Table 1.2AGRADE evidence profile

Author(s): Caitlin Kennedy

Date: 2015-03-13

Question: Should trained lay providers perform HIV testing and counselling services using HIV rapid diagnostic tests?

Quality assessmentNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsHTS using RDTs by trained lay providersHTS using RDTs by trained health professionals, or no interventionRelative
(95% CI)
Absolute
Uptake of HTS (assessed with: proportion who completed HTS)
11randomized trials2no serious risk of biasno serious inconsistencyno serious indirectnessno serious imprecisionsingle RCT in a high-income country1382/2446 (56.5%)643/2409 (26.7%)Relative Risk: 2.1168
(1.9643 to 2.2811)
298 more per 1000
(from 257 more to 342 more)
□□□□
MODERATE
CRITICAL
Measures of testing quality (assessed with: concordance of HIV test results)
33observational studiesno serious risk of biasno serious inconsistencyno serious indirectnessno serious imprecisionnone---3,963 of 3,986 cases4□□□□
LOW
CRITICAL
-2,907 of 2,911 cases5
-559 of 563 cases6
Accurate test results (assessed with: sensitivity)
27observational studiesno serious risk of biasno serious inconsistencyno serious indirectnessno serious imprecisionnone--98.0% (96.3- 98.9%)8-□□□□
LOW
CRITICAL
99.6%9-
Accurate test results (assessed with: specificity)
27observational studiesno serious risk of biasno serious inconsistencyno serious indirectnessno serious imprecisionnone--99.6% (99.4-99.7%)8-□□□□
LOW
CRITICAL
100%9
Adverse events - not reported
0-----none----CRITICAL
Rate of CD4 measurement - not reported
0-----none----IMPORTANT
Linkage to medical visit after diagnosis - not reported
0-----none----IMPORTANT
Initiation of ART - not reported
0-----none----IMPORTANT
1

Walensky et al., 2011(29)

2

In addition to the one RCT by Walensky et al. 2011 (29), one non-randomized study examined HTS uptake before and after the introduction of lay providers in Thyolo District, Malawi (Bemelmans et al., 2010) (30). This study found HTS uptake increased from 1300 tests per month in 2003 to 6500 tests per month in 2009. This was the result of an increase from 14 HTS sites at the end of 2003 (with an average of 93 tests per site per month) to 39 sites at the end of 2009 (with an average of 167 tests per site per month).

3

Jackson et al., 2013 (31); Molesworth et al., 2010 (10); Kanal et al., 2005 (32).

4

Jackson et al., 2013 (31): Of 3,986 matched samples, lay provider and laboratory results of HTS were concordant in all but 23 cases. Of these, further examination revealed only 2 cases that could be considered “critical errors” where the lay provider found a positive result and the laboratory had a negative result; the rest were cases where at least one result was indeterminate, and most of these were considered cases of the lay provider being extra cautious.

5

Molesworth et al., 2010 (10): Of 2911 matched samples, lay provider and laboratory results were concordant in all but 4 cases, 3 of which were considered most likely the result of “sample peculiarities”.

6

Kanal et al., 2005 (32): Of 563 matched samples, lay provider and laboratory results of HTS were concordant in all but 4 cases; of these, “Further investigation confirmed that all the reports by the counsellors [lay providers] were correct, and that human error in writing reports in the laboratory was a cause of these discordant reports”.

7

Jackson et al., 2013 (31); Molesworth et al., 2010(10).

8

Jackson et al., 2013(31).

9

Molesworth et al., 2010 (10); 95% CI not reported

From: ANNEX 1, Should trained lay providers perform HIV testing and counselling services using HIV rapid diagnostic tests? A systematic review

Cover of Consolidated Guidelines on HIV Testing Services
Consolidated Guidelines on HIV Testing Services: 5Cs: Consent, Confidentiality, Counselling, Correct Results and Connection 2015.
Geneva: World Health Organization; 2015 Jul.
Copyright © World Health Organization 2015.

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