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Direct provision versus facility collection of HIV self-tests among female sex workers in Uganda: A cluster-randomized controlled health systems trial


Author
Ortblad et al.

Publication year
2017

Country

Type of approach
Dual

Type of assistance
Unassisted

Specimen
Oral-fluid

Study population
Key population: Female sex workers

Study design
Trials

Sample size
960

UNAIDS HIV prevalence (2017)

Methodology
Cluster-randomised controlled trial among female sex workers in Kampala, Uganda measuring the effect of two HIV self-testing delivery models on HIV testing and linkage to care outcomes. Female sex worker peer educator groups were randomised to either (1) direct provision of oral HIV self-tests (HIVST), (2) provision of coupons for free collection of HIVST in a healthcare facility, or (3) standard of care HIV testing. The study was conducted between October and November 2016.

Summary of findings
In total, 960 female sex workers participated in 120 peer educator groups. Participants in the direct provision arm were significantly more likely to have tested for HIV than those in the standard of care arm, both at 1 month (RR 1.33, p < 0.001) and at 4 months (RR 1.14, p < 0.001). Participants in the direct provision arm were also significantly more likely to have tested for HIV than those in the facility collection arm, both at 1 month (RR 1.18, p = 0.001) and at 4 months (RR 1.03, p = 0.02). At 1 month, fewer participants in the intervention arms had sought medical care for HIV than in the standard of care arm, but these differences were not significant and were reduced in magnitude at 4 months. There were no statistically significant differences in antiretroviral initiation across study arms. At 4 months, participants in the direct provision arm were significantly more likely to have tested twice for HIV than those in the standard of care arm (RR 1.51, p < 0.001) and those in the facility collection arm (RR 1.22, p = 0.001). Participants in the HIVST arms almost completely replaced facility-based testing with self-testing. Two adverse events related to HIVST were reported: interpersonal violence and mental distress.

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
16.9-27.7% (n=n/a)

Accuracy details
n/a

Social harm
Two adverse events were related to HIV self-testing (HIVST): (1) interpersonal violence (verbal abuse from boyfriend, in the facility collection arm) and (2) mental distress following a positive HIVST result (the participant later tested HIV negative at a healthcare facility, in the direct provision arm).

Linkage to prevention, care and treatment
Overall, few people tested HIV positive and were eligible for linkage to care (female sex workers with known positive HIV status were excluded from the study). Seeking HIV-related medical care appeared to be lower in both HIVST intervention arms compared to the standard of care arm at 1 month (direct provision RR 0.65, p = 0.28; facility collection RR 0.50, p = 0.06), but these differences were not statistically significant and were reduced in magnitude at 4 months.

Source

Study status
Completed