Multilevel Stigma and Its Associations with Medical Care Ratings Among Men Who Have Sex With Men in HPTN 078.

INTRODUCTION: Our research assessed associations between stigma-related variables and medical care ratings among clients with HIV in HIV Prevention Trials Network (HPTN) 078 who were men who have sex with men (MSM). METHODS: Logistic regression explored care ratings, stigma, socio-demographics (N = 637). Qualitative thematic coding and themes explored stigmatizing experiences in different settings (N = 111). RESULTS: Whites were twice as likely as African-Americans to report high care ratings (P < .05). Clients who reported familial exclusion due to having sex with men were 40% less likely to report high medical care ratings (P < .05). Clients who agreed healthcare providers think people with HIV "sleep around" were half as likely to report high care ratings (P < .08). Stigmatization included "treating me like they'll catch HIV from my hand," and care avoidance so others didn't "know I was having sex with men". CONCLUSIONS: Providers can promote African American MSM client retention with more affirming healthcare provision, namely minimizing assumptions and addressing identities and client needs beyond just HIV care.

Tough Talks COVID-19 Digital Health Intervention for Vaccine Hesitancy Among Black Young Adults: Protocol for a Hybrid Type 1 Effectiveness Implementation Randomized Controlled Trial.

BACKGROUND: Interventions for increasing the uptake of COVID-19 vaccination among Black young adults are central to ending the pandemic. Black young adults experience harms from structural forces, such as racism and stigma, that reduce receptivity to traditional public health messaging due to skepticism and distrust. As such, Black young adults continue to represent a priority population on which to focus efforts for promoting COVID-19 vaccine uptake. OBJECTIVE: In aims 1 and 2, the Tough Talks digital health intervention for HIV disclosure will be adapted to address COVID-19 vaccine hesitancy and tailored to the experiences of Black young adults in the southern United States (Tough Talks for COVID-19). In aim 3, the newly adapted Tough Talks for COVID-19 digital health intervention will be tested across the following three southern states: Alabama, Georgia, and North Carolina. METHODS: Our innovative digital health intervention study will include qualitative and quantitative assessments. A unique combination of methodological techniques, including web-based surveys, choose-your-own-adventures, digital storytelling, user acceptability testing, and community-based participatory approaches, will culminate in a 2-arm hybrid type 1 effectiveness implementation randomized controlled trial, wherein participants will be randomized to the Tough Talks for COVID-19 intervention arm or a standard-of-care control condition (N=360). Logistic regression will be used to determine the effect of the treatment arm on the probability of vaccination uptake (primary COVID-19 vaccine series or recommended boosters). Concurrently, the inner and outer contexts of implementation will be ascertained and catalogued to inform future scale-up. Florida State University's institutional review board approved the study (STUDY00003617). RESULTS: Our study was funded at the end of April 2021. Aim 1 data collection concluded in early 2022. The entire study is expected to conclude in January 2025. CONCLUSIONS: If effective, our digital health intervention will be poised for broad, rapid dissemination to reduce COVID-19 mortality among unvaccinated Black young adults in the southern United States. Our findings will have the potential to inform efforts that seek to address medical mistrust through participatory approaches. The lessons learned from the conduct of our study could be instrumental in improving health care engagement among Black young adults for several critical areas that disproportionately harm this community, such as tobacco control and diabetes prevention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05490329; https://clinicaltrials.gov/ct2/show/NCT05490329. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41240.

Examining Associations Between Mental Health, IPV Exposure, HIV Risk Behaviors, and PrEP Use in South African Women: An Analysis of Data from the Charisma Study.

Intimate partner violence (IPV) has been associated with poorer mental health outcomes and increased human immunodeficiency virus (HIV) risk behaviors. We examine the relations between IPV, mental health symptomology (defined as psychological distress and alcohol misuse), and engagement in HIV risk behaviors among a sample of South African women who participated in a randomized controlled trial of CHARISMA, an intervention to increase women's agency to use oral pre-exposure prophylaxis (PrEP) safely and consistently as well as mitigate relationship challenges. We also examined the impact of trial participation on women's mental health, as well as the impact of psychological distress on the effectiveness of the CHARISMA intervention. Mental health symptomology and IPV exposure were prevalent and associated with some HIV risk and protective behaviors. Trial participation reduced psychological distress. There was no evidence for mental health symptomology impacting the effectiveness of the CHARISMA intervention.

Communicating about microbicides with women in mind: tailoring messages for specific audiences.

INTRODUCTION: Current HIV prevention options are unrealistic for most women; however, HIV prevention research has made important strides, including on-going development of antiretroviral-based vaginal microbicide gels. Nevertheless, social-behavioural research suggests that women's ability to access and use new HIV prevention technologies will be strongly influenced by a range of socio-cultural, gender and structural factors which should be addressed by communications and marketing strategies, so that these products can be positioned in ways that women can use them. METHODS: Based on an extensive literature review and in-country policy consultation, consisting of approximately 43 stakeholders, we describe barriers and facilitators to HIV prevention, including potential microbicide use, for four priority audiences of Kenyan women (female sex workers [FSWs], women in stable and discordant relationships, and sexually active single young women). We then describe how messages that position microbicides might be tailored for each audience of women. RESULTS: We reviewed 103 peer-reviewed articles and reports. In Kenya, structural factors and gender inequality greatly influence HIV prevention for women. HIV risk perception and the ability to consistently use condoms and other prevention products often vary by partner type. Women in stable relationships find condom use challenging because they connote a lack of trust. However, women in other contexts are often able to negotiate condom use, though they may face challenges with consistent use. These women include FSWs who regularly use condoms with their casual clients, young women in the initial stages of a sexual relationship and discordant couples. Thus, we consider two approaches to framing messages aimed at increasing general awareness of microbicides - messages that focus strictly on HIV prevention and ones that focus on other benefits of microbicides such as increased pleasure, intimacy or sexual empowerment, in addition to HIV prevention. CONCLUSIONS: If carefully tailored, microbicide communication materials may facilitate product use by women who do not currently use any HIV prevention method. Conversely, message tailoring for women with high-risk perception will help ensure that microbicides are used as additional protection, together with condoms.

The importance of choice in the rollout of ARV-based prevention to user groups in Kenya and South Africa: a qualitative study.

INTRODUCTION: Stakeholders continue to discuss the appropriateness of antiretroviral-based pre-exposure prophylaxis (PrEP) for HIV prevention among sub-Saharan African and other women. In particular, women need formulations they can adhere to given that effectiveness has been found to correlate with adherence. Evidence from family planning shows that contraceptive use, continuation and adherence may be increased by expanding choices. To explore the potential role of choice in women's use of HIV prevention methods, we conducted a secondary analysis of research with female sex workers (FSWs) and men and women in serodiscordant couples (SDCs) in Kenya, and adolescent and young women in South Africa. Our objective here is to present their interest in and preferences for PrEP formulations - pills, gel and injectable. METHODS: In this qualitative study, in Kenya we conducted three focus groups with FSWs, and three with SDCs. In South Africa, we conducted two focus groups with adolescent girls, and two with young women. All focus groups were audio-recorded, transcribed and translated into English as needed. We structurally and thematically coded transcripts using a codebook and QSR NVivo 9.0; generated code reports; and conducted inductive thematic analysis to identify major trends and themes. RESULTS: All groups expressed strong interest in PrEP products. In Kenya, FSWs said the products might help them earn more money, because they would feel safer accepting more clients or having sex without condoms for a higher price. SDCs said the products might replace condoms and reanimate couples' sex lives. Most sex workers and SDCs preferred an injectable because it would last longer, required little intervention and was private. In South Africa, adolescent girls believed it would be possible to obtain the products more privately than condoms. Young women were excited about PrEP but concerned about interactions with alcohol and drug use, which often precede sex. Adolescents did not prefer a particular formulation but noted benefits and limitations of each; young women's preferences also varied. CONCLUSIONS: The circumstances and preferences of sub-Saharan African women are likely to vary within and across groups and to change over time, highlighting the importance of choice in HIV prevention methods.

An interdisciplinary framework for measuring and supporting adherence in HIV prevention trials of ARV-based vaginal rings.

INTRODUCTION: Product adherence and its measurement have emerged as a critical challenge in the evaluation of new HIV prevention technologies. Long-acting ARV-based vaginal rings may simplify use instructions and require less user behaviour, thereby facilitating adherence. One ARV-based ring is in efficacy trials and others, including multipurpose rings, are in the pipeline. Participant motivations, counselling support and measurement challenges during ring trials must still be addressed. In previous HIV prevention trials, this has been done largely using descriptive and post-hoc methods that are highly variable and minimally evaluated. We outline an interdisciplinary framework for systematically investigating promising strategies to support product uptake and adherence, and to measure adherence in the context of randomized, blinded clinical trials. DISCUSSION: The interdisciplinary framework highlights the dual use of adherence measurement (i.e. to provide feedback during trial implementation and to inform interpretation of trial findings) and underscores the complex pathways that connect measurement, adherence support and enacted adherence behaviour. Three inter-related approaches are highlighted: 1) adherence support - sequential efforts to define motivators of study product adherence and to develop, test, refine and evaluate adherence support messages; 2) self-reported psychometric measures - creation of valid and generalizable measures based in easily administered scales that capture vaginal ring use with improved predictive ability at screening, baseline and follow-up that better engage participants in reporting adherence; and 3) more objective measurement of adherence - real-time adherence monitoring and cumulative measurement to correlate adherence with overall product effectiveness through innovative designs, models and prototypes using electronic and biometric technologies to detect ring insertion and/or removal or expulsion. Coordinating research along these three pathways will result in a comprehensive approach to product adherence within clinical trials. CONCLUSIONS: Better measurement of adherence will not, by itself, ensure that future effectiveness trials will be able to address the most basic question: if the product is used per instructions, will it prevent HIV transmission? The challenges to adherence measurement must be addressed as one component of a more integrated system that has as its central focus adherence as a behaviour emerging from the social context of the user.