Adherence to Pre-exposure Prophylaxis in Black Men Who Have Sex with Men and Transgender Women in a Community Setting in Harlem, NY.

While oral pre-exposure prophylaxis (PrEP) has proven efficacious for HIV prevention, consistent use is necessary to achieve its intended impact. We compared effectiveness of enhanced PrEP (enPrEP) adherence support to standard of care (sPrEP) among Black MSM and TGW attending a community clinic in Harlem, NY. EnPrEP included peer navigation, in-person/online support groups, and SMS messages. Self-reported adherence over previous 30 days, collected in quarterly interviews, was defined as ≥ 57%. Crude and adjusted analyses examined factors associated with adherence. A total of 204 participants were enrolled and randomized; 35% were lost to follow-up. PrEP adherence was 30% at 12-months; no intervention effect was observed (p = 0.69). Multivariable regression analysis found that lower adherence was associated with low education and depressive symptoms. We found that an enhanced adherence intervention did not improve PrEP adherence. Findings point to the need for innovative methods to improve PrEP adherence among Black MSM and TGW.Clinical Trial Registration NCT02167386, June 19, 2014.

Latent tuberculous infection in the United States and Canada: who completes treatment and why?

OBJECTIVES: To assess latent tuberculous infection (LTBI) treatment completion rates in a large prospective US/Canada multisite cohort and identify associated risk factors. METHODS: This prospective cohort study assessed factors associated with LTBI treatment completion through interviews with persons who initiated treatment at 12 sites. Interviews were conducted at treatment initiation and completion/cessation. Participants received usual care according to each clinic's procedure. Multivariable models were constructed based on stepwise assessment of potential predictors and interactions. RESULTS: Of 1515 participants initiating LTBI treatment, 1323 had information available on treatment completion; 617 (46.6%) completed treatment. Baseline predictors of completion included male sex, foreign birth, not thinking it would be a problem to take anti-tuberculosis medication, and having health insurance. Participants in stable housing who received monthly appointment reminders were more likely to complete treatment than those without stable housing or without monthly reminders. End-of-treatment predictors of non-completion included severe symptoms and the inconvenience of clinic/pharmacy schedules, barriers to care and changes of residence. Common reasons for treatment non-completion were patient concerns about tolerability/toxicity, appointment conflicts, low prioritization of TB, and forgetfulness. CONCLUSIONS: Less than half of treatment initiators completed treatment in our multisite study. Addressing tangible issues such as not having health insurance, toxicity concerns, and clinic accessibility could help to improve treatment completion rates.

Can a peer-based intervention impact adherence to the treatment of latent tuberculous infection?

OBJECTIVE: To assess the effectiveness of a peer-based intervention on adherence to and completion of latent tuberculous infection (LTBI) treatment. METHODS: Patients prescribed self-administered LTBI treatment were enrolled in a randomized controlled trial of an experimental, peer-based adherence support intervention. Primary outcomes were treatment adherence and completion. Adherence was assessed through self-report, electronic monitoring devices and clinic visits. RESULTS: Of 250 participants, 70% were male; 71% were Black and 20% Latino; the mean age was 40 years; 67% were foreign-born and 39% were married. No significant baseline differences were noted between the intervention groups. Treatment completion was 61% in the intervention group compared to 57% in the controls (P = 0.482). The corresponding completion rate for other clinic patients was 44%. Foreign birth, marriage and history of mental illness were associated with non-completion of treatment after controlling for the intervention group; increased completion rates were found among foreign-born married persons and older participants. A substantial difference in adherence rates was observed between the intervention groups. Adherence among non-completers decreased early, while adherence among completers remained constant. CONCLUSIONS: The peer-based intervention was not significantly associated with LTBI treatment completion, but was associated with greater adherence. Findings suggest the importance of interventions to support adherence that target early non-adherence with LTBI treatment, particularly in the first 2 months, when there is a substantial risk of default.

Acceptance of treatment for latent tuberculosis infection: prospective cohort study in the United States and Canada.

SETTING: An estimated 300 000 individuals are treated for latent tuberculosis infection (LTBI) in the United States and Canada annually. Little is known about the proportion or characteristics of those who decline treatment. OBJECTIVE: To define the proportion of individuals in various groups who accept LTBI treatment and to identify factors associated with non-acceptance of treatment. DESIGN: Persons offered LTBI treatment at 30 clinics in 12 Tuberculosis Epidemiologic Studies Consortium sites were prospectively enrolled. Multivariate regression models were constructed based on manual stepwise assessment of potential predictors. RESULTS: Of 1692 participants enrolled from March 2007 to September 2008, 1515 (89.5%) accepted treatment and 177 (10.5%) declined. Predictors of acceptance included believing one could personally spread TB germs, having greater TB knowledge, finding clinic schedules convenient and having low acculturation. Predictors of non-acceptance included being a health care worker, being previously recommended for treatment and believing that taking medicines would be problematic. CONCLUSION: This is the first prospective multisite study to examine predictors of LTBI treatment acceptance in general clinic populations. Greater efforts should be made to increase acceptance among health care workers, those previously recommended for treatment and those who expect problems with LTBI medicines. Ensuring convenient clinic schedules and TB education to increase knowledge could be important for ensuring acceptance.

Predictors of latent tuberculosis infection treatment completion in the United States: an inner city experience.

BACKGROUND: Few studies have examined predictors of latent tuberculosis infection (LTBI) treatment completion in inner city populations in the United States. OBJECTIVE: To assess LTBI treatment completion rates and predictors in an inner city cohort. METHODS: Data from control groups of two sequentially conducted randomized controlled trials of LTBI treatment were analyzed for treatment completion rates. Participants in Study A (n = 191), conducted in 1996-1999, self administered daily isoniazid (INH) for 6-12 months, while participants in Study B (n = 123), conducted in 2002-2005, self administered daily INH for 9 months. RESULTS: Overall, 44.6% of participants completed therapy, with significantly higher completion rates in Study B than Study A (37.0% vs. 56.1%, P = 0.001). Marriage and alcohol use were significant predictors of completion (aOR = 2.153, 95%CI 1.301-3.562) and non-completion (aOR = 0.530, 95%CI 0.320-0.877), respectively; multivariate analysis indicated increased completion among married persons of foreign birth and among alcohol users who were homeless. Knowledge of and attitudes to tuberculosis were not significant predictors. CONCLUSIONS: The design provided an opportunity to assess predictors of LTBI treatment completion in this inner city population. Social circumstances were the strongest predictors of treatment completion, suggesting that tangible social services may be more effective than educational programs in encouraging treatment completion.

Adherence to treatment for latent tuberculosis infection: systematic review of studies in the US and Canada.

BACKGROUND: There is renewed attention to the critical role of successfully treating latent tuberculosis infection (LTBI) in reducing the overall impact of tuberculosis (TB). However, levels of treatment adherence are consistently low in industrialized countries such as the United States and Canada. OBJECTIVE: A systematic review of studies in the US and Canada was undertaken to analyze measurement of adherence to treatment of LTBI (TLTBI), TLTBI completion rates, predictors of TLTBI adherence and TLTBI adherence interventions. METHODS: PUBMED, MEDLINE and PsycINFO electronic databases were searched for quantitative studies published between 1997 and 2007. Full texts of articles were reviewed for data abstraction and studies were critically examined for their methodology and rigor. The present review presents outcomes from 78 studies. RESULTS: Adherence and completion rates of TLTBI are suboptimal across high-risk groups, regardless of regimen. Associations between adherence and patient factors, clinic facilities or treatment characteristics were found to be inconsistent across studies. Several adherence interventions have been developed to improve TLTBI adherence in the US and Canada; however, no single intervention has shown consistent effectiveness. CONCLUSION: LTBI must be effectively treated if the goal of TB elimination is to be realized. Consistently employing tools for measuring and improving adherence is fundamental. Identifying barriers to adherence and treatment completion will facilitate the development of effective, appropriate interventions. A 'one-size-fits-all' approach to treatment for TLTBI adherence is not likely to succeed across all settings. Innovative approaches can inspire future interventions and suggest solutions for the current problems facing LTBI programs and their patients.

Help-seeking behavior of marginalized groups: a study of TB patients in Harlem, New York.

SETTING: Harlem Hospital Directly Observed Therapy (DOT) Program, New York City. OBJECTIVE: To identify various pathways to tuberculosis (TB) diagnosis, and determine time to diagnosis and reasons for delay, to ensure rapid diagnosis of TB and prompt initiation of appropriate treatment. DESIGN: Cross-sectional survey of the help-seeking behavior of TB patients within 2 months of their enrollment into DOT from May 2001 to December 2004. RESULTS: The average total delay between symptom onset and a patient's diagnosis of TB was 18 weeks among 39 patients. The average delay to diagnosis attributed to patient delay and health care system delay were 10.5 and 7.5 weeks, respectively. Patients visited on average 1.6 sources of care prior to receiving a TB diagnosis. Foreign-born patients in particular were found to have more complex paths to diagnosis. The most common reason for delaying seeking care reported by patients was that they didn't think it was serious' (29.1%). CONCLUSION: There was a substantial time interval between the onset of symptoms and TB diagnosis due to both patient and health care system delay. Foreign-born status, economic and social factors, and missed opportunities for diagnosis by the health care system played important roles in delaying TB diagnoses for the marginalized patients in this study.

Physician attitudes regarding latent tuberculosis infection: international vs. U.S. medical graduates.

Tuberculosis in the U.S. is increasingly noted among the foreign-born, with many individuals at risk being managed by international medical graduates (IMGs). We utilized anonymous surveys using hypothetical scenarios to assess and compare the attitudes of IMGs and U.S. medical graduates regarding the treatment of latent tuberculosis infection (LTBI) to identify how attitudes and intentions may influence physician behavior. IMGs were less likely to treat LTBI in almost all scenarios. Educational efforts should focus on IMGs to encourage attitudes more consistent with U.S. guidelines.

Physician attitudes regarding bacille Calmette-Guérin vaccination and treatment of latent tuberculosis infection.

OBJECTIVE: To investigate the attitudes of international medical graduates (IMGs) about treatment of latent tuberculosis infection (LTBI). DESIGN: Anonymous survey among physicians in training, all IMGs from TB endemic countries. Attitudes were assessed through hypothetical scenarios regarding the protective effect of BCG and LTBI treatment. RESULTS: Of 77 participants, 72.4% were male, the mean age was 31.4 years, and mean years post-graduation 8. Positive tuberculin skin tests (TSTs) were reported among 64.0%, and 89.6% had received BCG vaccine. Over a quarter of IMGs (27.4%) believed that BCG protects for many years. Only 59.2% believed that LTBI treatment was effective and 16% that the risks of treatment were greater than the benefits. Most would treat BCG-vaccinated patients with positive TST in various scenarios (63-94.7%), with less agreement about treating themselves (49.3%) or their family members (54.2%). For recent converters, more than 80% would recommend LTBI treatment. Over half felt that LTBI treatment should be mandatory for new immigrants with positive TST. CONCLUSIONS: IMGs are cautious about LTBI treatment except for recent converters. They are less likely to treat themselves and family members than others. Educational efforts should address discrepancies between these physicians' attitudes and current guidelines for treating LTBI in the US.

Reliability of self-reports about sexual risk behavior for HIV among homeless men with severe mental illness.

The reliability of self-reports of sexual behaviors related to HIV transmission was examined in a study of homeless men with severe mental illness. Thirty-nine patients of a New York City shelter psychiatric program were interviewed about their sexual behaviors in the past six months. The same interview was administered twice, with a one- to two-week interval between interviews. Test-retest reliability was assessed using kappa and intraclass correlation coefficients. Reliability estimates ranged from.49 to.93 for overall sexual activity, number of partners, and specific behaviors other than receptive anal sex. Reliability was lower for condom use. The authors conclude that reliable self-reports about sexual behavior can be obtained from homeless men with severe mental illness.