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Evaluation of rapid HIV self-testing among men who have sex with men (Estamp)


Author
MacGowan et al.

Publication year
2014


Type of approach
Community-based

Type of assistance
Unassisted

Specimen
Fingerstick/whole blood, Oral-fluid

Study population
Key population: Men who have sex with men

Study design
Trials

Sample size
515

UNAIDS HIV prevalence (2017)
0.2 [0.2 - 0.2]

Methodology
Study seeks to determine the public health impact of providing HIVST kits to men who have sex with men. Study includes 4 parts including formative research and implementation. Research study will use 2 different types of rapid HIV tests (oral fluid-based and blood-based) and compare them regarding their usability as HIVST kits. An Investigational Device Exemption will be obtained from the FDA to allow the contractor to supply the blood-based assay to study participants since it is not approved for home use.

Summary of findings
Forthcoming

Acceptability
n/a

Acceptability details
n/a

Willingness to pay
n/a

Willingness to pay details
n/a

Sensitivity
n/a

Specificity
n/a

Concordance
n/a

HIV positivity
2.7% (14/515)

Accuracy details
Specificity is high for both tests. Sensitivity has very wide confidence intervals due to the low number of positive results. Fingerstick blood based RDT arm sensitivity and specificity was 100% (54.1-100) and 100% (99.2-100), respectively. Oral fluid-based rapid diagnostic test arm sensitivity and specificity was 88.9% (51.8-99.7) and 100% (99.3-100), respectively.

Social harm
n/a

Linkage to prevention, care and treatment
n/a

Source

Study status
Ongoing