Shifting the Narrative of Preexposure Prophylaxis Adherence Counseling for Cisgender Women

More than a decade after the approval of emtricitabine and tenofovir disoproxil fumarate (F/TDF) for HIV preexposure prophylaxis (PrEP), rates of new HIV infections remain high globally, with most occurring among cisgender women, and exceed the United Nations global targets. In the US, rates of PrEP use are substantially low in cisgender women, with disparities by race and ethnicity and across regions. Concerns about the effectiveness of F/TDF and limited PrEP alternatives complicate efforts to in-crease the use of PrEP in cisgender women

Human immunodeficiency virus pre-exposure prophylaxis knowledge, attitudes, and self-efficacy among family planning providers in the Southern United States: Bridging the gap in provider training

BACKGROUND: Pre-exposure prophylaxis (PrEP) is an effective human immunodeficiency virus (HIV) prevention intervention, but its access and use are suboptimal, especially for women. Healthcare providers provision of PrEP is a key component of the METHODS: We used data from providers in clinics that did not currently provide PrEP from a web-based survey administered to Title X clinic staff in 18 Southern states from February to June 2018. We developed generalized linear mixed models to evaluate associations between provider-, clinic-, and county-level variables with provider knowledge, attitudes, and self-efficacy in PrEP care, guided by the Consolidated Framework for Implementation Research. RESULTS: Among 351 providers from 193 clinics, 194 (55%) were nonprescribing and 157 (45%) were prescribing providers. Provider ability to prescribe medications was significantly associated PrEP knowledge, attitudes, and self-efficacy. Self-efficacy was lowest in the PrEP initiation step of PrEP care and was positively associated with PrEP attitudes, PrEP knowledge, and contraception self-efficacy. CONCLUSIONS: Our findings suggest that PrEP training gaps for family planning providers may be bridged by addressing unfavorable PrEP attitudes, integrating PrEP and contraception training, tailoring training by prescribing ability, and focusing on the initiation steps of PrEP care

Pre-exposure Prophylaxis Implementation in Family Planning Services Across the Southern United States: Findings from a Survey Among Staff, Providers and Administrators Working in Title X-Funded Clinics

To improve women's access to pre-exposure prophylaxis (PrEP) in family planning (FP) clinics, we examined readiness to provide PrEP, and barriers and facilitators at the clinic level to integrate PrEP services into Title X-funded FP clinics across the Southern US. Title X-funded FP clinics across DHHS regions III (Mid-Atlantic), IV (Southeast), and VI (Southwest), comprising the Southern US. From February to June, 2018, we conducted a web-based, geographically targeted survey of medical staff, providers and administrators of Title X-funded FP clinics in DHHS regions III (Mid-Atlantic), IV (Southeast), and VI (Southwest). Survey items were developed using the Consolidated Framework for Implementation Research to assess constructs relevant to PrEP implementation. One-fifth of 283 unique Title X clinics across the South provided PrEP. Readiness for PrEP implementation was positively associated with a climate supportive of HIV prevention, leadership engagement, and availability of resources, and negatively associated with providers holding negative attitudes about PrEP's suitability for FP. The Title X FP network is a vital source of sexual health care for millions of individuals across the US. Clinic-level barriers to providing PrEP must be addressed to expand onsite PrEP delivery in Title X FP clinics in the Southern US

State-level clustering in PrEP implementation factors among family planning clinics in the Southern United States

Background: Availability of PrEP-providing clinics is low in the Southern U.S., a region at the center of the U.S. HIV epidemic with significant HIV disparities among minoritized populations, but little is known about state-level differences in PrEP implementation in the region. We explored state-level clustering of organizational constructs relevant to PrEP implementation in family planning (FP) clinics in the Southern U.S. Methods: We surveyed providers and administrators of FP clinics not providing PrEP in 18 Southern states (Feb-Jun 2018, N = 414 respondents from 224 clinics) on these constructs: readiness to implement PrEP, PrEP knowledge/attitudes, implementation climate, leadership engagement, and available resources. We analyzed each construct using linear mixed models. A principal component analysis identified six principal components, which were inputted into a K-means clustering analysis to examine state-level clustering. Results: Three clusters (C1–3) were identified with five, three, and four states, respectively. Canonical variable 1 separated C1 and C2 from C3 and was primarily driven by PrEP readiness, HIV-specific implementation climate, PrEP-specific leadership engagement, PrEP attitudes, PrEP knowledge, and general resource availability. Canonical variable 2 distinguished C2 from C1 and was primarily driven by PrEP-specific resource availability, PrEP attitudes, and general implementation climate. All C3 states had expanded Medicaid, compared to 1 C1 state (none in C2). Conclusion: Constructs relevant for PrEP implementation exhibited state-level clustering, suggesting that tailored strategies could be used by clustered states to improve PrEP provision in FP clinics. Medicaid expansion was a common feature of states within C3, which could explain the similarity of their implementation constructs. The role of Medicaid expansion and state-level policies on PrEP implementation warrants further exploration

Brief report: Substance use care continuum in women with and without HIV in the Southern United States

BACKGROUND: Substance use (SU) contributes to poor outcomes among persons living with HIV. Women living with HIV (WWH) in the United States are disproportionately affected in the South, and examining SU patterns, treatment, and HIV outcomes in this population is integral to addressing HIV and SU disparities. METHODS: WWH and comparable women without HIV (WWOH) who enrolled 2013-2015 in the Women\u27s Interagency HIV Study Southern sites (Atlanta, Birmingham/Jackson, Chapel Hill, and Miami) and reported SU (self-reported nonmedical use of drugs) in the past year were included. SU and treatment were described annually from enrollment to the end of follow-up. HIV outcomes were compared by SU treatment engagement. RESULTS: At enrollment, among 840 women (608 WWH, 232 WWOH), 18% (n = 155) reported SU in the past year (16% WWH, 24% WWOH); 25% (n = 38) of whom reported SU treatment. Over time, 30%, 21%, and 18% reported SU treatment at 1, 2, and 3 years, respectively, which did not significantly differ by HIV status. Retention in HIV care did not differ by SU treatment. Viral suppression was significantly higher in women who reported SU treatment only at enrollment ( P = 0.03). CONCLUSIONS: We identified a substantial gap in SU treatment engagement, with only a quarter reporting treatment utilization, which persisted over time. SU treatment engagement was associated with viral suppression at enrollment but not at other time points or with retention in HIV care. These findings can identify gaps and guide future strategies for integrating HIV and SU care for WWH

Pre-Exposure Prophylaxis Integration into Family Planning Services at Title X Clinics in the Southeastern United States: A Geographically-Targeted Mixed Methods Study (Phase 1 ATN 155)

BACKGROUND: Black adolescent and young adult women (AYAW) in the Southern United States are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is an effective, scalable, individual-controlled HIV prevention strategy that is grossly underutilized among women of all ages and requires innovative delivery approaches to optimize its benefit. Anchoring PrEP delivery to health services that AYAW already trust, access routinely, and deem useful for their sexual health may offer an ideal opportunity to reach women at risk for HIV and to enhance their PrEP uptake and adherence. These services include those of family planning (FP) providers in high HIV incidence settings. However, PrEP has not been widely integrated into FP services, including Title X-funded FP clinics that provide safety net sources of care for AYAW. To overcome potential implementation challenges for AYAW, Title X clinics in the Southern United States are uniquely positioned to be focal sites for conceptually informed and thoroughly evaluated PrEP implementation science studies. OBJECTIVE: The aim of this study is to assess inner and outer context factors (barriers and facilitators) that may influence the adoption of PrEP prescription and treatment services in Title X clinics serving AYAW in the Southern United States. METHODS: Phase 1 of Planning4PrEP is an explanatory sequential, mixed methods study consisting of a geographically-targeted Web-based survey of Title X clinic administrators and providers in the Southern United States, followed by key informant interviews among a purposively selected subset of responders to more comprehensively assess inner and outer context factors that may influence adoption and implementation of PrEP in Title X FP clinics in the South. RESULTS: Phase 1 of Planning4PrEP research activities began in October 2017 and are ongoing. To date, survey and key informant interview administration is near completion, with quantitative and qualitative data analysis scheduled to begin soon after data collection completion. CONCLUSIONS: This study seeks to assess inner and outer contextual factors (barriers and facilitators) that may influence the adoption and integration of PrEP prescription and treatment services in Title X clinics serving AYAW in the Southern United States. Data gained from this study will inform a type 1 hybrid effectiveness implementation study, which will evaluate the multilevel factors associated with successful PrEP implementation while evaluating the degree of PrEP uptake, continuation, and adherence among women seen in Title X clinics

Pre-Exposure Prophylaxis Integration Into Family Planning Services at Title X Clinics in the Southeastern United States: Protocol for a Mixed Methods Hybrid Type I Effectiveness Implementation Study (Phase 2 ATN 155)

BACKGROUND: Adolescent and young adult women (AYAW), particularly racial and ethnic minorities, in the Southern United States are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is an effective, scalable, individual-controlled HIV prevention strategy that is grossly underutilized among women of all ages and requires innovative delivery approaches to optimize its benefit. Anchoring PrEP delivery to family planning (FP) services that AYAW already trust, access routinely, and deem useful for their sexual health may offer an ideal opportunity to reach women at risk for HIV and to enhance their PrEP uptake and adherence. However, PrEP has not been widely integrated into FP services, including Title X-funded FP clinics that provide safety net sources of care for AYAW. To overcome potential implementation challenges for AYAW, Title X clinics in the Southern United States are uniquely positioned to be focal sites for conceptually informed and thoroughly evaluated PrEP implementation science studies. OBJECTIVE: The objective of this study is two-fold: to evaluate multilevel factors associated with the level of PrEP adoption and implementation (eg, PrEP screening, counseling, and prescription) within and across 3 FP clinics and to evaluate PrEP uptake, persistence, and adherence among female patients in these clinics over a 6-month follow-up period. METHODS: Phase 2 of Planning4PrEP (Adolescent Medicine Trials Network for HIV/AIDS Interventions 155) is a mixed methods hybrid type 1 effectiveness implementation study to be conducted in three clinics in Metro Atlanta, Georgia, United States. Guided by the Exploration, Preparation, Implementation, and Sustainment framework, this study will prepare clinics for PrEP integration via clinic-wide trainings and technical assistance and will develop clinic-specific PrEP implementation plans. We will monitor and evaluate PrEP implementation as well as female patient PrEP uptake, persistence, and adherence over a 6-month follow-up period. RESULTS: Phase 2 of Planning4PrEP research activities began in February 2018 and are ongoing. Qualitative data analysis is scheduled to begin in Fall 2020. CONCLUSIONS: This study seeks to evaluate factors associated with the level of PrEP adoption and implementation (eg, PrEP screening, counseling, and prescription) within and across 3 FP clinics following training and implementation planning and to evaluate PrEP uptake, persistence, and adherence among female patients over a 6-month follow-up period. This will guide future strategies to support PrEP integration in Title X-funded clinics across the Southern United States

Co-Utilization of HIV, Substance Use, Mental Health Services Among Women With Current Substance Use: Opportunities for Integrated Care?

BackgroundThe syndemic of HIV, substance use (SU), and mental illness has serious implications for HIV disease progression among women. We described co-utilization of HIV care, SU treatment, and mental health treatment among women with or at risk for HIV.MethodsWe included data from women with or at risk for HIV (n = 2559) enrolled in all 10 sites of the Women's Interagency HIV Study (WIHS) from 2013 to 2020. Current SU was defined as self-reported, non-medical use of drugs in the past year, excluding use of only marijuana. Tobacco and alcohol were assessed separately. We described co-utilization of SU treatment, tobacco and alcohol use treatment, HIV care, and mental health care in the past year among women who were eligible for each service. We compared service utilization by those who did/did not utilize SU treatment using Wald Chi-square tests.ResultsAmong women with current SU (n = 358), 42% reported utilizing SU treatment. Among those with current SU+HIV (n = 224), 84% saw their HIV provider, and 34% saw a mental health provider. Among women with current SU+heavy alcohol use (n = 95), 18% utilized alcohol use treatment; among current SU+tobacco use (n = 276), 8% utilized tobacco use treatment. Women who utilized SU treatment had higher utilization of alcohol use treatment (59% vs. 5%; P < .001) and tobacco use treatment (12% vs. 5%; P = .028). HIV care engagement was high regardless of SU treatment.ConclusionsWe found high engagement in SU and HIV care, but low engagement in alcohol and tobacco use treatment. Integrated SU treatment services for women, including tobacco/alcohol treatment and harm reduction, are needed to optimize treatment engagement and HIV care continuum outcomes

Examining adherence barriers among women with HIV to tailor outreach for long-acting injectable antiretroviral therapy

Background Long-acting (LA) injectable antiretroviral therapy (ART) has been found non-inferior to daily oral ART in Phase 3 trials. LA ART may address key barriers to oral ART adherence and be preferable to daily pills for some people living with HIV. To date, women have been less represented than men in LA ART research. Using longitudinal data from the Women’s Interagency HIV Study (WIHS) cohort of women living with HIV in the United States, we examined barriers and facilitators of daily oral ART adherence that may be related to or addressed by LA ART. Methods We conducted a secondary analysis of WIHS cohort data from 1998 to 2017 among participants seen for at least 4 visits since 1998 who reported using ART at least once (n = 2601). Two dichotomous outcomes, patient-reported daily oral ART adherence and viral suppression were fit using generalized linear models, examining the role of socio-demographic and structural factors. Results At study enrollment, the median age was 40.5 years, 63% of participants were African American and 22% were Latina. The majority (82%) reported taking ART more than 75% of the time and 53% were virally suppressed. In multivariate analysis, several sub-groups of women had lower odds of reported adherence and viral suppression: 1) younger women (adherence aOR: 0.71; viral suppression aOR: 0.63); 2) women who inject drugs (adherence aOR: 0.38; viral suppression aOR: 0.50) and those with moderate (adherence aOR: 0.59; viral suppression aOR: 0.74) and heavy alcohol consumption (adherence aOR: 0.51; viral suppression aOR: 0.69); 3) those with depressive symptoms (adherence aOR: 0.61; viral suppression aOR: 0.76); and 4) those with a history of going on and off ART (adherence aOR: 0.62, viral suppression aOR: 0.38) or changing regimens (adherence aOR: 0.83, viral suppression aOR: 0.56). Conclusions Current injectable contraceptive users (vs. non-users) had greater odds of oral ART adherence (aOR: 1.87) and viral suppression (aOR: 1.28). Findings identify profiles of women who may benefit from and be interested in LA ART. Further research is warranted focused on the uptake and utility of LA ART for such key subpopulations of women at high need for innovative approaches to achieve sustained viral suppression

A Patient Decision Aid (i.ARTs) to Facilitate Women’s Choice Between Oral and Long-Acting Injectable Antiretroviral Treatment for HIV: Protocols for its Development and Randomized Controlled Pilot Trial

Background: Many women with HIV (WWH) have suboptimal adherence to oral antiretroviral therapy (ART) due to multilevel barriers to HIV care access and retention. A long-acting injectable (LAI) version of ART was approved by the US Food and Drug Administration in January 2021 and has the potential to overcome many of these barriers by eliminating the need for daily pill taking. However, it may not be optimal for all WWH. It is critical to develop tools that facilitate patient-provider shared decision making about oral versus LAI ART modalities to promote women's adherence and long-term HIV outcomes. Objective: This study will develop and pilot test a web-based patient decision aid called i.ART+support (i.ARTs). This decision aid aims to support shared decision making between WWH and their providers, and help women choose between oral and LAI HIV treatment. Methods: The study will occur in 3 phases. In phase 1, we will utilize a mixed methods approach to collect data from WWH and medical and social service providers to inform i.ARTs content. During phase 2, we will conduct focus groups with WWH and providers to refine i.ARTs content and develop the web-based decision aid. In phase 3, i.ARTs will be tested in a randomized controlled trial with 180 women in Miami, Florida, and assessed for feasibility, usability, and acceptability, as well as to evaluate the associations between receiving i.ARTs and viral suppression, ART pharmacy refills, and clinic attendance. Results: This study was funded in March 2021. Columbia University's IRB approved the study protocols (approval number IRB-AAAT5314). Protocols for phase 1 interviews have been developed and interviews with service providers started in September 2021. We will apply for Clinicaltrials.gov registration prior to phase 3, which is when our first participant will be enrolled in the randomized controlled trial. This is anticipated to occur in April 2023. Conclusions: This study is the first to develop a web-based patient decision aid to support WWH choices between oral and LAI ART. Its strengths include the incorporation of both patient and provider perspectives, a mixed methods design, and implementation in a real-world clinical setting. International registered report identifier (irrid): DERR1-10.2196/35646.VoRSUNY DownstateInfectious DiseasesN/