Health Outcomes around Pregnancy and Exposure to HIV/Antiretrovirals (HOPE) study protocol: a prospective observational cohort study of reproductive-aged women living with HIV.

INTRODUCTION: Over 265 000 women are living with HIV in the USA, but limited research has investigated the physical, mental and behavioural health outcomes among women living with HIV of reproductive age. Health status during the reproductive years before, during and after pregnancy affects pregnancy outcomes and long-term health. Understanding health outcomes among women living with HIV of reproductive age is of substantial public health importance, regardless of whether they experience pregnancy. The Health Outcomes around Pregnancy and Exposure to HIV/Antiretrovirals (HOPE) study is a prospective observational cohort study designed to investigate physical and mental health outcomes of young women living with HIV as they age, including HIV disease course, engagement in care, reproductive health and choices and cardiometabolic health. We describe the HOPE study design, and characteristics of the first 437 participants enrolled as of 1 January 2024. METHODS AND ANALYSIS: The HOPE study seeks to enrol and follow 1630 women living with HIV of reproductive age, including those with perinatally-acquired HIV, at 12 clinical sites across 9 US states and Puerto Rico. HOPE studies multilevel dynamic determinants influencing physical, mental and social well-being and behaviours of women living with HIV across the reproductive life course (preconception, pregnancy, post partum, not or never-pregnant), informed by the socioecological model. Key research areas include the clinical course of HIV, relationship of HIV and antiretroviral medications to reproductive health, pregnancy outcomes and comorbidities and the influence of racism and social determinants of health. HOPE began enrolling in April 2022. ETHICS AND DISSEMINATION: The HOPE study received approval from the Harvard Longwood Campus Institutional Review Board, the single institutional review board of record for all HOPE sites. Results will be disseminated through conference presentations, peer-reviewed journals and lay summaries.

Routine Vaccination During Pregnancy Among People Living With HIV in the United States.

Importance: Pregnancy represents a window of opportunity for vaccination due to established maternal and fetal benefits of vaccination. Little is known about receipt of routinely recommended vaccines in pregnancy, specifically tetanus, diphtheria, plus acellular pertussis (Tdap) and influenza, among pregnant people living with HIV (PLHIV). Objective: To estimate prevalence of vaccination receipt among pregnant people with HIV (PLHIV) and identify demographic and clinical characteristics associated with vaccination. Design, Setting, and Participants: This multicenter cohort study included women participating in Women's Health Study (WHS) of the Surveillance Monitoring for ART Toxicities (SMARTT) Study of the Pediatric HIV/AIDS Cohort Study. The network has been enrolling pregnant PLHIV at 22 US sites since 2007. Participants for this study enrolled between December 2017 and July 2019. Data analysis was conducted from October 2021 to March 2022. Exposure: Data on vaccination in pregnancy were collected through medical record abstraction. Main Outcomes and Measures: Vaccination receipt was defined as Tdap vaccination received at less than 36 weeks' gestation and influenza vaccination at any gestational age, based on current guidelines. Log-binomial and modified Poisson regression models with generalized estimating equations were fit to identify factors associated with successful receipt of (1) Tdap, (2) influenza, and (3) both vaccinations. Results: A total of 310 pregnancies among 278 people participating in the WHS were included (mean [SD] age, 29.5 [6.1] years; 220 [71%] Black, 77 [25%] Hispanic, and 77 [25%] race and ethnicity other than Black; 64 [21%] with perinatally acquired HIV). Less than one-third of pregnancies were vaccinated as recommended (Tdap, 32.6% [95% CI, 27.4%-38.1%]; influenza, 31.6% [95% CI, 26.5%-37.1%]; both, 22.6% [95% CI, 18.0%-27.6%]). People living with perinatally acquired HIV, those who did not identify as Black, or those who were multiparous had adjusted risk ratios (aRRs) less than 1, while older PLHIV had aRRs greater than 1, but these differences did not reach statistical significance (perinatally acquired HIV: adjusted risk ratio [aRR], 0.46; 95% CI, 0.21-1.02; race other than Black: aRR, 0.53; 95% CI, 0.26-1.08; multiparous: aRR, 0.59; 95% CI, 0.35-1.00; age 24-29 years: aRR, 2.03; 95% CI, 0.92-4.48). Conclusions and Relevance: In this diverse, multicenter cohort of pregnant PLHIV, receipt of recommended vaccinations was low. Identifying and addressing barriers to vaccination receipt is urgently needed for pregnant people with HIV.

Factors associated with internalized HIV-related stigma among biological mothers living with HIV enrolled in a US cohort study.

Understanding factors associated with internalized HIV-related stigma among mothers living with HIV may improve health outcomes. We examined factors (age, race/ethnicity, education, income, employment, marital status, health limitations, and years since HIV diagnosis) associated with internalized HIV-related stigma among biological mothers of children enrolled in the Surveillance Monitoring for ART Toxicities study of the US-based Pediatric HIV/AIDS Cohort Study. Stigma was measured with the Internalized HIV Stigma Scale (IHSS), completed biennially at their child's 11-17-year visits. Linear regression models were fit with generalized estimating equations to evaluate the association between the factors of interest and internalized HIV-related stigma using all completed IHSS surveys. Among 438 eligible mothers, the mean IHSS score was 43.7 (SD = 19.5). Higher IHSS scores were observed for widowed women compared to married women, with an estimated mean difference of 8.91 (95% CI: 2.25, 15.57) after adjusting for age, education, income, and health limitations. Years since HIV diagnosis was associated with internalized HIV-related stigma. For every year of increase since HIV diagnosis, IHSS scores decreased by 0.54 per year, after adjusting for age (95% CI: -0.92, -0.17). Interventions to reduce internalized HIV-related stigma should target mothers who are widowed and those with a more recent HIV diagnosis.

The role of internalised HIV stigma in disclosure of maternal HIV serostatus to children perinatally HIV-exposed but uninfected: a prospective study in the United States.

INTRODUCTION: Decisions to disclose HIV serostatus may be complicated by internalised HIV stigma. We evaluated the association of internalised HIV stigma in biological mothers living with HIV with disclosure of their serostatus to their children perinatally HIV-exposed but uninfected (CHEU). METHODS: Mothers and their CHEU were enrolled in the United States (U.S.)-based Surveillance Monitoring for Antiretroviral Therapy (ART) Toxicities (SMARTT) study of the Pediatric HIV/AIDS Cohort Study (PHACS), a longitudinal study of outcomes related to in utero exposure to HIV and ART among CHEU. Mothers completing at least one stigma and disclosure assessment starting at the child's age 11-, 13-, 15- and/or 17-year study visits between 16 August 2016 and 1 October 2020 were eligible. Stigma was measured with the 28-item Internalised HIV Stigma Scale (IHSS). Mean stigma scores were linearly transformed to a range of 0-100, with higher scores indicating greater levels of stigma. At each visit, mothers were asked if their child was aware of their HIV diagnosis and at what age the child became aware. The Kaplan-Meier estimator evaluated the cumulative probability of disclosure at each child age. Logistic regression models with generalised estimating equations to account for repeated measures were fit to examine the association between stigma and disclosure, controlling for relevant socio-demographic variables. RESULTS: Included were 438 mothers of 576 children (mean age 41.5 years, 60% U.S.-born, 60% Black/African American and 37% with household income ≤$10,000). The prevalence of disclosure across all visits was 29%. Mothers whose children were aware versus not aware of their serostatus reported lower mean IHSS scores (38.2 vs. 45.6, respectively). The cumulative proportion of disclosure by age 11 was 18.4% (95% CI: 15.5%, 21.8%) and 41% by age 17 (95% CI: 35.2%, 47.4%). At all child ages, disclosure was higher among children of U.S.-born versus non-U.S.-born mothers. After adjusting for age, marital status and years since HIV diagnosis, higher IHSS scores were associated with lower odds of disclosure (OR = 0.985, 95% CI: 0.975, 0.995). CONCLUSIONS: Providing support to women as they make decisions about serostatus disclosure to their children may entail addressing internalised HIV stigma and consideration of community-level factors, particularly for non-U.S.-born mothers.

Health Insurance Coverage, Clinical Outcomes, and Health-Related Quality of Life Among Youth Born to Women Living With HIV.

BACKGROUND: Although sustained access to health care is essential, little is known about the relationship between insurance coverage and health among people born to women living with HIV (WLHIV). SETTING: Prospective cohort studies of youth and young adults born to WLHIV from 2007 to 2019. METHODS: We used adjusted generalized estimating equation models to estimate mean differences in, and relative risks (RRs) of, health-related quality of life (HR-QoL) and HIV disease measures over time by insurance status. HR-QoL scales with limited variability were dichotomized. Modified Poisson models were used to estimate RRs. RESULTS: Six hundred sixty-nine Adolescent Master Protocol (AMP) youth [66% living with perinatally-acquired HIV (PHIV), 72% Black] and 939 AMP Up/AMP Up Lite young adults (89% PHIV, 68% Black) reported insurance. Most were publicly insured (87% youth, 67% young adults). Privately insured young adults living with PHIV had lower risk of antiretroviral therapy nonadherence [adjusted RR (aRR): 0.82, 95% CI: 0.70 to 0.97] than those with public insurance. There was a lower risk of suboptimal role functioning for young adults with private insurance (aRR: 0.58, 95% CI: 0.35 to 0.97) and those unaware of their coverage (aRR: 0.41, 95% CI: 0.21 to 0.78). Young adults with private insurance had higher health perception scores than those with public insurance (adjusted mean difference: 3.87, 95% CI: 0.37 to 7.38). For youth, we observed no differences in HR-QOL and HIV disease measures by insurance. CONCLUSION: These findings suggest meaningful differences in antiretroviral therapy adherence and some HR-QoL outcomes by health insurance coverage among young adults born to WLHIV.

Using Social Media and Technology to Communicate in Pediatric HIV Research: Qualitative Study With Young Adults Living With or Exposed to Perinatal HIV.

BACKGROUND: As young adults living with perinatal HIV (PHIV) or perinatal HIV exposure but uninfected (PHEU) grow older and manage the challenges and competing demands of young adulthood, new approaches are needed to facilitate their retention in longitudinal research and clinical care beyond in-person clinic visits. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the novel virus that causes coronavirus disease (COVID-19), emerged in the United States in January 2020 and has underscored this need; studies are adapting to remote communication with and data collection from participants. However, there are limited data on communication preferences among young adults who are living with PHIV or PHEU. OBJECTIVE: The objectives of this qualitative study were to describe participants' perceptions and use of social media and technology in their personal lives and in the context of participating in longitudinal pediatric HIV research and to describe the implications of the use of technology and social media for communication and retention purposes within a longitudinal pediatric study about HIV. METHODS: We conducted 6 focus group discussions with 31 young adults living with PHIV and 13 in-depth interviews with 6 young adults living with PHIV and 7 living with PHEU. We asked about their preferences for the use of social media and digital technology in the Adolescent Master Protocol, a US-based longitudinal cohort study of youth affected by HIV. RESULTS: Participants' willingness to use social media platforms, telephone calls, SMS text messages, and video calls within the context of HIV research varied due to fears of HIV stigma and inadvertent disclosure. However, trusting relationships with clinical staff positively impacted their willingness to use these platforms. CONCLUSIONS: Our findings offer insight into how pediatric studies and clinics can communicate with participants as they age, even as new technologies and social media platforms emerge and replace old ones. For optimal retention, pediatric clinical staff should consider communication approaches offering flexible and tailored options for young adults participating in HIV research.

HIV prevention and HIV care among transgender and gender diverse youth: design and implementation of a multisite mixed-methods study protocol in the U.S.

BACKGROUND: In the U.S., transgender and gender diverse (TGD) populations face structural, interpersonal, and individual barriers to healthcare. Less is known, however, about the HIV prevention and treatment experiences of TGD youth in the U.S. The current study was developed to fill this research gap. METHODS: This article describes the research protocol for a multi-site, U.S.-based mixed-methods study that sought to identify the multi-level facilitators and barriers that influence participation of TGD youth in various stages of the HIV prevention (e.g., pre-exposure prophylaxis uptake) and care continua. A sample of diverse TGD youth ages 16-24 was recruited from 14 U.S. sites. TGD youth participants completed a one-time, in-person visit that included an informed consent process, computer-based quantitative survey, and in-depth qualitative interview assessing experiences accessing HIV prevention and/or care services. Providers serving TGD youth were recruited from the same 14 sites and completed a one-time visit via phone that included informed consent, demographic questionnaire, and in-depth qualitative interview assessing their experiences providing HIV prevention or treatment services to TGD youth. RESULTS: Overall, 186 TGD youth ages 16-24 and 59 providers serving TGD youth were recruited and enrolled from across the 14 U.S. sites. TGD youth participants had a mean age of 20.69; 77.3% youth of color; 59.7% trans-feminine; 15.5% trans-masculine; 24.9% non-binary; 53.6% family income under poverty level. Providers included medical and mental health providers as well as case manager/care coordinators, HIV test counselors, and health educators/outreach workers. Providers were 81.3% cisgender and 30.5% people of color. Successes with community-engagement strategies and gender-affirming research methods are reported. CONCLUSIONS: This study addresses critical gaps in current knowledge about the HIV prevention and care experiences of TGD youth. Findings have implications for the development of HIV interventions across levels to support the health and well-being of TGD youth. Future research is warranted to replicate and expand on lessons learned regarding recruitment and engagement of communities of TGD youth, including longitudinal designs to assess engagement across their developmental stages. Lessons learned working with TGD youth through developing and implementing the study protocol are shared. TRIAL REGISTRATION: Registered on ClinicalTrials.gov on 05/20/2015 (NCT02449629).

Characterizing the HIV Prevention and Care Continua in a Sample of Transgender Youth in the U.S.

In the U.S., transgender and other gender minority (TG) youth are an at-risk group understudied in HIV prevention and treatment. This study sought to characterize the HIV prevention and care continua in a diverse sample of 181 sexually-active TG ages 16-24 years (mean age = 20.7 years; 76.8% trans feminine; 69.1% youth of color) recruited July-December 2015 in 14 U.S. cities. Overall, 30.9% reported living with HIV, of which 71.4% were on antiretroviral therapy (ART) and 55.0% were medication adherent; 65.6% were known to be virally suppressed. In multivariable models, medical gender affirmation was associated with lower odds of viral suppression. Medical gender affirmation and stigma in HIV care were each independently associated with elevated odds of having missed HIV care appointments. Among at-risk TG youth not living with HIV, only 8.2% had accessed pre-exposure prophylaxis (PrEP). Early biobehavioral prevention and treatment interventions are needed for TG youth.

Psychometric Properties and Validity of a Multi-dimensional Risk Perception Scale Developed in the Context of a Microbicide Acceptability Study.

Currently available risk perception scales tend to focus on risk behaviors and overall risk (vs partner-specific risk). While these types of assessments may be useful in clinical contexts, they may be inadequate for understanding the relationship between sexual risk and motivations to engage in safer sex or one's willingness to use prevention products during a specific sexual encounter. We present the psychometric evaluation and validation of a scale that includes both general and specific dimensions of sexual risk perception. A one-time, audio computer-assisted self-interview was administered to 531 women aged 18-55 years. Items assessing sexual risk perceptions, both in general and in regards to a specific partner, were examined in the context of a larger study of willingness to use HIV/STD prevention products and preferences for specific product characteristics. Exploratory and confirmatory factor analyses yielded two subscales: general perceived risk and partner-specific perceived risk. Validity analyses demonstrated that the two subscales were related to many sociodemographic and relationship factors. We suggest that this risk perception scale may be useful in research settings where the outcomes of interest are related to motivations to use HIV and STD prevention products and/or product acceptability. Further, we provide specific guidance on how this risk perception scale might be utilized to understand such motivations with one or more specific partners.

Measuring self-efficacy to use vaginal microbicides: the Microbicide Use Self-Efficacy instrument.

UNLABELLED: Objectives To evaluate the psychometric properties of the Microbicide Use Self-Efficacy (MUSE) instrument and to examine correlates of self-efficacy to use vaginal microbicides among a sample of racially and ethnically diverse women living in the north-eastern United States. METHODS: Exploratory and confirmatory factor analytic methods were used to explore and determine the dimensionality and psychometric properties of the MUSE instrument. Construct validity was assessed by examining the relationships of the MUSE instrument to key sexual behaviour, partner communication, relationship and psychosocial variables. RESULTS: Two dimensions of self-efficacy to use microbicides were psychometrically validated and identified as 'Adherence and Access' and 'Situational Challenges.' The two four-item subscales measuring Adherence and Access and Situational Challenges had reliability coefficients of 0.78 and 0.85, respectively. Correlates of the two measures were tested at a Bonferroni-adjusted α level of P=0.001, and 19 of 43 variables analysed were found to significantly relate to Adherence and Access, whereas 16 of 43 variables were significantly related to Situational Challenges. Of the 35 significant relationships, 32 were in the domains of partner communication, partner relationships, and behavioural and psychosocial variables. CONCLUSIONS: The MUSE instrument demonstrated strong internal validity, reliability and initial construct validity. The MUSE instrument can be a useful tool in capturing the multidimensional nature of self-efficacy to use microbicides among diverse populations of women.

Using integrated mixed methods to develop behavioral measures of factors associated with microbicide acceptability.

Our current understanding of factors associated with microbicide acceptability and consistent use typically has been derived from separate and distinct qualitative or quantitative studies. Specifically, rarely have investigators used mixed methods to both develop and validate behavioral measures. We utilized an integrated mixed methods design, including qualitative metasyntheses, cognitive interviews and expert reviews, psychometric evaluation, and confirmatory qualitative analyses of the correspondence between quantitative items and original qualitative data to develop and validate measures of factors associated with microbicide acceptability and use. We describe this methodology and use the development of the Relationship Context Scale to illustrate it. As a result of independent confirmatory analyses of qualitative passages corresponding to survey items, we demonstrated that items from the same subscales are frequently double coded within a particular textual passage, and thematically related, suggesting associations that resulted in a unique factor structure within the subscale. This integrated mixed method design was critical to the development of this psychometrically validated behavioral measure, and could serve as a model for future measure development.

Developing an HIV-prevention intervention for HIV-infected men who have sex with men in HIV care: project enhance.

Men who have sex with men (MSM) represent the largest group with HIV in the U.S. (CDC 2005). Interventions for prevention with HIV-infected MSM are urgently needed, and integrating prevention into HIV care represents one opportunity for this advancement. This article describes the development and results of initial pilot testing of a behavioral intervention to reduce HIV sexual risk transmission behavior for HIV-infected MSM that is integrated into HIV care. To illustrate our intervention development process, we describe the setting and population (HIV-infected MSM patients at Fenway Community Health in Boston) for the project, the initial conceptualization of the project including its guiding conceptual model (information, motivation, and behavioral skills model, IMB: Fisher and Fischer 1993), the iterative process of attaining and integrating input from stakeholders, the use of peer interventionists, the open phase pilot and participant input, an overview of the intervention content, and, finally, lessons learned. The result of this process is an example of an intervention developed with strong input from the community and other stakeholders, which is ready for further testing in a randomized controlled trial.

The utility of non-proportional quota sampling for recruiting at-risk women for microbicide research.

In the context of a measurement development study designed to contextualize microbicide acceptability, a sample that represented a range of at-risk women and maintained the statistical power needed for validity analyses was required. A non-proportional quota sampling strategy focused on race/ethnicity and number of sexual partners was utilized. This strategy resulted in enrollment of approximately equal proportions of Latina (31%), Black (36%), and White (32%) women, and an approximately 1:2 ratio of single-partnered (29%) and multi-partnered (71%) women. About 17% of women screened were ineligible based on eligibility criteria; an additional 16% were ineligible based on quota closures. Most participants were recruited through word of mouth (39%), community-based organizations (19%), or media sources (19%). Women recruited through word of mouth had the highest screen-to-interview completion percentage (67%). Non-proportional quota sampling is a feasible option for ensuring adequate representation of sample characteristics in microbicide research, but this goal should be weighed against cost and staff burden.