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1.  Delayed initiation of antiretroviral therapy among HIV-discordant couples in Kenya 
AIDS care  2012;25(3):265-272.
Timely initiation of antiretroviral therapy (ART) is particularly important for HIV-discordant couples because viral suppression greatly reduces the risk of transmission to the uninfected partner. To identify issues and concerns related to ART initiation among HIV-discordant couples, we recruited a subset of discordant couples participating in a longitudinal study in Nairobi to participate in in-depth interviews and focus group discussions about ART. Our results suggest that partners in HIV-discordant relationships discuss starting ART, yet most are not aware that ART can decrease the risk of HIV transmission. Additionally, their concerns about ART initiation include side effects, sustaining an appropriate level of drug treatment, HIV/AIDS related stigma, medical/biological issues, psychological barriers, misconceptions about the medications, the inconvenience of being on therapy, and lack of social support. Understanding and addressing these barriers to ART initiation among discordant couples is critical to advancing the HIV “treatment as prevention” agenda.
doi:10.1080/09540121.2012.712660
PMCID: PMC3523215  PMID: 22866934
HIV/AIDS; serodiscordant couples; serodiscordant; antiretroviral therapy; Africa
2.  Contraceptive method and pregnancy incidence among African women in HIV-1 serodiscordant partnerships 
AIDS (London, England)  2012;26(4):513-518.
Background
Effective contraception reduces unintended pregnancies and is a central strategy to reduce vertical HIV-1 transmission for HIV-1 infected women.
Methods
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.
Results
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.
Conclusions
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.
doi:10.1097/QAD.0b013e32834f981c
PMCID: PMC3932300  PMID: 22156966
HIV-1; serodiscordant couples; contraception; Africa; women
3.  Maternal Valacyclovir and Infant Cytomegalovirus Acquisition: A Randomized Controlled Trial among HIV-Infected Women 
PLoS ONE  2014;9(2):e87855.
Background
Studies in HIV-1-infected infants and HIV-1-exposed, uninfected infants link early cytomegalovirus (CMV) acquisition with growth delay and cognitive impairment. We investigated maternal valacyclovir to delay infant acquisition of CMV.
Methods
Pregnant women with HIV-1, HSV-2 and CD4 count >250 cells/µl were randomized at 34 weeks gestation to 500 mg twice-daily valacyclovir or placebo for 12 months. Maternal CMV DNA was measured in plasma at 34 weeks gestation, in cervical secretions at 34 and 38 weeks gestation, and in breast milk at 7 postpartum timepoints; infant CMV DNA was measured in dried blood spots at 8 timepoints including birth.
Results
Among 148 women, 141 infants were compared in intent-to-treat analyses. Maternal and infant characteristics were similar between study arms. Infant CMV acquisition did not differ between study arms, with 46/70 infants (66%) in placebo arm and 47/71 infants (66%) in the valacyclovir arm acquiring CMV; median time to CMV detection did not differ. CMV DNA was detected in 92% of 542 breast milk specimens with no difference in CMV level between study arms. Change in cervical shedding of CMV DNA between baseline and 38 weeks was 0.40-log greater in the placebo arm than the valacyclovir arm (p = 0.05).
Conclusions
In this cohort of HIV-1-seropositive mothers, two-thirds of infants acquired CMV by one year. Maternal valacyclovir had no effect on timing of infant CMV acquisition or breast milk CMV viral loads, although it modestly reduced cervical CMV shedding. Maternal prophylaxis to reduce infant CMV acquisition warrants further evaluation in trials with antiviral agents.
Trials Registration
ClinicalTrials.gov NCT00530777
doi:10.1371/journal.pone.0087855
PMCID: PMC3913686  PMID: 24504006
4.  Short Communication: T Cell Activation in HIV-1/Herpes Simplex Virus-2-Coinfected Kenyan Women Receiving Valacyclovir 
Abstract
Herpes simplex virus-2 (HSV-2) suppression with acyclovir or valacyclovir reduces HIV-1 viral RNA levels; one hypothesis is that HSV-2 suppression reduces immune activation. We measured T cell immune activation markers among women participating in a randomized placebo-controlled trial of valacyclovir to reduce HIV-1 RNA levels among pregnant women. Although valacyclovir was associated with lower HIV-1 RNA levels, the distribution of both CD4+ and CD8+ CD38+HLA-DR+ T cells was not different among women taking valacyclovir when compared to women taking placebo. Further study is needed to understand the mechanism of HIV-1 RNA reduction following herpes suppression among those coinfected with HIV-1 and HSV-2.
doi:10.1089/aid.2012.0071
PMCID: PMC3537320  PMID: 22852760
5.  Prevalence and Correlates of Genital Warts in Kenyan Female Sex Workers 
Sexually transmitted diseases  2012;39(11):902-905.
Background
Our goal in the present study was to investigate the prevalence and correlates of genital warts in a population of female sex workers in Mombasa, Kenya. Because of the high prevalence of HIV-1 in this population, we were particularly interested in the association between HIV-1 infection and genital warts.
Methods
We conducted a cross-sectional study of the prevalence and correlates of genital warts among high-risk women in Mombasa, Kenya. Between 2001 and 2007, 1182 women were enrolled, of whom 613 (51.4%) were HIV-1-seropositive. Chi square tests and logistic regression were used to examine the associations between genital warts and potential correlates.
Results
Genital warts were identified on clinical examination in 27 (2.3%) women. Women who were HIV-1-seropositive were nearly 8 times as likely to have genital warts compared to HIV-1-seronegative women (OR 7.69, 95% CI 2.30–25.6).
Conclusion
Understanding the prevalence and correlates of genital warts will help to determine whether coverage for the wart-inducing subtypes 6 and 11 in an HPV vaccine is an important consideration in resource-limited countries.
doi:10.1097/OLQ.0b013e318275ec7f
PMCID: PMC3506016  PMID: 23060082
genital warts; human immunodeficiency virus; human papilloma virus; Africa
6.  Male, Mobile, and Moneyed: Loss to Follow-Up vs. Transfer of Care in an Urban African Antiretroviral Treatment Clinic 
PLoS ONE  2013;8(10):e78900.
Objectives
The purpose of this study was to analyze characteristics, reasons for transferring, and reasons for discontinuing care among patients defined as lost to follow-up (LTFU) from an antiretroviral therapy (ART) clinic in Nairobi, Kenya.
Design
The study used a prospective cohort of patients who participated in a randomized, controlled ART adherence trial between 2006 and 2008.
Methods
Participants were followed from pre-ART clinic enrollment to 18 months after ART initiation, and were defined as LTFU if they failed to return to clinic 4 weeks after their last scheduled visit. Reasons for loss were captured through phone call or home visit. Characteristics of LTFU who transferred care and LTFU who did not transfer were compared to those who remained in clinic using log-binomial regression to estimate risk ratios.
Results
Of 393 enrolled participants, total attrition was 83 (21%), of whom 75 (90%) were successfully traced. Thirty-seven (49%) were alive at tracing and 22 (59%) of these reported having transferred their antiretroviral care. In the final model, transfers were more likely to have salaried employment [Risk Ratio (RR), 2.7; 95% confidence interval (CI), 1.2-6.1; p=0.020)] and pay a higher monthly rent (RR, 5.8; 95% CI, 1.3-25.0; p=0.018) compared to those retained in clinic. LTFU who did not transfer care were three times as likely to be men (RR, 3.1; 95% CI, 1.1-8.1; p=0.028) and nearly 4 times as likely to have a primary education or less (RR, 3.8; 95% CI, 1.3-10.6; p=0.013). Overall, the most common reason for LTFU was moving residence, predominantly due to job loss or change in employment.
Conclusion
A broad definition of LTFU may include those who have transferred their antiretroviral care and thereby overestimate negative effects on ART continuation. Interventions targeting men and considering mobility due to employment may improve retention in urban African ART clinics.
Clinical Trials
The study’s ClinicalTrials.gov identifier is NCT00273780.
doi:10.1371/journal.pone.0078900
PMCID: PMC3812001  PMID: 24205345
7.  HIV-1-Specific Enzyme-Linked Immunosorbent Spot Assay Responses in HIV-1-Exposed Uninfected Partners in Discordant Relationships Compared to Those in Low-Risk Controls 
Clinical and Vaccine Immunology : CVI  2012;19(11):1798-1805.
A number of studies of highly exposed HIV-1-seronegative individuals (HESN) have found HIV-1-specific cellular responses. However, there is limited evidence that responses prevent infection or are linked to HIV-1 exposure. Peripheral blood mononuclear cells (PBMC) were isolated from HESN in HIV-1-discordant relationships and low-risk controls in Nairobi, Kenya. HIV-1-specific responses were detected using gamma interferon (IFN-γ) enzyme-linked immunosorbent spot (ELISpot) assays stimulated by peptide pools spanning the subtype A HIV-1 genome. The HIV-1 incidence in this HESN cohort was 1.5 per 100 person years. Positive ELISpot responses were found in 34 (10%) of 331 HESN and 14 (13%) of 107 low-risk controls (odds ratio [OR] = 0.76; P = 0.476). The median immunodominant response was 18.9 spot-forming units (SFU)/106 peripheral blood mononuclear cells (PBMC). Among HESN, increasing age (OR = 1.24 per 5 years; P = 0.026) and longer cohabitation with the HIV-1-infected partner (OR = 5.88 per 5 years; P = 0.003) were associated with responses. These factors were not associated with responses in controls. Other exposure indicators, including the partner's HIV-1 load (OR = 0.99 per log10 copy/ml; P = 0.974) and CD4 count (OR = 1.09 per 100 cells/μl; P = 0.238), were not associated with responses in HESN. HIV-1-specific cellular responses may be less relevant to resistance to infection among HESN who are using risk reduction strategies that decrease their direct viral exposure.
doi:10.1128/CVI.00179-12
PMCID: PMC3491560  PMID: 22971780
8.  Barriers to Antiretroviral Initiation in HIV-1-Discordant Couples 
BACKGROUND
In Kenya and much of sub-Saharan Africa, nearly half of all couples affected by HIV are discordant. Antiretroviral therapy (ART) slows disease progression in HIV-1-infected individuals, and reduces transmission to uninfected partners. We examined time to ART initiation and factors associated with delayed initiation in HIV-1-discordant couples in Nairobi.
METHODS
HIV-1-discordant couples were enrolled and followed quarterly for up to 2 years. Clinical staff administered questionnaires and conducted viral loads and CD4 counts. Participants with a CD4 count meeting ART criteria were referred to a nearby PEPFAR-funded treatment center. Barriers to ART initiation among participants with a CD4 count eligible for ART were assessed by Cox regression.
RESULTS
Of 439 HIV-1-infected participants (63.6% females and 36.4% males) 146 met CD4 count criteria for ART during follow-up. Median time from meeting CD4 criteria until ART initiation was 8.9 months, with 42.0% of eligible participants on ART by 6 months and 63.4% on ART by 1 year. The CD4 count at the time of eligibility was inversely associated with time to ART initiation (HR=0.49, p< 0.001). Compared to homeowners, those paying higher rents started ART 48% more slowly (p=0.062) and those paying lower rents started 71% more slowly (p=0.002).
CONCLUSIONS
Despite access to regular health care, referrals to treatment centers, and free access to ART, over a third of participants with an eligible CD4 count had not started ART within 1 year. Factors of lower socioeconomic status may slow ART initiation and targeted approaches are needed to avoid delays in treatment initiation.
doi:10.1097/QAI.0b013e31822f064e
PMCID: PMC3202340  PMID: 21826010
HIV; discordant couples; serodiscordant; antiretroviral; ART; HAART
9.  Compliance with antiretroviral regimens to prevent perinatal HIV-1 transmission in Kenya 
AIDS (London, England)  2003;17(1):65-71.
Objective
To compare compliance and infant HIV-1 infection risk at 6 weeks with the Thai-CDC and HIVNET-012 antiretroviral regimens in a field setting.
Design
Randomized clinical trial.
Setting
Tertiary hospital antenatal clinic in Nairobi, Kenya.
Participants
HIV-1 infected women referred from primary care clinics.
Interventions
Thai-CDC zidovudine regimen or HIVNET-012 nevirapine regimen.
Main outcome measures
Women were considered compliant if they used ≥ 80% of the doses. Infants were tested for HIV-1 at 6 weeks.
Results
Seventy women were randomized to Thai-CDC and 69 to HIVNET-012 regimens. More women were compliant with the antenatal (86%) than the intrapartum (44%) Thai-CDC regimen doses (P = 0.001). Ninety-seven per cent took the maternal and 91% gave the infant dose of the HIVNET-012 regimen (P = 0.2). Overall, 41% were compliant with the Thai-CDC regimen and 87% with the HIVNET-012 regimen (P < 0.001). Compliance with the Thai-CDC regimen was associated with partner support of antiretroviral use [odds ratio (OR), 3.0;, 95% confidence interval (CI), 1.0–9.1] and knowledge at recruitment that antiretroviral drugs could prevent infant HIV-1 (OR, 2.9; 95% CI, 1.0–8.1). Compliance with the HIVNET-012 regimen was associated with partner notification (OR, 8.0; 95% CI, 1.5–50) and partner willingness to have HIV-1 testing (OR, 7.5; 95% CI, 1.4–40). There was a trend for a higher risk of transmission with the HIVNET-012 regimen than with the Thai-CDC regimen (22% versus 9%; P = 0.07).
Conclusion
Compliance with the Thai-CDC and HIVNET-012 regimens was comparable to that in efficacy trials. Partner involvement, support and education on perinatal HIV-1 prevention may improve compliance and increase the number of infants protected from HIV-1 infection.
doi:10.1097/01.aids.0000042938.55529.e1
PMCID: PMC3387271  PMID: 12478070
antiretroviral therapy; vertical transmission; compliance; prevention of perinatal transmission
10.  Antenatal Couple Counseling Increases Uptake of Interventions to Prevent HIV-1 Transmission 
Summary
To determine effect of partner involvement and couple counseling on uptake of interventions to prevent HIV-1 transmission, women attending a Nairobi antenatal clinic were encouraged to return with partners for voluntary HIV-1 counseling and testing (VCT) and offered individual or couple posttest counseling. Nevirapine was provided to HIV-1-seropositive women and condoms distributed to all participants. Among 2104 women accepting testing, 308 (15%) had partners participate in VCT, of whom 116 (38%) were couple counseled. Thirty-two (10%) of 314 HIV-1-seropositive women came with partners for VCT; these women were 3-fold more likely to return for nevirapine (P = 0.02) and to report administering nevirapine at delivery (P = 0.009). Nevirapine use was reported by 88% of HIV-infected women who were couple counseled, 67% whose partners came but were not couple counseled, and 45% whose partners did not present for VCT (P for trend = 0.006). HIV-1-seropositive women receiving couple counseling were 5-fold more likely to avoid breast-feeding (P = 0.03) compared with those counseled individually. Partner notification of HIV-1-positive results was reported by 138 women (64%) and was associated with 4-fold greater likelihood of condom use (P = 0.004). Partner participation in VCT and couple counseling increased uptake of nevirapine and formula feeding. Antenatal couple counseling may be a useful strategy to promote HIV-1 prevention interventions.
PMCID: PMC3384734  PMID: 15577420
voluntary counseling and testing; couple counseling; mother-to-child HIV-1 transmission; breastfeeding; nevirapine; condom use; partner notification
11.  Domestic violence and prevention of mother-to-child transmission of HIV-1 
AIDS (London, England)  2006;20(13):1763-1769.
Objectives
To determine the prevalence of life-time domestic violence by the current partner before HIV-1 testing, its impact on the uptake of prevention of mother-to-child transmission (PMTCT) interventions and frequency after testing.
Design
A prospective cohort.
Methods
Antenatally, women and their partners were interviewed regarding physical, financial, and psychological abuse by the male partner before HIV-1 testing and 2 weeks after receiving results.
Results
Before testing, 804 of 2836 women (28%) reported previous domestic violence, which tended to be associated with increased odds of HIV-1 infection [univariate odds ratio (OR) 1.7, 95% confidence interval (CI) 1.3–2.2; P < 0.0001, adjusted OR 1.2, 95% CI 0.9–1.6; P = 0.1], decreased odds of coming with partners for counseling (adjusted OR 0.7, 95% CI 0.5–1.0; P = 0.04), and decreased odds of partner notification (adjusted OR 0.7, 95% CI 0.5–1.1; P = 0.09). Previous domestic violence was not associated with a reduced uptake of HIV-1 counseling, HIV-1 testing, or nevirapine. After receiving results, 15 out of 1638 women (0.9%) reported domestic violence. After notifying partners of results, the odds of HIV-1-seropositive women reporting domestic violence were 4.8 times those of HIV-1-seronegative women (95% CI 1.4–16; P = 0.01). Compared with women, men reported similar or more male-perpetrated domestic violence, suggesting a cultural acceptability of violence.
Conclusion
Domestic violence before testing may limit partner involvement in PMTCT. Although infrequent, immediate post-test domestic violence is more common among HIV-1-infected than uninfected women. Domestic violence prevention programmes need to be integrated into PMTCT, particularly for HIV-1-seropositive women.
doi:10.1097/01.aids.0000242823.51754.0c
PMCID: PMC3384736  PMID: 16931941
Adverse effects; Africa; domestic violence; HIV; vertical transmission; prevention of mother-to-child transmission
12.  Pediatric HIV Type 1 Vaccine Trial Acceptability among Mothers in Kenya 
Vaccination of infants against human immunodeficiency virus type 1 (HIV-1) may prevent mother-to-child HIV-1 transmission. Successful trials and immunization efforts will depend on the willingness of individuals to participate in pediatric vaccine research and acceptance of infant HIV-1 vaccines. In a cross-sectional study, pregnant women presenting to a Nairobi antenatal clinic for routine care were interviewed regarding their attitudes toward participation in research studies and HIV-1 vaccine acceptability for their infants. Among 805 women, 782 (97%) reported they would vaccinate their infant against HIV-1 and 729 (91%) reported willingness to enroll their infant in a research study. However, only 644 (80%) would enroll their infants if HIV-1 testing was required every 3 months and 513 (64%) would agree to HIV-1 vaccine trial participation. Reasons for not wanting to enroll in a pediatric HIV-1 vaccine trial included concerns about side effects (75%), partner objection (34%), and fear of discrimination (10%), HIV-1 acquisition (8%), or false-positive HIV-1 results (5%). The strongest correlate of pediatric vaccine trial participation was maternal willingness to be a vaccine trial participant herself; in univariate and multivariate models this was associated with a 17-fold increased likelihood of participation (HR 17.1; 95% CI 11.7–25; p < 0.001). We conclude from these results that immunizing infants against HIV-1 and participation in pediatric vaccine trials are generally acceptable to women at high risk for HIV-1 infection. It will be important to address barriers identified in this study and to include male partners when mobilizing communities for pediatric HIV-1 vaccine trials and immunization programs.
doi:10.1089/aid.2006.22.491
PMCID: PMC3382079  PMID: 16796522
13.  Breast milk HIV-1 suppression and decreased transmission: a randomized trial comparing HIVNET 012 nevirapine versus short-course zidovudine 
AIDS (London, England)  2005;19(13):1415-1422.
Objective
To compare the effect of perinatal regimens of short-course nevirapine (HIVNET 012) and zidovudine [Thai-Centers for Disease Control and Prevention (CDC) regimen] on breast milk viral shedding and perinatal transmission during the first 6 weeks postpartum in a randomized clinical trial.
Design
Randomized clinical trial.
Methods
Pregnant HIV-1 seropositive women in Nairobi, Kenya who planned to breastfeed were randomized to HIVNET 012 or Thai-CDC regimens. Two to four breast milk samples were collected each week between delivery and 6 weeks postpartum. Breast milk HIV-1 RNA was quantified using the Gen-Probe TMA assay. Infants were tested for HIV-1 DNA at birth and 6 weeks.
Results
From March to October 2003, 76 women were enrolled and 795 breast milk samples were collected from 60 women who were randomized and followed after delivery. Between 3 and 21 days postpartum, nevirapine was associated with significantly greater suppression of breast milk log10 HIV-1 RNA: days 3 to 7 (1.98 versus 2.42, P = 0.1); days 8 to 14 (1.78 versus 2.48, P = 0.005); days 15 to 21 (1.90 versus 2.97, P = 0.003). At 6 weeks, the HIV-1 perinatal transmission rate was significantly lower among those who took nevirapine than zidovudine (6.8% versus 30.3%, P = 0.02).
Conclusions
Compared to a peripartum zidovudine regimen, nevirapine was significantly more likely to decrease HIV-1 RNA in breast milk during the first week and through the third week postpartum following single-dose administration, and corresponded with decreased transmission risk at 6 weeks. Sustained breast milk HIV-1 suppression may contribute to the ability of nevirapine to decrease perinatal transmission of HIV-1.
PMCID: PMC3381340  PMID: 16103773
Africa; vertical transmission; mother-to-child transmission; HIV-1; perinatal transmission; nevirapine; zidovudine
14.  Infant Feeding Practices of Women in a Perinatal HIV-1 Prevention Study in Nairobi, Kenya 
Objective
To determine feeding practices and nutritional status of infants born to HIV-1–infected women.
Methods
Feeding plans and practices were evaluated by questionnaires and focus group discussions. Infants were weighed at 1 and 6 weeks and tested for HIV-1 at 6 weeks.
Results
Of 128 women seen after delivery, 111 completed the study. Mothers who planned to breast feed were more likely to feed their infants as planned (86% vs. 55%; P < 0.001). Women opted to breast feed due to financial constraints, partner influence, and fear of losing confidentiality. Women who reported that their partners were willing to have HIV-1 testing were less likely to be breast feeding at 6 weeks (odds ratio [OR] = 0.3, 95% confidence interval [CI]: 0.1–0.8; P = 0.01). At 6 weeks, more infants were mixed fed (31% vs. 21%; P = 0.05) than at 1 week. Lower infant weight at 6 weeks was associated with not breast feeding (P = 0.001), HIV-1 infection (P = 0.05), birth weight <3000 g (P = 0.01), maternal employment (P = 0.02), and paying <$12.5 per month in house rent (among infants not breast fed; P = 0.05).
Conclusions
Replacement feeding was difficult, particularly without partner support in HIV-1 testing. Mixed feeding was common and increased by 6 weeks. Mothers of low socioeconomic status who opt not to breast feed require support to avoid nutritional compromise of infants.
PMCID: PMC3380107  PMID: 14707796
breast feeding; prevention of perinatal transmission; infant feeding options
15.  Cofactors for HIV-1 Incidence during Pregnancy and Postpartum Period 
Current HIV Research  2010;8(7):510-514.
Objectives
To estimate HIV-1 incidence and cofactors for HIV-1 incidence during pregnancy and postpartum.
Design
Retrospective study among women who were HIV seronegative during pregnancy.
Methods
Mothers accompanying their infants for routine 6-week immunizations at 6 maternal child health clinics in Nairobi and Western Kenya were tested for HIV-1 after completing a questionnaire that included assessment of sociodemographics, obstetric history and HIV-1 risk perception.
Results
Of 2,135 mothers who had tested HIV-1 seronegative antenatally, 2,035 (95.3%) accepted HIV-1 re-testing at 6 weeks postpartum. Of these, 53 (2.6%) were HIV-1 seropositive yielding an estimated HIV-1 incidence of 6.8 (95% CI: 5.1-8.8) per 100 woman-years). Mothers who seroconverted were more likely to be employed (45.3% vs 29.0%, p=0.01), married (96.2 vs 86.6%, p=0.04) and from a higher HIV-1 prevalence region (60.4% in Western Kenya vs 28.8% in Nairobi, p<0.001). Among married women, those in polygamous relationship were significantly more likely to seroconvert (19.6% vs 6.7%, p<0.001). In multivariate analysis, region and employment independently predicted seroconversion.
Conclusions
Repeat HIV-1 testing in early postpartum was highly acceptable and resulted in detection of substantial HIV-1 incidence during pregnancy and postpartum period. Within prevention of mother-to-child HIV-1 transmission programs strategic approaches to prevent maternal HIV-1 acquisition during pregnancy are urgently needed.
PMCID: PMC3372399  PMID: 20946093
Seroconversion; pregnancy; incidence; sub Saharan Africa; risk factors; heterosexual transmission
16.  Antenatal Couple Counseling Increases Uptake of Interventions to Prevent HIV-1 Transmission 
AIDS (London, England)  2001;15(6):815-817.
Summary
To determine effect of partner involvement and couple counseling on uptake of interventions to prevent HIV-1 transmission, women attending a Nairobi antenatal clinic were encouraged to return with partners for voluntary HIV-1 counseling and testing (VCT) and offered individual or couple posttest counseling. Nevirapine was provided to HIV-1-seropositive women and condoms distributed to all participants. Among 2104 women accepting testing, 308 (15%) had partners participate in VCT, of whom 116 (38%) were couple counseled. Thirty-two (10%) of 314 HIV-1-seropositive women came with partners for VCT; these women were 3-fold more likely to return for nevirapine (P = 0.02) and to report administering nevirapine at delivery (P = 0.009). Nevirapine use was reported by 88% of HIV-infected women who were couple counseled, 67% whose partners came but were not couple counseled, and 45% whose partners did not present for VCT (P for trend = 0.006). HIV-1-seropositive women receiving couple counseling were 5-fold more likely to avoid breast-feeding (P = 0.03) compared with those counseled individually. Partner notification of HIV-1-positive results was reported by 138 women (64%) and was associated with 4-fold greater likelihood of condom use (P = 0.004). Partner participation in VCT and couple counseling increased uptake of nevirapine and formula feeding. Antenatal couple counseling may be a useful strategy to promote HIV-1 prevention interventions.
PMCID: PMC3358138  PMID: 11371706
voluntary counseling and testing; couple counseling; mother-to-child HIV-1 transmission; breastfeeding; nevirapine; condom use; partner notification
17.  Association between Participant Self-Report and Biological Outcomes Used to Measure Sexual Risk Behavior in HIV-1-Seropositive Female Sex Workers in Mombasa, Kenya 
Sexually transmitted diseases  2011;38(5):429-433.
Background
Few studies have examined the association between self-reported sexual risk behaviors and biological outcomes in HIV-1-seropositive African adults.
Methods
We conducted a prospective cohort study in 898 HIV-1-seropositive women who reported engaging in transactional sex in Mombasa, Kenya. Primary outcome measures included detection of sperm in genital secretions, pregnancy, and sexually transmitted infections (STIs). Because three outcomes were evaluated, data are presented with odds ratios [OR] and 96.7% confidence intervals [CI] to reflect that we would reject a null hypothesis if a p-value were ≤0.033 (Simes’ methodology).
Results
During 2,404 person-years of follow-up, self-reported unprotected intercourse was associated with significantly higher likelihood of detecting sperm in genital secretions (OR 2.32, 96.7% CI 1.93, 2.81), and pregnancy (OR 2.78, 96.7% CI 1.57, 4.92), but not with detection of STIs (OR 1.20, 96.7% CI 0.98, 1.48). At visits where women reported being sexually active, having >1 sex partner in the past week was associated with lower likelihood of detecting sperm in genital secretions (OR 0.74, 96.7% CI 0.56, 0.98). This association became non-significant after adjustment for reported condom use (adjusted OR 0.81, 96.7% CI 0.60, 1.08).
Conclusions
Combining behavioral and biological outcomes, which provide complementary information, is advantageous for understanding sexual risk behavior in populations at risk for transmitting HIV-1. The paradoxical relationship between higher numbers of sex partners and less frequent identification of sperm in genital secretions highlights the potential importance of context-specific behavior, such as condom use dependent on partner type, when evaluating sexual risk behavior.
doi:10.1097/OLQ.0b013e31820369f6
PMCID: PMC3155001  PMID: 21217420
HIV-1; sexually transmitted disease; women; Africa; sexual risk behavior
18.  Independent Effects of Nevirapine Prophylaxis and HIV-1 RNA Suppression in Breast Milk on Early Perinatal HIV-1 Transmission 
Background
The mechanism of action of single-dose nevirapine on reducing mother-to-child transmission of HIV-1 may involve reduction of maternal HIV-1 or prophylaxis of infants.
Methods
In a study that randomized pregnant mothers to HIVNET 012 nevirapine versus short-course antenatal zidovudine, we compared breast milk HIV-1 RNA viral shedding and administration of single-dose nevirapine between mothers who transmitted HIV-1 to their infants at 6 weeks postpartum and those who did not.
Results
In multivariate analyses, maximum breast milk HIV-1 RNA levels (hazard ratio [HR] = 2.50, 95% confidence interval [CI]: 1.25 to 4.99; P = 0.01) and nevirapine use (HR = 0.12, 95% CI: 0.02 to 0.97; P = 0.05) were each independently associated with perinatal transmission at 6 weeks postpartum. Mothers who transmitted HIV-1 to their infants had significantly higher HIV-1 RNA levels in their breast milk between the second day and sixth week postpartum. Among mothers with maximum breast milk virus levels less than a median of 3.5 log10 copies/mL, the administration of nevirapine further decreased HIV-1 transmission risk from 22.2% to 0.0% (P = 0.04).
Conclusions
Peripartum administration of single-dose nevirapine to mother and infant decreases early perinatal HIV-1 transmission by means of breast milk HIV-1 RNA suppression and, independently, by providing the infant with exposure prophylaxis.
PMCID: PMC3310242  PMID: 18077838
Africa; breast milk; HIV-1; mother-to-child transmission; nevirapine; prevention of perinatal transmission
19.  Uptake of prevention of mother to child transmission interventions in Kenya: health systems are more influential than stigma 
Background
We set out to determine the relative roles of stigma versus health systems in non-uptake of prevention of mother to child transmission (PMTCT) of HIV-1 interventions: we conducted cross-sectional assessment of all consenting mothers accompanying infants for six-week immunizations.
Methods
Between September 2008 and March 2009, mothers at six maternal and child health clinics in Kenya's Nairobi and Nyanza provinces were interviewed regarding PMTCT intervention uptake during recent pregnancy. Stigma was ascertained using a previously published standardized questionnaire and infant HIV-1 status determined by HIV-1 polymerase chain reaction.
Results
Among 2663 mothers, 2453 (92.1%) reported antenatal HIV-1 testing. Untested mothers were more likely to have less than secondary education (85.2% vs. 74.9%, p = 0.001), be from Nyanza (47.1% vs. 32.2%, p < 0.001) and have lower socio-economic status. Among 318 HIV-1-infected mothers, 90% reported use of maternal or infant antiretrovirals. Facility delivery was less common among HIV-1-infected mothers (69% vs. 76%, p = 0.009) and was associated with antiretroviral use (p < 0.001). Although internal or external stigma indicators were reported by between 12% and 59% of women, stigma was not associated with lower HIV-1 testing or infant HIV-1 infection rates; internal stigma was associated with modestly decreased antiretroviral uptake. Health system factors contributed to about 60% of non-testing among mothers who attended antenatal clinics and to missed opportunities in offering antiretrovirals and utilization of facility delivery. Eight percent of six-week-old HIV-1-exposed infants were HIV-1 infected.
Conclusions
Antenatal HIV-1 testing and antiretroviral uptake was high (both more than 90%) and infant HIV-1 infection risk was low, reflecting high PMTCT coverage. Investment in health systems to deliver HIV-1 testing and antiretrovirals can effectively prevent infant HIV-1 infection despite substantial HIV-1 stigma.
doi:10.1186/1758-2652-14-61
PMCID: PMC3313883  PMID: 22204313
mother-to-child HIV transmission; HIV/AIDS; Health system; testing; antiretrovirals; facility delivery
20.  Antiretroviral Adherence and Development of Drug Resistance Are the Strongest Predictors of Genital HIV-1 Shedding among Women Initiating Treatment 
The Journal of infectious diseases  2010;202(10):1538-1542.
Persistent genital HIV-1 shedding among women taking antiretroviral therapy (ART) may present a transmission risk. We investigated associations between genital HIV-1 suppression after ART initiation and adherence, resistance, pre-treatment CD4 count, and hormonal contraceptive use. First-line ART was initiated in 102 women. Plasma and genital HIV-1 RNA were measured at months 0, 3, and 6. Adherence was a strong and consistent predictor of genital HIV-1 suppression (p<0.001), while genotypic resistance was associated with higher vaginal HIV-1 RNA at 6 months (p=0.04). These results emphasize the importance of adherence to optimize the potential benefits of ART for reducing HIV-1 transmission risk.
doi:10.1086/656790
PMCID: PMC2957525  PMID: 20923373
antiretroviral therapy; HIV infection; women; genital HIV-1 shedding
21.  Predicting Pregnancy in HIV-1-Discordant Couples 
AIDS and behavior  2010;14(5):1066-1071.
This study examines the incidence and predictors of pregnancy in HIV-1-discordant couples from Nairobi, Kenya. Women from 454 discordant couples were followed for up to 2 years. One-year cumulative incidence of pregnancy was 9.7%. Pregnancy rates did not differ significantly between HIV-1-infected and uninfected women (HR = 1.46). The majority of pregnancies occurred among women < 30 years old reporting a desire for future children (1-year incidence 22.2%). Pregnancy rates may be high among discordant couples, indicating desire for children may override concerns of HIV-1 transmission and increase unprotected sex, and highlighting the need to make conception safer.
doi:10.1007/s10461-010-9716-x
PMCID: PMC3051103  PMID: 20544384
HIV; Discordant couples; Serodiscordant; Pregnancy; Predictors; Risk factor
22.  Increased Risk of HIV-1 Transmission in Pregnancy: A Prospective Study among African HIV-1 Serodiscordant Couples 
AIDS (London, England)  2011;25(15):1887-1895.
Background
Physiologic and behavioral changes during pregnancy may alter HIV-1 susceptibility and infectiousness. Prospective studies exploring pregnancy and HIV-1 acquisition risk in women have found inconsistent results. No study has explored the effect of pregnancy on HIV-1 transmission risk from HIV-1 infected women to male partners.
Methods
In a prospective study of African HIV-1 serodiscordant couples, we evaluated the relationship between pregnancy and the risk of 1) HIV-1 acquisition among women and 2) HIV-1 transmission from women to men.
Results
3321 HIV-1 serodiscordant couples were enrolled, 1085 (32.7%) with HIV-1 susceptible female partners and 2236 (67.3%) with susceptible male partners. HIV-1 incidence in women was 7.35 versus 3.01 per 100 person-years during pregnant and non-pregnant periods (hazard ratio [HR] 2.34, 95% confidence interval [CI] 1.33–4.09). This effect was attenuated and not statistically significant after adjusting for sexual behavior and other confounding factors (adjusted HR 1.71, 95% CI 0.93–3.12). HIV-1 incidence in male partners of infected women was 3.46 versus 1.58 per 100 person-years when their partners were pregnant versus not pregnant (HR 2.31, 95% CI 1.22–4.39). This effect was not attenuated in adjusted analysis (adjusted HR 2.47, 95% CI 1.26–4.85).
Conclusions
HIV-1 risk increased two-fold during pregnancy. Elevated risk of HIV-1 acquisition in pregnant women appeared in part to be explained by behavioral and other factors. This is the first study to show pregnancy increased the risk of female-to-male HIV-1 transmission, which may reflect biological changes of pregnancy that could increase HIV-1 infectiousness.
doi:10.1097/QAD.0b013e32834a9338
PMCID: PMC3173565  PMID: 21785321
pregnancy; HIV-1 transmission; Africa; heterosexual; serodiscordant
23.  A Randomized Controlled Trial Comparing the Effects of Counseling and Alarm Device on HAART Adherence and Virologic Outcomes 
PLoS Medicine  2011;8(3):e1000422.
Michael Chung and colleagues show that intensive early adherence counseling at HAART initiation resulted in sustained, significant impact on adherence and virologic treatment failure, whereas use of an alarm device had no effect.
Background
Behavioral interventions that promote adherence to antiretroviral medications may decrease HIV treatment failure. Antiretroviral treatment programs in sub-Saharan Africa confront increasing financial constraints to provide comprehensive HIV care, which include adherence interventions. This study compared the impact of counseling and use of an alarm device on adherence and biological outcomes in a resource-limited setting.
Methods and Findings
A randomized controlled, factorial designed trial was conducted in Nairobi, Kenya. Antiretroviral-naïve individuals initiating free highly active antiretroviral therapy (HAART) in the form of fixed-dose combination pills (d4T, 3TC, and nevirapine) were randomized to one of four arms: counseling (three counseling sessions around HAART initiation), alarm (pocket electronic pill reminder carried for 6 months), counseling plus alarm, and neither counseling nor alarm. Participants were followed for 18 months after HAART initiation. Primary study endpoints included plasma HIV-1 RNA and CD4 count every 6 months, mortality, and adherence measured by monthly pill count. Between May 2006 and September 2008, 400 individuals were enrolled, 362 initiated HAART, and 310 completed follow-up. Participants who received counseling were 29% less likely to have monthly adherence <80% (hazard ratio [HR] = 0.71; 95% confidence interval [CI] 0.49–1.01; p = 0.055) and 59% less likely to experience viral failure (HIV-1 RNA ≥5,000 copies/ml) (HR 0.41; 95% CI 0.21–0.81; p = 0.01) compared to those who received no counseling. There was no significant impact of using an alarm on poor adherence (HR 0.93; 95% CI 0.65–1.32; p = 0.7) or viral failure (HR 0.99; 95% CI 0.53–1.84; p = 1.0) compared to those who did not use an alarm. Neither counseling nor alarm was significantly associated with mortality or rate of immune reconstitution.
Conclusions
Intensive early adherence counseling at HAART initiation resulted in sustained, significant impact on adherence and virologic treatment failure during 18-month follow-up, while use of an alarm device had no effect. As antiretroviral treatment clinics expand to meet an increasing demand for HIV care in sub-Saharan Africa, adherence counseling should be implemented to decrease the development of treatment failure and spread of resistant HIV.
Trial registration
ClinicalTrials gov NCT00273780
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Adherence to HIV treatment programs in poor countries has long been cited as an important public health concern, especially as poor adherence can lead to drug resistance and inadequate treatment of HIV. However, two factors have recently cast doubt on the poor adherence problem: (1) recent studies have shown that adherence is high in African HIV treatment programs and often better than in Western HIV clinics. For example, in a meta-analysis of 27 cohorts from 12 African countries, adequate adherence was noted in 77% of subjects compared to only 55% among 31 North America cohorts; (2) choice of antiretroviral regimens may impact on the development of antiretroviral resistance. In poor countries, most antiretroviral regimens contain non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as nevirapine or efavirenz, which remain in the patient's circulation for weeks after single-dose administration. This situation means that such patients may not experience antiretroviral resistance unless they drop below 80% adherence—contrary to the more stringent 95% plus adherence levels needed to prevent resistance in regimens based on unboosted protease inhibitors—ultimately, off-setting some treatment lapses in resource-limited settings where NNRTI-based regimens are widely used.
Why Was This Study Done?
Given that adherence may not be as crucial an issue as previously thought, antiretroviral treatment programs in sub-Saharan Africa may be spending scarce resources to promote adherence to the detriment of some potentially more effective elements of HIV treatment and management programs. Although many treatment programs currently include adherence interventions, there is limited quality evidence that any of these methods improve long-term adherence to HIV treatment. Therefore, it is necessary to identify adherence interventions that are inexpensive and proven to be effective in resource-limited settings. As adherence counseling is already widely implemented in African HIV treatment programs and inexpensive alarm devices are thought to also improve compliance, the researchers compared the impact of adherence counseling and the use of an alarm device on adherence and biological outcomes in patients enrolled in HIV programs in rural Kenya.
What Did the Researchers Do and Find?
The researchers enrolled 400 eligible patients (newly diagnosed with HIV, never before taken antiretroviral therapy, aged over 18 years) to four arms: (1) adherence counseling alone; (2) alarm device alone; (3) both adherence counseling and alarm device together; and (4) a control group that received neither adherence counseling nor alarm device. The patients had blood taken to record baseline CD4 count and HIV-1 RNA and after starting HIV treatment, returned to the study clinic every month with their pill bottles for the study pharmacist to count and recorded the number of pills remaining in the bottle, and to receive another prescription. Patients were followed up for 18 months and had their CD4 count and HIV-1 RNA measured at 6, 12, and 18 months.
Patients receiving adherence counseling were 29% less likely to experience poor adherence compared to those who received no counseling. Furthermore, those receiving intensive early adherence counseling were 59% less likely to experience viral failure. However, there was no significant difference in mortality or significant differences in CD4 counts at 18 months follow-up between those who received counseling and those who did not. There were no significant differences in adherence, time to viral failure, mortality, or CD4 counts in patients who received alarm devices compared to those who did not.
What Do These Findings Mean?
The results of this study suggest that intensive adherence counseling around the time of HIV treatment initiation significantly reduces poor adherence and virologic treatment failure, while using an alarm device has no effect. Therefore, investment in careful counseling based on individual needs at the onset of HIV treatment initiation, appears to have sustained benefit, possibly through strengthening the relationship between the health care provider and patient through communication, education, and trust. Interactive adherence counseling supports the bond between the clinic and the patient and may result in fewer patients needing to switch to expensive second-line medications and, possibly, may help to decrease the spread of resistant HIV. These findings define an adherence counseling protocol that is effective and are highly relevant to other HIV clinics caring for large numbers of patients in sub-Saharan Africa.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000422.
UNAIDS provides information about HIV treatment strategies
The American Public Health Association has information about adherence to HIV treatment regimens
The US Department of Health and Human Services has information for patients about adherence to HIV treatment
The World Health Organization provides information about HIV treatment pharmacovigilance
doi:10.1371/journal.pmed.1000422
PMCID: PMC3046986  PMID: 21390262
24.  HIV testing men in the antenatal setting: understanding male non-disclosure 
International journal of STD & AIDS  2009;20(11):765-767.
Summary
Prevention of infant HIV is a powerful incentive for maternal HIV diagnosis and an opportunity to increase male HIV testing and disclosure of HIV status within couples. We examined male HIV disclosure in couples who attended a Nairobi antenatal clinic (ANC), had individual HIV testing, and were counseled to disclose to their partner. At 2-week follow-up, males and females independently reported HIV disclosure. Of 2,104 women, 1,993 requested partner attendance; 313 male partners came, of whom 183 chose individual HIV testing. Of 106 couples who followed-up, 93% of both partners reported disclosure by females vs. 71% by males (p<0.0001); 27% of men reported disclosure while their female partner reported not knowing partner HIV status. In these couples, male ANC HIV testing did not result in shared knowledge of HIV status. Couple counseling models that incorporate disclosure may yield greater HIV prevention benefits than offering individual partner HIV testing services at ANC.
doi:10.1258/ijsa.2009.009139
PMCID: PMC3042848  PMID: 19833691
HIV counseling and testing; Africa; men; serostatus disclosure; couples
25.  Impact of Prior HAART Use on Clinical Outcomes in a Large Kenyan HIV Treatment Program 
Current HIV research  2009;7(4):441-446.
Background
HIV treatment programs in Africa typically approach all enrolling patients uniformly. Growing numbers of patients are antiretroviral experienced. Defining patients on the basis of antiretroviral experience may inform enrollment practices, particularly if medical outcomes differ.
Methods
Baseline and follow-up measures (CD4, weight change, and survival) were compared in a retrospective analysis between antiretroviral-naïve (ARV-N) and antiretroviral experience (ARV-E) patients enrolled at the Coptic Hope Center for Infectious Diseases in Nairobi, Kenya and followed between January 2004 and August 2006.
Results
1,307 ARV-N and 962 ARV-E patients receiving highly active antiretroviral therapy (HAART) were followed for median of 9 months (interquartile range: 4-16 months). Compared to ARV-N, ARV-E had substantially higher CD4 count (median cells/mm3, 193 versus 95, P < 0.001) and weight (median kg, 62 versus 57, P < 0.001) at baseline, and lower rates of change in CD4 (-9.2 cells/mm3/month; 95% CI, -11.4 - -7.0) and weight (-0.24 kg/month; 95% CI, -0.35 - -0.14) over 12 months. Mortality was significantly higher in ARV-N than ARV-E (P = 0.001).
Conclusions
ARV-E patients form a growing group that differs significantly from ARV-N patients and requires a distinct approach from ARV-N clients. Systematic approaches to streamline care of ARV-E patients may allow focused attention on early ARV-N clients whose mortality risks are substantially higher.
PMCID: PMC2735680  PMID: 19601781
Africa; HAART; HIV-1; clinic flow; experience; mortality

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