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Table 3 Intention-to-treat comparisons of the primary and secondary outcomes between the combined intervention group and usual care control, and between the two intervention groups (SCC1 vs. SCC2), with and without covariate adjustment

From: “Our Choice” improves use of safer conception methods among HIV serodiscordant couples in Uganda: a cluster randomized controlled trial evaluating two implementation approaches

Overall

SCC1

SCC2

Sig. test(unadjusted)

Intervention effect(covariate adjusted)

Intervention(SCC1/SCC2)

Usual care control

Sig. test(unadjusted)

Intervention effect(covariate adjusted)

n (%)

n (%)

Chi-sq

OR (95% CI)

n (%)

n (%)

Chi-sq

OR (95% CI)

Among all participants in the sample (n=389)

n

129

130

  

259

130

  

Primary outcome: Used SCM accurately if tryingto conceive or modern contraception if not tryingto conceive

35 (27.1%)

19 (14.6%)

0.013

4.50** (1.44-14.01)

54 (20.8%)

9 (6.9%)

<0.001

10.63** (2.79-40.49)

Secondary outcomes: Used SCM accurately iftrying to conceive or any contraception(incl condoms) if not trying to conceive

46 (35.7%)

33 (25.4%)

0.073

3.44* (1.31-9.02)

79 (30.5%)

27 (20.8%)

0.042

3.63** (1.38-9.61)

Partner seroconversion to HIV positive at studyendpoint

0 (0%)

1 (0.8%)

0.320

0.94 (0.01-75.66)

1 (0.4%)

0 (0%)

0.46

2.23 (0.02-257.6)

Among those trying to conceive throughout study (n=212) or during one 6-month period (n=64): total n=276

n

104

87

  

191

85

  

Primary outcome: Used TCI or MSI accurately

36 (34.6%)

10 (11.5%)

<0.001

6.43** (1.90-21.73)

46 (24.1%)

0 (0%)

<0.001

91.84** (4.94-1709)

Secondary outcomes

 Used any (un-named) strategy to reduce risk inconceiving

81 (77.9%)

61 (70.1%)

0.221

7.05** (2.07-23.99)

142 (74.3%)

26 (30.6%)

<0.001

27.17** (7.84-94.15)

 Reported using SCM (TCI/MSI)

75 (72.1%)

50 (57.5%)

0.034

4.75** (1.64-13.71)

125 (65.4%)

4 (4.7%)

<0.001

494.4** (26.06-9378)

 Reported using TCI

67 (64.4%)

42 (48.3%)

0.025

5.12** (1.86-14.50)

109 (57.1%)

4 (4.7%)

<0.001

424.6** (22.63-7968)

 Reported accurate TCI

30 (28.8%)

9 (10.3%)

0.002

10.33** (2.60-41.08)

39 (20.4%)

0 (0%)

<0.001

121.9** (6.30-2360)

 Reported using MSI (among females)

14/69 (20.3%)

8/39 (20.5%)

0.978

1.06 (0.27-4.11)

22/108 (20.4%)

0/34 (0%)

0.002

9.88 (0.48-201.9)

 Reported accurate MSI

8/69 (11.6%)

1/39 (2.6%)

0.152

1.13 (0.13-9.54)

9/108 (8.3%)

0/34 (0%)

0.114

2.77 (0.11-67.26)

 Became pregnant

32 (30.8%)

29 (33.3%)

0.760

0.44 (0.15-1.25)

61 (31.9%)

27 (31.8%)

0.902

0.73 (0.25-2.09)

Among those not trying to conceive throughout study (n=113) or in one 6-month time period (n=64): total n=177

n

48

61

  

109

68

  

Primary outcome: Using modern contraceptive

7 (14.6%)

12 (19.4%)

0.487

3.72 (0.37-37.48)

19 (17.4%)

12 (17.6%)

0.971

1.20 (0.22-6.501)

Secondary outcomes:

 Using modern contraceptive or always usecondoms or not having sex

28 (58.3%)

35 (56.5%)

0.92

1.07 (0.28-4.19)

63 (57.8%)

37 (54.4%)

0.658

0.52 (0.16-1.75)

 Always use condoms

13 (27.1%)

16 (25.8%)

0.92

2.78 (0.50-15.63)

29 (26.6%)

18 (26.5%)

0.984

2.66 (0.57-12.44)

 Did not become pregnant

44 (91.7%)

54 (88.5%)

0.589

1.40 (0.17-11.58)

98 (89.9%)

61 (89.7%)

0.965

0.18 (0.01-4.30)

  1. Adjusted models controlled for site, age, sex, education, time since HIV diagnosis, marital status, length of relationship, and whether had child with partner
  2. SCM safer conception method, TCI timed condomless sex, MSI manual self-insemination, SCC1 safer conception counseling implemented with high intensity approach, SCC2 safer conception counseling implemented with low intensity approach, OR odds ratio, CI confidence interval
  3. **p<0.01
  4. *p<0.05