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1.  Intersection of HIV and Reproductive Health 
AIDS Research and Treatment  2013;2013:418918.
PMCID: PMC3857734  PMID: 24349767
2.  Diaphragm Used with Replens Gel and Risk of Bacterial Vaginosis: Results from a Randomized Controlled Trial 
Background. Bacterial vaginosis (BV) has been linked to female HIV acquisition and transmission. We investigated the effect of providing a latex diaphragm with Replens and condoms compared to condom only on BV prevalence among participants enrolled in an HIV prevention trial. Methods. We enrolled HIV-seronegative women and obtained a vaginal swab for diagnosis of BV using Nugent's criteria; women with BV (score 7–10) were compared to those with intermediate (score 4–6) and normal flora (score 0–3). During quarterly follow-up visits over 12–24 months a vaginal Gram stain was obtained. The primary outcome was serial point prevalence of BV during followup. Results. 528 participants were enrolled; 213 (40%) had BV at enrollment. Overall, BV prevalence declined after enrollment in women with BV at baseline (OR = 0.4, 95% CI 0.29–.56) but did not differ by intervention group. In the intention-to-treat analysis BV prevalence did not differ between the intervention and control groups for women who had BV (OR = 1.01, 95% CI 0.52–1.94) or for those who did not have BV (OR = 1.21, 95% CI 0.65–2.27) at enrollment. Only 2.1% of participants were treated for symptomatic BV and few women (5–16%) were reported using anything else but water to cleanse the vagina over the course of the trial. Conclusions. Provision of the diaphragm, Replens, and condoms did not change the risk of BV in comparison to the provision of condoms alone.
PMCID: PMC3485870  PMID: 23133307
3.  Developing Content for a mHealth Intervention to Promote Postpartum Retention in Prevention of Mother-To-Child HIV Transmission Programs and Early Infant Diagnosis of HIV: A Qualitative Study 
PLoS ONE  2014;9(9):e106383.
Maternal attendance at postnatal clinic visits and timely diagnosis of infant HIV infection are important steps for prevention of mother-to-child transmission (PMTCT) of HIV. We aimed to use theory-informed methods to develop text messages targeted at facilitating these steps.
We conducted five focus group discussions with health workers and women attending antenatal, postnatal, and PMTCT clinics to explore aspects of women's engagement in postnatal HIV care and infant testing. Discussion topics were informed by constructs of the Health Belief Model (HBM) and prior empirical research. Qualitative data were coded and analyzed according to the construct of the HBM to which they related. Themes were extracted and used to draft intervention messages. We carried out two stages of further messaging development: messages were presented in a follow-up focus group in order to develop optimal phrasing in local languages. We then further refined the messages, pretested them in individual cognitive interviews with selected health workers, and finalized the messages for the intervention.
Findings indicated that brief, personalized, caring, polite, encouraging, and educational text messages would facilitate women bringing their children to clinic after delivery, suggesting that text messages may serve as an important “cue to action.” Participants emphasized that messages should not mention HIV due to fear of HIV testing and disclosure. Participants also noted that text messages could capitalize on women's motivation to attend clinic for childhood immunizations.
Applying a multi-stage content development approach to crafting text messages – informed by behavioral theory – resulted in message content that was consistent across different focus groups. This approach could help answer “why” and “how” text messaging may be a useful tool to support maternal and child health. We are evaluating the effect of these messages on improving postpartum PMTCT retention and infant HIV testing in a randomized trial.
PMCID: PMC4152282  PMID: 25181408
4.  Linkage to HIV care, postpartum depression, and HIV-related stigma in newly diagnosed pregnant women living with HIV in Kenya: a longitudinal observational study 
While studies have suggested that depression and HIV-related stigma may impede access to care, a growing body of literature also suggests that access to HIV care itself may help to decrease internalized HIV-related stigma and symptoms of depression in the general population of persons living with HIV. However, this has not been investigated in postpartum women living with HIV. Furthermore, linkage to care itself may have additional impacts on postpartum depression beyond the effects of antiretroviral therapy. We examined associations between linkage to HIV care, postpartum depression, and internalized stigma in a population with a high risk of depression: newly diagnosed HIV-positive pregnant women.
In this prospective observational study, data were obtained from 135 HIV-positive women from eight antenatal clinics in the rural Nyanza Province of Kenya at their first antenatal visit (prior to testing HIV-positive for the first time) and subsequently at 6 weeks after giving birth.
At 6 weeks postpartum, women who had not linked to HIV care after testing positive at their first antenatal visit had higher levels of depression and internalized stigma, compared to women who had linked to care. Internalized stigma mediated the effect of linkage to care on depression. Furthermore, participants who had both linked to HIV care and initiated antiretroviral therapy reported the lowest levels of depressive symptoms.
These results provide further support for current efforts to ensure that women who are newly diagnosed with HIV during pregnancy become linked to HIV care as early as possible, with important benefits for both physical and mental health.
PMCID: PMC4261547  PMID: 25467187
HIV; Stigma; Postpartum; Depression; Linkage to care
5.  Socio-demographic and health associations with body mass index at the time of enrollment in HIV care in Nyanza Province, Kenya 
AIDS care  2013;25(12):10.1080/09540121.2013.775399.
Low BMI at time of enrollment into HIV care has been shown to be a strong predictor of mortality independent of CD4 count. This study investigated socio-demographic associations with underweight (BMI<18.5) among adults in Nyanza Province, Kenya upon enrollment into HIV care. BMI, socio-demographic, and health data from a cross-sectional sample of 8,254 women and 3,533 men were gathered upon enrollment in the Family AIDS Care and Education Services (FACES) program in Nyanza Province, Kenya between January 2005 and March 2010. Overall, 27.4% of adults were underweight upon enrollment in HIV care. Among both women [W] and men [M], being underweight was associated with younger age (W: adjusted odds ratio [AOR] 2.90; 95% confidence interval [CI] 1.85-4.55; M: AOR, 5.87; 95% CI, 2.80-12.32 for age 15-19 compared to ≥50 years old), less education (W: AOR 2.92; 95% CI, 1.83-4.65; M: AOR, 1.55; 95% CI, 1.04-2.31 for primary education compared to some college/university), low CD4 count (W: AOR 2.13; 95% CI, 1.50-3.03; M: AOR, 1.43; 95% CI, 0.76-2.70 for 0-250 compared to ≥750 cells/mm3), and poor self-reported health status (W: AOR 1.72; 95% CI, 0.89-3.33; M: AOR, 9.78; 95% CI, 1.26-75.73 for poor compared to excellent). Male gender, lower educational attainment, younger age, and poor self-reported health are associated with low BMI at enrollment into HIV care in Nyanza Province. HIV care and treatment programs should consider using socio-demographic and health risk factors associated with low BMI to target and recruit patients with the goal of preventing late enrollment into care.
PMCID: PMC3708981  PMID: 23464799
HIV/AIDS; socio-economic status; anthropometry; body mass index; Kenya; Africa
6.  Prevalence, characteristics, and outcomes of HIV-positive women diagnosed with invasive cancer of the cervix in Kenya 
To determine the prevalence of invasive cervical cancer (ICC) and assess access to, and outcomes of, treatment for ICC among HIV-infected women in Kisumu, Kenya.
We performed a retrospective chart review to identify women diagnosed with ICC between October 2007 and June 2012, and to examine the impact of a change in the referral protocol. Prior to June 2009, all women with ICC were referred to a regional hospital. After this date, women with stage IA1 disease were offered treatment with loop electrosurgical excision procedure (LEEP) in-clinic.
Of 4308 women screened, 58 (1.3%) were diagnosed with ICC. The mean age at diagnosis was 34 years (range, 22–50 years). Fifty-four (93.1%) women had stage IA1 disease, of whom 36 (66.7%) underwent LEEP, 7 (12.9%) had a total abdominal hysterectomy, and 11 (20.4%) had unknown or no treatment. At 6, 12, and 24 months after LEEP, 8.0% (2/25), 25.0% (6/24), and 41.2% (7/17) of women had a recurrence of cervical intraepithelial neoplasia 2 or worse, respectively.
Most HIV-positive women diagnosed with ICC through screening had early-stage disease. The introduction of LEEP in-clinic increased access to treatment; however, recurrence was high, indicating the need for continued surveillance.
PMCID: PMC4151462  PMID: 24095308
Cervical cancer screening; HIV; Kenya; Loop Electrosurgical Excision Procedure; Resource-limited settings
To explore the impact of HIV/AIDS on maternity care providers (MCP) in labor and delivery in a high HIV prevalence setting in sub-Saharan Africa.
Qualitative one-on-one in-depth interviews with MCPs.
Four health facilities providing labor and delivery services (2 public hospitals, a public health center, and a small private maternity hospital) in Kisumu, Nyanza Province, Kenya.
Eighteen (18) MCPs, including 14 nurse/midwives, 2 physician assistants, and 2 physicians (ob/gyn specialists).
The HIV/AIDS epidemic has had numerous adverse effects and a few positive effects on MCPs in this setting. Adverse effects include reductions in the number of health care providers, increased workload, burnout, reduced availability of services in small health facilities when workers are absent due to attending HIV/AIDS training programs, difficulties with confidentiality and unwanted disclosure, and MCPs' fears of becoming HIV infected and the resulting stigma and discrimination. Positive effects include improved infection control procedures on maternity wards and enhanced MCP knowledge and skills.
A multi-faceted package including policy, infrastructure, and training interventions is needed to support MCPs in these settings and ensure that they are able to perform their critical roles in maternal healthcare and prevention of HIV/AIDS transmission.
PMCID: PMC2556865  PMID: 18811779
HIV/AIDS; maternity care providers; safe motherhood; Kenya
8.  “It is all about the fear of being discriminated [against]…the person suffering from HIV will not be accepted”: a qualitative study exploring the reasons for loss to follow-up among HIV-positive youth in Kisumu, Kenya 
BMC Public Health  2014;14(1):1154.
Youth represent 40% of all new HIV infections in the world, 80% of which live in sub-Saharan Africa. Youth living with HIV (YLWH) are more likely to become lost to follow-up (LTFU) from care compared to all other age groups. This study explored the reasons for LTFU among YLWH in Kenya.
Data was collected from: (1) Focus group Discussions (n = 18) with community health workers who work with LTFU youth. (2) Semi-structured interviews (n = 27) with HIV + youth (15–21 years old) that had not received HIV care for at least four months. (3) Semi-structured interviews (n = 10) with educators selected from schools attended by LTFU interview participants. Transcripts were coded and analyzed employing grounded theory.
HIV-related stigma was the overarching factor that led to LTFU among HIV + youth. Stigma operated on multiple levels to influence LTFU, including in the home/family, at school, and at the clinic. In all three settings, participants’ fear of stigma due to disclosure of their HIV status contributed to LTFU. Likewise, in the three settings, the dependent relationships between youth and the key adult figures in their lives were also adversely impacted by stigma and resultant lack of disclosure. Thus, at all three settings stigma influenced fear of disclosure, which in turn impacted negatively on dependent relationships with adults on whom they rely (i.e. parents, teachers and clinicians) leading to LTFU.
Interventions focusing on reduction of stigma, increasing safe disclosure of HIV status, and improved dependent relationships may improve retention in care of YLWH.
PMCID: PMC4232620  PMID: 25377362
Adolescent; HIV/AIDS; Kenya; Lost to follow-up; Stigma
9.  Fertility intentions among HIV-infected, sero-concordant Kenyan couples in Nyanza Province, Kenya 
Culture, health & sexuality  2013;15(10):10.1080/13691058.2013.811289.
Research in sub-Saharan Africa has shown significant diversity in how HIV influences infected couples’ fertility intentions. Supporting HIV-infected, sero-concordant couples in sub-Saharan Africa to make informed choices about their fertility options has not received sufficient attention. In-depth interviews were conducted among 23 HIV-positive, sero-concordant married couples in Kenya, to better understand how HIV impacted fertility intentions. HIV compelled many to reconsider fertility plans, sometimes promoting childbearing intentions in some individuals but often reducing fertility plans among most, largely due to fears of early death, health concerns, stigma, perinatal HIV transmission and financial difficulties (particularly in men). Preferences for sons and large families influenced some couples’ intentions to continue childbearing, although none had discussed their intentions with health care providers. Additional support and services for HIV-infected, sero-concordant couples are needed. Family planning counselling should be tailored to the unique concerns of HIV-infected couples, addressing perinatal transmission but also individual, couple-level, and socio-cultural fertility expectations. Community-level programmes are needed to reduce stigma and make HIV-infected couples more comfortable in discussing fertility intentions with health care providers.
PMCID: PMC3835420  PMID: 23885924
Africa; HIV/AIDS; reproductive health; pregnancy; Kenya
10.  Does integrating family planning into HIV care and treatment impact intention to use contraception? Patient perspectives from HIV-infected individuals in Nyanza Province, Kenya 
To evaluate whether HIV-infected women and men in HIV care and not using highly effective methods of contraception thought they would be more likely to use contraception if it were available at the HIV clinic.
A face-to-face survey assessing family-planning knowledge, attitudes, and practices was conducted among 976 HIV-infected women and men at 18 public-sector HIV clinics in Nyanza, Kenya. Data were analyzed using logistic regression and generalized estimating equations.
The majority of women (73%) and men (71%) thought that they or their partner would be more likely to use family planning if it were offered at the HIV clinic. In multivariable analysis, women who reported making family-planning decisions with their partner (adjusted odds ratio [aOR] 3.22; 95% confidence interval [CI], 1.53–6.80) and women aged 18–25 years who were not currently using family planning (aOR 4.76; 95% CI, 2.28–9.95) were more likely to think they would use contraception if integrated services were available. Women who perceived themselves to be infertile (aOR 0.07; 95% CI, 0.02–0.31) and had access to a cell phone (aOR 0.40; 95% CI, 0.25–0.63) were less likely to think that integrated services would change their contraceptive use. Men who were not taking antiretroviral medications (aOR 3.30; 95% CI, 1.49–7.29) were more likely, and men who were unsure of their partner’s desired number of children (aOR 0.36; 95% CI, 0.17–0.76), were not currently using family planning (aOR 0.40; 95% CI, 0.22–0.73), and were living in a peri-urban setting (aOR 0.46; 95% CI, 0.21–0.99) were less likely to think their partner would use contraception if available at the HIV clinic.
Integrating family planning into HIV care would probably have a broad impact on the majority of women and men accessing HIV care and treatment. Integrated services would offer the opportunity to involve men more actively in the contraceptive decision-making process, potentially addressing 2 barriers to family planning: access to contraception and partner uncertainty or opposition.
PMCID: PMC3842365  PMID: 24008310
Contraception; Decision making; Family planning; HIV; Integration
11.  Screening for HIV-Associated Peripheral Neuropathy in Resource-Limited Settings 
Muscle & nerve  2013;48(4):516-524.
Peripheral neuropathy is the most common neurological complication of HIV but is widely under-diagnosed in resource-limited settings. We investigated the utility of screening tools administered by non-physician health care workers (HCW) and quantitative sensory testing (QST) administered by trained individuals for identification of moderate/severe neuropathy.
We enrolled 240 HIV-infected outpatients using two-stage cluster randomized sampling. HCWs administered the several screening tools. Trained study staff performed QST. Tools were validated against a clinical diagnosis of neuropathy.
Participants were 65% women, mean age 36.4 years, median CD4 324 cells/μL. 65% were taking antiretrovirals, and 18% had moderate/severe neuropathy. The screening tests were 76% sensitive in diagnosing moderate/severe neuropathy with negative predictive values of 84–92%. QST was less sensitive but more specific.
Screening tests administered by HCW have excellent negative predictive values and are promising tools for scale-up in resource-limited settings. QST shows promise for research use.
PMCID: PMC4019398  PMID: 24037693
sensitivity and specificity; HIV; peripheral nervous system diseases; developing countries; screening tools
12.  High Medication Adherence During Periconception Periods Among HIV-1–Uninfected Women Participating in a Clinical Trial of Antiretroviral Pre-exposure Prophylaxis 
Pre-exposure prophylaxis (PrEP) may be an important safer conception strategy for HIV-1–uninfected women with HIV-1–infected partners. Understanding medication adherence in this population may inform whether PrEP is a feasible safer conception strategy.
We evaluated predictors of pregnancy and adherence to study medication among HIV-1–uninfected women enrolled in a randomized placebo-controlled trial of PrEP among African HIV-1–serodiscordant couples. Participants were counseled on HIV-1 risk reduction, contraception, and adherence and tested for pregnancy at monthly study visits. Pill counts of dispensed drug were performed and, at a subset of visits, plasma was collected to measure active drug concentration.
Among 1785 women, pregnancy incidence was 10.2 per 100 person-years. Younger age, not using contraception, having an additional sexual partner, and reporting unprotected sex were associated with increased likelihood of pregnancy. Monthly clinic pill counts estimated that women experiencing pregnancy took 97% of prescribed doses overall, with at least 80% pill adherence for 98% of study months, and no difference in adherence in the periconception period compared with previous periods (P = 0.98). Tenofovir was detected in plasma at 71% of visits where pregnancy was discovered. By multiple measures, adherence was similar for women experiencing and not experiencing pregnancy (P ≥ 0.1).
In this clinical trial of PrEP, pregnancy incidence was 10% per year despite excellent access to effective contraception. Women experiencing pregnancy had high medication adherence, suggesting that PrEP may be an acceptable and feasible safer conception strategy for HIV-1–uninfected women with HIV-1–serodiscordant partners.
PMCID: PMC4149628  PMID: 25118795
pregnancy; HIV-1 prevention; pre-exposure prophylaxis; adherence; safer conception; serodiscordant couples; sub-Saharan Africa
13.  Association of Cervical Biopsy with HIV Type 1 Genital Shedding Among Women on Highly Active Antiretroviral Therapy 
AIDS Research and Human Retroviruses  2013;29(7):1000-1005.
HIV-1 genital shedding is associated with increased HIV-1 transmission risk. Inflammation and ulceration are associated with increased shedding, while highly active antiretroviral therapy (HAART) has been shown to have a protective effect. We sought to examine the impact of cervical biopsies, a routine component of cervical cancer screening, on HIV-1 genital RNA levels in HIV-infected women on HAART. We enrolled HIV-1-infected women undergoing cervical biopsy for diagnosis of cervical intraepithelial neoplasia (CIN) 2/3 in this prospective cohort study. All were stable on HAART for at least 3 months. Clinical and demographic information as well as plasma HIV-1 viral load were collected at the baseline visit. Specimens for cervical HIV-1 RNA were collected immediately prior to biopsy, and 2 and 7 days afterward. Quantitative PCR determined HIV-1 concentration in cervical specimens at each time point to a lower limit of detection of 40 copies/specimen. Among the 30 participants, five (16.6%) women had detectable cervical HIV-1 RNA at baseline, of whom four (80%) had detectable HIV-1 RNA after cervical biopsy, with no significant increase in viral load in the follow-up specimens. Only one woman (3.3%) with undetectable baseline cervical HIV-1 RNA had detection postbiopsy. Detectable plasma HIV-1 RNA was the only factor associated with baseline cervical HIV-1 RNA. In women on HAART, an increase in cervical HIV-1 RNA detection or concentration was not associated with cervical biopsy. These findings help provide safety data regarding cervical cancer screening and diagnosis in HIV-infected women and inform postprocedure counseling.
PMCID: PMC3685685  PMID: 23594240
14.  Is there an association between HIV-1 genital shedding and cervical intraepithelial neoplasia 2/3 among women on antiretroviral therapy? 
Given the high prevalence of cervical intraepithelial neoplasia (CIN) grade 2/3 among HIV-infected women, we sought to examine the relationship between CIN 2/3 and HIV-1 genital shedding among women on highly active antiretroviral therapy (HAART).
Materials and Methods
Paired plasma and cervical wick specimens for HIV-1 RNA measurements were obtained from 44 HIV-infected women (cases) with biopsy-confirmed CIN2/3 and 44 age-matched HIV-infected women with normal cervical findings on colposcopy (controls). All subjects tested negative for sexually transmitted infections and had been stable on HAART for at least three months. HIV-1 viral load was measured in both blood and cervical specimens using commercial real-time PCR assays.
CIN2/3 was not significantly associated with the detection or magnitude of plasma or cervical HIV-1 RNA shedding. HIV was detected in the plasma in 10 (23%) cases and 10 (25%) controls (OR=1.0 95% CI 0.33–3.1). Cervical HIV-1 was detected in 6 (13.6%) cases and 9 (20.4%) controls (OR= 0.61 95% CI=0.20–1.90). Mean HIV-1 concentration in cervical secretions among women with CIN2/3 who shed was 2.93 log10 copies versus 2.72 among controls (p=0.65).
Among women on HAART, we found no relationship between CIN 2/3 and HIV-1 genital shedding.
PMCID: PMC3690152  PMID: 23486070
HIV-1 Genital Shedding; Highly Active Anti-Retroviral Therapy; Cervical Intraepithelial Neoplasia 2/3
15.  Effect of the levonorgestrel intrauterine device on genital HIV-1 RNA shedding among HIV-1–infected women not taking antiretroviral therapy in Nairobi, Kenya 
We evaluated the effect of the levonorgestrel intrauterine device (LNG-IUD) on genital HIV-1 RNA shedding and inflammation among 25 HIV-infected women. Blood, endocervical, and cervicovaginal lavage samples were collected from HIV-infected women not taking antiretrovirals before LNG-IUD insertion and 1-, 3-, and 6-months thereafter. HIV-1 RNA was quantitated by real-time RT-PCR. Inflammatory markers were measured by EIA. Genital HIV-1 RNA shedding and inflammatory markers did not differ between LNG-IUD placement and month 6, with the exception of interleukin-1B, which increased (0.42 log10; 95% CI: 0.10, 0.75). The LNG-IUD did not increase genital HIV-1 RNA shedding after 6-months of use.
PMCID: PMC3668353  PMID: 23446496
HIV infection; IUD; genital HIV shedding; levonorgestrel
16.  HIV serostatus and disclosure: implications for infant feeding practice in rural south Nyanza, Kenya 
BMC Public Health  2014;14:390.
The World Health Organization (WHO) recommends that HIV-infected women practice exclusive breastfeeding (EBF) for the first 6 months postpartum to reduce HIV transmission. The aim of this study was to determine the effects of HIV/AIDS knowledge and other psychosocial factors on EBF practice among pregnant and postpartum women in rural Nyanza, Kenya, an area with a high prevalence of HIV.
Data on baseline characteristics and knowledge during pregnancy, as well as infant feeding practices 4–8 weeks after the birth were obtained from 281 pregnant women recruited from nine antenatal clinics. Factors examined included: fear of HIV/AIDS stigma, male partner reactions, lack of disclosure to family members, knowledge of prevention of mother-to-child transmission (PMTCT) and mental health. In the analysis, comparisons were made using chi-squared and t-test methods as well as logistic multivariate regression models.
There were high levels of anticipated stigma 171(61.2%), intimate partner violence 57(20.4%) and postpartum depression 29(10.1%) and low levels of disclosure among HIV positive women 30(31.3%). The most significant factors determining EBF practice were hospital delivery (aOR = 2.1 95% CI 1.14-3.95) HIV positive serostatus (aOR 2.5 95% CI 1.23-5.27), and disclosure of HIV-positive serostatus (aOR 2.9 95% CI 1.31-6.79). Postpartum depression and PMTCT knowledge were not associated with EBF (aOR 1.1 95% CI 0.47-2.62 and aOR 1.2 95% CI 0.64-2.24) respectively.
Health care workers and counselors need to receive support in order to improve skills required for diagnosing, monitoring and managing psychosocial aspects of the care of pregnant and HIV positive women including facilitating disclosure to male partners in order to improve both maternal and child health outcomes.
PMCID: PMC4041135  PMID: 24754975
Infant feeding choices; Breastfeeding; PMTCT; Disclosure; Mental health; Kenya; HIV
17.  The impact of routine cryptococcal antigen screening on survival among HIV-infected individuals with advanced immunosuppression in Kenya 
We hypothesized that a screening and treatment intervention for early cryptococcal infection would improve survival among HIV-infected individuals with low CD4 cell counts.
Newly enrolled patients at Family AIDS Care and Education Services (FACES) in Kenya with CD4≤100 cells/μl were tested for serum Cryptococcal antigen (sCrAg). Individuals with sCrAg titer≥1:2 were treated with high-dose fluconazole. Cox proportional hazard models of Kaplan-Meier curves were used to compare survival among individuals with CD4≤100 cells/μl in the intervention and historical control groups.
The median age was 34 years [IQR: 29,41], 54% were female, and median CD4 was 43 cells/μl [IQR: 18,71]. Follow-up time was 1224 person-years. In the intervention group 66% (514/782) were tested for sCrAg; of whom 11% (59/514) were sCrAg positive. Mortality was 25% (196/782) in the intervention group and 25% (191/771) in the control group. There was no significant difference between the intervention and control group in overall survival [Hazard Ratio(HR): 1.1 (95%CI:0.9,1.3)] or three-month survival [HR: 1.0 (95%CI:0.8,1.3)]. Within the intervention group, sCrAg positive individuals had borderline lower survival rates than sCrAg negative individuals [HR:1.8 (95%CI: 1.0, 3.0)].
A screening and treatment intervention to identify sCrAg positive individuals and treat them with high-dose fluconazole did not significantly improve overall survival among HIV-infected individuals with CD4 counts≤100 cells/μl as compared to a historical control. Potential explanations include intervention uptake rates or poor efficacy of high-dose oral fluconazole. Future studies to identify the best treatments for early cryptococcal infection and improve uptake of the intervention are critical.
PMCID: PMC3809891  PMID: 23368667
Cryptococcus; screening; prevention; Africa; outcomes; cryptococcal meningitis
18.  Descriptive Characteristics and Health Outcomes of the Food by Prescription Nutrition Supplementation Program for Adults Living with HIV in Nyanza Province, Kenya 
PLoS ONE  2014;9(3):e91403.
The clinical effects and potential benefits of nutrition supplementation interventions for persons living with HIV remain largely unreported, despite awareness of the multifaceted relationship between HIV infection and nutrition. We therefore examined descriptive characteristics and nutritional outcomes of the Food by Prescription (FBP) nutrition supplementation program in Nyanza Province, Kenya.
Demographic, health, and anthropometric data were gathered from a retrospective cohort of 1,017 non-pregnant adult patients who enrolled into the FBP program at a Family AIDS Care and Education Services (FACES) site in Nyanza Province between July 2009 and July 2011. Our primary outcome was FBP treatment success defined as attainment of BMI>20, and we used Cox proportional hazards to assess socio-demographic and clinical correlates of FBP treatment success.
Mean body mass index was 16.4 upon enrollment into the FBP program. On average, FBP clients gained 2.01 kg in weight and 0.73 kg/m2 in BMI over follow-up (mean 100 days), with the greatest gains among the most severely undernourished (BMI <16) clients (p<0.001). Only 13.1% of clients attained a BMI>20, though 44.5% achieved a BMI increase ≥0.5. Greater BMI at baseline, younger age, male gender, and not requiring highly active antiretroviral therapy (HAART) were associated with a higher rate of attainment of BMI>20.
This study reports significant gains in weight and BMI among patients enrolled in the FBP program, though only a minority of patients achieved stated programmatic goals of BMI>20. Future research should include well-designed prospective studies that examine retention, exit reasons, mortality outcomes, and long-term sustainability of nutrition supplementation programs for persons living with HIV.
PMCID: PMC3960130  PMID: 24646586
19.  Contraceptive method and pregnancy incidence among African women in HIV-1 serodiscordant partnerships 
AIDS (London, England)  2012;26(4):513-518.
Effective contraception reduces unintended pregnancies and is a central strategy to reduce vertical HIV-1 transmission for HIV-1 infected women.
Among 2269 HIV-1 seropositive and 1085 seronegative women from 7 African countries who were members of HIV-1 serodiscordant heterosexual partnerships and who were participating in an HIV-1 prevention clinical trial, we assessed pregnancy incidence for women using various contraceptive methods using multivariate Andersen-Gill analysis.
Compared with women using no contraceptive method, pregnancy incidence was significantly reduced among HIV-1 seropositive and seronegative women using injectable contraception (adjusted hazard ratio (aHR) 0.24, p=0.001 and aHR 0.25, p<0.001, respectively). Oral contraceptives significantly reduced pregnancy risk only among HIV-1 seropositive women (aHR 0.51, p=0.004) but not seronegative women (aHR 0.64, p=0.3), and, for both seropositive and seronegative women, oral contraceptive pill users were more likely to become pregnant than injectable contraceptive users (aHR 2.22, p=0.01 for HIV-1 seropositive women and aHR 2.65, p=0.09 for HIV-1 seronegative women). Condoms, when reported as being used as the primary contraceptive method, marginally reduced pregnancy incidence (aHR 0.85, p=0.1 for seropositive women and aHR 0.67, p=0.02 for seronegative women). There were no pregnancies among women using intrauterine devices, implantable methods or who had undergone surgical sterilization, although these methods were used relatively infrequently.
Family planning programs and HIV-1 prevention trials need innovative ways to motivate uptake and sustained use of longer acting, less user-dependent contraception for women who do not desire pregnancy.
PMCID: PMC3932300  PMID: 22156966
HIV-1; serodiscordant couples; contraception; Africa; women
20.  Associations between genital tract infections, genital tract inflammation and cervical cytobrush HIV-1 DNA in US versus Kenyan women 
Cervical shedding of HIV-1 DNA may influence HIV-1 sexual transmission. HIV-1 DNA was detected in 250/316 (80%) and 207/259 (79%) cervical cytobrush specimens from 56 United States (US) and 80 Kenyan women, respectively. Plasma HIV-1 RNA concentration was associated with increased HIV-1 DNA shedding among US and Kenyan women. Kenyan women had higher cervicovaginal concentrations of pro-inflammatory interleukins (IL)-1β, IL-6, IL-8 and anti-inflammatory secretory leukocyte protease inhibitor (SLPI) compared to US women (all p < 0.01). HIV-1 DNA shedding was associated with increased concentrations of IL-1β and IL-6 and lower SLPI among US women, but not Kenyan women.
PMCID: PMC3549039  PMID: 23018377
21.  Direct Questioning Is More Effective Than Patient-Initiated Report for the Detection of Sexually Transmitted Infections in a Primary Care HIV Clinic in Western Kenya 
Sexually transmitted diseases  2013;40(2):158-161.
In resource-limited settings, detection of sexually transmitted infections (STIs) often relies on self-reported symptoms to initiate management. We found self-report demonstrated poor sensitivity for STI detection. Adding clinician-initiated questions about symptoms improved detection rates. Vaginal examination further increased sensitivity. Including clinician-initiated screening in resource-limited settings would improve management of treatable STIs.
PMCID: PMC3644217  PMID: 23324978
22.  Predictors of outcome in routine care for Cryptococcal meningitis in Western Kenya: Lessons for HIV outpatient care in resource-limited settings 
Postgraduate medical journal  2012;89(1048):73-77.
Cryptococcal meningitis is a leading cause of mortality among HIV-infected individuals in sub-Saharan Africa but little is known about its treatment and outcomes in decentralized HIV outpatient settings. We assessed adherence to treatment guidelines and determined predictors of survival.
A computerized laboratory database identified HIV-infected adults with cryptococcal meningitis at Family AIDS Care and Education Services in Nyanza Province, Kenya, between 2005-2009. Medical records were reviewed. Kaplan-Meier survival curves were generated. Bivariate and multivariate Cox proportional hazards models were used to determine associations between key clinical characteristics and survival.
Medical records were located for 79% (71/90). Mortality was 38% (27/71) over a median follow-up period of 201 days [Inter-quartile range (IQR): 10-705 days]. Adherence to local guidelines for treatment of cryptococcal meningitis was 48% (34/71). Higher BMI was associated with improved survival (HR: 0.82, 95%CI [0.68,0.99]) even after controlling for factors such as age, CD4 cell count, receipt of HAART, and treatment with any anti-fungal therapy.
Cryptococcal meningitis diagnosed in routine HIV outpatient settings is largely treated as an outpatient and adherence to treatment guidelines is poor. BMI is a critical independent predictor of outcome. Additional research to determine the most effect strategies to reduce premature mortality is urgently needed.
PMCID: PMC3722584  PMID: 23112217
Meningitis; Cryptococcal; AIDS-Related Opportunistic Infection; ambulatory care; Kenya; HIV
23.  Interaction Between Lactobacilli, Bacterial Vaginosis-Associated Bacteria, and HIV Type 1 RNA and DNA Genital Shedding in U.S. and Kenyan Women 
Bacterial vaginosis has been associated with genital HIV-1 shedding; however, the effect of specific vaginal bacterial species has not been assessed. We tested cervicovaginal lavage from HIV-1-seropositive women for common Lactobacillus species: L. crispatus, L. jensenii, and seven BV-associated species: BVAB1, BVAB2, BVAB3, Leptotrichia, Sneathia, Megasphaera, and Atopobium spp. using quantitative PCR. We used linear and Poisson regression to evaluate associations between vaginal bacteria and genital HIV-1 RNA and DNA. Specimens from 54 U.S. (310 visits) and 50 Kenyan women (137 visits) were evaluated. Controlling for plasma viral load, U.S. and Kenyan women had similar rates of HIV-1 RNA (19% of visits vs. 24%; IRR=0.95; 95% CI 0.61, 1.49) and DNA shedding (79% vs. 76%; IRR=0.90; 0.78, 1.05). At visits during antiretroviral therapy (ART), the likelihood of detection of HIV-1 RNA shedding was greater with BVAB3 (IRR=3.16; 95% CI 1.36, 7.32), Leptotrichia, or Sneathia (IRR=2.13; 1.02, 4.72), and less with L. jensenii (IRR=0.39; 0.18, 0.84). At visits without ART, only L. crispatus was associated with a lower likelihood of HIV-1 RNA detection (IRR=0.6; 0.40, 0.91). Vaginal Lactobacillus species were associated with lower risk of genital HIV-1 shedding, while the presence of certain BV-associated species may increase that risk.
PMCID: PMC3537306  PMID: 23020644
AIDS care  2012;24(11):1442-1447.
A cluster randomized controlled trial was initiated in Kenya to determine if full integration (FI) of HIV care, including HAART, into antenatal care (ANC) clinics improves health outcomes among HIV-infected women and exposed infants, compared to a non-integrated (NI) model. This paper examines ANC clients’ satisfaction with and preferences regarding HIV-integrated services. In this cross-sectional study, pregnant women attending five FI clinics (n=185) and four NI clinics (n=141) completed an interviewer-administered questionnaire following an ANC visit. By self-report, 55 women (17%) were HIV(+), 230 (71%) were HIV(−) and 40 (12%) did not know their HIV status. Among HIV-infected women, 79% attending FI clinics were very satisfied with their clinic visit compared to 54% of women attending NI clinics (P=0.044); no such difference was found among HIV-uninfected women. In multivariate analysis, overall satisfaction was also independently associated with satisfaction with administrative staff, satisfaction with health care providers, positive evaluation of wait time, and having encountered a receptionist. Full integration of HIV care into antenatal clinics can significantly increase overall satisfaction with care for HIV-infected women, with no significant decrease in satisfaction for HIV-uninfected women served in the same clinics.
PMCID: PMC3495002  PMID: 22296261
patient satisfaction; HIV; antenatal care; service integration; Kenya
25.  Exploring a Road Map to Counter Misconceptions About the Cervicovaginal Microbiome and Disease 
Reproductive Sciences  2012;19(11):1154-1162.
Urogenital diseases, especially infection and cancer, are major causes of death and morbidity in females. Yet, millions of women in the developing world have no access to basic urogynecological care, and the diagnosis and treatment of widespread aberrant bacterial conditions (bacterial vaginosis [BV] and aerobic vaginitis [AV]) remain suboptimal the world over. Samples from women living in resource-disadvantaged and developed countries have been analyzed by high-throughput sequencing to reveal the diversity of bacteria in the vagina, how rapidly the bacterial population fluctuates over time, and how rapidly the switch occurs between healthy and aberrant conditions. Unfortunately, clinical diagnostic methods are inefficient and too often outdated therapies are administered. The net result is suboptimal care and recurrent disease that adversely affects the quality of life. This viewpoint outlines a scientific and translational road map designed to improve the cervicovaginal health and treatment of disease. This comprises (1) improving education of women and physicians on the vaginal microbiota; (2) having agencies target funding for research to improve diagnosis and test new therapies; and (3) making sure that new approaches are accessible in developing countries, empowering to women, and are acceptable and appropriate for different populations.
PMCID: PMC4051403  PMID: 22614624
cervicovagina; bacteria; vaginosis; diagnosis; gardnerella; lactobacillus; Nugent; Amsel; microbiome

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