Dataset Information

Increased risk of genital ulcer disease in women during the first month after initiating antiretroviral therapy.

ABSTRACT: INTRODUCTION:Genital ulcer disease (GUD) is common in HIV-1-infected women, and a small number of studies have suggested increased GUD risk after antiretroviral therapy (ART) initiation. To better define this risk, we monitored 134 women at ART initiation and monthly thereafter. METHODS:Women were evaluated monthly for genital ulcers. Syphilis serology was tested quarterly, and chancroid culture was performed on ulcers that were felt to be clinically consistent with a diagnosis of chancroid. A logistic model with generalized estimating equations was used to analyze predictors of GUD from baseline until 6 months after ART initiation. RESULTS:During the study period, GUD occurred in 54 women (40.3%) at 85 visits (10.0%). GUD prevalence was 9.7% at baseline, increased to 16.7% at month 1 [adjusted odds ratio (aOR) 1.9 (1.0-3.6), P = 0.04], then decreased to 6.4% by month 6. History of GUD [aOR 3.8 (1.9-7.7), P < 0.001) and CD4 count <100 [aOR 1.8 (1.0-3.4), P = 0.06] were associated with increased risk of GUD after ART initiation. DISCUSSION:Women experience increased risk of GUD in the first month after ART initiation, particularly if they have low CD4 counts or a history of GUD.

SUBMITTER: Graham SM

PROVIDER: S-EPMC2787852 | biostudies-literature | 2009 Dec

REPOSITORIES: biostudies-literature

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Increased risk of genital ulcer disease in women during the first month after initiating antiretroviral therapy.

Graham Susan M SM Masese Linnet L Gitau Ruth R Mwakangalu Dickson D Jaoko Walter W Ndinya-Achola Jeckoniah J Mandaliya Kishor K Peshu Norbert N Baeten Jared M JM McClelland R Scott RS

Journal of acquired immune deficiency syndromes (1999) 20091201 5

<h4>Introduction</h4>Genital ulcer disease (GUD) is common in HIV-1-infected women, and a small number of studies have suggested increased GUD risk after antiretroviral therapy (ART) initiation. To better define this risk, we monitored 134 women at ART initiation and monthly thereafter.<h4>Methods</h4>Women were evaluated monthly for genital ulcers. Syphilis serology was tested quarterly, and chancroid culture was performed on ulcers that were felt to be clinically consistent with a diagnosis of ...[more]

PMID: 19648822

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Project description:BACKGROUND:Inflammation and hemostasis perturbation may be involved in vascular complications of HIV infection. We examined atherogenic biomarkers and subclinical atherosclerosis in HIV-infected adults before and after beginning highly active antiretroviral therapy (HAART). METHODS:In the Women's Interagency HIV Study, 127 HIV-infected women studied pre and post HAART were matched to HIV-uninfected controls. Six semiannual measurements of soluble CD14, tumor necrosis factor (TNF) alfa, soluble interleukin (IL) 2 receptor, IL-6, IL-10, monocyte chemoattractant protein 1, D-dimer, and fibrinogen were obtained. Carotid artery intima-media thickness was measured by B-mode ultrasound. RESULTS:Relative to HIV-uninfected controls, HAART-naive HIV-infected women had elevated levels of soluble CD14 (1945 vs 1662 ng/mL, Wilcoxon signed rank P < 0.0001), TNF-? (6.3 vs 3.4 pg/mL, P < 0.0001), soluble IL-2 receptor (1587 vs 949 pg/mL, P < 0.0001), IL-10 (3.3 vs 1.9 pg/mL, P < 0.0001), monocyte chemoattractant protein 1 (190 vs 163 pg/mL, P < 0.0001), and D-dimer (0.43 vs 0.31 ?g/mL, P < 0.01). Elevated biomarker levels declined after HAART. Although most biomarkers normalized to HIV-uninfected levels, in women on effective HAART, TNF-? levels remained elevated compared with HIV-uninfected women (+0.8 pg/mL, P = 0.0002). Higher post-HAART levels of soluble IL-2 receptor (P = 0.02), IL-6 (P = 0.05), and D-dimer (P = 0.03) were associated with increased carotid artery intima-media thickness. CONCLUSIONS:Untreated HIV infection is associated with abnormal hemostasis (eg, D-dimer), proatherogenic (eg, TNF-?), and antiatherogenic (eg, IL-10) inflammatory markers. HAART reduces most inflammatory mediators to HIV-uninfected levels. Increased inflammation and hemostasis are associated with subclinical atherosclerosis in recently treated women. These findings have potential implications for long-term risk of cardiovascular disease in HIV-infected patients, even with effective therapy.

Project description:BACKGROUND: Guidelines for initiating ART recommend pregnancy testing, typically a urine test, as part of the basic laboratory package. The principal reason for this recommendation is that Efavirenz, a first-line antiretroviral medication, has the potential of causing birth defects when used in the first trimester of pregnancy and is therefore contraindicated for use by pregnant women. Unfortunately, in many African countries pregnancy tests are not routinely provided or available in ART clinics, and, when available outside clinics, are often not affordable for clients.Recently, the World Health Organization added a family planning job aid called the 'pregnancy checklist,' developed by researchers at Family Health International, as a recommended tool for screening new ART clients to exclude pregnancy. Although the checklist has been validated for excluding pregnancy among family planning clients, there are no data on its efficacy among ART clients.This study was conducted to assess the clinical performance of a job aid to exclude pregnancy among HIV positive women initiating ART. METHODS: Non-menstruating women eligible for ART were enrolled from 20 sites in four provinces in Zambia. The pregnancy checklist was administered followed by a urine pregnancy test as a reference standard. Sensitivity, specificity, and positive and negative predictive values were estimated. RESULTS: Of the 200 women for whom the checklist ruled out pregnancy, 198 were not pregnant, for an estimated negative predictive value of 99%. The sensitivity of the checklist was 90.0%, and specificity was 38.7%. Among the women, 416 out of 534 (77.9%) did not abstain from sex since their last menses. Only 72 out of the 534 women (13.4%) reported using reliable contraception. Among the 416 women who did not abstain, 376 (90.4%) did not use reliable contraception. CONCLUSION: The pregnancy checklist is effective for excluding pregnancy in many women initiating ART, but its moderate sensitivity and specificity precludes its use to completely replace pregnancy testing. Its use should be encouraged in low resource settings where pregnancy tests are unavailable or must be rationed. Family planning methods should be available and integrated into ART clinics.

Project description:High rates of patient attrition from care between HIV testing and antiretroviral therapy (ART) initiation have been documented in sub-Saharan Africa, contributing to persistently low CD4 cell counts at treatment initiation. One reason for this is that starting ART in many countries is a lengthy and burdensome process, imposing long waits and multiple clinic visits on patients. We estimated the effect on uptake of ART and viral suppression of an accelerated initiation algorithm that allowed treatment-eligible patients to be dispensed their first supply of antiretroviral medications on the day of their first HIV-related clinic visit.RapIT (Rapid Initiation of Treatment) was an unblinded randomized controlled trial of single-visit ART initiation in two public sector clinics in South Africa, a primary health clinic (PHC) and a hospital-based HIV clinic. Adult (?18 y old), non-pregnant patients receiving a positive HIV test or first treatment-eligible CD4 count were randomized to standard or rapid initiation. Patients in the rapid-initiation arm of the study ("rapid arm") received a point-of-care (POC) CD4 count if needed; those who were ART-eligible received a POC tuberculosis (TB) test if symptomatic, POC blood tests, physical exam, education, counseling, and antiretroviral (ARV) dispensing. Patients in the standard-initiation arm of the study ("standard arm") followed standard clinic procedures (three to five additional clinic visits over 2-4 wk prior to ARV dispensing). Follow up was by record review only. The primary outcome was viral suppression, defined as initiated, retained in care, and suppressed (?400 copies/ml) within 10 mo of study enrollment. Secondary outcomes included initiation of ART ?90 d of study enrollment, retention in care, time to ART initiation, patient-level predictors of primary outcomes, prevalence of TB symptoms, and the feasibility and acceptability of the intervention. A survival analysis was conducted comparing attrition from care after ART initiation between the groups among those who initiated within 90 d. Three hundred and seventy-seven patients were enrolled in the study between May 8, 2013 and August 29, 2014 (median CD4 count 210 cells/mm3). In the rapid arm, 119/187 patients (64%) initiated treatment and were virally suppressed at 10 mo, compared to 96/190 (51%) in the standard arm (relative risk [RR] 1.26 [1.05-1.50]). In the rapid arm 182/187 (97%) initiated ART ?90 d, compared to 136/190 (72%) in the standard arm (RR 1.36, 95% confidence interval [CI], 1.24-1.49). Among 318 patients who did initiate ART within 90 d, the hazard of attrition within the first 10 mo did not differ between the treatment arms (hazard ratio [HR] 1.06; 95% CI 0.61-1.84). The study was limited by the small number of sites and small sample size, and the generalizability of the results to other settings and to non-research conditions is uncertain.Offering single-visit ART initiation to adult patients in South Africa increased uptake of ART by 36% and viral suppression by 26%. This intervention should be considered for adoption in the public sector in Africa.ClinicalTrials.gov NCT01710397, and South African National Clinical Trials Register DOH-27-0213-4177.

Dataset Information

Increased risk of genital ulcer disease in women during the first month after initiating antiretroviral therapy.

Publications

Increased risk of genital ulcer disease in women during the first month after initiating antiretroviral therapy.

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