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

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.