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. 2012 Dec 18;9(12):e1001358. doi: 10.1371/journal.pmed.1001358

Table 1. Results for studies on preventive therapy in HIV-infected individuals and in household contacts.

Appraisal HIV Infection, n = 59 Household Contacts, n = 14 Total, n = 73
Major Category Minor Category Major Category Minor Category Major Category Minor Category
Year of publication
1990–1995 2 0 2
1996–2000 11 1 12
2001–2005 11 2 13
2006–2012 35 11 46
Objective
Effects on health outcomes 44 3 47
Evaluation of IPT for preventing TB or progression to AIDS 33 3 36
Comparing IPT versus no IPT only 11 0 11
Comparing various regimens and dosing schedules 9 0 9
Comparing various durations 2 0 2
Comparing various patient groupsa 1 0 1
Comparing IPT versus HAART with or without IPT 4 0 4
No comparison 6 3 9
Frequency of and risk factors for adverse effectsb 31 3 34
Drug resistance among TB cases during or after IPTb 6 0 6
Delivery 35 13 48
Evaluation of IPT completion/adherence ratec
 Comparing different regimens 2 1 3
Comparing interventions for enhancing completion and/or adherence 1 0 1
Frequency of and risk factors for non-completion or non-adherenced 28 6 34
Comparison of various IPT enrolment methods 1 1 2
Barriers to implementation 1 0 1
Assessment of practices 2 5 7
Cost-effectiveness 4 0 4
Study design
Comparative studies 31 2 33
Individually randomized trials 19 0 19
Group-randomized trials 0 0 0
Non-randomized cohort comparisons 10 1 11
Before–after comparisons 1 0 1
Other 1 1 2
Non-comparative studies 28 12 40
Prospective cohort studies 19 4 23
Retrospective cohort studies 5 5 10
Cross-sectional clinical studies 2 1 3
Surveys 2 2 4
Setting
Estimated TB incidence per 100,000 population (2005) 57e 14 71e
<50 2 1 3
50–99 5 2 7
100–299 7 3 10
≥300 43 8 51
Estimated HIV prevalence among TB patients (2005) 57e 14 71e
<5% 3 4 7
≥5% 54 10 64
Study location 59 14 73
Research setting 22 0 22
Mixed research – routine setting 10 2 12
Routine setting 27 12 39
Generalizability
Study results are generalizable: 59 14 73
Irrespective of epidemiological or health care setting 31 4 35
To similar epidemiological or health care settings 18 7 25
Not beyond national/local setting 2 2 4
Other
Small sample size 3 0 3
Assessment of operational issues in research setting 5 1 6
Effectiveness versus efficacy
Methods aimed at establishing (relevant studies) 44f 3f 47f
Efficacy 16 0 16
Effectiveness 12 3 15
Mixed 16 0 16
a

For example, comparing patients with positive versus negative tuberculin skin tests.

b

Including studies that addressed effects on treatment outcomes.

c

Studies testing a hypothesis about measures to improve treatment completion or adherence.

d

As specific study objective, no hypothesis testing about measures to improve treatment completion or adherence.

e

Two multi-country studies situated at locations with different TB incidences and HIV prevalence; one of these in various regions.

f

Number of studies evaluating effects on health outcomes.

HAART, highly active antiretroviral treatment.