Effectiveness of JYNNEOS vaccine against symptomatic mpox disease in adult men in Los Angeles County, August 29, 2022 to January 1, 2023.

We describe real-world estimates of JYNNEOS vaccine effectiveness (VE) against symptomatic mpox in Los Angeles County (LAC). We conducted a retrospective cohort study of men aged ≥18 years residing in LAC who were at risk for mpox and eligible for the JYNNEOS vaccine from 5/19/2022 to 1/1/2023. Case demographics and route of JYNNEOS administration were obtained through vaccine administration data systems. HIV and sexually transmitted infection (STI) status was obtained through disease reporting systems for HIV and STI diagnoses in LAC. To estimate VE, we calculated weekly incidence of confirmed mpox for unvaccinated, partially vaccinated (episode date ≥14 days after first dose), and fully vaccinated (episode date ≥14 days after second dose) cohorts starting on 8/29/2022, when fully vaccinated coverage exceeded 3 %, and ending on 1/1/2023. Overall, 2,171 men had confirmed mpox, and 1,002 (46 %) of those were persons living with diagnosed HIV (PLWDH). 2,019 (93 %) mpox cases were unvaccinated, 114 (5 %) were partially vaccinated and 38 (2 %) were fully vaccinated. VE was 69 % (95 % CI 59-77) for partially vaccinated and 84 % (95 % CI 80-87) for fully vaccinated individuals. Among PLWDH, VE was 72 % (95 % CI 57-82) for fully vaccinated and 28 % (95 % CI -96 to 73) VE for partially vaccinated individuals. Among persons not living with diagnosed HIV, VE was 88 % (95 % CI 86-90) for fully vaccinated and 80 % (95 % CI 76-83) for partially vaccinated individuals. Of 111 individuals hospitalized with mpox, one was partially vaccinated, and the remaining were unvaccinated. Our results align with other published studies that reported that two doses of the JYNNEOS vaccine provided significant protection against symptomatic mpox.

Projected Benefits of Long-Acting Antiretroviral Therapy in Nonsuppressed People With Human Immunodeficiency Virus Experiencing Adherence Barriers.

Background: In a demonstration project, long-acting, injectable cabotegravir-rilpivirine (CAB-RPV) achieved viral suppression in a high proportion of people with HIV (PWH) who were virologically nonsuppressed with adherence barriers. We projected the long-term impact of CAB-RPV for nonsuppressed PWH experiencing adherence barriers. Methods: Using the Cost-Effectiveness of Preventing AIDS Complications (CEPAC) model, we compared 3 strategies: (1) standard of care oral integrase inhibitor-based ART (INSTI); (2) INSTI-based ART with supportive social services ("wraparound services" [WS]) (INSTI/WS); and (3) CAB-RPV with WS (CAB-RPV/WS). Model outcomes included viral suppression (%) and engagement in care (%) at 3 years, and life expectancy (life-years [LYs]). Base case cohort characteristics included mean age of 47y (standard deviation [SD], 10y), 90% male at birth, and baseline mean CD4 count 150/µL (SD, 75/µL). Viral suppression at 3 months was 13% (INSTI), 28% (INSTI/WS), and 60% (CAB-RPV/WS). Mean loss to follow-up was 28/100 person-years (PY) (SD, 2/100 PY) without WS and 16/100 PY (SD, 1/100 PY) with WS. Results: Projected viral suppression at 3 years would vary widely: 16% (INSTI), 38% (INSTI/WS), and 44% (CAB-RPV/WS). Life expectancy would be 7.4 LY (INSTI), 9.0 LY (INSTI/WS), and 9.4 LY (CAB-RPV/WS). Projected benefits over oral ART would be greater for PWH initiating CAB-RPV/WS at lower CD4 counts. Across plausible key parameter ranges, CAB-RPV/WS would improve viral suppression and life expectancy compared with oral INSTI strategies. Conclusions: These model-based results support that long-acting injectable CAB-RPV with extensive support services for nonsuppressed PWH experiencing adherence barriers is likely to increase viral suppression and improve survival. A prospective study to provide further evidence is needed.

Racial, gender, and psychosocial disparities in viral suppression trends among people receiving coordinated HIV care in Los Angeles County.

OBJECTIVE: To longitudinally evaluate differences in HIV viral suppression (<200 copies/ml) by intersections of race/ethnicity, gender, and psychosocial issues in people with HIV in the Los Angeles County Medical Care Coordination Program. DESIGN: We analyzed 74 649 viral load measurements over 10 184 people with HIV enrolled in the Medical Care Coordination Program between January 1, 2013 and March 1, 2020.Methods: We fit Bayesian logistic hierarchical random effects models to test interactions between gender, race/ethnicity, and a psychosocial acuity score on viral suppression over time from 1 year prior to program enrollment to 24 months after enrollment. RESULTS: The probability of viral suppression declined prior to enrollment, then increased and stabilized by 6 months after enrollment. Black/African American patients with low and moderate psychosocial acuity scores did not achieve the same increase in percentage of viral suppression as those in other racial/ethnic groups. Transgender women with high psychosocial acuity scores took longer (about 1 year) to achieve the same percentage of viral suppression as clients of other gender identities. CONCLUSIONS: Some racial/ethnic and gender disparities in viral suppression persisted after enrollment in the Los Angeles County Medical Care Coordination Program while accounting for psychosocial acuity score, which may be explained by factors not assessed in the program.

Are Unequal Policies in Pre-Exposure Prophylaxis Uptake Needed to Improve Equality? An Examination Among Men Who Have Sex with Men in Los Angeles County.

Racial and ethnic minority men who have sex with men (MSM) are disproportionately affected by HIV/AIDS in Los Angeles County (LAC), an important epicenter in the battle to end HIV. We examine tradeoffs between effectiveness and equality of pre-exposure prophylaxis (PrEP) allocation strategies among different racial and ethnic groups of MSM in LAC and provide a framework for quantitatively evaluating disparities in HIV outcomes. To do this, we developed a microsimulation model of HIV among MSM in LAC using county epidemic surveillance and survey data to capture demographic trends and subgroup-specific partnership patterns, disease progression, patterns of PrEP use, and patterns for viral suppression. We limit analysis to MSM, who bear most of the burden of HIV/AIDS in LAC. We simulated interventions where 3000, 6000, or 9000 PrEP prescriptions are provided annually in addition to current levels, following different allocation scenarios to each racial/ethnic group (Black, Hispanic, or White). We estimated cumulative infections averted and measures of equality, after 15 years (2021-2035), relative to base case (no intervention). By comparing allocation strategies on the health equality impact plane, we find that, of the policies evaluated, targeting PrEP preferentially to Black individuals would result in the largest reductions in incidence and disparities across the equality measures we considered. This result was consistent over a range of PrEP coverage levels, demonstrating that there are "win-win" PrEP allocation strategies that do not require a tradeoff between equality and efficiency.

Using Microsimulation Modeling to Inform EHE Implementation Strategies in Los Angeles County.

BACKGROUND: Pre-exposure prophylaxis (PrEP) is essential to ending HIV. Yet, uptake remains uneven across racial and ethnic groups. We aimed to estimate the impacts of alternative PrEP implementation strategies in Los Angeles County. SETTING: Men who have sex with men, residing in Los Angeles County. METHODS: We developed a microsimulation model of HIV transmission, with inputs from key local stakeholders. With this model, we estimated the 15-year (2021-2035) health and racial and ethnic equity impacts of 3 PrEP implementation strategies involving coverage with 9000 additional PrEP units annually, above the Status-quo coverage level. Strategies included PrEP allocation equally (strategy 1), proportionally to HIV prevalence (strategy 2), and proportionally to HIV diagnosis rates (strategy 3), across racial and ethnic groups. We measured the degree of relative equalities in the distribution of the health impacts using the Gini index (G) which ranges from 0 (perfect equality, with all individuals across all groups receiving equal health benefits) to 1 (total inequality). RESULTS: HIV prevalence was 21.3% in 2021 [Black (BMSM), 31.1%; Latino (LMSM), 18.3%, and White (WMSM), 20.7%] with relatively equal to reasonable distribution across groups (G, 0.28; 95% confidence interval [CI], 0.26 to 0.34). During 2021-2035, cumulative incident infections were highest under Status-quo (n = 24,584) and lowest under strategy 3 (n = 22,080). Status-quo infection risk declined over time among all groups but remained higher in 2035 for BMSM (incidence rate ratio, 4.76; 95% CI: 4.58 to 4.95), and LMSM (incidence rate ratio, 1.74; 95% CI: 1.69 to 1.80), with the health benefits equally to reasonably distributed across groups (G, 0.32; 95% CI: 0.28 to 0.35). Relative to Status-quo, all other strategies reduced BMSM-WMSM and BMSM-LMSM disparities, but none reduced LMSM-WMSM disparities by 2035. Compared to Status-quo, strategy 3 reduced the most both incident infections (% infections averted: overall, 10.2%; BMSM, 32.4%; LMSM, 3.8%; WMSM, 3.5%) and HIV racial inequalities (G reduction, 0.08; 95% CI: 0.02 to 0.14). CONCLUSIONS: Microsimulation models developed with early, continuous stakeholder engagement and inputs yield powerful tools to guide policy implementation.

Using evaluation to enhance a pre-exposure prophylaxis (PrEP) social marketing campaign in real time in Los Angeles County, California.

OBJECTIVE: To describe the application of a formative evaluation conducted concurrently with implementation of a public health social marketing campaign to allow for substantive changes to the campaign messaging to subsequently improve acceptability. METHOD: A serial cross-sectional survey was used to evaluate the acceptability of two campaign messages among Black and Latino men who have sex with men (MSM) and transgender persons (TGP) in Los Angeles County from 2016 to 2018 through an online survey. Theinitial message, which presented the PrEP Protectors, a trio of superheroes embodying the power, knowledge, and protection pre-exposure prophylaxis (PrEP) can provide, was revised based on respondent feedback collected in the survey to increase specificity and clarity. An adjusted regression model tested whether the revised campaign message, (the initial campaign plus revised imagery and streamlined language) was predictive of increased campaign acceptability compared to the initial message alone. RESULTS: A total of 911 eligible respondents were surveyed, most were MSM (83 %),

Trajectories of Viral Suppression in People Living With HIV Receiving Coordinated Care: Differences by Comorbidities.

BACKGROUND: In March of 2013, the Los Angeles County (LAC) Division of HIV and STD Programs implemented a clinic-based Medical Care Coordination (MCC) Program to increase viral suppression (VS) (<200 c/mL) among people living with HIV (PLWH) at high risk for poor health outcomes. OBJECTIVE: This study aimed to estimate trajectories of VS and to assess whether these trajectories differed by stimulant use, housing instability, and depressive symptom severity as reported by PLWH participating in MCC. METHODS: Data represent 6408 PLWH in LAC receiving services from the MCC Program and were obtained from LAC HIV surveillance data matched to behavioral assessments obtained across 35 Ryan White Program clinics participating in MCC. Piecewise mixed-effects logistic regression with a random intercept estimated probabilities of VS from 12 months before MCC enrollment through 36 months after enrollment, accounting for time by covariate interactions for 3 comorbid conditions: housing instability, stimulant use, and depressive symptoms. RESULTS: The overall probability of VS increased from 0.35 to 0.77 within the first 6 months in the MCC Program, and this probability was maintained up to 36 months after enrollment. Those who reported housing instability, stimulant use, or multiple comorbid conditions did not achieve the same probability of VS by 36 months as those with none of those comorbidities. CONCLUSIONS: Findings suggest that MCC improved the probability of VS for all patient groups regardless of the presence of comorbidities. However, those with comorbid conditions will still require increased support from patient-centered programs to address disparities in VS.

Life Chaos is Associated with Reduced HIV Testing, Engagement in Care, and ART Adherence Among Cisgender Men and Transgender Women upon Entry into Jail.

Life chaos, the perceived inability to plan for and anticipate the future, may be a barrier to the HIV care continuum for people living with HIV who experience incarceration. Between December 2012 and June 2015, we interviewed 356 adult cisgender men and transgender women living with HIV in Los Angeles County Jail. We assessed life chaos using the Confusion, Hubbub, and Order Scale (CHAOS) and conducted regression analyses to estimate the association between life chaos and care continuum. Forty-eight percent were diagnosed with HIV while incarcerated, 14% were engaged in care 12 months prior to incarceration, mean antiretroviral adherence was 65%, and 68% were virologically suppressed. Adjusting for sociodemographics, HIV-related stigma, and social support, higher life chaos was associated with greater likelihood of diagnosis while incarcerated, lower likelihood of engagement in care, and lower adherence. There was no statistically significant association between life chaos and virologic suppression. Identifying life chaos in criminal-justice involved populations and intervening on it may improve continuum outcomes.

Methamphetamine use drives decreases in viral suppression for people living with HIV released from a large municipal jail: Results of the LINK LA clinical trial.

BACKGROUND: People living with HIV (PLWH) often experience decreases in HIV viral suppression (VS) after release from jail. The Linking Inmates to Care in LA (LINK LA) peer navigation intervention helped maintain VS 12 months after release from jail compared to standard of care. In this study, we analyzed correlates of substance use and tested whether substance use was an independent correlate of decreased VS in LINK LA participants. METHODS: We analyzed LINK LA data collected at baseline, 3, and 12 months. We defined high-risk drug use as any reported methamphetamine, cocaine, or opioid use in the 30 days prior to a study visit (or jail entry at baseline). We used generalized linear mixed models to test associations of sociodemographic variables with type of substance used, and we tested correlates of VS while controlling for time, the intervention, and their interaction. RESULTS: At baseline (n = 356), 71% of participants reported high-risk drug use: 58%, methamphetamine; 17%, cocaine; 7%, heroin; and 4%, prescription opioids. Non-Hispanic Whites and those younger than 35 were most likely to use methamphetamine; Blacks were most likely to use cocaine; people who inject drugs were most likely to use opioids. Participants who used high-risk drugs had 53% lower adjusted odds than non-users of maintaining VS (AOR 0.47, 95% CI 0.31-0.70, p < 0.001). CONCLUSION: High-risk drug use, dominated by methamphetamine use, independently correlated with decreased VS among recently incarcerated PLWH. Improving HIV care continuum outcomes among populations leaving jail requires attention to efforts to address high-risk drug use.

Cost-effectiveness of a Medical Care Coordination Program for People With HIV in Los Angeles County.

BACKGROUND: The Los Angeles County (LAC) Division of HIV and STD Programs implemented a medical care coordination (MCC) program to address the medical and psychosocial service needs of people with HIV (PWH) at risk for poor health outcomes. METHODS: Our objective was to evaluate the impact and cost-effectiveness of the MCC program. Using the CEPAC-US model populated with clinical characteristics and costs observed from the MCC program, we projected lifetime clinical and economic outcomes for a cohort of high-risk PWH under 2 strategies: (1) No MCC and (2) a 2-year MCC program. The cohort was stratified by acuity using social and clinical characteristics. Baseline viral suppression was 33% in both strategies; 2-year suppression was 33% with No MCC and 57% with MCC. The program cost $2700/person/year. Model outcomes included quality-adjusted life expectancy, lifetime medical costs, and cost-effectiveness. The cost-effectiveness threshold for the incremental cost-effectiveness ratio (ICER) was $100 000/quality-adjusted life-year (QALY). RESULTS: With MCC, life expectancy increased from 10.07 to 10.94 QALYs, and costs increased from $311 300 to $335 100 compared with No MCC (ICER, $27 400/QALY). ICERs for high/severe, moderate, and low acuity were $30 500/QALY, $25 200/QALY, and $77 400/QALY. In sensitivity analysis, MCC remained cost-effective if 2-year viral suppression was ≥39% even if MCC costs increased 3-fold. CONCLUSIONS: The LAC MCC program improved survival and was cost-effective. Similar programs should be considered in other settings to improve outcomes for high-risk PWH.

A comparison of MSM stigma, HIV stigma and depression in HIV-positive Latino and African American men who have sex with men (MSM).

Little research has examined differences in HIV stigma versus MSM stigma and the role of these stigmas in depression for HIV-positive Latino and African American men who have sex with men (MSM), subgroups disproportionately impacted by HIV in the US. MSM stigma, HIV stigma, depression, stress and social support were examined among HIV-positive Latino (n = 100) and African American (n = 99) MSM patients at five HIV clinics in Los Angeles County, California. In multiple regression models, Latino MSM had higher HIV stigma scores (p = 0.002) but lower MSM stigma scores (p < 0.001) compared to African American MSM. General support and stress were associated with HIV stigma (p < 0.001), but not MSM stigma. Both HIV stigma (p < 0.0001) and MSM stigma (p < 0.0001) were associated with depression. These data underscore the differences in experienced stigma for Latino and African American MSM and can be used to shape effective stigma reduction programs and behavioral counseling.

A youth-focused case management intervention to engage and retain young gay men of color in HIV care.

HIV-positive Latino and African-American young men who have sex with men (YMSM) have low rates of engagement and retention in HIV care. An evaluation of a youth-focused case management intervention (YCM) designed to improve retention in HIV care is presented. HIV-positive Latino and African-American YMSM, ages 18-24, who were newly diagnosed with HIV or in intermittent HIV care, were enrolled into a psychosocial case management intervention administered by Bachelor-level peer case managers at two HIV clinics in Los Angeles County, California. Participants met weekly with a case manager for the first two months and monthly for the next 22 months. Retention in HIV primary care at three and six months of follow-up was evaluated as were factors associated with retention in care. From April 2006 to April 2009, 61 HIV-positive participants were enrolled into the intervention (54% African-American, 46% Latino; mean age 21 years). At the time of enrollment into the intervention, 78% of the YMSM had a critical or immediate need for stable housing, nutrition support, substance abuse treatment, or mental health services. Among intervention participants (n=61), 90% were retained in primary HIV care at three months and 70% at six months. Among those who had previously been in intermittent care (n=33), the proportion attending all HIV primary care visits in the previous six months increased from 7% to 73% following participation in the intervention (p<0.0001). Retention in HIV care at six months was associated with increased number of intervention visits (p=0.05), more hours in the intervention (p=0.02), and prescription of HAART. These data highlight the critical needs of HIV-positive African-American and Latino YMSM and demonstrate that a clinic-based YCM can be effective in stabilizing hard-to-reach clients and retaining them in consistent HIV care.

Do social support, stress, disclosure and stigma influence retention in HIV care for Latino and African American men who have sex with men and women?

Limited research has examined the role that social support, stress, stigma and HIV disclosure play in retention in HIV care for African Americans and Latinos. Among 398 Latino and African American men who have sex with men (MSM) and women, the major predictor of retention in HIV care was disclosure of HIV status to more social network members (OR = 1.5; 95% CI: 1.1, 1.9). Among those who had disclosed (n = 334), female gender (OR = 1.8, 95% CI: 1.1, 3.1) and disclosure of HIV status to more network members (OR = 1.5, 95% CI: 1.1, 1.9) was associated with retention in HIV care. General stress was associated with retention in care (OR = 1.2; 95% CI: 1.1, 1.3) for African American MSM who had disclosed. More MSM-stigma was associated with poorer retention (OR = 0.9; 95% CI: 0.8, 0.9) for Latino MSM. Interventions that help patients safely disclose their HIV status to more social network members may improve HIV care retention as would social network counseling for Latino MSM to reduce MSM-stigma.

Social support, stress and social network characteristics among HIV-positive Latino and African American women and men who have sex with men.

Social support and stress have been poorly characterized for persons with HIV, particularly for racial/ethnic minorities. To address this gap, data on general and HIV-specific support and stress and social network characteristics were collected for 399 African American and Latino women and men who have sex with men (MSM) in Los Angeles County. African American (mean = 41; SD = 17) and Latina (mean = 40; SD = 19) women reported the highest general support. Stress was also highest for Latina women (mean = 18; SD = 11) and higher compared to Latino and African American MSM. African American and Latina women reported receiving most of their social support and stress from family members, while African American and Latino MSM received their support and stress from friends and providers. Finally, Latina and African American women disclosed their HIV status to more network members and received more HIV-specific support compared to MSM. Interventions are needed to help Latino and African American MSM enhance their support networks to manage a stigmatized illness.

Low risk sexual and drug-using behaviors among Latina women with AIDS in Los Angeles County.

Latina women represent nearly half of all females diagnosed with AIDS in Los Angeles County, yet little is known about their risk behaviors compared to women of other race/ethnicities. Compared to white and African American women with AIDS, Latinas with AIDS had fewer lifetime male sexual partners (P < .0001); reported fewer sexually transmitted diseases (OR = 0.24; 95% CI: 0.1, 0.5); were less likely to trade sex for drugs/money (OR = 0.18; 95% CI: 0.07, 0.5); and were less likely to report exposure to HIV via injection drug use (OR = 0.3; 95% CI: 0.09, 0.99). Latinas were also more likely to be single mothers (OR = 3.02; 95% CI: 1.4, 6.4); less likely to receive public assistance (OR = 0.33; 95% CI: 0.16, 0.70); were less likely to have completed high-school (OR = 0.11; 95% CI: .04, .31) and were more likely to never have had health insurance (OR = 2.44; 95% CI: 1.15, 5.18). The data demonstrate low-risk behaviors for Latinas and underscores the challenge of delivering effective HIV prevention to women without traditional risk profiles.

Sources and types of social support that influence engagement in HIV care among Latinos and African Americans.

The change in HIV from acute to chronic disease due to the introduction of HAART in the mid-1990s increased the importance of its successful management and imposed substantial lifestyle adjustments on HIV-positive people and their support networks. Few studies have examined the sources and types of social support and the areas of care relevant for engagement in HIV treatment among HIV-positive Latinos and African Americans. This paper reports the results of 24 semi-structured in-depth interviews that were conducted with HIV-positive African American and Latino women and men who have sex with men. Formal networks were found to be more critical for engagement in HIV-specific medical care; specifically, study participants relied primarily on health care providers for support in accessing and maintaining illness-specific care. In contrast, informal networks (family and friends) were crucial for other general subsistence care, such as emotional, household-related, and financial support.

The costs of HIV antiretroviral therapy adherence programs and impact on health care utilization.

From a trial comparing interventions to improve adherence to antiretroviral therapy-directly administered antiretroviral therapy (DAART) or an intensive adherence case management (IACM)-to standard of care (SOC), for HIV-infected participants at public HIV clinics in Los Angeles County, California, we examined the cost of adherence programs and associated health care utilization. We assessed differences between DAART, IACM, and SOC in the rate of hospitalizations, hospital days, and outpatient and emergency department visits during an average of 1.7 years from study enrollment, beginning November 2001. We assigned costs to health care utilization and program delivery. We calculated incremental costs of DAART or IACM v SOC, and compared those costs with savings in health care utilization among participants in the adherence programs. IACM participants experienced fewer hospital days compared with SOC (2.3 versus 6.7 days/1000 person-days, incidence rate ratio [IRR]: 0.34, 97.5% confidence interval [CI]: 0.13-0.87). DAART participants had more outpatient visits than SOC (44.2 versus 31.5/1000 person-days, IRR: 1.4; 97.5% CI: 1.01-1.95). Average per-participant health care utilization costs were $13,127, $8,988, and $14,416 for DAART, IACM, and SOC, respectively. Incremental 6-month program costs were $2,120 and $1,653 for DAART and IACM participants, respectively. Subtracting savings in health care utilization from program costs resulted in an average net program cost of $831 per DAART participant; and savings of $3,775 per IACM participant. IACM was associated with a significant decrease in hospital days compared to SOC and was cost saving when program costs were compared to savings in health care utilization.

A randomized trial of directly administered antiretroviral therapy and adherence case management intervention.

BACKGROUND: A randomized, controlled trial was conducted to evaluate the impact of a directly administered antiretroviral therapy program (DAART) and intensive adherence case management (IACM) intervention on virologic and immunologic response to highly active antiretroviral therapy (HAART) among patients at 3 public human immunodeficiency virus clinics in Los Angeles County, California. METHODS: Participants included 250 treatment-naive and treatment-experienced persons for whom no more than 1 prior HAART regimen had failed. Five days per week for 6 months, a community worker delivered 1 HAART dose to DAART participants and observed the participant take it. IACM participants met weekly with a case manager to overcome barriers to HAART adherence. A control group (the standard of care [SOC] group) received the usual care. RESULTS: The majority of patients were Latino (64%) or African American (24%); 57% were monolingual Spanish speakers. Seventy-five percent of the patients were male, and 64% reported an annual income of <10,000 dollars. In an intent-to-treat analysis, no statistical differences were observed in the percentage of patients with an undetectable viral load (i.e., <400 copies/mL) at 6 months between the DAART group (54%), IACM group (60%), and SOC group (54%; P>.05). An on-treatment analysis determined that there were no statistical differences in the percentage of patients with an undetectable viral load at 6 months between the DAART group (71%), IACM group (80%), and SOC group (74%; P>.05). Additionally, there were no statistical differences in 6-month changes in the CD4+ cell count or in self-reported adherence to therapy. CONCLUSIONS: Among patients with limited prior HAART experience and adherence barriers that had not been assessed before randomization, no differences were found in virologic or immunologic response for DAART or IACM, compared with SOC, at 6 months. DAART and IACM did not improve short-term outcomes when SOC included other means of adherence support that were not controlled for by the study design.

The feasibility of a community-based directly administered antiretroviral therapy program.

Improved treatment-adherence support programs are needed to help human immunodeficiency virus (HIV)-infected persons comply with complex highly active antiretroviral treatment (HAART) regimens. In an experimental directly administered antiretroviral therapy (DAART) program, treatment-naive and treatment-experienced persons who experienced failure of no more than 1 prior regimen were recruited from 3 public HIV/AIDS clinics in Los Angeles County. For 6 months, trained community workers observed ingestion of 1 of 2 daily HAART doses, 5 days per week, and questioned the patient about the second dose, which enabled intense adherence monitoring and real-time intervention. From November 2001 through November 2003, there were 67 DAART patients enrolled (69% Latino, 21% African American, and 9% white; 63% with annual income of <10,000 dollars). Preliminary findings show that a DAART program based in 3 public HIV/AIDS clinics was feasible in a low-income urban population. Effective communication between the DAART staff, the medical providers, and the pharmacy is essential for the successful implementation of this program.