After young Black men who have sex with men (MSM) receive a prescription for pre-exposure prophylaxis (PrEP), those who are uninsured and rely on Gilead Sciences’ payment assistance program to pay for PrEP experience a median delay of an additional 16 days before taking their first dose compared with those who have insurance.

So found a new study of PrEP uptake among young Black MSM in Atlanta in which investigators were particularly hands-on in helping ensure that their HIV prevention medication was promptly covered. The finding is concerning given that delays in PrEP initiation in a population with a high risk for HIV—young Black MSM in Atlanta have an extremely high overall risk—leave individuals vulnerable to acquiring the virus.

Published in the Journal of the International AIDS Society, the study was led by David P. Serota, MD, of the department of medicine in the division of infectious diseases at the University of Miami Miller School of Medicine.

The EleMENt study was a longitudinal cohort study of 298 sexually active HIV-negative Black MSM 18 to 29 years old in Atlanta who were enrolled starting in June 2015. They were each followed for two months, through February 2019 at the latest. The study was designed to assess the association between substance use and HIV and other sexually transmitted infections (STIs).

A total of 154 (52%) of the participants saw a clinician about initiating PrEP and received a prescription for Truvada (tenofovir disoproxil fumarate/emtricitabine). By the end of the study’s follow-up period, 131 (44%) of these men reported taking at least one dose of PrEP.

The 55% of the men who were insured were given Gilead’s co-pay assistance card, which covers up to $7,200 in annual out-of-pocket costs for PrEP, including co-pays and deductibles, with no monthly limit. All but one of these men had private insurance. Uninsured men were provided with an application for Gilead’s payment assistance program, which covers the cost of PrEP for low-income people lacking insurance.

If the uninsured participants did not submit documentation for the payment assistance program at the time of their visit, the investigators contacted them regularly to remind them to do so. Upon receipt of the program forms, the study staff submitted them to Gilead along with other required documents within one business day. After submitting the forms, the staff followed up with the company each day to check on the processing of the application.

During the study’s follow-up, the participants were asked to estimate the date of their first PrEP dose.

Among the men who started PrEP, the median delay between their receipt of a PrEP prescription and their first dose of Truvada was 12 days. The delay lasted for less than three days for a quarter of the men, for three to 32 days for half of the men and for more than 32 days for the remaining quarter of the group.

After adjusting the data to account for various factors, the study authors found that compared with 18- to 21-year-olds, the delay between the PrEP prescription and initiation of Truvada was 48% narrower among 22- to 25-year-olds and 61% narrower among 26- to 29-year-olds.

The adjusted median delay between receiving a PrEP prescription and starting Truvada was five days among those with insurance and 21 days among those without insurance—a 16-day difference. Compared with the uninsured men, those with insurance had a 63% narrower PrEP initiation delay.

Those with a diagnosis of an STI during the previous 12 months, received PrEP 35% shorter delay than those without such a diagnosis during this period.

“Although uninsured participants theoretically had equal access to medication through the [payment assistance program], lack of insurance was strongly associated with longer delays in [PrEP] initiation,” the study authors concluded. “Interventions aimed at expediting PrEP uptake regardless of insurance status are needed.”

To read the study, click here.