Uptake and Persistence of Safer Conception Strategies Among South African Women Planning for Pregnancy.

Safer conception strategies can minimize HIV acquisition during periconception periods among women living in HIV-endemic areas. We examined uptake and predictors of persistent use of the same safer conception strategy among a cohort of HIV-uninfected South African women ages 18-35 years planning for pregnancy with a partner living with HIV or of unknown HIV-serostatus. The safer conception strategies we evaluated included oral PrEP, condomless sex limited to peak fertility, and waiting for a better time to have a child (until, for example, the risks of HIV acquisition are reduced and/or the individual is prepared to care for a child); persistence was defined as using the same safer conception strategy from the first visit through 9 months follow-up. Modified Poisson regression models were used to examine predictors of persistent use of the same strategy. The average age of 227 women in our cohort was 24.6 (range: 18.0, 35.7) years. In this cohort, 121 (74.2%) women reported persisting in the same strategy through 9 months. Employment and HIV knowledge were associated with the persistent use of any strategy. Our results highlight the need to provide safer conception services to women exposed to HIV during periconception periods. Findings also offer some insights into factors that might influence persistent use. Further research is needed to better understand how to involve male partners and how their involvement might influence women's consistent use of safer conception strategies during periconception periods.

Provocative Findings From a Transdiagnostic Counseling Intervention to Improve Psychiatric Comorbidity and HIV Care Engagement Among People With HIV: A Pilot Randomized Clinical Trial.

BACKGROUND: Depression, anxiety, post-traumatic stress, and alcohol/substance use disorders are prevalent among people with HIV (PWH), commonly co-occur, and predict worse HIV care outcomes. Transdiagnostic counseling approaches simultaneously address multiple co-occurring mental health disorders. METHODS: We conducted a pilot individually randomized trial of the Common Elements Treatment Approach adapted for people with HIV (CETA-PWH), a transdiagnostic counseling intervention, compared with usual care at a large academic medical center in the southern United States. Participants were adults with HIV; at risk for HIV care disengagement; and with elevated symptoms of depression, anxiety, post-traumatic stress, and/or alcohol/substance use. Mental health and HIV care engagement were assessed at 4 and 9 months. RESULTS: Among participants (n = 60), follow-up was high at 4 (92%) and 9 (85%) months. Intervention engagement was challenging: 93% attended ≥1 session, 43% attended ≥6 sessions in 3 months ("moderate dose"), and 30% completed treatment. Although not powered for effectiveness, mental health outcomes and HIV appointment attendance improved in CETA-PWH relative to usual care in intent-to-treat analyses; those receiving a moderate dose and completers showed progressively greater improvement. Viral load showed small differences between arms. The dose-response pattern was not explained by differences between those who did and did not complete treatment. CONCLUSIONS: This pilot trial provides preliminary evidence for the potential of CETA-PWH to simultaneously address co-occurring mental health comorbidities and support HIV appointment attendance among PWH. Additional strategies may be an important part of ensuring that clients can engage in the full course of treatment and realize its full benefits.

Who declines "opt-out" HIV/HCV testing? Experience of an internal medicine resident continuity clinic serving a predominantly Black adult population in South Carolina.

BACKGROUND: Universal "opt-out" human immunodeficiency virus (HIV) or hepatitis C virus (HCV) testing involves testing individuals for HIV or HCV regardless of symptoms, unless they decline. Little is known about the characteristics of individuals who decline. METHODS: We conducted a retrospective, medical record review of adults evaluated at an outpatient clinic in South Carolina. "Opt-out" HIV/HCV testing was implemented in Feb 2019; we reviewed medical records of individuals evaluated in May - July 2019. We excluded individuals who did not meet age-based screening criteria (HIV: 18-65 years; HCV: 18-74 years), had a prior HIV/HCV diagnosis, were tested for HIV/HCV within the preceding 12 months, and whose "opt-out" decision was not documented. We used multivariable logistic regression to estimate adjusted odds ratios (aOR) and 95 % confidence intervals (CI) for "opt-out" decision, with age, sex, race/ethnicity, insurance status, visit type, and genitourinary vs. non-genitourinary chief complaints as predictors. RESULTS: The final analyses included 706 individuals for HIV and 818 for HCV. Most individuals were non-Hispanic Black (77 % and 78 %) and female (66 % and 64 %). The mean ages were 49.1 (±11.9) and 51.9 (±13.2). Nearly one-third of individuals declined HIV and HCV testing (31 % and 30 %). Black males were more likely to decline HIV and HCV testing than Black females (aOR = 1.61 [95 % CI. 1.08 - 2.40] and aOR = 1.50 [95 %CI. 1.04 - 2.16]). CONCLUSION: Despite HIV/HCV testing being the standard of care, approximately one-third of eligible individuals may decline testing, the demographic characteristics of whom may overlap with individuals who are traditionally unaware of their status. MAIN POINT: Despite HIV/HCV testing being the standard of care, approximately one-third of eligible individuals may decline testing, the demographic characteristics of whom may overlap with individuals who are traditionally unaware of their status.

Acceptability, feasibility and preliminary effectiveness of the mHealth intervention, InTSHA, on retention in care and viral suppression among adolescents with HIV in South Africa: a pilot randomized clinical trial.

We describe the results of a pilot randomized clinical trial of a mobile phone-based intervention, InTSHA: Interactive Transition Support for Adolescents with HIV, compared to standard care. Encrypted, closed group chats delivered via WhatsApp provided peer support and improved communication between adolescents with HIV, their caregivers, and healthcare providers. We randomized 80 South African adolescents ages 15 to 19 years with perinatally-acquired HIV to receive either the intervention (n=40) or standard of care (n=40). We measured acceptability (Acceptability of Intervention Measure [AIM]) and feasibility (Feasibility of Intervention Measure [FIM]) as primary outcomes. We evaluated impact on retention in care and viral suppression six months after randomization as secondary endpoints. We performed bivariable and multivariable analyses using logistic regression models to assess the effect of the InTSHA intervention compared to standard of care. Among the adolescents randomized to the InTSHA intervention, the median AIM was 4.1/5.0 (82%) and median FIM was 3.9/5.0 (78%). We found no difference in retention in care or in viral suppression comparing intervention and control groups. Among adolescents who attended three or more sessions, retention in care was 100% at 6 months. InTSHA is an acceptable and feasible mHealth intervention warranting further study in a larger population.

Is gravidity associated with COVID-19 vaccination among pregnant women in Jamaica?

Introduction: In 2021, Jamaica's maternal mortality ratio doubled as a result of COVID-19-related deaths. Yet, COVID-19 vaccination among pregnant Jamaican women remained low. In the United States, COVID-19 vaccination is lower among pregnant women who have had multiple pregnancies (multigravidas) versus women who were pregnant for the first time (primigravidas). We examined whether this pattern exists in Jamaica. Methods: A cross-sectional survey of a convenience sample of 79 pregnant Jamaican women recruited from a teaching hospital (May-July 2022) was used to assess self-reported COVID-19 vaccination and medical mistrust beliefs-operationalized as low vaccine confidence, government mistrust, and race-based mistrust-by gravidity. We used modified Poisson regression to estimate adjusted prevalence ratios (aPR) and 95% confidence intervals (CI) for vaccination by gravidity, adjusting for age, education, and comorbidities. Results: Thirty-nine (49%) of the participants were multigravidas. Socioeconomic status was similar between multigravidas and primigravidas. COVID-19 vaccination was lower in multigravidas (46%) than primigravidas (75%) after adjusting for age, education, and comorbidities (aPR = 0.67, 95% CI = 0.46-0.99; p = 0.044). Vaccine confidence was lower in multigravidas (p = 0.044). Government mistrust and race-based mistrust did not differ between the two groups. Conclusion: In Jamaica, multigravidas may have lower COVID-19 vaccine uptake and lower vaccine confidence compared with primigravidas. Understanding the distinct needs of pregnant subpopulations is essential for crafting effective maternal vaccination campaigns.

HPTN 083-02: factors influencing adherence to injectable PrEP and retention in an injectable PrEP study.

INTRODUCTION: HPTN 083 demonstrated the superiority of long-acting cabotegravir (CAB-LA) versus daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) as pre-exposure prophylaxis (PrEP) among cisgender men and transgender women who have sex with men (MSM/TGW). HPTN 083 provided the first opportunity to understand experiences with injectable PrEP in a clinical trial. METHODS: Participants from two US sites (Chicago, IL and Atlanta, GA) and one international site (Rio de Janeiro, Brazil) were purposively sampled for individual qualitative interviews (N = 40), between November 2019 and March 2020, to explore trial experiences, barriers to adherence and other factors that may have impacted study implementation or outcomes. The blinded phase ended early due to efficacy; this analysis includes interviews conducted prior to unblinding with three groups defined by adherence (i.e. injection visit attendance): adherent (n = 27), non-adherent (n = 12) and early discontinuers (n = 1). Data were organized using NVivo software and analysed using content analysis. RESULTS: Participants (mean age: 27) were primarily cisgender MSM (90%) and Black/African American (60%). Reasons for trial enrolment and PrEP use included a preference for using HIV prevention medication versus treatment in the event of HIV acquisition; the ability to enhance health via study-related education and services; access to a novel, convenient HIV prevention product at no cost; and contributing to MSM/TGW communities through research. Participants contrasted positive experiences with study staff with their routine clinical care, and emphasized increased scheduling flexibility, thorough communication, non-judgemental counselling and open, affirming environments (e.g. compassion, less stigma) as adherence facilitators. Injection experiences were positive overall; some described early injection-related anxiety, which abated with time and when given some measure of control (e.g. pre-injection countdown), and minimal injection site discomfort. Some concerns and misperceptions about injectable PrEP were reported. Barriers to adherence, across all adherence categories, included structural factors (e.g. financial constraints, travel) and competing demands (e.g. work schedules). CONCLUSIONS: Respondents viewed injectable PrEP trial participation as a positive experience and a means of enhancing wellbeing. Study site flexibility and affirming clinic environments, inclusive of non-judgemental counselling, were key facilitators of adherence. To support injection persistence, interventions that address structural barriers and promote flexible means of injection delivery may be most effective.

Oral preexposure prophylaxis uptake, adherence, and persistence during periconception periods among women in South Africa.

OBJECTIVE: We developed the Healthy Families-PrEP intervention to support HIV-prevention during periconception and pregnancy. We evaluated preexposure prophylaxis (PrEP) use with three objective measures. DESIGN: This single-arm intervention study enrolled women in KwaZulu-Natal, South Africa, who were HIV-uninfected, not pregnant, in a relationship with a partner with HIV or unknown-serostatus, and with pregnancy plans. PrEP was offered as part of a comprehensive HIV prevention intervention. Participants were followed for 12 months. METHODS: We evaluated periconception PrEP uptake and adherence using quarterly plasma tenofovir concentrations. We modeled factors associated with PrEP uptake and high plasma tenofovir (past day dosing). Patterns of use were analyzed using electronic pillcap data. Dried blood spots to measure intracellular tenofovir product (past 2 months dosing) were analyzed for a subset of women. RESULTS: Three hundred thirty women with median age 24 (IQR: 22-27) years enrolled. Partner HIV-serostatus was unknown by 96% ( N  = 316); 60% (195) initiated PrEP. High plasma tenofovir concentrations were seen in 35, 25, 22, and 20% of samples at 3, 6, 9, and 12 months, respectively. Similar adherence was measured by pillcap and dried blood spots. In adjusted models, lower income, alcohol use, and higher HIV stigma were associated with high plasma tenofovir. Eleven HIV-seroconversions were observed (incidence rate: 4.04/100 person-years [95% confidence interval: 2.24-7.30]). None had detectable plasma tenofovir. CONCLUSION: The Healthy Families-PrEP intervention supported women in PrEP use. We observed high interest in periconception PrEP and over one-third adhered to PrEP in the first quarter; one-fifth were adherent over a year. High HIV incidence highlights the importance of strategies to reduce HIV incidence among periconception women. CLINICAL TRIAL NUMBER: NCT03194308.

A resiliency intervention adapted for older women with HIV: Results from a pilot randomized controlled trial in the northeastern US.

Aging with HIV often results in psychosocial and health-related challenges for women; however, no resiliency interventions exist for older women with HIV (WWH). WWH aged ≥50 were randomized to 10 group sessions of an adapted resiliency intervention or time-matched supportive psychotherapy. Assessments were conducted at three timepoints. Feasibility and acceptability metrics were defined a priori; differences in resilience, stress coping, anxiety, and depression across timepoints were assessed. Overall, 44 WWH enrolled; participants were 58 years old on average, and 56.4% identified as Black/African American. Among those who attended any sessions, all feasibility metrics were met, and the intervention was acceptable. The interaction of study arm and time was associated with significant decreases in depression and a trend toward significant decreases in anxiety. The intervention was not associated with changes in resilience or stress coping. Adjusting delivery modality may further reduce barriers to attendance, improving feasibility and clinical outcomes.

Implementation of a safer conception programme for HIV-affected men and women in rural Uganda.

We integrated safer conception care into a Ugandan HIV clinic. People with HIV (PWH), or partnered with a PWH, and desiring children were eligible for the Healthy Families Clinic Program. Clients completed quarterly safer conception counselling visits and questionnaires to provide information around method preferences and outcomes (partner pregnancy, partner seroconversion). We used clinic level data to evaluate longitudinal viral suppression among PWH. Between November 2016 and January 2020, 361 clients (53% men) accessed services. 75% were PWH (51% women, 96% men): 99% were on antiretroviral therapy (ART) and most reported HIV-sero-different partnerships (97%). Frequently selected safer conception methods included ART (86%), timed condomless sex (74%), and PrEP (40%) with important differences by HIV-serostatus and gender. 22.5% reported pregnancy. Most (97%) PWH were virally suppressed at enrolment and 81% of non-virally suppressed PWH were virally suppressed at 15 months. Two HIV-negative clients (2%) had HIV seroconversion. There is demand for safer conception care in a public sector HIV-clinic in Uganda. Men and women have unique safer conception care preferences. The majority of clients engaged in safer conception care had viral suppression at follow up.

Using Positive Psychology to Address Emotional Barriers to Physical Activity After Bariatric Surgery: Proof-of-Concept Trial of the Gaining Optimism After Weight Loss Surgery (GOALS) Project.

Physical activity promotes health and longevity after metabolic/bariatric surgery (MBS), but most patients do not meet recommended levels. The Gaining Optimism After weight Loss Surgery (GOALS) Project was a positive psychological intervention designed to address common emotional barriers to physical activity in patients who have recently undergone MBS (e.g., low confidence around exercise, internalized weight bias, fear of injury) and use motivational interviewing and standard behavior change techniques (e.g., self-monitoring) to increase physical activity. This single-arm proof-of-concept trial was designed to refine the intervention, test feasibility and acceptability, and explore pre-post changes in behavioral and psychological outcomes. Participants were 12 adults 6-12 months post-MBS (M age of 46, 58% female, 67% non-Hispanic white). GOALS was a 10-week telephone counseling program that introduced new positive psychological skills and physical activity topics each week. Participants tracked physical activity with a Fitbit and set weekly goals. Results showed that the intervention was feasible (85% of sessions completed) and acceptable (average participant ratings of session ease and utility above 8.0 on a 0-10 scale). There were medium-to-large effect size improvements in physical activity and psychological well-being (e.g., depressive symptoms). The GOALS intervention will next be tested in a pilot randomized controlled trial with longer-term follow-up to assess its effect more robustly.

Swiping right on PrEP: a qualitative study of MSM preferences for PrEP public health messaging on dating apps.

Men who have sex with men (MSM) are disproportionately affected by HIV. Given that over 70% of MSM meet sexual partners via dating apps, such apps may be an effective platform for promoting HIV pre-exposure prophylaxis (PrEP) use. We aimed to describe preferences among MSM for PrEP advertisements displayed on dating apps. We conducted individual in-depth interviews with 16 MSM recruited from a mobile sexual health unit in Boston, Massachusetts. Two focus groups were also held: one with mobile unit staff (N = 3) and one with mobile unit users (N = 3). Content analysis was used to identify themes related to advertisement content and integration with app use. Mean participant age was 28 (SD 6.8); 37% identified as White and 63% as Latinx. 21% of interviews were conducted in Spanish. Preferences were organized around four themes: (1) relevant and relatable advertisements, (2) expansion of target audiences to promote access, (3) concise and captivating advertisements, and (4) PrEP advertisements and services as options, not obligations. MSM are supportive of receiving information about PrEP on dating apps, but feel that existing advertisements require modification to better engage viewers. Dating apps may be an underutilized tool for increasing PrEP awareness and knowledge among MSM.

Perceptions of and preferences for PrEP use among African American women and providers in the U.S. South: a qualitative study.

OBJECTIVE: African American (AA) women in the U.S. South experience significant HIV incidence, and efforts to support antiretroviral pre-exposure prophylaxis (PrEP) uptake and maintenance among this group have been insufficient. This study aimed to explore perceptions, attitudes, and implementation preferences surrounding PrEP use for AA women in the U.S. South. METHODS AND MEASURES: The study team conducted qualitative interviews with AA cisgender women clients (n = 21) and their providers (n = 20) in Federally Qualified Health Centers and HIV clinics in Alabama. The research team employed directed qualitative content analysis to analyze interview data. RESULTS: Five themes emerged: a) inconsistent access to PrEP and PrEP knowledge, b) need for improving low PrEP awareness, c) managing hesitancy to prescribe or use PrEP, d) perceived HIV vulnerability and inherent stigma, and e) normalizing PrEP as part of routine sexual healthcare to increase uptake and maintenance. Interviews revealed an openness towards PrEP as an HIV prevention strategy for AA, cisgender women in Alabama. CONCLUSION: Improving PrEP uptake and maintenance among AA women in the U.S. South must go beyond increasing awareness to improving PrEP access and trust through visibility of AA women's PrEP use and incorporating PrEP education and services into routine sexual healthcare.

Medical Nutrition Therapy, In-Person, or Telephone Group Lifestyle Intervention for Type 2 Diabetes? A Qualitative Study of Patient Perceptions and Treatment Preferences.

PURPOSE: The purpose of the study was to explore the thoughts, feelings, motivations, and assignment preferences of community health center patients with type 2 diabetes considering participation in a 2-year lifestyle intervention trial aimed at weight loss and increased physical activity. The reasons for patients' delivery mode preferences were also explored to aid in the design of future interventions for controlled trials. METHODS: Using structured telephone interview guides, 57 patients with type 2 diabetes receiving primary care at 3 community health centers affiliated with an academic medical center were interviewed regarding the perceived pros and cons of each of the 3 possible treatment assignments: telephone conference group, in-person group, or individual medical nutrition therapy. The interview data were organized using NVIVO and analyzed using content analysis. Findings on whether preferences varied by age, gender, or diabetes duration were also examined. RESULTS: Six categories related to patient treatment preferences were identified: (1) perception of time, (2) learning style, (3) comfort, (4) prior experience with weight loss programs and conference calls, (5) desire for support/idea exchange, and (6) accountability. Preferences did not seem to vary by age, gender, or diabetes duration. CONCLUSIONS: Key factors influencing preference of treatment assignment included schedule demands, belief about learning style, and past experiences. These findings demonstrate the importance of having a variety of nutrition and lifestyle treatment options available to meet the needs of people with type 2 diabetes.

Electronic Partner Notification for Sexually Transmitted Infections: A Qualitative Assessment of Patient, Clinical Staff, and State Field Epidemiologist Perspectives.

In Massachusetts (MA), partner notification is routinely offered for new HIV and infectious syphilis cases, but there are no formal partner notification services for gonorrhea and chlamydia. Electronic partner notification (ePN), which allows patients to anonymously notify their partners of sexually transmitted infection exposure, could fill this gap. We evaluated the acceptability of and ideal characteristics for a statewide ePN service in MA. We performed semistructured interviews with patients at a Boston area sexual health clinic and conducted focus groups with clinicians and Massachusetts Department of Public Health Field Epidemiologists (FEs). We developed a codebook and thematically analyzed interview and focus group data; 25% of interviews were double coded. We identified six main themes from our data: (1) partner notification is a relational process and (2) partner notification is situation dependent. There are three pairs of challenges and core values for an effective ePN system: (3) stigmatization versus inclusivity, (4) trust versus mistrust, and (5) privacy versus helpful information sharing. Therefore, (6) a statewide ePN platform must be customizable at each possible step. Although ePN was acceptable across all three groups, the likelihood of individual use was grounded in a patient's sociocultural context, interpersonal relationships, trust in the platform and health authorities, desire to avoid stigmatization, and privacy needs. These factors are best accommodated by a platform that adapts to users' preferences and needs. ePN presents an opportunity to link partners at risk for gonorrhea or chlamydia to clinical care that is complementary to the more labor-intensive FE role.

Sexually transmitted infection (STI) knowledge and perceptions among people in HIV-sero-different partnerships in rural southwestern Uganda.

Globally, over one million people acquire curable sexually transmitted infections (STI) each day. Understanding how people think about STIs is key to building culturally appropriate STI prevention and treatment programs. We explored STI knowledge and perceptions in rural, southwestern Uganda to inform future interventions. From August 2020 to December 2020, we conducted individual in-depth interviews among adult men and women (≥18 years) with recent or current personal or partner pregnancy, a history of an STI diagnosis and treatment, and membership in an HIV-sero-different relationship. Interviews explored STI knowledge, perceptions, and barriers and facilitators to engaging in STI care. We used inductive and deductive approaches to generate a codebook guided by the healthcare literacy skills framework in a thematic analysis. Ten men with STI, five of their female partners, eighteen women with STI, and four of their male partners participated in individual in-depth interviews. The median age was 41 (range 27-50) for men and 29 (range 22-40) for women. Sixteen (43%) participants were with HIV. Significant themes include: 1) Participants obtained STI knowledge and information from the community (friends, family members, acquaintances) and medical professionals; 2) While participants knew STIs were transmitted sexually, they also believed transmission occurred via non-sexual mechanisms. 3) Participants associated different connotations and amounts of stigma with each STI, for example, participants reported that syphilis was passed down "genetically" from parent to child. 4) Participants reported uncertainty about whether STIs affected pregnancy outcomes and whether antenatal STI treatment was safe. The complicated nature of STIs has led to understandable confusion in settings without formal sexual healthcare education. Robust counseling and education prior to sexual debut will help allow men and women to understand the signs, symptoms, and treatments necessary for STI cure and to navigate often complicated and overburdened healthcare systems.

Sexual Networking and HIV/STI Prevention Among Men who have Sex with Men and Identify as Persons of Color in the Era of COVID-19 in Boston, MA: Qualitative Findings from the National HIV Behavioral Surveillance Project.

Men who have sex with men and identify as persons of color (MSM of color) are significantly impacted by HIV in the United States. The COVID-19 pandemic may have disproportionately exacerbated HIV-related disparities among MSM of color by affecting sexual networking behaviors and disrupting access to sexual health care. The current study explored the impact of COVID-19 on sexual networking and HIV/sexually transmitted infection (STI) prevention behaviors among MSM of color in Boston, MA. Eighteen semi-structured interviews were conducted via the 2020-2021 Boston sample of the National HIV Behavioral Surveillance (NHBS) project. Eligible participants were at least 18 years old, identified as a man or non-binary person assigned male at birth and as a person of color, and endorsed ever having sex with men. Interviews were coded using inductive and deductive approaches, and themes were extracted using thematic analysis. When participants were asked about the impact of COVID-19 on sexual networking and HIV/STI prevention, the following themes emerged: (1) differing interpretations of COVID-19 public health guidance, (2) behavior change to meet social and sexual needs, (3) limited or changed access to HIV/STI prevention services; and (4) avoidance of healthcare appointments. Overall, the pandemic affected sexual networking and HIV/STI prevention behaviors among MSM of color. Though changes in sexual networking varied, most participants decreased in-person networking, increased dating app use, and prioritized longer-term relationships. Despite loosening of restrictions, these impacts may persist and should inform the adaptation of sexual networking guidance and interventions to mitigate HIV-related disparities in communities of color.

Influences on decision-making about disclosure of HIV status by adolescents and young adults living with HIV in KwaZulu-Natal, South Africa.

Background: Adolescents and young adults living with HIV (AYA) are faced with the challenge of living with a life-long chronic condition. We investigated the influences on the decisions by AYA to disclose their HIV status to family, intimate partners and friends.Methods: Twenty AYA aged between 15 and 24 years were purposely selected through local community-based organisations in eThekwini municipality and uMkhanyakude district in KwaZulu-Natal Province, South Africa. Virtual in-depth interviews were conducted between September 2020 to October 2021 using a topic guide focusing on HIV-status disclosure and the impact of stigma on decision-making capacity. An iterative thematic process was used for analysis.Results: Findings revealed the challenges that AYA experience for disclosure because of stigma and how this impacts their decision-making capacity. Family and friends influenced AYA in processing their discovery of their HIV status offering support needed to manage living with HIV. However, for some AYA disclosing to relatives, friends and intimate partners was difficult because of fears of rejection and recrimination. The act of disclosure was influenced by both internalised and external stigma and the type of relationships and interactions that AYA had with relatives, friends and caregivers.Conclusions: The decision to disclose is challenging for AYA because of the fear of rejection, along with internal and external stigma. The provision of support, whether from family or peers, is important. Enhancing the decision-making capacity of AYA is essential for developing their self-esteem as well as supporting future healthcare choices.

Adherence to daily, oral TDF/FTC PrEP during periconception among HIV-exposed South African women.

Background: Daily, oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as pre-exposure prophylaxis (PrEP) reduces HIV acquisition for African women. Adherence is key to efficacy and patterns of adherence can be highly variable in real-world settings. Using group-based trajectory modeling (GBTM), we sought to identify distinct patterns of periconception PrEP adherence and evaluate potential baseline predictors of such adherence trajectories. Methods: We conducted a single-arm longitudinal study for women aged 18-35 years living in Durban, South Africa with personal or partner plans for pregnancy with a partner with HIV or of unknown serostatus. Participants were offered safer conception counseling, including daily oral PrEP; women who initiated PrEP were given a bottle with an electronic pillcap that recorded when device opens. Weekly adherence to daily PrEP was modeled using GBTM with a censored normal outcome distribution as a function of weeks since PrEP initiation. The number and functional form of the adherence trajectory groups were primarily selected based on Bayesian information criteria (BIC) and confirmed by mean estimated probabilities of group membership. A multivariable version of the selected model assessed baseline predictors of membership in adherence trajectory groups. Results: Overall mean (95% CI) adherence to PrEP was 63% (60%, 67%). We identified four groups of women with distinct patterns of adherence: (1) high (i.e., ≥6 doses per week) steady adherence throughout follow-up (22% of PrEP initiators); (2) moderate (i.e., 4-5 doses per week), but steady adherence (31%); (3) initially high, but consistently declining adherence (21%); and (4) initially moderate adherence, followed by a rapid decline and subsequent rebound (26%). In multivariable-adjusted analyses, older age was associated with membership in the high, steady adherence group as compared to the group identified with an adherence trajectory of initially high, then decline, and finally a rebound. Conclusions: GBTM is useful for exploring potential heterogeneity in longitudinal patterns of medication adherence. Although a large proportion of women in this study achieved high levels of adherence by electronic pillcap initially, far fewer women maintained these levels consistently. Knowledge of different adherence trajectories could be used to develop targeted strategies for optimizing HIV prevention during periconception.

Efficacy, safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis in transgender women: a secondary analysis of the HPTN 083 trial.

BACKGROUND: The HIV Prevention Trials Network (HPTN) 083 trial showed that long-acting injectable cabotegravir was more effective than tenofovir disoproxil fumarate plus emtricitabine in preventing HIV in cisgender men and transgender women who have sex with men. We aimed to characterise the cohort of transgender women included in HPTN 083. METHODS: HPTN 083 is an ongoing, phase 2b/3, randomised, multicentre, double-blind, double-dummy clinical trial done at 43 sites in seven countries (Argentina, Brazil, Peru, the USA, South Africa, Thailand, and Viet Nam). HIV-negative participants were randomly assigned (1:1) to receive injectable cabotegravir or tenofovir disoproxil fumarate plus emtricitabine. The study design and primary outcomes of the blinded phase of HPTN 083 have already been reported. An enrolment minimum of 10% transgender women was set for the trial. Here we characterise the cohort of transgender women enrolled from Dec 6, 2016, to May 14, 2020, when the study was unblinded. We report sociodemographic characteristics, use of gender affirming hormone therapy, and behavioural assessments of the transgender women participants. Laboratory testing and safety evaluations are also reported. The trial is registered at ClinicalTrials.gov, NCT02720094. FINDINGS: HPTN 083 enrolled 570 transgender women (304 tenofovir disoproxil fumarate plus emtricitabine; 266 injectable cabotegravir). Transgender women were primarily from Asia (225 [39%]) and Latin America (205 [36%]); 330 (58%) reported using gender affirming hormone therapy. Intimate partner violence was common (270 [47%] reported emotional abuse and 172 [30%] reported physical abuse) and 323 (57%) reported a history of childhood sexual abuse. 159 (28%) transgender women disagreed that they were at risk for HIV, and 142 (25%) screened positive for depressive symptoms. During study follow-up, incidence of syphilis was 16·25% (95% CI 13·28-19·69), rectal gonorrhoea was 11·66% (9·14-14·66), and chlamydia was 20·61% (17·20-24·49). Frequency of adverse events was similar between the treatment groups. Nine seroconversions occurred among transgender women during the blinded phase of the study (seven in the tenofovir disoproxil fumarate plus emtricitabine group and two in the injectable cabotegravir group); overall incidence was 1·19 per 100 person-years (95% CI 0·54-2·25): 1·80 per 100 person-years (0·73-3·72) in the tenofovir disoproxil fumarate plus emtricitabine group and 0·54 per 100 person-years (0·07-1·95) in the injectable cabotegravir group (hazard ratio 0·34 [95% CI 0·08-1·56]). Cabotegravir concentrations did not differ by gender affirming hormone therapy use. INTERPRETATION: HIV prevention strategies for transgender women cannot be addressed separately from social and structural vulnerabilities. Transgender women were well represented in HPTN 083 and should continue to be prioritised in HIV prevention studies. Our results suggest that injectable cabotegravir is a safe and effective pre-exposure prophylaxis option for transgender women. FUNDING: National Institute of Allergy and Infectious Diseases and ViiV Healthcare.

A qualitative exploration of how to support PrEP adherence among young men who have sex with men.

New HIV infections disproportionately affect young men who have sex with men (YMSM). PrEP is effective in preventing HIV acquisition; however, adherence is critical and is often suboptimal among YMSM. Interventions addressing the unique PrEP adherence challenges faced by YMSM are needed. We conducted qualitative interviews with 20 HIV-negative, YMSM (ages 15-24) with a PrEP indication and 11 healthcare professionals to inform adaption of a PrEP adherence intervention (Life-Steps for PrEP) for YMSM. We explored environmental, healthcare, and individual factors influencing uptake, adherence, attitudes, and perspectives (including desired modifications) on the Life-Steps intervention. Interviews were analyzed using content analysis. Of YMSM study participants (mean age 21.6) 55% were White, 15% Hispanic, and 5% Black. Most YMSM were PrEP-experienced (70%). Healthcare professionals (6 prescribers, 1 nurse, 2 health educators, 2 other/unspecified) averaged 6.9 years of experience caring for YMSM. All described stigma as a barrier to PrEP; YMSM expressed concern around being perceived as "risky" and concern about inadvertent PrEP disclosure if family/friends found their medication, or if parental insurance was used. Difficulty with planning for potential adherence challenges were identified by both groups. YMSM highlighted benefits of a nurse-led intervention (i.e., adding "legitimacy"), but stressed need for nonjudgmental, "savvy" interventionists. YMSM expressed a desire for comprehensive YMSM-specific sexual health information. These findings informed modification and expansion of Life-Steps content. Results highlight key potential barriers, many of which center around privacy. Content that addresses PrEP stigma, disclosing PrEP use, navigating insurance, and planning ahead in a nonjudgmental environment by trusted providers emerged as important components of a YMSM-focused delivery of Life-Steps for PrEP.