Design of the HPTN 065 (TLC-Plus) study: A study to evaluate the feasibility of an enhanced test, link-to-care, plus treat approach for HIV prevention in the United States.

Background/Aims HIV continues to be a major public health threat in the United States, and mathematical modeling has demonstrated that the universal effective use of antiretroviral therapy among all HIV-positive individuals (i.e. the "test and treat" approach) has the potential to control HIV. However, to accomplish this, all the steps that define the HIV care continuum must be achieved at high levels, including HIV testing and diagnosis, linkage to and retention in clinical care, antiretroviral medication initiation, and adherence to achieve and maintain viral suppression. The HPTN 065 (Test, Link-to-Care Plus Treat [TLC-Plus]) study was designed to determine the feasibility of the "test and treat" approach in the United States. Methods HPTN 065 was conducted in two intervention communities, Bronx, NY, and Washington, DC, along with four non-intervention communities, Chicago, IL; Houston, TX; Miami, FL; and Philadelphia, PA. The study consisted of five components: (1) exploring the feasibility of expanded HIV testing via social mobilization and the universal offer of testing in hospital settings, (2) evaluating the effectiveness of financial incentives to increase linkage to care, (3) evaluating the effectiveness of financial incentives to increase viral suppression, (4) evaluating the effectiveness of a computer-delivered intervention to decrease risk behavior in HIV-positive patients in healthcare settings, and (5) administering provider and patient surveys to assess knowledge and attitudes regarding the use of antiretroviral therapy for prevention and the use of financial incentives to improve health outcomes. The study used observational cohorts, cluster and individual randomization, and made novel use of the existing national HIV surveillance data infrastructure. All components were developed with input from a community advisory board, and pragmatic methods were used to implement and assess the outcomes for each study component. Results A total of 76 sites in Washington, DC, and the Bronx, NY, participated in the study: 37 HIV test sites, including 16 hospitals, and 39 HIV care sites. Between September 2010 and December 2014, all study components were successfully implemented at these sites and resulted in valid outcomes. Our pragmatic approach to the study design, implementation, and the assessment of study outcomes allowed the study to be conducted within established programmatic structures and processes. In addition, it was successfully layered on the ongoing standard of care and existing data infrastructure without disrupting health services. Conclusion The HPTN 065 study demonstrated the feasibility of implementing and evaluating a multi-component "test and treat" trial that included a large number of community sites and involved pragmatic approaches to study implementation and evaluation.

Protective Factors Using the Life Course Perspective in Maternal and Child Health.

The life course perspective (LCP), a valuable theoretical framework for investigating racial disparities in birth outcomes, examines the cumulative exposure of risk and protective factors throughout the life span. Although risk and protective exposures are equally vital to health, most studies have focused solely on the risk factor exposures faced by vulnerable populations. In clear contrast to the traditional public health approach, which emphasizes a deficit model, strengths-based approaches focus on protective factors and fostering resilience. These approaches view communities as valuable assets that have the capacity to fully engage themselves and their residents to achieve optimal health. Participatory action research methods are well suited to apply a strengths-based approach to understand health disparities. Our study aimed to explore maternal and child health protective factors from community residents' perspective. A group of researchers, including active members in the community with a long history of grassroots development work, conducted ten community-based participatory focus groups with community residents in Tampa, FL, using the LCP framework. A total of 78 residents participated in ten focus groups. Perceived protective factors during pregnancy included self-esteem, spirituality, pregnancy support, good nutrition, prenatal care, and community resources. Protective factors for non-pregnant women were self-esteem, spirituality, social support, health literacy, community support and community resources, and societal factors. For children and adolescents, relevant protective factors were self-esteem, positive role models, nutrition and physical activity, and community support. The identified factors are community assets or strengths that mitigate or eliminate maternal and child health risks in families and communities residing in low-income neighborhoods, which must be considered in developing effective maternal and child health interventions.

Exploring the Life Course Perspective in Maternal and Child Health through Community-Based Participatory Focus Groups: Social Risks Assessment.

Little is known about the patterns of risk factors experienced by communities of color and how diverse community contexts shape the health trajectory of women from the early childhood period to the time of their pregnancies. Thus, we conducted a focus group study to identify social risks over the life course that contribute to maternal and child health from the perspective of community members residing in low income urban areas. Ten community-based participatory focus groups were conducted with residents from selected communities in Tampa, Florida, from September to November 2013. We used the life course perspective to illuminate and explain the experiences reported by the interviewees. A total of 78 residents participated in the focus groups. Children and adolescents' health risks were childhood obesity, lack of physical activity, and low self-esteem. Women's health risks were low self-esteem, low educational level, low health literacy, inadequate parenting skills, and financial problems. Risks during pregnancy included stress, low self-esteem, inadequate eating patterns, lack of physical activity, healthcare issues, lack of social support, and lack of father involvement during pregnancy. Multiple risk factors contribute to maternal and child health in low income communities in Tampa Bay. The intersection of risk factors in different life periods suggest possible pathways, cumulative, and latent effects, which must be considered in future longitudinal studies and when developing effective maternal and child health programs and policies.