Procurement of patient medical records from multiple health care facilities for public health research: feasibility, challenges, and lessons learned.

Objectives: Studies that combine medical record and primary data are typically conducted in a small number of health care facilities (HCFs) covering a limited catchment area; however, depending on the study objectives, validity may be improved by recruiting a more expansive sample of patients receiving care across multiple HCFs. We evaluate the feasibility of a novel protocol to obtain patient medical records from multiple HCFs using a broad representative sampling frame. Materials and Methods: In a prospective cohort study on HIV pre-exposure prophylaxis utilization, primary data were collected from a representative sample of community-dwelling participants; voluntary authorization was obtained to access participants' medical records from the HCF at which they were receiving care. Medical record procurement procedures were documented for later analysis. Results: The cohort consisted of 460 participants receiving care from 122 HCFs; 81 participants were lost to follow-up resulting in 379 requests for medical records submitted to HCFs, and a total of 343 medical records were obtained (91% response rate). Less than 20% of the medical records received were in electronic form. On average, the cost of medical record acquisition was $120 USD per medical record. Conclusions: Obtaining medical record data on research participants receiving care across multiple HCFs was feasible, but time-consuming and resulted in appreciable missing data. Researchers combining primary data with medical record data should select a sampling and data collection approach that optimizes study validity while weighing the potential benefits (more representative sample; inclusion of HCF-level predictors) and drawbacks (cost, missing data) of obtaining medical records from multiple HCFs.

The Magnetic Couples Study: protocol for a mixed methods prospective cohort study of HIV-serodifferent heterosexual couples' perspectives and use of pre-exposure prophylaxis (PrEP).

INTRODUCTION: HIV transmission within serodifferent heterosexual couples plays a key role in sustaining the global HIV pandemic. In the USA, transmission within established mixed-status couples accounts for up to half of all new HIV infections among heterosexuals. Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective prevention method, although underutilised among serodifferent couples. Moreover, there is a dearth of research on US HIV-serodifferent couples' perspectives and use of PrEP, alone or in combination with other prevention methods. In this paper, we describe the study protocol for the Magnetic Couples Study, designed to fill critical knowledge gaps regarding HIV-serodifferent heterosexual couples' perspectives, experiences and utilisation of PrEP. METHODS AND ANALYSIS: The Magnetic Couples Study is a mixed methods prospective cohort study designed to describe temporal patterns and identify determinants at multiple levels (individual, couple, HCF) of PrEP outcomes along the care continuum (PrEP awareness, linkage, uptake, retention and medication adherence) among HIV-serodifferent heterosexual couples residing in New York City. The study will also examine clinical management of PrEP, side effects and changes in sexual-related and substance use-related behaviour. A prospective cohort of 230 mixed-status couples already on oral PrEP was recruited, with quarterly assessments over 18 months; in addition, a cross-sectional sample of 150 mixed-status couples not currently on PrEP was recruited. In-depth semistructured qualitative interviews were conducted with a subsample of 25 couples. Actor-partner interdependence modelling using multilevel analysis will be employed for the analysis of longitudinal dyadic data. Framework analysis will be used to analyse qualitative data. A parallel convergent design will be used for mixed methods integration. ETHICS AND DISSEMINATION: The study was approved by the University of Rochester Institutional Review Board (RSRB00052766). Study findings will be disseminated to community members and providers and to researchers and policy makers.

Couple-based HIV counseling and testing: a risk reduction intervention for US drug-involved women and their primary male partners.

To help reduce the elevated risk of acquiring HIV for African-American and Latina women drug users in primary heterosexual relationships, we developed a brief couple-based HIV counseling and testing prevention intervention. The intervention was based on an integrated HIV risk behavior theory that incorporated elements of social exchange theory, the theory of gender and power, the stages-of-change model, and the information-motivation-behavior skills model. In this article, we describe the development, content, and format of the couple-based HIV testing and counseling intervention, and its delivery to 110 couples (220 individuals) in a randomized effectiveness trial, the Harlem River Couples Project, conducted in New York City from 2005 to 2007. Components of the couple-based intervention included a personalized dyadic action plan based on the couple's risk profile and interactive exercises designed to help build interpersonal communication skills, and facilitated discussion of social norms regarding gender roles. The couple-based HIV testing and counseling intervention significantly reduced women's overall HIV risk compared to a standard-of-care individual HIV testing and counseling intervention. Experiences and perceptions of the intervention were positive among both clients and interventionists. The study was the first to demonstrate the effectiveness and feasibility of delivering a brief couple-based HIV counseling and testing intervention to reduce risk among drug-using heterosexual couples in high HIV prevalent urban communities in the USA. The intervention can be expanded to include new HIV prevention strategies, such as pre-exposure prophylaxis. Further research is needed to evaluate cost-effectiveness and implementation of the intervention in clinical settings.

Effectiveness of Couple-Based HIV Counseling and Testing for Women Substance Users and Their Primary Male Partners: A Randomized Trial.

A randomized trial was conducted to test the effectiveness of couple-based HIV counseling and testing (CB-HIV-CT) and women-only relationship-focused HIV counseling and testing (WRF-HIV-CT) in reducing HIV risk compared to the National Institute on Drug Abuse HIV-CT standard intervention. Substance using HIV-negative women and their primary heterosexual partner (N = 330 couples) were randomized to 1 of the 3 interventions. Follow-up assessments measuring HIV risk behaviors and other relevant variables were conducted at 3- and 9-months postintervention. Repeated measures generalized linear mixed model analysis was used to assess treatment effects. A significant reduction in HIV risk was observed over the 9-month assessment in the CB-HIV-CT group compared to that of the control group (b = -0.51, t[527] = -3.20, P = 0.002) and compared to that of the WRF-HIV-CT group (b = -0.34, t[527] = -2.07, P = 0.04), but no significant difference was observed between WRF-HIV-CT and controls (b = -0.17, t[527] = -1.09, P = 0.28). A brief couple-based HIV counseling and testing intervention designed to address both drug-related and sexual risk behaviors among substance using women and their primary male partners was shown to be more effective at reducing overall HIV risk compared to a standard HIV-CT intervention in an urban setting.

Intranasal transmission of hepatitis C virus: virological and clinical evidence.

Intranasal transmission of hepatitis C virus (HCV) via contaminated drug-sniffing implements is a potential but unconfirmed source of viral infection. We demonstrate the virological plausibility of intranasal transmission by confirming that blood and HCV RNA are present in the nasal secretions and drug-sniffing implements of HCV-infected intranasal drug users recruited from a community health clinic in New York City.

Recruitment of heterosexual couples in public health research: a study protocol.

BACKGROUND: Public health research involving social or kin groups (such as sexual partners or family members), rather than samples of unrelated individuals, has become more widespread in response to social ecological approaches to disease treatment and prevention. This approach requires the development of innovative sampling, recruitment and screening methodologies tailored to the study of related individuals. METHODS: In this paper, we describe a set of sampling, recruitment and screening protocols developed to enlist urban, drug-using, heterosexual couples into a public health research study. This population is especially hard to reach because they are engaged in illegal and/or stigmatized behaviors. The protocols were designed to integrate adaptive sampling, street- and referral-based recruitment, and screening procedures to verify study eligibility and relationship status. DISCUSSION: Recruitment of heterosexual couples through one partner, preferably the female, can be an effective enlistment technique. Verification of relationship status is an important component of dyadic research. Comparison of parallel questionnaires administered to each member of a dyad can aid in the assessment of relationship status. However, multiple independent sources of information should be used to verify relationship status when available. Adaptive sampling techniques were effective in reaching drug-using heterosexual couples in an urban setting, and the application of these methods to other groups of related individuals in clinical and public health research may prove to be useful. However, care must be taken to consider potential sources of sampling bias when interpreting and generalizing study results.