Delay of antiretroviral therapy initiation is common in East African HIV-infected individuals in serodiscordant partnerships.

Objective: WHO guidance recommends antiretroviral therapy (ART) initiation for all persons with a known HIV-uninfected partner, as a strategy to prevent HIV transmission. Uptake of ART among HIV-infected partners in serodiscordant partnerships is not known, which we evaluated in African HIV serodiscordant couples.

Design: Prospective cohort study.

Pre-exposure prophylaxis for HIV-1 prevention does not diminish the pregnancy prevention effectiveness of hormonal contraception.

Background: For women at risk of HIV-1, effective contraception and effective HIV-1 prevention are global priorities.

Methodology: In a clinical trial of pre-exposure prophylaxis (PrEP) for HIV-1 prevention in HIV-1-serodiscordant couples, we estimated the effectiveness of hormonal contraceptives (oral contraceptive pills, injectable depot medroxyprogesterone acetate, and hormonal implants) for pregnancy prevention relative to no contraception among 1785 HIV-1-uninfected women followed up to 36 months. We compared the effectiveness of each method among women assigned PrEP versus placebo.

HIV protective efficacy and correlates of tenofovir blood concentrations in a clinical trial of PrEP for HIV prevention.

Background: Antiretroviral pre-exposure prophylaxis (PrEP) is a novel HIV prevention strategy for which adherence is a known determinant of efficacy. Blood concentrations of PrEP medications are one objective marker of adherence.

Methods: In a placebo-controlled PrEP efficacy trial of tenofovir disoproxil fumarate (TDF) and TDF with emtricitabine (FTC/TDF) among 4747 African women and men with an HIV-infected partner, we measured plasma tenofovir concentrations from participants in the active PrEP arms: 29 HIV seroconverters (cases) and 196 randomly selected controls who remained uninfected.

My intention was a child but I was very afraid: fertility intentions and HIV risk perceptions among HIV-serodiscordant couples experiencing pregnancy in Kenya.

We sought to understand fertility intentions and HIV risk considerations among Kenyan HIV-serodiscordant couples who became pregnant during a prospective study. We conducted individual in-depth interviews (n = 36) and focus group discussions (n = 4) and performed qualitative data analysis and interpretation using an inductive approach. Although most of the couples were aware of the risk of horizontal and vertical HIV transmission, almost all couples reported that they had intended to become pregnant and that the desire for children superseded HIV risk considerations.

A prospective study of the effect of pregnancy on CD4 counts and plasma HIV-1 RNA concentrations of antiretroviral-naive HIV-1-infected women.

Background: In HIV-1-infected women, CD4 count declines occur during pregnancy, which has been attributed to hemodilution. However, for women who have not initiated antiretroviral therapy, it is unclear if CD4 declines are sustained beyond pregnancy and accompanied by increased viral levels, which could indicate an effect of pregnancy on accelerating HIV-1 disease progression.

Methods: In a prospective study among 2269 HIV-1-infected antiretroviral therapy-naive women from 7 African countries, we examined the effect of pregnancy on HIV-1 disease progression.

HIV-1 subtype C is not associated with higher risk of heterosexual HIV-1 transmission: a multinational study among HIV-1 serodiscordant couples.

Background: HIV-1 subtype C has emerged as the most prevalent strain of HIV-1 worldwide, leading to speculation that subtype C may be more transmissible than other subtypes. We compared the risk of HIV-1 transmission for subtype C versus non-C subtypes (A, D, G and recombinant forms) among heterosexual African HIV-1 serodiscordant couples.

Methods: We conducted a nested case-control analysis using data from two prospective cohort studies of heterosexual HIV-1 serodiscordant couples from six countries in eastern and southern Africa.

'If I am given antiretrovirals I will think I am nearing the grave': Kenyan HIV serodiscordant couples' attitudes regarding early initiation of antiretroviral therapy.

Objectives: Early initiation of antiretroviral therapy (ART) - that is, at higher CD4 cell counts (>350 cells/μl) - is a potent HIV prevention strategy. The WHO recommends ART initiation by all HIV-infected individuals in HIV serodiscordant relationships to prevent HIV transmission, yet the acceptability of early ART among couples has not been well studied.

Design: Qualitative study exploring HIV serodiscordant couples' attitudes toward early initiation of ART.

Efficacy of preexposure prophylaxis for HIV-1 prevention among high-risk heterosexuals: subgroup analyses from a randomized trial.

Background: Daily oral antiretroviral preexposure prophylaxis (PrEP) is a promising strategy for prevention of HIV-1 acquisition. Three clinical trials demonstrated PrEP efficacy; however, two PrEP trials among women did not find protection against HIV-1. One hypothesis proposed for these divergent results is that PrEP efficacy may be reduced in populations with higher HIV-1 incidence.

Prevalence and incidence of cervical intra-epithelial neoplasia among female sex workers in Korogocho, Kenya.

Setting: Sex Workers Outreach Programme Clinic, Korogocho, Nairobi, Kenya.

Objective: In a cohort of sex workers, to determine 1) the prevalence of cervical intra-epithelial neoplasia (CIN) and its association with human immunodeficiency virus-1 (HIV-1) infection, and 2) the incidence rate of CIN during the 3-year follow-up from December 2009 to December 2012.

Design: Prospective nested cohort study.

Clustering patterns of human papillomavirus infections among HIV-positive women in Kenya.

Background: HIV-positive women are at increased risk of human papillomavirus (HPV) infection, and, especially, multiple infections compared to HIV-negative women. Whether certain HPV types have a tendency to cluster in multiple infections beyond or below what would be expected by shared risk factors (e.g.

Toll-like receptor polymorphism associations with HIV-1 outcomes among sub-Saharan Africans.

Objective: We evaluated Toll-like receptors (TLRs) single nucleotide polymorphisms (SNPs) for associations with HIV-1 acquisition, set-point and disease progression in African couples.

Methods: Seven candidate and 116 haplotype-tagging SNPs (tagSNPs) were genotyped in 504 HIV-1 infected cases, and 343 seronegative controls.

Results: TLR9 1635A/G was associated with reduced HIV-1 acquisition among HIV-seronegative controls with high but not low HIV-1 exposure (odds ratio [OR] = 0.

Sexual behaviour of heterosexual men and women receiving antiretroviral pre-exposure prophylaxis for HIV prevention: a longitudinal analysis.

Background: Scarce data are available to assess sexual behaviour of individuals using antiretroviral pre-exposure prophylaxis for HIV prevention. Increased sexual risk taking by individuals using effective HIV prevention strategies, like pre-exposure prophylaxis, could offset the benefits of HIV prevention. We studied whether the use of pre-exposure prophylaxis in HIV-uninfected men and women in HIV-serodiscordant couples was associated with increased sexual risk behaviour.

Stable CD4 expression and local immune activation in the ectocervical mucosa of HIV-infected women.

Studies using genital tissue samples from HIV-infected women might provide important information about HIV susceptibility and transmission. In this study, ectocervical biopsies were obtained from 20 HIV-seropositive (HIV(+)) Kenyan female sex workers (FSW) and 20 HIV-seronegative lower risk (HIV(-) LR) women. To control for the impact of sex work, 20 HIV(-) FSW were also recruited.

High-risk human papillomavirus messenger RNA testing in physician- and self-collected specimens for cervical lesion detection in high-risk women, Kenya.

Background: Little is known about the performance of physician-versus self-collected specimens for high-risk human papillomavirus (hrHPV) messenger RNA (mRNA) testing or risk factors for hrHPV mRNA positivity in physician- versus self-collected specimens. We compared the performance of hrHPV mRNA testing of physician- and self-collected specimens for detecting cytological high-grade squamous intraepithelial lesions or more severe (≥HSIL) and examined risk factors for hrHPV mRNA positivity in female sex workers in Nairobi.

Methods: From 2009 to 2011, 344 female sex workers participated in this cross-sectional study.

Comparing Papanicolau smear, visual inspection with acetic acid and human papillomavirus cervical cancer screening methods among HIV-positive women by immune status and antiretroviral therapy.

Background: A rigorous comparison of cervical cancer screening methods utilizing data on immune status, antiretroviral therapy (ART) and colposcopy-directed biopsy has not been performed among HIV-positive women.

Methods: Between June and November 2009, 500 HIV-positive women were enrolled at an HIV treatment clinic in Nairobi, Kenya, and underwent Papanicolau (Pap) smear, visual inspection with acetic acid (VIA), human papillomavirus (HPV) and colposcopy-directed biopsy (gold standard). Positive Pap smear (ASCUS+, LSIL+, HSIL+), VIA, HPV and their combinations were compared with CIN2/3+.

Daily short message service surveys to measure sexual behavior and pre-exposure prophylaxis use among Kenyan men and women.

Pre-exposure prophylaxis (PrEP) is a novel HIV prevention strategy which requires high adherence. We tested the use of daily short message service (i.e.

Multiple human papillomavirus infections and HIV seropositivity as risk factors for abnormal cervical cytology among female sex workers in Nairobi.

We estimated type-specific prevalence of human papillomavirus (HPV) and examined risk factors for abnormal cervical cytology among 296 female sex workers from Nairobi, Kenya. Over half (54%) were infected with a high-risk (HR) HPV type, of which HPV16 and 52 were the most common types. HIV-1 prevalence was 23% and HIV-1 sero-positivity was associated with high-grade cervical lesions, particularly among women with CD4 count less than 500 cells/mm(3) (odds ratio [OR] = 6.

Comparison of HPV DNA testing in cervical exfoliated cells and tissue biopsies among HIV-positive women in Kenya.

HIV-positive women are infected with human papillomavirus (HPV) (especially with multiple types), and develop cervical intraepithelial neoplasia (CIN) and cervical cancer more frequently than HIV-negative women. We compared HPV DNA prevalence obtained using a GP5+/6+ PCR assay in cervical exfoliated cells to that in biopsies among 468 HIV-positive women from Nairobi, Kenya. HPV prevalence was higher in cells than biopsies and the difference was greatest in 94 women with a combination normal cytology/normal biopsy (prevalence ratio, PR = 3.

Plasma viral loads during early HIV-1 infection are similar in subtype C- and non-subtype C-infected African seroconverters.

Recent data suggest that infection with human immunodeficiency virus type 1 (HIV-1) subtype C results in prolonged high-level viremia (>5 log10 copies/mL) during early infection. We examined the relationship between HIV-1 subtype and plasma viremia among 153 African seroconverters. Mean setpoint viral loads were similar for C and non-C subtypes: 4.

Using plasma viral load to guide antiretroviral therapy initiation to prevent HIV-1 transmission.

Background: Current WHO guidelines recommend antiretroviral therapy (ART) initiation at CD4 counts ≤350 cells/µL. Increasing this threshold has been proposed, with a primary goal of reducing HIV-1 infectiousness. Because the quantity of HIV-1 in plasma is the primary predictor of HIV-1 transmission, consideration of plasma viral load in ART initiation guidelines is warranted.

An empiric risk scoring tool for identifying high-risk heterosexual HIV-1-serodiscordant couples for targeted HIV-1 prevention.

Background And Objectives: Heterosexual HIV-1-serodiscordant couples are increasingly recognized as an important source of new HIV-1 infections in sub-Saharan Africa. A simple risk assessment tool could be useful for identifying couples at highest risk for HIV-1 transmission.

Methods: Using data from 3 prospective studies of HIV-1-serodiscordant couples from 7 African countries and standard methods for development of clinical prediction rules, the authors derived and validated a risk scoring tool developed from multivariate modeling and composed of key predictors for HIV-1 risk that could be measured in standard research and clinical settings.

Immune response to hepatitis B virus vaccination among HIV-1 infected and uninfected adults in Kenya.

Background: In studies from high-income countries, human immunodeficiency virus type 1 (HIV-1)-infected persons have diminished responses to hepatitis B virus (HBV) vaccination, compared with HIV-1-uninfected persons, but data from other settings are limited.

Methods: We compared the immune response to HBV vaccination among HIV-1-infected and HIV-1-uninfected Kenyan adults and assessed the response of HIV-1-infected initial nonresponders to revaccination with a standard HBV vaccine series.

Results: Of 603 participants, 310 (51.