Comparison of practicability and effectiveness between unassisted HIV self-testing and directly assisted HIV self-testing in the Democratic Republic of the Congo: a randomized feasibility trial

Table 2 Characteristics of practicability and effectiveness of HIV self-testing in unassisted versus directly assisted approach and effects of unassisted approach on the practicability and effectiveness of HIV self-testing

Outcome	Directly assisted HIVST	Unassisted HIVST	Difference^a % (95% CI)	Non-inferiority of unassisted HIVST^b	Adjusted Risk Ratio^c (95% CI)	p-value^c
Primary outcomes, n/N (%)
- Successful performance of HIV self-test	245/263 (93.2)	222/237 (93.7)	0.5 (−0.1 to 1.1)	Yes	1.11 [0.68 to 1.81]	0.817
- Correct interpretation of HIV self-test results	245/263 (93.2)	206/237 (86.9)	−6.3 (−10.8 to 2.5)	No	0.60 [0.36 to 0.98]	0.019
Secondary outcome, n/N (%)
- Assistance requested	110/263 (41.8)	80/237 (33.8)^d	−8.0 (−13.9 to 2.7)	No	0.87 [0.67 to 1.14]	0.063
- Retention rate^e	263/265 (99.2)	237/265 (89.4)^f	−9.8 (−15.9 to 4.9)	No	0.13 [0.03 to 0.51]	0.004
- Positivity rate with confirmation HIV testing	9/263 (3.4)	4/137 (1.7)	−1.7 (−6.1 to 2.7)	Yes	0.65 [0.32 to 2.02]	0.854
- Linkage to care	7/9 (77.8)	3/4 (75.0)	−2.8 (−9.5 to 5.1)	Yes	0.89 [0.42 to 1.89]	0.763
- Willing to buy HIV self-test kit if locally available^g	195/263 (74.1)	217/237 (91.6)	17.5 (14.1 to 21.1)	Yes	4.20 [2.42 to 7.32]	< 0.001

^aDifference assessed with Wald asymptotic test;
^bNon-inferiority was defined as a lower limit > −10 of the 95% CI around the difference in outcomes;
^cEstimates and confidence intervals are marginal effect from regression of Poisson;
^dMajority (72/80; 90%) requested assistance via telephone; and 8 (10%) participants declared to have been assisted by a trusted person;
^eReturn rate was defined as the number of included participant who completed the evaluation throughout the follow-up period;
^gThe mean of self-test purchase price was estimated at 2.80 USD per test (limit: 0.33–5.41) in the unassisted HIV self-testing group while it was 2.96 USB per test (limit: 0.36–10.25) in the directly assisted group
CI Confidence internal, HIVST HIV self-testing

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