARY ............................................................................................................... 6 
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BACKGROUND/RATIONALE ................................................................................................ 8 
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Importance of the problem ...................................................................................................... 8 
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PrEP is efficacious and safe for HIV-1 prevention. ................................................................. 8 
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Adherence is key to PrEP efficacy. ......................................................................................... 8 
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Point-of-care HIV-1 testing is a standard component of PrEP delivery. ................................ 9 
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Self-testing offers an innovative way to test for HIV-1 .......................................................... 10 
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No studies have put HIV-1 self-testing and PrEP together. ................................................. 10 
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INNOVATION ....................................................................................................................... 11 
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HIV-1 self-testing in PrEP delivery has not been formally studied ....................................... 11 
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Differentiated care models of PrEP delivery are needed ..................................................... 11 
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Blood-based HIV-1 self-tests are new .................................................................................. 11 
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PRELIMINARY RESULTS ................................................................................................... 12 
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PrEP is effective and safe for prevention .............................................................................. 12 
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Costing studies and cost-effectiveness modeling. ................................................................ 13 
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METHODS ............................................................................................................................ 13 
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Study Aims............................................................................................................................. 14 
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Population .............................................................................................................................. 14 
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Study services ....................................................................................................................... 14 
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Eligibility ................................................................................................................................. 15 
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Sample size ........................................................................................................................... 15 
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PrEP medication .................................................................................................................... 15 
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HIV-1 self-test kits ................................................................................................................. 16 
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Recruitment ........................................................................................................................... 17 
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Randomization ....................................................................................................................... 17 
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Study procedures .................................................................................................................. 17 
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Seroconversion ...................................................................................................................... 23 
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Participant retention and withdrawal ..................................................................................... 23 
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Adherence ............................................................................................................................. 23 
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Discontinuation of PrEP ........................................................................................................ 23 
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SAFETY ................................................................................................................................ 23 
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Pregnancy among partner (HIV-1 uninfected) participants .................................................. 24 
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HIV-testing safety .................................................................................................................. 24 
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Social harm considerations for HIV-1 self-testing and PrEP ................................................ 24 
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DATA AND ANALYSIS ......................................................................................................... 25 
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Data collection ....................................................................................................................... 25 
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Qualitative data collection ..................................................................................................... 25 
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Provider barriers and facilitators to HIV-1 self-testing .......................................................... 25 
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Outcomes .............................................................................................................................. 26 
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For key delivery informants ................................................................................................... 28 
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Quantitative Analysis ............................................................................................................. 28 
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Qualitative Analysis ............................................................................................................... 28 
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HUMAN SUBJECTS CONSIDERATIONS .......................................................................... 29 
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Study oversight ...................................................................................................................... 29 
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Risks ...................................................................................................................................... 29 
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Benefits .................................................................................................................................. 29 
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Care for persons identified as HIV-1 infected ....................................................................... 30 
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Treatment for injury ............................................................................................................... 30 
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Study records......................................................................................................................... 30 
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Confidentiality ........................................................................................................................ 30 
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Dissemination Plan ................................................................................................................ 30 
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Appendix I:  Screening and Enrollment informed Consent – HIV uninfected .............................. 35 
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Appendix II.  Screening and Enrollment informed Consent – HIV infected ................................. 45 
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Appendix  III: In-depth qualitative guide ....................................................................................... 50 
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Appendix IV: Participant Information sheet with oral HIV self-test Instructions ........................... 58 
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Appendix V: Participant Information sheet with bloodbased  HIV self-test Instructions .............. 61 
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Appendix VI-Focus Group Discussion Guide ............................................................................... 62 
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Abbreviations 
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3TC 
 
Lamivudine 
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AIDS  
Acquired Immunodeficiency Virus 
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AE 
 
Adverse Event 
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ART 
 
Antiretroviral Therapy 
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ARC 
 
AIDS Related Complex 
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CDC 
 
Centers for Disease Control and Prevention (US) 
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CHCT  
Couples HIV testing and Counseling 
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DAIDS  
Division of AIDS (NIH) 
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DALY  
Disability-Adjusted Life Year  
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DBS 
 
Dried Blood Spots 
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EC 
 
Ethics Committee 
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FDA 
 
Food and Drug Administration (US) 
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FTC 
 
Emtricitabine 
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FTC-TP 
Emtricitabine-triphosphate  
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HIV 
 
Human Immunodeficiency Virus 
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GEE 
 
Generalized Estimating Equations  
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HTTP    
Hypertext Transfer Protocol (presentation of web data) 
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ICER  
Incremental Cost-Effectiveness Ratios  
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IRB 
 
Institutional Review Board 
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KEMRI  
Kenya Medical Research Institute 
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NACOSTI  
National Council of Science, Technology and Innovation  
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NIH 
 
National Institutes of Health (US) 
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PrEP  
Pre-exposure prophylaxis 
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SAS 
 
Statistical Analysis Software 
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STI 
 
Sexually transmitted infection 
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TDF 
 
Tenofovir 
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TFV-DP 
Tenofovir diphosphate 
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UNAIDS 
Joint United Nations Program on HIV/AIDS 
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US 
 
United States 
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UW 
 
University of Washington 
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VCT 
 
Voluntary counseling and testing 
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WHO  
World Health Organization
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PROTOCOL  SUMMARY 
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Maximizing access and minimizing costs of delivery are key challenges for optimizing the 
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public health impact of pre-exposure prophylaxis (PrEP) for HIV-1 prevention, particularly for 
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resource-constrained settings.  PrEP is highly effective and safe when taken as prescribed, 
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and demonstration studies are showing how PrEP can be delivered in clinical settings.  In 
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Africa, PrEP will be added to an already-burdened health infrastructure and the ability of public 
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health systems to afford PrEP will necessitate making its delivery cost-effective and time-
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efficient.  PrEP delivery programs will need to be cost-sensitive to staffing needs (e.g., frequent 
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clinic visits); moreover, patients may not continue PrEP if their costs (e.g., travel to / waiting 
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in clinics) are high.  HIV-1 testing is central to PrEP: testing must occur prior to initiation and 
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ongoing HIV-1 testing is essential for delivery.  Like PrEP, HIV-1 self-testing is a recent 
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innovation and its opportunities to improve HIV-1 prevention have not been fully realized.  We 
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hypothesize that HIV-1 self-testing can streamline PrEP delivery – through decreasing the 
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frequency of PrEP clinic visits by having self-tests at home replace clinic-based testing.  Both 
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oral fluid and new finger stick blood-based HIV-1 self-tests could be used, and these two 
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modalities might have different costs or preferences.   
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In May 2017, Kenya announced national scale-up of PrEP for persons at risk for HIV-1, 
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prioritizing HIV-1 serodiscordant couples, women at risk, and other priority groups, and also 
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the prioritization of HIV-1 self-testing in the country.  This project proposes to address key 
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access and cost of delivery challenges for PrEP by integrating the new modality of HIV-1 self-
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testing, with the following Aims: 
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Aim 1: 
In a randomized trial, we will test the use of HIV-1 self-testing to decrease 
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the frequency and burden of clinic visits for PrEP while resulting in 
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equivalent adherence and testing.    
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Hypothesis:  Guidelines recommend HIV-1 testing quarterly on PrEP; we propose HIV-1 self-
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testing at home could alternate (e.g., Months 3, 9) with clinic-based testing (e.g., 
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Months 6, 12), eliminating half of clinic visits and saving staffing and patient costs.  
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Reducing clinic contact frequency will not result in reductions in PrEP adherence 
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or completion of HIV-1 testing, overall or in subgroups.     
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Approach:  Design: We will conduct a randomized trial using a non-inferiority design among 
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495 women and men at risk for HIV-1 in Kenya initiating PrEP.  Population: We 
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will enroll men (n=165) and women (n=165) who are HIV-1 uninfected partners 
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in HIV-1 serodiscordant couples and women at risk of HIV-1 (n=165), populations 
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prioritized for PrEP delivery in Kenya and more generally in Africa.  Intervention: 
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Approximately one month after PrEP initiation, participants will be randomly 
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assigned in a 2:1 fashion to either: six-monthly clinic visits with either oral fluid-
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based or blood-based HIV-1 self-testing at home for quarters between clinic visits 
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(self-testing arm) or quarterly clinic visits with in-clinic finger stick blood-based 
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rapid HIV-1 testing (standard of care arm).  Follow-up: PrEP refills will occur at 
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clinic visits – quarterly (standard of care) and 6-monthly (self-testing), outcomes 
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will be measured at Months 6 and 12.  Outcomes: PrEP adherence (defined by 
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PrEP quantity in dried blood spots and persistence in refilling PrEP), HIV-1 
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testing, and safety (including side effects and social harm).   
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Aim 2: 
We will conduct mixed-methods work to understand user and provider 
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experiences, preferences, barriers, and facilitators related to HIV-1 self-
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testing.   
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Hypothesis:  HIV-1 self-testing will appeal to patients, because of greater self-efficacy and 
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reduced opportunity costs, and providers, for reduced workload.  Blood-based 
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tests may inspire greater confidence than oral fluid tests.  Gender and partner 
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involvement may influence acceptability of HIV-1 self-testing.  
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Approach:  Triangulating data from structured survey and qualitative interviews, we will 
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assess patient and provider perceived benefits of and concerns about HIV-1 self-
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testing in the context of PrEP.   
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Aim 3: 
We will assess costs and cost-effectiveness of HIV-1 self-testing to 
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optimize PrEP delivery.   
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Hypothesis:  HIV-1 self-testing will decrease the cost of PrEP delivery and improve PrEP cost-
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effectiveness.  
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Approach:  Using activity-based micro-costing data and outcome information from Aim 1, we 
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will define the costs and model the cost-effectiveness of HIV-1 self-testing for 
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optimized PrEP delivery. 
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Strategies to decrease the frequency of PrEP follow-up visits would improve its cost-
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effectiveness, reach, and impact.   Combining self-testing and PrEP brings together two 
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cutting-edge interventions, and the simple HIV-1 self-testing strategy in this application could 
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cut the number of PrEP follow-up visits in half.   
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BACKGROUND/RATIONALE 
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Importance of the problem   
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More than two million persons become newly infected with HIV-1 each year, the majority in 
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sub-Saharan Africa [1]. In Kenya, more than 1.4 million people are living with HIV-1 [2], making 
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it the country with the fourth greatest number of persons living with HIV-1.   The past five years 
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have witnessed major strides in the development of highly-effective HIV-1 prevention 
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interventions, particularly ones using antiretroviral medications: antiretroviral therapy (ART) 
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for HIV-1 infected persons to decrease infectiousness and pre-exposure prophylaxis (PrEP) 
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for uninfected persons to prevent acquisition.  Novel strategies to successfully and efficiently 
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deliver these strategies are needed to achieve maximum impact among populations at the 
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highest risk of HIV-1.  
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PrEP is an effective and recommended strategy for HIV-1 prevention  
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PrEP is efficacious and safe for HIV-1 prevention.   
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PrEP has been demonstrated to be efficacious and safe for reducing HIV-1 risk among men 
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who have sex with men [3], heterosexual men and women [4, 5], and injection drug users [6] in 
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diverse geographic settings. In 2012, the US Food and Drug Administration approved 
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combination tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as the first medication with 
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a label indication for HIV-1 prevention in adults [7] – an action followed by drug regulatory 
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authorities in a number of other countries including Kenya (in December 2015).  In 2015, the 
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World Health Organization issued guidance recommending PrEP as an additional prevention 
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option for all persons at high risk for acquiring HIV-1 [8]. The 2016 Kenyan ART guideline have 
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incorporated 
Tenofovir/Emtricitabine 
(TDF/FTC) 
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Tenofovir/Lamivudine (TDF/3TC) and Tenofovir (TDF) alone as recommended options for 
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HIV-1 pre-exposure prophylaxis [58]. 
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Adherence is key to PrEP efficacy. 
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Like for ART, adherence is essential for PrEP efficacy. PrEP clinical trials had a wide range of 
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results for estimates of PrEP’s efficacy for HIV-1 protection – explained by the degree to which 
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the trial populations were adherent to PrEP [9].  Secondary analyses from clinical trials and 
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demonstration studies have shown that PrEP is clearly efficacious when taken as prescribed. 
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At the individual level, HIV-1 protection is on the order of 90-100% in both men who have sex 
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with men and heterosexual populations when PrEP adherence was high, as measured by the 
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presence and quantity of PrEP in blood samples [4, 10, 11]. PrEP adherence and HIV-1 
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prevention effectiveness have been higher in open-label demonstration projects among HIV-
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1 serodiscordant couples, men who have sex with men, and young women at risk for HIV-1 
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than in prior clinical trials [12-14], which has been hypothesized to be a result of offering a 
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strategy with demonstrated safety and effectiveness, and without a placebo.  In those PrEP 
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demonstration studies, HIV-1 incidence has been low and visits were generally quarterly and 
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brief, suggesting that many who initiate PrEP in the context of known safety and efficacy may 
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not need frequent or intensive follow-up to achieve high adherence. 
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Strategies to effectively and efficiently deliver PrEP are needed 
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PrEP delivery can be expensive, in terms of medication costs, staffing time, laboratory testing, 
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and patient opportunity costs.  Multiple analyses from high-income settings have argued that, 
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while PrEP is cost-effective when delivered to high-risk persons, it is still a costly intervention 
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[15-17]. For developing country settings, the results are similar – even when taking into account 
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lower cost inputs such as generic or discounted medication pricing, lower staff salary costs, 
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and more truncated laboratory testing recommended by WHO and country policies [16, 18].  
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Thus, costs will be a barrier to PrEP delivery for impact, in all settings. 
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In costing analyses we have conducted in East Africa, we estimated that adding PrEP to 
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routine public health services using Ministry of Health personnel, drug, and laboratory costs 
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would cost ~US$100 annually per person. Notably, in those models, the greatest proportion 
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of the total costs was not medication costs but was instead personnel (39%) [19].  That finding 
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emphasizes the need for efficiency in PrEP delivery, particularly so given that qualified medical 
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staff in Kenya and similar settings are often highly over-stretched, because of competing 
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priorities in overburdened health systems.  Our modeling did not take into account patient 
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costs related to PrEP; however, we have learned through providing PrEP in studies to over 
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5000 individuals over the past 10 years that travel and time away from work and costs for 
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getting to PrEP clinic visits can be a challenge for persons taking PrEP. Efficient strategies to 
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deliver PrEP could reduce costs, potentially improving patient engagement and allow services 
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to be available to a larger number of people as a result – and this kind of approach would be 
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applicable in a variety of settings worldwide.  
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HIV-1 testing is central to PrEP; HIV-1 self-testing is a novel approach that could 
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streamline PrEP delivery 
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Point-of-care HIV-1 testing is a standard component of PrEP delivery.  
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PrEP requires regular HIV-1 testing – at the time of PrEP initiation and then in an ongoing 
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basis. HIV-1 testing is necessary to reduce the risk of antiretroviral resistance if HIV-1 infection 
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is present prior to PrEP, in which case PrEP will not be started, or occurs while prescribed 
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PrEP, in which case it will be discontinued.  PrEP clinical trials were carried out in the context 
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of monthly HIV-1 testing, generally using point-of-care third-generation antibody-based tests, 
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conducted at the clinical trial sites.  Although this frequent approach to HIV-1 testing was 
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important for the clinical trials, which were the first evaluations of PrEP use, monthly testing 
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would be logistically impossible for routine public health settings because of excessive costs 
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and burden to PrEP takers and providers.  Thus, initial guidance about PrEP delivery from the 
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US FDA and CDC recommended testing every three months, and demonstration projects of 
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PrEP distribution conducted quarterly testing [13, 14, 20].  The safety of this approach has been 
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borne out in analyses of HIV-1 acquisition among persons receiving PrEP, which have 
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repeatedly demonstrated that the risk of HIV-1 during PrEP use is greatest at the start of PrEP 
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(i.e., unrecognized acute infection coincident with PrEP initiation), that HIV-1 acquisition after 
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PrEP initiation is rare except for persons not taking PrEP, and that resistance risk is thus also 
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rare during PrEP follow-up (as either persons take PrEP and do not get HIV-1 or don’t take 
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PrEP and thus cannot select for resistance of they acquire HIV-1) [3, 4, 21, 22]. WHO recommends 
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quarterly testing as the global standard in an effort to balance costs, safety, and burden to 
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PrEP takers and providers [8], and US and global guidelines do not restrict either the assay 
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(point-of-care versus laboratory, antibody- vs. antigen/RNA-based) or the location (in-clinic 
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versus laboratory versus home) of HIV-1 testing for persons receiving PrEP follow-up.  
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Nevertheless, to our knowledge, no programs distributing PrEP have attempted to move HIV-
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1 testing out of clinical settings and into the home with self-testing, and evidence is needed to 
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motivate policy change for this opportunity.  As PrEP expands into public health clinical 
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settings there are new opportunities for easier models of HIV-1 testing.  
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Self-testing offers an innovative way to test for HIV-1  
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In 2012, the US FDA approved use of the OraQuick In-Home HIV Test as the first self-
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administered test for HIV-1, opening a new opportunity for evaluating HIV-1 testing directly 
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under the control of an individual [23].  Several other self-testing assays in addition to OraQuick 
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are under development or available. Self-testing offers strong advantages: privacy and 
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convenience, and these may appeal to both patients and providers.  HIV-1 self-testing has 
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been proposed as a strategy to increase both first-time HIV-1 testing (i.e., as a general 
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population screening tool) and repeat HIV-1 testing (i.e., for persons with ongoing HIV-1 risk), 
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both of which could be extremely valuable in high-prevalence settings. A study conducted in 
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Malawi demonstrated high use and accuracy: only 8% of subjects chose not to test and self-
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testing results were 99% concordant with rapid finger-stick tests collected in parallel [24]. In 
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Kenya, a recent population based survey found 74% reported willingness to use HIV-1 self-
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test kits for first-time HIV-1 testing [2].  Ongoing projects, some at very large scale [25, 26], are 
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evaluating wide-scale distribution of HIV-1 self-tests in Africa. WHO now recommends HIV-1 
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self-testing as an additional testing option for individuals and countries [27].   
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No studies have put HIV-1 self-testing and PrEP together.  
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Evaluating HIV-1 self-testing within a PrEP context has not been evaluated, although our pilot 
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work (detailed below) suggested both feasibility and acceptability.  In the present study, we 
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propose that HIV-1 self-testing can reduce facility-based periodical testing and clinics visits 
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among persons receiving PrEP and can do so safely and without detrimentally affecting 
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adherence.  Our proposed model has several potential advantages.  First, self-testing could 
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provide an efficient method that achieves the objectives of achieving high adherence to PrEP 
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and ensuring HIV-1 testing is done without increasing the delivery costs and participant 
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burden, compared to standard of care. Second, both PrEP and self-testing are new and seeing 
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how they fit together is an incredible new opportunity. Third, efficiency of delivery could be 
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appealing not only to the policy makers (reduced cost) and health providers (reduced work 
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load) but also to the PrEP users (reduced clinic visits). 
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Summary: unanswered questions and central hypothesis 
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For persons taking PrEP for HIV-1 prevention, regular HIV-1 testing at fixed-site clinics has 
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been the standard.  We hypothesize that HIV-1 self-testing can replace some of the periodic 
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follow-up HIV-1 testing otherwise done at a facility for persons receiving PrEP, reducing clinic 
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and patient burdens.  As detailed below, the proposed work will build on and extend our prior 
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work in PrEP and HIV-1 self-testing, by proposing a novel model of delivering PrEP through 
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fewer clinic visits which has the potential to revolutionize PrEP delivery.   
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The Government of Kenya has proposed a visionary 20-year plan for evidence-based 
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HIV-1 prevention, including prioritizing PrEP and encouraging use of HIV-1 self-testing. 
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In Kenya, the Ministry of Health developed the Kenya HIV Prevention Revolution Road Map: 
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Count Down to 2030, a national plan to drive new HIV-1 infections towards zero between 2013 
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and 2030 [28]. The approach is based on key concepts in combination prevention: recognition 
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of a heterogeneous epidemic, prioritization of sub-populations for prevention (HIV-1 
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serodiscordant couples, sex workers, men who have sex with men, and women at risk), and 
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delivery of evidence-based prevention. Kenya was one of the first countries to implement 
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point-of-care testing for HIV-1 [29, 30], and the Ministry of Health has supported research for 
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self-testing.  In May 2017, Kenya formally launched PrEP and HIV-1 self-testing as part of this 
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plan 
(http://www.nation.co.ke/news/Govt-launches-two-approaches-to-fight-HIV-Aids/1056-
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3914614-8p6ubc/).  Our proposed work aligns tightly with the Kenya HIV Prevention 
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Revolution Road Map and our work will be supported by the Kenya Ministry of Health (see 
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letter of support). 
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INNOVATION 
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PrEP is a potent and safe HIV-1 prevention strategy.  To maximize impact, optimal approaches 
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are now needed for delivering PrEP effectively and efficiently, particularly for resource-
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constrained settings.  In our recent PrEP demonstration project among HIV-1 serodiscordant 
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couples in East Africa, HIV-1 transmission was virtually eliminated [14].  In that study, we 
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delivered PrEP with quarterly clinic-based visits, and we piloted HIV-1 self-testing at home 
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between quarterly visits, finding that self-testing was acceptable and feasible in the setting.  
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We now propose to extend that work and simplify PrEP delivery further with HIV-1 self-testing 
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as a strategy to reduce the frequency of clinic visits (from quarterly to six-monthly), which we 
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will test through a randomized trial.  This approach is highly innovative, in four key ways: 
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integration of HIV-1 self-testing into PrEP, understanding for whom the proposed approach 
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works and does not work (as a model of differentiated care for HIV-1 prevention [31]), testing 
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of blood-based HIV-1 self-tests, and support by the government of Kenya, which makes the 
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probability of impact high. 
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HIV-1 self-testing in PrEP delivery has not been formally studied 
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PrEP is a biomedical intervention, and its evaluation in clinical trials and demonstration 
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settings has been clinic based.  However, with greater deployment of PrEP in many settings, 
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strategies to simplify its delivery have been a priority.  We hypothesize that HIV-1 self-testing 
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can successfully be used to conduct the HIV-1 testing that is a necessary part of PrEP delivery, 
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but which can be done by PrEP patients instead of clinic-based staff.  Reducing the frequency 
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of follow-up clinic visits has the potential to reduce staffing costs associated with frequent visits 
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and client-related opportunity costs such travel to the clinic and waiting time which could 
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increase client persistence with PrEP use.  While many studies are using HIV-1 self-testing to 
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link people to care and prevention, self-testing use among those taking PrEP has not been 
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done to our knowledge, and has potential to further efficient strategies for PrEP provision. 
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Differentiated care models of PrEP delivery are needed 
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In HIV-1 treatment settings, simplified approaches to follow-up care (e.g., 6-monthly visits for 
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those with stable viral suppression) allow human and financial resources to be directed to 
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those individuals needing more attention, a concept known as differentiated care.  For PrEP, 
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differentiated care models have not been developed yet, and thus a “one size fits all” approach 
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is being done.  It is very likely that many patients receiving PrEP, like those on ART, can 
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achieve high adherence without frequent follow-up.  We will conduct subgroup analyses (in 
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Aim 1) and use mixed-methods behavioral science (in Aim 2) to explore how HIV-1 self-testing 
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fits into PrEP provision and for whom this simplified HIV-1 testing and follow-up approach to 
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PrEP works well and for whom it does not work well, including assessment of gender and 
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partner knowledge of PrEP use, as a first approach to defining a differentiated care model for 
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PrEP.  
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Blood-based HIV-1 self-tests are new 
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The OraQuick oral fluid-based HIV-1 self-test is an established, FDA-approved product.  
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Blood-based HIV-1 tests are new and have not been tested nearly as widely.  However, blood 
434 
tests are commonly used in clinics for HIV-1 testing, and blood-based testing could offer 
435 
greater confidence in results to at least some patients (and providers).  In Aim 2, we will directly 
436 
compare acceptability, usability, and confidence for oral fluid versus blood for HIV-1 self-
437 

Protocol: HIV-1 self-testing & PrEP 
     
ersion 1.7   April 18 2019 
12           V 
testing.  
438 
 
439 
 
440 
PRELIMINARY RESULTS 
441 
 
442 
We have conducted randomized trials, behavioral science, implementation science, and 
443 
mathematical modeling to define the efficacy, acceptability, and cost-effectiveness of PrEP for 
444 
HIV-1 prevention. 
445 
 
446 
PrEP is effective and safe for prevention   
447 
 
448 
We conducted the Partners PrEP Study, the randomized clinical trial that demonstrated the 
449 
efficacy of PrEP for HIV-1 prevention in heterosexual populations [4, 32].  Secondary analyses 
450 
from that trial confirmed that PrEP provided significant protection including in key subgroups: 
451 
both men and women [33], couples with high-risk characteristics (e.g., those practicing 
452 
unprotected sex, couples in which the HIV-1 infected partner had a high plasma viral load, 
453 
those with sexually transmitted infections) [33], and in women using contraception [34].  We also 
454 
conducted analyses to demonstrate limited selection of antiretroviral resistance [21], safety in 
455 
women using contraception or who become pregnant [35, 36], and limited renal toxicity [37-39]. Our 
456 
work has been central to the development of PrEP guidance for populations worldwide [40, 41].   
457 
 
458 
We conducted a large-scale demonstration of integrated ART and PrEP that showed 
459 
near-elimination of HIV-1 transmission.  We conducted the Partners Demonstration Project,  
460 
an implementation science project delivering PrEP among 1013 HIV-1 serodiscordant couples 
461 
who attended four HIV-1 research centers in East Africa.   The primary goal was to 
462 
demonstrate a model of PrEP delivery; ART was promoted for all couples for clinical and 
463 
prevention benefits, and PrEP offered until 6 
464 
months after ART initiation by the infected 
465 
partner, permitting time to achieve viral 
466 
suppression, a pragmatic strategy we called 
467 
“PrEP as a bridge to ART”, which has directly 
468 
influenced Kenya’s PrEP guidelines for 
469 
couples; in this study, the majority of couples 
470 
used PrEP for at least 12 months, because 
471 
many HIV-1 infected partners delayed ART 
472 
initiation for at least 3 months or more. We 
473 
found high adherence (85% of blood samples 
474 
had PrEP detected) and near-elimination of 
475 
HIV-1 
transmission: 
only 
4 
infections 
476 
observed (all among persons not using PrEP) 
477 
compared to 83 in a simulated counterfactual 
478 
cohort (Figure 1).  
479 
 
480 
 
481 
Figure 1.   Near-elimination of HIV-1 transmission using 
an integrated delivery strategy for ART and 
PrEP: the Partners Demonstration Project  
 
 
0
1
2
3
4
5
6
EXPECTED
N=83 infections
incidence = 4.9 
(95% CI 3.9-6.0)
OBSERVED
N=4 infections
incidence = 0.2 
(95% CI 0.1-0.6)
95% reduction 
(95% CI 87-98%)
P<0.0001

Protocol: HIV-1 self-testing & PrEP 
     
ersion 1.7   April 18 2019 
13           V 
Pilot study: HIV-1 self-testing is highly acceptable in the context of PrEP.  Within the 
482 
Partners Demonstration Project, we completed a pilot evaluation of HIV-1 self-testing at the 
483 
Thika site [42].  OraQuick HIV-1 oral fluid self-test kits were provided for use, at home, in the 
484 
two-month interval between scheduled quarterly clinic visits. We found 222 of 226 (98%) 
485 
persons on PrEP offered self-testing accepted and nearly all (96.8%) reported using the self-
486 
testing 
kit 
was 
easy. 
Many 
487 
reported that HIV-1 self-testing 
488 
was empowering (Table 1); there 
489 
was a range of opinions about oral 
490 
fluid versus blood tests for HIV-1, 
491 
with some participants voicing 
492 
greater confidence in blood (which 
493 
we also heard anecdotally from 
494 
providers working as part of that 
495 
pilot).  Across all visits, a total of 
496 
1225 HIV-1 self-testing kits (95.6% 
497 
of 1282 dispensed) were reported 
498 
to have been used, 253 (98.1%) 
499 
and 972 (94.9%) among HIV-1 uninfected women and men, respectively. A total of 17 calls 
500 
were made to the 24-hour helpline in relation to challenges in performing or interpreting the 
501 
test results; one was a positive test, not confirmed on follow-up testing, and no participants 
502 
seroconverted to HIV-1.  Other studies in Kenya have demonstrated that HIV-1 self-testing at 
503 
home is acceptable for women at risk of HIV-1, including women at risk not in known HIV-1 
504 
serodiscordant couples [43, 44] 
505 
 
506 
Costing studies and cost-effectiveness modeling. 
507 
 
508 
We have extensive experience with cost and cost-effectiveness studies to understand the 
509 
deliverability of prevention interventions.  Within the Partners Demonstration Project, we 
510 
conducted micro-costing and time and motion analyses in Uganda [19]. The cost of PrEP (and 
511 
ART) was assessed, with and without research components.  Then, using Ministry of Health 
512 
data, the costs within a government program were estimated.  We parameterized an HIV-1 
513 
transmission model to estimate the health and economic impacts of the intervention, with 
514 
incremental cost-effectiveness ratios (ICERs) per HIV-1 infection and disability-adjusted life 
515 
year (DALY) averted calculated over 10 years.  We found that the annual cost of PrEP and 
516 
ART delivery for couples would be $453 in the government setting, with $92 due to PrEP.  
517 
Over 10 years, a program of PrEP and ART for couples was projected to cost $1340 per 
518 
infection averted.  By Uganda’s gross domestic product per capita of $1681, this intervention 
519 
thus is cost-effective [19].  At the Thika, Kenya site, we recently completed a similar costing 
520 
exercise (Irungu, Ngure, Baeten, et al., data presented at R4P conference, October 2016 and 
521 
submitted).  Using Kenya Ministry of Health personnel, drug, and laboratory costs, we 
522 
estimated that the incremental cost of delivering PrEP in Kenya to be $110 per couple per 
523 
year, with a total cost of $544 per couple per year for ART plus PrEP. The largest cost was 
524 
due to personnel (39%) – emphasizing the importance of efficiencies – followed by medication 
525 
(34%).   
526 
 
527 
 
528 
METHODS 
529 
 
530 
Taking PrEP to scale will require simplifying models for delivery, for cost savings and patient 
531 
preference.  We have assembled a multidisciplinary team to test a simplifying strategy for 
532 
PrEP delivery. We hypothesize that alternating home HIV-1 self-testing with clinic based HIV-
533 
1 testing – with resulting reductions in clinic visits from quarterly to semiannually – will translate 
534 
into cost savings for PrEP programs as well as patient related opportunity costs, without 
535 
Table 1. Experiences with HIV-1 self-testing and PrEP: pilot study  
Reduced anxiety 
• “Every day, every time thinking, “How will it be when I go back there 
[clinic]? When you test yourself, you know your status, you relax” 
Testing alone versus with others:  
• 
“Sometimes I call my husband. Like the last time I tested, I called 
my husband and told him “Come you see mine is okay until now.“ 
• 
“Like me, I hide myself… [Participants laugh] I go to the bedroom.”  
Preferences of HIV-1 self-tests:  
• 
“You know … to many people…they know blood is the accurate 
one. But you know this [oral self-test kit] doesn’t have any blood. 
• 
“You know sometimes for blood draw it can happen you [referring 
to himself] prick yourself wrongly. And you have nothing to prevent 
germs from getting in… But this one [oral kit] is easy….” 

Protocol: HIV-1 self-testing & PrEP 
     
ersion 1.7   April 18 2019 
14           V 
reducing PrEP adherence, and will be feasible, acceptable, preferred, and safe.   
536 
 
537 
Study Aims 
538 
 
539 
Aim 1: 
In a randomized trial, we will test the use of HIV-1 self-testing to decrease 
540 
the frequency and burden of clinic visits for PrEP while resulting in 
541 
equivalent adherence and testing. 
542 
 
543 
Hypothesis.  Global guidelines recommend HIV-1 testing quarterly for persons on PrEP; we 
544 
propose that HIV-1 self-testing could alternate (e.g., Months 3, 9) with clinic-based testing 
545 
(e.g., Months 6, 12) to cut the frequency of clinic visits in half, saving staffing and patient costs, 
546 
without reducing PrEP adherence or persistence.   
547 
  
548 
Aim 2: 
We will conduct mixed-methods work to understand user and provider 
549 
experiences, preferences, barriers, and facilitators related to HIV-1 self-
550 
testing.   
551 
 
552 
Hypothesis.  HIV-1 self-testing will appeal to patients, because of greater self-efficacy and 
553 
reduced opportunity costs, and providers, for reduced workload.  Blood-based tests may 
554 
inspire greater confidence.  Understanding for whom self-testing “works” will help define 
555 
differentiated care models for PrEP delivery.  
556 
 
557 
Aim 3: 
Assess the cost and cost-effectiveness of HIV-1 self-testing to optimize 
558 
PrEP delivery.   
559 
 
560 
Hypothesis.   HIV-1 self-testing will decrease the cost of PrEP delivery and improve PrEP 
561 
cost-effectiveness, allowing for greater efficiency, reach, and impact.  
562 
 
563 
Population  
564 
 
565 
At the Thika clinic, we will recruit women and men in HIV-1 serodiscordant relationships 
566 
(n=165 HIV-1 uninfected women and n=165 HIV-1 uninfected men) and HIV-1 uninfected 
567 
women at risk (n=165) who have recently initiated PrEP for this project.  We will aim to have 
568 
equal enrollment for the three study groups, but will over-enroll HIV-1 uninifected women at 
569 
risk if we have difficulties or delays in enrolling men or women in HIV-1 serodiscordant 
570 
relationships, whom historically have been more difficult to enroll.  
571 
 
572 
Study services 
 
573 
 
574 
Standard HIV-1 testing arm 
575 
Participants will receive baseline and quarterly HIV-1 counseling, condoms, risk reduction 
576 
counseling, and syndromic management of sexually transmitted infections according to local 
577 
guidelines.   
578 
 
579 
HIV-1 self-testing arm 
580 
Participants will receive baseline and semiannual HIV-1 counseling, condoms, risk reduction 
581 
counseling, and syndromic management of sexually transmitted infections according to local 
582 
guidelines.   
583 
  
584 
Both study arms 
585 
To ensure as real world assessment of uptake and sustained use of PrEP as possible, tracing 
586 
of participants will occur only for follow-up of safety issues and for HIV-1 assessment, but not 
587 
for completion of routine visits and PrEP refills. 
588 

Protocol: HIV-1 self-testing & PrEP 
     
ersion 1.7   April 18 2019 
15           V 
 
589 
Eligibility   
590 
 
591 
Inclusion 
592 
- 
Age ≥18 years HIV-1 uninfected based on negative HIV-1 rapid testing  
593 
- 
Not currently enrolled in an HIV-1 prevention clinical trial 
594 
- 
Taking PrEP and planning to continue   
595 
- 
Willing to be randomized to either clinic based HIV-1 testing or HIV-1 self testing 
596 
- 
Note: Women who are pregnant at screening/enrollment are still eligible 
597 
 
598 
For the HIV-1 serodiscordant couples, HIV-1 infected members of the couple will be enrolled 
599 
for a single visit at baseline, if:  
600 
- 
Age ≥18  
601 
- 
Able and willing to provide written informed consent  
602 
 
603 
Exclusion 
604 
- 
Unable to provide written informed consent  
605 
- 
Contraindication to use TDF/FTC/3TC 
606 
 
607 
Sample size   
608 
 
609 
A total of 825 individuals will be recruited: 165 HIV-1 uninfected men and their partners in HIV-
610 
1 serodiscordant relationships, 165 HIV-1 uninfected women and their partners in HIV-1 
611 
serodiscordant relationships, and 165 HIV-1 uninfected women at-risk for HIV-1 who are not 
612 
in disclosed HIV-1 serodiscordant partnerships. If we have difficulties enrolling HIV-1 
613 
uninifected men or women in serodiscordant relationships, we will plan on over-enrolling HIV-
614 
1 uninifected women at-risk for HIV-1 who are not in disclosed serodiscordant relatinships to 
615 
ensure we have sufficient statistical power to determine interventional effectiveness.  
616 
 
617 
Table 2. Sample distribution 
618 
 
619 
Cohort 
Number 
HIV-1 Infected 
Partners 
Number 
Women in HIV-1 
serodiscordant 
relationships 
165 
Men 
165 
Men in HIV-1 
serodiscordant 
relationships 
165 
Women 
165 
Women 
165 
n/a 
n/a 
TOTAL 
 
495 
 
330 
825 
 
620 
 
621 
PrEP medication 
622 
 
623 
Tenofovir disoproxil fumarate (or TDF, 9-[(R)-2-[[bis [[(isopropoxycarbonyl) oxy] methoxy] 
624 
phosphinyl] methoxy] propyl] adenine fumarate), emtricitabine (or FTC, 5-fluoro-1-(2R,5S)-
625 
[2-(hydroxymethyl)-1,3-oxatholan-5-yl]cytosine), and lamivudine (or 3TC, 2',3'-dideoxy-3'-
626 
thiacytidine 
4-Amino- 
1-[(2R,5S)- 
2-(hydroxymethyl)- 
1,3-oxathiolan-5-yl]- 
1,2-
627 
dihydropyrimidin- 2-one) are reverse transcriptase inhibitors that have been approved for the 
628 
treatment of HIV-1 infection in humans in Kenya and the United States. A fixed-dose, oral 
629 
co-formulation of FTC/TDF (Truvada®) has also been approved for HIV-1 prevention in 
630 

Protocol: HIV-1 self-testing & PrEP 
     
ersion 1.7   April 18 2019 
16           V 
Kenya and the United States. The World Health Organization recommends TDF-containing 
631 
medications as PrEP, which includes TDF combined with FTC as well as potentially TDF 
632 
alone and TDF combined with lamivudine (or 3TC, a medication closely related to FTC). 
633 
Any TDF-containing medications that align with WHO and Kenya national guidelines for 
634 
PrEP will be used in this study. PrEP will be prescribed for once-daily use.  Study medication 
635 
will be provided by the Kenya Ministry of Health. 
636 
 
637 
The study drug will be stored in accordance with the drug manufacturer’s recommendations. 
638 
The pharmacy and storage facility will have locked, climate-controlled environments, with 
639 
controlled humidity and temperature to remain within limits allowed by the manufacturer for 
640 
drug storage.  Dispensing will be sufficient to last until the next visit – thus, at enrollment 
641 
month, a three month and six monthly supply depending on the study arm. 
642 
 
643 
Counseling on the medications being used, their side effect profiles, how to take the study 
644 
medication, what to do if side effects are experienced, and the importance of not sharing study 
645 
medication to optimize potential efficacy and to reduce the chances of developing resistance 
646 
through suboptimal HIV-1 suppression if study medication is shared with others.   
647 
 
648 
HIV-1 self-test kits 
649 
 
650 
The OraQuick In-Home HIV Test (Figure 2) is the 
651 
first FDA approved test (2012) that uses oral fluid 
652 
to test for antibodies to HIV-1 and HIV-2. The 
653 
OraQuick In-Home HIV Test is a qualitative test 
654 
that 
gives 
visually 
read 
results: preliminary 
655 
positive, negative, or test not working (invalid) in 
656 
about 20 minutes and its ease of use makes it ideal 
657 
as an in-home test kit. The OraQuick oral fluid test 
658 
has a sensitivity 91.7 percent and a specificity of 
659 
99.9 percent and is categorized as a "screening" 
660 
test, therefore a second test to confirm the results 
661 
is recommended. 
662 
 
663 
The AtomoRapidTM HIV (1&2) Test (Figure 3, 
664 
(http://atomodiagnostics.com/ products/atomorapid-
665 
hiv/) is an integrated HIV test of blood for the 
666 
presence of antibodies to HIV-1 and HIV-2.  It uses a 
667 
contact-activated auto-retracting safety lancet, which 
668 
safeguards against needlestick injuries and cross 
669 
contamination (all material and waste are within the 
670 
kit itself). The all-in-one device puts the end user first 
671 
and makes it easy to test. AtomoRapid’s interlocking 
672 
features ensure each user step is performed in the 
673 
correct sequence, which helps to reduce user errors. 
674 
Additionally, its blood collection and delivery is 
675 
controlled which simplifies test procedures, improves blood volume accuracy and delivers 
676 
blood to the correct location on the test strip. The AtomoRapidTM HIV (1&2) Test has 
677 
demonstrated sensitivity 99.8% and a specificity of 100% in laboratory tests conducted by the 
678 
Institute of Tropical Medicine, Belgium and the German Red Cross. Pilot studies of the 
679 
AtomoRapidTM HIV (1&2) Test have been done in both Kenya and South Africa. The retail 
680 
price of the AtomoRapidTM HIV (1&2) Test in Kenya is anticipated to be about 20-40% less 
681 
than of the current price of the OraQuick In-Home HIV Test in Kenya (personal 
682 
communication, Atomo Diagnostics).   
683 
 
684 
Figure 2.   The OraQuick In-Home HIV Test 
 
Figure 3.   The  AtomoRapidTM HIV  (1&2) Test 
 

Protocol: HIV-1 self-testing & PrEP 
     
ersion 1.7   April 18 2019 
17           V 
If there are any issues or interruptions with the procurement of AtomoRapid HIV self-testing 
685 
kits in country, we will procure and train participants on the use of other HIV self-testing kits 
686 
that have been prequalified by the WHO, an official observer of the International Medical 
687 
Device Regulators Forum. We will ensure that all HIV self-testing kits utilized by participants 
688 
in this study will have a greater than 95% sensitivity and specificity. A list of applicable HIV 
689 
self-testing kits is available in the UNITAID’s HIV Rapid Diagnostic Tests for Self-Testing, 4th 
690 
Edition. [45] 
691 
 
 
692 
Recruitment 
693 
 
694 
The Thika site has established local recruitment and screening methods that operationalize 
695 
protocol-specified requirements for eligibility determination in a manner that is tailored to and 
696 
most efficient for the local study setting and target study population.   
697 
 
698 
Thika is an urban center, about 40 km outside of Nairobi, and has a large peri-urban and rural 
699 
population base surrounding it; over the past decade, the Thika site team established a multi-
700 
disciplinary site, focused on HIV-1 and sexually transmitted disease prevention research 
701 
(more than two dozen projects) and on provision of clinical care (HIV-1 testing, HIV-1 
702 
comprehensive care, HIV-1 prevention services).  Our experienced community outreach team 
703 
at the Thika site has established successful recruitment strategies, including collaborating with 
704 
existing HIV-1 testing centers and community-based mobilization for couples and women to 
705 
engage in HIV-1 prevention.  The Thika clinic is a center of excellence for PrEP in Kenya and 
706 
is leading training of other clinics as part of Kenya national scale-up.  
707 
 
708 
Recruitment strategies will include partnering with existing voluntary counseling and testing 
709 
(VCT) centers and outreach workers, public promotion of couples VCT by well-known figures 
710 
and community organizations such as churches, and community mobilization around couples 
711 
and women’s VCT promotion (e.g., around Valentine’s Day).  Recruitment materials will 
712 
educate couples and women about PrEP.  Individuals on PrEP referred to the Thika clinic or 
713 
those initiating PrEP at the Thika clinic will then be recruited to this study approximately one 
714 
month after PrEP initiation.  
715 
 
716 
Screening and enrollment may occur on the same day or may be split across days, depending 
717 
on the preferences of the potential participant.  Informed consent for study participation and 
718 
enrollment in the study may proceed on the same day when eligibility is determined.  For 
719 
couples, HIV-1 infected partners will provide separate informed consent for a single visit but 
720 
will not have longitudinal trial follow-up.  
721 
  
722 
Randomization 
723 
 
724 
Randomization will be done in variable-sized blocks using opaque envelopes opened at the 
725 
time of randomization. Randomization will occur in a 2:1 fashion to alternating HIV-1 testing 
726 
at home and in-clinic testing, or standard of care (HIV-1 testing at in-clinic follow-up visits every 
727 
3 months). Those randomized to the self-testing arm will then be further randomized in a 1:1 
728 
fashion to either blood-based or oral fluid-based self-testing kits. Randomization will be 
729 
stratified by group (HIV-1 uninfected men in serodiscordant couples, HIV-1 uninfected women 
730 
in serodiscordant couples, and HIV-1 uninfected women at risk).  Randomization will be  done 
731 
at the enrollment visit which will occur approximately one month after the participants have 
732 
begun taking PrEP. 
733 
Study procedures 
734 
 
735 
Specific study procedures will take place at screening and enrollment, and then quarterly for 
736 
the standard testing arm and biannually for the HIV self-testing arm, for up to 12 months.   
737 

Protocol: HIV-1 self-testing & PrEP 
     
ersion 1.7   April 18 2019 
18           V 
 
738 
At screening, eligibility information will be collected.  Subjects who meet the eligibility criteria 
739 
will then be enrolled in the study.   
740 
 
741 
Demographic and behavioral information will be collected at enrollment.  As part of PrEP 
742 
intiation and continuation, several standard of care laboratory tests will be completed including 
743 
HIV-1 testing, serum creatinine, and a urine pregnancy test. For this study, additional 
744 
information will be collected on medical history, physical exam findings, and STI syndromic 
745 
assessment and additional testing will be done as part of standard of care PrEP follow-up. 
746 
Other laboratory tests will be conducted to measure adherence to PrEP medication by testing 
747 
drug levels in the collected blood specimen (dried blood spots, blood hemoglobin, and blood 
748 
plasma).   
749 
 
750 
HIV-1 positive participants will also be assessed at baseline. Assessment will include 
751 
demographic and sexual-behavior information, ART adherence data, and a brief medical 
752 
history. Laboratory procedures carried out on HIV positive participants will include standard 
753 
HIV-1 testing, CD4 count, and plasma HIV-1 viral load.  
754 
 
755 
PrEP delivery will be according to the 2016 Kenya PrEP guidelines [46], including measurement 
756 
of renal function (estimated creatinine clearance >50 mL/min to start PrEP and periodic 
757 
monitoring over time, aligned to the visit schedule of the study), standard clinical assessment 
758 
to avoid initiating PrEP during acute HIV-1 infection, and adherence counseling.  Subjects will 
759 
then be randomized at enrollment (Month 0) in a 2:1 fashion to alternating HIV-1 testing at 
760 
home (Months 3, 9) with in clinic testing (Months 6, 12), translating to clinic visits every 6 
761 
months (the self-testing arm), or in-clinic follow-up visits with HIV-1 testing every 3 months 
762 
(the standard of care arm).  Those randomized to self-testing will be further randomly assigned 
763 
to half receive oral-fluid tests and half blood-based tests (and will use the same type of test 
764 
throughout their follow-up).  Participants in the self-testing arms will get 6 months of PrEP 
765 
medication at each visit while only those on the clinic based arm will get 3 months of PrEP, 
766 
corresponding to enough to last until the next clinic-based visit. Participants in both arms will 
767 
be counseled on PrEP discontinuation according to Kenya national guidelines (e.g., for HIV-1 
768 
uninfected members of HIV-1 serodiscordant couples, 6 months after their partner has begun 
769 
taking ART, if there are no other HIV-1 risks). Tracing for retention at Months 6 and 12 will be 
770 
done, particularly to establish PrEP continuation and HIV-1 status. All HIV-1 serodiscordant 
771 
couples will receive counseling on PrEP as a bridge to ART; infected partners will be 
772 
encouraged to start ART if not already started (Tables 2-4). 
773 
 
774 
As we did in our pilot evaluation (detailed above) those assigned to self-testing will receive 
775 
training – blood or oral depending on their assignment and will complete one test in clinic on 
776 
the day of randomization including interpretation of the test result under the guidance of the 
777 
study staff to increase comfort with the process.  Those assigned to HIV-1 self-testing will be 
778 
provided with two self-testing kits to conduct quarterly testing until their next scheduled visit 
779 
(i.e., one test kit for the quarterly visit and an extra kit to be used as back-up), and participants 
780 
will be counseled to use the self-testing kit at a place and time where they will feel comfortable 
781 
performing the testing (e.g., at home). Participants will also be asked to bring back the used 
782 
HIV-1 self-test kits to confirm HIV-1 self-testing (though this method has limitations, it will be 
783 
a proxy measure). As we did for our pilot study, a pictorial information brochure translated into 
784 
local languages will be provided and a toll-free 24-hour helpline will be provided to call in case 
785 
of challenges in performing the self-testing or in the event of a positive test result.  Participants 
786 
will be informed that any positive self-test result will need to be confirmed by study staff in 
787 
accordance with the Kenyan testing algorithm and additional testing as needed (we have used 
788 
both laboratory-based HIV-1 antigen/antibody enzyme-linked immunoassay testing and HIV-
789 
1 RNA PCR to confirm HIV-1 seroconversions in our prior studies and would do so in this 
790 
project as well, to provide a complete ascertainment of HIV-1 status).  
791 
 
792 

Protocol: HIV-1 self-testing & PrEP 
     
ersion 1.7   April 18 2019 
19           V 
At the final visit (Month 12, for most participants) all participants will be trained on a HIV-1 self-
793 
testing method that they had not used  and offered an opportunity to self test using the new 
794 
method, specifically those on the standard arm will be trained on both oral HIV self-testing and 
795 
blood based HIV self-testing while those on the oral HIV-1 self-testing arm will be trained on 
796 
the blood based HIV self-testing and those on the blood based HIV-1 self-testing will be trained 
797 
on the oral HIV-1 self-testing. A HIV-1 testing preference questionnaire will then be 
798 
administered to assses participants preferences between the three HIV-1 testing methods. 
799 
 
800 
At each study visit, we will offer counseling for participants for HIV-1 testing (pre- and post-
801 
testing), HIV-1 infection risk reduction best practices, condom promotion and provision, 
802 
adherence to HIV-1 medication, adherence to HIV-1 self-testing, and PrEP and ART as HIV-
803 
1 prevention strategies.  
804 
805 

Protocol: HIV-1 self-testing & PrEP 
     
ersion 1.7   April 18 2019 
20           V 
Table 2.  Procedures for HIV-1 uninfected participants: standard of care testing arm 
806 
 
807 
[ ] as indicated 
808 
 
 
809 
Procedure 
 
E) 
M3 M6 M9 M12/final 
visit 
Obtain informed consent 
X 
 
 
 
 
Apply inclusion/exclusion criteria, including behavioral 
and lab eligibility 
X 
 
 
 
 
Collect/update locator information 
X 
X 
X 
X 
X 
Collect demographic information 
X 
 
 
 
 
Collect sexual behavioral information 
X 
 
X 
 
X 
Collect alcohol and substance use data 
X 
 
X 
 
X 
Collect depression indicators 
X 
 
X 
 
X 
Collect HIV-1 risk perception data 
X 
 
X 
 
X 
Collect general self-efficacy indicators 
X 
 
X 
 
X 
Provide HIV-1 rapid test results 
X 
X 
X 
X 
X 
Medical history / symptoms information 
X 
X 
X 
X 
X 
Perform physical exam 
X 
[X] 
[X] [X] 
[X] 
STI syndromic assessment and management 
X 
[X] 
[X] [X] 
[X] 
 
 
 
 
 
Offer and provide PrEP sufficient until next visit, 
instructions; discontinue PrEP 6 months after HIV-1 
infected partner initiates ART 
X 
X 
X 
X 
X 
Randomization 
X 
 
 
 
 
Risk reduction counseling and condom promotion & 
provision 
X 
X 
X 
X 
X 
Contraception counseling and provision/referral 
X 
X 
X 
X 
X 
Adherence counseling  
X 
X 
X 
X 
X 
Provide HIV-1 pre and post-test counseling 
X 
X 
X 
X 
X 
Collect PrEP adherence data 
X 
 
X 
 
X 
HIV-1 self-testing preferences 
X 
 
X 
 
X 
Collect antiretroviral-based prevention preference data, 
information on fertility intentions, other sociobehavioral 
data to inform PrEP and ART preferences and use 
X 
 
X 
 
X 
Collect blood specimen for HIV-1 testing and other lab 
tests as defined here 
X 
X 
X 
X 
X 
Measure serum creatinine 
 
 
X 
 
X 
Dried blood spot collection for PrEP adherence 
X 
 
X 
 
X 
Measure blood hemoglobin to calibrate measures of 
PrEP adherence 
X 
 
X 
 
X 
Plasma for PrEP adherence. 
X 
 
X 
 
X 
HIV-1 serology (rapid test and, if positive, confirmatory 
testing according to Kenya policies ) 
X 
X 
X 
X 
X 
Urine pregnancy test (women only, as clinically indicated 
or requested by the participant) 
[X] 
[X] 
[X] [X] 
[X] 

Protocol: HIV-1 self-testing & PrEP 
     
ersion 1.7   April 18 2019 
21           V 
Table 3.  Procedures for HIV-1 uninfected participants: HIV-1 self-testing arms 
810 
 
811 
 
812 
 
813 
 
814 
 
815 
 
816 
 
817 
 
818 
 
819 
 
820 
 
821 
 
822 
 
823 
 
824 
 
825 
 
826 
 
827 
 
828 
 
829 
 
830 
 
831 
 
832 
 
833 
 
834 
 
835 
 
836 
 
837 
 
838 
 
839 
 
840 
 
841 
 
842 
 
843 
 
844 
 
845 
 
846 
 
847 
 
848 
 
849 
 
850 
 
851 
 
852 
 
853 
 
854 
 
855 
 
856 
[ ] as 
857 
indicated 
858 
 
859 
 
 
860 
Procedure 
 
E 
M6 
M12/final 
visit 
Obtain informed consent 
X 
 
 
Apply inclusion/exclusion criteria, including behavioral 
and lab eligibility 
X 
 
 
Collect/update locator information 
X 
X 
X 
Collect demographic information 
X 
 
 
Collect sexual behavioral information 
X 
X 
X 
Collect alcohol and substance use data 
X 
X 
X 
Collect depression indicators 
X 
X 
X 
Collect HIV-1 risk perception data 
X 
X 
X 
Collect general self-efficacy indicators 
X 
X 
X 
Provide HIV-1 rapid test results 
X 
X 
X 
Medical history / symptoms information 
X 
X 
X 
Perform physical exam 
X 
[X] 
[X] 
STI syndromic assessment and management 
X 
[X] 
[X] 
 
 
 
Collect used HIV-1 self test kits 
 
X 
X 
Offer and provide 6 months of PrEP, instructions; 
discontinue PrEP 6 months after HIV-1 infected partner 
initiates ART 
X 
X 
X 
Randomization (half will be randomized to blood-based 
test while the other half will receive oral-based test) 
X 
 
 
Risk reduction counseling and condom promotion & 
provision 
X 
X 
X 
Contraception counseling and provision/referral 
X 
X 
X 
Adherence counseling (at M1, by phone, an adherence 
check-in) 
X 
X 
X 
Provide HIV-1 pre and post-test counseling 
X 
X 
X 
Collect PrEP adherence data 
X 
X 
X 
Collect HIV-1 self-testing data 
X 
X 
X 
HIV self-testing preferences  
 
X 
X 
Collect antiretroviral-based prevention preference data, 
information on fertility intentions, other sociobehavioral 
data to inform PrEP and ART preferences and use 
X 
X 
X 
Collect blood specimen for HIV-1 testing and other lab 
tests as defined here 
X 
X 
X 
Measure serum creatinine 
 
X 
X 
Dried blood spot collection for PrEP adherence 
X 
X 
X 
Measure blood hemoglobin to calibrate measure of PrEP 
adherence 
X 
X 
X 
Plasma for PrEP adherence. 
X 
X 
X 
HIV-1 serology (rapid test and, if positive, confirmatory 
testing according to Kenya policies) 
X 
X 
X 
Urine pregnancy test (women only, as clinically indicated 
or requested by the participant) 
[X] 
[X] 
[X] 

Protocol: HIV-1 self-testing & PrEP 
     
ersion 1.7   April 18 2019 
22           V 
Table 4.  Procedures for index (HIV-1 seropositive) participants at the SINGLE study 
861 
visit 
862 
 
863 
Table 5. Procedures for Qualitative data collection (from both study arms).  
864 
 
865 
866 
Baseline Procedures 
Obtain informed consent 
Apply inclusion/exclusion criteria 
Collect demographic information 
Collect sexual behavior information 
Medical history 
Risk reduction counseling and condom promotion & provision 
Collect ART adherence data  
Adherence counseling (if on ART) 
Provide HIV-1 pre and post-test counseling 
Collect antiretroviral-based prevention preference data, information on fertility intentions, other 
sociobehavioral data to inform PrEP and ART preferences and use 
Laboratory procedures 
Conduct standard HIV-1 testing 
CD4 count 
Plasma HIV-1 viral load 
Procedure 
 
Basel
ine 
M6 
M12/final 
visit/study 
end 
In-depth interviews 
X 
X 
X 
Focus Group Discussions 
 
 
X 
Health provider interview 
 
 
X 

Protocol: HIV-1 self-testing & PrEP 
     
ersion 1.7   April 18 2019 
23           V 
Seroconversion 
867 
 
868 
Seroconversion will be determined by local HIV-1 testing guidelines.  For initially HIV-1 
869 
uninfected participants who seroconvert, a plasma sample or dried blood spot will be collected 
870 
and archived for tenofovir levels and resistance testing.  Couples  and young women in which 
871 
the initially HIV-1 uninfected participant seroconverts will be exited from the study but will 
872 
continue with their normal HIV clinic care follow up as usual. A suspected seroconversion will 
873 
be confirmed per the Kenyan National Testing Algorithm. In addition, suspected 
874 
seroconverters will have a blood sample drawn that will be sent to laboratory identified by 
875 
NASCOP for drug resistance testing as per Kenyan National Guidelines. Laboratory testing 
876 
for suspected seroconverters is done as per standard clinical care and is not considered part 
877 
of the study procedures. 
878 
 
879 
Participant retention and withdrawal 
880 
 
881 
Thika site will develop retention methods tailored to and most efficient for the local study 
882 
setting.  Retention activities may include explanation of the study visit schedule and procedural 
883 
requirements during the informed consent process and re-emphasis at each study visit, 
884 
collection and updating of locator information, and use of appropriate and timely visit reminder 
885 
mechanisms (including phone calls and text messages).  To provide complete information at 
886 
the end of the study, efforts will be made to have a final follow-up visit for each participant.  
887 
 
888 
Participants may voluntarily withdraw from the study for any reason at any time.  The site 
889 
Investigator also may withdraw participants from the study in order to protect their safety 
890 
and/or if they are unwilling or unable to comply with required study procedures.  Reasons for 
891 
withdrawal will be recorded.  
892 
  
893 
Adherence 
894 
 
895 
High adherence is important for PrEP effectiveness in preventing HIV-1 acquisition. Study 
896 
staff also will provide brief adherence counseling at each scheduled visit, in accordance with 
897 
Kenya PrEP counseling guidelines.   
898 
 
899 
Data on adherence to the product use regimen will be collected via standardized interviewer-
900 
administered questions to ascertain product use. Finally, adherence will also be assessed 
901 
through batched drug levels at enrollment and study visits at Months 6 and 12.  Dried blood 
902 
spots and plasma from batched drug levels will be shipped to the University of Washington for 
903 
processing and analysis for tenofovir drug levels. Dried blood spot data are improved when 
904 
analyzed with standardization against hemoglobin concentrations. 
905 
 
906 
Discontinuation of PrEP  
907 
 
908 
PrEP continuation will be according to Kenya PrEP guidelines.  Use of PrEP may be 
909 
interrupted by the site Investigator due to safety concerns for the participant, use of 
910 
concomitant medications that could interfere with PrEP or present a safety concern, or if the 
911 
participant is unable or unwilling to comply with study procedures.  All treatment interruptions 
912 
will be documented.   
913 
 
914 
 
915 
 
916 
 
917 
SAFETY  
918 
 
919 

Protocol: HIV-1 self-testing & PrEP 
     
ersion 1.7   April 18 2019 
24           V 
Multinational studies including the Thika site conducted  Partners PrEP Study and Partners 
920 
Demonstration Project demonstrated that PrEP (including FTC/TDF) was safe for use in 
921 
heterosexual men and women from Kenya and Uganda.  There were no statistically significant 
922 
differences in the frequency of deaths, serious adverse events, adverse events overall, or key 
923 
laboratory adverse events (specifically, creatinine elevation and phosphorus decrease) for 
924 
those receiving PrEP compared to those receiving placebo in the Partners PrEP study.   
925 
 
926 
For the purposes of this study, only serious adverse events (SAEs), for both index (HIV-1 
927 
infected) and partner (HIV-1 uninfected) participants, and adverse events felt related to PrEP 
928 
or self-testing will be documented.  SAEs felt to be related to PrEP will result in temporary hold 
929 
of PrEP.  In the case of temporary holds, the hold will continue until the event is stabilized or 
930 
resolved.  If the event resolves, PrEP may be reinitiated at the discretion of the Investigator, 
931 
resuming safety monitoring.  The severity of clinical symptoms will be scored using the DAIDS 
932 
Table (July 2017 Version) for Grading the Severity of Adult and Pediatric AEs.  Reporting on 
933 
adverse events to relevant IRBs will be according to relevant regulations.   
934 
 
935 
Pregnancy among partner (HIV-1 uninfected) participants  
936 
 
937 
Animal and human data, including from the Partners PrEP Study and Partners Demonstration 
938 
Project, suggest safety of FTC/TDF when used by HIV-1 infected women during pregnancy 
939 
and breastfeeding.  Other studies are exploring detailed safety of PrEP use in pregnancy.  For 
940 
this study, PrEP will not  be discontinued when pregnancy is detected. 
941 
 
942 
HIV-testing safety  
943 
 
944 
HIV-1 testing is an essential component of PrEP delivery to protect patient safety – specifically, 
945 
to prevent the initiation of PrEP among persons who have already acquired HIV-1 and to 
946 
prevent continuation of PrEP if HIV-1 is acquired while receiving PrEP.  In clinical trials and 
947 
delivery projects of PrEP, the greatest risk of HIV-1 infection is at the time of initiation – either 
948 
because of unrecognized chronic HIV-1 infection prior to HIV-1 testing as part of PrEP start or 
949 
recent (acute) HIV-1 infection acquired just prior to PrEP initiation.  Global and national 
950 
guidelines for PrEP use do not have a consistent standard for the type of test to be used; 
951 
Kenya, for example, recommends testing according to the national HIV-1 testing algorithm, 
952 
which uses third-generation HIV-1 antibody based tests, done in sequence (i.e., if a positive 
953 
first test, then perform a second test for confirmation, and a third as tie-breaker).  Antigen-
954 
based tests (and HIV-1 RNA testing) are not in widespread use, although antigen-based 
955 
options are becoming more available.   
956 
 
957 
For the self-testing arms, there is an inherent difference in sensitivity between the oral fluid- 
958 
and blood-based tests, as detailed above; we recognize this as a potential risk for undetected 
959 
infection, and ascertainment of the magnitude of that risk will be part of this evaluation.  
960 
Incident HIV-1 infections are rare among persons offered PrEP (<0.5% per year in our prior 
961 
work, and essentially 0% among those taking PrEP) and thus HIV-1 acquisition is expected to 
962 
be very uncommon in this study. 
963 
 
964 
Social harm considerations for HIV-1 self-testing and PrEP 
965 
 
966 
We have extensively considered the risk of social harm related to both PrEP use and HIV-1 
967 
self-testing at home, including risks of depression/anxiety and disclosure and stigma.  Our 
968 
extensive experience with longitudinal follow-up of heterosexual HIV-1 serodiscordant couples 
969 
and women at risk mitigates some of this risk, and we found very little risk of social harms or 
970 
anxiety related to HIV-1 self-testing in our pilot evaluation, among couples (detailed above).  
971 
Low evidence of social harms has been reported in other HIV-1 self-testing studies [47].  The 
972 

Protocol: HIV-1 self-testing & PrEP 
     
ersion 1.7   April 18 2019 
25           V 
24-hour helpline that that Thika clinic has, and which we used for our pilot study, will be 
973 
available in case of anxiety, social harm, depression, or a positive test.  Analyses of social 
974 
harm related to self-testing will be done overall, by sex and by relationship status, given the 
975 
potential for differential gendered and relationship risks (detailed more in Aim 2).  In the event 
976 
of a clinical need (e.g., side effects, symptoms of a sexually transmitted infection), participants 
977 
will be requested to return to the clinic for care. 
978 
 
979 
 
980 
 
981 
DATA AND ANALYSIS 
982 
 
983 
The primary goal of this project is to address key access and cost of delivery challenges for 
984 
PrEP by using the new modality of HIV-1 self-testing.  
985 
 
986 
Data collection 
987 
 
988 
We will use structured interviews on HIV-1 testing practices and self-reported PrEP adherence 
989 
(e.g., frequency, ability, self-rating, missed doses).  We will use CommCare, an electronic data 
990 
capture platform, to collect data at the Thika site. 
991 
 
992 
Qualitative data collection   
993 
 
994 
Qualitative data collection will include serial in-depth interviews using pre-piloted semi-
995 
structured guides (n=20 men in couples, n=20 women in couples, and n=20 women at risk, 
996 
from both self-testing modalities and the standard of care randomization arm) and focus group 
997 
discussions (n=8, stratified by gender and whether or not in a serodiscordant partnership), 
998 
conducted by experienced social scientists acting in the roles of facilitator and note taker.The 
999 
semi-structured qualitative  interview guide  will provide a general  structure for discussion  but 
1000 
require  participants  to share their own barriers and facilitators [48]. The serial in-depth 
1001 
interviews will be conducted soon after enrollment to get information on early experiences, at 
1002 
Month 6, and after Month 12 after participants have tested for a couple of visits. The focus 
1003 
group discussions will be conducted at study exit.  Interviews will be conducted using the 
1004 
participants preferred language and by consensus in the focus group discussions.  The 
1005 
sampling for the qualitative interviews to include a range of possible perspectives (stratified-
1006 
purposive sampling), to allow for stratification by study arm, gender, HIV-1 serodiscordant 
1007 
relationship status, and other relevant factors that may emerge during the work.    
1008 
 
1009 
 
1010 
Qualitative discussions will be recorded, transcribed, and translated into English by the study 
1011 
team. Audio recordings will be destroyed by the qualitative team after being transcribed not 
1012 
later than August 2023. Qualitative work will extend our prior work among couples and women 
1013 
at risk, and we will adapt existing questionnaires and topic guides to focus on questions related 
1014 
to HIV-1 testing in the context of PrEP delivery, specifically to gain a deeper understanding of 
1015 
participants’ experiences with HIV-1 self-testing, including challenges, benefits, concerns, 
1016 
risks, preferences (self- versus provider-based testing) and intention to use in the future, if 
1017 
available.   
1018 
 
1019 
Health provider barriers and facilitators to HIV-1 self-testing 
1020 
 
1021 
Health providers are key to PrEP delivery [49].  Therefore, in addition to self-testing users, we 
1022 
will study operational delivery at the level of providers. We will conduct key informant 
1023 
interviews (n=6-8) with providers at the research clinic (counselors, nurses, clinicians) to 
1024 
understand acceptance, barriers, facilitators, and confidence regarding HIV-1 self-testing in 
1025 

Protocol: HIV-1 self-testing & PrEP 
     
ersion 1.7   April 18 2019 
26           V 
the context of PrEP.  Interviews will be conducted at the end of the study.   We will document 
1026 
suggestions on how to optimize PrEP delivery through the use of HIV-1 self-testing.  We will 
1027 
use similar interview and analysis methods detailed above.  
1028 
 
1029 
Outcomes 
1030 
 
1031 
Trial outcomes will be PrEP adherence (PrEP quantity in dried blood spots and PrEP refills), 
1032 
HIV-1 testing completion, and safety (including accuracy of HIV-1 testing, management of side 
1033 
effects, and social harm).  Timing.  All outcomes will be assessed at the Month 6 and 12 clinic 
1034 
visits.  The study is powered against a single measurement of adherence (Month 6, see 
1035 
calculations below).  Adherence outcome.  Adherence by PrEP in dried blood spots is 
1036 
defined as the primary trial outcome for the purposes of sample size calculations.  Cumulative 
1037 
and recent adherence to PrEP will be measured by concentrations of tenofovir diphosphate 
1038 
(TFV-DP) and emtricitabine triphosphate (FTC-TP), respectively, in a 3 mm punch from a dried 
1039 
blood spot in the laboratory of Dr. Anderson. TFV-DP and FTC-TP are measured by validated 
1040 
liquid chromatography tandem mass spectrometry (LC-MS/MS), which has become the gold 
1041 
standard for research evaluations of PrEP adherence [10, 11].  High TFV-DP levels will define 
1042 
good adherence.  In recent studies, levels ≥1250 fmol/punch (=the median among persons 
1043 
taking 7 doses/week) and ≥700 (=≥4 doses/week, associated with high HIV-1 protection in 
1044 
some studies) have been used.  FTC-TP detection with low TFV-DP will distinguish those with 
1045 
only recent (e.g., “white coat dosing”) adherence [10, 11, 50]. In addition, we will be standardizing 
1046 
drug levels in dried blood spots by collecting whole blood to measure levels of hemoglobin, 
1047 
which has been validated as a more accurate means of interpretating drug levels.PrEP refills 
1048 
will be measured through data from the clinic’s electronic pharmacy system.  Testing and 
1049 
safety outcomes. HIV-1 testing will be measured as the combination of in-clinic tests and 
1050 
home tests, recorded by self-report and by requesting that completed self-test cartridges be 
1051 
returned to the clinic for validation of self-report.  HIV-1 incidence will be measured but is 
1052 
expected to be low (0.2% per year in the Partners Demonstration Project, and 0% for those 
1053 
taking PrEP) and the study would need to be considerably larger to be powered to assess 
1054 
incident HIV-1 (and unnecessary, given the established relationship between PrEP adherence 
1055 
and efficacy); we will assess genotypic HIV-1 resistance among any seroconverters.  PrEP 
1056 
duration.  In our recently-completed Partners Demonstration Project, most couples used 
1057 
PrEP for 9-12 months, justifying our 12 months of follow-up for the couples; those who are 
1058 
established on ART by 6 months will be recommended to discontinue PrEP and their follow-
1059 
up thereafter for the purposes of PrEP adherence and continuation will be censored.  All 
1060 
individuals requiring PrEP for longer than 12 months will continue to receive PrEP through the 
1061 
clinic’s services. Analyses for Aim 1, and Aim 2, will be done overall (total population of n=495), 
1062 
separately for serodiscordant couples (n=330) and for women (n=330, half in serodiscordant 
1063 
relationships) – each of these separate subgroups (i.e., couples and women) is well-powered 
1064 
for adherence assessment.   
1065 
 
1066 
Self-testing to standard of care clinic testing, powered for the PrEP adherence outcome; we 
1067 
hypothesize that HIV-1 self-testing at home will not substantially undermine PrEP use, and 
1068 
thus a non-inferiority design is most appropriate.  Most individuals will continue to be eligible 
1069 
for PrEP for 12 months (minus those with a clinical hold, expected to be rare, and those in the 
1070 
couples who for whom the HIV-1 infected partner immediately began ART at baseline and has 
1071 
continued with high adherence); we have powered the study for a single adherence 
1072 
assessment (e.g., Month 6) and increased power will result from repeated measurement of 
1073 
most participants at Month 12.  Primary comparison.  The primary comparison will be self-
1074 
testing versus clinic testing; the two self-testing modalities will be analyzed together (versus 
1075 
clinic testing) because we hypothesize that the effect on adherence and other outcomes 
1076 
relates to the use of self-tests and frequency of follow-up, not the self-test modality; Aim 2 and 
1077 
3 are designed to explore potential differences in acceptability and cost between self-testing 
1078 
modalities.  Power.  The trial will be powered for the adherence outcome (measured by 
1079 

Protocol: HIV-1 self-testing & PrEP 
     
ersion 1.7   April 18 2019 
27           V 
detection of PrEP in dried blood spots).  Based on our prior work in couples, and published 
1080 
work for women at risk, we estimate ~80% among those seeking to initiate PrEP will achieve 
1081 
blood levels consistent with high PrEP adherence [51, 52].  Thus, if PrEP adherence is 80% in 
1082 
both the standard of care and self-testing arms, with 80% power, 10% loss-to-follow-up, a one-
1083 
sided 95% confidence interval (common for non-inferiority trials), and a 10% non-inferiority 
1084 
margin, a sample size of n=495 is needed (n=330 self-testing, n=165 standard of care).  A 
1085 
10% non-inferiority margin has been chosen as an important reduction in PrEP use that might 
1086 
be tolerated in order to gain programmatic efficiency through HIV-1 self-testing.  We have 
1087 
planned for two sub-analyses with sample sizes of n=330: those in HIV-1 serodiscordant 
1088 
relationships (which will include 165 men and 165 women) and women (which will include the 
1089 
165 in serodiscordant relationships pus an additional 165 women at risk).  These primary sub-
1090 
analyses will have 80% power to rule out a 12% decrease in adherence (i.e., a slightly greater 
1091 
non-inferiority margin).  We have considered whether enrolling n=330 women at risk (rather 
1092 
than n=165, alone or in addition to n=330 couples) would be warranted but feel we can gain 
1093 
important information about both of these populations through the hybrid design, with greater 
1094 
efficiency, in time and in costs. However, we recognize that women outside of serodiscordant 
1095 
relationships may face unique adherence challenges and less frequent follow-up could be truly 
1096 
inferior to quarterly follow-up; thus, among the n=165 women at risk, we will also plan a 
1097 
superiority analysis, for which we will have 80% power to detect a decline in adherence from 
1098 
80% to 66% (14% lower) with self-testing.  For the HIV-1 testing outcome, utilization of self-
1099 
test kits will be compared between arms; assuming 95% of participants test, we have 80% 
1100 
power to detect a difference of 5% in use of consistent use of self-testing kits (90% vs. 95%). 
1101 
Also, if we end up having to over-enroll HIV-1 uninfected women at HIV-1 risk not in disclosed 
1102 
HIV-1 serodiscordant relationships to compensate for difficulties or delays in enrolling HIV-1 
1103 
uninfected men and women in HIV-1 serodiscordant relationships, we will have more power 
1104 
to detect outcomes in this important sub-group. 
1105 
 
1106 
 
1107 
Costing. The costs for a PrEP delivery program that uses HIV-1 self-testing with 6-monthly 
1108 
visits compared to quarterly visits with standard testing will be estimated. Activity-based micro-
1109 
costing will be conducted and compared by study arm for costs incurred (start-up activities, 
1110 
recruitment, service delivery, monitoring costs, and adherence support) and costs averted 
1111 
(personnel, lab monitoring, incident HIV-1 cases, social, and health benefits). Time and motion 
1112 
studies will be conducted by observing clinic visits, and staff time spent on training on use of 
1113 
home HIV-1 self-testing, counseling clinical procedures, cost of the three types of HIV-1 self-
1114 
testing kits (blood based provider kit, blood based HIV-1 self-testing kit and oral based HIV-1 
1115 
self-testing kit) and ART and PrEP delivery. Adjusting for time spent on research activities 
1116 
(e.g., informed consent, research questionnaires), the total time required for PrEP delivery will 
1117 
be estimated. Estimates of cost using the activity-based approach will be compared with the 
1118 
top down (dividing the budget by the number of clients) approach to support scalable estimates 
1119 
of cost.  Costs incurred by clients for clinic visits (which contribute to the societal perspective) 
1120 
will be estimated with standard questionnaires that we have used previously. 
1121 
    
1122 
 
1123 
Model. Mathematical models will be used to simulate health outcomes from a combination of 
1124 
study data and the literature, allowing us to consider clinical outcomes beyond the scope of 
1125 
the prospective cohort. We will adapt our existing compartmental dynamic transmission 
1126 
models (programmed in Matlab) to estimate and compare the impact of each of the 
1127 
interventions on HIV-1 incidence [19, 53, 54]. The model explicitly includes patterns of risk 
1128 
behavior and can account for risk compensation. Our simulation model of HIV-1 progression, 
1129 
transmission, and treatment in HIV-1 serodiscordant couples includes the composition of 
1130 
couples (by sex, age, and CD4 counts), aging, use of ART, conception and pregnancies, 
1131 
variations in coital frequency within stable partnerships and partner change rate. To adapt and 
1132 
parameterize the model, we will use data from our prior studies including the Partners 
1133 
Demonstration Project and the Kenya AIDS Indicator Survey [2, 14].  An alternative modeling 
1134 

Protocol: HIV-1 self-testing & PrEP 
     
ersion 1.7   April 18 2019 
28           V 
approach would be adapting our individual-based HIV-1 model to include PrEP [55].  
1135 
Assumptions will be as published previously, including our publication on micro-costing work 
1136 
within the Partners Demonstration Project [19]. 
1137 
For key delivery informants 
1138 
 
1139 
Health providers are key to PrEP delivery [49].  Therefore, in addition to self-testing users, we 
1140 
will study operational delivery at the level of providers. We will conduct key informant 
1141 
interviews (n=6-8) with healthcare providers at the research clinic (counselors, nurses, 
1142 
clinicians) to understand acceptance, barriers, facilitators, and confidence regarding HIV-1 
1143 
self-testing in the context of PrEP.  Interviews will be conducted at the end of the study.   We 
1144 
will document suggestions on how to optimize PrEP delivery through the use of HIV-1 self-
1145 
testing.  We will use similar interview and analysis methods detailed above.  
1146 
 
1147 
 
1148 
 
1149 
Quantitative Analysis 
1150 
 
1151 
Analyses will be intention-to-treat.  HIV-1 testing and PrEP detection in blood will be compared 
1152 
between arms using repeated measures analysis of proportions (e.g., generalized estimating 
1153 
equations [GEE]); PrEP continuation, defined as not missing any refill, will be analyzed as a 
1154 
time-to-event outcome using Cox proportional hazards regression.  As noted above, for the 
1155 
couples, those in which the HIV-1 uninfected partner completes PrEP use because the 
1156 
infected partner has initiated and sustained ART for >6 months (the Kenya standard for 
1157 
discontinuing PrEP) will be considered to have successfully used PrEP and will be counted as 
1158 
adherent; similarly, if PrEP is discontinued by the treating clinician for safety reasons (but not 
1159 
adherence reasons), follow-up thereafter will be censored, since the subject will not be able 
1160 
to be assessed for adherence to PrEP.  Adjusted analyses will be done as needed, controlling 
1161 
for potential confounders based on our prior work assessing correlates of PrEP use: 
1162 
demographics (e.g., gender, age, educational level), sexual behaviors (e.g., condom use, 
1163 
outside partnerships), medical status (e.g., depression), and beliefs (e.g., risk perception, 
1164 
PrEP efficacy). SAS or R will be used.  
1165 
 
1166 
For quantitative data, descriptive analyses will be done at baseline and over time, and GEE 
1167 
will be used to test associations between facilitators/barriers and testing preferences 
1168 
outcomes. Analyses will be done to test effect modification by gender and, within women, by 
1169 
serodiscordant couple status 
1170 
 
1171 
Qualitative Analysis 
1172 
 
1173 
The transcripts will be reviewed separately by two investigators for completeness and initial 
1174 
theme generation. Coding and analysis will be performed with Atlas.ti, using inductive 
1175 
approach informed by grounded theory [56]. We will then review the results of our coding for 
1176 
consistency of text segmentation and code application with continued inter-coder agreement, 
1177 
and inconsistent results will be reviewed by the coders until consensus is reached and then 
1178 
codes will be grouped together into themes through consensus among coders [57, 58]. We have 
1179 
extensive experience with in-depth interviews with purposefully sampled individuals and 
1180 
couples; for couples we have found dyadic interviews to be a powerful tool to explore joint 
1181 
decision-making and power/gender dynamics [49]. Analyses of the qualitative data will assess 
1182 
how both individuals and dyads respond to HIV-1 self-testing in the context of PrEP, with areas 
1183 
of focus such as gender roles, sexual negotiation, trust, and power.  In addition, we will probe 
1184 
delivery, including preference of quarterly versus 6-monthly visit schedule, confidence in HIV-
1185 
1 self-testing, confidence in blood versus oral fluid, and confidence in HIV-1 testing and PrEP 
1186 
more broadly.  
1187 

Protocol: HIV-1 self-testing & PrEP 
     
ersion 1.7   April 18 2019 
29           V 
 
1188 
 
1189 
HUMAN SUBJECTS CONSIDERATIONS 
1190 
 
1191 
The protocol, informed consent forms (for cohort participation and for interviews of providers), 
1192 
and patient education and recruitment materials will be reviewed and approved by the 
1193 
institutional review boards at the University of Washington and at KEMRI.  All participants will 
1194 
provide written informed consent before participation in the quantitative and qualitative 
1195 
interviews. Participants will be informed the purpose of the study, the procedures to be 
1196 
followed and the risks and benefits of participation. The consents forms will be translated into 
1197 
Kiswahili. Specifically the participants will be informed that this novel study will answer a critical 
1198 
questions on acceptability, performance and barriers of HIV-1 self testing in the context of 
1199 
implementation of PrEP.  Participants will also be informed that the counselors may conduct 
1200 
a home visit to provide additional support after a positive test result if required.   
1201 
 
1202 
Study oversight 
1203 
 
1204 
This study will be subject to oversight by an independent data monitoring committee that will 
1205 
periodically review data from the study, including study execution, adherence, HIV-1 
1206 
incidence, HIV-1 drug resistance, and serious adverse events. Review will be in an unblinded 
1207 
fashion, consistent with the open-label, randomized, unblinded nature of the study.  The 
1208 
independent data monitoring committee will provide recommendations to the study team as 
1209 
part of six-monthly reviews. Reports from all reviews will be provided for submission to 
1210 
overseeing IRBs/ECs. 
1211 
 
1212 
Risks 
1213 
 
1214 
Partner participants may feel pain or discomfort from phlebotomy if selected for a blood 
1215 
sample archive. Participants may become embarrassed, worried, or anxious when 
1216 
answering behavioral or demographic questions.  We have trained counselors who are 
1217 
available through the study to help participants deal with any feelings or questions they may 
1218 
have.  The study staff will make every effort to protect participant privacy and confidentiality 
1219 
while you are in the study. However it is possible that participants' involvement in the study 
1220 
could become known to others, and that social harms may result (i.e., because participants 
1221 
could become known as participating in a trial involving HIV-1 infected persons).  For 
1222 
example, participants could be treated unfairly or discriminated against, or could have 
1223 
problems being accepted by their families and/or communities.   
1224 
 
1225 
Benefits 
1226 
 
1227 
Participants will benefit from ongoing access to this prevention package.   
1228 
 
1229 
This study aims to provide HIV-1 prevention policy makers with information on how to best 
1230 
implement antiretroviral-based HIV-1 prevention.  In addition to the provision of this biomedical 
1231 
method, the study site will provide CHCT, and routine adherence counseling.  The outcome 
1232 
of the study will be evidence upon which to based policy guidelines for scaling up HIV-1 
1233 
prevention centers in Kenya and nearby countries with similar HIV-1 prevention needs.  The 
1234 
HIV-1 treatment centers that serve as sites for this study will be models upon which future 
1235 
centers can be based.  Summary outcomes from this study will be submitted to overseeing 
1236 
regulatory bodies and will be especially important for the development of normative guidance. 
1237 
 
1238 
 
1239 

Protocol: HIV-1 self-testing & PrEP 
     
ersion 1.7   April 18 2019 
30           V 
Care for persons identified as HIV-1 infected 
1240 
 
1241 
This study will identify persons who are infected with HIV-1, either as part of the study 
1242 
screening process or during follow-up of enrolled participants. Study staff will provide 
1243 
participants with their HIV-1 test results in the context of post-test counseling.  Persons 
1244 
identified as HIV-1 infected will be referred for care.   
1245 
 
1246 
 
  
1247 
Treatment for injury 
1248 
 
1249 
Participants will be asked to inform the clinic staff if they feel they have been injured because 
1250 
of taking part in the study. Injuries may also be identified during laboratory testing, medical 
1251 
histories, and physical examinations. Treatment for adverse events related to study 
1252 
participation will be provided by the treatment clinic. If treatment is required that is beyond the 
1253 
capacity of the clinic, the clinic staff will refer the participant to appropriate services or 
1254 
organizations that can provide care for the injury.  
1255 
 
1256 
Study records 
1257 
 
1258 
Implementation investigators will maintain, and store in a secure manner, complete, accurate, 
1259 
and current study records throughout the study.  Study records include administrative 
1260 
documentation and regulatory documentation as well as documentation related to each 
1261 
participant enrolled in the cohort, including informed consent forms, data forms, notations of 
1262 
all contacts with the participant, and all other source documents.   
1263 
 
1264 
Biometric Identification 
1265 
 
1266 
Thika site will use a biometric system (fingerprint scanner) to identify participants during 
1267 
follow-up visits. Participants will be offered an informed consent form with the option to 
1268 
accept or decline to have their fingerprint taken. Participants who decline to have their finger 
1269 
print taken will not be excluded from taking part in the study. The finger print database will be 
1270 
destroyed after completion of active follow-up in the study. 
1271 
 
1272 
Confidentiality 
1273 
 
1274 
Every effort will be made to protect participant privacy and confidentiality to the extent 
1275 
possible.  Personal identifying information will be retained at the local study site 
1276 
 
1277 
Dissemination Plan 
1278 
 
1279 
The study team for this award is committed to public dissemination of results of clinical trial, 
1280 
to trial participants, local stakeholders in Kenya, the global scientific community, and US, 
1281 
Kenyan, and global policymakers.   Dissemination of study results will follow principles of 
1282 
good participatory practice. The clinical trial will be registered with Clinicaltrials.gov prior to 
1283 
initiation and results will be updated there in a timely fashion.  Results will be published in 
1284 
conference abstracts and peer-reviewed journals.  Study results will be disseminated 
1285 
through presentations to local stakeholders and policymakers in Kenya, including the 
1286 
Ministry of Health.   
1287 
 
1288 
 
 
1289 

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ersion 1.7   April 18 2019 
31           V 
 
1290 
REFERENCES 
1291 
 
1292 
1. UNAIDS. The Gap Report. In. Geneva, Switzerland: UNAIDS; 2014. 
1293 
2. Cherutich P, Kaiser R, Galbraith J, Williamson J, Shiraishi RW, Ngare C, et al. Lack of 
1294 
knowledge of HIV status a major barrier to HIV prevention, care and treatment efforts 
1295 
in Kenya: results from a nationally representative study. PLoS One 2012; 7(5):e36797. 
1296 
3. Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. Preexposure 
1297 
chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med 
1298 
2010; 363(27):2587-2599. 
1299 
4. Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, et al. Antiretroviral 
1300 
prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med 2012; 
1301 
367(5):399-410. 
1302 
5. Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, et al. 
1303 
Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. 
1304 
N Engl J Med 2012; 367(5):423-434. 
1305 
6. Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, et al. 
1306 
Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand 
1307 
(the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 
1308 
3 trial. Lancet 2013; 381(9883):2083-2090. 
1309 
7. U.S. Food and Drug Administration. FDA approves first drug for reducing the risk of 
1310 
sexually acquired HIV infection. In; 2012. 
1311 
8. World Health Organization. Guideline on when to start antiretroviral therapy and on 
1312 
pre-exposure prophylaxis for HIV. In. Geneva: WHO; 2015. pp. 78. 
1313 
9. Baeten JM, Haberer JE, Liu AY, Sista N. Preexposure prophylaxis for HIV prevention: 
1314 
where have we been and where are we going? J Acquir Immune Defic Syndr 2013; 63 
1315 
Suppl 2(2):S122-129. 
1316 
10. Grant RM, Anderson PL, McMahan V, Liu A, Amico KR, Mehrotra M, et al. Uptake of pre-
1317 
exposure prophylaxis, sexual practices, and HIV incidence in men and transgender 
1318 
women who have sex with men: a cohort study. Lancet Infect Dis 2014; 14(9):820-829. 
1319 
11. Anderson PL, Glidden DV, Liu A, Buchbinder S, Lama JR, Guanira JV, et al. 
1320 
Emtricitabine-tenofovir concentrations and pre-exposure prophylaxis efficacy in men 
1321 
who have sex with men. Sci Transl Med 2012; 4(151):151ra125. 
1322 
12. McCormack S, Dunn DT, Desai M, Dolling DI, Gafos M, Gilson R, et al. Pre-exposure 
1323 
prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results 
1324 
from the pilot phase of a pragmatic open-label randomised trial. Lancet 2015; 
1325 
9(15):00056-00052. 
1326 
13. Liu AY, Cohen SE, Vittinghoff E, Anderson PL, Doblecki-Lewis S, Bacon O, et al. 
1327 
Preexposure prophylaxis for HIV infection integrated with municipal- and community-
1328 
based sexual health services. JAMA Intern Med 2016; 176(1):75-84. 
1329 
14. Baeten JM, Heffron R, Kidoguchi L, Mugo NR, Katabira E, Bukusi EA, et al. Integrated 
1330 
delivery of antiretroviral treatment and pre-exposure prophylaxis to HIV-1-
1331 
serodiscordant couples: A prospective implementation study in Kenya and Uganda. 
1332 
PLoS Med 2016; 13(8):e1002099. doi: 1002010.1001371/journal.pmed.1002099. 
1333 
15. Gomez GB, Borquez A, Case KK, Wheelock A, Vassall A, Hankins C. The cost and 
1334 
impact of scaling up pre-exposure prophylaxis for HIV prevention: a systematic review 
1335 
of cost-effectiveness modelling studies. PLoS Med 2013; 10(3):e1001401. 
1336 
16. Mugo NR, Ngure K, Kiragu M, Irungu E, Kilonzo N. The preexposure prophylaxis 
1337 
revolution; from clinical trials to programmatic implementation. Curr Opin HIV AIDS 
1338 
2016; 11(1):80-86. 
1339 
17. Cambiano V, Miners A, Phillips A. What do we know about the cost-effectiveness of 
1340 
HIV preexposure prophylaxis, and is it affordable? Curr Opin HIV AIDS 2016; 11(1):56-
1341 
66. 
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ersion 1.7   April 18 2019 
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18. Walensky RP, Park JE, Wood R, Freedberg KA, Scott CA, Bekker LG, et al. The cost-
1343 
effectiveness of pre-exposure prophylaxis for HIV infection in South African women. 
1344 
Clin Infect Dis 2012; 54(10):1504-1513. 
1345 
19. Ying R, Sharma M, Heffron R, Celum CL, Baeten JM, Katabira E, et al. Cost-
1346 
effectiveness of pre-exposure prophylaxis targeted to high-risk serodiscordant couples 
1347 
as a bridge to sustained ART use in Kampala, Uganda. J Int AIDS Soc 2015; 18(4 Suppl 
1348 
3):20013. doi: 20010.27448/IAS.20018.20014.20013. eCollection 22015. 
1349 
20. Centers for Disease Control and Prevention. Preexposure prophylaxis for the 
1350 
prevention of HIV infection in the United States - 2014: A clinical practice guideline. In: 
1351 
US Public Health Service; 2014. 
1352 
21. Lehman DA, Baeten JM, McCoy CO, Weis JF, Peterson D, Mbara G, et al. Risk of drug 
1353 
resistance among persons acquiring HIV within a randomized clinical trial of single- or 
1354 
dual-agent preexposure prophylaxis. J Infect Dis 2015; 211(8):1211-1218. doi: 
1355 
1210.1093/infdis/jiu1677. 
1356 
22. Parikh UM, Mellors JW. Should we fear resistance from tenofovir/emtricitabine 
1357 
preexposure prophylaxis? Curr Opin HIV AIDS 2016; 11(1):49-55. 
1358 
23. U.S. Food and Drug Administration. First rapid home-use HIV kit approved. In; 2012. 
1359 
24. Choko AT, Desmond N, Webb EL, Chavula K, Napierala-Mavedzenge S, Gaydos CA, et 
1360 
al. The uptake and accuracy of oral kits for HIV self-testing in high HIV prevalence 
1361 
setting: a cross-sectional feasibility study in Blantyre, Malawi. PLoS Med 2011; 
1362 
8(10):e1001102. 
1363 
25. Choko AT, MacPherson P, Webb EL, Willey BA, Feasy H, Sambakunsi R, et al. Uptake, 
1364 
accuracy, safety, and linkage into care over two years of promoting annual self-testing 
1365 
for HIV in Blantyre, Malawi: a community-based prospective study. PLoS Med 2015; 
1366 
12(9):e1001873. 
1367 
26. UNITAID. Increase in number of countries adopting HIV self-testing policies. In; 
1368 
2016. 
1369 
27. Johnson CC, Kennedy C, Fonner V, Siegfried N, Figueroa C, Dalal S, et al. Examing the 
1370 
effects of HIV self-testing compared to standard HIV testing services: a systematic 
1371 
review and meta-analysis. J Int AIDS Soc 2017; 20:21594. 
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28. Kenya Ministry of Health. Kenya HIV prevention revolution road map: Count down to 
1373 
2030. In; 2014. 
1374 
29. Bunnell R, Mermin J, De Cock KM. HIV prevention for a threatened continent: 
1375 
implementing positive prevention in Africa. JAMA 2006; 296(7):855-858. 
1376 
30. Marum E, Taegtmeyer M, Chebet K. Scale-up of voluntary HIV counseling and testing 
1377 
in Kenya. JAMA 2006; 296(7):859-862. 
1378 
31. Geldsetzer P, Ortblad K, Barnighausen T. The efficiency of chronic disease care in 
1379 
sub-Saharan Africa. BMC Med 2016; 14(1):127. 
1380 
32. Baeten JM, Donnell D, Mugo NR, Ndase P, Thomas KK, Campbell JD, et al. Single-agent 
1381 
tenofovir versus combination emtricitabine plus tenofovir for pre-exposure prophylaxis 
1382 
for HIV-1 acquisition: an update of data from a randomised, double-blind, phase 3 trial. 
1383 
Lancet Infect Dis 2014; 14(11):1055-1064. 
1384 
33. Murnane PM, Celum C, Mugo N, Campbell JD, Donnell D, Bukusi E, et al. Efficacy of 
1385 
preexposure prophylaxis for HIV-1 prevention among high-risk heterosexuals: 
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Subgroup analyses from a randomized trial. AIDS 2013; 27(13):2155-2160. 
1387 
34. Heffron R, Mugo N, Were E, Kiarie J, Bukusi EA, Mujugira A, et al. Preexposure 
1388 
prophylaxis is efficacious for HIV-1 prevention among women using depot 
1389 
medroxyprogesterone acetate for contraception. AIDS 2014; 28(18):2771-2776. doi: 
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2710.1097/QAD.0000000000000493. 
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35. Murnane PM, Heffron R, Ronald A, Bukusi EA, Donnell D, Mugo NR, et al. Pre-exposure 
1392 
prophylaxis for HIV-1 prevention does not diminish the pregnancy prevention 
1393 
effectiveness 
of 
hormonal 
contraception. AIDS 
2014; 28(12):1825-1830. doi: 
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1810.1097/QAD.0000000000000290. 
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36. Mugo NR, Hong T, Celum C, Donnell D, Bukusi EA, John-Stewart G, et al. Pregnancy 
1396 
incidence and outcomes among women receiving preexposure prophylaxis for HIV 
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ersion 1.7   April 18 2019 
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prevention: 
a 
randomized 
clinical 
trial. 
JAMA 
2014; 
312(4):362-371. 
doi: 
1398 
310.1001/jama.2014.8735. 
1399 
37. Mugwanya KK, Wyatt C, Celum C, Donnell D, Mugo NR, Tappero J, et al. Changes in 
1400 
glomerular kidney function among HIV-1-uninfected men and women receiving 
1401 
emtricitabine-tenofovir disoproxil fumarate preexposure prophylaxis: a randomized 
1402 
clinical 
trial. 
JAMA 
Intern 
Med 
2015; 
175(2):246-254. 
doi: 
1403 
210.1001/jamainternmed.2014.6786. 
1404 
38. Mugwanya K, Baeten J, Celum C, Donnell D, Nickolas T, Mugo N, et al. Low risk of 
1405 
proximal tubular dysfunction associated with emtricitabine-tenofovir disoproxil 
1406 
fumarate preexposure prophylaxis in men and women. J Infect Dis 2016; 214(7):1050-
1407 
1057. 
1408 
39. Mugwanya KK, Wyatt C, Celum C, Donnell D, Kiarie J, Ronald A, et al. Reversibility of 
1409 
glomerular renal function decline in HIV-uninfected men and women discontinuing 
1410 
emtricitabine-tenofovir disoproxil fumarate pre-exposure prophylaxis. J Acquir Immune 
1411 
Defic Syndr 2016; 71(4):374-380. 
1412 
40. Karim SS, Karim QA. Antiretroviral prophylaxis: a defining moment in HIV control. 
1413 
Lancet 2011; 378(9809):e23-25. 
1414 
41. Cohen J. AIDS research. Complexity surrounds HIV prevention advances. Science 
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2011; 333(6041):393. 
1416 
42. Ngure K, Heffron R, Mugo N, Thomson KA, Irungu E, Njuguna N, et al. Feasibility and 
1417 
acceptability of HIV self-testing among pre-exposure prophylaxis users in Kenya. J Int 
1418 
AIDS Soc 2017; 20(1):1-8. 
1419 
43. Masters SH, Agot K, Obonyo B, Napierala Mavedzenge S, Maman S, Thirumurthy H. 
1420 
Promoting partner testing and couples testing through secondary distribution of HIV 
1421 
self-tests: a randomized clinical trial. PLoS Med 2016; 13(11):e1002166. 
1422 
44. Mugo PM, Micheni M, Shangala J, Hussein MH, Graham SM, Rinke de Wit TF, et al. 
1423 
Uptake and acceptability of oral HIV self-testing among community pharmacy clients in 
1424 
Kenya: a feasibility study. PLoS One 2017; 12(1):e0170868. 
1425 
45. Unitaid. Market and technology landscaep: HIV rapid diagnostic tests for self-testing. 
1426 
In. Edited by Services JE. 4th edition ed. Geneva: Unitaid; 2018. 
1427 
46. National AIDS & STI Control Programme. Guidelines on the use of antiretroviral drugs 
1428 
for treating and preventing HIV infection in Kenya. In: Ministry of Health, Kenya; 2016. 
1429 
47. Brown AN, Djimeu EW, Cameron DB. A review of the evidence of harm from self-tests. 
1430 
AIDS Behav 2014; 18 Suppl 4(4):S445-449. 
1431 
48. Office of Behavioral and Social Science Research. Qualitative methods in health 
1432 
research: opportunities and considerations in application and review. . In. Bethesda, 
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MD: National Institutes of Health; 2001. 
1434 
49. Ngure K, Heffron R, Curran K, Vusha S, Ngutu M, Mugo N, et al. I knew I would be safer. 
1435 
Experiences of Kenyan HIV serodiscordant couples soon after pre-exposure 
1436 
prophylaxis (PrEP) initiation. AIDS Patient Care STDS 2016; 30(2):78-83. 
1437 
50. Castillo-Mancilla J, Seifert S, Campbell K, Coleman S, McAllister K, Zheng JH, et al. 
1438 
Emtricitabine-triphosphate in dried blood spots as a marker of recent dosing. Antimicrob 
1439 
Agents Chemother 2016; 60(11):6692-6697. 
1440 
51. Bekker L-G, Hughes J, Amico R, Roux S, Hendrix C, Anderson PL, et al. HPTN 
1441 
067/ADAPT Cape Town: a comparison of daily and nondaily PrEP dosing in African 
1442 
women. In: CROI 2015: Conference on Retroviruses and Opportunistic Infections. Seattle, 
1443 
USA 2015. pp. Abstract 978LB. 
1444 
52. Baeten JM, Heffron R, Kidoguchi L, Mugo NR, Katabira E, Bukusi EA, et al. Integrated 
1445 
delivery of antiretroviral treatment and pre-exposure prophylaxis to HIV-1-
1446 
serodiscordant couples: a prospective implementation study in Kenya and Uganda. 
1447 
PLoS Med 2016; 13(8):e1002099. 
1448 
53. Ying R, Sharma M, Celum C, Baeten JM, van Rooyen H, Hughes JP, et al. Home testing 
1449 
and counselling to reduce HIV incidence in a generalised epidemic setting: a 
1450 
mathematical modelling analysis. Lancet HIV 2016; 3(6):e275-282.  doi: 210.1016/S2352-
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3018(1016)30009-30001. 
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54. Sharma M, Farquhar C, Ying R, Krakowiak D, Kinuthia J, Osoti A, et al. Modeling the 
1453 
cost-effectiveness of home-based HIV testing and education (HOPE) for pregnant 
1454 
women and their male partners in Nyanza Province, Kenya. J Acquir Immune Defic Syndr 
1455 
2016; 72 Suppl 2(72):S174-180. 
1456 
55. Smith JA, Sharma M, Levin C, Baeten JM, van Rooyen H, Celum C, et al. Cost-
1457 
effectiveness of community-based strategies to strengthen the continuum of HIV care 
1458 
in rural South Africa: a health economic modelling analysis. Lancet HIV 2015; 2(4):e159-
1459 
168. doi: 110.1016/S2352-3018(1015)00016-00018. 
1460 
56. Glaser BC, Strauss AL. The Discovery of Grounded Theory: Strategies for Qualitative 
1461 
Research. New York: Aldiric de Gruyter; 1967. 
1462 
57. Barbour RS. Checklists for improving rigour in qualitative research: a case of the tail 
1463 
wagging the dog? Bmj 2001; 322(7294):1115-1117. 
1464 
58. Mays N, Pope C. Rigour and qualitative research. Bmj 1995; 311(6997):109-112. 
1465 
1466 

Study Consent    
 
 
 Version 1.7   April 18 2019 
35 
Appendix I:  Enrollment informed Consent – HIV uninfected 
1467 
 
1468 
Study Title: HIV self-testing to improve the efficiency of PrEP delivery  
1469 
 
1470 
Protocol version 1.7 
1471 
18 April, 2019 
1472 
 
1473 
INVESTIGATORS 
1474 
Investigator 
Title 
Institution 
Telephone  
Kenneth Ngure 
MPH, PhD 
Jomo Kenyatta University of 
Agriculture and Technology 
067 22561 
Nelly Mugo 
MBChB, 
MMed, MPH 
Kenya Medical Research 
Institute 
020 2736744 
Elizabeth Irungu 
MD, MPH 
Jomo Kenyatta University of 
Agriculture and Technology 
067 22561 
Jared Baeten 
 
MD, PhD 
University of Washington 
001 206-520-3808 
 
1475 
24 HOUR EMERGENCY TELEPHONE NUMBER: Tel: 0736464299 
1476 
  
1477 
INFORMED CONSENT  
1478 
We are asking you to volunteer in a research study. This study is sponsored by the University of 
1479 
Washington and funded by the National Institutes of Health which are located in the USA.  
1480 
 
1481 
If you decide to take part in this study  you will be asked to sign this consent form or make your 
1482 
mark in front of a witness. We will give you a copy of this form. This consent form might contain 
1483 
some words that are unfamiliar to you. Please ask us to explain anything you may not understand.  
1484 
 
1485 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
1486 
U.S. Law. This Web stie will not include information that can identify you. At most, the Web site 
1487 
will include a summary of the results. You can search this Web site at any time.  
1488 
 
1489 
PURPOSE OF THE STUDY  
1490 
Studies have shown that the medications used to treat HIV infection can also be used to prevent 
1491 
passing the virus. This concept is called pre-exposure prophylaxis, or PrEP. These studies have 
1492 
also learned that PrEP is safe (meaning that it does not produce significant health problems in 
1493 
persons who take them) when taken by HIV-uninfected men and women.  Studies have also 
1494 
shown that women and men are able to test themselves for HIV using special types of HIV-self 
1495 
test kits and that HIV uninfected persons taking PrEP are able to use HIV self-tests safely and 
1496 
correctly at home.  
1497 
 
1498 
Both HIV self-testing and PrEP have been recently endorsed and launched by the Kenyan 
1499 
Ministry of Health. 
1500 
 
1501 
The purpose of this study therefore is to find out more about how PrEP could be delivered more 
1502 
efficiently to HIV uninfected men and women with some of the participants testing for HIV at home 
1503 
for some of the visits.   
1504 
 
1505 
Through a method similar to tossing a coin the you will be assigned to a group that: (1) comes to 
1506 
the clinic every three months and gets tested by a health provider, (2) comes to the clinic every 
1507 

Study Consent    
 
 
 Version 1.7   April 18 2019 
36 
six months and tests at home between clinic visits for HIV using an oral fluid HIV self-test kit, (3) 
1508 
comes to the clinic every six months and tests at home between clinic visits for HIV using a blood 
1509 
based HIV self-test kit.   
1510 
 
1511 
Approximately 495 participants who are using PrEP will be enrolled in this study and will be in the 
1512 
study for up to 12 months.   
1513 
 
1514 
 
1515 
YOUR PARTICIPATION IS VOLUNTARY  
1516 
Before you learn about this study, it is important that you know the following:  
1517 
• 
You do not have to be in this study if you do not want to. 
1518 
 
1519 
• 
You may decide not to be in the study, or to being in the study at any time, without losing 
1520 
your regular medical care.  
1521 
 
1522 
• 
If you decide not to be in the study, you can still join other research studies later, if available 
1523 
and you qualify.  
1524 
 
1525 
• 
You may be asked about joining other studies. Due to the time commitment from being in 
1526 
this study, you may not be eligible to join this study if you are in other studies. If you do not 
1527 
agree to join these other studies, you may still take part in this study.  
1528 
 
1529 
• 
If you decide to enroll in this study, after your enrollment visit you will be in the study up to 
1530 
12 months.   
1531 
 
1532 
• 
You will receive the results of the HIV related tests.  
1533 
 
1534 
• 
The answers you provide to survey questions will remain confidential and identifying 
1535 
information about you will not be shared.  
1536 
 
1537 
 
1538 
ENROLLMENT  PROCEDURES 
1539 
The enrollment tests for this study will include questions and tests done from samples of blood.  
1540 
The enrollment  procedures will include the following:  
1541 
 
1542 
• 
The study staff will ask you where you live and other questions about you and your sexual 
1543 
practices.  
1544 
 
1545 
• 
We will counsel you about HIV and other infections passed during sex, and how to avoid 
1546 
these infections including the use of condoms and other contraceptives. We will provide you 
1547 
with free condoms at your screening visit as well as at each visit throughout the study. 
1548 
 
1549 
• 
Even if you have recently been tested for HIV, we will need to repeat the HIV test today as 
1550 
part of the study. The study staff will talk with you about the HIV test, what it may mean to 
1551 
know your HIV test results, including issues for partners when one partner is HIV-infected 
1552 
and the other is HIV-uninfected. You must receive your HIV test results to be in the research 
1553 
study.  
1554 
 
1555 
• 
We will ask you questions about your medical history, you will have a physical 
1556 
examination, and you will undergo an STI assessment. 
1557 

Study Consent    
 
 
 Version 1.7   April 18 2019 
37 
 
1558 
• 
You will be asked to give us permission to obtain a blood sample for laboratory tests. No 
1559 
more than 10 ml (about two teaspoons) will be collected for all the enrollment tests, including 
1560 
the HIV test. We will use the blood to test for PrEP drug levels and hemoglobin levels in 
1561 
your blood. We will also test your blood for PrEP drug levels and hemoglobin levels at six 
1562 
months and at the final study visit.  
1563 
 
1564 
• 
In this research study, some of you will come to the clinic every 3 months for 12 months for 
1565 
HIV testing, while others will be offered two oral-fluid or blood-based HIV self-tests to test 
1566 
themselves at home instead of coming back to the clinic on month 3 and month 9 visits. The 
1567 
self-test group will only come to the clinic on month 6 and month 12. We will also provide 
1568 
advice about when it might be best to use the self-tests. We may also visit you at home after 
1569 
a positive test result to provide additional support if required.  More training on the use of 
1570 
the self-testswill be done the 6-month visit.  Please note that the HIV self-tests provided to 
1571 
you will only be for your own use and should not be used to test others. 
1572 
 
1573 
• 
Additionally, you will continue to be offered PrEP to be taken as one pill once each day to 
1574 
prevent HIV infection. The PrEP medication will be provided by this clinic, free of charge.    
1575 
 
1576 
FOLLOW-UP PROCEDURES  
1577 
 
1578 
• 
You will be asked questions about your health and medical history, including whether you 
1579 
have any clinical symptoms, your sexual practices and other behaviors, and your feelings 
1580 
about taking medications for HIV prevention.  
1581 
 
1582 
• 
Talk with study staff about ways to avoid HIV and other infections passed during sex. We 
1583 
encourage you to have this counseling with your partner, but you can have it by yourself if 
1584 
you wish. You will be offered condoms.  
1585 
 
1586 
• 
Get medical care or referrals for medical care and other services if you need them. 
1587 
 
1588 
• 
Give updated information on where you live and how to keep in contact with you. The study 
1589 
staff will use this information to remind you of scheduled visits. If you miss a visit, the study 
1590 
staff will try to contact you by telephone. They may try to reach you through the contact 
1591 
people that you list. If they talk to these people, they will not tell them why they are trying to 
1592 
reach you. The study staff may also visit you at your home, however if they visit they will 
1593 
visit you as ‘friends’ so that your neighbors and other community members will not know 
1594 
why they are visiting.  
1595 
 
1596 
• 
Women will be asked whether they think they may be pregnant.  A urine pregnancy test may 
1597 
be done if unsure about being pregnant. Women who are pregnant will not be excluded from 
1598 
the study.  
1599 
 
1600 
• 
If your HIV test is negative you can continue to receive PrEP medication. You will be asked 
1601 
to answer questions about the pills you took during the previous month and be counseled 
1602 
about methods for not forgetting to take your pills during the following month. The pharmacy 
1603 
staff will provide you with new bottles with pills to last until your next visit. 
1604 
 
1605 

Study Consent    
 
 
 Version 1.7   April 18 2019 
38 
• 
At the sixth month after starting PrEP and then at 12 months, you will have a blood sample 
1606 
to check the safety of PrEP for your kidneys.  If at any time you have an abnormal result, 
1607 
we will contact you so that you will know. 
1608 
 
1609 
Those in the HIV self testing arms will be requested to bring back used HIV self-tests (if 
1610 
available) at their month 6 and month 12 visits. 
1611 
 
1612 
At any time in the study:  
1613 
 
1614 
• 
If you or the study staff thinks you may have any health problems, you may need to undergo 
1615 
a physical exam and may need to provide blood or other samples for testing.  
1616 
 
1617 
• 
You can have extra counseling and testing for HIV if needed between scheduled visits, 
1618 
either with your partner or by yourself.  
1619 
 
1620 
• 
If you decide to leave the study before your last scheduled study visit, we will ask you to 
1621 
have a final study visit with all the exams and tests listed above.  
1622 
 
1623 
• 
If you test positive in the clinic for HIV, we will take additional blood samples amounting to 
1624 
no more than 15 mL (about three teaspoons) to confirm your test, measure your CD4 count 
1625 
and viral load, and send a sample to the Kenyan Ministry of Health laboratories to test for 
1626 
drug resistance.  
1627 
 
1628 
At month 12 visit: 
1629 
 
1630 
• 
You will be provided with an opportunity to experience either a blood based or oral fluid-
1631 
based HIV self-testing kit or both if you had not used them during the study.  
1632 
 
1633 
After experiencing the kit/s we will request you to complete a brief questionnaire on your 
1634 
testing  experiences. 
1635 
 
1636 
Long interviews 
1637 
At some point during the study, the staff may invite you to answer more questions about your 
1638 
opinions on HIV self-testing, including perceptions, preferences, challenges, and concerns. An 
1639 
interview will take no more than two hours.  Some interviews will be done individually and some 
1640 
will be done as a group session with other people who are participating in the study.  We will 
1641 
record the interviews so we can write them down later.  This recording will then be destroyed not 
1642 
later than August 2023. 
1643 
 
1644 
Pregnancy 
1645 
If you become pregnant at any time during this study you will be referred for antenatal care and 
1646 
will have the option to continue in the study. 
1647 
 
1648 
 
1649 
 
1650 
IF YOU BECOME HIV INFECTED  
1651 
During the course of the study we will provide you with condoms, PrEP, and other materials to 
1652 
help prevent getting HIV. However, it is possible to become HIV infected.  
1653 
 
1654 
If you have a positive HIV test during the study:  
1655 

Study Consent    
 
 
 Version 1.7   April 18 2019 
39 
 
1656 
• 
The study staff will talk with you about this test result and what this means for you.  
1657 
 
1658 
• 
You will stop taking the PrEP medication.  
1659 
 
1660 
• 
The staff will ask your permission to obtain a second blood test [no more than 15 ml / about 
1661 
3 teaspoons ] that will be used to confirm the initial positive test, measure of your immune 
1662 
function (CD4 count) and viral load, and test for drug resistance.  
1663 
 
1664 
• 
You will undergo a physical exam  
1665 
 
1666 
• 
Women will be asked to provide a urine sample for a pregnancy test.  
1667 
 
1668 
• 
You will then be asked to return for another visit within about 2 weeks. At that visit, results 
1669 
from the confirmatory HIV test will be available. If those results confirm that you have 
1670 
become infected with HIV, you will be referred to an HIV care clinic. 
1671 
 
1672 
IMPORTANCE OF NOT SHARING THE STUDY MEDICATION  
1673 
 
1674 
It is very important that you do not share HIV medications medication with your partner or 
1675 
with anyone else. Although the PrEP medication is used to treat HIV infection, it is only effective 
1676 
for treating people who already have HIV infection if they are used in combination with other 
1677 
medications. Thus, PrEP by itself is only for HIV uninfected people. Similarly, HIV medications for 
1678 
treatment are only for HIV infected people, and must be used every day.   
1679 
 
1680 
IMPORTANCE OF NOT SHARING THE STUDY HIV SELF-TESTING KITS 
1681 
 
1682 
It is very important that you do not share HIV self-test kits with anyone else. This is because 
1683 
the persons you share the kits with have not been trained to conduct the tests and have do not 
1684 
have linkage system established for them. However, if for any reason your HIV self-testing kit is 
1685 
used by someone else please inform the study staff during the next visit or by phone so that the 
1686 
staff can offer the support if necessary. 
1687 
 
1688 
SPECIMEN STORAGE AND USE OF SAMPLES AND DATA FOR FUTURE STUDIES  
1689 
 
1690 
Some of the blood taken at study visits will be shipped to University of Washington in the United 
1691 
States for testing of tenofovir. We would also like to save data from this study and samples of 
1692 
your blood at Thika site and at the University of Washington for future research by us and by other 
1693 
researchers. We will use these samples only for research related to HIV, HIV-related diseases, 
1694 
and sexually-transmitted infections. Before your samples leave the clinic, they will be assigned a 
1695 
code and your name will not be on them. Your name will be linked to the code only at this clinic 
1696 
and only for five years after the study is completed. After that time, the link between your name 
1697 
and the code on your data and samples will be destroyed. An Institutional Review Board or 
1698 
Independent Ethics Committee, which watches over the safety and rights of research participants, 
1699 
must approve any future research studies using your data and samples. If you agree to store your 
1700 
samples, we will keep them for as long as sample remains that can be used for future research. 
1701 
If you do not want to have your samples saved for future research, you can still be in this study 
1702 
and your samples will be destroyed once testing for this study is completed. If you agree to store 
1703 
your samples now, but change your mind before the end of the study, let the study staff know and 
1704 
we will make sure that your samples do not get stored for future research. We will not sell your 
1705 

Study Consent    
 
 
 Version 1.7   April 18 2019 
40 
data or samples. Tests done on your samples may lead to a new invention or discovery. We have 
1706 
no plans to share any money or other benefits resulting from this invention or discovery with you.  
1707 
 
1708 
RISKS AND/OR DISCOMFORTS 
1709 
You may feel discomfort or pain when your blood is drawn. You may feel dizzy or faint. You may 
1710 
have a bruise where the needle goes into your arm.  
1711 
 
1712 
You may become embarrassed, worried, or anxious when talking about your sexual practices, 
1713 
ways to protect against HIV and other infections passed during sex, and your HIV test results. 
1714 
You may become worried or anxious while waiting for your test results. If you become infected 
1715 
with HIV, knowing this could make you worried or anxious. Talking about HIV and finding out your 
1716 
test results could cause problems between you and your partner. Trained counselors will help you 
1717 
and your partner deal with any feelings or questions you may have.  
1718 
 
1719 
The study staff will make every effort to protect your privacy and confidentiality while you are 
1720 
having the study procedures. However, it is possible that others may learn of your participation 
1721 
here and, because of this, may treat you unfairly or discriminate against you. For example, you 
1722 
could have problems getting or keeping a job, or being accepted by your family or community.  
1723 
 
1724 
You may experience discomfort when performing the oral HIV self-test.  You may feel worried 
1725 
when interpreting HIV results - please call the 24-hour toll free line on the front of this form for any 
1726 
result that appears positive or for any result that you have difficulties in interpreting. You should 
1727 
also call this line in case of a positive test result. We will record all the main content of our 
1728 
conversations with you and others in a book in the clinic, this will enable us to make our training 
1729 
and counseling to be more responsive to your needs. You may feel embarrassed, worried, or 
1730 
anxious when talking about your experiences with HIV self-testing or when discussing the results 
1731 
of your self-testing.  Counselors are available through the study that will help you deal with any 
1732 
feelings or questions you have. The study staff will make every effort to protect your privacy and 
1733 
confidentiality while you are answering the questions.  However, it is possible that others will learn 
1734 
of your answers and, because of this, may treat you unfairly or discriminate against you. In the 
1735 
group discussions, even though all participants will promise to not talk about the group discussion 
1736 
outside of the discussion, anything you say will not be fully confidential since all members of the 
1737 
group discussion will hear it. 
1738 
 
1739 
For more information about risks of this study, ask your study clinician.  
1740 
 
1741 
BENEFITS  
1742 
You will be receiving PrEP, which is known to help keep HIV-uninfected individuals who have 
1743 
HIV-infected partners from getting HIV. You will get counseling and testing for HIV. You will get 
1744 
free condoms. If you or your partner have health problems that may be due to infections passed 
1745 
during sex, you will get medicine to treat them, if needed. For other health problems, the study 
1746 
staff will give you care and treatment that is available at the clinic. For care and treatment that is 
1747 
not available at the clinic, study staff will tell you about other places where care and treatment 
1748 
may be available.  
1749 
 
1750 
HIV self-testing has the potential of capturing a positive HIV test before your scheduled clinic visit 
1751 
and there are medical benefits to identifying an HIV infection sooner. Your participation in this 
1752 
study will contribute to understanding about HIV self-testing among couples in Kenya, which will 
1753 
help others in the future. 
1754 
 
1755 
NEW FINDINGS  
1756 

Study Consent    
 
 
 Version 1.7   April 18 2019 
41 
You will be told any new information learned during this study that is important for your health or 
1757 
might cause you to change your mind about staying in the study. You will be told when the results 
1758 
of the study may be available, and how to learn about them.  
1759 
 
1760 
COSTS TO YOU  
1761 
There is no cost to you for being in this study. Treatments available to you from the study will be 
1762 
given free of charge.  
1763 
 
1764 
 
1765 
REASONS WHY YOU MAY BE WITHDRAWN FROM THE STUDY  
1766 
You may be removed from the study without your consent for the following reasons:  
1767 
 
1768 
• The study is stopped or canceled.  
1769 
 
1770 
• The study staff feel that staying in the study would be harmful to you.  
1771 
 
1772 
ALTERNATIVES TO PARTICIPATION  
1773 
There may be other studies going on here or in the community that you or your partner may be 
1774 
eligible for. If you wish, we will tell you about other studies that we know about. There also may 
1775 
be other places where you can go for HIV counseling and testing. We will tell you about those 
1776 
places if you wish.  
1777 
 
1778 
REIMBURSEMENT 
1779 
You will receive transportation reimbursement and an additional 200 Kshs for your time and effort 
1780 
spent at the clinic. 
1781 
 
1782 
BIOMETRIC FINGERPRINT SCAN 
1783 
To help us keep track of who is enrolled in our clinic and who is coming for follow up visits, we 
1784 
will ask you to put either your right or left index finger on a small machine that will scan your finger 
1785 
print. This scan will be linked to a unique identification number and will be accessible only to study 
1786 
staff.  We will take your fingerprint at each study visit. You are free to refuse to have your 
1787 
fingerprint taken and this will not affect your participation in the study. The finger print database 
1788 
will be destroyed after completion of active follow up in the study. 
1789 
 
1790 
CONFIDENTIALITY  
1791 
Efforts will be made to keep your personal information confidential. However, absolute 
1792 
confidentiality cannot be guaranteed. Your personal information may be disclosed if required by 
1793 
law. Any sample from you or information about you will be identified only by code. The link 
1794 
between your name and code will be kept in a secure location at the clinic only. We will not discuss 
1795 
any information about you with your partner unless you give written permission, and will 
1796 
encourage you to be present during the discussion. Any publication of this study will not use your 
1797 
name or identify you personally.  
1798 
 
1799 
Your study records may be reviewed by study staff and representatives of:  
1800 
 
1801 
• 
the University of Washington, including study monitors  
1802 
 
1803 
• 
The United States National Institutes of Health 
1804 
 
1805 
• 
Kenya Medical Research Institute (KEMRI) 
1806 
 
1807 

Study Consent    
 
 
 Version 1.7   April 18 2019 
42 
• 
National Council of Science and Technology (NACOSTI) 
1808 
 
1809 
RESEARCH-RELATED INJURY  
1810 
The study staff will monitor your health and the health of your partner while you are in this study.  
1811 
 
1812 
If you or your partner has any health problems between visits, or if you have a medical emergency 
1813 
that requires immediate care, please contact the study staff. 
1814 
 
1815 
If you are injured from participating in this study, you will be offered care at the study clinic, free 
1816 
of charge. It is important that you tell the members of the team of researchers at this clinic if you 
1817 
feel that you have been injured because of taking part in this study. There is not a program of 
1818 
monetary compensation through this institution. If you require medical care that the study clinic 
1819 
cannot provide, the study clinicians will refer you to the appropriate services or organizations that 
1820 
can provide care for the injury. You do not give up any legal rights by signing this consent form.  
1821 
 
1822 
PROBLEMS OR QUESTIONS 
1823 
 
1824 
If you ever have any questions about this study, you should contact Dr. Kenneth Ngure at the 
1825 
Thika Study clinic at Tel 06721305/22561.  For research related injury, please call the 24-hour 
1826 
emergency number: 0736464299. 
1827 
 
1828 
If you have questions about your rights as a participant, contact the secretary of the KEMRI 
1829 
Scientific and Ethics Review Unit, P.O. Box 54840-00200, Nairobi, Telephone number 020272-
1830 
2541, 0722205901, 0733-400003. Email address: seru@kemri.org. 
1831 
 
1832 
 
1833 
STATEMENT OF CONSENT AND SIGNATURES  
1834 
I have read this form or had it read to me. I have discussed the information with study staff. My 
1835 
questions have been answered. I understand that my decision whether or not to take part in the 
1836 
study is voluntary. I understand that if I decide to join the study I may withdraw at any time. By 
1837 
signing this form, I do not give up any rights that I have as a research participant.  
1838 
 
1839 
 
_______________________ 
Participant Name (print) 
 
___________________________ 
Participant Signature/Thumbprint 
 
_____________ 
Date 
 
 
_______________________ 
Study Staff Conducting Study 
Consent Discussion (print) 
 
 
___________________________ 
Staff Signature 
 
 
_____________ 
Date 
 
_______________________ 
Witness Name (print)  
 
___________________________ 
Witness Signature 
 
_____________ 
Date 
 
1840 
 
1841 
SPECIMEN STORAGE AND USE OF YOUR DATA AND SAMPLES FOR FUTURE STUDIES:  
1842 
Please initial and date one option:  
1843 
 
1844 

Study Consent    
 
 
 Version 1.7   April 18 2019 
43 
___________  I DO agree to store my data and samples for future research into HIV, HIV-                  
1845 
related diseases, and other sexually transmitted diseases.  
1846 
 
1847 
____________ I DO NOT agree to store my data and samples for future research into HIV, HIV-
1848 
related diseases, and other sexually transmitted diseases. 
1849 
 
1850 
 
_______________________ 
Participant Name (print) 
 
___________________________ 
Participant Signature/Thumbprint 
 
_____________ 
Date 
 
 
_______________________ 
Study Staff Conducting Study 
Consent Discussion (print) 
 
 
___________________________ 
Staff Signature 
 
 
_____________ 
Date 
 
_______________________ 
Witness Name (print)  
 
___________________________ 
Witness Signature 
 
_____________ 
Date 
 
1851 
SPECIMEN SHIPMENT TO UNIVERSITY OF WASHINGTON  
1852 
Please initial and date one option:  
1853 
 
1854 
___________  I DO agree to allow my biological samples to be shipped to University of 
1855 
Washington for specialized tests and used for future research tests  
1856 
 
1857 
____________ I DO NOT agree to allow my biological samples to be shipped to University of 
1858 
Washington for specialized tests and used for future research tests 
1859 
 
1860 
 
_______________________ 
Participant Name (print) 
 
___________________________ 
Participant Signature/Thumbprint 
 
_____________ 
Date 
 
 
_______________________ 
Study Staff Conducting Study 
Consent Discussion (print) 
 
 
___________________________ 
Staff Signature 
 
 
_____________ 
Date 
 
_______________________ 
Witness Name (print)  
 
___________________________ 
Witness Signature 
 
_____________ 
Date 
 
1861 
 
1862 
STATEMENT OF CONSENT: BIOMETRIC FINGERPRINT 
1863 
 
1864 
Please initial and date one option 
1865 
 
1866 
___________  I DO agree to have my finger print taken  
1867 
 
1868 
____________I DO NOT agree to have my fingerprint taken 
1869 
 
1870 
 
1871 

Study Consent    
 
 
 Version 1.7   April 18 2019 
44 
______________________ __________________________ 
________________ 
1872 
Participant Name (print) 
Participant Signature/Thumbprint 
 
Date 
1873 
 
1874 
______________________ __________________________ 
________________ 
1875 
Study Staff Conducting  
 
Study Staff Signature  
Date 
1876 
Consent Discussion (print) 
1877 
 
_______________________ 
Witness Name (print)  
 
___________________________ 
Witness Signature 
 
_____________ 
Date 
 
1878 
 
1879 
PERMISSION FOR AUDIO RECORDING 
1880 
 
1881 
Please initial and date one option:  
1882 
 
1883 
_____________ I give permission for the interviews that I participate in to be recorded. 
1884 
 
1885 
_____________ I DO NOT give permission for the interviews that I participate in to be recorded. 
1886 
 
Participant Name 
 
Participant Signature 
 
Date 
 
 
Study Staff Conducting Consent 
(print) 
 
 
Study Staff Signature 
 
 
Date 
 
 
Witness Name (print) 
 
 
Witness Signature 
 
 
Date 
 
1887 
 
1888 
Copies to:  
1. Investigators 
1889 
 
 
2. Study participant 
1890 
1891 

Study Consent    
 
 
 Version 1.7   April 18 2019 
45 
Appendix II.  Enrollment informed Consent – HIV infected 
1892 
 
1893 
Study Title: HIV self-testing to improve the efficiency of PrEP delivery 
1894 
 
1895 
Protocol version 1.7 
1896 
18 April, 2019 
1897 
 
1898 
INVESTIGATORS 
1899 
Investigator 
Title 
Institution 
Telephone  
Kenneth Ngure 
MPH, PhD 
Jomo Kenyatta University of 
Agriculture and Technology 
067 22561 
Nelly Mugo 
MBChB, 
MMed, MPH 
Kenya Medical Research 
Institute 
020 2736744 
Elizabeth Irungu 
MD, MPH 
Jomo Kenyatta University of 
Agriculture and Technology 
067 22561 
Jared Baeten 
 
MD, PhD 
University of Washington 
001 206-520-3808 
 
1900 
24 HOUR EMERGENCY TELEPHONE NUMBER: Tel: 0736464299 
1901 
 
1902 
INFORMED CONSENT  
1903 
 
1904 
We are asking you to volunteer to for a research study. This study is sponsored by the University 
1905 
of Washington and funded by the National Institutes of Health which are located in the USA.  
1906 
 
1907 
If you decide to take part in this study you will be asked to sign this consent form or make your 
1908 
mark in front of a witness. We will give you a copy of this form. This consent form might contain 
1909 
some words that are unfamiliar to you. Please ask us to explain anything you may not understand.  
1910 
 
1911 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
1912 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site 
1913 
will include a summary of the results. You can search this Web site at any time. 
1914 
 
1915 
PURPOSE OF THE STUDY  
1916 
Studies have shown that the medications used to treat HIV infection can also be used to prevent 
1917 
passing the virus.  This concept is called pre-exposure prophylaxis, or PrEP. These studies have 
1918 
also learned that PrEP is safe (meaning that it does not produce significant health problems in 
1919 
persons who take them) when taken by HIV-uninfected men and women.  Studies have also 
1920 
shown that women and men are able to test themselves for HIV using special types of HIV-self 
1921 
test kits and that HIV uninfected persons taking PrEP are able to use HIV self-tests safely and 
1922 
correctly at home.  
1923 
 
1924 
Both HIV self-testing and PrEP have been recently endorsed and launched by the Kenyan 
1925 
Ministry of Health. 
1926 
 
1927 
The purpose of this study, therefore, is to find out more about how PrEP could be delivered more 
1928 
efficiently to HIV uninfected men and women with some of the participants testing for HIV at home 
1929 
for some of the visits 
1930 
 
1931 

Study Consent    
 
 
 Version 1.7   April 18 2019 
46 
Approximately 495  participants weill be enrolled in this study and will be in the study for up to 12 
1932 
months. 330 HIV uninfected individiuals, whose partner is HIV positive, will be enrolled in this 
1933 
study and followed up  for up to 12 months, while their HIV infected partners will have a single 
1934 
visit. 
1935 
 
1936 
YOUR PARTICIPATION IS VOLUNTARY  
1937 
Before you learn about this study, it is important that you know the following:  
1938 
• 
You do not have to be in this study if you do not want to. 
1939 
 
1940 
• 
If you decide not to participate in this study , you can still join other research studies later, if 
1941 
available and you qualify.  
1942 
 
1943 
• 
You will receive the results of the HIV related tests.  
1944 
 
1945 
• 
The answers you provide to survey questions will remain confidential and identifying 
1946 
information about you will not be shared.  
1947 
 
1948 
 
1949 
STUDY PROCEDURES  
1950 
The procedures for this visit will include questions and tests done from samples of blood. These 
1951 
procedures will include the following:  
1952 
 
1953 
• 
The study staff will ask basic questions about yourself your sexual practices, and your ART 
1954 
adherence (if applicable).  
1955 
 
1956 
• 
We will counsel you about HIV and other infections passed during sex, and how to avoid 
1957 
these infections including the use of condoms and other contraceptives. We will provide you 
1958 
with free condoms if you need them 
1959 
 
1960 
• 
Even if you have recently been tested for HIV, we will need to repeat the HIV test today. 
1961 
The study staff will talk with you about the HIV test, what it may mean to know your HIV test 
1962 
results, including issues for partners when one partner is HIV-infected and the other is HIV-
1963 
uninfected. We will then ask your partner and you whether you are ready to be tested today 
1964 
and receive your HIV test results. You must receive your HIV test results to be in the 
1965 
research study.  
1966 
 
1967 
• 
We will ask you questions about your medical history. As part of these questions, you will 
1968 
be asked about symptoms of AIDS.  
1969 
 
1970 
• 
You will be asked to give us permission to obtain a blood sample for laboratory tests. No 
1971 
more than 10 mL (about two teaspoons) will be collected for all the screening tests, including 
1972 
the HIV test. Some of the blood sample will be used for a test called a CD4 cell count. The 
1973 
CD4 count is a measure of how well your immune system is functioning. The lower the CD4 
1974 
count in persons who are HIV-infected, the more at risk they are for having problems from 
1975 
AIDS. Some of the blood sample will be used to test for the amount of HIV virus in your 
1976 
blood, called ‘viral load.’ 
1977 
 
1978 
• 
Be asked questions about your health and medical history, including whether you have any 
1979 
clinical symptoms, your sexual practices and other behaviors,and your feelings about taking 
1980 
medications for HIV prevention.  
1981 

Study Consent    
 
 
 Version 1.7   April 18 2019 
47 
Your partner 
1982 
 
1983 
• 
Your partner may be assigned to one of two groups. One group will come to the clinic every 
1984 
3 months for HIV testing for 12 months, while the other group will be offered two oral-fluid 
1985 
or blood-based HIV self-test kits to test themselves at home instead of coming back to the 
1986 
clinic on month 3 and month 9 visits. Therefore, if your partner is randomized to the second 
1987 
group, they will only come to the clinic on month 6 and month 12 for testing.  
1988 
 
1989 
• 
Additionally your partner will be offered PrEP to be taken as one pill once each day, as pre-
1990 
exposure prophylaxis to prevent HIV infection. The PrEP medication will be provided by this 
1991 
clinic, free of charge.    
1992 
 
1993 
RISKS AND/OR DISCOMFORTS 
1994 
You may feel discomfort or pain when your blood is drawn. You may feel dizzy or faint. You may 
1995 
have a bruise where the needle goes into your arm.  
1996 
 
1997 
You may become embarrassed, worried, or anxious when talking about your sexual practices, 
1998 
ways to protect against other infections passed during sex, and your HIV test results. You may 
1999 
become worried or anxious while waiting for your test results. Talking about HIV and finding out 
2000 
your test results could cause problems between you and your partner. Trained counselors will 
2001 
help you and your partner deal with any feelings or questions you may have.  
2002 
 
2003 
The study staff will make every effort to protect your privacy and confidentiality while you are 
2004 
having the study procedures. However, it is possible that others may learn of your participation 
2005 
here and, because of this, may treat you unfairly or discriminate against you. For example, you 
2006 
could have problems getting or keeping a job, or being accepted by your family or community.  
2007 
 
2008 
For more information about risks of this study, ask your study clinician.  
2009 
 
2010 
BENEFITS  
2011 
Your HIV uninfected partner will be receiving PrEP, which is known to help keep HIV-uninfected 
2012 
individuals who have HIV-infected partners from getting HIV. You will get counseling and testing 
2013 
for HIV. You will get free condoms.  
2014 
 
2015 
COSTS TO YOU  
2016 
There is no cost to you for being in this study. Treatments available to you from the study will be 
2017 
given free of charge. 
2018 
 
2019 
ALTERNATIVES TO PARTICIPATION  
2020 
There may be other studies going on here or in the community that you or your partner may be 
2021 
eligible for. If you wish, we will tell you about other studies that we know about. There also may 
2022 
be other places where you can go for HIV counseling and testing. We will tell you about those 
2023 
places if you wish.  
2024 
 
2025 
REIMBURSEMENT 
2026 
You will receive transportation reimbursement and an additional 200 Kshs for your time and effort 
2027 
spent at the clinic. 
2028 
 
2029 
 
2030 
 
2031 
 
2032 

Study Consent    
 
 
 Version 1.7   April 18 2019 
48 
BIOMETRIC FINGERPRINT SCAN 
2033 
To help us keep track of who is enrolled in our clinic and who is coming for follow up visits, we 
2034 
will ask you to put either your right or left index finger on a small machine that will scan your finger 
2035 
print. This scan will be linked to a unique identification number and will be accessible only to study 
2036 
staff.  We will take your fingerprint at each study visit. You are free to refuse to have your 
2037 
fingerprint taken and this will not affect your participation in the study. The finger print database 
2038 
will be destroyed after completion of active follow up in the study. 
2039 
 
2040 
CONFIDENTIALITY  
2041 
Efforts will be made to keep your personal information confidential. However, absolute 
2042 
confidentiality cannot be guaranteed. Your personal information may be disclosed if required by 
2043 
law. Any sample from you or information about you will be identified only by code. The link 
2044 
between your name and code will be kept in a secure location at the clinic only. We will not discuss 
2045 
any information about you with your partner unless you give written permission, and will 
2046 
encourage you to be present during the discussion. Any publication of this study will not use your 
2047 
name or identify you personally.  
2048 
 
2049 
Your study records may be reviewed by study staff and representatives of:  
2050 
 
2051 
• 
the University of Washington, including study monitors  
2052 
 
2053 
• 
The United States National Institutes of Health 
2054 
 
2055 
• 
Kenya Medical Research Institute (KEMRI) 
2056 
 
2057 
• 
National Council of Science and Technology (NACOSTI) 
2058 
 
2059 
RESEARCH-RELATED INJURY  
2060 
The study staff will monitor your health and the health of your partner while you are in this study.  
2061 
If you or your partner has any health problems between visits, or if you have a medical emergency 
2062 
that requires immediate care, please contact the study staff.  
2063 
 
2064 
If you are injured from participating in this study, you will be offered care at the study clinic, free 
2065 
of charge. It is important that you tell the members of the team of researchers at this clinic if you 
2066 
feel that you have been injured because of taking part in this study. There is not a program of 
2067 
monetary compensation through this institution. If you require medical care that the study clinic 
2068 
cannot provide, the study clinicians will refer you to the appropriate services or organizations that 
2069 
can provide care for the injury. You do not give up any legal rights by signing this consent form.  
2070 
 
2071 
PROBLEMS OR QUESTIONS 
2072 
If you ever have any questions about this study, you should contact Dr. Kenneth Ngure at the 
2073 
Thika Study clinic at Tel 06721305/22561.  For research related injury, please call the 24-hour 
2074 
emergency number: 0736464299. 
2075 
 
2076 
If you have questions about your rights as a participant, contact the secretary of the KEMRI 
2077 
Scientific and Ethics Review Unit, P.O. Box 54840-00200, Nairobi, Telephone number 020272-
2078 
2541, 0722205901, 0733-400003. Email address: seru@kemri.org. 
2079 
 
2080 
STATEMENT OF CONSENT AND SIGNATURES  
2081 

Study Consent    
 
 
 Version 1.7   April 18 2019 
49 
I have read this form or had it read to me. I have discussed the information with study staff. My 
2082 
questions have been answered. I understand that my decision whether or not to take part in the 
2083 
study is voluntary. I understand that if I decide to join the study I may withdraw at any time. By 
2084 
signing this form, I do not give up any rights that I have as a research participant.  
2085 
 
2086 
 
_______________________ 
Participant Name (print) 
 
___________________________ 
Participant Signature/Thumbprint 
 
_____________ 
Date 
 
 
_______________________ 
Study Staff Conducting Study 
Consent Discussion (print) 
 
 
___________________________ 
Staff Signature 
 
 
_____________ 
Date 
 
_______________________ 
Witness Name (print)  
 
___________________________ 
Witness Signature 
 
_____________ 
Date 
 
2087 
 
2088 
Statement of Consent: Biometric fingerprint 
2089 
 
2090 
Please initial and date one option 
2091 
 
2092 
___________  I DO agree to have my finger print taken  
2093 
 
2094 
____________I DO NOT agree to have my fingerprint taken 
2095 
 
2096 
 
2097 
______________________ __________________________ 
________________ 
2098 
Participant Name (print) 
Participant Signature/Thumbprint 
 
Date 
2099 
 
2100 
______________________ __________________________ 
________________ 
2101 
Study Staff Conducting  
 
Study Staff Signature  
Date 
2102 
Consent Discussion (print) 
2103 
 
_______________________ 
Witness Name (print)  
 
___________________________ 
Witness Signature 
 
_____________ 
Date 
 
2104 
 
2105 
Copies to:  
1. Investigators 
2106 
 
 
2. Study participant 
2107 
 
2108 

In Depth Guide    
 
 
 Version 1.7   April 18 2019 
50 
 
2109 
Appendix III: Provider Interview - Consent Form 
2110 
 
2111 
Study Title: HIV Self-Testing to Improve the Efficiency of PrEP Delivery 
2112 
Protocol Version 1.7 
2113 
18 April 2019 
2114 
 
2115 
INVESTIGATORS 
2116 
Investigator 
Title 
Institution 
Telephone  
Kenneth Ngure 
MPH, PhD 
Jomo Kenyatta University of 
Agriculture and Technology 
067 22561 
Nelly Mugo 
MBChB, 
MMed, MPH 
Kenya Medical Research 
Institute 
020 2736744 
Elizabeth Irungu 
MD, MPH 
Jomo Kenyatta University of 
Agriculture and Technology 
067 22561 
Jared Baeten 
 
MD, PhD 
University of Washington 
001 206-520-3808 
 
2117 
24 HOUR EMERGENCY TELEPHONE NUMBER: Tel: 0736464299 
2118 
 
2119 
INFORMED CONSENT  
2120 
We are asking you to volunteer for a study to answer questions about your experiences 
2121 
providing HIV prevention and Self-Testing services to participants. Before you decide 
2122 
whether to take part in the study, we would like to explain the purpose of the study, the 
2123 
risks and benefits, and what would be expected of you if you agree to participate. This 
2124 
study is sponsored by the University of Washington with funding from the National 
2125 
Institutes of Health which are located in the USA.  
2126 
 
2127 
If you decide to participate in this study, you will be asked to sign this consent form. We 
2128 
will give you a copy of this form. Please ask us to explain anything you may not 
2129 
understand. 
2130 
 
2131 
PURPOSE OF THE STUDY  
2132 
Studies have shown that the medications used to treat HIV infection can also be used to 
2133 
prevent passing the virus. This concept is called pre-exposure prophylaxis, or PrEP. 
2134 
These studies have also learned that PrEP is safe (meaning that it does not produce 
2135 
significant health problems in persons who take them) when taken by HIV-uninfected men 
2136 
and women.  Studies have also shown that women and men are able to test themselves 
2137 
for HIV using special types of HIV-self test kits and that HIV uninfected persons taking 
2138 
PrEP are able to use HIV self-tests safely and correctly at home.  
2139 
 
2140 
Both HIV self-testing and PrEP have been recently endorsed and launched by the Kenyan 
2141 
Ministry of Health. 
2142 
 
2143 
The purpose of this study therefore is to find out more about how PrEP could be delivered 
2144 
more efficiently to HIV uninfected men and women with some of the participants testing 
2145 
for HIV at home for some of the visits.   
2146 
 
2147 

In Depth Guide    
 
 
 Version 1.7   April 18 2019 
51 
Through a method similar to tossing a coin participants will be assigned to a group that: 
2148 
(1) comes to the clinic every three months and gets tested by a health care provider, (2) 
2149 
comes to the clinic every six months and tests at home between clinic visits for HIV using 
2150 
an oral fluid HIV self-test kit, (3) comes to the clinic every six months and tests at home 
2151 
between clinic visits for HIV using a blood based HIV self-test kit.   
2152 
 
2153 
Approximately 495 participants who are using PrEP will be enrolled in this study and will 
2154 
be in the study for up to 12 months. In addition to self-testing users, we will study 
2155 
operational delivery at the level of the providers by conducting key informant interviews 
2156 
with 6-8 providers at the research clinic (counselors, nurses, clinicians).  
2157 
 
2158 
YOUR PARTICIPATION IS VOLUNTARY  
2159 
This consent form gives information about the study that we will discuss with you. Once 
2160 
you understand the study, and if you agree to take part, we will ask you to sign your name 
2161 
or make your mark on this form. We will offer you a copy to keep.  
2162 
 
2163 
Before you learn about the study procedures, it is important that you know the following:  
2164 
 
2165 
• 
You do not have to be in this study if you do not want to. 
2166 
 
2167 
• 
The answers you provide to survey questions will remain confidential and 
2168 
identifying information about you will not be shared.  
2169 
 
2170 
• 
You may decide not to take part in this study, or to withdraw from the study at any 
2171 
time, without any repercussions to your job.  
2172 
 
2173 
• 
If you decide not to take part in this study, you can still provide clinical guidance to 
2174 
our research studies later, if available and you qualify. 
2175 
 
2176 
STUDY PROCEDURES 
2177 
 
2178 
After you read, discuss, and sign or make your mark on this form, we will set up a time 
2179 
for your interview. During your interview(s), the interview staff will invite you to answer 
2180 
questions about your experience working with participants in the HIV self-testing study. 
2181 
You should not identify any of the study participants that you know by their names. The 
2182 
interview will take approximately one hour. We will make sure that the space where the 
2183 
interview takes place is private and the conversation cannot be overheard. During the 
2184 
interviews, the research staff member will ask for your permission to record what you 
2185 
say, so we can write it down later. These recordings will be destroyed immediately after. 
2186 
If you do not want to answer any of the questions, that is okay. Just let the research staff 
2187 
member know and we will move on to another question. 
2188 
 
2189 
RISKS AND/OR DISCOMFORTS 
2190 
 
2191 
You may feel uncomfortable when talking about your experiences working with study 
2192 
participants and their partners. Counselors are available through our research clinic in 
2193 
Thika who will help you deal with any feelings or questions you may have. The study 
2194 
staff will make every effort to protect your privacy and confidentiality during the interview. 
2195 
However, it is possible that others will learn of your answers and, because of this, may 
2196 
treat you unfairly or discriminate against you.  
2197 

In Depth Guide    
 
 
 Version 1.7   April 18 2019 
52 
If you become tired or uncomfortable during the long interview, we can: (a) discuss the 
2198 
situation, (b) take a break, or (c) stop. If you choose to stop, we can either finish the 
2199 
interview another day or you can end your participation in the study. 
2200 
 
2201 
For more information about risks of this study, ask your study clinician.  
2202 
 
2203 
BENEFITS 
2204 
 
2205 
You may get no direct benefit from answering the questions. However, you will 
2206 
contribute to understanding about HIV prevention in Africa, which will help others in the 
2207 
future. 
2208 
 
2209 
REASONS WHY YOU MAY BE WITHDRAWN FROM THE STUDY 
2210 
 
2211 
You may be removed from the study without your consent for the following reasons: 
2212 
• 
The study is stopped or cancelled 
2213 
• 
You are not able to complete the study interview process 
2214 
• 
The study staff feel that the interview questions in this study would be harmful to 
2215 
you 
2216 
 
2217 
COSTS TO YOU 
2218 
 
2219 
There is no cost to you for the answering the questions. 
2220 
 
2221 
REIMBURSEMENT 
2222 
 
2223 
You will be reimbursed for any transport costs incurred in order to meet with the study 
2224 
staff for your interview, if the interview occurs out of your usual work place.  You will 
2225 
receive these reimbursements at the end of your individual interview. 
2226 
 
2227 
CONFIDENTIALITY 
2228 
 
2229 
Efforts will be made to keep your personal information confidential. However, absolute 
2230 
confidentiality cannot be guaranteed. Your personal information may be disclosed if 
2231 
required by law. Any information about you will be identified only by code and not by 
2232 
name. The link between your name and code will be kept in a secure location at the 
2233 
clinic only. Any publication of this study will not use your name or identify you personally. 
2234 
 
2235 
Your responses to the questions may be reviewed by study staff and representatives of: 
2236 
 
2237 
• 
The University of Washington, including study monitors 
2238 
• 
The United States National Institutes of Health 
2239 
• 
Kenya Medical Research Institute (KEMRI) 
2240 
• 
National Council of Science and Technology (NACOSTI) 
2241 
 
2242 
RESEARCH-RELATED INJURY 
2243 
 
2244 
If you are injured from participating in this study, the study staff will give you immediate 
2245 
necessary treatment for your injuries until complete cure or stabilization. If you require 
2246 
medical care that the study clinic cannot provide, the study clinician will refer you to the 
2247 

In Depth Guide    
 
 
 Version 1.7   April 18 2019 
53 
appropriate services or organizations that can provide care for the injury and care for you 
2248 
until the injury resolves.. There is not a program of monetary compensation through this 
2249 
institution. If you require medical care that the study clinic cannot provide, the study 
2250 
clinicians will refer you to the appropriate services or organizations that can provide care 
2251 
for the injury. You do not give up any legal rights by signing this consent form. 
2252 
 
2253 
PROBLEMS OR QUESTIONS 
2254 
 
2255 
If you ever have any questions about this study, you should contact Dr. Kenneth Ngure at 
2256 
the Thika Study clinic at Tel 06721305/22561.  For research related injury, please call the 
2257 
24-hour emergency number: 0736464299. 
2258 
 
2259 
If you have questions about your rights as a participant, contact the secretary of the 
2260 
KEMRI Scientific and Ethics Review Unit, P.O. Box 54840-00200, Nairobi, Telephone 
2261 
number 020272-2541, 0722205901, 0733-400003. Email address: seru@kemri.org. 
2262 
 
2263 
STATEMENT OF CONSENT AND SIGNATURES 
2264 
 
2265 
I have read this consent form or had it read to me. I have discussed the information with 
2266 
study staff. My questions have been answered. It is clear to me that my decision whether 
2267 
or not to take part in this study is voluntary. It is also clear to me that if I decide to 
2268 
answer the questions, I may withdraw at any time. By signing this form, I do not give up 
2269 
any rights that I have as a research participant. 
2270 
 
2271 
 
Participant Name (print) 
 
Participant Signature 
 
Date 
 
 
Study Staff Conducting 
Consent (print) 
 
 
Study Staff Signature 
 
 
Date 
 
Witness Name (print) 
 
Witness Signature 
 
Date 
PERMISSION FOR AUDIO RECORDING 
2272 
 
2273 
Please initial and date one option:  
2274 
 
2275 
 
2276 
_____________ I give permission for the interviews that I participate in to be recorded. 
2277 
 
2278 

In Depth Guide    
 
 
 Version 1.7   April 18 2019 
54 
_____________ I DO NOT give permission for the interviews that I participate in to be 
2279 
recorded. 
2280 
 
Participant Name 
 
Participant Signature 
 
Date 
 
 
Study Staff Conducting 
Consent (print) 
 
 
Study Staff Signature 
 
 
Date 
 
 
Witness Name (print) 
 
 
Witness Signature 
 
 
Date 
  
2281 
Copies to:  
1. Investigators 
2282 
 
 
2. Study participant 
 
2283 

In Depth Guide    
 
 
 Version 1.7   April 18 2019 
55 
Appendix  IV: In-depth qualitative guide  
2284 
 
2285 
 
2286 
Qualitative component: Exploring HIV self-testing experiences among HIV-1 uninfected 
2287 
men and women. 
2288 
 
2289 
Target group: HIV uninfected partners enrolled in the Partners HIV Self-testing Project in 
2290 
Thika 
2291 
 
2292 
Objectives:  
2293 
1. Learn opinions of HIV uninfected partners on HIV self-testing. 
2294 
2. Gain an understanding of how participants performed the HIV self-test including 
2295 
any challenges experienced. 
2296 
  
2297 
Approach:  
2298 
Focus group discussions: Three different groups of participants: HIV-uninfected women 
2299 
in serodiscordant relationship, HIV-uninfected men in serodiscordant relationship and 
2300 
young women, enrolled in the study. Two focus group discussions of 5-8 participants will 
2301 
be conducted with each type of group (6 focus groups total) to strengthen comparisons 
2302 
made across groups. 
2303 
 
 
2304 

In Depth Guide    
 
 
 Version 1.7   April 18 2019 
56 
 
2305 
In-depth Interview Guide 
2306 
 
2307 
INTRODUCTION 
2308 
 
2309 
Ice breaker 
2310 
 
2311 
What kinds of HIV tests are you aware of? 
2312 
 
2313 
Probe:  
2314 
• 
Clinic based HIV testing and HIV self testing 
2315 
 
2316 
• 
How is HIV self testing performed? 
2317 
 
2318 
Topic 1: Acceptability 
2319 
 
2320 
What do you think about HIV Self Testing? What are the advantages? What are the 
2321 
disadvantages? 
2322 
 
2323 
 
2324 
Possible probes: 
2325 
• 
What would be the advantages or benefits? What would motivate you to take / do 
2326 
a HIV self test? 
2327 
• 
What would be the challenges or disadvantages?  
2328 
• 
Are there any reasons that would make you not perform a HIV self test?  
2329 
• 
Possible concerns with HIV self testing? 
2330 
• 
How did your partner feel about you performing a HIV self test? 
2331 
 
2332 
 
2333 
Topic 2: Usability 
2334 
 
 
2335 
 How was your experience in using the HIV self test? 
2336 
 
2337 
Possible probes: 
2338 
• 
How (easy/difficult) was it to perform a HIV self test? 
2339 
• 
What challenges did you experience in performing the HIV self test? 
2340 
• 
How was the training provided at the clinic? 
2341 
• 
Have you shared your results with others? 
2342 
• 
Have you tested others with your HIV self test kits? 
2343 
• 
Have you used the 24 hour helpline? 
2344 
 
2345 
Topic 3: HIV testing preferences 
2346 
 
2347 
What would you prefer self testing at home or clinic based testing? 
2348 
 
2349 
Possible probes: 
2350 
 
2351 
• 
What would you prefer, oral HIV self testing at home or clinic based testing? 
2352 
What are your reasons? 
2353 

In Depth Guide    
 
 
 Version 1.7   April 18 2019 
57 
• 
What are the things that would make you prefer self testing?  
2354 
• 
What are the things that would make you prefer clinic based testing? 
2355 
• 
How did you find the monthly testing schedule? 
2356 
 
2357 
Topic 4: Disclosure 
2358 
    
2359 
Possible probes: 
2360 
 
2361 
• 
How was it like to tell someone that you used an HIV self test?   
2362 
• 
Was there any difference disclosing results from a self test than disclosing results 
2363 
from clinic  based tests 
2364 
 
2365 
 
2366 
Topic 5: Sexual Behavior 
2367 
 
2368 
Possible probes: 
2369 
 
2370 
• 
How does sexual behavior change after HIV test results?  
2371 
Condom use? The number of partners? 
2372 
  
2373 
Topic 6: Closing discussion  
2374 
 
2375 
Possible probes: 
2376 
 
2377 
• 
 When people self-test and get a positive result, what are some ways to help 
2378 
them? 
2379 
• 
Probe about helping via the phone calls, packaging inserts that could provide 
2380 
helpful messages, what kind of preparation should people have before they self-
2381 
test to prepare for the results, etc. 
2382 
• 
What would make it easier for you or others to perform self testing?  
2383 
• 
Any other thoughts or suggestions or questions on HIV self testing that you 
2384 
would like to share? 
2385 
 
2386 

Participant Information Sheet  
  
 
  
Version 1.7   April 18 2019 
58 
Appendix V: Participant Information sheet with oral HIV self-test Instructions   
2387 
 
2388 
Participant information sheet: HIV-1 self-testing 
2389 
 
2390 
OraQuick® HIV1/2 is a qualitative, in vitro immunoassay. It detects antibodies to the 
2391 
human immunodeficiency virus types 1 and 2 (HIV1/2) in human oral fluid. The assay is 
2392 
read visually and is intended for the detection of such antibodies from individuals 
2393 
infected by HIV-1 or HIV-2. 
2394 
 
2395 
Summary and explanation of the test. 
2396 
 
2397 
Clinical evidence of HIV infection may be obtained by testing for HIV antibodies in oral 
2398 
fluid of individuals who may be at risk for HIV infection. OraQuick® HIV1/2 detects 
2399 
antibodies to HIV-1 and HIV-2 present in oral fluid. 
2400 
 
2401 
Accessories. 
2402 
 
2403 
No accessories are required to run the oral fluid test. However, a timer or watch is 
2404 
needed to determine when to read the result. 
2405 
Warning and precautions  
2406 
• 
Dispose of all potentially contaminated materials in accordance with local 
2407 
regulations for disposal of dangerous materials. 
2408 
• 
If an oral fluid test must be repeated (following the gum-swab procedure), start the 
2409 
process over using a new test device, and use the blood test procedure. 
2410 
• 
Use adequate lighting to visually check a test result. If two lines are present at any 
2411 
visible intensity, the test result is interpreted as positive. 
2412 
• 
Do not cover or otherwise obstruct the two small holes on the back of the test 
2413 
device. The flow of fluid can be impaired. 
2414 
Storage. 
2415 
 
2416 
Store unused OraQuick® HIV1/2 tests unopened at 2-30°C. Do not open the foil pouch 
2417 
until you are ready to perform a test. If stored refrigerated, allow the pouch to come to 
2418 
room temperature before opening it. 
2419 
 
2420 
Specimen collection and test procedure.  
2421 
 
2422 
The administrator of the test should first instruct the subject about the test and how to 
2423 
collect an oral fluid sample. The test device is then offered to the subject. Instruct the 
2424 
subject to collect a sample, as outlined below: 
2425 
1. Set the reusable stand on a flat, level surface. 
2426 
2. Tear open the foil pouch containing the test device and developer vial. Remove 
2427 
the developer vial 
2428 
3. Carefully uncap the vial gently rocking the cap back and forth. 
2429 
4. Place the uncapped vial into the stand. 
2430 
5. Have the subject grasp the test device and remove it from foil pouch without 
2431 
touching the collection pad. Check to see if desiccant pack is present. If no 
2432 
desiccant is present, discard the unit. 
2433 
6. Instruct the subject to swab completely around the outer gums with the test device, 
2434 
by gently wiping the porous flat pad completely across the upper and lower gums, 
2435 
one time around. 
2436 

Participant Information Sheet  
  
 
  
Version 1.7   April 18 2019 
59 
7. When the subject has finished swabbing the gums, have the subject insert the pad 
2437 
end of the test device all the way down into the vial. 
2438 
8. Be sure the result window faces forward so it can be read. 
2439 
9. Start the timer, or note the time. 
2440 
10. Read test result in 20 to 40 minutes. Record the test result seen in the result 
2441 
window, then dispose of the device and vial in a dangerous waste container. 
2442 
 
2443 
Interpretation of results. 
2444 
 
2445 
Negative test result – only the control line appears. 
2446 
If a single line appears on the test strip in the area adjacent to the triangle labeled ‘C’, 
2447 
the result is negative. This suggests the absence of anti-HIV antibodies in the 
2448 
specimen. 
2449 
Positive test result – two lines appear 
2450 
If two lines appear on the test strip, adjacent to the ‘T’ and ‘C’ triangles, respectively, the 
2451 
result is considered reactive. One of these lines may be darker than the other. This 
2452 
suggests presence of anti-HIV antibodies in the specimen. Please call our Thika clinic 
2453 
on 0736464299. 
2454 
Invalid – no line present in ‘C’ area of the window 
2455 
If there is no line in the area labeled ‘C’, the result is invalid. An invalid test should be 
2456 
repeated with a new test device. If the invalid test was obtained with an oral fluid 
2457 
specimen, use the blood test procedure for repeat testing. 
2458 
 
2459 
For any challenges in conducting or interpreting the test results please call our Thika 
2460 
Clinic on 0736464299.  
2461 
 
2462 
Quality control. 
2463 
 
2464 
A control line in the ‘C’ area of the result window indicates a valid result. A valid result 
2465 
indicates a suitable sample was collected and the test functioned properly. The control 
2466 
line will appear on all valid tests, whether or not the result is reactive. 
2467 
Kit control reagents are available separately. These are used to verify adequate test 
2468 
performance. Kit controls should be run once per shift by the test administrator, and 
2469 
whenever changing to a different lot of tests. Refer to the Kit control product insert when 
2470 
using these reagents. 
2471 
 
2472 
Limitations of the procedure.  
2473 
 
2474 
1. The OraQuick® HIV1/2 test kit must be used in accordance with these instructions 
2475 
to obtain an accurate result. 
2476 
2. Oral fluid specimens for OraQuick® HIV1/2 testing must be freshly collected, as 
2477 
detailed in the procedure. 
2478 
3. The test is not for use with body fluids not specified here, with oral fluid collected 
2479 
by other methods or with other commercially available oral fluid collectors, or with 
2480 
pooled specimens. 
2481 
4. Clinical data has not been collected to demonstrate the performance of OraQuick® 
2482 
HIV1/2 in persons under 13 years of age. 
2483 
5. Do not use this test as the sole basis for a diagnosis of AIDS, ARC or HIV infection. 
2484 
Any reactive result should be confirmed. Please call our Thika Clinic on 
2485 
0736464299. 
2486 
6. For a reactive result, the intensity of the test line does not necessarily correlate to 
2487 

Participant Information Sheet  
  
 
  
Version 1.7   April 18 2019 
60 
the titer of antibody in the specimen. 
2488 
7. A non-reactive result does not preclude the possibility of exposure to HIV or 
2489 
infection by HIV. An antibody response to recent exposure may take some 
2490 
time to reach detectable levels. 
2491 
8. If a red background in the result window makes it difficult to read the test at 20 
2492 
minutes, wait until the background clears to read the result (but not more than 40 
2493 
minutes total time). 
2494 

HIV-1 self testing instructions  
 
Version 1.7   April 18 2019 
 
61 
Appendix VI: Participant Information sheet with bloodbased  HIV self-test Instructions         
2495 
  
2496 
[attached as supplement] 
2497 

Focus Group Guide  
 
 
 
 
 
Version 1.7   April 18, 2019 
62 
Appendix VII-Focus Group Discussion Guide 
2498 
 
2499 
 
2500 
Qualitative component: Exploring HIV self-testing experiences among HIV-1 uninfected men 
2501 
and women with HIV-1 infected partners. 
2502 
 
2503 
Objectives:  
2504 
1. Learn opinions of HIV uninfected partners in on HIV self testing. 
2505 
2. Gain an understanding of how participants performed the HIV self test including any 
2506 
challenges experienced. 
2507 
3. To explore preferences for HIV testing 
2508 
  
2509 
Approach:  
2510 
Focus group discussions:  Two focus group discussions of 5-8 participants will be conducted 
2511 
with each type of group (6 focus groups total) to strengthen comparisons made across groups. 
2512 
 
2513 

Focus Group Guide  
 
 
 
 
 
Version 1.7   April 18, 2019 
63 
                                 Focus Group Discussion Guide  
2514 
INTRODUCTION 
2515 
 
2516 
Topic 1: Community Perceptions 
2517 
 
2518 
What does your community think about HIV Self Testing? What are the advantages? 
2519 
What are the disadvantages? 
2520 
 
2521 
Possible probes: 
2522 
• 
What are the advantages or benefits?  
2523 
• 
What would be the challenges or disadvantages?  
2524 
• 
Any reasons they would not want to perform a HIV self test?  
2525 
• 
Possible concerns with HIV self tests? 
2526 
 
2527 
Topic 2: Acceptability 
2528 
 
2529 
What do you think about HIV Self Testing? What are the advantages? What are the 
2530 
disadvantages? 
2531 
 
2532 
Possible probes: 
2533 
• 
What would be the advantages or benefits? What would motivate you to take do a HIV 
2534 
self test? 
2535 
• 
What would be the challenges or disadvantages?  
2536 
• 
Any reasons why you would not want to perform a HIV self test?  
2537 
• 
Possible concerns with HIV self tests? 
2538 
• 
How did your partner feel about you performing a self test 
2539 
 
2540 
Topic 3: Usability 
 
2541 
 
2542 
 How was your experience in using the HIV self test? 
2543 
 
2544 
Possible probes: 
2545 
• 
How (easy/difficult) was it to perform a HIV self test? 
2546 
• 
Any challenges in performing the HIV self test? 
2547 
• 
How was the training provided at the clinic? 
2548 
• 
Have you shared your results with others? 
2549 
• 
Have you tested others with your test kits? 
2550 
 
2551 
 
2552 
Topic 4: HIV testing preferences 
2553 
 
2554 
What would you prefer self testing at home or clinic based testing? 
2555 
 
2556 
Possible probes: 
2557 
 
2558 
• 
What would you prefer, oral HIV self testing at home or clinic based testing? Why? 
2559 
• 
What are the things that would make you prefer self testing?  
2560 
• 
What are the things that would make you prefer clinic based testing? 
2561 
• 
How did you find the monthly testing schedule? 
2562 
 
2563 

Focus Group Guide  
 
 
 
 
 
Version 1.7   April 18, 2019 
64 
Topic 5: Disclosure 
2564 
    
2565 
Possible probes: 
2566 
 
2567 
• 
What was it like to tell someone that you used an HIV self test?   
2568 
• 
Was there any difference disclosing results from a self test than disclosing results from 
2569 
clinic  based tests 
2570 
 
2571 
Topic 6: Sexual Behavior 
2572 
 
2573 
Possible probes: 
2574 
 
2575 
• 
How does sexual behavior change after HIV test results? Negative test results? Condom 
2576 
use? 
2577 
 
2578 
Topic 7: Closing discussion 
2579 
 
2580 
Possible probes: 
2581 
 
2582 
• 
 When people self-test and get a positive result, what are some ways to help them? 
2583 
• 
Probe about helping via the phone calls, packaging inserts that could provide helpful 
2584 
messages, what kind of preparation should people have before they self-test to prepare 
2585 
for the results, etc. 
2586 
• 
What would make it easier for you or others to perform self testing?  
2587 
• 
Any other thoughts or suggestions on self testing that you would like to share? 
2588 
 
2589 
 
2590 
 
2591