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1.
MMWR Recomm Rep ; 73(2): 1-8, 2024 Jun 06.
Article in English | MEDLINE | ID: mdl-38833414

ABSTRACT

No vaccines and few chemoprophylaxis options exist for the prevention of bacterial sexually transmitted infections (STIs) (specifically syphilis, chlamydia, and gonorrhea). These infections have increased in the United States and disproportionately affect gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW). In three large randomized controlled trials, 200 mg of doxycycline taken within 72 hours after sex has been shown to reduce syphilis and chlamydia infections by >70% and gonococcal infections by approximately 50%. This report outlines CDC's recommendation for the use of doxycycline postexposure prophylaxis (doxy PEP), a novel, ongoing, patient-managed biomedical STI prevention strategy for a selected population. CDC recommends that MSM and TGW who have had a bacterial STI (specifically syphilis, chlamydia, or gonorrhea) diagnosed in the past 12 months should receive counseling that doxy PEP can be used as postexposure prophylaxis to prevent these infections. Following shared decision-making with their provider, CDC recommends that providers offer persons in this group a prescription for doxy PEP to be self-administered within 72 hours after having oral, vaginal, or anal sex. The recommended dose of doxy PEP is 200 mg and should not exceed a maximum dose of 200 mg every 24 hours.Doxy PEP, when offered, should be implemented in the context of a comprehensive sexual health approach, including risk reduction counseling, STI screening and treatment, recommended vaccination and linkage to HIV PrEP, HIV care, or other services as appropriate. Persons who are prescribed doxy PEP should undergo bacterial STI testing at anatomic sites of exposure at baseline and every 3-6 months thereafter. Ongoing need for doxy PEP should be assessed every 3-6 months as well. HIV screening should be performed for HIV-negative MSM and TGW according to current recommendations.


Subject(s)
Centers for Disease Control and Prevention, U.S. , Doxycycline , Post-Exposure Prophylaxis , Sexually Transmitted Diseases, Bacterial , Humans , Doxycycline/therapeutic use , United States , Male , Female , Sexually Transmitted Diseases, Bacterial/prevention & control , Anti-Bacterial Agents/therapeutic use , Sexual and Gender Minorities
2.
Open Forum Infect Dis ; 11(5): ofae230, 2024 May.
Article in English | MEDLINE | ID: mdl-38784760

ABSTRACT

Genital herpes is caused by infection with herpes simplex virus types 1 and 2 (HSV-1 and HSV-2) and currently has no cure. The disease is the second-most common sexually transmitted infection in the United States, with an estimated 18.6 million prevalent genital infections caused by HSV-2 alone. Genital herpes diagnostics and treatments are not optimal, and no vaccine is currently available. The Centers for Disease Control and Prevention and the National Institute of Allergy and Infectious Diseases convened a workshop entitled "CDC/NIAID Joint Workshop on Genital Herpes." This report summarizes 8 sessions on the epidemiology of genital herpes, neonatal HSV, HSV diagnostics, vaccines, treatments, cures, prevention, and patient advocacy perspective intended to identify opportunities in herpes research and foster the development of strategies to diagnose, treat, cure, and prevent genital herpes.

3.
JAMA ; 331(20): 1701-1702, 2024 05 28.
Article in English | MEDLINE | ID: mdl-38683579

ABSTRACT

This Viewpoint discusses the US Food and Drug Administration's authorization of marketing an at-home testing system for chlamydia and gonorrhea as a good first step in boosting access to screening and treatment and in reducing infection rates.


Subject(s)
Chlamydia Infections , Gonorrhea , Self-Testing , Female , Humans , Male , Chlamydia Infections/diagnosis , Chlamydia trachomatis/isolation & purification , Gonorrhea/diagnosis , Health Services Accessibility , Neisseria gonorrhoeae/isolation & purification , United States , United States Food and Drug Administration
4.
J Org Chem ; 89(4): 2764-2770, 2024 Feb 16.
Article in English | MEDLINE | ID: mdl-38271990

ABSTRACT

In this study, we delve into the regioselectivity of nucleophilic reactions involving brominated perylene bisimides (PBIs) and various bidentate aryloxide anions, previously associated with an SRN1 mechanism. We present herein a new perspective, suggesting that a single-electron-transfer aromatic nucleophilic substitution (SeT-SNAr) mechanism is a more plausible scenario. Our study reveals the favorable impact of photostimulation on reaction yields, making our method a convenient approach for accessing O-arylated PBIs.

5.
AIDS Care ; 36(4): 472-481, 2024 Apr.
Article in English | MEDLINE | ID: mdl-37331017

ABSTRACT

Uptake and retention in clinical care for pre-exposure prophylaxis (PrEP) is suboptimal, particularly among young African American men who have sex with men (MSM) in the Deep South. We conducted a two-phase study to develop and implement an intervention to increase PrEP persistence. In Phase I, we conducted focus groups with 27 young African American MSM taking PrEP at a community health center in Jackson, Mississippi to elicit recommendations for the PrEP persistence intervention. We developed an intervention based on recommendations in Phase I, and in Phase II, ten participants were enrolled in an open pilot. Eight participants completed Phase II study activities, including a single intervention session, phone call check-ins, and four assessments (Months 0, 1, 3, and 6). Exit interviews demonstrated a high level of acceptability and satisfaction with the intervention. These formative data demonstrate the initial promise of a novel intervention to improve PrEP persistence among young African American MSM.


Subject(s)
Anti-HIV Agents , HIV Infections , Pre-Exposure Prophylaxis , Sexual and Gender Minorities , Male , Humans , Homosexuality, Male , Black or African American , HIV Infections/prevention & control , HIV Infections/drug therapy , Pilot Projects , Anti-HIV Agents/therapeutic use
7.
Prev Med Rep ; 36: 102490, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38116259

ABSTRACT

Intimate partner violence (IPV) can constraint Black women's ability to prioritize and access Human Immunodeficiency Virus (HIV) pre-exposure prophylaxis (PrEP) services. Recent research has called for the development of trauma-informed PrEP implementation programs to improve the delivery of PrEP to Black cisgender women; however, many PrEP-prescribing settings do not reflect this recommendation. The current study sought to identify key components to develop a trauma-informed PrEP implementation program for Black cisgender women and clinical staff. We conducted focus groups with PrEP-eligible Black cisgender women (February-June 2019), and semi-structured interviews with clinical staff offering HIV prevention and treatment services (October-November 2020) in community healthcare clinics in Mississippi. Seven themes were identified as needed to facilitate integration of trauma-informed approaches into existing PrEP programs, including defining intimate partner violence (IPV), appropriate IPV screening and response, HIV prevention in abusive relationships, staff training needs, and creating supportive clinic environments. PrEP-eligible Black women and clinical staff generally agreed on how to best operationalize IPV screening and response, the importance of trauma-informed staff training, and the need for Black women-specific informational campaigns. However, Black women highlighted the need for providers to discuss HIV prevention in controlling relationships, and to respond to IPV disclosure. HIV pre-exposure prophylaxis has yet to achieve the potential impact observed in trials. Ultimately, realizing the HIV prevention potential of PrEP in the US necessitates centering the perspectives of Black cisgender women and staff to better integrate trauma-informed approaches.

8.
MMWR Morb Mortal Wkly Rep ; 72(46): 1269-1274, 2023 Nov 17.
Article in English | MEDLINE | ID: mdl-37971936

ABSTRACT

Introduction: Congenital syphilis cases in the United States increased 755% during 2012-2021. Syphilis during pregnancy can lead to stillbirth, miscarriage, infant death, and maternal and infant morbidity; these outcomes can be prevented through appropriate screening and treatment. Methods: A cascading framework was used to identify and classify missed opportunities to prevent congenital syphilis among cases reported to CDC in 2022 through the National Notifiable Diseases Surveillance System. Data on testing and treatment during pregnancy and clinical manifestations present in the newborn were used to identify missed opportunities to prevent congenital syphilis. Results: In 2022, a total of 3,761 cases of congenital syphilis in the United States were reported to CDC, including 231 (6%) stillbirths and 51 (1%) infant deaths. Lack of timely testing and adequate treatment during pregnancy contributed to 88% of cases of congenital syphilis. Testing and treatment gaps were present in the majority of cases across all races, ethnicities, and U.S. Census Bureau regions. Conclusions and implications for public health practice: Addressing missed opportunities for prevention, primarily timely testing and appropriate treatment of syphilis during pregnancy, is important for reversing congenital syphilis trends in the United States. Implementing tailored strategies addressing missed opportunities at the local and national levels could substantially reduce congenital syphilis.


Subject(s)
Pregnancy Complications, Infectious , Syphilis, Congenital , Syphilis , Infant , Infant, Newborn , Pregnancy , Female , Humans , United States/epidemiology , Syphilis, Congenital/epidemiology , Syphilis, Congenital/prevention & control , Syphilis/diagnosis , Syphilis/epidemiology , Syphilis/prevention & control , Pregnancy Complications, Infectious/diagnosis , Pregnancy Complications, Infectious/epidemiology , Pregnancy Complications, Infectious/prevention & control , Population Surveillance , Stillbirth , Vital Signs
9.
Transgend Health ; 8(4): 307-327, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37525832

ABSTRACT

Purpose: Providing inclusive and comprehensive gender-affirming care is critical to reducing health disparities (gaps in care) experienced by sexual and gender minorities (SGM). Currently, little is known about how medical students and residents are being trained to address the health needs of SGM persons or of the most effective methods. Methods: We conducted a systematic review of the research literature from 2000 to 2020 on the effectiveness of teaching medical students and residents on knowledge, attitudes, and skills in addressing the health of SGM persons and the strength of the research sample, design, and methods used. Results: We identified a total of 36 articles that assessed the impact of medical student and resident education on knowledge, comfort, attitudes, confidence, and skills in working with SGM patients. All studies utilized quasi-experimental designs, and found efficacious results. No study examined the impact of training on patient outcomes. Conclusion: Future studies will need to be powered and designed to assess the impact of training on patient outcomes.

10.
Chem Commun (Camb) ; 59(64): 9726-9729, 2023 Aug 08.
Article in English | MEDLINE | ID: mdl-37476912

ABSTRACT

We present a computational approach for predicting key properties of organic radical anions, including excited-state lifetimes and redox potentials. The approach shows good agreement with experimental data and has potential for in silico screening to facilitate the rational design of photocatalysts.

11.
BMC Public Health ; 23(1): 1130, 2023 06 13.
Article in English | MEDLINE | ID: mdl-37312077

ABSTRACT

INTRODUCTION: Mississippi has one of the highest rates of HIV in the United States but low PrEP uptake. Understanding patterns of PrEP use can improve PrEP initiation and persistence. METHODS: This is a mixed-method evaluation of a PrEP program in Jackson, Mississippi. Between November 2018-December 2019, clients at high risk for HIV attending a non-clinical testing site were referred to a pharmacist for same-day PrEP initiation. The pharmacist provided a 90-day PrEP prescription and scheduled a follow-up clinical appointment within three months. We linked client records from this visit to electronic health records from the two largest PrEP clinics in Jackson to determine linkage into ongoing clinical care. We identified four distinct PrEP use patterns, which we used for qualitative interview sampling: 1) filled a prescription and linked into care within three months; 2) filled a prescription and linked into care after three months; 3) filled a prescription and never linked into care; and 4) never filled a prescription. In 2021, we purposively sampled patients in these four groups for individual interviews to ascertain barriers and facilitators to PrEP initiation and persistence, using guides informed by the Theory of Planned Behavior. RESULTS: There were 121 clients evaluated for PrEP; all were given a prescription. One-third were less than 25 years old, 77% were Black, and 59% were cisgender men who have sex with men. One-quarter (26%) never filled their PrEP prescription, 44% picked up the prescription but never linked into clinical care, 12% linked into care at some point after three months (resulting in a gap in PrEP coverage), and 18% linked into care within 3 months. We interviewed 26 of 121 clients. Qualitative data revealed that cost, stigmas related to sexuality and HIV, misinformation about PrEP, and perceived side effects were barriers to uptake and persistence. Individuals' desire to stay healthy and the support of PrEP clinic staff were facilitators. CONCLUSIONS: The majority of individuals given a same-day PrEP prescription either never started PrEP or stopped PrEP within the first three months. Addressing noted barriers of stigma and misinformation and reducing structural barriers may increase PrEP initiation and persistence.


Subject(s)
HIV Infections , Sexual and Gender Minorities , Male , Humans , Adult , Pharmacists , Mississippi , Homosexuality, Male , HIV Infections/prevention & control
12.
AIDS Patient Care STDS ; 37(7): 332-336, 2023 07.
Article in English | MEDLINE | ID: mdl-37222734

ABSTRACT

Although pre-exposure prophylaxis (PrEP) is an efficacious biomedical intervention, the effectiveness of same-day PrEP programs has not been widely studied. We utilized data from three of the four largest PrEP providers in Mississippi from September 2018 to September 2021 linked to the Mississippi State Department of Health's Enhanced HIV/AIDS reporting system. HIV diagnosis was defined as testing newly positive for HIV at least 2 weeks after the initial PrEP visit. We calculated the cumulative incidence and incidence rate of HIV per 100 person-years (PY). Person-time was calculated as time from the initial PrEP visit to (1) HIV diagnosis or (2) December 31, 2021 (HIV surveillance data end date). We did not censor individuals if they discontinued PrEP to obtain an estimate of PrEP effectiveness rather than efficacy. Among the 427 clients initiating PrEP during the study period, 2.3% [95% confidence interval (CI): 0.9-3.8] subsequently tested positive for HIV. The HIV incidence rate was 1.18 per 100 PY (95% CI: 0.64-2.19) and median time to HIV diagnosis after the initial PrEP visit was 321 days (95% CI: 62-686). HIV incidence rates were highest among transgender and nonbinary individuals [10.35 per 100 PY (95% CI: 2.59-41.40)] compared with cisgender men and women, and among people racialized as Black [1.45 per 100 PY (95% CI: 0.76-2.80)] compared with White and other racialized groups. These findings indicate a need for more clinical and community interventions that support PrEP persistence and restarts among those at high risk of HIV acquisition.


Subject(s)
Anti-HIV Agents , HIV Infections , Pre-Exposure Prophylaxis , Transgender Persons , Male , Humans , Female , HIV Infections/diagnosis , HIV Infections/epidemiology , HIV Infections/prevention & control , Incidence , Homosexuality, Male , Anti-HIV Agents/therapeutic use
13.
J Int Assoc Provid AIDS Care ; 22: 23259582231167959, 2023.
Article in English | MEDLINE | ID: mdl-37032460

ABSTRACT

Compared to other states in the United States, Mississippi has the lowest uptake of PrEP relative to the number of people newly diagnosed with HIV in the state. Open Arms Healthcare Center is the largest provider of PrEP in Mississippi, and has systematically documented PrEP eligibility, offers, and acceptance (ie, agreed to undergo a clinical PrEP evaluation) from 2017 to mid-2020. In encounter-based analyses, we examined factors associated with PrEP acceptance. Among 721 encounters where patients were eligible for PrEP, staff offered PrEP at 680 (94%) of encounters (526 unique individuals); individuals accepted a PrEP offer at 58% of encounters. Accepting a PrEP offer was lowest (15.8%) among transgender/non-binary individuals and highest (93.3%) among individuals who reported having sex partners living with HIV. This clinic's model worked to offer PrEP to a highly impacted population, though there is a need to enhance PrEP acceptance for key groups such as transgender/non-binary individuals.


Subject(s)
Anti-HIV Agents , HIV Infections , Pre-Exposure Prophylaxis , Transgender Persons , Male , Humans , United States , Mississippi/epidemiology , Homosexuality, Male , Anti-HIV Agents/therapeutic use , HIV Infections/epidemiology , HIV Infections/prevention & control , HIV Infections/drug therapy , Sexual Partners
14.
J Sch Nurs ; 39(3): 248-261, 2023 Jun.
Article in English | MEDLINE | ID: mdl-33375901

ABSTRACT

Social media may promote health and social connectedness, but its misuse and frequency of use may pose risks. Social media use during adolescence requires parental monitoring and mediation to mitigate potentially harmful effects such as depression, anxiety, and risk-taking behaviors. While parents and health care professionals convey concern surrounding exposure to inappropriate content, prolonged screen time, and cyberbullying, appropriate social media monitoring remains challenging. The purpose of this study was to explore parental monitoring and mediation of social media use in adolescents. Online recruitment yielded a nationwide sample (n = 836) of parents of adolescents. The results of the online survey indicated that parents are concerned about adolescent social media use and endorse positive attitudes toward monitoring. Yet parents perceived little control over monitoring. Findings from this study support the school nurse in promoting healthy social media use, media literacy among parents and adolescents, and the use of screening tools.


Subject(s)
Nurses , Social Media , Humans , Adolescent , Intention , Health Promotion , Parents
15.
AIDS Care ; 35(4): 495-508, 2023 04.
Article in English | MEDLINE | ID: mdl-36215734

ABSTRACT

Despite the efficacy of HIV pre-exposure prophylaxis (PrEP), retention in care in the United States remains suboptimal. The goal of this study was to explore factors that lead to suboptimal retention in PrEP care for men who have sex with men (MSM) in real-world clinical settings in the United States. Trained interviewers conducted semi-structured interviews with MSM (N = 49) from three clinics who had been engaged in PrEP care in the Midwest (n = 15), South (n = 15), and Northeast (n = 19) geographic regions and had experienced a lapse in PrEP use. Factors that emerged as related to suboptimal retention in PrEP care included structural factors such as transportation and out-of-pocket costs; social factors such as misinformation on media and in personal networks; clinical factors such as frequency and timing of appointments; and behavioral factors such as changes in sexual behavior and low perceived risk for HIV. Participants suggested reducing the out-of-pocket costs of medications and lab visits, having flexible appointment times, culturally responsive services, and comprehensive patient navigation to help retention in care. These findings leveraged real-world experiences and opinions of patients to inform gaps in current services and how to make changes to optimize PrEP care.


Subject(s)
Anti-HIV Agents , HIV Infections , Pre-Exposure Prophylaxis , Sexual and Gender Minorities , Male , Humans , United States , Homosexuality, Male , HIV Infections/prevention & control , HIV Infections/drug therapy , Sexual Behavior , Anti-HIV Agents/therapeutic use
16.
AIDS Behav ; 27(4): 1082-1090, 2023 Apr.
Article in English | MEDLINE | ID: mdl-36094635

ABSTRACT

Pre-exposure prophylaxis (PrEP) persistence is suboptimal in the United States. In the Deep South, a region with high rates of new HIV diagnosis, patterns of PrEP discontinuation remain unexplored. We evaluated data from a clinic-based PrEP program in Jackson, Mississippi and included patients initiating PrEP between August 2018 and April 2021. We considered patients to have a gap in PrEP coverage if they had at least 30 days without an active PrEP prescription; those who restarted PrEP after 30 days were classified as 'stopped and restarted' and those who never obtained a new PrEP prescription were classified as 'stopped and did not restart'. Patients without a gap in coverage were considered 'continuously on PrEP'. We estimated median time to first PrEP discontinuation and examined factors associated with time to first PrEP discontinuation. Of 171 patients who received an initial 90-day PrEP prescription; 75% were assigned male at birth and 74% identified as Black. The median time to first discontinuation was 90 days (95% CI 90-114). Twenty-two percent were continuously on PrEP, 28% stopped and restarted (median time off PrEP = 102 days), and 50% stopped and did not restart. Associations with early PrEP stoppage were notable for patients assigned sex female vs male (adjusted hazard ratio [aHR] = 1.6, 95% CI 1.0-2.5) and those living over 25 miles from clinic vs. 0-10 miles (aHR 1.89, 95% CI 1.2-3.0). Most patients never refilled an initial PrEP prescription though many patients re-started PrEP. Interventions to improve persistence and facilitate re-starts are needed.


Subject(s)
Anti-HIV Agents , HIV Infections , Pre-Exposure Prophylaxis , Infant, Newborn , Humans , Male , United States , Female , Mississippi/epidemiology , HIV Infections/epidemiology , HIV Infections/prevention & control , HIV Infections/drug therapy , Anti-HIV Agents/therapeutic use , Homosexuality, Male
17.
AIDS Behav ; 27(5): 1548-1563, 2023 May.
Article in English | MEDLINE | ID: mdl-36318432

ABSTRACT

Given their disproportionate HIV incidence, there is a critical need to identify factors related to HIV risk among Black young men who have sex with men (YMSM) in the southeastern United States. This study investigated the association of family factors and HIV-related outcomes among Black YMSM in Mississippi ages 14-20 (n = 72). Multivariable regression models evaluated associations of family factors and outcomes. Greater parent/child communication about sex was associated with fewer lifetime male sex partners and lower odds of lifetime anal sex. Greater parental monitoring was associated with greater likelihood of future condom use. Sexual orientation disclosure was associated with more lifetime male sex partners. Parental monitoring and parent/child communication about sex were protective, suggesting that family-based interventions are promising for HIV prevention among Black YMSM in Mississippi. Results also indicated that YMSM who are "out" to family are important to reach, and families could be useful in encouraging healthy behaviors.


Subject(s)
HIV Infections , Sexual and Gender Minorities , Child , Male , Humans , Female , Homosexuality, Male , HIV Infections/epidemiology , HIV Infections/prevention & control , Mississippi/epidemiology , Sexual Behavior , Risk-Taking
18.
Sex Transm Dis ; 49(11S Suppl 2): S36-S40, 2022 11 01.
Article in English | MEDLINE | ID: mdl-36219706

ABSTRACT

ABSTRACT: In the United States, sexually transmitted infections (STIs) are among the most persistent threats to health equity. Increasing access to STI prevention and control services through the provision of Remote Health and Telehealth can improve sexual health outcomes. Telehealth has been shown to increase access to care and even improve health outcomes. The increased flexibility offered by Telehealth services accommodates both patient and provider. Although both Telehealth and Remote Health strategies are important for STI prevention, share common attributes, and, in some circumstances, overlap, this article will focus more specifically on considerations for Telehealth and how it can contribute to increasing health equity by offering an important complement to and, in some cases, substitute for in-person STI services for some populations. Telehealth assists a variety of different populations, including those experiencing STI disparities; however, although the Internet offers a promising resource for many American households and increasing percentages of Americans are using its many resources, not all persons have equal access to the Internet. In addition to tailoring STI programs to accommodate unique patient populations, these programs will likely be faced with adapting services to fit reimbursement and licensing regulations.


Subject(s)
Sexually Transmitted Diseases , Telemedicine , Humans , Sexual Behavior , Sexually Transmitted Diseases/prevention & control
19.
J Int AIDS Soc ; 25(9): e26006, 2022 09.
Article in English | MEDLINE | ID: mdl-36097674

ABSTRACT

INTRODUCTION: The CUSTOMIZE hybrid III implementation-effectiveness study evaluated implementation of once-monthly long-acting (LA) cabotegravir + rilpivirine in diverse US healthcare settings. Here, we report patient participant perspectives after 12 months in CUSTOMIZE. METHODS: CUSTOMIZE was a phase IIIb, 12-month study conducted from July 2019 to October 2020 at eight diverse US HIV clinics that enrolled virologically suppressed people living with HIV-1 (PLHIV) on a stable oral regimen to receive monthly cabotegravir + rilpivirine LA injections after a 1-month oral lead-in. Participants were administered quantitative surveys before injections at months 1 (baseline), 4 and 12. A randomly selected subset of participants was interviewed at baseline and month 12. Data collection at month 12 was completed by October 2020 (during the COVID-19 pandemic). RESULTS: At baseline, 109 and 34 participants completed surveys and interviews, respectively; 87% were male; 35% were Black or African American. All participants who remained in the study at month 12 (n = 102) maintained HIV-1 RNA <50 copies/ml; two participants withdrew due to injection-related reasons. Mean total scores measuring acceptability and appropriateness of cabotegravir + rilpivirine LA were high at baseline (4.5-4.6 out of 5) and month 12 (4.7-4.9). At month 12, 74% of participants reported nothing interfered with receiving LA injections; injection pain or soreness was the most common concern (15%). Time spent in the clinic and coming to the clinic for monthly injections was very or extremely acceptable after 12 months for most participants (93% and 87%, respectively), with 64% reporting having spent ≤30 minutes in the clinic for injection visits. At month 12, 92% of participants preferred LA injections to daily oral tablets (3%); 97% plan to continue LA treatment going forward. In month 12 interviews, 24 (77%) of 31 participants reported the COVID-19 pandemic did not impact their ability to receive treatment. CONCLUSIONS: Once-monthly cabotegravir + rilpivirine LA was highly acceptable among PLHIV who were virologically suppressed on a stable antiretroviral regimen and interested in trying LA therapy, with few participants reporting challenges receiving LA injections. Implementation data from CUSTOMIZE suggest that monthly LA injections provide a convenient and appealing treatment option for PLHIV.


Subject(s)
Anti-HIV Agents , COVID-19 Drug Treatment , HIV Infections , HIV Seropositivity , HIV-1 , Anti-HIV Agents/therapeutic use , Anti-Retroviral Agents/therapeutic use , Delivery of Health Care , Diketopiperazines , Female , HIV Infections/drug therapy , HIV Seropositivity/drug therapy , Humans , Male , Pandemics , Pyridones , Rilpivirine/therapeutic use
20.
J Int AIDS Soc ; 25(9): e26003, 2022 09.
Article in English | MEDLINE | ID: mdl-36094142

ABSTRACT

INTRODUCTION: CUSTOMIZE evaluated the implementation of long-acting (LA) cabotegravir + rilpivirine, a novel healthcare provider-administered injectable antiretroviral therapy regimen, in diverse US healthcare settings. Findings from staff-study participants (SSPs) through 12 months of implementation are reported. METHODS: CUSTOMIZE was a phase IIIb, 12-month, single-arm, hybrid III implementation-effectiveness study conducted from July 2019 to October 2020 at eight US clinics of five clinic types: private practice (n = 2), federally qualified health centre (n = 2), university (n = 2), AIDS Healthcare Foundation (n = 2) and health maintenance organization (n = 1). Eligible patient participants received monthly cabotegravir + rilpivirine LA injections after a 1-month oral lead-in. At baseline, month 4 and month 12, SSPs (n = 3 each per clinic), including physicians, nurses or injectors, and administrators, completed quantitative surveys and semi-structured interviews to assess implementation outcomes (acceptability, appropriateness and feasibility of intervention measures), programme sustainability and SSP perceptions of, attitudes towards, and expectations for cabotegravir + rilpivirine LA. Month 12 data collection occurred during the COVID-19 pandemic. RESULTS: In surveys, SSPs reported high mean total scores for acceptability, appropriateness and feasibility of cabotegravir + rilpivirine LA implementation at baseline (4.43, 4.52 and 4.38 of 5, respectively) and month 12 (4.45, 4.61 and 4.46 of 5, respectively), regardless of clinic type. At month 12, SSPs were positive about the implementation sustainability (mean Program Sustainability Assessment Tool score, 5.83 out of 7). At baseline, SSPs' top concern was patients' ability to maintain monthly appointments (81%); at month 12, 39% had this concern. The proportion of SSPs reporting patient injection pain or soreness as a barrier was consistent at month 12 versus baseline (48% vs. 46%). Most (78%) SSPs reported optimal implementation of cabotegravir + rilpivirine LA in their clinics was achieved in 1-3 months. In interviews, SSP-reported strategies for successful implementation included teamwork, using a web-based treatment planner and having a designated person to track appointment scheduling. In month 12 interviews, SSP-reported structural changes needed for implementation included changing clinic hours and purchasing refrigerators. CONCLUSIONS: In CUSTOMIZE, cabotegravir + rilpivirine LA was successfully implemented across a range of US healthcare settings. Barriers were mitigated with minor process adjustments.


Subject(s)
Anti-HIV Agents , COVID-19 Drug Treatment , HIV Infections , Anti-HIV Agents/therapeutic use , Anti-Retroviral Agents/therapeutic use , Delivery of Health Care , Diketopiperazines , HIV Infections/drug therapy , Health Personnel , Humans , Pandemics , Pyridones , Rilpivirine/therapeutic use
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