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Promoting partner testing and couples testing through secondary distribution of HIV self-tests: a randomized clinical trial


Author
Masters et al.

Publication year
2016

Country

Type of approach
Dual

Type of assistance
Directly assisted

Specimen
Oral-fluid

Study population
Vulnerable population: Antenatal and postpartum women and their male partners

Study design
Trials

Sample size
570

UNAIDS HIV prevalence (2017)
5.9 [4.9 - 7.0]

Methodology
A randomised trial was conducted in Kisumu, Kenya in which 600 antenatal and postpartum women were randomised to an HIV self-testing group or a comparison group. Participants in the HIV self-testing group were given two oral fluid-based self-test kits and encouraged to distribute them to their male partners or take the test as a couple. Each test was accompanied with an instruction sheet that described step-by-step self-testing procedures in multiple languages. Study staff also provided the participants with a brief demonstration of how to use the test. In the comparison group, participants were encouraged to give a card for clinic-based HIV testing to their male partners. Data was collected monthly from participants over three months to determine if they had distributed the test to their partner or if their partner had come in for clinic-based testing. Researchers conducted interviews with participants who reported distributing a test to their partner or whose partner sought clinic-based testing. Study period: June 2015 and January 2016.

Summary of findings
A total of 1929 women were screened for participation in the study. Among those, 614 (32%) were determined to be ineligible, 715 declined to participate (37%), and 600 (31%) were enrolled and randomized. The majority of participants reported that their partner had tested for HIV in the past 12 months (56%), and only a small percentage of participants (14%) had heard of HIVST prior to the study. Among 570 participants analyzed, partner HIV testing was more likely in the HIVST group (90.8%, 258/284) than the comparison group (51.7%, 148/286); difference = 39.1%, 95% CI 32.4% to 45.8%, p < 0.001. Couples testing was also more likely in the HIVST group than the comparison group (75.4% versus 33.2%), difference = 42.1%, 95% CI 34.7% to 49.6%, p <0.001. Among participants in the HIVST group whose partners used a self-test, 76% and 17% reported that their partner found it 'very easy' or 'somewhat easy,' respectively, to use the self-test, while 6% reported that their partner found it 'somewhat difficult' or 'very difficult.'

Acceptability
0.908

Acceptability details
90.8% (258/284) of male partners tested using an HIV self-test within three months of enrollment.

Willingness to pay
n/a

Willingness to pay details
n/a

Sensitivity
n/a

Specificity
n/a

Concordance
n/a

HIV positivity
3.5% (10/286) comparison group and 4.6% (13/284) HIVST group

Accuracy details
n/a

Social harm
Inter-partner violence reported in 0.3% (1/286) women comparison group and 0.4% (1/284) HIVST group.

Linkage to prevention, care and treatment
Among the eight male partners who tested HIV-positive in the HIV self-testing group, two went for confirmatory testing, were confirmed positive, and were linked to care.

Source

Study status
Completed