Back HIV Prevention Pre-exposure (PrEP) AIDS 2016: PrEP Study Achieves High Engagement and Adherence Among Black Gay Men

AIDS 2016: PrEP Study Achieves High Engagement and Adherence Among Black Gay Men

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What was described at the 21st International AIDS Conference (AIDS 2016) as the first PrEP trial devised and run by black gay men has shown that high levels of pre-exposure prophylaxis (PrEP) use, retention, and adherence can be achieved in a demonstration project if recruitment and support structures are tailored to the needs of black men who have sex with men.

[Produced in collaboration with Aidsmap.com]

Although the HPTN 073 "My Life, My Health, My Choice" study, which recruited 226 participants, was too small to demonstrate a statistically significant reduction in HIV infections, HIV incidence was 62% lower among men electing to take daily Truvada (tenofovir/emtricitabine) PrEP during the study than among the minority who never did.

Although black men who have sex with men (MSM) only make up 0.4% of the U.S. population, 20% of new HIV infections occur in this group. 57% of African Americans diagnosed with HIV are men who have sex with men, and HIV incidence among black MSM under 25 has nearly doubled in the last decade. However, other PrEP demonstration projects such as the ADAPT study have found lower uptake of and adherence to PrEP among black MSM than in other groups, and particularly among young men.

About the HPTN 03 Study

Darrell Wheeler of the State University of New York introduced the study and its findings. A total of 344 black MSM were screened for the study and of these, 226 were enrolled. Reasons for exclusion included 40% for medical reasons such as 21% who had tests indicating liver or kidney problems. 6% of those screened turned out to already have HIV.

The year-long study took place at 3 sites in Los Angeles, Washington, DC, and Chapel Hill, North Carolina, with sites recruiting between August 2013 and September 2014.

A poster presented at the conference showed high levels of comorbidities among men who did enroll: 30% had a diagnosed psychiatric condition, 15% a cardiovascular condition, and two-thirds had at least one "clinically significant comorbidity."

Participants were offered significant support in a program of so-called "client-centered coordinated care" (C4) operated by an interdisciplinary team, which assessed them for sexually transmitted infections (STIs), other illnesses, and psychiatric condition, and gave counseling and prevention support. On average participants taking PrEP attended 6 of these C4 sessions and those who chose not to take it attended 4 sessions.

In a separate presentation, Christopher Hucks-Ortiz, who chairs the HIV Prevention Trials Network Black Caucus, said that the trial was also strongly embedded within local communities. All trial staff ranging from physicians to receptionists were given cultural responsiveness training, and there was a specific work plan with targets around engagement of the local community with the trial.

Wheeler said that 79% of men enrolled chose to take PrEP, in the form of daily Truvada, with 92% retention over the 12 months.

PrEP uptake varied by site, as did retention. In Chapel Hill 88% started PrEP and 67% were still taking it at the end of the study; in Washington, DC, 79% started and 60% were still taking it at month 12; in Los Angeles the figures were 68% and 51%, respectively. Most people who started PrEP did so immediately, except in Los Angeles, where a significant minority delayed starting by a few weeks. A higher proportion of young men (under 25) started PrEP -- 84% -- and 96% of those with an HIV-positive primary partner did so.

Of the participants, roughly three-quarters defined as gay, 20% as bisexual, and 7% as heterosexual or other. A third had a primary male partner and a third of those partners had HIV (only 3 individuals had a primary female partner). 90% defined as black American or Caribbean; most of the rest were mixed black/Latino.

Nearly half (48%) of participants earned less than $20,000 a year, but 23% earned more than $50,000. A considerably higher proportion of those who were screened but not enrolled had an income of under $20,000 a year (63%). 69% had at least some health insurance coverage and 75% had some tertiary education. But more than a quarter (27%) were unemployed or on disability benefits and 30% had been in prison at some point.

Adherence and HIV Infections

Two-thirds of men throughout the trial self-reported adherence of more than 90%, and 85% reported more than 50% adherence. The only factors significantly associated with low or high adherence were poly-drug use (self-reported adherence 50% lower than average) and having a primary partner (75% higher than average). There was a trend toward better adherence among participants with more education.

Directly measured drug levels correlated well with self-reported adherence, especially near the start of the trial, though it tailed off somewhat later. At 8 weeks into the trial, 67% of men had drug levels in blood consistent with taking 4 or more doses of PrEP a week, but by week 52 this had declined to 56%. Interestingly, at week 8 drug levels in cells were a little lower than those in blood (61% consistent with 4 or more doses a week), but at weeks 26 and 52 they were exactly the same. This may indicate how slowly drug levels reach a steady state in tissues.

There were 5 HIV infections among men who started PrEP versus 3 among those who did not. But because many fewer men elected not to start PrEP, this translates to a considerably reduced annual incidence in men starting PrEP: 2.9% versus 7.7%, representing a 62% reduction in incidence -- though because of the size of the trial this difference was marginally statistically non-significant. Of the 5 men who started PrEP but still got HIV, 2 were known to have stopped taking PrEP more than 7 weeks before they tested HIV-positive.

STIs and Condom Use

Another presentation looked as STIs and sexual behavior in the study. Self-reported condomless sex actually declined over the course of the study. At the start of the study 46% of men reported condomless insertive anal sex at their last sexual contact and 45% receptive anal sex; by week 52 this had declined to 34% and 32%, respectively, though these declines were not significant. Condomless sex with known HIV-positive partners did not change, staying at 15% insertive and 8% receptive.

STI diagnoses increased somewhat during the study, though non-significantly. At baseline 14% were diagnosed with an STI, with a considerably higher rate among under-25s (35% versus 6.7%, or 4.39 times the risk). This equated to an annual incidence of 31% -- 33% among those who started to take PrEP and 27% among those who decided not to.

By week 52 annual STI incidence had declined in those not taking PrEP (24%) but had increased in those taking PrEP (38%), though again these differences were not statistically significant. Altogether, 60 of 226 participants (27%) acquired an STI during the study, with some acquiring several.

Wheeler commented that the study had shown that the answer to whether black MSM would utilize PrEP was "a resounding yes" if they were engaged and supported in culturally appropriate ways, though he did add that the slight decline in adherence and HIV incidence of nearly 3% even among those who started PrEP showed that there was room for further improvements such as injectable formulations.

9/2/16

References

D Wheeler, S Fields, L Nelson, et al. Correlates for levels of self-reported PrEP adherence among Black men who have sex with men in three U.S. Cities. 21st International AIDS Conference. Durban, July 18-22, 2016. Abstract WEAC0104.

C Hucks-Ortiz, JP Lucas, DP Wheeler, et alHPTN 073: successful engagement of Black MSM into a culturally relevant clinical trial for pre-exposure prophylaxis (PrEP). 21st International AIDS Conference. Durban, July 18-22, 2016. Abstract WEAC0103.

L Hightow-Weidman, M Magnus, G Beauchamp, et al. Incidence and correlates of STIs among Black men who have sex with men participating in a US PrEP study. 21st International AIDS Conference. Durban, July 18-22, 2016. Abstract THAC0105LB.

L Hightow-Weidman, M Magnus, S Shoptaw, et al. Significant health comorbidities in Black men who have sex with men presenting for a US PrEP study. 21st International AIDS Conference. Durban, July 18-22, 2016. Abstract WEPEC240.