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Out-of-Care HIV+ US MSM Will Resume Treatment, But Only Half Control HIV in 12 Months
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10th IAS Conference on HIV Science (IAS 2019), July 21-24, 2019, Mexico City
Mark Mascolini
More than 90% US men who have sex with men (MSM) with HIV and out of care with a detectable viral load returned to care in the HPTN 078 trial [1]. But only half who resumed treatment had a viral load below 200 copies after 12 months, regardless of whether randomized to enhanced case management or standard of care.
Young MSM, especially men of color, account for a disproportionate share of HIV infections in the United States. Getting all HIV-positive MSM into care and getting their viral load undetectable with antiretroviral therapy are essential to stopping onward transmission of HIV.
Toward those ends, HPTN 078 used deep-chain respondent-driven sampling and direct recruitment to identify MSM living with detectable HIV in four US cities-- Atlanta, Birmingham, Baltimore, and Boston. Researchers randomized them to enhanced case management for linkage and treatment or to standard care. Enhanced case management involved (1) access to case management and referral services, (2) counseling via motivational interviewing techniques, and (3) automated adherence and motivational messaging. People randomized to enhanced case management could determine the intensity of that care by choosing the frequency and content of interactions and automated messaging.
HPTN 078 investigators identified and screened 1305 potential participants, 154 (12%) of whom had HIV and detectable viral load out of care, and 144 of whom (94% of 154) enrolled in the trial. Among enrolled participants, median age stood at 39 (interquartile range 29 to 49), 139 identified themselves as men and 3 as transgender female. Most participants (84%) were black, and most (90%) had more than a high-school education. Two thirds had an annual income below $20,000. Most enrolled people (81%) had some form of health coverage, yet 35% had syphilis and 15% had a positive HCV antibody test.
Researchers randomized 72 participants to enhanced case management and 72 to standard of care. The two study arms differed little in age, gender, race, education, or income. Similar high proportions of people in the intervention arm and the control arm had health coverage (82% and 79%), and more than 80% in each arm had previously taken antiretroviral therapy. Overall, 131 people (91%) remained in care for 12 months.
Median viral load stood at 19,459 copies when participants entered the study. After 12 months, 42% in the enhanced case-management arm and 54% in the standard-of-care arm had a viral load below 200 copies, a nonsignificant difference (odds ratio 0.615, 95% confidence interval 0.315 to 1.197, P = 0.1526). The proportion of people with a sub-200-copy load did improve slowly throughout follow-up: overall 28% at 3 months, 36% at 6 months, 39% at 9 months, and 48% at 12 months.
Although the intervention did not help out-of-care MSM reach an undetectable load after they started antiretrovirals, the HPTN investigators stressed three positive findings of their trial: (1) Deep-chain respondent-driven sampling and direct recruitment proved successful in identifying a target population of 1305 people, most of them black and educated but poor. (2) Among the 154 participants (12%) with a detectable viral load, 144 (94%) agreed to enter the trial and reengage in care. (3) A large majority of HIV-positive unsuppressed participants (89%) knew their HIV status.
The researchers proposed that "greater investment for more intensive interventions is likely needed to address the multiple societal and behavioral challenges among disenfranchised MSM in the US."
References
1. Remien RH, Gamble T, Farley JE, et al. HPTN 078: primary results of a randomized study to engage men who have sex with men (MSM) living with HIV who are virally unsuppressed in the US. 10th IAS Conference on HIV Science (IAS 2019), July 21-24, 2019, Mexico City. Abstract MOAX0101LB.
2. ClinicalTrials.gov. Enhancing recruitment, linkage to care and treatment for HIV-infected MSM in the United States. ClinicalTrials.gov identifier NCT02663219. https://clinicaltrials.gov/ct2/show/NCT02663219
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