A text messaging intervention to improve retention in care and virologic suppression in a U.S. urban safety-net HIV clinic: study protocol for the Connect4Care (C4C) randomized controlled trial.

BACKGROUND: Few data exist on the use of text messaging as a tool to promote retention in HIV care and virologic suppression at the clinic level in the United States. We describe the protocol for a study designed to investigate whether a text messaging intervention that supports healthy behaviors, encourages consistent engagement with care, and promotes antiretroviral persistence can improve retention in care and virologic suppression among patients in an urban safety-net HIV clinic in San Francisco. METHODS/DESIGN: Connect4Care (C4C) is a single-site, randomized year-long study of text message appointment reminders vs. text message appointment reminders plus thrice-weekly supportive, informational, and motivational text messages. Eligible consenting patients are allocated 1:1 to the two arms within strata defined by HIV diagnosis within the past 12 months (i.e. "newly diagnosed") vs. earlier. Study participants must receive primary care at the San Francisco General Hospital HIV clinic, speak English, possess a cell phone and be willing to send/receive up to 25 text messages per month, a have viral load >200 copies/µL, and be either new to the clinic or have a history of poor retention. The primary efficacy outcome is virologic suppression at 12 months and the key secondary outcome, which will also be examined as a mediator of the primary outcome, is retention in HIV care, as operationalized by kept and missed primary care visits. Process outcomes include text message response rate and percent of time in study without cell phone service. Generalized estimating equation log-binomial models will be used for intent to treat, per protocol, and mediation analyses. An assessment of the cost and cost-effectiveness of the intervention is planned along with a qualitative evaluation of the intervention. DISCUSSION: Findings from this study will provide valuable information about the use of behavioral-theory based text messaging to promote retention in HIV care and virologic suppression, further elucidate the challenges of using texting technology with marginalized urban populations, and help guide the development of new mobile health strategies to improve HIV care cascade outcomes. TRIAL REGISTRATION: NCT01917994.

Leveraging a rapid, round-the-clock HIV testing system to screen for acute HIV infection in a large urban public medical center.

OBJECTIVE: To describe the prevalence and location of new and acute HIV diagnoses in a large urban medical center. Secondary objectives were to evaluate rapid HIV test performance, the added yield of acute HIV screening, and linkage-to-care outcomes. DESIGN: Cross-sectional study from November 1, 2008, to April 30, 2009. METHODS: The hospital laboratory performed round-the-clock rapid HIV antibody testing on venipuncture specimens from patients undergoing HIV testing in hospital and community clinics, inpatient settings, and the emergency department (ED). For patients with negative results, a public health laboratory conducted pooled HIV RNA testing for acute HIV infection. The laboratories communicated positive results from the hospital campus to a linkage team. Linkage was defined as 1 outpatient HIV-related visit. RESULTS: Among 7927 patients, 8550 rapid tests resulted in 137 cases of HIV infection [1.7%, 95% confidence interval (CI): 1.5% to 2.0%], of whom 46 were new HIV diagnoses (0.58%, 95% CI: 0.43% to 0.77%). Pooled HIV RNA testing of 6704 specimens (78.4%) resulted in 3 cases of acute HIV infection (0.05%, 95% CI: 0.01% to 0.14%) and increased HIV case detection by 3.5%. Half of new HIV diagnoses and two thirds of acute infections were detected in the ED and urgent care clinic. Rapid test sensitivity was 98.9% (95% CI: 93.8% to 99.8%) and the specificity 99.9% (95% CI: 99.7% to 99.9%). More than 95% of newly diagnosed and out-of-care HIV-infected patients were linked to care. CONCLUSIONS: Patients undergoing HIV testing in EDs and urgent care clinics may benefit from being simultaneously screened for acute HIV infection.

A qualitative study of provider thoughts on implementing pre-exposure prophylaxis (PrEP) in clinical settings to prevent HIV infection.

BACKGROUND: A recent clinical trial demonstrated that a daily dose tenofovir disoproxil fumarate and emtricitabrine (TDF-FTC) can reduce HIV acquisition among men who have sex with men (MSM) and transgender (TG) women by 44%, and up to 90% if taken daily. We explored how medical and service providers understand research results and plan to develop clinical protocols to prescribe, support and monitor adherence for patients on PrEP in the United States. METHODS: Using referrals from our community collaborators and snowball sampling, we recruited 22 healthcare providers in San Francisco, Oakland, and Los Angeles for in-depth interviews from May-December 2011. The providers included primary care physicians seeing high numbers of MSM and TG women, HIV specialists, community health clinic providers, and public health officials. We analyzed interviews thematically to produce recommendations for setting policy around implementing PrEP. Interview topics included: assessing clinician impressions of PrEP and CDC guidance, considerations of cost, office capacity, dosing schedules, and following patients over time. RESULTS: Little or no demand for PrEP from patients was reported at the time of the interviews. Providers did not agree on the most appropriate patients for PrEP and believed that current models of care, which do not involve routine frequent office visits, were not well suited for prescribing PrEP. Providers detailed the need to build capacity and were concerned about monitoring side effects and adherence. PrEP was seen as potentially having impact on the epidemic but providers also noted that community education campaigns needed to be tailored to effectively reach specific vulnerable populations. CONCLUSIONS: While PrEP may be a novel and clinically compelling prevention intervention for MSM and TG women, it raises a number of important implementation challenges that would need to be addressed. Nonetheless, most providers expressed optimism that they eventually could prescribe and monitor PrEP in their practice.

A comparative evaluation of the process of developing and implementing an emergency department HIV testing program.

BACKGROUND: The 2006 Centers for Disease Control and Prevention (CDC) HIV testing guidelines recommend screening for HIV infection in all healthcare settings, including the emergency department (ED). In urban areas with a high background prevalence of HIV, the ED has become an increasingly important site for identifying HIV infection. However, this public health policy has been operationalized using different models. We sought to describe the development and implementation of HIV testing programs in three EDs, assess factors shaping the adoption and evolution of specific program elements, and identify barriers and facilitators to testing. METHODS: We performed a qualitative evaluation using in-depth interviews with fifteen 'key informants' involved in the development and implementation of HIV testing in three urban EDs serving sizable racial/ethnic minority and socioeconomically disadvantaged populations. Testing program HIV prevalence ranged from 0.4% to 3.0%. RESULTS: Three testing models were identified, reflecting differences in the use of existing ED staff to offer and perform the test and disclose results. Factors influencing the adoption of a particular model included: whether program developers were ED providers, HIV providers, or both; whether programs took a targeted or non-targeted approach to patient selection; and the extent to which linkage to care was viewed as the responsibility of the ED. A common barrier was discomfort among ED providers about disclosing a positive HIV test result. Common facilitators were a commitment to underserved populations, the perception that testing was an opportunity to re-engage previously HIV-infected patients in care, and the support and resources offered by the medical setting for HIV-infected patients. CONCLUSIONS: ED HIV testing is occurring under a range of models that emerge from local realities and are tailored to institutional strengths to optimize implementation and overcome provider barriers.

Retention in care among HIV-infected patients in resource-limited settings: emerging insights and new directions.

In resource-limited settings--where a massive scale-up of HIV services has occurred in the last 5 years--both understanding the extent of and improving retention in care presents special challenges. First, retention in care within the decentralizing network of services is likely higher than existing estimates that account only for retention in clinic, and therefore antiretroviral therapy services may be more effective than currently believed. Second, both magnitude and determinants of patient retention vary substantially and therefore encouraging the conduct of locally relevant epidemiology is needed to inform programmatic decisions. Third, socio-structural factors such as program characteristics, transportation, poverty, work/child care responsibilities, and social relations are the major determinants of retention in care, and therefore interventions to improve retention in care should focus on implementation strategies. Research to assess and improve retention in care for HIV-infected patients can be strengthened by incorporating novel methods such as sampling-based approaches and a causal analytic framework.