Improving HIV Prevention Among Heterosexual Men Seeking Sexually Transmitted Infection Services in Malawi: Protocol for a Type I Effectiveness-Implementation Hybrid Randomized Controlled Trial of Systems Navigator–Delivered Integrated Prevention Package (HPTN 112-NJIRA Study)

Sarah E Rutstein   ¹ , MD, PhD ;   Laura Limarzi-Klyn   ² , MSc ;   Jane S Chen   ² , PhD ;   Yaw O Agyei   ³ , MPH ;   Shahnaz Ahmed   ³ , AAS, BS, MLT ;   Ian Bell   ⁴ , BA ;   Myron Cohen   ¹ , MD ;   Jessica M Fogel   ³ , PhD ;   Vivian Go   ² , PhD ;   Dan Haines   ⁴ , MStat ;   Erica L Hamilton   ⁵ , MPH ;   Irving F Hoffman   ¹ , MPH, PA ;   Mina C Hosseinipour   ¹ , MD, MPH ;   Mark A Marzinke   ^{3, 6} , PhD ;   William C Miller   ⁷ , MD, MPH, PhD ;   Mathews Mukatipa   ⁸ , BBA ;   Julie Pulerwitz   ⁹ , ScD, ScM ;   Hans M L Spiegel   ¹⁰ , DTMH, MD, PhD ;   Ting Ye   ⁴ , PhD ;   Mitch Matoga   ⁸ , MBBS, MSc, PhD

¹ Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States

² Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States

³ Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, United States

⁴ University of Washington, Department of Biostatistics, HPTN Statistical and Data Management Center, Seattle, WA, United States

⁵ Network and Collaborative Research Division, FHI 360, Durham, NC, United States

⁶ Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States

⁷ Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States

⁸ UNC Project Malawi, Lilongwe, Malawi

⁹ Population Council, Washington, DC, United States

¹⁰ Kelly Government Solutions, Contractor to National Institute of Allergy and Infectious Diseases, National Institutes of Health, HHS, Rockville, MD, United States