Undermining the Translational Potential of Clinical Research with Adolescents and Young Adults: Differential Enrollment in Randomized Clinical Trials During COVID-19.

BACKGROUND: COVID-19 stay-at-home orders and research restrictions halted recruitment and follow-up of clinical research patients. While clinical research has resumed, it is an open question whether research participation has returned to levels similar to those before COVID-19. METHODS: We utilized data from the TECH-PN (NCT# NCT03828994) study, a single-center RCT enrolling 13-25-year-olds with mild-moderate pelvic inflammatory disease (PID) receiving ambulatory care. We examined enrollment patterns before COVID-19 and during/after COVID-19 among those assessed for eligibility by estimating the average rate of recruitment visits for each period. We focused on this monthly rate by pandemic status, the length of stay (LOS) by pandemic status, as well as the relationship between the LOS and patient demographics. Descriptive analyses were conducted, including Student's t-test to compare rates between time periods and a Chi-square test to compare the proportion refusing enrollment. RESULTS: The monthly enrollment rate during/post-pandemic was significantly lower than before COVID-19 (4.8 per month compared to 7.4 per month, p < 0.001). However, eligible participants' age, race, and insurance type were similar pre- and during/post-pandemic. Among eligible patients, LOS for receiving PID care was slightly increased, from a median of 5.4 hours to 6.4 hours (p = 0.650), and the rate of refusal to participate among those eligible was similar (23% versus 27%, p = 0.362). There was a similar number of ineligible patients due to inpatient admissions during both periods. CONCLUSION: COVID-19 pandemic restrictions negatively impacted recruitment into this RCT. Enrollment differences may reflect ongoing perceptions of restrictions in care access or a hesitancy to use health services. More research is needed to stabilize access to ambulatory STI/PID care and access to clinical trials.

Cash Transfers and After-School Programs: A Randomized Controlled Trial for Young Men at Risk of Violence Exposure in Wilmington, Delaware.

We conducted a randomized controlled trial to determine whether an after-school program paired with a cash transfer (a conditional cash transfer) or a cash transfer alone (an unconditional cash transfer) can help improve health and economic outcomes for young men between the ages of 14 and 17 whose parents have low incomes and who live in neighborhoods with high crime rates. We find that receiving the cash transfer alone was associated with an increase in healthy behaviors (one of our primary outcome composite measures) and that the cash transfer paired with after-school programming was associated with an improvement in the financial health of participants (one of our secondary outcome composite measures). We find no differences in spending on alcohol, marijuana, cigarettes, or other drugs between either the treatment group and the control group. Neither the cash transfer alone nor the programming plus cash transfer had statistically significant effects on our other primary composite measures (physical and mental health or school attendance and disciplinary actions), or our other secondary composite measures (criminal justice engagement or social supports) but in most cases, confidence intervals were too large to rule out meaningful effects. Results suggest that cash transfers hold promise to improve the health of youth without any indication of any adverse effects.

Patient Portal Privacy: Perspectives of Adolescents and Emerging Adults Living with HIV and the Parental/Guardian Role in Supporting Their Care.

BACKGROUND: Increasing the percentage of people living with human immunodeficiency virus (HIV), including youth, who are virally suppressed to 95% is an overall goal of the ending the HIV epidemic initiative. While patient portals have become ubiquitous, questions remain about how best to operationalize parental/guardian access to youth's patient portals in alignment with optimizing HIV care outcomes and patient preferences. This qualitative study focuses on understanding perspectives among youth with HIV (YHIV) about parental access to patient portals. METHODS: Eligible participants were YHIV aged 13 to 25 years receiving care at an urban academic hospital. Semistructured individual/paired interviews were conducted between May 2022 and March 2023. Participants were asked to discuss thoughts on parental access to patient portals, and roles parents/guardians have in supporting their HIV care. Semistructured interviews were conducted with adolescent and emerging adult health care workers (HCWs) to gain perspectives on YHIV emergent themes. Audio-recorded interviews were transcribed verbatim, and we conducted thematic analysis using an inductive approach to identify codes and themes. RESULTS: Sixteen YHIV and four HCWs participated in interviews. Parental roles in coordinating HIV care ranged from supporting YHIV needs for transportation, acquiring, and taking medications, to not having any role at all. Participants shared heterogeneous perspectives about their openness to share patient portal access with their parents/guardians. Perspectives were not strictly congruent along lines of participant age or parental roles in helping youth to manage HIV care. Sharing passwords emerged both as a pathway that YHIV grant access to their accounts and a source of confusion for clinicians when parents/guardians send messages using their child's account. CONCLUSION: Findings suggest HCWs should initiate conversations with YHIV patients to determine preferences for parental/guardian access to their patient portal, educate on proxy access, and explain the extent of medical information that is shared with proxy accounts, regardless of age and perceived parental involvement in HIV care.

Safe Spaces 4 Sexual Health: A Status-Neutral, Mobile Van, HIV/STI Testing Intervention Using Online Outreach to Reach MSM at High Risk for HIV Acquisition or Transmission.

BACKGROUND: Black men who have sex with men (MSM) carry the greatest burden of new HIV diagnoses in the United States. Ending the HIV epidemic requires strategic, culturally specific approaches to target factors contributing to persistent HIV disparities. SETTING: Safe Spaces 4 Sexual Health (SS4SH), a community-informed HIV/sexually transmitted infection (STI) testing strategy combining mobile van testing with online outreach, was implemented over a 14-month period from 2018 to 2019 in Baltimore, MD. METHODS: We evaluated the reach of MSM at high risk with high acquisition or transmission risk by SS4SH mobile van combined with online outreach as compared with the Baltimore City Health Department's venue-based mobile van (with no online outreach) operating during the same period based on the following HIV/STI testing outcome measures: (1) number of MSM HIV or STI tested, (2) new HIV diagnosis rate, (3) percent with new syphilis diagnosis, (4) percent at high risk for HIV acquisition, and (5) percent people living with HIV at high risk for transmission. RESULTS: Over a 14-month period, SS4SH HIV/STI tested 151 MSM. Of these, 74% were Black and the mean age was 34 (SD = 10, range = 19-68). Seven percent (10/148) were new HIV diagnoses, and 10% (13/130) were diagnosed with syphilis. The Baltimore City Health Department's venue-based mobile van strategy yielded 53% (231) more MSM (71% Black, mean age 38, SD = 14, range = 15-74), but the HIV/syphilis positivity rate was significantly lower: 0.5% new HIV diagnosis rate (P < 0.001) and 0.5% with syphilis diagnosis (P < 0.001). CONCLUSIONS: Our findings suggest SS4SH combing online outreach with mobile van testing may be more effective at reaching high-risk Black MSM than venue-based mobile testing.

Dyadic Intervention for Sexually Transmitted Infection Prevention in Urban Adolescents and Young Adults (The SEXPERIENCE Study): Protocol for a Randomized Controlled Trial.

BACKGROUND: Adolescents and young adults (AYA) aged younger than 25 years have the highest rates of sexually transmitted infections (STIs) in the United States. Current STI prevention strategies for AYA rely primarily on individual approaches, leaving sexual partners with significant unmet sexual and reproductive health care and health education needs. Dyadic interventions may hold promise for harnessing the power of communal coping within relationship dynamics to enhance sexual decision making, communication, and behavior changes that reduce the future risk of STIs. OBJECTIVE: This paper describes the protocol and research methods of a dyad-based behavioral intervention that augments individual evidence-based interventions with joint health education counseling for heterosexual AYA dyads within a primary care setting. The trial aims to improve partner communication and collaborative sexual decision making and promote the adoption of sexual behaviors such as consistent condom use. The primary objective of this study is to assess the feasibility, acceptability, and effectiveness of a dyadic intervention targeted at preventing STIs in heterosexual couples in an urban setting. METHODS: A total of 100 AYA (50 dyads) aged 16 to 25 years, engaged in heterosexual intercourse, who reside in the city and are willing to recruit their main sexual partner for the study will be recruited and randomized into 2 groups, an intervention arm and a control arm. Participants will be recruited from an AYA medicine clinic and by using social media (Facebook and Instagram). The index participant and partner will complete a single individual session separately (Sister to Sister or Focus on the Future) with a gender-matched health educator. Dyads will then be randomized to receive an additional joint debriefing session together to discuss relationship dynamics, condom negotiation, etc. Participants will separately complete a telephone interview 6 weeks postintervention to determine the feasibility, acceptability, and impact of the intervention on mutual sexual negotiation, consistency of condom use, and communal coping skills, etc. RESULTS: So far, 25.4% (44/173) of eligible participants have been enrolled and randomized. Participants are mostly female (20/22, 91%), with at least a high school diploma (19/22, 86%), and 9 average lifetime sexual partners. Acceptability is high, with 98% (43/44) of participants expressing satisfaction with their study experience; 100% of dyads recruited were still together at 6-week follow-up. CONCLUSIONS: Findings from this study will add to the current literature on the approaches to STI prevention, and its success will inform its application in risk reduction counseling for youth who are most at risk. TRIAL REGISTRATION: Clinical Trials.gov NCT03275168; https://www.clinicaltrials.gov/ct2/history/NCT03275168. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/29389.

Can Automated Text Messaging Successfully Monitor Antibiotic Adherence for Urban Adolescents and Young Women Managed for Pelvic Inflammatory Disease in the Outpatient Setting.

Objective: This study evaluates patient responsiveness to an automated text messaging system for pelvic inflammatory disease (PID) self-care support, and measures the reliability of text-reported adherence. Design: Patients aged 13-25-years with mild to moderate PID were recruited from urban, academic outpatient settings. Enrolled patients received antibiotics and were randomized into a standard of care or intervention group. During a 14-day treatment period, participants in the intervention arm received a community-based nursing visit and daily text message medication reminders with evening prompts to report the number of doses taken. Result: Of the 97 participants randomized into the intervention arm, 91 (94%) were eligible for analysis. Most were African American and low income, with a mean age of 18.3 (SD=2.2) years. Participants responded to ~53% (SD=34%) of all dosage inquiry messages. Responsiveness attenuated at approximately 2.2% per day over the treatment period. Ninety-three percent (n=85) of the analyzed intervention arm returned for the two-week follow-up. Despite overall adherence and general responsiveness, text-reported and self-reported medication adherence were not well correlated (r=0.37, p<0.001). Conclusion: Our findings show that text messaging is a feasible strategy for reaching urban adolescents being managed for complicated sexually transmitted infections in outpatient settings. However, patient responsiveness to self-care text messages do vary, limiting the adherence monitoring capacity of this technology. Given the number of unanswered text messages and incomplete text-reported adherence data, additional measures to assess adolescents' adherence to PID medications are needed in clinical trials.

Adolescent and Young Women's Daily Reports of Emotional Context and Episodes of Dating Violence.

PURPOSE: To investigate same day, previous day, and next day associations between trust, closeness, commitment, jealousy and provision of instrumental support with dating violence victimization and perpetration. METHOD: A convenience sample of young women, 16-19 years, in a heterosexual dating relationship with at least one act (past month) of physical or psychological victimization or perpetration, were recruited from urban public locations. Participants answered questions daily via text continuously for four months on dating violence and partner-specific emotions. Daily surveys asked about trust, closeness, commitment for their partner, jealousy, perceptions of partner's jealousy and provision of instrumental support to and from partner, and dating violence victimization and perpetration. Multilevel modeling examined within-relationship associations over time. RESULTS: Mean (sd) age for the full sample was 18.1 (1.1) years. Same-day emotional context (trust, closeness, commitment, jealousy and provision of instrumental support) was more strongly associated with victimization and perpetration compared to previous day emotions. Strongest same-day positive associations were with partner's perpetration, both partner's jealousy, and females' instrumental support. Partner's jealousy and increased trust were best predictors of next day victimization. Closeness, commitment and trust went down on the day of violence. Perpetration was positively associated with next day commitment. Victimization was positively associated with next day trust. CONCLUSIONS: This event-level analysis demonstrates the role and timing that emotional aspects of adolescent relationships - including positive feelings - have surrounding episodes of dating violence. This granular understanding of the emotional context of dating violence has the potential to facilitate development of effective, developmentally appropriate interventions.

Characterising HIV and STIs among transgender female sex workers: a longitudinal analysis.

OBJECTIVES: Though highly vulnerable to HIV and STIs, transgender female sex workers (TFSWs) are understudied in the US HIV and STI response. This study examined the correlates of laboratory-confirmed STIs among a cohort of 62 TFSWs followed over the course of 1 year and explored associations between specimen site and self-reported engagement in insertive and receptive anal intercourse. METHODS: Participants completed an interviewer-administered computer-assisted personal interview at baseline, 3-, 6-, 9- and 12-month visits where self-administered anal swabs and urine samples for gonorrhea, chlamydia and trichomoniasis were also collected. HIV testing was conducted at baseline, 6-month and 12-month visits. RESULTS: Baseline HIV prevalence was 40.3% with no HIV seroconversions over follow-up. Baseline prevalence of gonorrhea, chlamydia and trichomoniasis was 9.7%, 17.7% and 14.5%, respectively. In the multivariable regression modelling, recent arrest was significantly associated with testing positive for any STI (adjusted risk ratio (RR) 1.77; 95% CI: 1.10 to 2.84). Insertive anal sex with clients was associated with increased risk of testing positive for an STI via urine specimen (RR 3.48; 95% CI: 1.14 to 10.62), while receptive anal sex was not significantly associated with specimen site. CONCLUSION: Our findings confirm a high prevalence of STIs among TFSWs and highlight the importance of addressing structural drivers such as criminal justice involvement as well as the need to ensure screening for STIs at all anatomical sites regardless of self-reported sites of potential exposure. More research is needed to better understand HIV and STI vulnerabilities and appropriate interventions for TFSWs in the USA.

Recruitment of Youth Living With HIV to Optimize Adherence and Virologic Suppression: Testing the Design of Technology-Based Community Health Nursing to Improve Antiretroviral Therapy (ART) Clinical Trials.

BACKGROUND: Despite advances in HIV diagnosis and treatment, adolescents and young adults 12-25 years old have high HIV incidence, poor engagement and retention in treatment, and low rates of adherence and virologic suppression when compared to their older counterparts. HIV has emerged as a chronic disease for which antiretroviral therapy (ART) adherence is critical for virologic suppression and long-term survival. Virologic suppression has been elusive for many youth with HIV (YHIV). Novel strategies designed to facilitate health care systems' support for YHIV between medical visits are essential for improving ART adherence, virologic suppression, and long-term survival. OBJECTIVE: The aim of this study is to compare the effectiveness of a technology-enhanced community health nursing intervention (TECH2CHECK) to a standard of care (SOC) control group for improving ART adherence and subsequent viral suppression using a randomized trial design. The objectives are to assess the feasibility, acceptability, and cost-effectiveness of TECH2CHECK as compared to SOC for management of HIV in the outpatient setting and to examine the sustainability of self-care behavior, adherence, and virologic suppression among youth following the intervention period. METHODS: We will recruit 120 adherence-challenged YHIV being followed at clinics specializing in HIV care in the Baltimore-Washington metropolitan area and in Jacksonville. Eligible participants complete an audio, computer-assisted self-interview and are randomized to either TECH2CHECK intervention or the SOC (60 participants in each arm). The primary outcome of interest is virologic suppression (viral load <20 copies/mL) and improved treatment adherence. Participants in the intervention arm receive community health nursing visits at 2 weeks, 6 weeks, 10 weeks, 14 weeks, and 26 weeks. The intervention arm also receives SMS messaging comprising daily adherence and appointment reminders and positive reinforcement for medication adherence daily for 2 weeks, on alternate days for 2 weeks, thrice weekly for 1 month, weekly for 3 months, and every 2 weeks for the rest of the study duration. The control group receives appointment reminders and SOC per clinic protocol. Exploratory analysis will be conducted to determine differences in medication adherence and virologic suppression in the 2 arms and to assess cost-effectiveness and study feasibility and acceptability. RESULTS: In the first 23 months of the study (July 2018-April 2020), 56 (55%) of 102 eligible patients were enrolled and randomized. At present, participating youths are primarily African American (53/56, 95%), male (37/56, 66%), and ≥18 years old (53/56, 95%). Follow-up study visits, as required per the protocol, have been completed by 77% (43/56), 94% (45/48), 95% (37/39), 96% (24/25), and 100% (10/10) of participants at the 1-month, 3-month, 6-month, 12-month, and 18-month follow-ups, respectively. CONCLUSIONS: Preliminary accrual and retention data suggest that TECH2CHECK is feasible and acceptable. TRIAL REGISTRATION: ClinicalTrials.gov NCT03600103 https://clinicaltrials.gov/ct2/show/NCT03600103. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/23480.

Clearance of Mycoplasma genitalium and Trichomonas vaginalis Among Adolescents and Young Adults With Pelvic Inflammatory Disease: Results From the Tech-N Study.

Current pelvic inflammatory disease (PID) treatment effectively treats Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT). However, coverage may be inadequate for Mycoplasma genitalium (MG)/Trichomonas vaginalis (TV) infections. We compared the longitudinal MG and TV outcomes with NG/CT outcomes for women enrolled in a longitudinal randomized controlled trial to optimize outcomes after PID. The prevalences of CT and NG were lower at 30- and 90-day follow-up compared with the prevalence at the time of diagnosis. No significant difference was observed for MG (odds ratio, 0.95; 0.86-1.04; P = 0.265) and TV (odds ratio, 0.89; 0.75-1.04; P = 0.146) over time for both treatment groups, showing that persistence and/or reinfection with MG and TV occurs more frequently than with CT or NG after treatment of PID using current national treatment guidelines.

"An ethnographic exploration of factors that drive policing of street-based female sex workers in a U.S. setting - identifying opportunities for intervention".

BACKGROUND: Building on a broader sociological discourse around policing approaches towards vulnerable populations, increasing public health and human rights evidence points to policing practices as a key health determinant, particularly among street-based sex workers. Despite the importance of policing as a structural health determinant, few studies have sought to understand the factors that underlie and shape harmful policing practices towards sex workers. This study therefore aimed to explore the drivers for policing attitudes and practices towards street-based cisgender female sex workers. METHODS: Drawing on ethnographic methods, 280 h of observations with police patrol and 10 stakeholder interviews with senior police leadership in Baltimore City, USA were carried out to better understand the drivers for policing strategies towards cisgender female sex workers. Analysis was data- and theory-driven, drawing on the concepts of police culture and complementary criminological and sociological literature that aided exploration of the influence of the ecological and structural environment on policing practices. RESULTS: Ecological factors at the structural (e.g., criminalization), organizational (e.g., violent crime control), community and individual level (e.g., stigmatizing attitudes) emerged as key to shaping individual police practices and attitudes towards cisgender female sex workers in this setting. Findings indicate senior police support for increased alignment with public health and human rights goals. However, the study highlights that interventions need to move beyond individual officer training and address the broader structural and organizational setting in which harmful police practices towards sex work operate. CONCLUSIONS: A more in-depth understanding of the circumstances that drive law enforcement approaches to street-based sex work is critical to the collaborative design of interventions with police in different settings. In considering public health-police partnerships to address the rights and health of sex worker populations in the U.S. and elsewhere, this study supports existing calls for decriminalization of sex work, supported by institutional and policy reforms, neighborhood-level dialogues that shift the cultural landscape around sex work within both the police and larger community, and innovative individual-level police trainings.

Barriers and facilitators to retaining a cohort of street-based cisgender female sex workers recruited in Baltimore, Maryland, USA: results from the SAPPHIRE study.

BACKGROUND: Despite experiencing HIV/STIs, violence, and other morbidities at higher rates than the general public, street-based female sex workers are often absent from public health research and surveillance due to the difficulty and high costs associated with engagement and retention. The current study builds on existing literature by examining barriers and facilitators of retaining a street-based cohort of cisgender female sex workers recruited in a mobile setting in Baltimore, Maryland who participated in the SAPPHIRE study. Participants completed interviews and sexual health testing at baseline, 3-, 6-, 9-, and 12-months. METHODS: Retention strategies are described and discussed in light of their benefits and challenges. Strategies included collecting several forms of participant contact information, maintaining an extensive field presence by data collectors, conducting social media outreach and public record searches, and providing cash and non-cash incentives. We also calculated raw and adjusted retention proportions at each follow-up period. Lastly, baseline sample characteristics were compared by number of completed visits across demographic, structural vulnerabilities, work environment, and substance use variables using F-tests and Pearson's chi-square tests. RESULTS: Although there were drawbacks to each retention strategy, each method was useful in tandem in achieving a successful follow-up rate. While direct forms of contact such as phone calls, social media outreach, and email were useful for retaining more stable participants, less stable participants required extensive field-based efforts such as home and site visits that increase the likelihood of random encounters. Overall, adjusted retention exceeded 70% for the duration of the 12-month study. Participants who were younger, recently experienced homelessness, and injected drugs daily were less likely to have completed all or most follow-up visits. CONCLUSION: Retention of street-based female sex workers required the simultaneous use of diverse retention strategies that were tailored to participant characteristics. With familiarity of the dynamic nature of the study population characteristics, resources can be appropriately allocated to strategies most likely to result in successful retention.

The development of the Police Practices Scale: Understanding policing approaches towards street-based female sex workers in a U.S. City.

Policing is an important structural determinant of HIV and other health risks faced by vulnerable populations, including people who sell sex and use drugs, though the role of routine police encounters is not well understood. Given the influence of policing on the risk environment of these groups, methods of measuring the aggregate impact of routine policing practices are urgently required. We developed and validated a novel, brief scale to measure police patrol practices (Police Practices Scale, PPS) among 250 street-based female sex workers (FSW) in Baltimore, Maryland, an urban setting with high levels of illegal drug activity. PPS items were developed from existing theory and ethnography with police and their encounters with FSW, and measured frequency of recent (past 3 months) police encounters. The 6-item scale was developed using exploratory factor analysis after examining the properties of the original 11 items. Confirmatory factor analysis was used to model the factor structure. A 2-factor model emerged, with law enforcement PPS items and police assistance PPS items loading on separate factors. Linear regression models were used to explore the relative distribution of these police encounters among FSW by modeling association with key socio-demographic and behavioral characteristics of the sample. Higher exposure to policing was observed among FSW who were homeless (ß = 0.71, p = 0.037), in daily sex work (ß = 1.32, p = 0.026), arrested in the past 12 months (ß = 1.44, p<0.001) or injecting drugs in the past 3 months (ß = 1.04, p<0.001). The PPS provides an important and novel contribution in measuring aggregate exposure to routine policing, though further validation is required. This scale could be used to evaluate the impact of policing on vulnerable populations' health outcomes, including HIV risk.

Inconsistent Condom Use Among Female Sex Workers: Partner-specific Influences of Substance Use, Violence, and Condom Coercion.

Female sex workers (FSWs) are disproportionately affected by HIV. Inconsistent condom use (ICU) represents the most proximal risk for acquisition and transmission. We evaluate associations of partner-specific factors including physical and sexual violence, coercion, and substance use with ICU with clients and regular non-paying partners, respectively, among FSWs. Baseline survey data from a prospective cohort of 250 street-based FSW in Baltimore, Maryland, USA included partner-level drug and alcohol use, violence, condom coercion and ICU, in addition to individual and structural exposures. Logistic regression analyses were stratified by partner type, followed by path analysis where indicated. Within client and regular non-paying partnerships, FSWs reported prevalent recent violence (34.8%, 16%, respectively), condom coercion (42.4%, 9.9%, respectively) and ICU (39.2%, 44.4%, respectively). Recent physical or sexual violence enabled coercive condom negotiation (AORclient 8.22, 95% CI 4.30, 15.73; AORnonpayingpartner 3.01 95% CI 1.05, 8.63). ICU with clients was associated with client condom coercion (AOR 1.76, 95% CI 1.03, 3.02), and client intoxication during sex (AOR 2.25, 95% CI 1.13, 4.45). In path analysis of client-FSW partnerships, condom coercion fully mediated the influences of both sex worker intoxication and recent violence on ICU. ICU with non-paying partners was associated with FSW intoxication during sex (AOR 8.66, 95% CI 3.73, 20.10), and past-year police violence (AOR 2.92, 1.30, 6.57). Partner-level substance use and gendered power differentials influenced FSWs' ICU patterns differently by partner type. ICU with clients was rooted solely in partner factors, and coercive condom negotiation mediated the roles of violence and partner-level substance use on ICU. By contrast, ICU with non-paying partners was rooted in partner-level substance use and police violence as a structural determinant. Addressing HIV risk behavior for FSWs requires condom promotion efforts tailored to partner type that addresses power differentials.

Efficacy of a Technology-Enhanced Community Health Nursing Intervention vs Standard of Care for Female Adolescents and Young Adults With Pelvic Inflammatory Disease: A Randomized Clinical Trial.

Importance: Pelvic inflammatory disease (PID) is a common reproductive health disorder that disproportionately affects female adolescents and young adults. Despite data indicating poor adherence and adverse outcomes among those who experience subsequent Neisseria gonorrhoeae and Chlamydia trachomatis infection, few trials have been designed to address this public health need. Objective: To examine the efficacy of a technology-enhanced community health nursing (TECH-N) intervention vs standard of care for improving PID self-management behaviors and 90-day longitudinal prevalence of N gonorrhoeae and C trachomatis infection. Design, Setting, and Participants: This randomized clinical trial of the TECH-N intervention was conducted among female patients 13 to 25 years of age diagnosed with mild to moderate PID who were being discharged to outpatient treatment from September 6, 2012, to December 8, 2016, at a large academic medical center. The final analysis of data was completed in November 2018. This study compared the efficacy of the intervention with that of the standard of care using an intention-to-treat analysis. Interventions: Enrolled participants completed an audio computer-assisted self-interview, provided specimens for N gonorrhoeae and C trachomatis testing, and were randomized to standard treatment (n = 137) or the TECH-N intervention (n = 149). Intervention participants received text-messaging support and a community health nurse visit within 5 days of diagnosis. Change in the prevalence of N gonorrhoeae and C trachomatis infection was estimated with logistic regression. The N gonorrhoeae and C trachomatis positivity rate over time was evaluated using generalized estimating equations. Main Outcomes and Measures: The primary outcome was the prevalence of N gonorrhoeae and C trachomatis infection at 90-day follow-up. The secondary outcome was adherence to the Centers for Disease Control and Prevention recommendations for self-care. Results: A total of 286 patients (mean [SD] age, 18.8 [2.5] years; 268 [93.7%] African American) participated in the study. Although the study groups were demographically similar, the intervention group had a higher baseline rate of C trachomatis infection (45 of 139 [32.4%] vs 25 of 132 [18.9%], P = .01). Although N gonorrhoeae and C trachomatis positivity was not statistically different between groups at 90-day follow-up (6 of 135 [4.4%] vs 13 of 125 [10.4%], P = .07), the differential rate of decrease was significantly higher in the intervention group (48 of 140 [34.4%] to 6 of 135 [4.4%] compared with 34 of 133 [25.6%] to 13 of 112 [10.4%], P = .02). Intervention participants were more likely to receive the Centers for Disease Control and Prevention-recommended short-term follow-up visit compared with the control group (131 of 139 [94.2%] vs 20 of 123 [16.3%], P < .001). Conclusions and Relevance: Adolescent and young adults with PID in the TECH-N intervention were more likely to experience decreases in N gonorrhoeae and C trachomatis positivity compared with the control group and to receive short-term clinical assessment. These findings suggest that the TECH-N intervention should be considered as a potential enhancement of standard of care approaches for management of female adolescents and young adults with mild to moderate PID in urban communities facing significant sexually transmitted infection disparities. Trial Registration: ClinicalTrials.gov identifier: NCT01640379.

Relationship Status and Sexual Behaviors in Post-Pelvic Inflammatory Disease (PID) Affected Urban Young Women: A Sub-Study of a Randomized Controlled Trial.

Adolescent and young adult women disproportionately experience Pelvic Inflammatory Disease (PID) as a complication of Sexually Transmitted Infections (STIs). This study seeks to understand the relationship context, changes in sexual behavior, and impact of partner sexual behavior on recurrent STI diagnoses at 3-months post-diagnosis. Adolescents and young adult women 13-25 were recruited from an outpatient disposition from an outpatient clinic, and pediatric and adult emergency rooms. Participants received treatment at baseline and follow-up at 2-weeks, 1-month and 3-month post-diagnosis, including interviews about personal and partner sexual behaviors and STI screening (n = 94). At the 2-week interview, 53% of participants (50/94) believed they could acquire an STI from their current partner if they did not use a condom. However, at 3-month follow-up only 35% reported condom usage at last sex. At 3-month follow-up, 55% (50/91) of participants were still in a sexual relationship with the previously reported partner and 38% of participants who reported they could get an STI from their partner were diagnosed with an STI; compared with 25% of participants who predicted that they could not get an STI (OR 1.85; 95% CI: 0.67-5.30). There was no association between maintaining the same partner and having an STI at 3-months (OR 0.5; 95% CI: 0.27-1.96). Most young women diagnosed with PID report exclusive relationships, but are simultaneously aware of their risk for recurrent STIs. Given the short-term stability of many relationships, couples interventions are an unexplored opportunity for prevention of recurrent STIs after PID.

Clinical and sexual risk correlates of Mycoplasma genitalium in urban pregnant and non-pregnant young women: cross-sectional outcomes using the baseline data from the Women's BioHealth Study.

OBJECTIVE: Research exploring the clinical and sexual risk correlates is essential to define universal standards for screening and management for Mycoplasma genitalium (MG). The objective of this study is to determine the baseline prevalence of MG and associated clinical risks using cross-sectional data. METHODS: Adolescent and young adult women 13-29 years were recruited during clinical visits during which biological specimens were collected for Neisseriagonorrhoeae (NG) and Chlamydia trachomatis (CT) testing to provide vaginal specimens for MG and Trichomonasvaginalis (TV) testing. Demographic, clinical and sexual risk data were collected after obtaining written consent. MG was tested using the Hologic Gen-Probe transcription-mediated amplification-MG analyte-specific reagent assay and TV by the Aptima TV assay. Bivariate analyses were used to evaluate differences in MG prevalence based on pregnancy status, demographic factors, clinical symptoms, concurrent STI and sexual risk behaviour quiz score (maximum score=10). RESULTS: 483 patients with a mean age of 22.4 years (SD 3.6) were enrolled. Most participants were not pregnant (66%) and asymptomatic (59%). MG was the most common STI (MG 16%, TV 9%, CT 8%, NG 1%). Neither pregnancy nor symptoms were predictive of STI positivity. Thirty-five percent of non-pregnant and 45% of pregnant adolescents ≤19 years were positive for any STI. Participants with MG were 3.4 times more likely to be co-infected with other STIs compared with those with other STIs (OR 3.4, 95% CI 1.17 to 10.3, P=0.021). Mean risk quiz scores for STI positive women were six points higher than those who were STI negative (ß=0.63, 95% CI 0.36 to 0.90, P<0.001). There were no differences in risk scores for MG-positive participants compared with other STI positivity. CONCLUSION: MG infection was common, associated with STI co-infection and often asymptomatic, and pregnancy status did not confer protection.

Recruitment of Minority Adolescents and Young Adults into Randomised Clinical Trials: Testing the Design of the Technology Enhanced Community Health Nursing (TECH-N) Pelvic Inflammatory Disease Trial.

PURPOSE: Pelvic inflammatory disease (PID) disproportionately affects adolescent and young adult (AYA) women and can negatively influence reproductive health trajectories. Few randomized controlled trials (RCTs) have focused on strategies to improve outpatient adherence or to reduce reproductive morbidity in this population. This paper describes the research methods and preliminary effectiveness of recruitment, retention, and intervention strategies employed in a novel RCT designed to test a technology-enhanced community-health nursing (TECH-N) intervention among urban AYA with PID. METHODS: AYA women aged 13-25 years were recruited during acute PID visits in outpatient clinics and emergency departments (ED) to participate in this IRB-approved trial. Participants completed an audio-computerized self-interview (ACASI), provided vaginal specimens, and were randomized to standard treatment or the intervention. Intervention participants received text-messaging support for 30 days and a community health nurse (CHN) interventionist performed a home visit with clinical assessment within 5 days after enrollment. All patients received a full course of medications and completed research visits at 14-days (adherence), 30 days and 90 days with by an outreach worker. STI testing performed at the 30-and 90-day visits. Exploratory analyses using descriptive statistics were conducted to examine recruitment, retention, and follow-up data to test the overall design of the intervention. RESULTS: In the first 48 months, 64% of 463 patients were eligible for the study and 81.2% of 293 eligible patients were recruited for the study (63.3%); 238 (81.2%) of eligible patients were enrolled. Most participants were African American (95.6%) with a mean age of 18.6 (2.3). Ninety-four percent of individuals assigned to the TECH-N intervention completed the nursing visits. All completed visits have been within the 5-day window and over 90% of patients in both arms have been retained over the 3-month follow-up period. Biological data suggests a shift in the biological milieu with the predominance of Chlamydia trachomatis, Mycoplasma genitalium, and Trichomonas vaginalis infections. CONCLUSIONS: Preliminary data from the TECH-N study demonstrated that urban, low-income, minority AYA with PID can effectively be recruited and retained to participate in sexual and reproductive health RCTs with sufficient investment in the design and infrastructure of the study. Community-based sexual health interventions appear to be both feasible and acceptable in this population.

Care-Seeking Behavior After Notification Among Young Women With Recurrent Sexually Transmitted Infections After Pelvic Inflammatory Disease.

UNLABELLED: Objective To determine the level of nurse case management and outreach required to notify young women with sexually transmitted infection (STI) positive test results after pelvic inflammatory disease (PID) and percent seeking treatment. METHODS: Participants (N = 153) were enrolled in a clinical trial of young women diagnosed with PID and followed for 3 months for recurrent STIs. Vaginal swabs were obtained at 1 and 3 months. All participants were notified of positive STIs at 1 and 3 months and treatment arranged. Data were analyzed with logistic regression for comparison of treatment status by number of nurse contacts. Results Over the 3-month period, 59 participants (38.6%) tested positive for one or more STIs and all received notification. Only 50% (19/38) of participants with STI at 1 month and 43% (16/37) at 3 months received treatment. Conclusions Despite the high notification rate of positive test results for young adults with recurrent STIs, many failed to seek treatment.

Understanding variability in adolescent women's sexually transmitted infection-related perceptions and behaviors associated with main sex partners.

BACKGROUND: It is not well understood whether characteristics of adolescent main partnerships differ categorically from one relationship to the next or whether observed differences in sexually transmitted infection (STI)-related perceptions and sexual behaviors between main partnerships results from a failure to capture variability within adolescent main partnerships. The objective of this study was to examine the extent to which female adolescents' STI-related feelings, perceptions, and sexual behavior associated with main sex partners varied over the course of their relationship. METHODS: A cohort of adolescent women aged 16 to 19 years at baseline, recruited from health clinics or community venues, completed daily diaries on a Smartphone continuously for 18 months. Participants reported daily on their partner-specific feelings of closeness, trust, commitment, perceived risk for acquiring a sexually transmitted disease (PRSTD), perception of partner concurrency (PPC), and condom use for their main sexual partners. RESULTS: Relationships from 49 participants were used to examine variability over time in STI-related feelings, perceptions, and behavior. Overall, relationships were characterized by high levels of trust, closeness, and commitment and low levels of PPC, PRSTD, and condom use. However, for all but PRSTD, there was more variation (>50%) within than between relationships for each of these measures, although variability of PRSTD was high (47.1%). Residual variability for all perceptions and behaviors remained significant after controlling for trends over time. CONCLUSIONS: Diary data illustrate wide day-to-day fluctuations in feelings of intimacy, PPCs, PRSTDs, and condom use indicating that these are dynamic attributes of adolescent romantic relationships.