Pathways to Completion Study
The Pathways to Completion Study is a randomized clinical trial
funded by the Heart Lung and Blood Institute of the National Institutes
of Health. The Principal Investigator is Dr. Wafaa El-Sadr. The
overall aim of this project is to compare two methods to ensure
completion of treatment for TB and LTBI in inner city settings.
The basis for comparison will include adherence rates and cost savings
as primary outcomes and impact on other parameters such as patient
satisfaction, development of social networks, and participation
in support programs as secondary outcomes.
For the LTBI component, the project compared a peer-led community-based
intervention conducted by trained graduates of the Harlem DOT program
(peer workers) to traditional self-administered treatment of LTBI.
The former DOT clients are well suited for the role of peer worker
because they know the Harlem community well and socially and culturally
reflect the community from which the patient population is drawn
from. The peer workers underwent extensive training that included
interactive techniques such as role-playing to accommodate persons
with low literacy. The peer workers' roles in this study include
system navigation, referrals, advocacy and social support. Preliminary
results suggest that most of the 379 participants benefited from
having a peer worker, particularly with regards to treatment adherence.
Participants included 58% men, 72% African-Americans, 22% Latino,
26% married, 48% foreign-born, 38% with a history of homelessness,
and 72% unemployed. Preliminary data indicate that 79% of patients
in the experimental (peer) group completed LTBI treatment, compared
to 62% of controls (p=.009). These findings suggest that peer workers
can make a vital contribution to completion of LTBI treatment.
For the TB component, 207 patients undergoing treatment for TB
were randomly assigned to clinic-based "surrogate family" model DOT or community-based off site DOT. The Harlem surrogate
family model DOT clinic is an on-site program, attracting patients
to the clinic by providing consistent personal support, food, tokens,
and other forms of tangible assistance in a warm supportive atmosphere
- with referrals to substance use counselor, social worker, and
health educator. Completion rates were available for 177 patients.
Of these, 73% of on site pts completed TB treatment, compared to
77% of off site patients (p=0.697). Among patients with confirmed
TB, 95% of on site patients completed treatment, compared to 99%
of off site (p=0.334). This preliminary analysis suggests that the
clinic-based surrogate family model DOT is as effective as community-based
DOT in achieving completion of TB treatment.