BACKGROUND: Integrating antenatal care (ANC) and HIV care may improve uptake and retention in services along the prevention of mother-to-child transmission (PMTCT) cascade. The current study aimed to determine if integration of HIV services into ANC settings improves PMTCT service utilization outcomes. METHODS: ANC clinics in rural Kenya were randomized to integrated (6 clinics, 569 women) or non-integrated (6 clinics, 603 women) services. Intervention clinics provided all HIV services, including highly active antiretroviral therapy (HAART), while control clinics provided PMTCT services but referred women to HIV care clinics within the same facility. PMTCT utilization outcomes among HIV-infected women (maternal HIV care enrollment, HAART initiation, and 3-month infant HIV testing uptake) were compared using generalized estimating equations and Cox regression. RESULTS: HIV care enrollment was higher in intervention compared to control clinics (69% versus 36%, Odds Ratio (OR)=3.94, 95% Confidence Interval (CI): 1.14-13.63). Median time to enrollment was significantly shorter among intervention arm women (0 versus 8 days, Hazard Ratio (HR)=2.20, 95% CI: 1.62-3.01). Eligible women in the intervention arm were more likely to initiate HAART (40% versus 17%, OR=3.22, 95% CI: 1.81-5.72). Infant testing was more common in the intervention arm (25% versus 18%), however not statistically different. No significant differences were detected in postnatal service uptake or maternal retention. CONCLUSIONS: Service integration increased maternal HIV care enrollment and HAART uptake. However, PMTCT utilization outcomes were still suboptimal, and postnatal service utilization remained poor in both study arms. Further improvements in the PMTCT cascade will require additional research and interventions.

BACKGROUND: Many HIV-infected pregnant women identified during antenatal care do not enroll in long-term HIV care, resulting in deterioration of maternal health and continued risk of HIV transmission to infants. METHODS: We performed a cluster-randomized trial to evaluate the effect of integrating HIV care into ANC clinics in rural Kenya. Twelve facilities were randomized to provide either integrated services (ANC, PMTCT, and HIV care delivered in the ANC clinic; n=6 intervention facilities), or standard ANC services (including PMTCT and referral to a separate clinic for HIV care; n=6 control facilities). RESULTS: There were high patient attrition rates over the course of this study. Among study participants who enrolled in HIV care, there was twelve month follow up data for 256/611 (41.8%) women, and postpartum data for only 325/1172 (28%) women. By 9 months of age, 382/568 (67.3%) infants at intervention sites and 338/594 (57.0%) at control sites had tested for HIV (OR 1.45, 95% CI 0.71-2.82); 7.3% of infants tested HIV-positive at intervention sites compared to 8.0% of infants at control sites (OR 0.89, 95% CI 0.56-1.43). The composite clinical/immunologic progression into AIDS was similar in both arms (4.9% vs. 5.1 %, OR 0.83, 95% CI 0.41 - 1.68). CONCLUSIONS: Despite the provision of integrated services, patient attrition was substantial in both arms, suggesting barriers beyond lack of service integration. Integration of HIV services into the ANC clinic was not associated with a reduced risk HIV transmission to infants and did not appear to affect short-term maternal health outcomes.

SETTING: In 2008, the Kenya tuberculosis (TB) program reported low (31%) antiretroviral therapy (ART) uptake among human immunodeficiency virus (HIV) infected TB patients. OBJECTIVE: To confirm ART coverage and identify factors associated with HIV clinic enrollment and ART initiation among TB patients. DESIGN: Retrospective chart abstraction of adult TB patients newly diagnosed with HIV and eligible for ART at 58 Nyanza Province TB clinics between October 2006 and April 2008. TB data were linked to HIV clinic data at 50 facilities that provided ART. Associations with HIV clinic enrollment and ART were evaluated. RESULTS: Among 1137 ART-eligible TB patient records sampled, 32% documented HIV clinic enrollment and 29% ART. Date fields were largely incomplete; 11% of the patient records included HIV testing dates and <=1% had dates for cotrimoxazole prophylaxis, HIV clinic enrollment and ART initiation. Adding HIV clinic data increased HIV clinic enrollment and ART documentation to respectively 62% and 44%. Among TB patients in HIV care, female sex, older age group and baseline CD4 documentation were associated with ART initiation. CONCLUSION: Linking data increased documentation of HIV clinic enrollment and ART uptake. Continued efforts are required to improve the documentation of HIV service delivery, especially in TB clinics. Interventions to increase ART uptake are needed for younger patients and men.

We present health and demographic surveillance system data to assess associations with healthcare use and human immunodeficiency virus (HIV) service receipt in a high HIV prevalence area of western Kenya. Eighty-six percent of 15,302 residents indicated a facility/clinician for routine medical services; 60% reported active (within the past year) attendance. Only 34% reported a previous HIV test, and self-reported HIV prevalence was 6%. Active attendees lived only slightly closer to their reported service site (2.8 versus 3.1 km; P < 0.001) compared with inactive attendees. Multivariate analysis showed that younger respondents (< 30 years of age) and active and inactive attendees were more likely to report an HIV test compared with non-attendees; men were less likely to report HIV testing. Despite traveling farther for HIV services (median distance = 4.4 km), 77% of those disclosing HIV infection reported HIV care enrollment. Men and younger respondents were less likely to enroll in HIV care. Socioeconomic status was not associated with HIV service use. Distance did not appear to be the major barrier to service receipt. The health and demographic surveillance system data identified patterns of service use that are useful for future program planning.

OBJECTIVES: To evaluate the clinical safety of daily tenofovir disoproxil fumarate (TDF) among HIV-negative MSM. DESIGN: Randomized, double-blind, placebo-controlled trial. Participants were randomized 1:1:1:1 to immediate or delayed study drug (TDF [300mg orally/day] or placebo). METHODS: 400 healthy HIV-uninfected MSM reporting anal sex with another man within the previous 12 months enrolled in Atlanta, Boston, and San Francisco. HIV serostatus, clinical and laboratory adverse events, adherence (pill count, Medical Event Monitoring System, [MEMS] and self-report), sexual and other sociobehavioral data were assessed at 3-month intervals for 24 months. Primary outcomes were clinical safety, assessed by incidence of adverse events and laboratory abnormalities. RESULTS: Study drug was initiated by 373 (93%) participants (186 TDF, 187 placebo), of whom 325 (87%) completed the final study visit. Of 2,428 adverse events reported among 334 (90%) participants, 2,366 (97%) were mild or moderate in severity.Frequencies of commonly reported adverse events did not differ significantly between TDF and placebo arms. In multivariable analyses, back pain was more likely among TDF recipients (p=0.04); these reports were not associated with documented fractures or other objective findings. There were no Grade ≥3 creatinine elevations; Grade 1 and 2 creatinine increases were not associated with TDF receipt. Estimated percent of study drug doses taken was 92% by pill count and 77% by MEMS. Seven seroconversions occurred; 4 on placebo and 3 among delayed arm participants not yet on study drug. CONCLUSION: Daily oral TDF was well tolerated, with reasonable adherence. No significant renal concerns were identified.

BACKGROUND: Despite strong evidence for the effectiveness of anti-retroviral therapy for improving the health of women living with HIV and for the prevention of mother-to-child transmission (PMTCT), HIV persists as a major maternal and child health problem in sub-Saharan Africa. In most settings antenatal care (ANC) services and HIV treatment services are offered in separate clinics. Integrating these services may result in better uptake of services, reduction of the time to treatment initiation, better adherence, and reduction of stigma. METHODOLOGY/PRINCIPAL FINDINGS: A prospective cluster randomized controlled trial design was used to evaluate the effects of integrating HIV treatment into ANC clinics at government health facilities in rural Kenya. Twelve facilities were randomized to provide either fully integrated services (ANC, PMTCT, and HIV treatment services all delivered in the ANC clinic) or non-integrated services (ANC clinics provided ANC and basic PMTCT services and referred clients to a separate HIV clinic for HIV treatment). During June 2009- March 2011, 1,172 HIV-positive pregnant women were enrolled in the study. The main study outcomes are rates of maternal enrollment in HIV care and treatment, infant HIV testing uptake, and HIV-free infant survival. Baseline results revealed that the intervention and control cohorts were similar with respect to socio-demographics, male partner HIV testing, sero-discordance of the couple, obstetric history, baseline CD4 count, and WHO Stage. Challenges faced while conducting this trial at low-resource rural health facilities included frequent staff turnover, stock-outs of essential supplies, transportation challenges, and changes in national guidelines. CONCLUSIONS/SIGNIFICANCE: This is the first randomized trial of ANC and HIV service integration to be conducted in rural Africa. It is expected that the study will provide critical evidence regarding the implementation and effectiveness of this service delivery strategy, with important implications for programs striving to eliminate vertical transmission of HIV and improve maternal health. TRIAL REGISTRATION: ClinicalTrials.gov NCT00931216 NCT00931216.

OBJECTIVE: To provide HIV seroincidence data among men who have sex with men (MSM) in the United States and to identify predictive factors for seroconversion. METHODS: From 1998-2002, 4684 high-risk MSM, age 18-60 years, participated in a randomized, placebo-controlled HIV vaccine efficacy trial at 56 U.S. clinical trial sites. Demographics, behavioral data, and HIV status were assessed at baseline and 6 month intervals. Since no overall vaccine efficacy was detected, data were combined from both trial arms to calculate HIV incidence based on person-years (py) of follow-up. Predictors of seroconversion, adjusted hazards ratio (aHR), were evaluated using a Cox proportional hazard model with time-varying covariates. RESULTS: Overall, HIV incidence was 2.7/100 py and was relatively uniform across study sites and study years. HIV incidence was highest among young men and men reporting unprotected sex, recreational drug use, and a history of a sexually transmitted infection. Independent predictors of HIV seroconversion included: age 18-30 years (aHR = 2.4; 95% CI 1.4,4.0), having >10 partners (aHR = 2.4; 95% CI 1.7,3.3), having a known HIV-positive male sex partner (aHR = 1.6; 95% CI 1.2, 2.0), unprotected anal intercourse with HIV positive/unknown male partners (aHR = 1.7; 95% CI 1.3, 2.3), and amphetamine (aHR = 1.6; 95% CI 1.1, 2.1) and popper (aHR = 1.7; 95% CI 1.3, 2.2) use. CONCLUSIONS: HIV seroincidence was high among MSM despite repeated HIV counseling and reported declines in sexual risk behaviors. Continuing development of new HIV prevention strategies and intensification of existing efforts will be necessary to reduce the rate of new HIV infections, especially among young men.