Adherence to Daily Oral TDF/FTC for PrEP in Community Health Center Populations: The Sustainable Health Center Implementation PrEP Pilot (SHIPP) Study

Smith, Dawn K.; Rawlings, M. Keith; Glick, Nancy; Mena, Leandro; Coleman, Megan; Houlberg, Magda; McCallister, Scott; Wiener, Jeffrey

doi:10.1007/s10461-021-03388-5

Cited by 5 publications

(5 citation statements)

References 29 publications

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“…[4][5][6] Daily oral antiretroviral drugs are currently the main method for HIV-1 PrEP, but the effectiveness of PrEP can be variable given the challenges associated with maintaining strict adherence to a daily oral dosing schedule. [7][8][9][10] In people at high risk of HIV infection, PrEP delivered using a long-acting implant has been identified as a preferred potential method of treatment compared with daily oral PrEP, particularly if a long dosing interval for an implant can be achieved. [11][12][13] Therefore, novel PrEP strategies that use a subdermal implant may improve outcomes for people at risk of acquiring HIV.…”

Section: Introductionmentioning

confidence: 99%

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Trial of Radiopaque Islatravir-Eluting Subdermal Implants for Pre-exposure Prophylaxis Against HIV-1 Infection

Matthews

Zang

Barrett

et al. 2022

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Background: Islatravir (MK-8591) is a deoxyadenosine analog in development for the treatment and prevention of HIV-1 infection. An islatravir-eluting implant could provide an additional option for preexposure prophylaxis (PrEP).Setting: Previous data support a threshold islatravir triphosphate concentration for PrEP of 0.05 pmol/10 6 cells in peripheral blood mononuclear cells. Prototype islatravir-eluting implants were previously studied to establish general tolerability and pharmacokinetics (PKs) of islatravir relative to the threshold level. Methods:In this randomized, double-blind, placebo-controlled, phase 1 trial, a next-generation radiopaque islatravir-eluting implant (48 mg, 52 mg, or 56 mg) or placebo implant was placed for a duration of 12 weeks in participants at low risk of HIV infection. Safety and tolerability, as well as PK for islatravir parent and islatravir triphosphate from plasma and peripheral blood mononuclear cells, were assessed throughout placement and 8 weeks after removal. Results:In total, 36 participants (8 active and 4 placebo per dose arm) were enrolled and completed this study. Implants were generally well tolerated, with no discontinuations due to an adverse event, and no clear dose-dependence in implant-related adverse events. No clinically meaningful relationships were observed for changes in laboratory values, vital signs, or electrocardiogram assessments. Mean islatravir triphosphate levels at day 85 (0.101-0.561 pmol/10 6 cells) were above the PK threshold for all dose levels. Conclusion:Islatravir administered using a subdermal implant has the potential to be an effective and well-tolerated method for administering PrEP to individuals at risk of acquiring HIV-1.

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Section: Introductionmentioning

confidence: 99%

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Trial of Radiopaque Islatravir-Eluting Subdermal Implants for Pre-exposure Prophylaxis Against HIV-1 Infection

Matthews

Zang

Barrett

et al. 2022

JAIDS Journal of Acquired Immune Deficiency Syndromes

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“…Supporting this, previous evaluations of [CLINIC] data have found that people with a partner living with HIV have high persistence on PrEP at 12 months after initiation. 20 Notably, both person and encounter-based analyses found no significant difference in PrEP acceptance by race and age. This was reassuring, given that [CLINIC] made substantial efforts to promote PrEP acceptance among young, Black MSM in particular and specifically hired clinic staff that reflected the community they served.…”

Section: Discussionmentioning

confidence: 93%

“…Indeed, a number of clinic-based PrEP programs in the US including in Mississippi have observed low persistence on PrEP, noting that 30-50% of individuals discontinue PrEP within the first 12 months of initiation. 20,25,[29][30][31][32][33][34] Additionally, it is important to recognize that over 50% of individuals newly diagnosed with HIV in Mississippi reside in rural communities, 35 and [CLINIC] is just one provider that is located in an urban area. Thus, continued efforts to increase PrEP awareness and education alongside interventions to improve PrEP persistence and implement same-day PrEP in settings outside large urban areas are needed to increase more widespread PrEP use Mississippi and elsewhere in the US.…”

Section: Discussionmentioning

confidence: 99%

“…Details on the clinic's PrEP program have been previously described. 20 , 21 Per routine clinical protocol, all patients—including those who preset to the clinic for reasons other than sexual healthcare—complete a health assessment that includes information on sexual behavior and sexual partners. The information is reviewed by clinic staff performing the patient's HIV test to determine whether or not the patient is eligible for PrEP.…”

Section: Methodsmentioning

confidence: 99%

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PrEP Acceptance among Eligible Patients Attending the Largest PrEP Clinic in Jackson, Mississippi

Hollcroft

Gipson²,

Barnes³

et al. 2023

J Int Assoc Provid AIDS Care

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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.

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“…16 Although a wide range of health care providers and clinics could provide PrEP, the delivery, laboratory testing, adherence support, and concerns about anticipated cost to programs and out-of-pocket costs to patients are major barriers that potentially limit wider coverage of PrEP nationwide. 16,17 In 2014, the Centers for Disease Control and Prevention (CDC) launched the Sustainable Health Center Implementation PrEP Pilot (SHIPP) study 18 to evaluate health service implementation challenges, including delivery, health outcomes, and sustainability of PrEP provision in community health centers. We assessed health care utilization and billable costs of PrEP use at 2 FQHCs that provide sexual health and primary care services in communities with high HIV incidence and prevalence.…”

mentioning

confidence: 99%

Costs of Providing Preexposure Prophylaxis for HIV Prevention at Community Health Centers in the United States

et al. 2022

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Objective: Preexposure prophylaxis (PrEP) is recommended for people at risk of acquiring HIV. We assessed billable costs associated with PrEP delivery at community health centers. Methods: The Sustainable Health Center Implementation PrEP Pilot (SHIPP) study is an observational cohort of people receiving daily oral PrEP at participating federally qualified health centers and other community health centers. We assessed health care utilization and billable costs of providing PrEP at 2 health centers, 1 in Chicago, Illinois, and 1 in Washington, DC, from 2014 to 2018. The health centers followed the clinical practice guidelines for PrEP provision, including regular visits with health care providers and ongoing laboratory monitoring. Using clinic billing records and Current Procedural Terminology (CPT) coding, we retrospectively extracted data on the frequency and costs (in 2017 US dollars) of PrEP clinic visits and laboratory screening, for each patient, for 12 months since first PrEP prescription. Results: The average annual number of PrEP clinic visits and associated laboratory screens per patient was 5.1 visits and 25.2 screens in Chicago (n = 482 patients) and 5.4 visits and 24.8 screens in Washington, DC (n = 56 patients). The average annual PrEP billable cost per patient was $583 for clinic visits and $1070 for laboratory screens in Chicago and $923 for clinic visits and $1018 for laboratory screens in Washington, DC. The average annual total cost per patient was $1653 (95% CI, $1639-$1668) in Chicago and $1941 (95% CI, $1811-$2071) in Washington, DC. Conclusions: Our analysis, which provides PrEP billable cost estimates based on empirical data, may help inform health care providers who are considering implementing this HIV prevention strategy.

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Adherence to Daily Oral TDF/FTC for PrEP in Community Health Center Populations: The Sustainable Health Center Implementation PrEP Pilot (SHIPP) Study

Cited by 5 publications

References 29 publications

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Trial of Radiopaque Islatravir-Eluting Subdermal Implants for Pre-exposure Prophylaxis Against HIV-1 Infection

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Trial of Radiopaque Islatravir-Eluting Subdermal Implants for Pre-exposure Prophylaxis Against HIV-1 Infection

PrEP Acceptance among Eligible Patients Attending the Largest PrEP Clinic in Jackson, Mississippi

Costs of Providing Preexposure Prophylaxis for HIV Prevention at Community Health Centers in the United States

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