Differential impact of missed initial wound clinic visit on 6-month wound healing by race/ethnicity among patients with chronic limb-threatening ischemia.

Chronic limb-threatening ischemia (CLTI) is associated with significant morbidity, including major limb amputation, and mortality. Healing ischemic wounds is necessary to optimise vascular outcomes and can be facilitated by dedicated appointments at a wound clinic. This study aimed to estimate the association between successful wound care initiation and 6-month wound healing, with specific attention to differences by race/ethnicity. This retrospective study included 398 patients with CLTI and at least one ischaemic wound who scheduled an appointment at our wound clinic between January 2015 and July 2020. The exposure was the completion status of patients' first scheduled wound care appointment (complete/not complete) and the primary outcome was 6-month wound healing (healed/not healed). The analysis focused on how this association was modified by race/ethnicity. We used Aalen-Johansen estimators to produce cumulative incidence curves and calculated risk ratios within strata of race/ethnicity. The final adjustment set included age, revascularization, and initial wound size. Patients had a mean age of 67 ± 14 years, were 41% female, 46% non-White and had 517 total wounds. In the overall cohort, 70% of patients completed their first visit and 34% of wounds healed within 6-months. There was no significant difference in 6-month healing based on first visit completion status for White/non-Hispanic individuals (RR [95% CI] = 1.18 [0.91, 1.45]; p-value = 0.130), while non-White individuals were roughly 3 times more likely to heal their wounds if they completed their first appointment (RR [95% CI] = 2.89 [2.66, 3.11]; p-value < 0.001). In conclusion, non-White patients were approximately three times more likely to heal their wound in 6 months if they completed their first scheduled wound care appointment while White/non-Hispanic individuals' risk of healing was similar regardless of first visit completion status. Future efforts should focus on providing additional resources to ensure minority groups with wounds have the support they need to access and successfully initiate wound care.

Using Principles of an Adaptation Framework to Adapt a Transdiagnostic Psychotherapy for People With HIV to Improve Mental Health and HIV Treatment Engagement: Focus Groups and Formative Research Study.

BACKGROUND: HIV treatment engagement is critical for people with HIV; however, behavioral health comorbidities and HIV-related stigma are key barriers to engagement. Treatments that address these barriers and can be readily implemented in HIV care settings are needed. OBJECTIVE: We presented the process for adapting transdiagnostic cognitive behavioral psychotherapy, the Common Elements Treatment Approach (CETA), for people with HIV receiving HIV treatment at a Southern US HIV clinic. Behavioral health targets included posttraumatic stress, depression, anxiety, substance use, and safety concerns (eg, suicidality). The adaptation also included ways to address HIV-related stigma and a component based on Life-Steps, a brief cognitive behavioral intervention to support patient HIV treatment engagement. METHODS: We applied principles of the Assessment, Decision, Administration, Production, Topical Experts, Integration, Training, Testing model, a framework for adapting evidence-based HIV interventions, and described our adaptation process, which included adapting the CETA manual based on expert input; conducting 3 focus groups, one with clinic social workers (n=3) and 2 with male (n=3) and female (n=4) patients to obtain stakeholder input for the adapted therapy; revising the manual according to this input; and training 2 counselors on the adapted protocol, including a workshop held over the internet followed by implementing the therapy with 3 clinic patients and receiving case-based consultation for them. For the focus groups, all clinic social workers were invited to participate, and patients were referred by clinic social workers if they were adults receiving services at the clinic and willing to provide written informed consent. Social worker focus group questions elicited reactions to the adapted therapy manual and content. Patient focus group questions elicited experiences with behavioral health conditions and HIV-related stigma and their impacts on HIV treatment engagement. Transcripts were reviewed by 3 team members to catalog participant commentary according to themes relevant to adapting CETA for people with HIV. Coauthors independently identified themes and met to discuss and reach a consensus on them. RESULTS: We successfully used principles of the Assessment, Decision, Administration, Production, Topical Experts, Integration, Training, Testing framework to adapt CETA for people with HIV. The focus group with social workers indicated that the adapted therapy made conceptual sense and addressed common behavioral health concerns and practical and cognitive behavioral barriers to HIV treatment engagement. Key considerations for CETA for people with HIV obtained from social worker and patient focus groups were related to stigma, socioeconomic stress, and instability experienced by the clinic population and some patients' substance use, which can thwart the stability needed to engage in care. CONCLUSIONS: The resulting brief, manualized therapy is designed to help patients build skills that promote HIV treatment engagement and reduce symptoms of common behavioral health conditions that are known to thwart HIV treatment engagement.

An Intervention to Improve Mental Health and HIV Care Engagement Among Perinatal Women in Malawi: A Pilot Randomized Controlled Trial.

Perinatal depression (PND) is common and an important barrier to engagement in HIV care for women living with HIV (WLHIV). Accordingly, we adapted and enhanced The Friendship Bench, an evidence-based counseling intervention, for perinatal WLHIV. In a pilot randomized trial (NCT04143009), we evaluated the feasibility, acceptability, fidelity, and preliminary efficacy of the Enhanced Friendship Bench (EFB) intervention to improve PND and engagement in HIV care outcomes. Eighty pregnant WLHIV who screened positive for PND symptoms on the Self-Report Questionnaire (≥ 8) were enrolled, randomized 1:1 to EFB or usual care, and followed through 6 months postpartum. Overall, 100% of intervention participants were satisfied with the intervention and 93% found it beneficial to their overall health. Of 82 counseling sessions assessed for fidelity, 83% met or exceeded the fidelity threshold. At 6 months postpartum, intervention participants had improved depression remission (59% versus 36%, RD 23%, 95% CI 2%, 45%), retention in HIV care (82% versus 69%, RD 13%, -6%, 32%), and viral suppression (96% versus 90%, RD 7%, -7%, 20%) compared to usual care. Adverse events did not differ by arm. These results suggest that EFB intervention should be evaluated in a fully powered randomized trial to evaluate its efficacy to improve PND and engagement in HIV care outcomes for WLHIV.

Stigma experienced by people living with HIV who are on methadone maintenance treatment and have symptoms of common mental disorders in Hanoi, Vietnam: a qualitative study.

BACKGROUND: Stigma around human immunodeficiency virus (HIV), injection drug use (IDU), and mental health disorders can be co-occurring and have different impacts on the well-being of people living with HIV (PWH) who use drugs and have mental health disorders. This stigma can come from society, health professionals, and internalized stigma. A person who has more than one health condition can experience overlapping health-related stigma and levels of stigma which can prevent them from receiving necessary support and healthcare, serving to intensify their experience with stigma. This study investigates HIV, drug use, and mental health stigmas in three dimensions (social, internalized, and professional) around PWH on methadone maintenance treatment (MMT) who have common mental disorders (CMDs) including depression, anxiety, and stress-related disorders in Hanoi, Vietnam.Please check and confirm whether corresponding author's email id is correctly identified.The cooresponding author's email is correct METHODS: We conducted semi-structured, in-depth interviews (IDIs) (n = 21) and two focus group discussions (FGDs) (n = 10) with PWH receiving MMT who have CMD symptoms, their family members, clinic health care providers, and clinic directors. We applied thematic analysis using NVIVO software version 12.0, with themes based on IDI and FGD guides and emergent themes from interview transcripts. RESULTS: The study found evidence of different stigmas towards HIV, IDU, and CMDs from the community, family, health care providers, and participants themselves. Community and family members were physically and emotionally distant from patients due to societal stigma around illicit drug use and fears of acquiring HIV. Participants often conflated stigmas around drug use and HIV, referring to these stigmas interchangeably. The internalized stigma around having HIV and injecting drugs made PWH on MMT hesitant to seek support for CMDs. These stigmas compounded to negatively impact participants' health. CONCLUSIONS: Strategies to reduce stigma affecting PWH on MMT should concurrently address stigmas around HIV, drug addiction, and mental health. Future studies could explore approaches to address internalized stigma to improve self-esteem, mental health, and capacities to cope with stigma for PWH on MMT. TRIAL REGISTRATION: NCT04790201, available at clinicaltrials.gov.

Adaptation of a Problem-solving Program (Friendship Bench) to Treat Common Mental Disorders Among People Living With HIV and AIDS and on Methadone Maintenance Treatment in Vietnam: Formative Study.

BACKGROUND: The prevalence of common mental disorders (CMDs) among people living with HIV and people who inject drugs is high worldwide and in Vietnam. However, few evidence-informed CMD programs for people living with HIV who inject drugs have been adapted for use in Vietnam. We adapted the Friendship Bench (FB), a problem-solving therapy (PST)-based program that was successfully implemented among patients with CMDs in primary health settings in Zimbabwe and Malawi for use among people living with HIV on methadone maintenance treatment (MMT) with CMDs in Hanoi, Vietnam. OBJECTIVE: This study aimed to describe the adaptation process with a detailed presentation of 4 phases from the third (adaptation) to the sixth (integration) of the Assessment-Decision-Adaptation-Production-Topical Experts-Integration-Training-Testing (ADAPT-ITT) framework. METHODS: The adaptation phase followed a qualitative study design to explore symptoms of CMDs, facilitators, and barriers to conducting FB for people living with HIV on MMT in Vietnam, and patient, provider, and caretaker concerns about FB. In the production phase, we revised the original program manual and developed illustrated PST cases. In the topical expert and integration phases, 2 investigators (BNG and BWP) and 3 subject matter experts (RV, DC, and GML) reviewed the manual, with reviewer comments incorporated in the final, revised manual to be used in the training. The draft program will be used in the training and testing phases. RESULTS: The study was methodologically aligned with the ADAPT-ITT goals as we chose a proven, effective program for adaptation. Insights from the adaptation phase addressed the who, where, when, and how of FB program implementation in the MMT clinics. The ADAPT-ITT framework guided the appropriate adaptation of the program manual while maintaining the core components of the PST of the original program throughout counseling techniques in all program sessions. The deliverable of this study was an adapted FB manual to be used for training and piloting to make a final program manual. CONCLUSIONS: This study successfully illustrated the process of operationalizing the ADAPT-ITT framework to adapt a mental health program in Vietnam. This study selected and culturally adapted an evidence-informed PST program to improve CMDs among people living with HIV on MMT in Vietnam. This adapted program has the potential to effectively address CMDs among people living with HIV on MMT in Vietnam. TRIAL REGISTRATION: ClinicalTrials.gov NCT04790201; https://clinicaltrials.gov/ct2/show/NCT04790201.

Pre-Exposure Prophylaxis Integration Into Family Planning Services at Title X Clinics in the Southeastern United States: Protocol for a Mixed Methods Hybrid Type I Effectiveness Implementation Study (Phase 2 ATN 155).

BACKGROUND: Adolescent and young adult women (AYAW), particularly racial and ethnic minorities, in the Southern United States are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is an effective, scalable, individual-controlled HIV prevention strategy that is grossly underutilized among women of all ages and requires innovative delivery approaches to optimize its benefit. Anchoring PrEP delivery to family planning (FP) services that AYAW already trust, access routinely, and deem useful for their sexual health may offer an ideal opportunity to reach women at risk for HIV and to enhance their PrEP uptake and adherence. However, PrEP has not been widely integrated into FP services, including Title X-funded FP clinics that provide safety net sources of care for AYAW. To overcome potential implementation challenges for AYAW, Title X clinics in the Southern United States are uniquely positioned to be focal sites for conceptually informed and thoroughly evaluated PrEP implementation science studies. OBJECTIVE: The objective of this study is two-fold: to evaluate multilevel factors associated with the level of PrEP adoption and implementation (eg, PrEP screening, counseling, and prescription) within and across 3 FP clinics and to evaluate PrEP uptake, persistence, and adherence among female patients in these clinics over a 6-month follow-up period. METHODS: Phase 2 of Planning4PrEP (Adolescent Medicine Trials Network for HIV/AIDS Interventions 155) is a mixed methods hybrid type 1 effectiveness implementation study to be conducted in three clinics in Metro Atlanta, Georgia, United States. Guided by the Exploration, Preparation, Implementation, and Sustainment framework, this study will prepare clinics for PrEP integration via clinic-wide trainings and technical assistance and will develop clinic-specific PrEP implementation plans. We will monitor and evaluate PrEP implementation as well as female patient PrEP uptake, persistence, and adherence over a 6-month follow-up period. RESULTS: Phase 2 of Planning4PrEP research activities began in February 2018 and are ongoing. Qualitative data analysis is scheduled to begin in Fall 2020. CONCLUSIONS: This study seeks to evaluate factors associated with the level of PrEP adoption and implementation (eg, PrEP screening, counseling, and prescription) within and across 3 FP clinics following training and implementation planning and to evaluate PrEP uptake, persistence, and adherence among female patients over a 6-month follow-up period. This will guide future strategies to support PrEP integration in Title X-funded clinics across the Southern United States. TRIAL REGISTRATION: ClinicalTrials.gov NCT04097834; https://clinicaltrials.gov/ct2/show/NCT04097834. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18784.