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 |
For example, comparing patients with positive versus negative tuberculin skin tests.
Including studies that addressed effects on treatment outcomes.
Studies testing a hypothesis about measures to improve treatment completion or adherence.
As specific study objective, no hypothesis testing about measures to improve treatment completion or adherence.
Two multi-country studies situated at locations with different TB incidences and HIV prevalence; one of these in various regions.
Number of studies evaluating effects on health outcomes.
HAART, highly active antiretroviral treatment.