A program that provides risk reduction counseling and case management to address potential barriers to remaining HIV negative may buttress adherence to pre-exposure prophylaxis (PrEP) among Black men who have sex with men (MSM).

Publishing their findings in the Journal of the International AIDS Society, Darrell Wheeler, PhD, MPH, of the School of Social Welfare at the State University of New York at Albany and other researchers from the open-label HPTN 073 study enrolled 226 at-risk HIV-negative Black MSM in Los Angeles, Washington, DC, and Chapel Hill, North Carolina, between February 2013 and September 2015.

The investigators offered participants daily Truvada (tenofovir disoproxil fumarate/emtricitabine) as PrEP for up to 52 weeks; they were permitted to start Truvada at any time up to week 48 of the study. The participants were scheduled to make study visits at weeks 4, 8, 13, 26 and 52 of the study.

The participants received a so-called client-centered care coordination intervention, which included comprehensive risk counseling and services that were based on what is known as a self-determination theory approach. This included case management to address various life challenges that may serve as barriers to using HIV prevention methods.

Of the 226 enrollees, 178 (79%) started PrEP, including 153 (68%) upon enrolling in the study and 25 (11%) at a later study visit.

The men had a median age of 26 years old. About three quarters identified as gay and 20% identified as bisexual; 83% were single. A quarter had a high school diploma or less, 38% worked full time and 27% were unemployed. Nearly half (48%) reported an annual income of less than $20,000, and 69% had health insurance.

Tests indicated that at week 26 of the study, 64% of those who initiated PrEP were taking at least four doses per week, which research has indicated is associated with full protection against HIV.

After adjusting the data to account for various differences among the men, the researchers found that reporting condomless anal sex with an HIV-positive or unknown-status partner was associated with a greater likelihood of starting PrEP. Being 25 years old or older, compared with being younger than 25, was associated with a 2.95-fold greater likelihood of adhering well to PrEP at the 26-week visit. Additionally, having a perception of having enough money in life and having knowledge of a male partner taking PrEP prior to sex were associated with a respective 3.58-fold and 2.22-fold increased likelihood of adhering to the daily drug regimen at the study’s midpoint.

Those who started PrEP did not report an increase in their number of recent sexual partners during the study; they consistently reported a median of three partners.

During a cumulative 172 years of follow-up, five of the 178 men who started PrEP tested positive for HIV, for an infection rate of 2.9 cases per 100 years of follow-up. During a cumulative 39 years of follow-up among those who did not start PrEP, three new diagnoses occurred, for an infection rate of 7.7 cases per 100 years of follow-up. The difference between these two figures was not statistically significant, meaning it could have been driven by chance. That said, had the study population been larger, it is possible that the researchers would have seen a significant difference in the HIV acquisition rate between those who did and did not start PrEP.

“Findings from this demonstration project suggest that recruitment, PrEP uptake/initiations, adherence and retention of Black MSM was feasible,” the study authors concluded.

To read the study abstract, click here.