Machine Learning Algorithms Using Routinely Collected Data Do Not Adequately Predict Viremia to Inform Targeted Services in Postpartum Women Living With HIV.

BACKGROUND: Adherence to antiretroviral treatment (ART) among postpartum women with HIV is essential for optimal health and prevention of perinatal transmission. However, suboptimal adherence with subsequent viremia is common, and adherence challenges are often underreported. We aimed to predict viremia to facilitate targeted adherence support in sub-Saharan Africa during this critical period. METHODS: Data are from PROMISE 1077BF/FF, which enrolled perinatal women between 2011 and 2014. This analysis includes postpartum women receiving ART per study randomization or country-specific criteria to continue from pregnancy. We aimed to predict viremia (single and confirmed events) after 3 months on ART at >50, >400, and >1000 copies/mL within 6-month intervals through 24 months. We built models with routine clinical and demographic data using the least absolute shrinkage and selection operator and SuperLearner (which incorporates multiple algorithms). RESULTS: Among 1321 women included, the median age was 26 years and 96% were in WHO stage 1. Between 0 and 24 months postpartum, 42%, 31%, and 28% of women experienced viremia >50, >400, and >1000 copies/mL, respectively, at least once. Across models, the cross-validated area under the receiver operating curve ranged from 0.74 [95% confidence interval (CI): 0.72 to 0.76] to 0.78 (95% CI: 0.76 to 0.80). To achieve 90% sensitivity predicting confirmed viremia >50 copies/mL, 64% of women would be classified as high risk. CONCLUSIONS: Using routinely collected data to predict viremia in >1300 postpartum women with HIV, we achieved moderate model discrimination, but insufficient to inform targeted adherence support. Psychosocial characteristics or objective adherence metrics may be required for improved prediction of viremia in this population.

Stillbirth And Faith: When Belief And Death Collide.

Mothers who had experienced stillbirth (n = 436) were asked about their "faith base" and whether it was "helpful to their healing." Only 178 (24.5%) indicated their faith base was "helpful;" there was also a wide range of other responses including those who indicated their faith was "lost" following their baby's death. Findings are discussed in terms of what participants found helpful from their pastor and/or church community.

Enrollment and transition challenges in the International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT) network's PROMISE trial for resource-limited regions.

BACKGROUND: We describe enrollment and accrual challenges in the "Promoting Maternal and Infant Survival Everywhere" (PROMISE) trial conducted in resource-limited countries, as well as the challenges in transitioning participants from the antepartum to the postpartum components of the study. METHODS: PROMISE was a large multi-national randomized controlled trial of the safety and efficacy of interventions to reduce perinatal transmission of HIV-1 (HIV) during pregnancy and breastfeeding and of interventions to preserve maternal health after cessation of perinatal transmission risk. The PROMISE study included two protocols for HIV-infected pregnant women in resource-limited countries who intended to either breastfeed or formula-feed their infants and did not meet country criteria for antiretroviral treatment. The PROMISE breastfeeding protocol (1077BF) used a sequential randomization design with up to three randomizations (Antepartum, Postpartum, and Maternal Health). The PROMISE formula-feeding protocol (1077FF) had two randomizations (Antepartum and Maternal Health). Women presenting to the clinic during early or active labor or in the immediate postpartum period were registered as Late Presenters and screened to determine whether eligible to participate in the Postpartum randomization. RESULTS: The study was conducted at 14 sites in seven countries and opened to enrollment in April 2011. A total of 3259 pregnant women intending to breastfeed and an additional 284 pregnant women intending to formula feed were randomized in the Antepartum component. A total of 204 Late Presenters were registered during labor or after delivery. Enrollment was high among breastfeeding women (representing 96% of the target of 3400 women) but was lower than expected among women intending to formula feed (28% of 1000 expected) and late-presenting women (8% of 2500 expected). The successful overall enrollment and final primary study analyses results were attributed to substantial preparation before the study opened, collaboration among all stakeholders, close study monitoring during implementation and the flexibility to change and streamline the protocol. CONCLUSIONS: Experiences from the PROMISE study illustrate the challenges of enrolling in longer term studies in the setting of rapidly evolving prevention and treatment standards priorities. The lessons learned will help the community, site investigators, and study coordinators in the design and implementation of future clinical trials.

Current pediatrician practices in identifying high-risk behaviors of adolescents.

OBJECTIVE: In the United States, 15- to 24-year-olds represent approximately 14% of HIV cases diagnosed in 2006 and almost 50% of the 19 million sexually transmitted infections (STIs) reported annually. This survey assessed pediatricians' practices regarding preventive health care screening, provision of reproductive health services including HIV and STI screening and counseling, and barriers to providing these services. METHODS: A random-sample mailed survey of 1626 US members of the American Academy of Pediatrics in 2005.A total of 752 completed questionnaires were returned (46% response rate). Analysis was limited to the 468 pediatricians who provided health supervision visits to patients who were older than 11 years. RESULTS: Most pediatricians discussed sexual activity at preventive care visits; similar numbers discuss abstinence (62%), condoms (61%), and STIs (61%) with slightly fewer discussing HIV (54%). Pediatricians occasionally or rarely/never discussed homosexuality/sexual identity (82%). Most (71%) identified adolescents with high-risk behaviors by clinical interviews. Approximately 30% prescribed condoms, 22% distributed condoms, and 19% provided condom demonstrations. Whereas 46% of pediatricians recommended STI tests for all sexually active teens, only 28% recommended HIV testing for this population. Hospital/clinic-based and inner-city practitioners were more likely to prescribe, provide, and demonstrate condoms and recommend HIV/STI tests for sexually active teens. The most frequently identified barrier to HIV and STI prevention counseling was lack of time. CONCLUSIONS: Pediatricians believed it is important to deliver reproductive health services, and most addressed adolescent sexual activity at preventive care visits but did not routinely address homosexuality/sexual identity. Counseling and testing practices varied by physician characteristics.