Substance use patterns of HVTN phase I clinical trial participants: Enrollment, risk reduction counseling and retention.

BACKGROUND: The primary objectives of HIV Vaccine Trials Network (HVTN) phase 1 preventive HIV vaccine clinical trials are to assess safety and immune response to study products. Participant alcohol and drug use may affect adherence, retention, and risk of HIV infection. Data on the effects of substance use are limited to medical care compliance and treatment adherence in HIV infected participants. To our knowledge, there are no data assessing substance use and retention in these vaccine trials. METHODS: We performed a meta-analysis on substance use and its impact on retention in HVTN phase I trials that recruited participants demonstrating lower risk profiles for HIV infection. Our analysis included data from 10 HVTN phase 1 clinical trials conducted between February 2009 and September 2014 in the Americas and Switzerland that utilized the identical interviewer-administered behavioral risk assessment questionnaire to capture participant self-report of substance use in the previous six months. Chi Square tests were used to assess statistical differences between variables. RESULTS: Among the 964 participants, 170 (18%) missed a clinic visit and 78 (8%) terminated early from clinic follow-up; 75/774 (10%) on studies with multiple vaccination timepoints did not complete their vaccinations. Neither frequency of alcohol use, binge drinking, marijuana, nor other drug use reported at screening visits were associated with the three adherence/retention measures. Binge drinking was associated with higher rates of unprotected sex while drunk (p < .001). CONCLUSIONS: Light to moderate alcohol use does not negatively impact adherence or retention in phase I clinical trials. Based on these screening data and the low infection rate of participants during the trial period, the screening process for participation in HVTN phase 1 trials has largely been successful in enrolling and retaining individuals with lower risk profiles. Focusing on binge drinking and increased HIV/STI risk during risk reduction counseling may be warranted.

A preliminary evaluation of a community-based campaign to increase awareness of concurrency and HIV transmission in African American and African-Born communities.

We evaluate an innovative grassroots community-based campaign in Seattle, WA focused on educating African American and African-born communities about concurrent partnerships and HIV transmission. Respondents completed a short self-administered questionnaire on a handheld personal digital assistant to evaluate the reach, acceptability and preliminary efficacy of the campaign. Of those who remembered seeing the campaign materials (82 %), social networks were the most common source of exposure (80 %). Respondents rated campaign materials very visually attractive (86 %), very interesting (91 %), and very important for themselves (90 %) and their community (93 %). Respondents reported that the campaign increased their knowledge about concurrency (84 %), changed their attitudes about it (77 %), and 65 % said it was likely or very likely that they would change their behavior as a result. This inexpensive grassroots campaign demonstrated extensive reach in the local black community and was able to move beyond individual exposure and into social networks.

Bridging the divide: HIV prevention research and Black men who have sex with men.

OBJECTIVES: We obtained contextual information regarding documented barriers to HIV clinical trial participation among Black men who have sex with men (MSM), and explored current preventive HIV clinical trial attitudes, beliefs, and perceptions among Black MSM leaders in the United States. METHODS: We conducted 2 focus groups with Black MSM leaders attending an annual African American MSM Leadership Conference on HIV/AIDS. Focus group questions explored biomedical research perceptions and attitudes, barriers to participation in biomedical prevention research, and steps that need to be taken to address these barriers. A feedback and member checking (participants presented with final themes to provide feedback and guidance) session was also held at the 2012 conference. RESULTS: Three distinct themes emerged regarding Black MSM engagement and participation in HIV vaccine research: (1) community-based organizations as true partners, (2) investment in the Black gay community, and (3) true efforts to inform and educate the community. CONCLUSIONS: A key focus for improving efforts to engage the Black MSM community in preventive HIV clinical trials is building and maintaining equitable and reciprocal partnerships among research institutions, Black-led AIDS service organizations and community-based organizations, and community members.

Exploring barriers and facilitators to participation of male-to-female transgender persons in preventive HIV vaccine clinical trials.

Observed seroincidence and prevalence rates in male-to-female (MTF) transgender individuals highlight the need for effective targeted HIV prevention strategies for this community. In order to develop an effective vaccine that can be used by transgender women, researchers must understand and address existing structural issues that present barriers to this group's participation in HIV vaccine clinical trials. Overcoming barriers to participation is important for ensuring HIV vaccine acceptability and efficacy for the MTF transgender community. To explore barriers and facilitators to MTF transgender participation in preventive HIV vaccine clinical trials, the HIV Vaccine Trials Network conducted focus groups among transgender women in four urban areas (Atlanta, Boston, Philadelphia, and San Francisco). Barriers and facilitators to engagement of transgender women in preventive HIV vaccine clinical trials led to the following recommendations: (a) transgender cultural competency training, (b) creating trans-friendly environments, (c) true partnerships with local trans-friendly organizations and health care providers, (d) protocols that focus on transgender specific issues, and (e) data collection and tracking of transgender individuals. These results have implications for the conduct of HIV vaccine trials, as well as engagement of transgender women in research programs in general.

Behavioral risk assessment in HIV Vaccine Trials Network (HVTN) clinical trials: a qualitative study exploring HVTN staff perspectives.

In HIV vaccine trials, the collection and analysis of participant behavior data associated with risk of acquiring HIV-infection is important for a number of reasons. Although the rationale for behavioral risk assessment in HIV vaccine clinical trials is clear, consistent collection of behavioral data over time and across protocols has been challenging for the HIV Vaccine Trials Network (HVTN). Integrating biomedical and behavioral research within the same preventive vaccine clinical trial has proven difficult. The HVTN conducted an internal landscape analysis to: (1) evaluate the challenges of behavioral risk assessment in HIV vaccine trials and observational studies; (2) explore the impact of the Step Study on behavioral risk assessment measures; and (3) identify strategies to overcome existing challenges and improve the quality of data resulting from behavioral risk analysis. These analyses of behavioral risk within the HVTN revealed several challenges and recommendations for improved behavioral risk data collection in future protocols. The recommendations for improvement include: (1) establishment of protocol-specific behavioral risk working groups that include social and behavioral experts; (2) provision of behavioral rationale and objectives to the development team; (3) creation of a template for geographic- and population-specific assessment of low and high risk behaviors; and (4) pilot testing of behavioral risk assessments. Results also underscored the need for routinely conducted analyses of behavioral data.

The potential of alcohol "heat-of-the-moment" scenarios in HIV prevention: A qualitative study exploring intervention implications.

Scenarios simulating real-world risk situations have proven effective for substance use intervention methods and could potentially prove useful as an HIV-prevention method. This study explored qualitatively the development and use of such "in-the-moment" methods. We interviewed 97 moderate-drinking women (50 % Caucasian) after participation in an experiment requiring that they project themselves into a risky-sex scenario. Most participants (58 %) reported experiencing the scenario as a reflective tool characterized by two primary themes: (1) increased awareness of risk and (2) contemplation of behavior change. Findings suggest that "in-the-moment" methods depicting real-world risk situations and providing opportunities to reflect about behavioral choices and subsequent outcomes could prove a useful adjunct to HIV/AIDS-prevention interventions. Such methods could potentially augment existing prevention protocols.

Developing concurrency messages for the black community in Seattle, Washington.

In the United States, Blacks are disproportionately impacted by HIV/AIDS. Sexual networks and concurrent relationships have emerged as important contributors to the heterosexual transmission of HIV. To date, Africa is the only continent where an understanding of the impact of sexual concurrency has been conveyed in HIV prevention messaging. This project was developed by researchers and members of the Seattle, Washington, African American and African-Born communities, using the principles of community-based participatory research (CBPR). Interest in developing concurrency messaging came from the community and resulted in the successful submission of a community-academic partnership proposal to develop and disseminate HIV prevention messaging around concurrency. The authors describe (a) the development of concurrency messaging through the integration of collected formative data and findings from the scientific literature; (b) the process of disseminating the message in the local Black community; and (c) important factors to consider in the development of similar campaigns.

Stress management effects on perceived stress and cervical neoplasia in low-income HIV-infected women.

OBJECTIVE: Risk for developing cervical neoplastic disease is greatly increased in women infected with oncogenic sexually transmitted human papillomaviruses (HPVs) and who have lowered cellular immunity due to coinfection with human immunodeficiency virus (HIV) infection. The majority of these individuals are low-income minority women. Factors associated with promotion of HPV to cervical neoplasia in HIV-infected populations include degree of immunosuppression as well as behavioral factors such as tobacco smoking and psychological stress. This study examined the effects of a cognitive behavioral stress management (CBSM) intervention on life stress and cervical neoplasia in HIV+ minority women. METHODS: Participants were 39 HIV+ African-American, Caribbean, and Hispanic women with a recent history of an abnormal Papanicolaou smear. Participants underwent colposcopic examination, psychosocial interview, and peripheral venous blood draw at study entry and 9 months after being randomly assigned to either a 10-week CBSM group intervention (n=21) or a 1-day CBSM workshop (n=18). RESULTS: Women assigned to the 10-week group-based CBSM intervention reported decreased perceived life stress and had significantly lower odds of cervical neoplasia over a 9-month follow-up. CBSM effects on life stress and neoplasia appeared independent of presence of neoplasia at study entry, HPV type, CD4+CD3+ cell count, HIV viral load, and substance use. Furthermore, CBSM intervention effects on cervical neoplasia were especially pronounced among women with residual life stress at follow-up. CONCLUSION: These findings suggest that stress management decreases perceived life stress and may decrease the odds of cervical neoplasia in women with HIV and a history of abnormal Papanicolaou smears. Although preliminary, these findings suggest the utility of stress management as a cancer prevention strategy in this high-risk population.

Barriers to cervical cancer screening among low-income HIV-positive African American women.

This study elucidates the perspective of low-income HIV-positive African American women who have not received cervical cancer screening for five or more years, on the barriers they face in accessing and using reproductive health care. We focused on how women who live in a severely economically depressed and racially segregated neighborhood experience barriers to cervical cancer screening. Andersen's Behavioral Model of Health Services Use, which allows for the organization of conditions and situations that bar utilization of health services, served as the theoretical framework. Findings from individual semi-structured interviews with 35 participants revealed the importance of psychological and emotional barriers as well as the more commonly reported economic, social, and health care system barriers. We suggest how access to care for this population can be increased by including psychological and emotional components in intervention efforts.