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Uptake, accuracy, safety, and linkage into care over two years of promoting annual self-testing for HIV in Blantyre, Malawi: a community-based prospective study

Choko et al.

Publication year


Type of approach

Type of assistance
Directly assisted


Study population
Mixed: Adults over 16 years

Study design

Sample size

UNAIDS HIV prevalence (2017)
9.1 [8.4 - 9.9]

Prospective study nested within a cluster-randomised trial (ISRCTN02004005) comparing health outcomes between 14 clusters randomised to HIVST and 14 clusters randomised to routine (facility-based) HIV testting services, to evaluate the uptake of testing, accuracy, linkage into care, and health outcomes when highly convenient and flexible, but supported, access to HIVST kits was provided to a well-defined and closely-monitored population. Participants (individuals or couples) received pre-test counseling, received instructions on performing HIVST, and were asked to demonstrate understanding using a cotton bud and vial of water in place of the kit itself.

Summary of findings
14 004 residents self-tested during months 1-12, with adolescents (16-19 years of age) most likely to test. HIVST uptake in months 13-24 was more rapid (70.9% uptake by 6 months), with fewer (7.3%, 95% CI 6.8-7.8%) HIV-positive participants. Being 'forced to test', usually by a main partner, was reported by 2.9% (95% CI 2.6-3.2%) of 10 017 questionnaire respondents in months 1-12, but satisfaction with HIVST (94.4%) remained high. No HIVST-related partner violence or suicides were reported. HIVST and repeat HIV testing results agreed in 1639/1649 systematically selected (1 in 20). 99.4% of participants went through a quality assesment, reporting a sensitivity of 93.6% (95% CI 88.2-97.0%) and a specificity of 99.9% (95% CI 99.6-100%).


Acceptability details
Revised uptake estimates of HIVST were 76.5% and 74.4% in months 1-12 and months 13-24, respectively.

Willingness to pay

Willingness to pay details




HIV positivity
8.6% (141/1649)

Accuracy details
Compared to stated HIVST results, there were 9/1508 (0.6%) false negatives (including four participants already on ART) and 1/133 false positives, giving agreement of 1639/1649 (99.4%), sensitivity of 93.6% (95% CI 88.2%-97.0%), and specificity of 99.9% (95% CI 99.6%-100%).

Social harm
Being forced to test, usually by a main partner, was reported by 2.9% (95% CI 2.6%-3.2%). No HIVST-related partner violence or suicides were reported.

Linkage to prevention, care and treatment
In total, 75.8% (10614/14004) (95% CI 75.1%-76.5%) of participants who underwent HIVST in months 12 reported their result to a volunteer-counsellor, with 1257 (11.8%, 95% CI 11.2%-12.5%) reporting a positive result.


Study status

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