Improving HIV prevention among heterosexual men seeking STI services in Malawi: examining the benefits, acceptability, and associated costs of a systems-navigator-delivered integrated prevention package
Study Details
To evaluate the potential benefit(s), acceptability, and associated costs of a systems navigator-delivered HIV prevention intervention in promoting and supporting persistent use of evidence-based HIV pre-exposure prophylaxis (PrEP) among heterosexual cisgender men receiving care for sexually transmitted infections (STIs) in Lilongwe, Malawi.
Single site pilot effectiveness-implementation hybrid type 1 trial
The study population will consist of the following participant types:
1. HIV seronegative heterosexual cisgender males seeking STI services who have accepted PrEP services.
2. Other key stakeholders relevant to systems navigation program implementation.
*Note: The HPTN 112 Study Team has completed the HANC Legacy Project’s Representative Studies Rubric (RSR) Questionnaire regarding representation of priority populations in HPTN studies. If you would like to review the RSR for HPTN 112, please reach out to erica hamilton (ehamilton@fhi360.org), Maxine Awekey (mawekey@fhi360.org), or Gabriela Salinas-Jimenez (gsalinas-jimenez@fhi360.org).
Approximately 200 heterosexual cisgender males, presenting as HIV-seronegative and initiating PrEP (followed rospectively) and approximately 15 other key stakeholders.
The proposed study duration is 15 months (65 weeks), including up to 39 weeks for participant recruitment. Seronegative participants will be on study for at least 26 weeks, and up to 52 weeks.
Systems navigation integrated into PrEP services delivered at an STI clinic in promotion of persistent effective PrEP use - either daily oral, 2-1-1 event driven, or injectable.
Navigators will:
• conduct brief counseling (and risk-focused) sessions,
• POC STI testing,
• assess barriers of PrEP use, and contact persons who default from PrEP care to facilitate PrEP re-engagement, offering PrEP “restart” kits as appropriate.
• To assess the effect of a systems-navigator facilitated HIV prevention package on PrEP persistence among heterosexual cisgender men seeking STI clinical services in Lilongwe, Malawi at 26 weeks.
• To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual cisgender men initiating PrEP at STI clinics.
• To assess feasibility of a future randomized controlled trial.
• To assess prevention-effective PrEP use among heterosexual cisgender men initiating PrEP at STI clinics.
• To assess PrEP modality preferences among heterosexual cisgender men initiating PrEP at STI clinics.
• To assess the effect of a systems-navigator facilitated HIV prevention package on PrEP persistence among heterosexual cisgender men seeking STI clinical services in Lilongwe, Malawi, at 39 and 52 weeks.
• To quantify costs and resources necessary to develop and integrate a systems-navigator delivered HIV prevention package into an urban STI clinic, informing future cost-effectiveness model development.
• To perform laboratory assessments that may include evaluation of factors related to HIV infection or other STIs;
characterization of HIV in participants who acquire HIV;
characterization of the host response to antiretroviral drugs;
and evaluation of virologic, pharmacologic, or STI-based laboratory assays.
• To evaluate event-driven PrEP drug concentrations within the context of TLFB reported PrEP use and sex acts.
• To explore the perceived and experienced PrEP related stigma and potential influence of perceived gender norms on PrEP persistence among heterosexual cisgender men initiating PrEP at the STI clinic.