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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)

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)

Literate participants will document their consent by signing the ICF(s). Nonliterate participants will document their informed consent by marking their ICF(s) (eg, with an X, thumbprint, or other mark) in the presence of a literate third-party witness. Participants will be provided with a copy of their ICF if they are willing to receive it. All minors (under the age of 18) will be required to provide assent along with parental consent.

Sarah E Rutstein, Laura Limarzi-Klyn, Jane S Chen, Yaw O Agyei, Shahnaz Ahmed, Ian Bell, Myron Cohen, Jessica M Fogel, Vivian Go, Dan Haines, Erica L Hamilton, Irving F Hoffman, Mina C Hosseinipour, Mark A Marzinke, William C Miller, Mathews Mukatipa, Julie Pulerwitz, Hans M L Spiegel, Ting Ye, Mitch Matoga

JMIR Res Protoc 2025;14:e72981