Dataset Information

Evaluation of Preexposure (PrEP) Eligibility Criteria, Using Sexually Transmissible Infections as Markers of Human Immunodeficiency Virus (HIV) Risk at Enrollment in PrEPX, a Large Australian HIV PrEP Trial.

ABSTRACT: Background:To determine participants' human immunodeficiency virus (HIV) risk, the Australian preexposure prophylaxis (PreEPX) trial used 6 eligibility criteria derived from the US Centers for Disease Control and Prevention PrEP guidelines. Participants who fulfilled no eligibility criteria could be enrolled if clinically assessed to need PrEP. This study evaluated whether PREPX eligibility criteria correlated with biological HIV risk markers-namely, syphilis, anorectal chlamydia, or anorectal gonorrhea (sexually transmitted infections [STIs]). Methods:We calculated adjusted odds ratios (aORs) to assess whether eligibility criteria predicted STI diagnoses at enrollment. Results:We included 1774 participants, of whom 10.2% tested positive for STIs. Eligibility criteria predicted STI diagnoses as follows: (1) aOR 2.5 (95% confidence interval [CI], 1.4-4.4) for condomless anal intercourse (CLAI) with an HIV-positive regular sexual partner (RSP) with detectable viral load; (2) aOR 1.8 (95% CI, 1.3-2.5) for receptive CLAI with casual sexual partners; (3) aOR 1.8 (95% CI, 1.3-2.5) for previous STIs; (4) aOR 2.1 (95% CI, 1.4-3.0) for methamphetamine use; (5) aOR 0.8 (95% CI, .6-1.1) for unsuccessful condom use; and (6) aOR 1.0 (95% CI, .7-1.4) for insertive CLAI when uncircumcised. Of participants enrolled outside eligibility criteria, 7.1% had STIs. Conclusions:Eligibility criteria 1-4 predicted diagnoses of STIs, but eligibility criteria 5 and 6 did not. Our findings support the use of PrEP eligibility criteria recommended in current guidelines. Participants enrolled outside the eligibility criteria had substantial prevalence of STIs, suggesting that people who request PrEP but do not fulfill eligibility criteria may nonetheless need PrEP.

SUBMITTER: Cornelisse VJ

PROVIDER: S-EPMC6260154 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Evaluation of Preexposure (PrEP) Eligibility Criteria, Using Sexually Transmissible Infections as Markers of Human Immunodeficiency Virus (HIV) Risk at Enrollment in PrEPX, a Large Australian HIV PrEP Trial.

Cornelisse Vincent J VJ Fairley Christopher K CK Stoove Mark M Asselin Jason J Chow Eric P F EPF Price Brian B Roth Norman J NJ Willcox Jeff J Tee B K BK Penn Matthew M Chang Christina C CC Armishaw Judith J Forgan-Smith George G Wright Edwina J EJ

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20181101 12

<h4>Background</h4>To determine participants' human immunodeficiency virus (HIV) risk, the Australian preexposure prophylaxis (PreEPX) trial used 6 eligibility criteria derived from the US Centers for Disease Control and Prevention PrEP guidelines. Participants who fulfilled no eligibility criteria could be enrolled if clinically assessed to need PrEP. This study evaluated whether PREPX eligibility criteria correlated with biological HIV risk markers-namely, syphilis, anorectal chlamydia, or ano ...[more]

PMID: 29741665

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Project description:ImportanceEmerging evidence suggests that risk of bacterial sexually transmitted infections (STIs) increases among gay and bisexual men following initiation of HIV preexposure prophylaxis (PrEP).ObjectiveTo describe STI incidence and behavioral risk factors among a cohort of predominantly gay and bisexual men who use PrEP, and to explore changes in STI incidence following PrEP commencement.Design, setting, and participantsThe Pre-exposure Prophylaxis Expanded (PrEPX) Study, a multisite, open-label intervention study, was nested within the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS) clinic network. A total of 4275 participants were enrolled (July 26, 2016-April 1, 2018) in Victoria, Australia. Of these, 2981 enrolled at 5 ACCESS clinics (3 primary care, 1 sexual health, and 1 community-based HIV rapid testing service), had at least 1 follow-up visit, and were monitored until April 30, 2018.ExposuresUpon enrollment, participants received daily oral tenofovir disoproxil fumurate and emtricitabine for HIV PrEP, quarterly HIV and STI testing, and clinical monitoring.Main outcomes and measuresThe primary outcome was incidence of chlamydia, gonorrhea, or syphilis. Incidence rates and hazard ratios describing behavioral risk factors of STI diagnosis were calculated. Incidence rate ratios (IRRs), adjusted for change in testing frequency, described changes in STI incidence from 1-year preenrollment to study follow-up among participants with preenrollment testing data (n = 1378).ResultsAmong the 2981 individuals (median age, 34 years [interquartile range, 28-42]), 98.5% identified as gay or bisexual males, 29% used PrEP prior to enrollment, 89 (3%) withdrew and were censored at date of withdrawal, leaving 2892 (97.0%) enrolled at final follow-up. During a mean follow-up of 1.1 years (3185.0 person-years), 2928 STIs were diagnosed among 1427 (48%) participants (1434 chlamydia, 1242 gonorrhea, 252 syphilis). STI incidence was 91.9 per 100 person-years, with 736 participants (25%) accounting for 2237 (76%) of all STIs. Among 2058 participants with complete data for multivariable analysis, younger age, greater partner number, and group sex were associated with greater STI risk, but condom use was not. Among 1378 participants with preenrollment testing data, STI incidence increased from 69.5 per 100 person-years prior to enrollment to 98.4 per 100 person-years during follow-up (IRR, 1.41 [95% CI, 1.29-1.56]). After adjusting for testing frequency, the increase in incidence from 1 year preenrollment to follow-up was significant for any STI (adjusted IRR, 1.12 [95% CI, 1.02-1.23]) and for chlamydia (adjusted IRR, 1.17 [95% CI, 1.04-1.33]).Conclusions and relevanceAmong gay and bisexual men using PrEP, STIs were highly concentrated among a subset, and receipt of PrEP after study enrollment was associated with an increased incidence of STIs compared with preenrollment. These findings highlight the importance of frequent STI testing among gay and bisexual men using PrEP.

Project description:Background: The effect of antiretroviral treatment (ART) eligibility expansions on patient outcomes, including rates of timely ART initiation among those enrolling in care, has not been assessed on a large scale. In addition, it is not known whether ART eligibility expansions may lead to "crowding out" of sicker patients.Methods and findings: We examined changes in timely ART initiation (within 6 months) at the original site of HIV care enrollment after ART eligibility expansions among 284,740 adult ART-naïve patients at 171 International Epidemiology Databases to Evaluate AIDS (IeDEA) network sites in 22 countries where national policies expanding ART eligibility were introduced between 2007 and 2015. Half of the sites included in this analysis were from Southern Africa, one-third were from East Africa, and the remainder were from the Asia-Pacific, Central Africa, North America, and South and Central America regions. The median age of patients enrolling in care at contributing sites was 33.5 years, and the median percentage of female patients at these clinics was 62.5%. We assessed the 6-month cumulative incidence of timely ART initiation (CI-ART) before and after major expansions of ART eligibility (i.e., expansion to treat persons with CD4 ? 350 cells/?L [145 sites in 22 countries] and CD4 ? 500 cells/?L [152 sites in 15 countries]). Random effects metaregression models were used to estimate absolute changes in CI-ART at each site before and after guideline expansion. The crude pooled estimate of change in CI-ART was 4.3 percentage points (95% confidence interval [CI] 2.6 to 6.1) after ART eligibility expansion to CD4 ? 350, from a baseline median CI-ART of 53%; and 15.9 percentage points (pp) (95% CI 14.3 to 17.4) after ART eligibility expansion to CD4 ? 500, from a baseline median CI-ART of 57%. The largest increases in CI-ART were observed among those newly eligible for treatment (18.2 pp after expansion to CD4 ? 350 and 47.4 pp after expansion to CD4 ? 500), with no change or small increases among those eligible under prior guidelines (CD4 ? 350: -0.6 pp, 95% CI -2.0 to 0.7 pp; CD4 ? 500: 4.9 pp, 95% CI 3.3 to 6.5 pp). For ART eligibility expansion to CD4 ? 500, changes in CI-ART were largest among younger patients (16-24 years: 21.5 pp, 95% CI 18.9 to 24.2 pp). Key limitations include the lack of a counterfactual and difficulty accounting for secular outcome trends, due to universal exposure to guideline changes in each country.Conclusions: These findings underscore the potential of ART eligibility expansion to improve the timeliness of ART initiation globally, particularly for young adults.

Dataset Information

Evaluation of Preexposure (PrEP) Eligibility Criteria, Using Sexually Transmissible Infections as Markers of Human Immunodeficiency Virus (HIV) Risk at Enrollment in PrEPX, a Large Australian HIV PrEP Trial.

Publications

Evaluation of Preexposure (PrEP) Eligibility Criteria, Using Sexually Transmissible Infections as Markers of Human Immunodeficiency Virus (HIV) Risk at Enrollment in PrEPX, a Large Australian HIV PrEP Trial.

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