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Identifying efficient linkage strategies for men (IDEaL): a study protocol for an individually randomised control

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This study tests scalable interventions to improve 6-month retention in antiretroviral therapy (ART) programs for men living with HIV in sub-Saharan Africa who are not currently engaged in care.

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Area of Science:

  • Public Health
  • HIV/AIDS Research
  • Clinical Trials

Background:

  • Men in sub-Saharan Africa exhibit lower initiation rates and higher disengagement from antiretroviral therapy (ART) programs compared to women.
  • There is a critical need for scalable, male-specific interventions to improve engagement in HIV care for men.

Purpose of the Study:

  • To evaluate the impact of different intervention intensities on 6-month retention in ART programs among men living with HIV who are disengaged from care.
  • To assess the cost-effectiveness and safety of these interventions.

Main Methods:

  • A programmatic, individually randomized, non-blinded, controlled trial involving men not currently engaged in ART care.
  • Participants are randomized to low-intensity (one-time counseling), high-intensity (immediate outside-facility initiation), or stepped care arms.
  • The primary outcome is 6-month retention in care, analyzed using intention-to-treat principles with binomial regression accounting for facility-level clustering.

Main Results:

  • Primary outcome data on 6-month retention are pending analysis.
  • Secondary outcomes including cost-effectiveness and adverse events will also be evaluated.

Conclusions:

  • The findings are expected to provide crucial data for designing and implementing effective, scalable interventions to improve ART retention among men living with HIV in sub-Saharan Africa.
  • Dissemination will occur through national/international forums and peer-reviewed publications to inform global health strategies.