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Exploring evidence for behavioral risk compensation among participants in an HIV vaccine clinical trial
Painter, Julia E; DiClemente, Ralph J; Jimenez, Lauren; Stuart, Theron; Sales, Jessica M; Mulligan, Mark J
BACKGROUND:HIV vaccine trial participants may engage in behavioral risk compensation due to a false sense of protection. We conducted an ancillary study of an HIV Vaccine Trials Network (HVTN) vaccine efficacy trial to explore risk compensation among trial participants compared to persons who were willing to participate but ineligible based on previous exposure to the Ad5 virus (Ad5+) across three timepoints. METHODS:Participants were drawn from the Atlanta, GA site of the HVTN 505 vaccine trial. From 2011-2013, all persons who met prescreening criteria for the clinical trial and presented for Ad5 antibody testing were invited to participate in the ancillary study. Data were collected from vaccine trial participants (n=51) and Ad5+ participants (n=60) via online surveys across three timepoints: baseline, T2 (after trial participants received 2/4 injections) and T3 (after trial participants received 4/4 injections). Data analyses assessed demographic, psychosocial, and behavioral differences at baseline and changes at each timepoint. RESULTS:At baseline, Ad5+ participants were less likely to have some college education (p=0.024) or health insurance (p=0.008), and were more likely to want to participate in the vaccine trial "to feel safer having unprotected sex" (p=0.005). Among vaccine trial participants, unprotected anal sex with a casual partner (p=0.05), HIV transmission worry (p=0.033), and perceived chance of getting HIV (p=0.027), decreased across timepoints. CONCLUSIONS:Study findings suggest that persons with previous exposure to Ad5 may be systematically different from their Ad5-negative peers. Unprotected anal sex with a casual partner significantly decreased among HIV vaccine trial participants, as did HIV worry and perceived chance of getting HIV. Findings did not support evidence of risk compensation among HIV vaccine trial participants compared to Ad5+ participants.
PMID: 28533053
ISSN: 1873-2518
CID: 3242252
Predicting Unprotected Sex and Unplanned Pregnancy among Urban African-American Adolescent Girls Using the Theory of Gender and Power
Rosenbaum, Janet E; Zenilman, Jonathan; Rose, Eve; Wingood, Gina; DiClemente, Ralph
Reproductive coercion has been hypothesized as a cause of unprotected sex and unplanned pregnancies, but research has focused on a narrow set of potential sources of reproductive coercion. We identified and evaluated eight potential sources of reproductive coercion from the Theory of Gender and Power including economic inequality between adolescent girls and their boyfriends, cohabitation, and age differences. The sample comprised sexually active African-American female adolescents, ages 15-21. At baseline (n = 715), 6 months (n = 607), and 12 months (n = 605), participants completed a 40-min interview and were tested for semen Y-chromosome with polymerase chain reaction from a self-administered vaginal swab. We predicted unprotected sex and pregnancy using multivariate regression controlling for demographics, economic factors, relationship attributes, and intervention status using a Poisson working model. Factors associated with unprotected sex included cohabitation (incidence risk ratio (IRR) 1.48, 95 % confidence interval (1.22, 1.81)), physical abuse (IRR 1.55 (1.21, 2.00)), emotional abuse (IRR 1.31 (1.06, 1.63)), and having a boyfriend as a primary source of spending money (IRR 1.18 (1.00, 1.39)). Factors associated with unplanned pregnancy 6 months later included being at least 4 years younger than the boyfriend (IRR 1.68 (1.14, 2.49)) and cohabitation (2.19 (1.35, 3.56)). Among minors, cohabitation predicted even larger risks of unprotected sex (IRR 1.93 (1.23, 3.03)) and unplanned pregnancy (3.84 (1.47, 10.0)). Adolescent cohabitation is a marker for unprotected sex and unplanned pregnancy, especially among minors. Cohabitation may have stemmed from greater commitment, but the shortage of affordable housing in urban areas could induce women to stay in relationships for housing. Pregnancy prevention interventions should attempt to delay cohabitation until adulthood and help cohabiting adolescents to find affordable housing.
PMCID:4899331
PMID: 27188460
ISSN: 1468-2869
CID: 3624162
Recommendations for Structure and Content for a School-Based Adolescent Immunization Curriculum
Salazar, Kelsey R; Seib, Katherine G; Underwood, Natasha L; Gargano, Lisa M; Sales, Jessica M; Morfaw, Christopher; Murray, Dennis; Diclemente, Ralph J; Hughes, James M
Despite high utilization of childhood vaccinations, adolescent immunization coverage rates lag behind recommended coverage levels. The four vaccines recommended for adolescents ages 11 to 18 years are tetanus, diphtheria, and pertussis vaccine; human papillomavirus vaccine; meningococcal conjugate vaccine; and an annual influenza vaccine. The Healthy People 2020 goal is 80% coverage for each recommended immunization, but coverage rates in Georgia among adolescents fall below those goals for all but the tetanus, diphtheria, and pertussis vaccine. We developed a multicomponent intervention that included a school-based, teacher-delivered educational curriculum to increase adolescent vaccination coverage rates in Richmond County, Georgia. We facilitated focus group discussions with middle- and high school science teachers who delivered the immunization curriculum in two consecutive school years. The objective of the focus group was to understand teachers' perspectives about the curriculum impact and to synthesize recommendations for optimal dissemination of the curriculum content, structure, and packaging. Teachers provided recommendations for curriculum fit within existing classes, timing of delivery, and dosage of delivery and recommended creating a flexible tool kit, such as a downloadable online package. Teachers also recommended increasing emphasis on disease transmission and symptoms to keep students engaged. These findings can be applied to the development of an online, cost-effective tool kit geared toward teaching adolescents about the immune system and adolescent vaccinations.
PMID: 27009129
ISSN: 1524-8399
CID: 3624102
Human Immunodeficiency Virus Prevention
Davis, Teaniese Latham; DiClemente, Ralph
Human immunodeficiency virus (HIV) is the virus that causes AIDS. Surveillance data from 2012 indicate an estimated 1.2 million people aged 13 years and older were living with HIV infection in the United States, and 12.8% do not know their status. There are approximately 50,000 new HIV infections annually. With no available cure for HIV, primary prevention to reduce incident cases of HIV is essential. Strategies to prevent HIV transmission include reducing sexual risk behavior and needle sharing. The Centers for Disease Control and Prevention has multiple resources available for primary and secondary prevention to reduce disease transmission and severity.
PMID: 26980130
ISSN: 1558-0490
CID: 3624082
Juvenile Justice-Translational Research on Interventions for Adolescents in the Legal System (JJ-TRIALS): a cluster randomized trial targeting system-wide improvement in substance use services
Knight, Danica K; Belenko, Steven; Wiley, Tisha; Robertson, Angela A; Arrigona, Nancy; Dennis, Michael; Bartkowski, John P; McReynolds, Larkin S; Becan, Jennifer E; Knudsen, Hannah K; Wasserman, Gail A; Rose, Eve; DiClemente, Ralph; Leukefeld, Carl
BACKGROUND:The purpose of this paper is to describe the Juvenile Justice-Translational Research on Interventions for Adolescents in the Legal System (JJ-TRIALS) study, a cooperative implementation science initiative involving the National Institute on Drug Abuse, six research centers, a coordinating center, and Juvenile Justice Partners representing seven US states. While the pooling of resources across centers enables a robust implementation study design involving 36 juvenile justice agencies and their behavioral health partner agencies, co-producing a study protocol that has potential to advance implementation science, meets the needs of all constituencies (funding agency, researchers, partners, study sites), and can be implemented with fidelity across the cooperative can be challenging. This paper describes (a) the study background and rationale, including the juvenile justice context and best practices for substance use disorders, (b) the selection and use of an implementation science framework to guide study design and inform selection of implementation components, and (c) the specific study design elements, including research questions, implementation interventions, measurement, and analytic plan. METHODS/DESIGN/METHODS:The JJ-TRIALS primary study uses a head-to-head cluster randomized trial with a phased rollout to evaluate the differential effectiveness of two conditions (Core and Enhanced) in 36 sites located in seven states. A Core strategy for promoting change is compared to an Enhanced strategy that incorporates all core strategies plus active facilitation. Target outcomes include improvements in evidence-based screening, assessment, and linkage to substance use treatment. DISCUSSION/CONCLUSIONS:Contributions to implementation science are discussed as well as challenges associated with designing and deploying a complex, collaborative project. TRIAL REGISTRATION/BACKGROUND:NCT02672150 .
PMCID:4850663
PMID: 27130175
ISSN: 1748-5908
CID: 3624132
Validation of the Sexual Communication Self-Efficacy Scale
Quinn-Nilas, Christopher; Milhausen, Robin R; Breuer, Rebecca; Bailey, Julia; Pavlou, Menelaos; DiClemente, Ralph J; Wingood, Gina M
This study assessed a newly developed Sexual Communication Self-Efficacy Scale designed to measure the sexual communication self-efficacy of adolescent men and women. Three-hundred and seventy-four U.K. adolescents completed this new scale, along with several other validity measures. Factor analysis revealed that the Sexual Communication Self-Efficacy Scale consisted of five underlying factors: contraception communication, positive sexual messages, negative sexual messages, sexual history, and condom negotiation. These factors demonstrated high internal consistency and presents evidence to support construct validity. This scale may have utility in assessing the effectiveness of interventions designed to enhance sexual communication and sexual health behaviors among young people.
PMID: 26286296
ISSN: 1552-6127
CID: 3623982
Do As I Say: Using Communication Role-Plays to Assess Sexual Assertiveness Following an Intervention
Mercer Kollar, Laura M; Davis, Teaniese L; Monahan, Jennifer L; Samp, Jennifer A; Coles, Valerie B; Bradley, Erin L P; Sales, Jessica McDermott; Comer, Sarah K; Worley, Timothy; Rose, Eve; DiClemente, Ralph J
Sexual risk reduction interventions are often ineffective for women who drink alcohol. The present study examines whether an alcohol-related sexual risk reduction intervention successfully trains women to increase assertive communication behaviors and decrease aggressive communication behaviors. Women demonstrated their communication skills during interactive role-plays with male role-play partners. Young, unmarried, and nonpregnant African American women (N = 228, ages 18-24) reporting unprotected vaginal or anal sex and greater than three alcoholic drinks in the past 90 days were randomly assigned to a control, a sexual risk reduction, or a sexual and alcohol risk reduction (NLITEN) condition. Women in the NLITEN condition significantly increased assertive communication behavior compared to women in the control condition, yet use of aggressive communicative behaviors was unchanged. These data suggest assertive communication training is an efficacious component of a sexual and alcohol risk reduction intervention. Public health practitioners and health educators may benefit from group motivational enhancement therapy (GMET) training and adding a GMET module to existing sexual health risk reduction interventions. Future research should examine GMET's efficacy in combination with other evidence-based interventions within other populations and examine talking over and interrupting one's sexual partner as an assertive communication behavior within sexual health contexts.
PMCID:5154169
PMID: 27164847
ISSN: 1552-6127
CID: 3624152
Preexisting Chronic Health Conditions and Health Insurance Status Associated With Vaccine Receipt Among Adolescents
Seib, Katherine; Underwood, Natasha L; Gargano, Lisa M; Sales, Jessica M; Morfaw, Christopher; Weiss, Paul; Murray, Dennis; Vogt, Tara M; DiClemente, Ralph J; Hughes, James M
PURPOSE/OBJECTIVE:Four vaccines are routinely recommended for adolescents: tetanus, diphtheria, and acellular pertussis (Tdap); human papillomavirus (HPV); meningococcal-conjugate (MCV4); and a yearly seasonal influenza vaccine. Vaccination promotion and outreach approaches may need to be tailored to certain populations, such as those with chronic health conditions or without health insurance. METHODS:In a controlled trial among middle and high school students in Georgia, 11 schools were randomized to one of three arms: no intervention, parent education brochure, or parent education brochure plus a student curriculum on the four recommended vaccines. Parents in all arms were surveyed regarding their adolescent's vaccine receipt, chronic health conditions, and health insurance status. RESULTS:Of the 686 parents, most (91%) reported their adolescent had received at least one of the four vaccines: Tdap (82%), MCV4 (59%), current influenza vaccine (53%) and HPV (48%). Twenty-three percent of parents reported that their adolescent had asthma. Most parents reported that their adolescent's insurance was Medicaid (60%) or private insurance (34%), and 6% reported no insurance. More adolescents with a chronic health condition received any adolescent vaccine than adolescents without a chronic health condition (p < .0001). Among those with no insurance, fewer had received any adolescent vaccine than those with Medicaid or private insurance (p < .0001). CONCLUSIONS:The federal Vaccines for Children program offers recommended vaccines free to eligible children (including those without health insurance). Our findings suggest that parents may not be aware of this program or eligibility for it, thus revealing a need for education or other fixes.
PMID: 26683985
ISSN: 1879-1972
CID: 3624052
Alcohol Use Problems and Sexual Risk Among Young Adult African American Mothers
Swartzendruber, Andrea; Sales, Jessica M; Rose, Eve S; DiClemente, Ralph J
Studies have documented high levels of alcohol use and sexual risk among young mothers. We examined parenting satisfaction and self-efficacy in relation to alcohol use problems and sexual risk among 346 young African American women enrolled in an HIV prevention trial, 41 % (n = 141) of whom were mothers. Among mothers, greater parenting satisfaction was associated with a reduced likelihood of problematic alcohol use, having multiple sex partners, and testing positive for Trichomonas vaginalis. Relative to non-parenting women, mothers reported lower condom use. Compared to non-parenting women, mothers with the highest parenting satisfaction reported fewer alcohol use problems; mothers with the lowest parenting satisfaction reported lower condom use and were more likely to have multiple partners and test positive for T. vaginalis. Parenting self-efficacy was not associated with the outcomes examined. Future research investigating relationships between parenting satisfaction, alcohol use and sexual risk may be useful for improving multiple maternal health outcomes.
PMCID:4827249
PMID: 26499334
ISSN: 1573-3254
CID: 3624042
Validity of Self-reported Sexual Behavior Among Adolescents: Where Do We Go from Here? [Editorial]
DiClemente, Ralph J
Adolescents have high rates of sexually transmitted infections (STIs). Adolescents consuming alcohol and using drugs have markedly greater HIV/STI risk and are a priority population for intervention. Accurate measurement of sexual risk behavior is critical for understanding individual's risk for HIV/STI, transmission dynamics of HIV/STI, and evaluating the efficacy of interventions designed reduce HIV/STI risk. However, significant challenges to accurately measuring adolescents' self-reported sexual behavior are well-documented. Recent advances in microbiology, such as the use of less invasive specimen collection for DNA assays, can assist researchers in more accurately measuring adolescents' sexual risk behavior. However, the majority of studies of adolescents' sexual risk rely solely on self-reported behavior; therefore, methods to improve the validity of adolescents' self-reported sexual behavior are needed. In addition, integrating biologic measures to complement self-reported measures are recommended, when appropriate and feasible.
PMID: 26459333
ISSN: 1573-3254
CID: 3624032