Prior incarceration associated with missed HIV care visits among young people living with HIV in the US.

Maintenance in HIV care is important to achieve optimal personal health and HIV viral load suppression for young people living with HIV (PLWH). We assessed the relationship between incarceration and missed visits in a longitudinal data cohort of PLWH (n = 910), ages 12-24, from 14 adolescent trial network sites across the US. The time from study entry to missed visits was modeled using Cox proportional hazards models. The cohort was mostly male (78%) and African American (75%) with a median age of 22. Prior incarceration had been experienced by 39% of the cohort, with a median number of times incarcerated of 2 (IQR: 1-3). The crude and adjusted hazard ratios for missed HIV care visits comparing those with incarceration histories to those without were 1.27 (95% CI: 1.06, 1.54) and 1.53 (95% CI: 1.26, 1.86). Among those returning to care, HIV viral loads were more likely to be unsuppressed among those with incarceration history compared to those without (RR: 1.28, 95% CI: 0.95, 1.74). This association was attenuated to the null after adjustment for suppression of viral load prior to the missed visit. Young PLWH with incarceration histories are at higher risk of missing HIV care visits.

Impact of Early Antiretroviral Therapy on Detection of Cell-Associated HIV-1 Nucleic Acid in Blood by the Roche Cobas TaqMan Test.

The Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test, v2.0 (the CAP/CTM assay), was used to quantify cell-associated HIV-1 (CAH) nucleic acid in peripheral blood mononuclear cells (PBMC) from well-characterized clinical specimens from HIV-1-infected individuals on antiretroviral therapy (ART). Chronically infected individuals on ART with no detectable plasma HIV-1 RNA demonstrated average CAH burdens of 3.2 HIV-1 log10 copies/million cells. Assay sensitivity and specificity were 98.9% and 100%, respectively, with the positive and negative predictive values being 100% and 98.6%, respectively. The CAH burden was also measured at weeks 0, 1, 2, 8, and 60 in 37 participants (RV254/SEARCH010, Bangkok, Thailand) stratified by Fiebig stage (Fiebig stage I [FI] to FVI) at ART initiation. Prior to ART initiation, the average CAH burden was 1.4, 4.1, and 3.6 log10 copies/million PBMCs for individuals who initiated ART at FI, FII, and FIII to FVI, respectively. Initiation of ART resulted in a rapid decline of CAH in all individuals, with the greatest decrease being observed in individuals who initiated ART at FI to FIII. By week 60, 100% (FI), 71.8% (FII/FIII), and 20.5% (FIV to FVI) of samples from individuals initiating treatment were at or near the limit of quantitation. Residual CAH was detectable at 60 weeks in most individuals who initiated ART at later stages (FIV to FVI) and averaged 1.9 ± 0.7 log10 copies/million PBMCs. The modified Roche CAP/CTM assay provides a convenient, standardized approach to measure residual HIV in blood and may be useful for monitoring patients under therapy or those participating in HIV remission studies.

A cross-sectional study examining associations between substance use frequency, problematic use and STIs among youth living with HIV.

OBJECTIVES: This study sought to examine the prevalence of STIs and whether substance use frequency and/or problematic use-specifically alcohol, marijuana and other drugs-was associated with having an STI diagnosis among youth living with HIV (YLWH) METHODS: A sample of 823 YLWH were recruited at 14 adolescent HIV clinics through the Adolescent Medicine Trials Network for HIV Interventions. Study staff abstracted STI data from medical records for up to 26 weeks prior to participants' completing a cross-sectional survey including the ASSIST (Alcohol, Smoking and Substance Involvement Screening Test), which measures substance use frequency and consequences. RESULTS: Almost one-third of youth had been diagnosed with an STI (30.5%) at the time of their baseline assessment. In multivariable analyses, those who engaged in weekly or greater marijuana use (adjusted OR (AOR)=10.66, 95% CI: 4.39 to 25.87, P<0.001) had an increased odds of being diagnosed with an STI. Additionally, youth who met alcohol use criteria for moderate (AOR=5.23, 95% CI: 2.50 to 10.93, P<0.001) and high risk (AOR=6.53, 95% CI: 1.20 to 35.68, P<0.05) alcohol use had an increased odds of being diagnosed with an STI compared with low-risk alcohol users. CONCLUSIONS: Study findings underscore the need to investigate the role of greater frequency of marijuana use and problematic alcohol use in STI incidence among YLWH. Given the associations between both substance use frequency and problematic use in STI diagnoses among YLWH seen in HIV care settings, clinicians should use validated substance use screening tools which capture both frequencies and consequences in order to identify YLWH who may need further evaluation and treatment.

Tobacco Use and Sustained Viral Suppression in Youth Living with HIV.

Tobacco has been associated with worse HIV disease progression in adult samples of people living with HIV; however, studies have yet to examine these effects in youth living with HIV (YLWH). This study examined the association between tobacco smoking behaviors and sustained viral suppression among a sample of 820 YLWH who were recruited through the Adolescent Medicine Trials Network for HIV Interventions. Participants completed a cross-sectional survey and then staff abstracted viral suppression data from medical records for up to 26 weeks prior to enrollment. Overall, 20.4% of youth reported daily or almost daily tobacco use. In multivariable analyses, older age and daily or almost daily tobacco smoking, and ART adherence remained statistically significant in predicting sustained viral suppression over the study period. These findings underscore the need for tobacco screening and interventions in HIV care settings in order to identify youth in need of additional smoking cessation services.

A genetic marker of risk in HIV-infected individuals with a history of hazardous drinking.

Impulsivity and sensation seeking have been linked to hazardous drinking, increased sexual risk behaviors, and lower treatment adherence among persons living with HIV (PLH). The dopamine active transporter1 (DAT1or SLC6A3) gene has been linked to impulsivity and sensation seeking in several populations but has not been investigated among populations of PLH. This study used data from 201 PLH who report a recent history of heavy episodic drinking. Results indicate that DAT1*10R vs DAT1*9R genotype was related to higher propensity for risk taking (standardized difference score (d) = 0.30 [95% CI: 0.02;0.59]), more hazardous drinking (d = 0.35 [0.05;0.64]), and more condomless sex (rate ratio (RR)= 2.35[1.94; 2.85]), but were counter-intuitively associated with fewer sexual partners (RR = 0.65[0.43;0.91]) and possibly better treatment adherence (d = 0.32 [-0.01;0.65]). Results are consistent with the suggested associations between DAT1 and risk-taking behavior. The counter-intuitive finding for partner selection and treatment adherence may be evidence of additional factors that place PLH at risk for engaging in hazardous drinking as well as relationship difficulties and problems with treatment adherence (e.g., depressive symptoms, avoidant coping, trauma history). Caution is required when using a single gene variant as a marker of complex behaviors and these findings need to be replicated using larger samples and additional variants.

State-civil society partnerships for HIV/AIDS treatment and prevention in Ghana: exploring factors associated with successes and challenges.

BACKGROUND: The past decade has seen an increased number of state-civil society partnerships in the global Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) response of many countries. However, there has been limited research carried out concerning the successes and challenges of these partnerships. METHODS: In-depth qualitative interviews were conducted with 23 participants from 21 different state-civil society partnerships throughout Ghana including all three major geographical zones (Northern, Middle, and Southern zones) to examine the nature of these partnerships and their positive and negative effects in responding to the national HIV/AIDS epidemic. RESULTS: Major themes included: 1) commitment by the government and civil society organizations to work cooperatively in order to support the development and implementation of HIV/AIDS interventions in Ghana; 2) the role of civil society organizations in facilitating community mobilization; capacity building; and information, resources and skills exchange to increase the efficiency and effectiveness of these partnerships for HIV prevention and treatment; and 3) significant challenges including funding issues and other structural barriers for these partnerships that need to be addressed moving forward. CONCLUSIONS: Future research should focus on examining the impact of recommended changes on state-civil partnerships and studying the extent and nature of these partnerships in other countries in order to establish the generalizability of the findings from this study.

OPRM1 and diagnosis-related posttraumatic stress disorder in binge-drinking patients living with HIV.

Posttraumatic stress disorder (PTSD) has been linked to numerous negative outcomes in persons living with HIV (PLH) and there is evidence that PTSD symptoms may play a role in maintaining alcohol use problems. The opioid receptor mu-1 (OPRM1) gene may play a role in both PTSD and alcohol use. We examined the association between PTSD and drinking motives as well as variation in the OPRM1 as a predictor of both PTSD and drinking motives in a sample of 201 PLH reporting recent binge drinking. Self-reported PTSD symptom severity was significantly associated with drinking motives for coping, enhancement, and socialization. OPRM1 variation was associated with decreased PTSD symptom severity as well as enhancement motives for drinking.

A trimeric, V2-deleted HIV-1 envelope glycoprotein vaccine elicits potent neutralizing antibodies but limited breadth of neutralization in human volunteers.

BACKGROUND: A key missing element in the development of a successful human immunodeficiency virus (HIV) vaccine is an immunogen that can generate broadly cross-neutralizing antibodies against primary isolates of the virus. METHODS: This phase 1 clinical trial employed a DNA prime and subunit envelope protein boost in an attempt to generate cellular and humoral immune responses that might be desirable in a protective HIV vaccine. Priming was performed via intramuscular injection with gag and env DNA adsorbed to polylactide coglycolide microspheres, followed by boosting with a recombinant trimeric envelope (Env) glycoprotein delivered in MF59 adjuvant. RESULTS: The DNA prime and protein boost were generally safe and well-tolerated. Env-specific CD4(+) cellular responses were generated that were predominantly detected after Env protein boosting. Neutralizing antibody responses against the homologous SF162 viral isolate were remarkably strong and were present in the majority of vaccine recipients, including a strong response against CD4-induced epitopes on gp120. Despite the promising potency of this vaccine approach, neutralization breadth against heterologous tier 2 strains of HIV-1 was minimal. CONCLUSIONS: Potent neutralization against neutralization-sensitive strains of HIV is achievable in humans through a DNA prime, recombinant oligomeric Env protein boost regimen. Eliciting substantial breadth of neutralization remains an elusive goal. CLINICAL TRIALS REGISTRATION: NCT00073216.

Metformin is Associated with Decreased 30-Day Mortality Among Nursing Home Residents Infected with SARS-CoV2.

OBJECTIVES: The COVID-19 pandemic presents an urgent need to investigate whether existing drugs can enhance or even worsen prognosis; metformin, a known mammalian target of rapamycin (m-TOR) inhibitor, has been identified as a potential agent. We sought to evaluate mortality benefit among older persons infected with SARS-CoV-2 who were taking metformin as compared to those who were not. DESIGN: Retrospective cohort study. SETTING AND PARTICIPANTS: 775 nursing home residents infected with SARS-CoV-2 who resided in one of the 134 Community Living Centers (CLCs) of the Veterans Health Administration (VHA) during March 1, 2020, to May 13, 2020, were included. METHODS: Using a window of 14 days prior to SARS-CoV-2 testing, bar-coded medication administration records were examined for dispensing of medications for diabetes. The COVID-19-infected residents were divided into 4 groups: (1) residents administered metformin alone or in combination with other medications, (2) residents who used long-acting or daily insulin, (3) residents administered other diabetes medications, and (4) residents not administered diabetes medication, including individuals without diabetes and patients with untreated diabetes. Proportional hazard models adjusted for demographics, hemoglobin A1c, body mass index, and renal function. RESULTS: Relative to those not receiving diabetes medications, residents taking metformin were at significantly reduced hazard of death [adjusted hazard ratio (HR) 0.48, 95% confidence interval (CI) 0.28, 0.84] over the subsequent 30 days from COVID-19 diagnosis. There was no association with insulin (adjusted HR 0.99, 95% CI 0.60, 1.64) or other diabetes medications (adjusted HR 0.71, 95% CI 0.38, 1.32). CONCLUSIONS AND IMPLICATIONS: Our data suggest a reduction in 30-day mortality following SARS-CoV-2 infection in residents who were on metformin-containing diabetes regimens. These findings suggest a relative survival benefit in nursing home residents on metformin, potentially through its mTOR inhibition effects. A prospective study should investigate the therapeutic benefits of metformin among persons with COVID-19.

Transmission Risk Among Youth Living With HIV in the U.S.

PURPOSE: HIV treatment as prevention is effective for reducing the risk of HIV transmission and the messaging campaign, undetectable = untransmittable, is gaining recognition. As youth living with HIV (YLWH) who have condomless sex may acquire and potentially transmit other sexually transmitted infections (STIs), the purpose of this study was to assess potential differences in transmission risk of HIV and other STIs among YLWH to inform subsequent HIV and STI prevention efforts. METHODS: A cohort of 600 HIV behaviorally infected youth aged 13-24 years who were engaged in medical care completed an audio computer-assisted self-interview including questions about demographics, HIV disclosure, mental health, substance use, and sexual behaviors and beliefs. HIV viral loads and the presence of other STIs were abstracted from medical records. A viral load <200 copies/mL was considered undetectable. Univariate and bivariate analyses were conducted to examine differences by viral load and STIs. RESULTS: Participants were categorized into four groups: (1) undetectable without STIs (55.2%); (2) undetectable with STIs (14.2%); (3) detectable without STIs (22.8%); and (4) detectable with STIs (7.8%). In comparison to the other three groups, youth in the undetectable group with STIs reported more favorable sexual risk reduction attitudes and beliefs, internet use for finding sex partners, anal sex with male partners, and condomless anal sex with male partners. CONCLUSIONS: YLWH with undetectable viral loads and other STIs engaged in higher risk behaviors. To realize the promise of the messaging campaign, undetectable = untransmittable, efforts must focus on sustained viral suppression and prevention of STIs among YLWH.

The Association between Use of Online Social Networks to Find Sex Partners and Sexually Transmitted Infection Diagnosis among Young Men Who Have Sex with Men and Transgender Women Living with HIV.

We conducted a cross-sectional analysis of baseline data from the Adolescent Trials Network for HIV/AIDS Interventions to examine the association between the use of social media sites to find sex partners and recent diagnosis of sexually transmitted infections (STIs) among 13- to 24-year-old men who have sex with men and transgender women living with HIV. We used linear regression to determine the relationship between the number of STIs and the number of social media sites used to find sex partners with each type of sex act included in the analysis. Secondary analyses substituted frequency of social media site use for number of social media sites. Among 741 participants, for every 1 social media account used to find sex partners, there was a 2.53% (95% confidence interval: 0.28-5.54) increase in STIs. This association was mediated through condomless receptive anal intercourse or condomless insertive anal intercourse but not barrierless oral intercourse. Similar but attenuated associations were found when frequency of social media site use was substituted for number of social media sites. Future research should examine innovative interventions on these social media sites with respect for its users.

HIV seroconversion without infection after receipt of adenovirus-vectored HIV type 1 vaccine.

BACKGROUND: We analyzed human immunodeficiency virus (HIV) seroresponses from 3 phase I HIV-1 vaccine trials to assess the frequency of vaccine-induced seroconversion. METHODS: HIV-1 and HIV-2 enzyme-linked immunosorbent assay (ELISA) was performed during trials of adenovirus type 5 (Ad5)-vectored clade B HIV-1 monovalent gag and trivalent gag/pol/nef vaccines given to HIV-seronegative adults. Doses were administered at day 1, week 4, and week 26. Results were analyzed by vaccine formulation and dose and were stratified by baseline Ad5 titer. ELISA-positive samples were reflexively tested by Western blotting. RESULTS: Overall, 165 (41%) of 406 evaluable vaccine recipients had positive ELISA results but negative PCR results by week 78. Seroconversion rates were directly related to vaccine dose, were inversely related to baseline Ad5 titer, and were unaffected by vaccine valency. One hundred (89%) of 113 evaluable patients with low baseline Ad5 antibody titers (or=1 dose of vaccine with >or=1 x 10(10) gag-containing Ad5 particles per dose experienced seroconversion. Of 163 vaccine recipients who had positive ELISA results and available Western blot results, 150 (92%) had indeterminate results of Western blot, typically involving bands at p24, p40, and/or p55. Thirteen uninfected patients (8%) had equivocally positive Western blot results, usually because of an additional weak glycoprotein 41 band. Env-specific enzyme immunoassay results were falsely positive for 2 uninfected vaccine recipients. CONCLUSIONS: Positive ELISA results were similarly common for monovalent and trivalent vaccine recipients. Vaccine dose and baseline Ad5 immunity were major determinants of vaccine-induced seroconversion rates. Corresponding Western blots characteristically showed bands directed only at Gag proteins, which helped to distinguish HIV-uninfected vaccine recipients who experienced seroconversion from true HIV-infected patients. If available, an enzyme immunoassay exclusively targeting proteins not expressed by the vaccine should be the screening test of first choice for vaccine recipients.

Partner Notification for Youth Living With HIV in 14 Cities in the United States.

BACKGROUND: Identifying factors associated with partner notification among youth living with HIV is critical for effective HIV prevention and treatment strategies. METHODS: A total of 924 male and female behaviorally infected youth aged 13-24 across 14 U.S. cities completed an audio computer-assisted self-interview including questions about demographics and experiences with patient- and provider-referral partner notification. RESULTS: The majority of participants self-identified as male (82.5%), Black/non-Hispanic (70.1%), and Hispanic/Latino (18.2%). Most males (93.4%) reported engaging in male-to-male sexual contact. Over three-quarters (77.6%) reported that all or some of their partners were contacted, while 22.4% indicated that none were contacted regarding potential HIV exposure. Most (52.4%) reported that only one person talked to them about notifying partners including the HIV tester (36.5%) followed by their health care provider/doctor (27.6%). Less than a fifth (18.3%) were themselves notified of their own exposure to HIV. Using multivariable logistic regression, 3 factors were associated with successful partner notification: (1) when more than one person talked to participants about partner notification (AOR = 1.87, 1.33-2.62); (2) if they themselves had been notified of their own HIV exposure (AOR = 1.83, 1.13-2.95); and (3) if their education included some college or technical school versus less than high school (AOR = 1.72, 1.04-2.85). CONCLUSIONS: Partner notification among youth living with HIV is unsuccessful at least 22.4% of the time, although minimal criteria for partner services are being met almost universally. Partner notification might benefit from enhanced guidelines that call for both HIV testers and HIV care providers to discuss this important strategy with HIV-positive youth.

HIV Continuum of Care for Youth in the United States.

BACKGROUND: Beneficial HIV treatment outcomes require success at multiple steps along the HIV Continuum of Care. Youth living with HIV are a key population, and sites in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) are known for modeling optimum HIV adolescent care. METHODS: A longitudinal cohort study conducted at 14 network sites across the United States assessed how the later steps of the Continuum of Care were achieved among the youth: engagement, treatment, and viral load (VL) suppression. Youth aged 13-24 who were behaviorally infected with HIV and linked to care at an ATN-affiliated site were eligible to participate. RESULTS: A total of 467 youth were enrolled and had 1 year of available data. Most were aged 22-24 (57%), male (79%), and black/non-Hispanic (71%). Most used alcohol (81%) and marijuana (61%) in the 3 months before enrollment, and 40% had a history of incarceration. Among this cohort of youth, 86% met criteria for care engagement; among these, 98% were prescribed antiretroviral therapy and 89% achieved VL suppression. Sustained VL suppression at all measured time points was found among 59% with initial suppression. Site characteristics were notable for the prevalence of adherence counseling (100%), case management (100%), clinic-based mental health (93%), and substance use (64%) treatment. CONCLUSIONS: Youth living with HIV in the United States can be successfully treated at health care sites with experience, excellence, and important resources and services. Sustained VL suppression may be an important step to add to the Continuum of Care for youth.

Vaccination in juvenile correctional facilities: state practices, hepatitis B, and the impact on anticipated sexually transmitted infection vaccines.

OBJECTIVES: Juvenile correctional facilities are an ideal setting to provide preventive vaccines to adolescents who are at risk. In many instances of incarceration, facilities overcome the need for parental consent by making young people wards of the state and the state providing consent. The authors investigated current state practices for administering hepatitis B vaccine to incarcerated adolescents. These may impact the delivery of anticipated sexually transmitted infection (STI) vaccines to incarcerated adolescents. METHODS: From June to August 2004, interviews were conducted with state Immunization Program Managers by telephone about hepatitis B vaccination and consent policies in juvenile correctional facilities. RESULTS: Forty-five states were able to provide information about hepatitis B immunization in publicly funded juvenile correctional facilities. Forty-one of the 45 states offered hepatitis B vaccine to adolescents who were sentenced and thereby considered to be wards of the state. Of those 41 states, 20 also made hepatitis B vaccine easily accessible to detained adolescents (no parental consent required). Those 20 states considered detained adolescents as wards of the state (n=13), or allowed them to self-consent for the vaccine (n=7). CONCLUSIONS: Most states offer hepatitis B vaccination to sentenced adolescents in correctional facilities. Just over half of these states also vaccinate detained adolescents. Juvenile correctional facilities have experience administering vaccines, and this might allow for expansion of vaccination services when new STI vaccines become available. Still, there are major barriers to universal vaccination of incarcerated adolescents, including the issue of consent.

Feasibility and acceptability of rapid HIV testing in jail.

For correctional HIV testing programs, delivery of HIV test results can be difficult because of short incarceration times for many inmates. Rapid HIV testing enables immediate delivery of test results and can be performed in conjunction with risk reduction counseling. The objective of this study was to determine the feasibility and acceptability of rapid HIV testing within the Rhode Island Department of Corrections jail. Jail detainees were randomly asked to participate in the study. The study included: (1) completing a questionnaire that investigated HIV risk behavior, incarceration history, HIV testing history, and attitudes toward routine HIV testing in jail and toward partner notification services; (2) individualized HIV risk reduction counseling; and (3) the option of rapid HIV testing with delivery of test results. One hundred thirteen inmates were asked to participate and 100 (88%) participated. Among the subjects, there was a high frequency of incarceration and subjects were at significant risk of HIV infection, yet there was low perceived risk. Ninety-five percent of participants underwent rapid HIV testing. Of those, 99% had negative test results and one subject had a preliminary positive result. All subjects received rapid test results and individualized risk reduction counseling. The majority of subjects supported routine HIV testing in jail and the concept of partner notification services. In this population of jail detainees, rapid HIV testing was feasible and highly acceptable. Further studies are needed to successfully incorporate rapid HIV testing into jail HIV screening programs.

HIV testing experiences among male and female inmates in Rhode Island.

We conducted a survey of 154 inmates of the Rhode Island Department of Corrections jail regarding HIV risk, HIV testing experiences, and attitudes toward rapid HIV testing in the correctional setting. HIV risk behavior was common during the 6 months before incarceration. Ninety-four percent of inmates were previously tested for HIV; of those, 50% reported at least 1 test for which they did not receive a result. Eighty-eight percent stated they would prefer rapid testing to standard HIV antibody testing in the correctional setting. Rapid HIV testing is acceptable to this high-risk prison population and may improve the delivery of HIV test results. Further research is needed to determine how to best incorporate rapid HIV testing into the delivery of health care in the correctional setting.

Stem-loop binding protein is a multifaceted cellular regulator of HIV-1 replication.

A rare subset of HIV-1-infected individuals is able to maintain plasma viral load (VL) at low levels without antiretroviral treatment. Identifying the mechanisms underlying this atypical response to infection may lead to therapeutic advances for treating HIV-1. Here, we developed a proteomic analysis to compare peripheral blood cell proteomes in 20 HIV-1-infected individuals who maintained either high or low VL with the aim of identifying host factors that impact HIV-1 replication. We determined that the levels of multiple histone proteins were markedly decreased in cohorts of individuals with high VL. This reduction was correlated with lower levels of stem-loop binding protein (SLBP), which is known to control histone metabolism. Depletion of cellular SLBP increased promoter engagement with the chromatin structures of the host gene high mobility group protein A1 (HMGA1) and viral long terminal repeat (LTR), which led to higher levels of HIV-1 genomic integration and proviral transcription. Further, we determined that TNF-α regulates expression of SLBP and observed that plasma TNF-α levels in HIV-1-infected individuals correlated directly with VL levels and inversely with cellular SLBP levels. Our findings identify SLBP as a potentially important cellular regulator of HIV-1, thereby establishing a link between histone metabolism, inflammation, and HIV-1 infection.

A model to provide comprehensive testing for HIV, viral hepatitis, and sexually transmitted infections at a short-term drug treatment center.

Substance users are at high risk for blood-borne infections as well as those that are transmitted sexually. Substance abuse treatment centers present an opportunity to offer comprehensive counseling and testing (CCT) for HIV, viral hepatitis, and sexually transmitted infections (STIs) to this high-risk population. We examined the feasibility and acceptability of one model of CCT among substance users. CCT was offered to 145 consecutive inpatients; study participants completed a risk factor questionnaire and selected from a menu of testing options. Thirty-six percent of those approached agreed to participate and accepted at least one biologic test. Sixty-two percent of participants accepted all tests that were offered. While beneficial to those who accept testing, the described model of CCT is feasible in a drug treatment center, but acceptable to only a minority of inpatients.

Adolescent decision making about participation in a hypothetical HIV vaccine trial.

PURPOSE: The purpose of this study was to examine the process of adolescent decision-making about participation in an HIV vaccine clinical trial, comparing it to adult models of informed consent with attention to developmental differences. METHODS: As part of a larger study of preventive misconception in adolescent HIV vaccine trials, we interviewed 33 male and female 16-19-year-olds who have sex with men. Participants underwent a simulated HIV vaccine trial consent process, and then completed a semistructured interview about their decision making process when deciding whether or not to enroll in and HIV vaccine trial. An ethnographic content analysis approach was utilized. RESULTS: Twelve concepts related to adolescents' decision-making about participation in an HIV vaccine trial were identified and mapped onto Appelbaum and Grisso's four components of decision making capacity including understanding of vaccines and how they work, the purpose of the study, trial procedures, and perceived trial risks and benefits, an appreciation of their own situation, the discussion and weighing of risks and benefits, discussing the need to consult with others about participation, motivations for participation, and their choice to participate. CONCLUSION: The results of this study suggest that most adolescents at high risk for HIV demonstrate the key abilities needed to make meaningful decisions about HIV vaccine clinical trial participation.