Table 4. Outcome data: incidence of STIs.
Study | Intervention group 1 |
Intervention group 2 |
Intervention group 3 |
Statistical significance | Other |
---|---|---|---|---|---|
Boyer 2005 (mean 14 months from baseline) | Cognitive-behavioural intervention | Health promotion control | N/A | Statistical significance | Other |
Any of three STIs | 47 (5.7%)a | 73 (8.8%)a | N/A | NR | |
DiClemente 2004 | HIV prevention intervention | General health promotion group | N/A | p-value for OR | Adjusted odds ratio (OR), 95% CI) for the 12 month period after baseline (from GEE regression model) |
Crude laboratory-determined chlamydia incidence per 100 person-months For full 0 to12 month period | 2.1 | 2.0 | P = 0.04 | OR 0.17 (0.03, 0.92) | |
Crude laboratory-determined Trichomonas incidence per 100 person-months For full 0 to 12 month period | 0.9 | 1.2 | P = 0.16 | OR 0.37 (0.09, 1.46) | |
Crude laboratory-determined gonorrhoea incidence per 100 person-months For full 0 to 12 month period | 0.9 | 0.7 | P = 0.21 | OR 0.14 (0.01, 3.02) | |
DiClemente 2009 | STI/HIV risk reduction intervention (Horizons) | Enhanced usual care comparison | N/A | Statistical significance | Generalised estimating equations regression models (GEE) Risk ratio (95% CI) |
chlamydia incidence baseline to 12 months, n | 42 | 67 | crude RR 0. 71, 95% CI 0.50 to 1.02) P = 0.059 | 0.65 (0.42 to 0.98) P = 0.04 | |
Gonorrhoea incidence baseline to 12 months, n | 23 | 25 | P = 0.62 | 0.85 (0.44 to 1.63) | |
Trichomoniasis incidence baseline to 12 months, n | 52 | 57 | P = 0.87 | 0.96 (0.59 to 1.54) | |
Downs 2004 | Interactive video intervention | Content-matched control | Topic-matched control | Statistically significant | Other |
% with self-reported diagnosis with any of 9 STIs (including chlamydia) during previous 3 months (6 month follow- up) | 11.8b | Data for groups 2 & 3 pooled for analysis 22.1b | OR 2.79 P = 0.05 | (Stated frequency lower in interactive video intervention group; same direction of difference applied to all 9 STIs; sign test P = 0.004) | |
% with self-reported diagnosis with chlamydia during previous 3 months (6 month follow-up) | 5.8b | Data for groups 2 & 3 pooled for analysis 7.8b | OR 7.75 P = 0.05 | (Stated frequency lower in interactive video intervention group) | |
% with clinically-determined chlamydia at 6 month follow-up | Not reported | Data for groups 2 & but not reported | 3 pooled for analysis | OR 2.79 P = 0.56 (underpowered)c | (Frequency lower in interactive video intervention) |
Jemmott 2005 | Skills-based HIV/ STD risk reduction intervention | Information-based HIV/ STD risk reduction intervention | Health promotion control | p-value for difference based on adjusted means; effect size, d (p-value for d) | |
Mean (SE) % testing positive for chlamydia, gonorrhoea and/or trichomoniasis 6 month follow-up with corresponding baseline data for 6-month completers | Baseline, unadjusted: 21.3 (3. 1) 3 months, unadjusted: 15.5 (2.8) 3 months, adjusted: 15.8 (2.7) | 27.2 (3.4) 16.0 (2.8) 15.5 (2.8) | 17.5 (2.9) 14.6 (2.7) 14.8 (2.8) | Group 1 versus Group 2: P = 0.91; d=NR Group 1 versus Group 3: P = 0.80; d=NR Group 2 versus Group 3: P = 0.89; d=NR | |
Mean (SE) % testing positive for chlamydia, gonorrhoea and/or trichomoniasis 12 month follow-up with corresponding baseline data for 12-month completers | Baseline, unadjusted: 23.6 (3. 5) 12 months, unadjusted: 10.8 (2.6) 12 months, adjusted: 10.5 (2.9) | 24.7 (3.5) 16.0 (3.0) 15.4 (2.9) | 14.3 (2.8) 17.4 (3.0) 18.2 (2.8) | Group 1 versus Group 2: P = 0.23; d=NR Group 1 versus Group 3: P = 0.05; d=0.18 (P = 0.05) Group 2 versus Group 3: P = 0.44; d=NR | |
Kershaw 2009 | Group prenatal care with an integrated HIV component | Group prenatal care | Individual prenatal care | OR, 95% CI) for difference [Group 1] versus/Groups 2 & 3 combined] adjusted for baseline variables | |
% testing positive for chlamydia and/ or gonorrhoea At 3rd trimester (ca 17 weeks after baseline) | 6.9 | 7.2 | 7.1 | OR 0.88 (0.53 - 1. 47); P = 0.63 | |
% testing positive for chlamydia and/ or gonorrhoea At 6 months postpartum (ca 49 weeks after baseline) | 6.9 | 6.6 | 5.8 | OR 0.95 (0.55 - 1. 64); P = 0.86 | |
% testing positive for chlamydia and/ or gonorrhoea At 12 months postpartum (ca 75 weeks after baseline) | 8.8 | 8.1 | 10.2 | OR 0.72 (0.38 - 1. 36); P = 0.32 | |
Orr 1996 | Brief clinic-based condom use education and practical skills development session | Brief clinic-based condom use education session | N/A | Difference between groups | |
% reinfected with chlamydia at 6 month follow-up | 26 | 17 | P = 0.3 | ||
Peipert 2008 | Individual-tailored dual contraception computer intervention | Enhanced standard care computer intervention | N/A | Hazard Rate Ratio, 95% CI) for Group 1
|
|
Any STI (chlamydia, gonorrhoea, trichomonas, HSV, PID) at 24 month follow-up n/N (%) | 43/272 (16) | 44/270 (16) |
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chlamydia at 24 month follow-up n/N (%) | 27/272 (10) | 26/270 (10) |
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Gonorrhoea at 24 month follow-up n/N (%) | 12/272 (4) | 13/270 (5) |
|
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Trichomonas at 24 month follow-up n/N (%) | 13/272 (5) | 9/270 (3) |
|
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Pelvic inflammatory disease (PID) at 24 month follow-up n/N (%) | 8/272 (3) | 4/270 (1) |
|
||
Roye 2007 | 1: Video + counselling; 2: Counselling only; 3: Video only; 4: Usual care | Group differences | |||
Self-reported recurrent STIs at 3 months follow-up | NR | Not explicitly reported but implied that there was no statistically signifi-cant difference between groups for this outcome (P > 0. 05) | |||
Postitive chlamydia tests at 3 months follow-up | NR | ||||
Scholes 2003 | Self-help intervention | Usual care | N/A | Unadjusted OR, 95% CI) | Adjusted OR, 95% CI); p-value |
Percentage sexually active who reported STI diagnosis in past 3 months At 6 month follow-up (total both groups n = 849) | 3.5 | 3.6 | 0.95 (0.49, 1.83) p-value NR | 0.97 (0.48, 1.96) P = 0.93 | |
Shain 1999 | Behavioural-cognitive intervention | Nurse practitioner-led counselling | N/A | Difference Group 1 versusGroup 2 (OR or Chi square test; p-value) | |
No (%) of episodes of chlamydia and/ or gonorrhoea infection during the 12 month study period 1) Zero 2) One 3) Two or more |
n = 285 1) 237 (83.2) 2) 32 (11.2) 3) 16 (5.6) |
n = 264 1) 193 (73.1) 2) 51 (19.3) 3) 20 (7.6) |
P = 0.01 | Chi-square test for the association ofgroup assignment with the number ofepisodes ofin-fection | |
No (%) of participants infected with chlamydia and/or gonorrhoea 0 to 6 months |
n = 265 30 (11.3) |
n = 244 42 (17.2) |
OR0.58,95%CI0. 34 to 0.99) P = 0.05 |
OR, 95% CI) from multiple logistic regression | |
No (%) of participants infected with chlamydia and/or gonorrhoea 6 to 12 months |
n = 285 26 (9.1) |
n = 260 46 (17.7) |
OR0.49,95%CI0. 29 to 0.83) P = 0.008 |
OR, 95% CI) from multiple logistic regression | |
No (%) of participants infected with chlamydia and/or gonorrhoea 0 to 12 months |
n = 285 48 (16.8) |
n = 264 71 (26.9) |
OR0.52,95%CI0. 34 to 0.81) P = 0.004 |
OR, 95% CI) from multiple logistic regression | |
Shrier 2001 (at 12 months) | Safer sex education | Standard care/STD education | N/A | Difference | |
% reported having an STD since enrolment | 17 | 32 | P = 0.17 |
NR=not reported
Denominator for both groups is 826 (which is less than the 1381 who completed the study, notwithstanding the fact that 486 women were not screened for STIs at 2nd post-intervention follow-up because of limited study resources). It is not clear what the denominator is for each of the randomised study groups.
Data estimated from a graph using a graphical measurement computer programme (Engauge); not reported whether this is a mean value
This test has only 12% power at alpha=0.05