Acceptability Assessment in HIV Prevention and Treatment Intervention and Service Delivery Research: A Systematic Review and Qualitative Analysis.

We reviewed the literature on the assessment of acceptability of HIV prevention and treatment interventions and service delivery strategies. Following PRISMA guidelines, we screened 601 studies published from 2015 to 2020 and included 217 in our review. Of 384 excluded studies, 21% were excluded because they relied on retention as the sole acceptability indicator. Of 217 included studies, only 16% were rated at our highest tier of methodological rigor. Operational definitions of acceptability varied widely and failed to comprehensively represent the suggested constructs in current acceptability frameworks. Overall, 25 studies used formal quantitative assessments (including four adapted measures used in prior studies) and six incorporated frameworks of acceptability. Findings suggest acceptability assessment in recent HIV intervention and service delivery research lacks harmonization and rigor. We offer guidelines for best practices and future research, which are timely and critical in this era of informed choice and novel options for HIV prevention and treatment.

High Acceptance and Completion of HIV Self-testing Among Diverse Populations of Young People in Kenya Using a Community-Based Distribution Strategy.

Oral HIV self-testing (HIVST) may expand access to testing among hard-to-reach reach adolescents and young adults (AYA). We evaluated community-based HIVST services for AYA in an urban settlement in Kenya. Peer-mobilizers recruited AYA ages 15-24 through homes, bars/clubs, and pharmacies. Participants were offered oral HIVST, optional assistance and post-test counseling. Outcomes were HIVST acceptance and completion (self-report and returned kits). Surveys were given at enrollment, post-testing, and 4 months. Log-binomial regression evaluated HIVST preferences by venue. Among 315 reached, 87% enrolled. HIVST acceptance was higher in bars/clubs (94%) than homes (86%) or pharmacies (75%). HIVST completion was 97%, with one confirmed positive result. Participants wanted future HIVST at multiple locations, include PrEP, and cost ≤ $5USD. Participants from bars/clubs and pharmacies were more likely to prefer unassisted testing and peer-distributers compared to participants from homes. This differentiated community-based HIVST strategy could facilitate engagement in HIV testing and prevention among AYA.

Perspectives on the utility and interest in a point-of-care urine tenofovir test for adherence to HIV pre-exposure prophylaxis and antiretroviral therapy: an exploratory qualitative assessment among U.S. clients and providers.

BACKGROUND: Real-time, objective measures of adherence to antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are needed to better assess adherence levels and to expedite clinical response for those with suboptimal adherence. Point-of-care tenofovir (POC-TFV) testing has been proposed as a solution to facilitate real-time antiretroviral adherence monitoring, but little is known about how health care providers, people living with HIV (PLWH) receiving ART, and people receiving PrEP will perceive POC-TFV testing. METHODS: We conducted an exploratory qualitative study to assess perspectives on the utility and interest in POC-TFV testing from potential end users. We conducted three focus group discussions (FGDs) among 17 PLWH receiving ART and four individuals receiving PrEP, as well as eight in-depth interviews (IDIs) with health care providers in the Seattle area and presented participants with a hypothetical urine-based POC-TFV test. FGDs and IDIs were audio recorded, transcribed, coded, and analyzed to describe emerging themes. RESULTS: Overall, study participants demonstrated divergent opinions about the POC-TFV test. Among study participants, PLWH were most ambivalent about POC-TFV testing, first demonstrating reluctance to TFV-level monitoring and shifting positions during the FGDs. However, all PLWH participants were receptive to POC-TFV testing if requested by their provider. PrEP participants were generally supportive of POC-TFV testing for routine adherence monitoring and emphasized potential value in self-administered testing. Providers' perceptions were equally divided - half suggested POC-TFV testing would be valuable, particularly for people receiving PrEP, while half indicated the test would have little benefit for most individuals receiving ART or PrEP in the U.S. All providers agreed that POC-TFV test results could be beneficial for assessing discrepancies in viral load results and self-reported adherence among PLWH. The study also revealed that a low-cost, non-urine-based POC-TFV test with a long-term limit of detection would be preferred over the hypothetical urine-based test. CONCLUSIONS: Our findings indicate POC-TFV testing may be beneficial for routine, clinic-based adherence monitoring, particularly for individuals receiving PrEP or for PLWH with persistent viremia or following recent ART initiation. These findings should also be used to formulate a target product profile for a POC-TFV test and to guide further developments in tools for objective antiretroviral adherence monitoring.

Does Stigma Toward Anal Sexuality Impede HIV Prevention Among Men Who Have Sex With Men in the United States? A Structural Equation Modeling Assessment.

INTRODUCTION: Men who have sex with men (MSM) are suboptimally engaged in efficacious HIV interventions, due in part to stigma. AIM: We sought to validate the Anal Health Stigma Model, developed based on theory and prior qualitative data, by testing the magnitude of associations between measures of anal sex stigma and engagement in HIV prevention practices, while adjusting for covariates. METHODS: We conducted a cross-sectional online survey of 1,263 cisgender MSM living in the United States and analyzed data with structural equation modeling. We tested a direct path from Anal Sex Stigma to Engagement in HIV Prevention alongside 2 indirect paths, 1 through Anal Sex Concerns and another through Comfort Discussing Anal Sexuality with Health Workers. The model adjusted for Social Support, Everyday Discrimination, and Sociodemographics. MAIN OUTCOME MEASURE: Engagement in HIV Prevention comprised an ad hoc measure of (i) lifetime exposure to a behavioral intervention, (ii) current adherence to biomedical intervention, and (iii) consistent use of a prevention strategy during recent penile-anal intercourse. RESULTS: In the final model, anal sex stigma was associated with less engagement (ß = -0.22, P < .001), mediated by participants' comfort talking about anal sex practices with health workers (ß = -0.52; ß = 0.44; both P < .001), adjusting for covariates (R2 = 67%; χ2/df = 2.98, root mean square error of approximation = 0.040, comparative fit index = 0.99 and Tucker-Lewis index = 0.99). Sex-related concerns partially mediated the association between stigma and comfort (ß = 0.55; ß = 0.14, both P < .001). Modification indices also supported total effects of social support on increased comfort discussing anal sex (ß = 0.35, P < .001) and, to a lesser degree, on decreased sex-related concerns (ß = -0.10; P < .001). CLINICAL IMPLICATIONS: Higher stigma toward anal sexuality is associated with less engagement in HIV prevention, largely due to discomfort discussing anal sex practices with health workers. STRENGTH & LIMITATIONS: Adjustment for mediation in a cross-sectional design cannot establish temporal causality. Self-report is vulnerable to social desirability and recall bias. Online samples may not represent cisgender MSM in general. However, findings place HIV- and health-related behaviors within a social and relational context and may suggest points for intervention in health-care settings. CONCLUSION: Providers' willingness to engage in discussion about anal sexuality, for example, by responding to questions related to sexual well-being, may function as social support and thereby bolster comfort and improve engagement in HIV prevention. Kutner BA, Simoni JM, King KM, et al. Does Stigma Toward Anal Sexuality Impede HIV Prevention Among Men Who Have Sex With Men in the United States? A Structural Equation Modeling Assessment. J Sex Med 2020;17:477-490.

Exploring HIV-Related Stigma as a Determinant of Engagement in HIV Care by African American Women.

Engagement in HIV care reduces HIV-related health disparities that persist across racial/ethnic and gender lines; yet, African American (AA) women face multiple challenges to remaining engaged in care, including HIV-related stigma. We analyzed longitudinal data from 239 participants in the Unity Health Study to estimate associations between HIV-related stigma and engagement in care among AA women linked to HIV care. In adjusted Poisson regression analyses, engagement in care was not associated with HIV-related stigma but was associated with older age (incidence rate ratio [IRR] = 1.01, 95% confidence interval [CI] = [1.00-1.01], p = .01), higher levels of education (IRR = 1.18, 95% CI = [1.02-1.35], p = .03), and higher levels of social support (IRR = 1.05, 95% CI = [1.01-1.09], p = .04). Our findings suggest the need for targeted interventions to enhance engagement in care and to incorporate social support into health promotion programming for AA women living with HIV.

Two Pilot Randomized Trials To Examine Feasibility and Impact of Treated Parents as Peer Interventionists in Family-Based Pediatric Weight Management.

BACKGROUND: To examine feasibility and initial efficacy of having previously treated parents serve as peer interventionists in family-based behavioral weight management treatment (FBT). METHODS: Children aged 7-11 years with overweight/obesity and parents (n = 59 families) were enrolled in one of two pilot trials, the EPICH (Engaging Parents in Child Health) randomized trial comparing professional versus peer FBT delivery or the Parent Partnership trial, which provided professionally delivered FBT to families (first generation) and then randomly assigned first generation parents to either be or not be peer interventionists for subsequent families (second generation). Efficacy (child zBMI change), feasibility, and costs for delivering FBT, and impacts of being a peer interventionist were examined. RESULTS: In EPICH, families receiving professional versus peer intervention had similar decreases in child zBMI and parent BMI, with markedly lower costs for peer versus professional delivery. In Parent Partnership, families receiving peer intervention significantly decreased weight status, with very preliminary evidence suggesting better maintenance of child zBMI changes if parents served as peer interventionists. Previously treated parents were willing, highly confident, and able to serve as peer interventionists in FBT. CONCLUSIONS: Two pilot randomized clinical trials suggest parents-as-peer interventionists in FBT may be feasible, efficacious, and delivered at lower costs, with perhaps some additional benefits to serving as a peer interventionist. More robust investigation is warranted of peer treatment delivery models for pediatric weight management.

Disparities in Physical Health Conditions Among Lesbian and Bisexual Women: A Systematic Review of Population-Based Studies.

We conducted a systematic review to assess evidence for disparities for lesbian and bisexual women (i.e., sexual minority women [SMW]) in comparison with heterosexual women across a range of nine physical health conditions. Among the k = 11 studies meeting eligibility criteria, almost every comparison (i.e., heterosexual vs. (a) lesbian, (b) bisexual, or (c) both lesbian and bisexual women) was in a direction indicating SMW disparities. Despite limited power due to small samples of SMW, we found evidence of disparities as indicated by a statistically significant adjusted odds ratios for asthma (5 of 7 comparisons), obesity (8 of 12), arthritis (2 of 3), global ratings of physical health (4 of 7), and cardiovascular disease (1 of 1). Evidence was lacking for cancer (1 of 4), diabetes and hypertension (both 1 of 5), and high cholesterol (0 of 3). Future work should confirm findings in more diverse, larger samples and should examine potential explanatory factors.

Barriers to HIV Care and Treatment Among Participants in a Public Health HIV Care Relinkage Program.

Improving patient retention in HIV care and use of antiretroviral therapy (ART) are key steps to improving the HIV care continuum in the US. However, contemporary quantitative data on barriers to care and treatment from population-based samples of persons poorly engaged in care are sparse. We analyzed the prevalence of barriers to clinic visits, ART initiation, and ART continuation reported by 247 participants in a public health HIV care relinkage program in King County, WA. We identified participants using HIV surveillance data (N=188) and referrals from HIV/STD clinics and partner services (N=59). Participants most commonly reported insurance (50%), practical (26-34%), and financial (30%) barriers to care, despite residing in a state with essentially universal access to HIV care. Perceived lack of need for medical care was uncommon (<20%), but many participants (58%) endorsed a perceived lack of need for medication as a reason for not initiating ART. Depression and substance abuse were both highly prevalent (69% and 54%, respectively), and methamphetamine was the most commonly abused substance. Barriers to HIV care and treatment may be amenable to intervention by health department outreach in coordination with existing HIV medical and support services.

"Please Don't Make Me Ask for Help": Implicit Social Support and Mental Health in Chinese Individuals Living with HIV.

China faces a growing HIV epidemic; psychosocial needs of HIV-positive individuals remain largely unaddressed. Research is needed to consider the gap between need for mental healthcare and lack of sufficiently trained professionals, in a culturally acceptable manner. This study assessed explicit and implicit forms of social support and mental health symptoms in 120 HIV-positive Chinese. Explicit social support refers to interactions involving active disclosure and discussion of problems and request for assistance, whereas implicit social support refers to the emotional comfort one obtains from social networks without disclosing problems. We hypothesized and found using multiple linear regression, that after controlling for demographics, only implicit, but not explicit social support positively predicted mental health. Future research is warranted on the effects of utilizing implicit social support to bolster mental health, which has the potential to circumvent the issues of both high stigma and low professional resources in this population.

The health equity promotion model: Reconceptualization of lesbian, gay, bisexual, and transgender (LGBT) health disparities.

National health initiatives emphasize the importance of eliminating health disparities among historically disadvantaged populations. Yet, few studies have examined the range of health outcomes among lesbian, gay, bisexual, and transgender (LGBT) people. To stimulate more inclusive research in the area, we present the Health Equity Promotion Model-a framework oriented toward LGBT people reaching their full mental and physical health potential that considers both positive and adverse health-related circumstances. The model highlights (a) heterogeneity and intersectionality within LGBT communities; (b) the influence of structural and environmental context; and (c) both health-promoting and adverse pathways that encompass behavioral, social, psychological, and biological processes. It also expands upon earlier conceptualizations of sexual minority health by integrating a life course development perspective within the health-promotion model. By explicating the important role of agency and resilience as well as the deleterious effect of social structures on health outcomes, it supports policy and social justice to advance health and well-being in these communities. Important directions for future research as well as implications for health-promotion interventions and policies are offered.

Computerized counseling reduces HIV-1 viral load and sexual transmission risk: findings from a randomized controlled trial.

OBJECTIVE: Evaluate a computerized intervention supporting antiretroviral therapy (ART) adherence and HIV transmission prevention. DESIGN: Longitudinal randomized controlled trial. SETTINGS: An academic HIV clinic and a community-based organization in Seattle. SUBJECTS: In a total of 240 HIV-positive adults on ART, 209 completed 9-month follow-up (87% retention). INTERVENTION: Randomization to computerized counseling or assessment only, 4 sessions over 9 months. MAIN OUTCOME MEASURES: HIV-1 viral suppression, and self-reported ART adherence and transmission risks, compared using generalized estimating equations. RESULTS: Overall, intervention participants had reduced viral load: mean 0.17 log10 decline, versus 0.13 increase in controls, P = 0.053, and significant difference in ART adherence baseline to 9 months (P = 0.046). Their sexual transmission risk behaviors decreased (odds ratio = 0.55, P = 0.020), a reduction not seen among controls (odds ratio = 1.1, P = 0.664), and a significant difference in change (P = 0.040). Intervention effect was driven by those most in need; among those with detectable virus at baseline (>30 copies/mL, n = 89), intervention effect was mean 0.60 log10 viral load decline versus 0.15 increase in controls, P = 0.034. ART adherence at the final follow-up was 13 points higher among intervention participants versus controls, P = 0.038. CONCLUSIONS: Computerized counseling is promising for integrated ART adherence and safer sex, especially for individuals with problems in these areas. This is the first intervention to report improved ART adherence, viral suppression, and reduced secondary sexual transmission risk behavior.

Sexually explicit online media and sexual risk among men who have sex with men in the United States.

This study aimed to describe sexually explicit online media (SEOM) consumption among men who have sex with men (MSM) in the United States and examine associations between exposure to unprotected anal intercourse (UAI) in SEOM and engagement in both UAI and serodiscordant UAI. MSM in the U.S. who accessed a men-seeking-men website in the past year (N = 1,170) were recruited online for a cross-sectional, Internet-based survey of sexual risk and SEOM consumption. In the 3 months prior to interview, more than half (57 %) of the men reported viewing SEOM one or more times per day and almost half (45 %) reported that at least half of the SEOM they viewed portrayed UAI. Compared to participants who reported that 0-24 % of the SEOM they viewed showed UAI, participants who reported that 25-49, 50-74, or 75-100 % of the SEOM they viewed portrayed UAI had progressively increasing odds of engaging in UAI and serodiscordant UAI in the past 3 months. As SEOM has become more ubiquitous and accessible, research should examine causal relations between SEOM consumption and sexual risk-taking among MSM as well as ways to use SEOM for HIV prevention.

MACH14: a multi-site collaboration on ART adherence among 14 institutions.

The integration of original data from multiple antiretroviral (ARV) adherence studies offers a promising, but little used method to generate evidence to advance the field. This paper provides an overview of the design and implementation of MACH14, a collaborative, multi-site study in which a large data system has been created for integrated analyses by pooling original data from 16 longitudinal ARV adherence studies. Studies selected met specific criteria including similar research design and data domains such as adherence measured with medication event monitoring system, psychosocial factors related to adherence behavior, and virologic and clinical outcomes. The data system created contains individual data (collected between 1997 and 2009) from 2,860 HIV patients. Collaboration helped resolve the challenges inherent in pooling data across multiple studies, yet produced a data system with strong statistical power and potentially greater capacity to address key scientific questions than possible with single-sample studies or even meta-analytic designs.

Project həli?dx(w)/Healthy Hearts Across Generations: development and evaluation design of a tribally based cardiovascular disease prevention intervention for American Indian families.

American Indian and Alaska Native (AIAN) populations are disproportionately at risk for cardiovascular disease (CVD), diabetes, and obesity, compared with the general US population. This article describes the həli?dx(w)/Healthy Hearts Across Generations project, an AIAN-run, tribally based randomized controlled trial (January 2010-June 2012) designed to evaluate a culturally appropriate CVD risk prevention program for AI parents residing in the Pacific Northwest of the United States. At-risk AIAN adults (n = 135) were randomly assigned to either a CVD prevention intervention arm or a comparison arm focusing on increasing family cohesiveness, communication, and connectedness. Both year-long conditions included 1 month of motivational interviewing counseling followed by personal coach contacts and family life-skills classes. Blood chemistry, blood pressure, body mass index, food intake, and physical activity were measured at baseline and at 4- and 12-month follow-up times.

Social capital, acculturation, mental health, and perceived access to services among Mexican American women.

OBJECTIVE: We examined whether individual-level social capital-the intangible resources in a community available through membership in social networks or other social structures and perceived trust in the community-was associated with acculturation, depression and anxiety symptoms, and perceived access to services among women of Mexican ancestry. METHOD: Recruited through venue-based targeted sampling in King County, Washington, 205 women of Mexican descent ages 18 to 64 years who differed in socioeconomic status and nativity completed a cross-sectional survey. Half completed the survey in Spanish and half in English. Structural equation modeling was used for model testing. RESULTS: Social capital increased with level of acculturation and was negatively related to depression and anxiety; it had no direct association with perceived access to services. Social capital mediated the relation between acculturation and both depression and anxiety symptoms. Acculturation had no direct association with psychological distress but was directly associated with perceived access to services. This community sample of women reported high levels of psychological distress, with 20% to 26% of women meeting diagnostic criteria for depression or anxiety. CONCLUSIONS: Social capital can be assessed at the individual level, increases with acculturation, and may be a potential target for interventions to improve mental health among Mexican American women residing in the United States.

Challenges in addressing depression in HIV research: assessment, cultural context, and methods.

Depression is one of the most common co-morbidities of HIV infection. It negatively impacts self-care, quality of life, and biomedical outcomes among people living with HIV (PLWH) and may interfere with their ability to benefit from health promotion interventions. State-of-the-science research among PLWH, therefore, must address depression. To guide researchers, we describe the main diagnostic, screening, and symptom-rating measures of depression, offering suggestions for selecting the most appropriate instrument. We also address cultural considerations in the assessment of depression among PLWH, emphasizing the need to consider measurement equivalence and offering strategies for developing measures that are valid cross-culturally. Finally, acknowledging the high prevalence of depression among PLWH, we provide guidance to researchers on incorporating depression into the theoretical framework of their studies and employing procedures that account for participants with depression.

Abuse, mastery, and health among lesbian, bisexual, and two-spirit American Indian and Alaska Native women.

American Indian and Alaska Native (AIAN) women have endured a history of colonial oppression in the United States. Current manifestations of colonization include an epidemic of violence toward AIAN women, who often are sexually and physically abused from early on in life. Such violence may erode AIAN women's sense of agency or mastery and contribute to their poor physical and mental health outcomes. AIAN women who identify as lesbian, bisexual, or "two-spirit" appear to experience disproportionate levels of violence and may be particularly vulnerable to disparities in health outcomes. In this study, 152 sexual minority AIAN women were interviewed as part of an investigation addressing the health concerns of two-spirit persons. Participants reported disturbingly high prevalence of both sexual (85%) and physical (78%) assault, both of which were associated with worse overall mental and physical health. These relationships generally were mediated by a diminished sense of control or mastery. The need to indigenize the concept of mastery is discussed, as is the urgency of interventions to work toward decreasing levels of abuse and increasing mastery among sexual minority AIAN women.

Ecological models of sexual satisfaction among lesbian/bisexual and heterosexual women.

Sexual satisfaction is an integral component of sexual health and well-being, yet we know little about which factors contribute to it among lesbian/bisexual women. To examine a proposed ecological model of sexual satisfaction, we conducted an internet survey of married heterosexual women and lesbian/bisexual women in committed same-sex relationships. Structural equation modeling included five final latent variables for heterosexual women and seven final latent variables for lesbian/bisexual women. Overall, results indicated that, for both groups of women, a similar constellation of factors (depressive symptoms, relationship satisfaction, sexual functioning, and social support) was related to sexual satisfaction. In lesbian/bisexual women, internalized homophobia was an additional factor. Contrary to expectations, the presence of children in the home and a history of childhood sexual abuse did not contribute significantly to the model for either group. Findings support the idea that gender socialization may influence sexual satisfaction more than socialization around sexual orientation. Additionally, given that for both groups of women relationship satisfaction explained a substantial amount of variance in sexual satisfaction, sexual concerns may be better addressed at the relationship than the individual level.

Peer support to promote medication adherence among people living with HIV/AIDS: the benefits to peers.

Since early in the AIDS epidemic, HIV-positive individuals have benefited from the services of peer support or buddy programs. However, little research has focused on the experience of the peer providing support. We conducted qualitative interviews with nine HIV-positive peers who had participated in an intervention designed to provide support to other HIV-positive individuals as one means of promoting antiretroviral therapy adherence. Analyses of the peers' common dialogue about their involvement in the study revealed four main themes: social acceptance, reciprocal support, personal growth and empowerment, and resistance and other challenges. Recommendations for future research and for implementing similar interventions in a health care setting are provided.

Adherence to antiretroviral therapy for pediatric HIV infection: a qualitative systematic review with recommendations for research and clinical management.

Although nonadherence to prescribed therapies is widespread, it is particularly problematic with highly active antiretroviral therapy for HIV infection. This review of >50 studies in the area of pediatric HIV infection revealed varying methods for assessing antiretroviral adherence with a wide range of estimates of adherence. Correlates of adherence could be grouped as those relating to the medication, the patient, and the caregiver/family, with many conflicting findings and a lack of theory guiding the research. Only 8 studies, mainly small feasibility or pilot investigations, evaluated highly active antiretroviral therapy adherence interventions in pediatric populations. We conclude with specific recommendations for assessment and clinical management of adherence and discuss directions for future research in this area.