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Preexposure Prophylaxis for HIV Infection Integrated With Municipal- and Community-Based Sexual Health Services.

ABSTRACT: Several randomized clinical trials have demonstrated the efficacy of preexposure prophylaxis (PrEP) in preventing human immunodeficiency virus (HIV) acquisition. Little is known about adherence to the regimen, sexual practices, and overall effectiveness when PrEP is implemented in clinics that treat sexually transmitted infections (STIs) and community-based clinics serving men who have sex with men (MSM).To assess PrEP adherence, sexual behaviors, and the incidence of STIs and HIV infection in a cohort of MSM and transgender women initiating PrEP in the United States.Demonstration project conducted from October 1, 2012, through February 10, 2015 (last date of follow-up), among 557 MSM and transgender women in 2 STI clinics in San Francisco, California, and Miami, Florida, and a community health center in Washington, DC. Data were analyzed from December 18, 2014, through August 8, 2015.A combination of daily, oral tenofovir disoproxil fumarate and emtricitabine was provided free of charge for 48 weeks. All participants received HIV testing, brief client-centered counseling, and clinical monitoring.Concentrations of tenofovir diphosphate in dried blood spot samples, self-reported numbers of anal sex partners and episodes of condomless receptive anal sex, and incidence of STI and HIV acquisition.Overall, 557 participants initiated PrEP, and 437 of these (78.5%) were retained through 48 weeks. Based on the findings from the 294 participants who underwent measurement of tenofovir diphosphate levels, 80.0% to 85.6% had protective levels (consistent with ?4 doses/wk) at follow-up visits. African American participants (56.8% of visits; P?=?.003) and those from the Miami site (65.1% of visits; P?

SUBMITTER: Liu AY

PROVIDER: S-EPMC5042323 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

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Preexposure Prophylaxis for HIV Infection Integrated With Municipal- and Community-Based Sexual Health Services.

Liu Albert Y AY Cohen Stephanie E SE Vittinghoff Eric E Anderson Peter L PL Doblecki-Lewis Susanne S Bacon Oliver O Chege Wairimu W Postle Brian S BS Matheson Tim T Amico K Rivet KR Liegler Teri T Rawlings M Keith MK Trainor Nikole N Blue Robert Wilder RW Estrada Yannine Y Coleman Megan E ME Cardenas Gabriel G Feaster Daniel J DJ Grant Robert R Philip Susan S SS Elion Richard R Buchbinder Susan S Kolber Michael A MA

JAMA internal medicine 20160101 1

<h4>Importance</h4>Several randomized clinical trials have demonstrated the efficacy of preexposure prophylaxis (PrEP) in preventing human immunodeficiency virus (HIV) acquisition. Little is known about adherence to the regimen, sexual practices, and overall effectiveness when PrEP is implemented in clinics that treat sexually transmitted infections (STIs) and community-based clinics serving men who have sex with men (MSM).<h4>Objective</h4>To assess PrEP adherence, sexual behaviors, and the inc ...[more]

PMID: 26571482

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Project description:ImportanceLong-term follow-up is needed to evaluate gaps in HIV preexposure prophylaxis (PrEP) care delivery and to identify individuals at risk for falling out of care.ObjectiveTo characterize the PrEP continuum of care, including prescription, initiation, discontinuation, and reinitiation, and evaluate incident HIV infections.Design, setting, and participantsThis retrospective cohort study used data from the electronic health records (EHR) at Kaiser Permanente Northern California to identify individuals aged 18 years and older who received PrEP care between July 2012 and March 2019. Individuals were followed up from date of linkage (defined as a PrEP referral or PrEP-coded encounter) until March 2019, HIV diagnosis, discontinuation of health plan membership, or death. Data were analyzed from December 2019 to January 2021.ExposuresSociodemographic factors included age, sex, race and ethnicity, and neighborhood deprivation index, and clinical characteristics were extracted from the EHR.Main outcomes and measuresThe primary outcomes were attrition at each step of the PrEP continuum of care and incident HIV infections.ResultsAmong 13 906 individuals linked to PrEP care, the median (interquartile range [IQR]) age was 33 (27-43) years, 6771 individuals (48.7%) were White, and 13 227 (95.1%) were men. Total follow-up was 26 210 person-years (median [IQR], 1.6 [0.7-2.8] years). Of individuals linked to PrEP care, 88.1% (95% CI, 86.1%-89.9%) were prescribed PrEP and of these, 98.2% (95% CI, 97.2%-98.8%) initiated PrEP. After PrEP initiation, 52.2% (95% CI, 48.9%-55.7%) discontinued PrEP at least once during the study period, and 60.2% (95% CI, 52.2%-68.3%) of these individuals subsequently reinitiated. Compared with individuals aged 18 to 25 years, older individuals were more likely to receive a PrEP prescription (eg, age >45 years: hazard ratio [HR], 1.21 [95% CI, 1.14-1.29]) and initiate PrEP (eg, age >45 years: HR, 1.09 [95% CI, 1.02-1.16]) and less likely to discontinue (eg, age >45 years: HR, 0.46 [95% CI, 0.42-0.52]). Compared with White patients, African American and Latinx individuals were less likely to receive a PrEP prescription (African American: HR, 0.74 [95% CI, 0.69-0.81]; Latinx: HR, 0.88 [95% CI, 0.84-0.93]) and initiate PrEP (African American: HR, 0.87 [95% CI, 0.80-0.95]; Latinx: HR, 0.90 [95% CI, 0.86-0.95]) and more likely to discontinue (African American: HR, 1.36 [95% CI, 1.17-1.57]; Latinx: 1.33 [95% CI, 1.22-1.46]). Similarly, women, individuals with lower neighborhood-level socioeconomic status (SES), and persons with a substance use disorder (SUD) were less likely to be prescribed (women: HR, 0.56 [95% CI, 0.50-0.62]; lowest SES: HR, 0.72 [95% CI, 0.68-0.76]; SUD: HR, 0.88 [95% CI, 0.82-0.94]) and initiate PrEP (women: HR, 0.71 [95% CI, 0.64-0.80]; lower SES: HR, 0.93 [95% CI, 0.87-.0.99]; SUD: HR, 0.88 [95% CI, 0.81-0.95]) and more likely to discontinue (women: HR, 1.99 [95% CI, 1.67-2.38]); lower SES: HR, 1.40 [95% CI, 1.26-1.57]; SUD: HR, 1.23 [95% CI, 1.09-1.39]). HIV incidence was highest among individuals who discontinued PrEP and did not reinitiate PrEP (1.28 [95% CI, 0.93-1.76] infections per 100 person-years).Conclusions and relevanceThese findings suggest that gaps in the PrEP care continuum were concentrated in populations disproportionately impacted by HIV, including African American individuals, Latinx individuals, young adults (aged 18-25 years), and individuals with SUD. Comprehensive strategies to improve PrEP continuum outcomes are needed to maximize PrEP impact and equity.

Project description:Reproductive-age women need effective interventions to prevent the acquisition of human immunodeficiency virus type 1 (HIV-1) infection.We conducted a randomized, placebo-controlled trial to assess daily treatment with oral tenofovir disoproxil fumarate (TDF), oral tenofovir-emtricitabine (TDF-FTC), or 1% tenofovir (TFV) vaginal gel as preexposure prophylaxis against HIV-1 infection in women in South Africa, Uganda, and Zimbabwe. HIV-1 testing was performed monthly, and plasma TFV levels were assessed quarterly.Of 12,320 women who were screened, 5029 were enrolled in the study. The rate of retention in the study was 91% during 5509 person-years of follow-up. A total of 312 HIV-1 infections occurred; the incidence of HIV-1 infection was 5.7 per 100 person-years. In the modified intention-to-treat analysis, the effectiveness was -49.0% with TDF (hazard ratio for infection, 1.49; 95% confidence interval [CI], 0.97 to 2.29), -4.4% with TDF-FTC (hazard ratio, 1.04; 95% CI, 0.73 to 1.49), and 14.5% with TFV gel (hazard ratio, 0.85; 95% CI, 0.61 to 1.21). In a random sample, TFV was detected in 30%, 29%, and 25% of available plasma samples from participants randomly assigned to receive TDF, TDF-FTC, and TFV gel, respectively. Independent predictors of TFV detection included being married, being older than 25 years of age, and being multiparous. Detection of TFV in plasma was negatively associated with characteristics predictive of HIV-1 acquisition. Elevations of serum creatinine levels were seen more frequently among participants randomly assigned to receive oral TDF-FTC than among those assigned to receive oral placebo (1.3% vs. 0.2%, P=0.004). We observed no significant differences in the frequencies of other adverse events.None of the drug regimens we evaluated reduced the rates of HIV-1 acquisition in an intention-to-treat analysis. Adherence to study drugs was low. (Funded by the National Institutes of Health; VOICE ClinicalTrials.gov number, NCT00705679.).

Project description:BACKGROUND:Despite being a priority population for HIV prevention and harm reduction programs, the sexual and reproductive health (SRH) needs of women who inject drugs are being overlooked. Furthermore, models for providing integrated SRH, HIV, and harm reduction services for women who inject drugs are rare. This article reports the development of community-based outreach services that integrated family planning and other SRH interventions with HIV and harm reduction services for this population in coastal Kenya. METHODS:Using mixed-methods implementation research, a qualitative baseline needs assessment was conducted with women who inject drugs and harm reduction stakeholders using a combination of in-depth interviews and focus group discussions. The qualitative data from participants was subjected to thematic analysis using Nvivo. Based on the baseline needs assessment, integration of SRH into existing HIV and harm reduction services was implemented. After two years of implementation, an evaluation of the program was conducted using a combination of qualitative interviews and review of quantitative service delivery records and other program documents. The process, impacts, and challenges of integrating SRH into a community-based HIV prevention and harm reduction program were identified. RESULTS:This article highlights: 1) low baseline utilization of family planning services among women who inject drugs, 2) improved utilization and high acceptability of outreach-based provision of SRH services including contraception among this population, 3) importance of training, capacity strengthening, technical support and financial resourcing of community-based organizations to integrate SRH into HIV prevention and harm reduction services, and 4) the value of beneficiary involvement, advocacy, and collaboration with other partners in the planning, designing and implementing of SRH interventions for women who inject drugs. CONCLUSIONS:Women who inject drugs in this study had low utilization of family planning and other SRH services, which can be improved through the integration of contraceptive and other SRH interventions into existing outreach-based HIV prevention and harm reduction programs. This integration is acceptable to women who inject drugs, and is programmatically feasible. For successful integration, a rights-based beneficiary involvement, coupled with sustainable technical and financial capacity strengthening at the community level is essential.

Dataset Information

Preexposure Prophylaxis for HIV Infection Integrated With Municipal- and Community-Based Sexual Health Services.

Publications

Preexposure Prophylaxis for HIV Infection Integrated With Municipal- and Community-Based Sexual Health Services.

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