ABSTRACT
BACKGROUND: Electronic health records (EHRs) are a cost-effective approach to provide the necessary foundations for clinical trial research. The ability to use EHRs in real-world clinical settings allows for pragmatic approaches to intervention studies with the emerging adult HIV population within these settings; however, the regulatory components related to the use of EHR data in multisite clinical trials poses unique challenges that researchers may find themselves unprepared to address, which may result in delays in study implementation and adversely impact study timelines, and risk noncompliance with established guidance. OBJECTIVE: As part of the larger Adolescent Trials Network (ATN) for HIV/AIDS Interventions Protocol 162b (ATN 162b) study that evaluated clinical-level outcomes of an intervention including HIV treatment and pre-exposure prophylaxis services to improve retention within the emerging adult HIV population, the objective of this study is to highlight the regulatory process and challenges in the implementation of a multisite pragmatic trial using EHRs to assist future researchers conducting similar studies in navigating the often time-consuming regulatory process and ensure compliance with adherence to study timelines and compliance with institutional and sponsor guidelines. METHODS: Eight sites were engaged in research activities, with 4 sites selected from participant recruitment venues as part of the ATN, who participated in the intervention and data extraction activities, and an additional 4 sites were engaged in data management and analysis. The ATN 162b protocol team worked with site personnel to establish the necessary regulatory infrastructure to collect EHR data to evaluate retention in care and viral suppression, as well as para-data on the intervention component to assess the feasibility and acceptability of the mobile health intervention. Methods to develop this infrastructure included site-specific training activities and the development of both institutional reliance and data use agreements. RESULTS: Due to variations in site-specific activities, and the associated regulatory implications, the study team used a phased approach with the data extraction sites as phase 1 and intervention sites as phase 2. This phased approach was intended to address the unique regulatory needs of all participating sites to ensure that all sites were properly onboarded and all regulatory components were in place. Across all sites, the regulatory process spanned 6 months for the 4 data extraction and intervention sites, and up to 10 months for the data management and analysis sites. CONCLUSIONS: The process for engaging in multisite clinical trial studies using EHR data is a multistep, collaborative effort that requires proper advanced planning from the proposal stage to adequately implement the necessary training and infrastructure. Planning, training, and understanding the various regulatory aspects, including the necessity of data use agreements, reliance agreements, external institutional review board review, and engagement with clinical sites, are foremost considerations to ensure successful implementation and adherence to pragmatic trial timelines and outcomes.
ABSTRACT
Many adolescents and young adults (AYAs; ages 13-24) are unaware of their HIV status despite participating in behavior that places them at risk for contracting HIV. This study examined possible predictors of self-reported HIV testing for high school students (grades 9-12) who completed the Youth Risk Behavior Survey (YRBS). Three sex-stratified, stepwise multivariable logistic models were used to estimate odds of having received a HIV test being associated with student characteristics and substance use. The likelihood of being tested for HIV was associated with students who were a racial/ethnic minority and age 18 and older. HIV testing was also associated with male students who reported same sex partners (males) or same sex partners (males) and different sex partners (females). Female students who reported same sex partners (females) and different sex partners (males) were more likely to have been tested for HIV. Male and female students were more likely to have been tested for HIV if they reported illicit drug and/or marijuana use, while prescription drug use was also associated with HIV testing for female students. Knowledge of the predictors of HIV testing for adolescents can guide efforts for the effective scale up of testing for this vulnerable population.
Subject(s)
Adolescent Behavior , HIV Infections , Substance-Related Disorders , Adolescent , Adult , Ethnicity , Female , HIV Infections/diagnosis , HIV Infections/epidemiology , Humans , Male , Minority Groups , Risk-Taking , Self Report , Sexual Behavior , Students , Substance-Related Disorders/diagnosis , Substance-Related Disorders/epidemiology , Young AdultABSTRACT
PURPOSE OF REVIEW: With the onset of the Coronavirus disease 2019 (COVID-19) pandemic, in-person human immunodeficiency virus (HIV) testing is no longer easily accessible. Therefore, alternative testing technologies must be considered and implemented on a large scale to continue prevention efforts. This review seeks to describe the benefits of utilizing at-home HIV testing technologies, traditionally deemed an alternative form of testing. RECENT FINDINGS: Utilizing at-home testing technology during the COVID-19 pandemic overcomes novel and previously identified barriers to HIV testing. SUMMARY: Ensuring access to HIV testing is imperative to long-term prevention goals. With the Ending the HIV Epidemic (EHE) initiative in the USA targeting achievement by 2030, obstacles to HIV testing must be addressed to ensure its success. Implementing alternative testing technology more broadly allows for continued prevention efforts for HIV in light of COVID era restrictions.
ABSTRACT
HIV stigma and future orientations impact the health of adolescents and young adults living with HIV (AYALWH); however, little is known about how these factors may impact tobacco use, and thereby long-term health status. This study examined associations between internalized HIV stigma, future orientations, and smoking behavior using a cross sectional survey of AYALWH ages 18 to 29 (N = 109). Greater levels of stigma were associated with increased odds of smoking, and greater future orientations were associated with a reduced odds of smoking. The interaction was significant, illustrating that stigma was significantly associated with an increased odds of smoking among AYALWH who reported low levels of future orientations, but not for those with high levels of future orientations. Findings underscore the importance of understanding how HIV stigma may undermine future aspirations of AYALWH. Interventions that target HIV stigma and future orientations may be critical for tobacco prevention and cessation.
Subject(s)
HIV Infections/psychology , Social Stigma , Stress, Psychological/psychology , Tobacco Smoking/adverse effects , Adolescent , Adult , Cross-Sectional Studies , Depression/psychology , Female , HIV Infections/drug therapy , Health Status , Humans , Male , Stereotyping , Young AdultABSTRACT
The average reported age of sexual debut for youth in the United States is 14.4 years, with approximately 7% reporting their sexual debut prior to age 13. While the research literature on sexual debut for youth addresses gender and ethnic differences (with males and African-American youth experiencing earlier sexual debut), there is limited data regarding factors associated with sexual debut for young men who have sex with men (YMSM). Early sexual debut poses potential health risks, such as contracting HIV with an increased risk of unprotected intercourse. Given current high HIV infection rates for racial/ethnic minority YMSM, learning more about their sexual debuts and associated risk factors of this population is of great importance. This study investigated risk behaviors and emotional distress, and their association with MSM sexual debut for a multisite cohort of racial/ethnic minority YMSM living with HIV. We hypothesized that a MSM sexual debut younger than age 16 would be associated with engagement in more high-risk sexual behaviors (unprotected sex and exchange sex), substance use, and emotional distress than a MSM sexual debut at age 16 or older. Results indicated that participants having a MSM sexual debut before the age of 16 reported more exchange sex; drug use (specifically marijuana); emotional/psychological problems related to substance use; and a history of suicide attempts, compared to participants with later MSM sexual debuts. Comprehensive interventions that are racially/ethnically sensitive, inquire about initial sexual experiences, and focus on sexual health and healthy relationships are needed to improve health outcomes for this population.
Subject(s)
Aging , Black or African American , HIV Infections/prevention & control , Hispanic or Latino , Homosexuality, Male , Minority Groups , Adolescent , HIV Infections/epidemiology , Humans , Male , Risk Factors , United States/epidemiology , Young AdultABSTRACT
The federal government has established rapid identification, linkage, and engagement in medical care of HIV-positive individuals as a high priority. Outreach workers and other linkage coordinators are identified as key personnel in implementing this policy. Young racial/ethnic minority men who have sex with men (MSM) have relatively high and growing rates of HIV infection and would benefit from the services of outreach workers. In this article, we describe the characteristics of outreach workers employed by eight demonstration sites participating in the federal Special Projects of National Significance (SPNS) Young MSM of Color Initiative, the linkage and retention models used by the sites, and the number of outreach/ linkage contacts and individuals referred to HIV care. We summarize rates of retention of outreach workers in employment, factors associated with worker turnover, and costs associated with their replacement. We also summarize the experiences of demonstration sites in employing and retaining outreach workers and improving their performance. The insights of outreach workers are reported regarding the challenges they experienced while conducting outreach. Recommendations from demonstration site project managers and outreach workers are offered to improve workplace performance and job retention. Outreach and retention strategies, as well as lessons learned in employing outreach workers, are useful to programs serving young racial/ethnic minority MSM and other HIV-positive groups.
Subject(s)
Community-Institutional Relations , HIV Infections/prevention & control , Health Personnel/psychology , Homosexuality, Male , Minority Groups , Adolescent , HIV Infections/epidemiology , Humans , Male , Personnel Turnover , Salaries and Fringe Benefits , United States/epidemiology , Workload , Young AdultABSTRACT
OBJECTIVES: We sought to determine whether field outreach with motivational interviewing, as compared with traditional field outreach, leads to increases in HIV counseling and testing and rates of return for test results among young African American men who have sex with men (MSM). METHODS: In a randomized, 2-group, repeated-measures design, 96 young African American MSM completed a motivational interviewing-based field outreach session and 92 young African American MSM completed a traditional field outreach session. The percentages of participants agreeing to traditional HIV counseling and testing (an oral swab of the cheek) and returning for test results were the primary outcome measures. RESULTS: More of the participants in the motivational interviewing condition than the control condition received HIV counseling and testing (49% versus 20%; chi(2)(1) = 17.94; P = .000) and returned for test results (98% versus 72%; chi(2)(1) = 10.22; P = .001). CONCLUSIONS: The addition of motivational interviewing to field outreach is effective in encouraging high-risk young African American MSM to learn their HIV status. Also, peer outreach workers can be effectively trained to reduce health disparities by providing evidence-based brief counseling approaches targeting high-risk minority populations.
Subject(s)
Black or African American , Community-Institutional Relations , HIV Seropositivity/blood , Homosexuality, Male , Interviews as Topic , Motivation , Adolescent , Counseling/statistics & numerical data , Humans , Male , Mass Screening/statistics & numerical data , Michigan , Program Evaluation , Young AdultABSTRACT
OBJECTIVE: This study investigated motivation to attend appointments, self-efficacy, self-esteem, substance use, and emotional distress as predictors of optimal HIV appointment adherence in minority youth living with HIV. METHODS: Utilizing a prospective design, questionnaires were collected from 82 minority youth (mean age = 20.3) at baseline and appointment adherence was assessed over the subsequent 12-month period. Appointment adherence was dichotomized to reflect optimal (i.e., at least one appointment in each of the four quarters) versus suboptimal appointment adherence (i.e., no appointment in at least one of the four quarters). RESULTS: High levels of motivation to attend appointments, high levels of self-efficacy, and low levels of alcohol use were associated with optimal HIV appointment adherence. CONCLUSIONS: Interventions promoting motivation and self-efficacy, while addressing alcohol use and awareness of appointment adherence may be promising in improving optimal HIV appointment adherence in minority youth.
Subject(s)
HIV Seropositivity/psychology , Minority Groups/psychology , Motivation , Patient Compliance/psychology , Adolescent , Appointments and Schedules , Female , Health Behavior , Humans , Logistic Models , Male , Prospective Studies , Self Concept , Self Efficacy , Surveys and Questionnaires , Young AdultABSTRACT
Youth living with HIV (YLH) are at particularly high risk for poor retention in HIV primary care. This study utilized Motivational Interviewing (MI) to improve youth retention in primary care and compared the fidelity and outcomes of peer outreach workers (POW) to masters level staff (MLS). Eighty-seven YLH were randomized to receive two MI sessions from POW or MLS. YLH were aged 16-29 and 92% were African American. Thirty-seven audiotaped sessions were coded with the Motivational Interviewing Treatment Integrity (MITI) coding system. Retention in care was assessed by review of medical records. POW had higher fidelity on two MITI scales, and did not differ from MLS on remaining three scales. While both groups improved the regularity of primary care appointments, the effect size for POW on retention in care and intervention dose was larger than that of MLS. The results suggest that POW can provide MI with quality comparable to MLS with adequate training and supervision. MI provided by POW to improve retention in health care services may increase the cost-effectiveness of evidence-based practices in urban settings.
Subject(s)
Clinical Competence/standards , HIV Infections/psychology , Interview, Psychological/standards , Outcome Assessment, Health Care/statistics & numerical data , Patient Acceptance of Health Care/statistics & numerical data , Adolescent , Adult , Analysis of Variance , Community Health Workers/education , Community Health Workers/standards , Female , Home Care Services/organization & administration , Home Care Services/standards , Humans , Inservice Training , Pilot Projects , Primary Health Care , Professional-Patient Relations , Young AdultABSTRACT
The purpose of this study was to contribute to the limited literature on newly diagnosed persons living with HIV/AIDS (PLWHA) by describing their retention in HIV primary care and changes in barriers to care over 12 months of follow-up subsequent to enrolling in outreach interventions. Medical chart review and interview data were collected from 104 newly diagnosed PLWHA at baseline, 6-month, and 12-month follow-up. Almost all newly diagnosed PLWHA (92%) had an HIV care appointment in the 6 months post-enrollment. Newly diagnosed persons were more likely to have undetectable viral loads at 6 and 12-month follow-up compared to baseline with 45% undetectable by 12 months. Adequate retention in care (at least one appointment in each 6-month window) was significantly associated with reductions in substance use and improvements in insurance coverage. Improvements in mental health status and the elimination of stigma as a barrier were not associated with retention, but those who reported stigma as a barrier at baseline and continued to report stigma at 6 months had less than adequate retention. These results suggest the need for early and intensive outreach interventions for newly diagnosed persons. Future directions include testing outreach interventions in a randomized clinical trial, and evaluating programs that integrate early HIV identification and intensive outreach to enroll and retain persons newly infected with HIV in care.