"The role of case management in HIV treatment adherence: HPTN 078".

Adherence to care and antiretroviral therapy is challenging, especially for people living with HIV (PLWH) with additional co-occurring risk factors. Case management interventions, including motivational interviewing (MI), show promise to improve HIV treatment adherence, but few studies have examined how such interventions are delivered to or experienced by PLWH who have been reengaged in care. We conducted qualitative interviews with six case managers and 110 PLWH exiting from a randomized study (HPTN 078) who received a MI-based case management intervention in addition to standard patient-navigation services, or standard services only. Our study provided greater insight into the main findings from HPTN 078, including an in-depth description of the multiple barriers to adherence faced by this largely "out-of-care" population, as well as a more nuanced understanding of the benefits and challenges of implementing MI. A blend of MI plus more intensive interventions may be needed for PLWH facing multiple structural barriers.

Beyond the Individual: Social and Cultural Influences on the Health-Seeking Behaviors of African American Men.

Morbidity and mortality rates are alarmingly high among African American men and are influenced by the health-seeking behaviors of this population. This study examined data from 40 focus groups with African American men in Durham, North Carolina, to better understand social and cultural influences on health-seeking behaviors. Data were analyzed using inductive thematic analysis. Three broad types of social/cultural influence on motivation to seek health care services were identified: family, culture and upbringing, and peers. Study findings confirm the importance of social relationships in influencing African American men's health-seeking behaviors and offer characterization of the nature of influence across different types of relationships, according to the direct support or indirect messages they provide. Future programs can draw on these data to inform efforts to include family and peers as well as utilize existing cultural gender norms to the advantage of health promotion for African American men.

Using theory of change frameworks to develop evaluation strategies for research engagement: results of a pre-pilot study.

INTRODUCTION: Inadequate community and stakeholder engagement can lead to accusations that research is unethical and can delay or slow research or translation of results to practice. Such experiences have led major funders as well as regulatory and advisory bodies to establish minimal requirements for community and stakeholder engagement in HIV and other clinical research. However, systematic efforts to formally evaluate the contributions and impact of particular practices are lacking. METHODS: A theory of change framework aligned with Good Participatory Practice for TB clinical trials was used to develop a set of measures for use in a minimally burdensome survey of trial implementing sites. The survey was pre-piloted with three TB trial sites in North America, South America and Asia to assess the feasibility of surveying global research sites in a systematic way, and to see if the measures captured informative variation in the use of engagement strategies and desired outcomes. Surveys were conducted at baseline and six months. In-depth interviews were conducted with site staff prior to the baseline survey to understand how sites conceptualized the concepts underlying the framework and the extent to which they viewed their work as aligned with the framework. RESULTS: Survey measures captured considerable variability in the intensity and variety of engagement strategies, both across sites and within sites over time, and moderate variability in outcomes. Interviews indicated that underlying concepts were often unfamiliar to staff at baseline, but the goals of engagement aligned well with existing values. CONCLUSIONS: Brief, targeted surveys of trial sites to characterize use of broad strategies, specific practices and some outcomes are a feasible option for evaluating good participatory practice. Additional testing is warranted to assess and enhance validity, reliability and predictive value of indicators. Options for collecting outcome measures through additional objective means should be explored.

Corrigendum: Relationship between Human Immunodeficiency Virus (HIV) Knowledge, HIV-Related Stigma, and HIV Testing among Young Black Adults in a Southeastern City.

[This corrects the article on p. 47 in vol. 5, PMID: 28349049.].

Relationship between Human Immunodeficiency Virus (HIV) Knowledge, HIV-Related Stigma, and HIV Testing among Young Black Adults in a Southeastern City.

The southeast is identified as the epicenter of the nation's human immunodeficiency virus (HIV) epidemic, accounting for nearly 44% of all persons living with a HIV diagnosis in the United States. HIV stigma and knowledge have been cited as some of the complex factors increasing risk of acquiring HIV within African-American communities. We sought to understand how HIV knowledge and HIV-related stigma impact HIV testing experience among young Black adults who completed a community-based participatory research survey in a Southeastern city. Survey measures were developed with active engagement among the research team and community members, with the goal of balancing community knowledge, interests and concerns with scientific considerations, and the realities of funding and the project timeline. A total of 508 of the 513 audio computer-assisted self-interview questionnaires completed were analyzed. Eighty-one percent of participants had ever tested and had an intention-to-test for HIV in the next 12 months. Overall, analyses revealed low HIV-related stigma and relatively moderate to high HIV knowledge among young Black adults in the Southeastern city. Logistic regression indicated that having ever tested for HIV was positively correlated with HIV knowledge [odds ratio (OR): 1.50; 95% confidence interval (CI): 1.23-1.84, p < 0.001], but inversely correlated with low HIV-related stigma (OR: 0.08; 95% CI: 0.01-0.76, p < 0.03). However, there were no significant relationships between HIV-related stigma, HIV knowledge, and intention-to test for HIV in the future. These findings suggest that reducing HIV-related stigma and increasing HIV knowledge are not sufficient in promoting HIV testing (i.e., intention-to-test) among young Black adults in this city, unless specific emphasis is placed on addressing internalized HIV-related stigma and misperceptions about HIV prevention and control.

Developing a Framework for Evaluating Ethical Outcomes of Good Participatory Practices in TB Clinical Drug Trials.

Good Participatory Practice Guidelines for TB Drug Trials (GPP-TB) were issued in 2012, based on similar guidelines for HIV prevention and reflecting growing acceptance of the importance of community engagement and participatory strategies in clinical research. Though the need for such strategies is clear, evaluation of the benefits and burdens are needed. Working with a diverse group of global TB stakeholders including advocates, scientists, and ethicists, we used a Theory of Change approach to develop an evaluation framework for GPP-TB that includes a clearly defined ethical goal, a set of powerful strategies derived from GPP-TB practices for achieving the goal, and outcomes connecting strategies to goal. The framework is a first step in systematically evaluating participatory research in clinical trials.

Concurrency and Other Sexual Risk Behaviors Among Black Young Adults in a Southeastern City.

Black Americans continue to have higher rates of HIV disease than other races/ethnicities. Conventional individual-level risk behaviors do not fully account for these racial/ethnic disparities. Sexual concurrency may help explain them. Respondent-driven sampling (RDS) was used to enroll 508 sexually active 18- to 30-year-old Black men and women in Durham, North Carolina in a cross-sectional survey on HIV-related topics. Consistent condom use was low for all participants, especially with steady partners. Concurrent partnerships in the past 6 months were relatively common for both men (38%) and women (25%). In general, men involved in concurrent relationships engaged in more risk behaviors than other men (e.g., inconsistent condom use and alcohol and drug use). A majority of concurrent partnerships involved steady partners. HIV-prevention programs should address the risks of concurrency and factors that discourage condom use, especially with steady partners with whom condom use is particularly low.

HIV Testing Experience and Risk Behavior Among Sexually Active Black Young Adults: A CBPR-Based Study Using Respondent-Driven Sampling in Durham, North Carolina.

African Americans are disproportionately affected by the HIV epidemic inclusive of men who have sex with men, heterosexual men, and women. As part of a community-based participatory research study we assessed HIV testing experience among sexually active 18-30 year old Black men and women in Durham, NC. Of 508 participants, 173 (74 %) men and 236 (86 %; p = 0.0008) women reported ever being tested. Barriers to testing (e.g., perceived risk and stigma) were the same for men and women, but men fell behind mainly because a primary facilitator of testing-routine screening in clinical settings-was more effective at reaching women. Structural and behavioral risk factors associated with HIV infection were prevalent but did not predict HIV testing experience. Reduced access to health care services for low income Black young adults may exacerbate HIV testing barriers that already exist for men and undermine previous success rates in reaching women.

Curriculum development to increase minority research literacy for HIV prevention research: a CBPR approach.

BACKGROUND: Minority engagement in HIV prevention research can improve the process and products of research. Using community-based participatory research (CBPR) to develop capacity-building tools can promote community awareness of HIV prevention, clinical research, and community roles in research. OBJECTIVES: We sought to describe a CBPR approach to curriculum development to increase HIV prevention research literacy among Blacks ages 18 to 30. METHODS: Community members and researchers documented the iterative and participatory nature of curriculum development and lessons learned.Results/Lessons Learned: We used specific strategies to support and verify multi-stakeholder engagement, team building, capacity building, and shared decision making. Objective or formal assessments of baseline capacity, ongoing stakeholder engagement, and reinforcing the value of multiple perspectives can promote further equity in curriculum development between researchers and community members. CONCLUSIONS: The iterative process of shared discussion, development, and consensus building strengthened collaboration between stakeholder groups and produced a stronger, more culturally appropriate curriculum to promote HIV prevention research engagement among young Blacks.

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. Participants suggested that condom adherence would be low. Differences were noted across sites on whether female participants should be actively seeking pregnancy or not actively seeking pregnancy but willing to accept a pregnancy. Recruitment of participants was expected to be difficult. CONCLUSIONS: Data suggest that a true contraceptive efficacy clinical trial may not be feasible at this time in these settings.