Abstract Body

Background:

Alcohol use is common among persons with HIV (PWH) and is a risk factor for TB disease, non-adherence to INH preventive therapy (IPT) and antiretroviral therapy (ART), and hepatotoxicity during IPT. Interventions are urgently needed to reduce hazardous alcohol use and improve IPT adherence among PWH.

Methods:

We conducted a 2×2 factorial randomized controlled trial among PWH (≥18 years) on ART, with latent TB infection (PPD≥5mm) and hazardous alcohol use in Uganda. We randomized 680 participants (1:1:1:1) initiating 6-months of IPT to: no incentives (Arm 1 control) or incentives contingent on no recent alcohol use (Arm 2), recent INH adherence (Arm 3), or both (awarded independently, Arm 4). The escalating financial incentives were contingent on monthly point-of-care (POC) urine tests that were negative for ethyl glucuronide, a biomarker of recent alcohol use (Arms 2 & 4), or positive on IsoScreen, a biomarker of recent INH use (Arms 3 & 4). The primary alcohol use outcome was non-hazardous use by self-report (Alcohol Use Disorder Identifier Test-Consumption [AUDIT-C< 3 women, < 4 men], prior 3 months) and phosphatidylethanol (PEth, past month alcohol biomarker) < 35 ng/mL at 3- and 6-months post-enrollment. The primary INH adherence outcome was >90% MEMS cap bottle opening of days INH prescribed. Secondary outcomes included PEth and MEMS cap openings as continuous measures.

Results:

At baseline (N&#3f680), median age was 39 (IQR: 32-47), 470 (69%) were male, 598/663 (90%) had HIV viral load < 40 c/mL, median AUDIT-C was 6 (IQR: 4-8) and median PEth was 252 ng/mL (IQR: 87-579). Non-hazardous alcohol use was more likely in the arms with the alcohol intervention (Arms 2+4) than those with no alcohol intervention (Arms 1+3): 17.6% vs. 9.9%, respectively, with adjusted risk difference of 7.6% (95% CI: 2.7%-12.5%, p=0.003). Incentives for INH adherence did not increase INH adherence vs control, with MEMS adherence of 72.8% and 72.9% in the INH incentive (Arms 3+4) and no INH incentive arms (Arms 1+2): adjusted risk difference -0.2%; 95% CI 7.0%-6.5%, p=0.944). Secondary outcomes are shown in Table.

Conclusions:

Escalating financial incentives contingent on reduced alcohol use and/or INH adherence by monthly POC testing led to significant reductions in biomarker-confirmed alcohol use, but no change in INH adherence among PWH with latent TB infection and hazardous alcohol use receiving IPT. This trial is among the first to show efficacy of incentives in reducing alcohol use in sub-Saharan Africa.

Primary and secondary endpoints in a randomized controlled trial of economic incentives for reduced alcohol use and increased INH adherence among PWH with latent TB infection and hazardous alcohol use in Uganda.