Among 40,000 people diagnosed with HIV annually in the United States (US), 20% are women.1 Most new HIV diagnoses among women occur in the South.1–3 Georgia, specifically, has the highest rate of new HIV diagnoses among the United States (the only state with a rate over 30 per 100,000 people).1 Thus, reducing HIV among women living in the Southern United States, particularly women in Georgia, is a public health priority.
Since approval of daily oral HIV pre-exposure prophylaxis (PrEP),4 there has been wide-scale endorsement to bring PrEP to scale through dissemination and implementation efforts in the United States.5,6 However, despite PrEP's safety, efficacy,7,8 and user-controllability, its use remains disproportionately low for women. Women were less than 5% of US PrEP users in 2016 and the fourth quarter of 2017, and accounted for only 2% of the estimated 176,670 heterosexual women for whom PrEP is indicated.9–11
Although clinical guidelines for women's health providers have recently incorporated recommendations for PrEP,12 and some have started offering PrEP (eg, Planned Parenthood), the extent to which women's health clinics, especially in the South, are delivering PrEP is unknown. First steps in PrEP adoption are ensuring those who can benefit from PrEP are aware of it and ensuring PrEP is accessible in health care settings where they seek care.13 To date, efforts to scale PrEP in the United States have largely focused on PrEP awareness and access for men who have sex with men,14 despite low PrEP knowledge among US women,15–20 and women's health providers.21 Encouragingly, studies suggest that family planning (FP) providers are willing to prescribe PrEP once trained, and women are interested in taking PrEP once informed.22–24 To begin filling these gaps to increase women's awareness and access to PrEP, we conducted a pilot implementation study focused on improving HIV risk assessment and PrEP counseling in 4 high-volume safety net FP clinics in Atlanta, Georgia.
This study was conducted from February to August 2017. Four safety net FP clinics in Atlanta, Georgia, were approached for study participation. All were located in high HIV incidence zip codes, historically served large populations of sexually active women, and were not offering PrEP. Staff/providers at each site underwent a 1.5-hour PrEP training. After training, 500 female FP clinic patients were enrolled to evaluate the effectiveness of the provider training on the provision of HIV prevention counseling.25 All participants provided written informed consent; Emory University Institutional Review Board and Grady Research Oversight Committee approved the protocol.
We crafted an HIV-risk assessment tailored for use with women based on the US Public Health Service (USPHS) clinical guidance26 but adapted to include additional partner and relationship characteristics pertinent for women's HIV risk.27–29 We created a 1.5-hour PrEP training tailored for FP providers that consisted of (1) quality FP recommendations for HIV prevention,30 (2) HIV epidemiology in the United States and Atlanta, (3) HIV prevention including PrEP and its use among women (per USPHS PrEP guidelines), (4) patient risk assessment, counseling, and referral for PrEP, and (5) case scenarios (see Supplemental Digital Content file for details about training content https://links.lww.com/QAI/B351). The first 3 components informed participants about national and local HIV rates and HIV prevention methods; the fourth introduced the use of the HIV-risk assessment (Table 1) to identify patients who may benefit from PrEP; and the fifth allowed participants to apply their knowledge to patient scenarios. The training, co-delivered by an infectious disease physician and an obstetrician/gynecology/FP specialist, was conducted with 28 providers and staff working in the 4 clinics.
Evaluation of Training
We conducted pre-training and post-training evaluations (immediately before/after) to assess changes in provider/staff PrEP knowledge and self-efficacy to screen and identify women who may benefit from PrEP. To assess change in clinical practice, we conducted exit interviews for ∼4 months with FP patients seen in these clinics after the trainings. Before their clinical visit, patients completed the HIV-risk assessment as part of intake paperwork. After their visit, participants completed a 10-minute face-to-face exit interview on PrEP discussion, awareness, and interest.
Providers/staff were eligible if they were currently employed by one of the clinics in a role where they provided STI/HIV counseling. Nonpregnant, HIV-negative, female patients aged 18 years and older who spoke English were eligible. From 637 eligible women, 500 (78%) were enrolled in the study.
PrEP Training Evaluation
Pre-test/post-test assessments adapted from previously used surveys31,32 measured: PrEP knowledge (summed score of 6 true/false questions—higher scores indicate more correct responses), confidence identifying patients at risk for HIV who could benefit from PrEP (summed score of 2-likert rating items—higher scores indicate higher confidence), and belief that HIV prevention is an essential part of FP services (1-likert rating item; 1 = not essential to 4 = always essential).
This tool assessed patient's recent STI history, sexual activity, partner characteristics, injection drug use, and abuse history (Table 1). Age, race and ethnicity were recorded. For study analyses, patients were considered at substantial risk for HIV if they reported never or inconsistently using condoms during vaginal/anal sex with a male partner in the last 6 months and also reported any of the following: partner injects drugs or has sex with someone who injects drugs, partner has sex with men, partner is positive or unknown HIV status, and/or experienced verbal, sexual, or physical abuse. Participants were also considered at substantial risk if they reported they recently had an STI, injected drugs or exchanged sex for goods.
PrEP Discussion, Awareness, and Interest
During the exit interview, participants were asked if their provider discussed PrEP, if they were interested in taking PrEP, if they were interested in being referred to a PrEP clinic, if they had heard of PrEP before their visit, and if they would be more willing to take PrEP if provided by the FP clinic (all yes/no).
Descriptive analyses were performed on all measures. Paired-sample t-tests were conducted to evaluate pre-training to post-training changes. Analyses were conducted with SPSS.24.
Provider/Staff Participant Characteristics
Among 28 providers/staff, 18 (64%) identified as FP providers (3 physicians, 9 advanced practice providers, 6 nurse/nurse-midwives); 10 (36%) were other staff (eg, clinic manager, health educator, and medical assistant). Before training, 19 (68%) had previously heard of PrEP, but only 7 (25%) were aware of USPHS guidelines.
Patient Participant Characteristics
Among 500 patient participants, ages were 18–69 [mean (M) = 34, SD = 12.9] years; 69% were black/African American, 12% identified as Hispanic/Latina. The majority were sexually active (77%) and in a current sexual relationship with a male partner (69%). Using responses from the HIV-risk assessment, 29% of sexually active participants (n = 110) were considered at substantial risk for HIV based on USPHS guidelines (Table 2).
Changes in Provider/Staff PrEP Knowledge and Confidence
Providers/staff had significantly higher PrEP knowledge after the PrEP training [pre M = 3.26 (SD = 1.43) vs. post M = 5.13 (SD = 1.18); t(22) = −5.63, P < 0.001]. Providers were significantly more confident in their ability to identify patients at risk for HIV and patients who could benefit from PrEP [pre M = 8.11 (SD = 1.02) vs. post M = 9.11 (SD = 0.96); t(17) = −3.09, P = 0.007]. Providers/staff were significantly more likely to believe that HIV prevention education should be an essential part of a FP visit [pre M = 3.56 (SD = 0.71) vs. post M = 3.78 (SD = 0.42); t(24) = −2.06, P = 0.05].
Patient PrEP Discussion With Provider, Awareness, and Interest in PrEP
Overall, 76% of women saw a provider who participated in the PrEP training. Only 19% had heard about PrEP before their visit. Over half (51%) reported the provider discussed their HIV risk assessment with them, and 55% reported the provider discussed how to prevent HIV; among those whose provider discussed HIV prevention, 74% reported the provider discussed PrEP. Among the 110 women reporting HIV-risk consistent with PrEP indication, 72 (66%) reported the provider discussed PrEP, 32 (29%) reported interest in taking PrEP, and 20 (18%) reported they were interested in, and accepted referral assistance for off-site PrEP services. Most (76%) were more willing to take PrEP if provided by the FP clinic.
We report one of the first implementation studies to focus on women and PrEP in the United States and to examine PrEP adoption in FP clinics. After brief provider/staff training, most women with HIV-risk indicators received HIV prevention counseling inclusive of PrEP during their FP visits. Expanding on previous literature,15–20 once informed about PrEP by their FP provider, most women with HIV-risk indicators expressed interest in PrEP. Although a small proportion of women (18%) accepted an off-site PrEP referral, most noted they would be more interested if it were offered at the FP clinic. At the epicenter of the US HIV epidemic, our results highlight the potential impact that even minimal PrEP capacity building within public FP clinics may have on PrEP scale-up for women.
Despite nearly a third of women seeking FP services reporting HIV risk consistent with PrEP indication, few knew about PrEP before their visit, consistent with earlier literature reporting low PrEP awareness among US women.15–20,22,24 Women deem women's health providers as trusted sources for health information,16,33 so even if public FP clinics do not provide PrEP-related care themselves, they can play an important role in increasing PrEP awareness and accessibility for women. Actionable steps FP clinics can take to increase PrEP awareness include providing women-focused PrEP education materials and ensuring their providers/staff are able to discuss PrEP during HIV prevention counseling.
Lack of knowledge about PrEP has also been found among women's health providers,21,23 particularly in the Southern United States,18 resulting in a barrier to PrEP implementation in otherwise potentially ideal settings for scaling PrEP for women.28,34–37 Trainings are one of the most widely used implementation strategies to increase adoption of new practices in health care settings.38 Our findings highlight that minimal training can help overcome provider PrEP knowledge and self-efficacy barriers, and altered HIV prevention discussions with women to include information about PrEP.
Importantly, after learning about PrEP from their FP providers, many women reported interest in taking PrEP, but only a small proportion accepted an off-site referral. Additional training and implementation strategies may be required for the provision of on-site PrEP delivery in FP clinics. In addition to ensuring providers/staff are knowledgeable about PrEP, for clinics that opt not to provide on-site PrEP, they may still make PrEP more accessible to women by routinizing HIV-risk assessment for patients during FP visits to normalize conversation about HIV, providing HIV prevention counseling inclusive of PrEP, and developing acceptable methods for linking interested women to PrEP-providing clinics.
Onsite PrEP delivery requires a higher level of engagement of health care providers than has typically been engaged for HIV prevention in public FP settings and has cost and resource considerations relevant for safety net clinics. Virtually nothing is known about acceptability, prioritization of, and capacity to integrate PrEP into current services at public FP clinics in the South. In addition, as learned through the roll-out of other sexual health innovations (eg, HPV vaccine), availability and access alone does not guarantee uptake. We have very limited data on factors influencing PrEP uptake, adherence, and continuation among women, especially in the Southern United States. These are areas of ongoing and future research.
As with most implementation studies, this study was in a convenience sample of clinics and women, and information on some factors pertinent to PrEP awareness and interest were not collected. We conducted one training per clinic, thus were not able to train every provider/staff. Furthermore, social desirability bias may have affected reporting of personal behaviors, attitudes, and preferences. Although patient exit interviews were face-to-face, we attempted to minimize bias by collecting all other surveys as self-administered without personal identifiers.
Continuing high HIV rates among women in the Southern United States, and especially Georgia, make it imperative to increase PrEP awareness, and access for women. Public FP clinics are trusted sources of care frequently accessed by women, and our study indicates that minimal PrEP capacity building in this setting can result in high-PrEP awareness, interest, and, to a lesser degree, potential access to PrEP through off-site referral. Further strengthening FP clinics' role in PrEP roll-out for women in the South is warranted, either through on-site PrEP delivery or through effective linkage to PrEP care in the community.
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