Implementation of a Clinician-led Medication Adherence Intervention Among Patients With Systemic Lupus Erythematosus.

Objective: Medication nonadherence in systemic lupus erythematosus (SLE) leads to poor clinical outcomes. We developed a clinician-led adherence intervention that involves reviewing real-time pharmacy refill data and using effective communication to address nonadherence. Prior pilot testing showed promising effects on medication adherence.

Pilot Intervention to Improve Medication Adherence Among Patients With Systemic Lupus Erythematosus Using Pharmacy Refill Data.

Objective: Despite high rates of medication nonadherence among patients with systemic lupus erythematosus (SLE), effective interventions to improve adherence in SLE are limited. We aimed to assess the feasibility of a pilot intervention and explore its effect on adherence.

Methods: The intervention used pharmacy refill data to monitor nonadherence and prompt discussions surrounding SLE medications during clinic encounters.

Barriers to Taking Medications for Systemic Lupus Erythematosus: A Qualitative Study of Racial Minority Patients, Lupus Providers, and Clinic Staff.

Objective: Underrepresented racial and ethnic minorities are disproportionately affected by systemic lupus erythematosus (SLE). Racial and ethnic minorities also have more severe SLE manifestations that require use of immunosuppressive medications, and often have lower rates of medication adherence. We aimed to explore barriers of adherence to SLE immunosuppressive medications among minority SLE patients.

Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study.

Background: The successful adoption of mobile technology for use in clinical trials relies on positive reception from key stakeholders, including clinical investigators; however, little information is known about the perspectives of investigators using mobile technologies in clinical trials.

Objective: The aim of this study was to seek investigators' insights on the advantages and challenges of mobile clinical trials (MCTs); site-level budgetary, training, and other support needs necessary to adequately prepare for and implement MCTs; and the advantages and disadvantages for trial participants using mobile technologies in clinical trials.

Methods: Using a qualitative descriptive study design, we conducted in-depth interviews with investigators involved in the conduct of MCTs.

Racial Differences in Patient-provider Communication, Patient Self-efficacy, and Their Associations With Systemic Lupus Erythematosus-related Damage: A Cross-sectional Survey.

Objective: Despite significant racial disparities in systemic lupus erythematosus (SLE) outcomes, few studies have examined how disparities may be perpetuated in clinical encounters. We aimed to explore associations between areas of clinical encounters - patient-provider communication and patient self-efficacy - with SLE-related damage, in order to identify potential areas for intervention to reduce SLE outcome disparities.

Methods: We collected cross-sectional data from a tertiary SLE clinic including patient-provider communication, general self-efficacy, self-efficacy for managing medications and treatments, patient-reported health status, and clinical information.

Racial Disparities in Medication Adherence between African American and Caucasian Patients With Systemic Lupus Erythematosus and Their Associated Factors.

Objective: Medication nonadherence is more common in African Americans compared with Caucasians. We examined the racial adherence gaps among patients with systemic lupus erythematosus (SLE) and explored factors associated with nonadherence.

Methods: Cross-sectional data were obtained from consecutive patients prescribed SLE medications seen at an academic lupus clinic between August 2018 and February 2019.

The science of being a study participant: FEM-PrEP participants' explanations for overreporting adherence to the study pills and for the whereabouts of unused pills.

Background: FEM-PrEP was unable to determine whether once-daily, oral emtricitabine/tenofovir disoproxil fumarate reduces the risk of HIV acquisition among women because of low adherence. Self-reported adherence was high, and pill-count data suggested good adherence. Yet, drug concentrations revealed limited pill use.

A descriptive analysis of perceptions of HIV risk and worry about acquiring HIV among FEM-PrEP participants who seroconverted in Bondo, Kenya, and Pretoria, South Africa.

Introduction: Risk perception is a core construct in many behaviour change theories in public health. Individuals who believe they are at risk of acquiring an illness may be more likely to engage in behaviours to reduce that risk; those who do not feel at risk may be unlikely to engage in risk reduction behaviours. Among participants who seroconverted in two FEM-PrEP sites - Bondo, Kenya, and Pretoria, South Africa - we explored perceived HIV risk and worry about acquiring HIV prior to HIV infection.

FEM-PrEP: adherence patterns and factors associated with adherence to a daily oral study product for pre-exposure prophylaxis.

Background: Several clinical trials have demonstrated the safety and effectiveness of oral tenofovir disoproxil fumarate (TDF), with or without emtricitabine (FTC), as pre-exposure prophylaxis (PrEP) for reducing the risk of HIV acquisition. Adherence to the study product was insufficient to demonstrate the effectiveness of FTC/TDF in 2 PrEP clinical trials conducted among women (FEM-PrEP and the Vaginal and Oral Interventions to Control the Epidemic study), but further analyses of adherence in these studies may inform PrEP demonstration projects and future HIV prevention clinical trials.

Methods: We randomly selected a subcohort of 150 participants randomized to FTC/TDF in 3 FEM-PrEP sites (Bondo, Kenya; Bloemfontein, South Africa; and Pretoria, South Africa) to examine adherence levels over time and to assess factors associated with adherence, based on plasma tenofovir and intracellular tenofovir diphosphate drug concentrations in specimens collected at 4-week visit intervals.

Accuracy of Self-Report and Pill-Count Measures of Adherence in the FEM-PrEP Clinical Trial: Implications for Future HIV-Prevention Trials.

Oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) has been evaluated as pre-exposure prophylaxis (PrEP). We describe the accuracy of self-reported adherence to FTC/TDF and pill counts when compared to drug concentrations in the FEM-PrEP trial. Using drug concentrations of plasma tenofovir (TFV) and intracellular tenofovir diphosphate (TFVdp) among a random sub-sample of 150 participants assigned to FTC/TDF, we estimated the positive predictive value (PPV) of four adherence measures.

No sex for science? Formative research on the acceptability and feasibility of a true contraceptive efficacy clinical trial.

Background: Recruitment challenges and restrictions on intercourse frequency and timing have stymied previous attempts to implement true contraceptive efficacy clinical trials.

Study Design: Qualitative research was conducted in Madagascar, South Africa, and the United States to explore the acceptability of three potential true contraceptive efficacy study designs and the feasibility of recruitment for such trials, including characteristics of potential participants who may be willing to join.

Results: Participants preferred the study design with the least restrictive sex criteria: participants have sex with assigned contraceptive method/no method on days around ovulation and use condoms on other days.

Improving participant understanding of informed consent in an HIV-prevention clinical trial: a comparison of methods.

Empirical research on informed consent has shown that study participants often do not fully understand consent information. This study assessed participant understanding of three mock consent approaches describing an HIV-prevention clinical trial in Lilongwe, Malawi prior to trial implementation. Pregnant women (n = 297) were systematically selected from antenatal-care waiting lines and sequentially allocated to receive an enhanced standard consent form (group 1), a context-specific consent form (group 2), or context-specific counseling cards (group 3).

Focusing HIV prevention on those most likely to transmit the virus.

Despite some success in reducing HIV incidence, the global epidemic continues to grow. For every person with AIDS in developing countries placed on treatment in 2005, many others were newly infected. We need more effective prevention programs that focus interventions on those most at risk for HIV transmission (MART), particularly those with 1) high behavioral risk and 2) high viral loads due to acute or recent infection, co-infections with other diseases, high viral set points, or untreated AIDS.

Applying research ethics guidelines: the view from a sub-saharan research ethics committee.

CONSIDERABLE VARIATION HAS BEEN demonstrated in applying regulations across research ethics committees (RECs) in the U.S., U.

Using formative research to develop a context-specific approach to informed consent for clinical trials.

PARTICIPANT UNDERSTANDING is of particular concern when obtaining informed consent. Recommendations for improving understanding include disclosing information using culturallyappropriate and innovative approaches. To increase the effectiveness of the consent process for a clinical trial in Malawi on interventions to prevent mother-tochild transmission of HIV during breastfeeding, formative research was conducted to explore the community's understanding of medical research as well as how to explain research through local terms and meanings.

Involving communities in the design of clinical trial protocols: the BAN Study in Lilongwe, Malawi.

Objective: To learn the attitudes and concerns of the local community on participating in research, infant feeding practices, and maternal nutrition in order to inform the design of a clinical trial in Lilongwe, Malawi on the safety and efficacy of antiretroviral and nutrition interventions to reduce postnatal transmission of HIV.

Design: Formative research methods were used, including semi-structured interviews, focus group discussions, home observations, and taste trials. Data were collected, analyzed, and incorporated into the protocol within 3 months.

Differences between international recommendations on breastfeeding in the presence of HIV and the attitudes and counselling messages of health workers in Lilongwe, Malawi.

Background: To prevent postnatal transmission of HIV in settings where safe alternatives to breastfeeding are unavailable, the World Health Organization (WHO) recommends exclusive breastfeeding followed by early, rapid cessation of breastfeeding. Only limited data are available on the attitudes of health workers toward this recommendation and the impact of these attitudes on infant feeding counselling messages given to mothers.

Methods: As part of the Breastfeeding, Antiretroviral, and Nutrition (BAN) clinical trial, we carried out an in-depth qualitative study of the attitudes, beliefs, and counselling messages of 19 health workers in Lilongwe, Malawi.

Perceptions of the role of maternal nutrition in HIV-positive breast-feeding women in Malawi.

A neglected issue in the literature on maternal nutrition and HIV is how HIV-positive women perceive their own bodies, health, and well-being, particularly in light of their infection, and whether these perceptions influence their infant feeding practices and their perceived ability to breast-feed exclusively through 6 mo. We conducted formative research to better understand breast-feeding practices and perceptions, and to inform the Breastfeeding, Antiretroviral, and Nutrition (BAN) Study, a clinical trial to evaluate antiretroviral and nutrition interventions to reduce mother-to-child transmission of HIV during breast-feeding in Lilongwe, Malawi. Twenty-two HIV-positive women living in semi-rural areas on the periphery of Lilongwe participated in in-depth interviews.

Experimental evaluation of rodent exclusion methods to reduce hantavirus transmission to residents in a Native American community in New Mexico.

We conducted a pilot study to evaluate the efficacy of rodent proofing continuously occupied homes as a method for lowering the risk for hantavirus pulmonary syndrome (HPS) among residents of a Native American community in northwestern New Mexico. Rodent proofing of dwellings was paired with culturally appropriate health education. Seventy homes were randomly assigned to treatment or control categories.