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1.  Single Dose Pharmacokinetics of Oral Tenofovir in Plasma, Peripheral Blood Mononuclear Cells, Colonic Tissue, and Vaginal Tissue 
AIDS Research and Human Retroviruses  2013;29(11):1443-1450.
HIV seroconversion outcomes in preexposure prophylaxis (PrEP) trials of oral tenofovir (TFV)-containing regimens are highly sensitive to drug concentration, yet less-than-daily dosing regimens are under study. Description of TFV and its active moiety, TFV diphosphate (TFV-DP), in blood, vaginal tissue, and colon tissue may guide the design and interpretation of PrEP clinical trials. Six healthy women were administered a single oral dose of 300 mg tenofovir disoproxil fumarate (TDF) and 4.3 mg (12.31 MBq, 333 μCi) 14C-TDF slurry. Blood was collected every 4 h for the first 24 h, then at 4, 8, 11, and 15 days postdosing. Colonic and vaginal samples (tissue, total and CD4+ cells, luminal fluid and cells) were collected 1, 8 and 15 days postdose. Samples were analyzed for TFV and TFV-DP. Plasma TFV demonstrated triphasic decay with terminal elimination half-life median [interquartile range (IQR)] 69 h (58–77). Peripheral blood mononuclear cell (PBMC) TFV-DP demonstrated biphasic peaks (median 12 h and 96 h) followed by a terminal 48 h (38–76) half-life; Cmax was 20 fmol/million cells (2–63). One day postdose, the TFV-DP paired colon:vaginal tissue concentration ratio was 1 or greater in all subjects' tissue homogenates, median 124 (range 1–281), but was not sustained. The ratio was lower and more variable in cells extracted from tissue. Among all sample types, TFV and TFV-DP half-life ranged from 23 to 139 h. PBMC TFV-DP rose slowly in the hours after dosing indicating that success with exposure-driven dosing regimens may be sensitive to timing of the dose prior to exposure. Colonic tissue homogenate TFV-DP concentrations were greater than in vaginal homogenate at 24 h, but not in cells extracted from tissue. These and the other pharmacokinetic findings will guide the interpretation and design of future PrEP trials.
PMCID: PMC3809387  PMID: 23600365
2.  Clinical and mental health correlates and risk factors for intimate partner violence among HIV-positive women in an inner city HIV clinic 
Intimate partner violence (IPV) is a serious health concern for women in the U.S, and HIV-positive women experience more frequent and severe abuse compared to HIV-negative women. The goals of this study were to determine the prevalence of IPV among HIV-infected women receiving care in an urban clinic and to determine the HIV clinical and mental health correlates of IPV among HIV-positive women.
We conducted a cross-sectional survey among 196 women visiting an inner city HIV clinic. Women were eligible if they were 18 years of age or older, English speaking and received both HIV primary and gynecological care at the clinic. The survey queried demographics, drug and alcohol history, depressive symptoms, and IPV, using the Partner Violence Scale (PVS). Antiretroviral therapy (ART), CD4 cell count, HIV-1 RNA level, and appointment adherence were abstracted from clinical records.
Overall, 26.5% of women reported experiencing IPV in the past year. There were no significant differences in sociodemographics, substance use, ART prescription, CD4 count or HIV-1 RNA level between women who experienced IPV and those who had not. Women with mild and severe depressive symptoms were significantly more likely to report IPV compared to those without, with adjusted odds ratios of 3.4 and 5.5, respectively. Women who missed gynecological appointments were 1.9 times more likely to report experiencing IPV.
IPV is prevalent among women presenting for HIV care, and depressive symptoms or missed gynecological appointments should prompt further screening for IPV.
PMCID: PMC3489982  PMID: 22939089
HIV/AIDS; intimate partner violence; appointment adherence; depressive symptoms
4.  Preconception and Contraceptive Care for Women Living with HIV 
Women living with HIV have fertility desires and intentions that are similar to those of uninfected women, and with advances in treatment most women can realistically plan to have and raise children to adulthood. Although HIV may have adverse effects on fertility, recent studies suggest that antiretroviral therapy may increase or restore fertility. Data indicate the increasing numbers of women living with HIV who are becoming pregnant, and that many pregnancies are unintended and contraception is underutilized, reflecting an unmet need for preconception care (PCC). In addition to the PCC appropriate for all women of reproductive age, women living with HIV require comprehensive, specialized care that addresses their unique needs. The goals of PCC for women living with HIV are to prevent unintended pregnancy, optimize maternal health prior to pregnancy, improve maternal and fetal outcomes in pregnancy, prevent perinatal HIV transmission, and prevent HIV transmission to an HIV-uninfected sexual partner when trying to conceive. This paper discusses the rationale for preconception counseling and care in the setting of HIV and reviews current literature relevant to the content and considerations in providing PCC for women living with HIV, with a primary focus on well-resourced settings.
PMCID: PMC3477542  PMID: 23097595
5.  Barriers to Recommended Gynecologic Care in an Urban United States HIV Clinic 
Journal of Women's Health  2010;19(8):1511-1518.
Despite an increased risk for cervical cytologic abnormalities, HIV-infected women frequently miss their gynecology appointments. We examined barriers to adherence with gynecologic care in an urban HIV clinic.
We conducted a cross-sectional survey of 200 women receiving gynecologic services in an urban HIV clinic, followed by focus groups. Primary outcomes included (1) missed gynecology appointments and (2) receipt of a Pap smear in the previous year. Independent variables included sociodemographic characteristics, child care responsibilities, substance use, depressive symptoms, social support, interpersonal violence, CD4 count, and HIV-1 RNA. We conducted multivariable logistic regression to examine associations between independent variables and outcomes. We then held two focus groups designed to gather opinions on and increase our understanding of the key findings from the survey.
Of 200 women, 69% missed at least one gynecology appointment, and 22% had no Pap smear in the past year. In logistic regression, moderate (odds ratio [OR] 3.1, 95% confidence interval [CI] 1.4-6.7) and severe (OR 3.1, 95% CI 1.3-7.5) depressive symptoms and past-month substance use (OR 2.3, 95% CI 1.0-5.3) were associated with missing an appointment in the prior year. An education level of less than high school (OR 0.3, 95% CI 0.1-0.6) compared with high school diploma or greater was associated with not having a Pap smear in the previous year. When analyses were limited to women with a cervix (n = 166), moderate (OR 2.5, 95% CI 1.1-5.7) and severe (OR 2.5, 95% CI 1.0-6.3) depressive systems remained significantly associated with missing a gynecology appointment in the previous year and age >50 (OR 0.3, 95% CI 0.1-0.9), an HIV-1 RNA > 50 (OR 0.4, 95% CI 0.2-0.9), and education level less than high school (OR 0.2, 95% CI 0.1-0.5) were associated with not having a Pap smear in the past 12 months. Qualitative analysis of the focus group data suggested that fear, inclement weather, and forgetting appointments may contribute to missed gynecology appointments.
Gynecologic healthcare is underused among HIV-infected women. We found that depressive symptoms, substance use, fear of the gynecologic examination, and simply forgetting about the appointment may be barriers to gynecologic care. Interventions targeting these barriers may improve use of gynecologic care among this population.
PMCID: PMC2924785  PMID: 20629573
6.  Do HIV-Infected Women Want to Discuss Reproductive Plans with Providers, and Are Those Conversations Occurring? 
AIDS Patient Care and STDs  2010;24(5):317-323.
The purpose of the study is to assess frequency and determinants of discussions between HIV-infected women and their HIV providers about childbearing plans, and to identify unmet need for reproductive counseling. We conducted a cross-sectional, audio computer-assisted self-interview (ACASI) among 181 predominately African American HIV-infected women of reproductive age receiving HIV clinical care in two urban health clinics. We used descriptive statistics to identify unmet need for reproductive counseling by determining the proportion of women who want to, but have not, discussed future reproductive plans with their primary HIV care provider. Multivariate analysis determined which factors were associated with general and personalized discussions about pregnancy. Of the 181 women interviewed, 67% reported a general discussion about pregnancy and HIV while 31% reported a personalized discussion about future childbearing plans with their provider. Of the personalized discussions, 64% were patient initiated. Unmet reproductive counseling needs were higher for personalized discussions about future pregnancies (56%) than general discussions about HIV and pregnancy (23%). Younger age was the most powerful determinant of provider communication about pregnancy. A significant proportion of HIV-infected women want to talk about reproductive plans with their HIV provider; however, many have not. HIV care providers and gynecologists can address this unmet communication need by discussing reproductive plans with all women of childbearing age so that preconception counseling can be provided when appropriate. Providers will miss opportunities to help women safely plan pregnancy if they only discuss reproductive plans with younger patients.
PMCID: PMC3120085  PMID: 20482467
7.  HIV Women's Health: A Study of Gynecological Healthcare Service Utilization in a U.S. Urban Clinic Population 
Journal of Women's Health  2008;17(10):1609-1614.
Women infected with HIV have a high rate of many gynecological problems. Adherence to recommended gynecological care among women enrolled in our urban HIV clinics was hypothesized to be low.
We conducted an analysis of data from the Johns Hopkins HIV Clinical Cohort Database examining demographic and clinical predictors of clinic visit adherence by women in the HIV primary care and HIV gynecological clinics.
Between January 2002 and April 2006, 1,086 women had 26,401 scheduled appointments to the two clinics, of which 21,959 were to HIV primary care and 4,442 were to HIV gynecological care. There were 12,097 (55%) completed primary care visits and 1,609 (36.2%) completed HIV gynecological visits (p < 0.001, accounting for clustering). By multivariate analysis, age <40 years (OR 0.81, 95% CI 0.70-0.94) and substance abuse (OR 0.67, 95% CI 0.61-0.73) were associated with a decreased likelihood of attending an HIV primary care appointment. African American race (OR 0.63, 95% CI 0.45-0.90), CD4 count <200 cells/mm3 (OR 0.73, 95% CI 0.56-0.95), and substance abuse (OR 0.57, 95% CI 0.45-0.71) were associated with a decreased likelihood of attending an HIV gynecological appointment.
This analysis determined that the rate of clinic visit adherence is significantly lower for HIV gynecological care than for HIV primary care in the same population of women. Factors associated with HIV gynecological clinic visit noncompliance included African American race/ethnicity, substance use, and more advanced immunosuppression. We have planned additional quantitative and qualitative studies to examine the associations with and barriers to HIV gynecological care, with the goal of creating appropriate interventions toward improving gynecological healthcare utilization among women enrolled in urban HIV clinics.
PMCID: PMC2716001  PMID: 19049355
8.  Tracking working status of HIV/AIDS-trained service providers by means of a training information monitoring system in Ethiopia 
The Federal Ministry of Health of Ethiopia is implementing an ambitious and rapid scale-up of health care services for the prevention, care and treatment of HIV/AIDS in public facilities. With support from the United States President's Emergency Plan for AIDS Relief, 38 830 service providers were trained, from early 2005 until December 2007, in HIV-related topics. Anecdotal evidence suggested high attrition rates of providers, but reliable quantitative data have been limited.
With that funding, Jhpiego supports a Training Information Monitoring System, which stores training information for all HIV/AIDS training events supported by the same funding source. Data forms were developed to capture information on providers' working status and were given to eight partners who collected data during routine site visits on individual providers about working status; if not working at the facility, date of and reason for leaving; and source of information.
Data were collected on 1744 providers (59% males) in 53 hospitals and 45 health centres in 10 regional and administrative states. The project found that 32.6% of the providers were no longer at the site, 57.6% are still working on HIV/AIDS services at the same facility where they were trained and 10.4% are at the facility, but not providing HIV/AIDS services. Of the providers not at the facility, the two largest groups were those who had left for further study (27.6%) and those who had gone to another public facility (17.6%). Of all physicians trained, 49.2% had left the facility. Regional and cadre variation was found, for example Gambella had the highest percent of providers no longer at the site (53.7%) while Harari had the highest percentage of providers still working on HIV/AIDS (71.6%).
Overall, the project found that the information in the Training Information Monitoring System can be used to track the working status of trained providers. Data generated from the project are being shared with key stakeholders and used for planning and monitoring the workforce, and partners have agreed to continue collecting data. The attrition rates found in this project imply an increased need to continue to conduct in-service training for HIV/AIDS in the short term. For long-term solutions, retention strategies should be developed and implemented, and opportunities to accelerate the incorporation of HIV/AIDS training in pre-service institutions should be explored. Further study on reasons why providers leave sites and why providers are not working on HIV at the sites where they were trained, in addition to our project findings, can provide valuable data for development of national and regional strategies and retention schemes. Project findings suggest that the development of national and region-specific human resources for health strategy and policies could address important human resources issues found in the project.
PMCID: PMC2671487  PMID: 19338670
9.  Effectiveness of a training-of-trainers model in a HIV counseling and testing program in the Caribbean Region 
To evaluate the effectiveness and sustainability of a voluntary counseling and testing (VCT) training program based on a training-of-trainers (TOT) model in the Caribbean Region, we gathered data on the percentage of participants trained as VCT providers who were providing VCT services, and those trained as VCT trainers who were conducting VCT training.
The VCT training program trained 3,489 providers in VCT clinical skills and 167 in VCT training skills within a defined timeframe. An information-monitoring system tracked HIV trainings conducted, along with information about course participants and trainers. Drawing from this database, a telephone survey followed up on program-trained VCT providers; an external evaluation analyzed data on VCT trainers.
Almost 65% of trained VCT providers could be confirmed as currently providing VCT services. This percentage did not decrease significantly with time. Of the VCT trainers, 80% became certified as trainers by teaching at least one course; of these, 66% taught more than one course.
A TOT-based training program is an effective and sustainable method for rapid scale-up of VCT services and training capacity in a large-scale VCT program.
PMCID: PMC2653459  PMID: 19222839
10.  Women living with HIV: Disclosure, violence, and social support 
This paper describes the frequency of women's disclosure of their HIV status, examines the extent to which they experience adverse social and physical consequences when others learn they are infected, and analyzes correlates of these negative outcomes. There were 257 HIV-positive women between the ages of 18 and 44, recruited from HIV/AIDS primary care clinics and from community sites, who completed a face-to-face interview. Women in the sample were 33 years old on average; 92% were African-American; 54% had less than 12 yeas of education; 56% had used intravenous drugs; and 30% knew they were HIV positive for 5 or more years. There were 97% who disclosed their HIV status; 64% told more than 5 people. Negative consequences associated with others knowing they were HIV-positive were reported by 44%, most commonly the loss of friends (24%), being insulted or sworn at (23%), and being rejected by family (21%). There were 10 women (4%) who reported being physically or sexually assaulted as a result of their being HIV positive, and 16% reported having no one they could count on for money or a place to stay. Violence was widespread in this sample, with 62% having experienced physical or sexual violence, including sexual abuse or rape (27%), being beaten up (34%), and weapon-related violence (26%). Logistic regression analysis indicated that women with a history of physical and sexual violence were significantly more likely to experience negative social and physical consequences when their infection became known to others, adjusting for age and the number of people women had disclosed to, both of which were only marginally significant. Partner notification policies and support programs must be responsive to the potential negative consequences associated with others learning that a woman is HIV positive. The high rates of historical violence in the lives of women living with HIV underscore the need for routine screening and intervention for domestic violence in all settings that provide health care to HIV-positive women.
PMCID: PMC3456042  PMID: 10976619
Disclosure and Partner Notification; Domestic Violence; HIV; Social Support; Women's Health
11.  A Multicenter Study of Bacterial Vaginosis in Women With or at Risk for Human Immunodeficiency Virus Infection 
Background: Bacterial vaginosis is a common gynecologic infection that has been associated with a variety of gynecologic and obstetric complications, including pelvic inflammatory disease, postabortal infection and premature delivery. Recent studies suggest that bacterial vaginosis may increase a woman’s risk for human immunodeficiency virus (HIV). We undertook this study to assess whether the prevalence and characteristics of bacterial vaginosis differed according to HIV status in high-risk US women.
Methods: Prevalence of bacterial vaginosis was assessed by Gram’s stain and clinical criteria for 854 HIV-infected and 434 HIV-uninfected women enrolled in the HIV Epidemiology Research (HER) Study.Multiple logistic regression techniques were used to determine whether HIV infection independently predicted bacterial vaginosis.
Results: Almost half (46%) the women had bacterial vaginosis by Gram’s stain. The prevalence of bacterial vaginosis was 47% in the HIV-positive women compared with 44% in the HIV-negativewomen; this difference was not statistically significant (p = 0.36). After adjustment for other covariates, HIV-positive women were more likely than HIV-negative women to have bacterial vaginosis (odds ratio (OR) 1.31; 95% confidence interval (CI) 1.01-1.70) by Gram's stain but not by clinical criteria (OR 1.16; CI 0.87-1.55). Among HIV-positive women, use of antiretroviral drugs was associated with a lower prevalence of bacterial vaginosis (adjusted OR 0.54; Cl 0.38 -0.77).
Conclusions: In this cross-sectional analysis of high-risk US women, HIV infection was positively correlated with bacterial vaginosis diagnosed by Gram’s stain.
PMCID: PMC1784649  PMID: 11516061

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