“Facilitating HIV status adjustment: Qualitative insights from the Tambua Mapema proof-of-concept study in Kenya”

Systematic efforts are needed to prepare persons newly diagnosed with acute or chronic HIV infection to cope. We examined how patients dealt with this news, looking at how readiness to accept an HIV diagnosis impacted treatment outcomes, prevention of transmission, and HIV status disclosure. We examined vulnerability and agency over time and considered implications for policy and practice. A qualitative sub-study was embedded in the Tambua Mapema (“Discover Early”) Plus (TMP) study (NCT03508908), conducted in coastal Kenya between 2017 and 2020, which was a stepped wedge trial to evaluate an opt-out HIV-1 nucleic acid testing intervention diagnosing acute and chronic HIV infections. Diagnosed participants were offered antiretroviral therapy (ART), viral load monitoring, HIV partner notification services, and provision of pre-exposure prophylaxis (PrEP) to their uninfected partners. Data were analyzed using thematic approaches. Participants included 24 individuals who completed interviews at four time points (2 weeks and 3, 6, and 9 months after diagnosis), including 18 patients (11 women and 7 men) and 6 partners (1 woman, 5 men, of whom 4 men started PrEP). Acceptance of HIV status was often a long, individualized, and complex process, whereby participants’ coping strategies affected day-to-day issues and health over time. Relationship status strongly impacted coping. In some instances, couples supported each other, but in others, couples separated. Four main themes impacted participants’ sense of agency: acceptance of diagnosis and commitment to ART; positive feedback after attaining viral load suppression; recognition of partner supportive role and focus on sustained healthcare support whereby religious meaning was often key to successful transition. To support patients with acute or newly diagnosed chronic HIV, healthcare and social systems must be more responsive to the needs of the individual, while also improving quality of care, strengthening continuity of care across facilities, and promoting community support.

Comparative evaluation of the applicability of fixed-dose combined drugs in HIV therapy / Avaliação comparativa da aplicabilidade de drogas combinadas em dose fixa na terapia do HIV

The principal global pandemic is Acquired Immunodeficiency Syndrome (AIDS), the early diagnosis and the premature treatment is the main current strategies in combating the development and spread of the disease. Antiretroviral therapy is effective and safe, what is sought nowadays is compliance and convenience for the patient. Different countries adopt different combinations of antiretroviral drugs when using the fixed-dose combination (FDC). The study design was a meta-analysis with clinical trials, patients experienced and naïve of treatment. The Pubmed, Scopus, Embase, Web of Science and Cochrane databases were searched for studies reporting AIDS treatment. The primary outcome was viral load and another outcome is adverse events. The results of the main analysis included 5224 patients. Since there was significant heterogeneity between studies, random effects were selected, and they showed an event rate of 0.67 (95%CI from 0.57 to 0.77). The exploratory analysis showed the general drug effects are not consistently significant along time, and treatments of longer times are more efficient. Specifically, the random analyses of 6 months and 1 year did not show significant drug effects on viral load, while a significant effect of 71% (95% CI from 0.61 to 0.80) in a very heterogeneous analyses (I296%). First, d4T-3TC-NVP showed a mean rate of only 21% efficacy and the second, EFV-TDF-FTC did not reach statistical significance (p=0.07). This meta-analysis shows that fixed-dose combination therapy is tolerability, safety and effective, occurred viral load suppression between patients on FDC.

Evaluating the outcomes of enhanced adherence counselling intervention on clients with high viral loads in selected health facilities in Monze.

To investigate the changes in Viral Load(VL) during Enhanced Adherence Counselling (EAC) sessions and its determinants among ART clients with unsuppressed VLs in Monze district. Method: A Cross-sectional study involving 616 HVL ART clients from 15 health facilities in Monze district which was conducted between October 1 2019 and March 30 2021. Results Out of 616 clients analysed, there was an improvement in viral load suppression following completion of EAC with a final outcome of 61% suppression. 28.7% remained unsuppressed. A total of 9.1% had no final viral load results documented and 0.2 % had been transferred out of their respective facilities and were not included in the study. Collection of repeat Viral loads was done on 84% of the clients with high viral load results while 16% had no record of sample collection. A total of 56 results were not received giving a result return of 89% from repeat samples collected. Females had a 40% likelihood of being unsuppressed at 95% CI (41% to 86%) compared to the males. Conclusion EAC improves the outcomes of HVLs and should be encouraged on all high viral clients. Programs should be developed to improve suppression in females on ART

COVID-19 infections post-vaccination by HIV status in the United States

ABSTRACTImportanceRecommendations for additional doses of COVID vaccine are restricted to people with HIV who have advanced disease or unsuppressed HIV viral load. Understanding SARS-CoV-2 infection risk post-vaccination among PWH is essential for informing vaccination guidelines.ObjectiveEstimate the risk of breakthrough infections among fully vaccinated people with (PWH) and without (PWoH) HIV in the US.Design, setting, and participantsThe Corona-Infectious-Virus Epidemiology Team (CIVET)-II cohort collaboration consists of 4 longitudinal cohorts from integrated health systems and academic health centers. Each cohort identified individuals ≥18 years old, in-care, and fully vaccinated for COVID-19 through 30 June 2021. PWH were matched to PWoH on date fully vaccinated, age group, race/ethnicity, and sex at birth. Incidence rates per 1,000 person-years and cumulative incidence of breakthrough infections with 95% confidence intervals ([,]) were estimated by HIV status. Cox proportional hazards models estimated adjusted hazard ratios (aHR) of breakthrough infections by HIV status adjusting for demographic factors, prior COVID-19 illness, vaccine type (BNT162b2, [Pfizer], mRNA-1273 [Moderna], Jansen Ad26.COV2.S [J&J]), calendar time, and cohort. Risk factors for breakthroughs among PWH, were also investigated.ExposureHIV infectionOutcomeCOVID-19 breakthrough infections, defined as laboratory evidence of SARS-CoV-2 infection or COVID-19 diagnosis after an individual was fully vaccinated.ResultsAmong 109,599 individuals (31,840 PWH and 77,759 PWoH), the rate of breakthrough infections was higher in PWH versus PWoH: 44 [41, 48] vs. 31 [29, 33] per 1,000 person-years. Cumulative incidence at 210 days after date fully vaccinated was low, albeit higher in PWH versus PWoH overall (2.8% versus 2.1%, log-rank p<0.001, risk difference=0.7% [0.4%, 1.0%]) and within each vaccine type. Breakthrough infection risk was 41% higher in PWH versus PWoH (aHR=1.41 [1.28, 1.56]). Among PWH, younger age (18-24 versus 45-54), history of COVID-19 prior to fully vaccinated date, and J&J vaccination (versus Pfizer) were associated with increased risk of breakthroughs. There was no association of breakthrough with HIV viral load suppression or CD4 count among PWH.Conclusions and RelevanceCOVID-19 vaccination is effective against infection with SARS-CoV-2 strains circulating through 30 Sept 2021. PWH have an increased risk of breakthrough infections compared to PWoH. Recommendations for additional vaccine doses should be expanded to all PWH.

HIV incidence, viremia, and the national response in Eswatini: Two sequential population-based surveys

With the highest HIV incidence and prevalence globally, the government of Eswatini started a substantial scale-up of HIV treatment and prevention services in 2011. Two sequential large population-based surveys were conducted before and after service expansion to assess the impact of the national response. Cross-sectional, household-based, nationally representative samples of adults, ages 18 to 49 years, were sampled in 2011 and 2016. We measured HIV prevalence, incidence (recent infection based on limiting antigen ≤1.5 optical density units and HIV RNA ≥1000 copies/mL), viral load suppression (HIV RNA <1000 copies/mL among all seropositive adults) and unsuppressed viremia (HIV RNA ≥1000 copies/mL among all, regardless of HIV status) and assessed for temporal changes by conducting a trend analysis of the log ratio of proportions, using a Z statistic distribution. HIV prevalence remained stable from 2011 to 2016 [32% versus 30%, p = 0.10]. HIV incidence significantly declined 48% [2.48% versus 1.30%, p = 0.01]. Incidence remained higher among women than men [2011: 3.16% versus 1.83%; 2016: 1.76% versus 0.86%], with a smaller but significant relative reduction among women [44%; p = 0.04] than men [53%; p = 0.09]. The proportion of seropositive adults with viral load suppression significantly increased from 35% to 71% [p < .001]. The proportion of the total adult population with unsuppressed viremia decreased from 21% to 9% [p < .001]. National HIV incidence in Eswatini decreased by nearly half and viral load suppression doubled over a five-year period. Unsuppressed viremia in the total population decreased 58%. These population-based findings demonstrate the national impact of expanded HIV services in a hyperendemic country.

Provider perspectives on the acceptability and tolerability of dolutegravir-based anti-retroviral therapy after national roll-out in Uganda: a qualitative study

Background The World Health Organization recommends dolutegravir (DTG) as the for first-line and second-line antiretroviral therapy (ART) worldwide. However, little is known about the acceptability and tolerability of DTG-based ART at routine points-of-care in Uganda. We set out to explore the perceptions of clinicians in ART clinics regarding the acceptability and tolerability of DTG-based ART since national roll-out in March 2018 in Uganda. Methods We adopted a qualitative exploratory design involving 49 participants. Between September 2020 and February 2021, we conducted 22 in-depth interviews with clinicians in the ART clinics of 12 purposively selected health facilities across Uganda. The selection of study sites ensured diversity in facility ownership-type (public/private), level of service delivery (tertiary/secondary/primary) and the four major geographic sub-regions of Uganda. We conducted three focus group discussions with 27 clinicians in the participating facilities. Data were analyzed by thematic approach. Results Clinicians in ART clinics acknowledged that DTG-based ART is well tolerated by the majority of their patients who appreciate the reduced pill burden, perceived less side effects and superior viral load suppression. However, they reported that a number of their patients experience adverse drug reactions (ADRs) after being transitioned to DTG. Hyperglycemia is, by far, the most commonly reported suspected ADR associated with DTG-based regimens and was cited in all but two participating facilities. Insomnia, weight gain and reduced libido are among the other frequently cited suspected ADRs. In addition, clinicians in ART clinics perceived some of the suspected ADRs as resulting from drug interactions between dolutegravir and isoniazid. Weak diagnostic capacities and shortage of associated commodities (e.g. glucometers and test kits) were reported as impediments to understanding the full extent of ADRs associated DTG-based ART. Conclusion While DTG-based regimens were perceived by clinicians in ART clinics to be well tolerated by the majority of their patients, they also reported that a number of patients experience suspected ADRs key among which were hyperglycemia, insomnia and reduced libido. Based on the perspectives of clinicians, we recommend that future studies examine the prevalence of dolutegravir-induced hyperglycemia in patients in Uganda.

“Deadly”, “fierce”, “shameful”: notions of antiretroviral therapy, stigma and masculinities intersecting men’s life-course in Blantyre, Malawi

Background Stigma and masculinity represent persistent barriers in delivering successful HIV interventions to men. Our study examined community perceptions of HIV and anti-retroviral therapy (ART) and their implications for men on ART across the life course in Blantyre, Malawi. Methods Our qualitative study is based on 72 face-to-face semi-structured interviews. Participants were selected purposively and included men on ART (with suppressed and unsuppressed viral loads), adult male community members irrespective of HIV status and other HIV stakeholders such as health personnel and program implementers. Interviews were conducted in Chichewa and English, transcribed verbatim and analyzed thematically in NVivo 12. We applied the socio-ecological model as our theoretical framework as well as a “life-course” perspective. Results Our findings highlight lingering negative perceptions towards ART in general and towards PLHIV irrespective of viral load suppression. With intersecting notions of masculinity and stigma, men’s descriptions of anticipated stigma in their relationships and when visiting health facilities dominated. Stigma was experienced at the personal, interpersonal, facility and community level. Yet, men living with HIV were perceived differently throughout the life-course, with young sexually active men seen as the most stigmatized group and older men seen as drawing resilience from a greater range of masculine norms. Some men of all ages displayed “transformative” masculinities independent of stigma and community expectations. Conclusions We propose the “life-course” as a useful concept for studies on masculinity, HIV and stigma. Considering gendered constructions of “respectable” midlife-older age vis-à-vis younger age, and how they influence stigma as well as uptake and adherence to ART might lead to more targeted services for men that build on “transformative masculinities”.

Effect and implementation experience of intensive adherence counseling in a public HIV care center in Uganda: a mixed-methods study

Background Intensive adherence counseling (IAC) is an intervention recommended by the World Health Organization to improve anti-retroviral therapy (ART) adherence among people living with HIV on ART with unsuppressed viral load; and in 2016, the intervention was implemented in Uganda. This study evaluated the effect and experiences of providing IAC in an urban HIV care center in Kampala, Uganda. Methods This was a sequential explanatory mixed-method study that compared viral load suppression during IAC implementation (intervention) to the period before IAC at Kisenyi Health centre IV. Data were abstracted from patient files and viral load register. The effect of IAC on viral load suppression and associated factors were analyzed using modified Poisson regression with robust standard errors. Using in-depth interviews and an inductive analysis approach in Atlas-ti 8. We also explored experiences of providing IAC among healthcare workers. Results A total of 500 records were sampled: 249 (49.8%) in the intervention period and 251 (51.2%) in the pre-intervention period. The mean age was lower during the intervention period 33.1 (± 12.0) than 36.5 (± 13.4) in the pre- intervention period, p = 0.002. More clients were currently on Protease-based regimen in the pre-intervention period 179 (71.3%) than 135 (54.2%) in the intervention period, p ≤ 0.001. In the intervention period, all eligible clients received IAC [249/249 (100.0%)]. Overall, 325 (65.0%) received IAC and of these, 143 (44.1%) achieved viral load suppression compared to 46 (26.3%) who received regular counseling. Receiving IAC significantly increased viral load suppression by 22% (aPR 1.22, 95% CI 1.01–1.47). Clients on Protease-based regimen were less likely to suppress than those on Efavirenz or Nevirapine-based regimens (aPR 0.11, 95% CI 0.08–0.15). All the interviewed healthcare workers lauded IAC for improving ART adherence. However, patient and health care system related factors hindered adherence during IAC. Conclusions The full potential of IAC in achieving viral load suppression in this setting has not been reached due to a combination of the patient and health care system related factors. Provision of adequate IAC necessities and use of patient centered approach should be emphasized to obtain the maximum benefit of the intervention.

896. Examining the Impact of the COVID-19 Pandemic on Delivery of HIV Care and Prevention Services Among Patients in a Ryan White Clinic

Background We sought to characterize the impact of the COVID-19 pandemic on HIV-related outcomes in a cohort of patients by examining rates of viral load (VL) suppression, retention-in-care, PrEP access, and STIs. Methods This was a single center, retrospective study of adults receiving HIV treatment or HIV/STI prevention services from 01/2019 - 12/2020. HIV outpatient visits were identified through HRSA’s CareWARE. Visits (in-person, telehealth) only included HIV primary care. HRSA core performance measures were utilized (Table 1). STI positivity rates and descriptive characteristics were calculated. New and refill PrEP prescriptions were tabulated. Chi-square tests compared unmatched non-parametric variables; McNemar’s test matched non-parametric variables. Multivariable logistic regression identified variables associated with retention in care and viral suppression. Results 1721 patients received care; 1234 were seen in both years, 334 only in 2019, 153 only in 2020. The number of telehealth visits increased significantly: video (0% to 31%, &lt; 0.001), phone (0% to 0.4%, p &lt; 0.001). Though the proportion of kept appointments increased (57.2% vs 61.2%), the annual retention in care rate decreased from 74.5% to 70.9% (p = 0.002). Overall, 9.7% of patients had detectable VLs at any point. Compared to 2019, a lower proportion of patients maintained VL suppression in 2020, (91.6% vs 83.5% p = 0.075). More patients did not have a VL drawn in 2020 than in 2019 (10.3% vs 2.0 %, p &lt; 0.001). Patients with detectable VLs in 2019 were more likely than those who were undetectable to have detectable VLs in 2020 (OR 18.2, 95% CI 9.91-33.42). Black race was associated with higher likelihood of lack of VL suppression (OR = 2.0; 95% CI 1.10-3.66). There were no significant differences between gender or age groups in rates of viral suppression, number screened for bacterial STIs or positive results. Visits for new and refill PrEP prescriptions decreased by 59% and 7%, respectively. Conclusion Rates of viral load suppression and retention in care decreased in 2020 compared to 2019. The proportion of clinic visits attended increased after the integration of telemedicine in 2020. These data may be used to inform evidence-based interventions to improve the HIV continuum of care through telehealth. Disclosures Ghady Haidar, MD, Karuys (Grant/Research Support)

878. Telemedicine Implementation in a Midwestern HIV Clinic: One Year Outcomes

Background During the COVID-19 pandemic, we realized the importance of limiting in-clinic interactions with patients who were stable on antiretroviral therapy to promote social distancing. Our HIV clinic adopted telemedicine practices, in line with the HHS Interim Guidance for COVID-19 and Persons With HIV. Several HIV clinics reported lower viral suppression rates during the pandemic. We aim to describe the implementation process as well as year one outcomes of telemedicine at our clinic. Methods In March 2020, we created telemedicine protocols; we also designed and continuously updated algorithms for determining patient eligibility for telemedicine based on recent viral loads and last clinic visit. We monitored outcomes through electronic medical record chart reviews between May 1, 2020, and April 30, 2021. We collected patient demographics, and federal poverty level (FPL) information. We collected baseline and post-intervention rates of viral load suppression (VLS, defined as HIV RNA &lt; 200 copies per mL), medical visit frequency (MVF, defined as percentage of patients who had one visit in each 6 months of the preceding 24 months with at least 60 days between visits) and lost to care (LOC, no follow up within 12 months period). Results We conducted a total of 2298 ambulatory medical visits; 1642 were in person and 656 (29%) were telemedicine visits. Out of those, 2177 were follow up visits (649, 30% telemedicine). There was no difference of telemedicine utilization based on race (28% in African Americans vs. 32% in Whites); ethnicity (30% in Hispanic vs. 30% in Hon-Hispanic); gender (24% in females vs. 30% in males); or FPL (28% in FPL &lt; 200% vs. 31% in FPL &gt;200%). By the end of April 2021, overall clinic VLS rate was 94%, MVF was 48%, and there were 40 patients LOC compared to 92%, 49%, and 43 patients in April 2020, respectively. Conclusion Telemedicine was a safe alternative to routine in-person HIV care during the COVID-19 pandemic. We observed similar rates of utilization across demographic and FPL status. Applying selection criteria, viral suppression and retention in care rates were not adversely impacted by shift to telemedicine modality. Disclosures All Authors: No reported disclosures