Effects of a Laboratory Health Information Exchange Intervention on Antiretroviral Therapy Use, Viral Suppression, and Racial/Ethnic Disparities.

BACKGROUND: Although antiretroviral therapy (ART) is available to treat HIV+ persons and prevent transmission, ineffective delivery of care may delay ART use, impede viral suppression (VS), and contribute to racial/ethnic disparities along the continuum of care. This study tested the effects of a bi-directional laboratory health information exchange (LHIE) intervention on each of these outcomes. METHODS: We used a quasi-experimental, interrupted time-series design to examine whether the LHIE intervention improved ART use and VS, and reduced racial/ethnic disparities in these outcomes among HIV+ patients (N = 1181) in a comprehensive HIV/AIDS clinic in Southern California. Main outcome measures were ART pharmacy fill and HIV viral load laboratory data extracted from the medical records over 3 years. Race/ethnicity and an indicator for the intervention (after vs. before) were the main predictors. The analysis involved 3-stage, multivariable logistic regression with generalized estimating equations. RESULTS: Overall, the intervention predicted greater odds of ART use (odds ratio [OR] = 2.50; 95% confidence interval: 2.29 to 2.73; P < 0.001) and VS (OR = 1.12; 95% confidence interval: 1.04 to 1.21; P < 0.05) in the final models that included sociodemographic, behavioral, and clinical covariates. Before the intervention, there were significant black/white disparities in ART use OR = 0.75 (0.58-0.98; P = 0.04) and VS OR = 0.75 (0.61-0.92; P = 0.001). After the intervention, the black/white disparities decreased after adjusting for sociodemographics and the number of HIV care visits, and Latinos had greater odds than whites of ART use and VS, adjusting for covariates. CONCLUSIONS: The intervention improved overall ART treatment and VS, and reduced black/white disparities. LHIE interventions may hold promise if implemented among similar patients.

Effects of laboratory data exchange in the care of patients with HIV.

BACKGROUND: Electronic health record (EHR) systems are often modified through the addition of new features over time. Few studies have examined the specific effects of such changes. We examined whether implementation of a bidirectional laboratory interface for order entry and data reporting within an existing ambulatory EHR would result in more prompt responses to laboratory indications for antiretroviral therapy (ART) changes or in improved communication with HIV+ patients about relevant laboratory results. METHODS: We conducted a single-arm intervention study comparing the timeliness of ART regimen changes, HIV viral load (VL) outcomes and patient-reported assessments of care before and after implementation of a laboratory data exchange interface within an existing EHR, without changing the EHR ordering or results reporting user interface. Patient data was extracted from the EHR covering the period from 1 year before to 2 years after the intervention for a cohort of 1181 patients who had received care during the baseline year. The timeliness of ART changes was represented by the days from a laboratory-result "signal" (CD4 dropping below 350 or 200 or VL increasing by a half-log or to a value over 100,000) to an ART-change "response". Patient assessments of care were collected by interviewing 100 anonymous patients at baseline and another 125 at 2 years post-intervention. RESULTS: A total of 171 laboratory "signal" events were followed within 80 days by a change in ART therapy. The mean time from signal to therapy change (adjusted for clustering by patient) initially increased, from 37.7 days during the pre-intervention year to 48.2 days during the quarter immediately following activation of the lab intervention. It then declined to a mean of 31.4 days over the remaining 21 months of observation (P=0.03 for the 6-day improvement from the pre-period). A majority of patients (65%) achieved undetectable VL values by the end of the observation period; faster signal-response times were not associated with greater achievement of undetectable VL. Patients rated communication about laboratory tests more highly after implementation of the interface (91 vs. 83 on a 100-point scale, P=0.01); ratings were not higher for other aspects of care. CONCLUSIONS: Adding laboratory data exchange interfaces within existing EHRs holds promise for improving HIV care, both in the timeliness of responses to important laboratory results and in the quality of provider communication about lab tests. However, the benefits from this incremental change may be modest unless more extensive redesign of laboratory follow-up workflows is undertaken, with support from enhanced user interfaces that take advantage of the laboratory information delivered. Providers should also consider increased staffing to compensate for dips in follow-up performance during the initial post-implementation months.

A small dose of HIV? HIV vaccine mental models and risk communication.

Existing knowledge and beliefs related to HIV vaccines provide an important basis for the development of risk communication messages to support future HIV vaccine dissemination. This study explored HIV vaccine mental models among adults from segments of the population disproportionately affected by HIV/AIDS. Nine focus groups were conducted with participants (N = 99; median age = 33 years; 48% female; 22% African American, 44% Latino, and 28% white) recruited from needle exchange sites, public clinics, and gay community centers in Los Angeles. Data were analyzed using narrative thematic analysis and Ethnograph qualitative software. Mental models of HIV vaccines included live virus, side effects, complete protection (100% efficacy, lifetime protection, reduced anxiety about HIV/AIDS), and "high-risk groups." HIV vaccine risk communication to counter undue fears of vaccine-induced infection and side effects and to mitigate exaggerated expectations of a "magic bullet" may be vital to the effectiveness of first-generation HIV vaccines in controlling the AIDS epidemic.

HIV vaccine acceptability among immigrant Thai residents in Los Angeles: a mixed-method approach.

This study examined HIV vaccine acceptability among immigrant Thai residents in Los Angeles, California. We combined a qualitative research method (focus groups) with an innovative market research method (conjoint analysis). Focus groups explored social issues, concerns, barriers and motivators associated with HIV vaccine acceptability. Conjoint analysis was used to assess preferences among eight hypothetical HIV vaccines with varying attribute profiles and the impact of various attributes on acceptability. Five main themes were identified in the focus groups regarding acceptance and utilization of preventive HIV vaccines: (1) vaccine characteristics, such as efficacy, physical side-effects and cost, (2) fear of a vaccine, (3) vaccine acceptability and optimism, (4) social and family responses and (5) behavioral disinhibition. Conjoint analysis revealed HIV vaccine acceptability ranging from 7.4 (SD = 19.4) to 85.2 (SD = 24.3) across eight hypothetical vaccines. The vaccine with the highest acceptability had the following attributes: 99% efficacy, no side-effects, 10 years of protection, protects against one sub-type, free, one dose and given by injection. Vaccine efficacy had the greatest impact on acceptability (51.4, p=.005), followed by side-effects (11.1, p=.005) and duration of protection (8.3, p=.005). Despite some apprehensions and concerns, Thai residents perceived an HIV vaccine as making an important contribution to society and to protecting oneself and one's family from HIV infection. Nevertheless, acceptability of a partially efficacious vaccine may be low, suggesting the need for tailored social marketing interventions that might emphasize a collectivistic rather than an individualistic focus. Assessing HIV vaccine acceptability using a mixed-method approach is feasible with Thai residents and should lend itself to HIV vaccine research with other Asian Pacific Islander populations in the US.

Willingness to participate in HIV vaccine trials: the impact of trial attributes.

OBJECTIVES: To assess willingness to participate (WTP) in hypothetical Phase III preventive HIV vaccine trials, and the impact of trial attributes on WTP, among low socioeconomic, ethnically diverse adults from communities at elevated risk for HIV infection. METHOD: Participants (n=123; median age=38; 69% male; 37% Latino; 14% African-American) were recruited in Los Angeles in 2003 using multi-site, venue-based sampling. WTP was assessed for eight hypothetical HIV vaccine trials that varied across seven dichotomous attributes, using a 2(7-4) fractional factorial experimental design. Individual-specific impact of vaccine trial attributes on WTP was estimated using within-individual ANOVA and then meta-analyzed across individuals. RESULTS: Mean WTP for eight hypothetical vaccine trials ranged from 1.74 to 3.81 (1=highly unlikely, 5=highly likely). Lower WTP was associated with vaccine-induced infection risk (impact=0.88, p<0.0001), false HIV-positives (0.53, p<0.0001), no provision of free HIV medications (0.52, p<0.0001), and longer trial duration (0.27; p=0.0002). CONCLUSION: HIV vaccine trial attributes may strongly influence WTP. Although existing candidate vaccines cannot cause HIV infection, perceptions of risk may impede WTP. Eliciting trial preferences and concerns prior to trial implementation may enable accommodation of participant preferences and support tailored interventions to address concerns and misconceptions to facilitate enrollment in safe and ethical trials among vulnerable communities.

HIV vaccine trial participation among ethnic minority communities: barriers, motivators, and implications for recruitment.

BACKGROUND: Underrepresentation of ethnic minority communities limits the generalizability of HIV vaccine trial results. We explored perceived barriers and motivators regarding HIV vaccine trial participation among low-socioeconomic ethnic minority respondents at risk for HIV. METHODS: Six focus group interviews were conducted using a semistructured interview guide. Participants (N = 58, mean age = 36 years, 37% female, and 56% Latino/a and 35% African American) were recruited using venue-based sampling in Los Angeles. Data were analyzed using narrative thematic analysis and Ethnograph qualitative software. RESULTS: Perceived barriers to HIV vaccine trial participation, in rank order, were (1) vaccine-induced HIV infection, (2) physical side effects, (3) uncertainty about vaccine efficacy, (4) uncertainty about other vaccine characteristics, (5) mistrust, (6) low perceived HIV risk, (7) study demands, (8) stigma, and (9) vaccine-induced HIV seropositivity. Motivators were (1) protection against HIV infection, (2) free insurance and/or medical care, (3) altruism, and (4) monetary incentives. CONCLUSIONS: Population-specific HIV vaccine trial recruitment and implementation strategies should address trial risks from a family perspective, cultural gender norms, mistrust, low perceived HIV risk, the importance of African-American and Latino/a community participation in HIV vaccine trials, and misconceptions about gaining protection against HIV infection. Increasing the cultural relevance of trial recruitment and implementation should facilitate the participation of Latinos/as and African Americans in HIV vaccine trials.

HIV vaccine acceptability among communities at risk: the impact of vaccine characteristics.

HIV vaccines offer the best long-term hope of controlling the AIDS pandemic; yet, the advent of HIV vaccines will not ensure their acceptability. We conducted a cross-sectional survey (n=143), incorporating conjoint analysis, to assess HIV vaccine acceptability among participants recruited using multi-site (n=9), venue-based sampling in Los Angeles. We used a fractional factorial experimental design to construct eight hypothetical HIV vaccines, each with seven dichotomous attributes. The acceptability of each vaccine was assessed individually and then averaged across participants. Next, the impact of each attribute on vaccine acceptability was estimated for each participant using ANOVA and then analyzed across participants. Acceptability of the eight hypothetical HIV vaccines ranged from 33.2 (S.D. 34.9) to 82.2 (S.D. 31.3) on a 0-100 scale; mean=60.0 (S.D. 21.9). Efficacy had the greatest impact on acceptability (22.7; CI: 18.5-27.1; p<0.0001), followed by cross-clade protection (12.5; CI: 8.7-16.3, p<0.0001), side effects (11.5; CI: 7.4-15.5; p<0.0001), and duration of protection (6.1; CI: 3.2-9.0; p<.0001). Route of administration, number of doses and cost were not significant. Low acceptability of "partial efficacy" vaccines may present obstacles to future HIV vaccine dissemination. Educational and social marketing interventions may be necessary to ensure broad HIV vaccine uptake.

HIV vaccine acceptability among women at risk: perceived barriers and facilitators to future HIV vaccine uptake.

The purpose of this study is to explore perceived barriers and facilitators to the uptake of future U.S. Food and Drug Administration-approved HIV vaccines among women at elevated risk for HIV. We conducted four client focus groups (N = 41) and one focus group of women's health care professionals (N =9). Participants were recruited from diverse community agencies and health care clinics in Los Angeles using purposive, venue-based sampling. Data were analyzed using narrative thematic analysis and Ethnograph qualitative software. Barriers to HIV vaccine uptake included fear of vaccine-induced HIV infection, reproductive side effects, injection concerns, gendered roles and power dynamics, HIV stigma, discrimination, affordability, and mistrust. The provision of affordable and accessible HIV vaccines, ideally through routine care, along with culturally tailored, gender-specific HIV vaccine intervention and policy, can ensure the full potential of HIV vaccines to empower women to protect themselves against HIV infection.