Four PrEP Studies Address Challenges and Best Practices for Uptake and Retention

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Four studies conducted in different parts of the United States among various populations were published in a recent issue of the Journal of Acquired Immune Deficiency Syndromes that focused on pre-exposure prophylaxis (PrEP). Two studies focused on cisgender women, noting that current guidelines do not indicate this prevention method for many women who may benefit from it and exploring the impact of family planning provider training on patients' awareness of PrEP as an option. A third study showed that young men who have sex with men (MSM) are willing to adhere to PrEP, but some face challenges that require additional support. Finally, getting PrEP prescriptions filled immediately after an initial clinic visit may help get people started on this prevention method, but was also linked to relatively high drop-out rates within a month, the final study found.

A few recommendations emerge from these studies: incorporate screening for HIV risk and discussions around PrEP into routine family planning care; don't overly rely on guidelines to determine screening criteria, especially for women; address competing life issues to keep people on PrEP; and consider not having them jump into PrEP after their initial discussion of the issue without adequately supporting the need for adherence and follow-up.

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Current PrEP Guidelines Disqualify Many Women Who Could Benefit

Current U.S. Centers for Disease Control and Prevention (CDC) guidelines on PrEP disqualify many heterosexual cisgender women who might benefit from this prevention method, a survey of women recently receiving care at Connecticut Planned Parenthood clinics found. The guidelines include two sets of criteria: guidance summary and recommended indications. While 82.3% of the 679 respondents qualified for PrEP according to the summary, only 1.5% did so based on the indications.

HIV risk assessment for a woman often relies on her knowledge of her male partner's risk for seroconversion, of which she may not be aware (e.g., he has multiple sexual partners). One of the problems with the CDC guidelines is their reliance on past behavior to indicate eligibility, which may be a poor predictor of anticipated changes (e.g., women planning to decrease/eliminate condom use), study authors noted. Similarly, past risk behavior may not necessarily indicate future risk.

"Therefore, we recommend that the guidelines also explicitly state the limitations of using eligibility criteria for screening purposes and recommend discussing PrEP with all patients as part of routine sexual health care to guard against missed opportunities," the authors concluded.

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Young MSM Can Adhere to PrEP, But Face Challenges in Doing So

Young MSM are willing and able to take PrEP at protective levels, but adherence challenges remain among men of color, those exposed to violence, and people trying to meet subsistence needs, a small study in Alameda County, California, showed.

A substantial proportion (nearly 12%) of the 257 study participants needed post-exposure prophylaxis after recent activity that put them at high risk of seroconversion, before they could start PrEP. Over time, PrEP adherence dropped off, with 87% having protective levels of the study drug in their blood at week 4 and 77% at week 48. Sixty percent of  Latino and 48% of African-American participants were highly adherent at week 48, compared to 79% of white men. Similarly, 25% of those financially struggling to survive and 66% of those barely covering their necessities showed high adherence compared to 86% of those reporting a comfortable income. High adherence was defined as blood levels of the study drug indicating at least four doses a week.

Participants received routine counseling and support, in addition to clinical care, during their visits. Study authors credited this intervention with the relatively high adherence levels observed, but conceded that it was insufficient for offsetting the effect of the daily life challenges faced by some participants. "Preventing violence, counseling following exposures to violence, and supporting young men of color in meeting basic survival needs may be as important as prescriptions and laboratory tests in enhancing access and adherence to PrEP," they concluded.

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Training Family Planning Providers in PrEP Aids Awareness Among Women

If family planning providers are trained on PrEP, they will discuss it with their patients -- many of whom would be interested in getting biomedical HIV prevention, if they could do so at the family planning clinic, a PrEP implementation study among women reported.

Researchers trained providers at four safety-net family planning clinics in Georgia and surveyed 500 of their female patients, 376 of whom were sexually active, about their knowledge of and interest in PrEP. Nineteen percent of all participants knew about biomedical HIV prevention before their clinic visit. During the visit, 51% reported that their provider conducted an HIV risk assessment and 55% said they talked about HIV prevention, with 74% of these discussions including PrEP. Two thirds of the 110 women who met the CDC indications for PrEP discussed the topic with their provider, and 32 women expressed interest in trying this HIV prevention method, 20 of whom accepted an off-site referral for this purpose. However, 76% said they might consider PrEP, if it were offered at the study site clinic.

Results show that family planning clinics should be more involved in PrEP roll-out among women, especially in the U.S. South, study authors concluded. This could be accomplished through PrEP provision on-site -- which does raise cost and resource considerations, they acknowledged -- or through linkage to community providers of PrEP.

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High Loss to Follow-Up Among Those Starting PrEP Immediately

Loss to follow-up after PrEP initiation was high among participants in a retrospective cohort analysis at a large clinic in New York City. Eighty percent of 867 people (93% assigned male sex at birth) assessed for PrEP started this prevention method, with nearly 50% of them doing so immediately.

While filling the prescription right away may help jump-start a PrEP routine, diving in head-first may also explain the relatively high rate of participants who dropped out within the first month, study authors hypothesized. Among those starting PrEP, 68% attended the first follow-up visit (14-60 days after initial visit), 48% the second visit (maximum of 120 days thereafter) and 35% the final study visit (again, maximum of 120 days after the previous visit). Prescription refill history was used as an alternative way of assessing retention in care.

Other studies have used different ways to assess whether participants were still engaged in HIV prevention care. "Standardizing definitions for PrEP engagement and retention are essential for planning larger studies and advancing PrEP research," authors noted. They also explained that people may stop taking PrEP when they perceive their risk of HIV acquisition to have dropped, and called for further research to help establish criteria by which those who continue to be at high risk and drop out of care could be distinguished from those who may no longer need PrEP. Additionally, ways to identify those at risk of loss to follow-up are needed to help allocate limited resources for targeted retention interventions, they said.