A sub-group evaluation of the multi-month dispensing strategy for differentiated HIV care: is personalization of care guidelines warranted in Haiti?

Background Differentiated care strategies are rapidly becoming the norm for HIV care delivery globally. Building upon an interest in tailoring antiretroviral therapy (ART) delivery for client-centered needs, the Ministry of Health and Population in Haiti formally endorsed multiple-month dispenses (MMD) in the 2016 national ART guidelines This study explores heterogeneity in retention in care with MMD for specific Haitian populations living with HIV and evaluates if a targeted algorithm for optimal ART prescription intervals is warranted in Haiti. Methods This study included ART-naïve individuals who started ART on or after January 1st, 2017 in Haiti. To identify subgroups in which to explore heterogeneity of retention, we implemented a double-lasso regression method to determine which individual characteristics would define the subgroups. Characteristics evaluated for potential subgroup definition included: sex, age category, WHO clinical stage, and body mass index category. We employed instrumental variable models to estimate the causal effect of increasing ART dispensing length on ART retention, by client subgroup. The outcome of interest was retention in care after one year in treatment. We then estimated the marginal effect of a 30-day increase to ART dispensing length to retention in care for each of these subgroups. Results There was evidence for heterogeneity in the effect of extending ART dispensing intervals on retention by WHO clinical stage. We observed significant improvements to retention in care at one year with a 30-day increase in ART dispense length for all subgroups defined by WHO clinical stages 1-4. The effects ranged from a 14.7% increase (95% CI: 12.4-17.0) to the likelihood of retention for people with HIV in WHO stage 1 to a 21.6% increase (95% CI: 18.7-24.5) to the likelihood of retention for those in WHO stage 3. Conclusions All the subgroups defined by WHO clinical stage experienced a benefit of extending ART intervals to retention in care at one year. Though the effect did differ slightly by WHO stage, the effects went in the same direction and were of similar magnitude. Therefore, a standardized recommendation for MMD among those living with HIV and new on ART is appropriate for Haiti treatment guidelines.

The Interconnected Dynamics of Partnership and HIV: A Qualitative Exploration of Experiences from Heterosexual Individuals Newly Diagnosed with HIV

Background Recent studies have focused on the role of intimate partnership on HIV care outcomes among men who have sex with men in the United States (US) and heterosexual couples in some African studies, leaving a gap in the recent US-based literature on the role of having an intimate partner on HIV care outcomes among heterosexual couples. Therefore, the objective of this study was to explore the lived experiences of heterosexual individuals newly diagnosed with HIV regarding the role of partnership on HIV care. MethodsThis phenomenological study conducted one time, virtual, in-depth interviews with six heterosexual individuals newly diagnosed with HIV ≥2017. The data analysis followed Moustakas approach to identify themes and sub-themes. ResultsThe participants were predominantly female and African American with median age of 46 years. Four themes identifying association between partnership and HIV care included role of HIV on partnership, under which impact of HIV on partnership and presumed reaction if partner was diagnosed with HIV were identified; Impact of partnership on HIV identified perception on dealing with HIV diagnosis without a partner and role of family vs. partner in HIV care as sub-themes; forms of support from partner in HIV care identified partner support around the time of HIV diagnosis and linkage to HIV care and around retention in care; and perceptions on the types of partner-based clinic services, which identified areas such as couples therapy, assistance with partner communication on sensitive topics such as HIV disclosure, and HIV education of the partner. The findings showed that partnership played a vital role in HIV care among partnered individuals; and the importance of a partner in HIV care was acknowledged by unpartnered participants. Various support practices by partners around HIV diagnosis and retention in care were identified. Quality of partnership played a bigger role in HIV care than presence of partnership. ConclusionThe importance of partner-based interventions in improving the HIV care of the person with HIV (PWH) was acknowledged. While demonstrating views of mainly African American women living with HIV in the Southern US, findings may be transferrable to other heterosexual PWH in other locales.

Longitudinal analysis of HIV outcomes for persons living with HIV in non-urban areas in southern Alberta, Canada

BACKGROUND: Many challenges remain in successfully engaging people with HIV (PWH) into lifelong HIV care. Living in non-urban or rural areas has been associated with worse outcomes. Uncertainties remain regarding how to provide optimal HIV care in non-urban areas. METHODS: Using a retrospective descriptive analysis framework, we compared multiple measurable HIV care metrics over time on the basis of urban versus non-urban residency, under a centralized HIV care model. We examined rates of HIV diagnosis, access to and retention in HIV care, and longitudinal outcomes for all newly diagnosed PWH between January 1, 2008, and January 1, 2020, categorized by their home location at the time of HIV diagnosis in southern Alberta. RESULTS: Of 719 newly diagnosed PWH, 619 (86%) lived in urban areas and 100 (14%) lived in non-urban areas. At HIV diagnosis, the groups had no significant differences in initial CD4 count or clinical characteristics ( p = 0.73). Non-urban PWH, however, had slightly longer times to accessing HIV care and initiating antiretroviral therapy (ART) ( p < 0.01). Non-urban PWH showed trends toward slightly lower retention in care and lower sustained ART use, with higher rates of unsuppressed viral loads at 12, 24, and 36 months after diagnosis ( p < 0.01). However, by 2020 both cohorts had suppression rates above 90%. CONCLUSIONS: Sustained retention in care was more challenging for non-urban PWH; however, adherence to ART and viral suppression rates was more than 90%. Although encouraging, challenges remain in identifying and reducing unique barriers for optimal care of PWH living in non-urban areas.

Interactive Transition Support for Adolescents Living with HIV using Social Media (InTSHA): Research Protocol (Preprint)

BACKGROUND Adolescents living with perinatally-acquired HIV often have poor retention in care and viral suppression during the transition from pediatric to adult based care. OBJECTIVE To evaluate a mobile phone-based intervention, InTSHA: Interactive Transition Support for Adolescents Living with HIV using Social Media, among adolescents living with perinatally-acquired HIV as they transition from pediatric to adult care in South Africa. METHODS InTSHA uses encrypted, closed group chats delivered via WhatsApp to develop peer support and improve communication between adolescents, their caregivers, and healthcare providers. The intervention is based on formative work with adolescents, caregivers, and healthcare providers and builds on several existing adolescent support programs as well as the Socioecological Model for Adolescent and Young Adult Readiness to Transition (SMART). The final InTSHA intervention involves ten modules conducted weekly through moderated WhatsApp group chats with adolescents and separately with their caregivers. We will randomize 80 South African adolescents living with perinatally-acquired HIV who are aware of their HIV status and aged between 15 to 19 years to receive either the intervention (n=40) or standard of care (n=40). RESULTS We will measure acceptability of the intervention as primary outcome and evaluate feasibility and preliminary effectiveness for retention in care and viral suppression after completion of the intervention and at least six months after randomization. In addition, we will measure secondary outcomes evaluating the impact of the InTSHA intervention on peer support, self-esteem, depression, stigma, sexual education, connection to healthcare providers and transition readiness. CONCLUSIONS If successful, the intervention will be evaluated in a fully powered randomized controlled trial with a larger number of adolescents from urban and rural populations to further evaluate the generalizability of InTSHA. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT03624413

Retention in Care, Mortality, Loss-to-Follow-Up, and Viral Suppression among Antiretroviral Treatment-Naïve and Experienced Persons Participating in a Nationally Representative HIV Pre-Treatment Drug Resistance Survey in Mexico

We describe associations of pretreatment drug resistance (PDR) with clinical outcomes such as remaining in care, loss to follow-up (LTFU), viral suppression, and death in Mexico, in real-life clinical settings. We analyzed clinical outcomes after a two-year follow up period in participants of a large 2017–2018 nationally representative PDR survey cross-referenced with information of the national ministry of health HIV database. Participants were stratified according to prior ART exposure and presence of efavirenz/nevirapine PDR. Using a Fine-Gray model, we evaluated virological suppression among resistant patients, in a context of competing risk with lost to follow-up and death. A total of 1823 participants were followed-up by a median of 1.88 years (Interquartile Range (IQR): 1.59–2.02): 20 (1%) were classified as experienced + resistant; 165 (9%) naïve + resistant; 211 (11%) experienced + non-resistant; and 1427 (78%) as naïve + non-resistant. Being ART-experienced was associated with a lower probability of remaining in care (adjusted Hazard Ratio(aHR) = 0.68, 0.53–0.86, for the non-resistant group and aHR = 0.37, 0.17–0.84, for the resistant group, compared to the naïve + non-resistant group). Heterosexual cisgender women compared to men who have sex with men [MSM], had a lower viral suppression (aHR = 0.84, 0.70–1.01, p = 0.06) ART-experienced persons with NNRTI-PDR showed the worst clinical outcomes. This group was enriched with women and persons with lower education and unemployed, which suggests higher levels of social vulnerability.

Integrating health services for HIV infection, diabetes and hypertension in sub-Saharan Africa: a cohort study

BackgroundHIV, diabetes and hypertension have a high disease burden in sub-Saharan Africa. Healthcare is organised in separate clinics, which may be inefficient. In a cohort study, we evaluated integrated management of these conditions from a single chronic care clinic.ObjectivesTo determined the feasibility and acceptability of integrated management of chronic conditions in terms of retention in care and clinical indicators.Design and settingProspective cohort study comprising patients attending 10 health facilities offering primary care in Dar es Salaam and Kampala.InterventionClinics within health facilities were set up to provide integrated care. Patients with either HIV, diabetes or hypertension had the same waiting areas, the same pharmacy, were seen by the same clinical staff, had similar provision of adherence counselling and tracking if they failed to attend appointments.Primary outcome measuresRetention in care, plasma viral load.FindingsBetween 5 August 2018 and 21 May 2019, 2640 patients were screened of whom 2273 (86%) were enrolled into integrated care (832 with HIV infection, 313 with diabetes, 546 with hypertension and 582 with multiple conditions). They were followed up to 30 January 2020. Overall, 1615 (71.1%)/2273 were female and 1689 (74.5%)/2266 had been in care for 6 months or more. The proportions of people retained in care were 686/832 (82.5%, 95% CI: 79.9% to 85.1%) among those with HIV infection, 266/313 (85.0%, 95% CI: 81.1% to 89.0%) among those with diabetes, 430/546 (78.8%, 95% CI: 75.4% to 82.3%) among those with hypertension and 529/582 (90.9%, 95% CI: 88.6 to 93.3) among those with multimorbidity. Among those with HIV infection, the proportion with plasma viral load <100 copies/mL was 423(88.5%)/478.ConclusionIntegrated management of chronic diseases is a feasible strategy for the control of HIV, diabetes and hypertension in Africa and needs evaluation in a comparative study.

880. Interim Analysis of Real-World Community-Based HIV Rapid Start Antiretroviral with BFTAF Versus Conventional HIV Antiretroviral Therapy Start – The RoCHaCHa Study, A Pilot Study

Background Trillium Health (TH) is a Federally Qualified Health Center look-alike and Ryan White C grantee in Rochester, NY providing primary and specialty care, including HIV prevention and treatment. Rapid Start Antiretroviral therapy (RSA) has been shown to decrease time to viral suppression while increasing linkage to and retention in care. However, data on a fixed-dose combination of BFTAF with these benefits are limited. We aim to show RSA with BFTAF time to viral suppression, adherence to medication, and retention in care is statistically significant in comparison to older treatment models. Additionally, we aim to demonstrate the feasibility and acceptability of RSA with BFTAF. Methods This is an interim analysis of participants who enrolled in the study and been in care at TH for at least 3 months as of May 2021. All participants complete a baseline assessment and start BFTAF. Follow up visits are conducted through 48 weeks. Primary and secondary endpoints are included in the attached table 2 Barriers to care and patient reported outcomes were evaluated through a standardized questionnaire at the final study visit. Study results were compared with non-RSA historical control data from patients who received standard of care universal ART initiation at TH. Results Thirty-four participants have been enrolled in the study for at least 12 weeks, 33 (97%) of whom have reached and maintained viral suppression. Twenty-one participants have completed all 48 weeks, with 20 (95%) reaching and maintaining viral suppression. In comparison to historical controls, the RSA study participants had a statistically significant shorter time to viral suppression, both from diagnosis and from ART initiation. The RSA patients had statistically significant higher retention at 12, 24, and 48 weeks in comparison to historical controls. Adherence was higher in the RSA patients, though not statistically significant. Enrollment Graphic for the Rochacha Study Baseline Demographics of Study Participants and Controls Clinical Outcomes of Study Participants compared to Controls Conclusion Our data show that RSA with BFTAF can be effective in a community based health center setting in participants facing barriers to care. The patients who were treated by RSA with BFTAF had a high viral suppression rate. To date, no BFTAF regimen had to be changed due to resistance or virologic failure in this study. These data support implementation of RSA with BFTAF as standard of care. Disclosures Ashley R. Zuppelli, PHARMD, BCACP, AAHIVP, Gilead Sciences (Research Grant or Support) Robert Biernbaum, DO, MS, FAAEM, AAHIVS, Gilead Sciences (Research Grant or Support) Roberto Corales, DO, AAHIVS, Gilead Sciences (Employee, Scientific Research Study Investigator) Shealynn Hilliard, MS, Gilead Sciences (Research Grant or Support) William M. Valenti, MD, FIDSA, Gilead Sciences (Research Grant or Support)