Factors associated with the timely uptake of initial HIV virologic test among HIV-exposed infants attending clinics within a faith-based HIV program in Kenya; a cross-sectional study.

BACKGROUND: Early infant diagnosis (EID) of HIV, followed by effective care including antiretroviral therapy (ART), reduces infant mortality by 76% and HIV progression by 75%. In 2015, 50% of 1.2 million HIV-exposed infants (HEI) in 21 priority countries received a virologic test within the recommended 2 months of birth. We sought to identify factors associated with timely uptake of virologic EID among HEI and gain insight into missed opportunities. METHODS: This was a cross-sectional study that used de-identified data from electronic medical records of 54 health facilities within the Christian Health Association of Kenya (CHAK) HIV Project database. All HEI who had their first HIV virologic test done between January 2015 and December 2017 were included in the study and categorized as either having the test within or after 8 weeks of birth. Multivariate linear mixed effects regression model was used to determine factors associated with uptake of the first HIV EID polymerase chain reaction (PCR). Predictor variables studied include sex, birth weight, the entry point into care, provision of ART prophylaxis for the infant, maternal ART at time of EID, mode of delivery, and place of delivery. RESULTS: We included 2020 HEI of whom 1018 (50.4%) were female. A majority, 1596 (79.0%) had their first HIV PCR within 2 months of birth at a median age of 6.4 weeks (interquartile range 6-7.4). Overall, HIV positivity rate at initial test among this cohort was 1.2%. Delayed HIV PCR testing for EID was more likely to yield a positive result [adjusted odds ratio (aOR) = 1.29 (95% confidence interval (CI) 1.09-1.52) p = 0.003]. Infants of mothers not on ART at the time of HIV PCR test and infants who had not received prophylaxis to prevent vertical HIV transmission had significant increased odds of a delayed initial test [aOR = 1.27 (95% CI = 1.18-1.37) p = < 0.0001] and [aOR = 1.43 (95% CI 1.27-1.61) p = < 0.001] respectively. CONCLUSION: An initial HIV PCR test done after 8 weeks of birth is likely to yield a positive result. Barriers to accessing ART for treatment among HIV-infected pregnant and breastfeeding women, and prophylaxis for the HEI were associated with delayed EID. In order to ensure timely EID, programs need to incorporate both facility and community strategy interventions to ensure all pregnant women seek antenatal care and deliver within health facilities.

Prevalence and correlates of cervical squamous intraepithelial lesions among HIV-infected and uninfected women in Central Kenya.

INTRODUCTION: cervical intraepithelial neoplasia the precursor of cervical cancer occurs with increased frequency in women infected with human immunodeficiency virus (HIV). This study aimed at determining the prevalence and correlates of abnormal cervical cytology among HIV-infected women and compare to the uninfected women. METHODS: a cross-sectional study conducted among HIV-infected and uninfected women enrolled in a HIV study in Central Kenya. All women had baseline Pap smear examination assessed using Bethesda system. Bivariate and multivariate logistic regression methods were employed to assess the correlates of cervical squamous epithelial lesions (CSIL). RESULTS: a total 480 women had an acceptable baseline smear, 373 (78%) were HIV-infected. Median age was 30.2 years [IQR 25.4-35.5]. Overall prevalence of CSIL was 37% (176/480) with the prevalence of low grade squamous intraepithelial lesion (LSIL), atypical squamous cells undetermined significance (ASCUS), high grade squamous intraepithelial lesions (HSIL) and atypical glandular cells (AGC) were 17%, 14%, 4% and 2% respectively. HIV-infected women had a higher prevalence of CSIL at 42% as compared to HIV-uninfected women at 19%. HIV infection was the predictor associated with development of CSIL at multivariate analysis and specifically, HIV-infected women were 3 times (AOR 3.1, 95% CI: 1.8 - 5.4, p<0.005) more likely to have CSIL than HIV-uninfected women. The age 35 - 44 years was protective to developing CSIL (AOR 0.45, 95% CI: 0.24 - 0.87, p=0.018). CONCLUSION: cervical squamous epithelial lesions is a major problem among Kenyan women. HIV infection confers a higher risk to development of CSIL. Cervical cancer screening should be an established practice in HIV programs.

Quadrivalent HPV vaccine in HIV-1-infected early adolescent girls and boys in Kenya: Month 7 and 12 post vaccine immunogenicity and correlation with immune status.

INTRODUCTION: In sub-Saharan Africa, a generation of HIV-1-infected children is approaching the age of sexual debut and becoming at risk for HPV infection and its sequelae. We assessed safety and immunogenicity of the quadrivalent HPV (qHPV) vaccine in HIV-1-infected adolescents. METHODS: In an open-label trial among Kenyan, HIV-1-infected adolescents aged 9-14 years, we administered the qHPV vaccine at 0, 2 and 6 months and measured antibody titers to HPV-16, 18, 6 and 11 at month 7 and 12 post-vaccination. Measures of immunogenic response from HIV-1-negative historical cohorts from Africa and HIV-1 positive adolescent cohorts from the USA were used for comparison. RESULTS: We enrolled 100 girls and 80 boys with a median age of 12 years and median baseline CD4 cell count of 684 (IQR 478, 935) cells/µL. One hundred and fifty four (86%) were receiving antiretroviral therapy for a median of 4.5 (IQR 2.3, 6.3) years; 110 (71%) had <400 copies of plasma HIV-1 RNA/mL. Of 189 enrolled children, 179 received all three doses. Two hundred and eighty five (64%) of 445 adverse events were injection site reactions; none were greater than grade 2. Of 6 Serious Adverse Events (SAEs), none were considered vaccine related. Seroconversion to HPV-18, 16, 11, 6 at month 7 occurred in 93.3%, 98.3%, 97.2% and 99.6% of vaccine recipients; similar rates have been reported in historical controls. The mean log10 HPV antibody titer measured at month 7 increased with each log10 increase in CD4 by 1.4 (95% CI: 1.1-1.7) for HPV-18; 1.2 (0.9-1.4) for HPV-16; 1.1 (0.8-1.3) for HPV-11; 0.7 (0.5-1.0) for HPV-6 (all p < 0.0001). CONCLUSION: Almost all Kenyan HIV-1-infected adolescents mounted an immune response comparable to other immunized populations. HPV antibody titers were higher in those with preserved CD4 cell counts. Longer term-follow up will determine sustainability of the immune response. ClinicalTrials.gov number, NCT00557245.

Feasibility and acceptability of HIV self-testing among pre-exposure prophylaxis users in Kenya.

INTRODUCTION: HIV testing is key to the delivery of pre-exposure prophylaxis (PrEP): testing HIV-uninfected at-risk persons is the first step for PrEP initiation and ongoing HIV testing is an essential part of PrEP delivery. Thus, novel and cost-effective HIV-testing approaches to streamline delivery of PrEP are urgently needed. Within a demonstration project of PrEP for HIV prevention among high-risk HIV serodiscordant couples in Kenya (the Partners Demonstration Project), we conducted a pilot evaluation of HIV self-testing. METHODS: Clinic visits were scheduled quarterly and included in-clinic HIV testing using fingerstick rapid HIV tests and refills of PrEP prescriptions. HIV oral fluid self-test kits were provided for participants to use in the two-month interval between scheduled quarterly clinic visits. Acceptability of HIV self-testing was assessed using both quantitative and qualitative methods. RESULTS: We found that 222 of 226 (98%) HIV-uninfected persons who were offered accepted self-testing. Nearly all (96.8%) reported that using the self-testing kit was easy. More than half (54.5%) reportedly did not share the HIV results from self-testing with anyone and almost all (98.7%) the participants did not share the HIV self-testing kits with anyone. Many participants reported that HIV self-testing was empowering and reduced anxiety associated with waiting between clinic HIV tests. CONCLUSION: HIV self-testing was highly acceptable and may therefore be a feasible strategy to efficiently permit routine HIV testing between PrEP refills.