Table 2.
Characteristics of 74 Randomized Controlled Trials Evaluating 75 STI Prevention Interventions
| First Author, Year (Reference No.) | Follow-up Rate, %a | Adherence, %b | Decreased Risk-taking Behavior During the Studyc | Accounting by Analysis for Differential Person-Time or Testing Frequency | Effect on STI Riskd | ||
| Intervention | Control | Intervention | Control | ||||
| Behavioral Interventions | |||||||
| Boyer, 1997 (11) | 72 | 48 | NR | Yes | Yes | No | No effect |
| Branson, 1998 (12) | 72 | 47e | NR | Yes | Yes | No | No effect |
| NIMH Multisite HIV Prevention Trial Group, 1998 (13) | 70 | 63f | NR | Yes | Yes | NA | No effect |
| Kamb, 1998 (14) and Gottlieb, 2004 (15) | 81 | 85 | 85 | Yes | Yes | Yes | Positive |
| Metcalf, 2005 (16) | 69 | 68 | 73 | Transient | NR | NR | No effect |
| Metcalf, 2005 (17) | 87 | 99 | 69 | Transient | NR | Yes | Adverse |
| Shain, 1999 (18) and 2002 (19) | 89 | 75 | NR | Yes | Yes | No | Positive |
| Shain, 2004 (20) | >90 | 86g | NR | NR | NR | Yes | Positive |
| VCT Efficacy Study Group, 2000 (21) | 73 | NR | NR | Yes | Yes | NA | No effect |
| Hobfoll, 2002 (22) | 77 | NR | NR | Yes | Yes | NA | Positive |
| Baker, 2003 (23) | 73 | NR | NR | Yes | Yes | No | No effect |
| Kamali, 2003 (24) | >70 | NR | NR | Yes | Yes | Yes | Positive |
| DiClemente, 2004 (25) | 90 | 95 | 94 | Yes | Yes | Yes | Positive |
| Wingood, 2004 (26) | 93 | 95 | 98 | Yes | Yes | Yes | Positive |
| Downs, 2004 (27) | 86 | NR | NR | Yes | Yes | NA | No effect |
| Artz, 2005 (28) | 84 | NR | 100 | Yes | Yes | Yes | No effect |
| Boyer, 2005 (29) | 38 | 85 | 86 | NR | NR | Yes | Positive |
| Feldblum, 2005 (30) | 90 | NR | NR | Yes | Yes | NA | Positive |
| Jemmott, 2005 (32) | 82 | 100 | 100 | Yes | No | NA | Positive |
| Jemmott, 2007 (33) | 85 | 100 | 100 | Yes | Yes | Yes | Positive |
| Jewkes, 2008 (34) | 80 | No | No | Yes | Positive | ||
| Men | 61h | 68h | |||||
| Women | 59h | 64h | |||||
| Patterson, 2008 (35) | 82 | 100 | 100 | Yes | Yes | NA | Positive |
| Peipert, 2008 (36) | 93 | NR | 100 | NR | NR | Yes | Positive |
| Warner, 2008 (37) | NA | 76i | 100i | NR | NR | Yes | Positive |
| Crosby, 2009 (38) | 100 | 100 | 100 | Yes | Yes | No | Positive |
| Grimley, 2009 (39) | 66 | 100 | 100 | Yes | Yes | NA | Positive |
| Marion, 2009 (40) | 53 | 48 | 58 | Yes | Yes | Yes | Positive |
| Physical Barrier Methods | |||||||
| Fontanet, 1998 (41) | 92 | NR | NR | Yes | No effect | ||
| Female condoms | 12j | ||||||
| Male or female condoms | 97j | 98j | |||||
| Feldblum, 2001 (42) | 91 | Yes | Yes | NA | No effect | ||
| Female condoms | 7k | ||||||
| Male condoms | 22k | 24k | |||||
| Steiner, 2006 (43) | 86 | 56l | 54l | Yes | Yes | Yes | No effect |
| Ramjee, 2008 (44) and Sawaya, 2008 (45) | 98 | NR | NR | Yes | No effect | ||
| Diaphragm/gel | 51m | ||||||
| Male condoms | 77m | 87m | |||||
| Vaginal Microbicides | |||||||
| Cutler, 1977 (46) | 43 | NR | NR | NR | NR | Yes | No effect |
| Rendon, 1980 (47) | 56 | NR | NR | NR | NR | Yes | No effect |
| Rosenberg, 1987 (48) | NR | NR | NR | NR | NR | Yes | Positive |
| Louv, 1988 (49) | 78 | NR | NR | NR | NR | Yes | Positive |
| Niruthisard, 1992 (50) | 76 | 47n | 48n | NR | NR | Yes | No effect |
| Kreiss, 1992 (51) | 84 | 81o | 90o | Yes | Yes | Yes | Positive |
| Roddy, 1998 (52) | 91 | 87p | 84p | Yes | Yes | Yes | No effect |
| Richardson, 2001 (53) | 94 | 75o | 80o | NR | NR | Yes | Adverse |
| Roddy, 2002 (54) | 99 | 76p | NA | No | No | Yes | Adverse |
| Van Damme, 2002 (55) | 86 | 82p | 82p | NR | NR | Yes | No effect |
| Van Damme, 2008 (56) | 98 | 87p | 87p | NR | NR | Yes | No effect |
| Halpern, 2008 (57) | 70 | 76q | 80q | Yes | Yes | Yes | No effect |
| Male Circumcision | |||||||
| Mattson, 2008 (58) and Mehta, 2009 (59) | 95 | NA | NA | Yes | Yes | Yes | No effect |
| Sobngwi-Tambekou, 2009 (60) and Auvert, 2009 (61) | NR | NA | NA | NR | NR | NA | Positive |
| Tobian, 2009 (62) | 92 | NA | NA | No | No | Yes | Positive |
| Gray, 2009 (63) | 95 | NA | NA | Yes | Yes | NA | Positive |
| Partner Services | |||||||
| Lyng, 1981 (64) | 89 | NR | NR | NR | NR | NA | Positive |
| Schillinger, 2003 (65) | 81 | NR | NR | No | No effect | ||
| Patients with 1 partner | 82r | 75r | |||||
| Patients with >1 partner | 47r | 25r | |||||
| Golden, 2005 (66) | 68 | 61s | 49s | NR | NR | NA | Positive |
| Kissinger, 2005 (67) | 30 | 70t | 49t | NR | NR | NA | Positive |
| Kissinger, 2006 (68) | 81 | 82t | 88t | NR | NR | NA | No effect |
| Cameron, 2009 (69) | 65 | 32u | 34u | NR | NR | Yes | No effect |
| Wilson, 2009 (70) | 86 | NR | NR | Yes | Yes | NA | Positive |
| Treatment | |||||||
| Harrison, 1979 (71) | 75 | 100 | 100 | NR | NR | NA | Positive |
| Wawer, 1999 (72) | 77 | >90v | >90v | Yes | Yes | NA | Positive |
| Kaul, 2004 (73) | 89 | 92w | 92w | Yes | Yes | Yes | Positive |
| McClelland, 2008 (74) | 98 | 92x | 92x | NR | NR | Yes | No effect |
| Schwebke, 2007 (75) | 85 | NR | NR | NR | NR | Yes | Positive |
| Corey, 2004 (76) | 78 | 70y | 70y | NR | NR | Yes | Positive |
| Mayaud 1997 (78) | 71 | NR | NR | No | No | NA | Positive |
| Kamali, 2003 (24) | >70 | NR | NR | Yes | Yes | Yes | Positive |
| Vaccines and Passive Immunization | |||||||
| Szmuness, 1981 (80) | >85 | 95 | 92 | NR | NR | Yes | Positive |
| Francis, 1982 (81) | >84 | 87 | 84 | NR | NR | Yes | Positive |
| Coutinho, 1983 (82) | 96 | 97 | 98 | NR | NR | Yes | Positive |
| Piazza, 1997 (83) | 98 | 100 | 100 | NR | NR | Yes | Positive |
| Corey, 1999 (84) | NR | 76 | 78 | Yes | Yes | Yes | No effect |
| Stanberry, 2002 (85) | >81 | 91 | 91 | NR | NR | Yes | No effect |
| Koutsky, 2002 (86) | 81 | NR | NR | NR | NR | Yes | Positive |
| Harper, 2006 (88) | 85 | 93 | 93 | NR | NR | Yes | Positive |
| Paavonen, 2009 (91) | >90 | 92 | 92 | NR | NR | Yes | Positive |
| Villa, 2006 (93) | 98 | 92 | 95 | NR | NR | Yes | Positive |
| Munoz, 2009 (100) | >96 | 97 | 97 | NR | NR | Yes | Positive |
| Wheeler, 2009 (101) | 97 | 97 | 97 | NR | NR | Yes | Positive |
| Multicomponent Interventions | |||||||
| Ross, 2007 (103) | 73 | NR | NR | Yes | NR | NA | Adverse |
Abbreviations: HIV, human immunodeficiency virus; HPV, human papillomavirus; NA, not applicable; NIMH, National Institute of Mental Health; NR, not reported; PDPT, patient-delivered partner therapy; STI, sexually transmitted infection; VCT, Voluntary HIV-1 Counselling and Testing.
The “follow-up rate” refers to the proportion of enrolled subjects included in the analysis of effect, except for 2 studies that included all randomized subjects in the analysis of effect, irrespective of attendance at study visits (16, 17), and 1 study that evaluated gonorrhea and chlamydia among 98% of randomized subjects, while new-type HPV was evaluated among 75% of subjects from Zimbabwe (45).
For behavioral interventions, “adherence” refers to attendance at all intervention sessions, unless otherwise noted. For vaccine studies, “adherence” refers to receiving all required doses, unless otherwise noted.
Compared with behaviors reported at baseline. The behaviors assessed included reports of the following: not being abstinent, having unprotected intercourse (anal or vaginal), inconsistent condom use or no condom use at last sex, greater condom failure rates, greater number of partners in an interval, nonmonogamy, and douching after sex. Change not necessarily statistically significant.
Positive effect: intervention significantly reduced the risk of ≥1 laboratory-confirmed STIs in the intervention arm compared with the control arm; adverse effect: intervention significantly increased the risk of ≥1 laboratory-confirmed STIs in the intervention arm compared with the control arm; no effect: intervention showed no significant effect (positive or adverse) and, thus, the null hypothesis could not be rejected.
Attended 4 or 5 intervention sessions (of 5 total).
Attended 6 or 7 intervention sessions (of 7 total).
The proportion attending all 3 scheduled risk reduction counseling sessions; only 37% attended any of the 5 optional monthly support group sessions.
The proportion of men and women attending ≥75% of the 17 intervention sessions or completing the single control session.
The proportion in the intervention arm who reported viewing “most” or “all” of the intervention video and identifying at least of 1 of 5 target prevention messages; all individuals in the control arm experienced the “standard” waiting room environment.
The proportion of sex acts involving female condoms or involving male or female condoms.
The proportion of women reporting “consistent” use of female or male condoms.
The proportion of men reporting always using male condoms during the study.
The proportion who reported 100% diaphragm/gel use or using male condoms at least two-thirds of the time.
The proportion who were “ >75% compliant.”
The number of days that the assigned product was used divided by the total number of days that intercourse was reported.
The number of sex acts that the assigned product was used (with or without a condom) divided by the total number of sex acts reported.
The number of vaginal sex acts that the gel was used divided by the total number of vaginal sex acts reported at month 12.
The proportion of patients who reported that their partner was treated among those with only 1 partner, or who reported that all partners were treated among those with >1 partner.
The proportion with “all partners ‘very likely’ to have been treated.”
The proportion of patients successfully reinterviewed who reported giving PDPT to partner (intervention arm) or told partner to get treated (control arm).
The proportion of total partners tested and/or treated based on the number of PDPT slips returned (intervention arm) or verification in clinic and laboratory databases (control arm).
The proportion of enrolled residents who received treatment, calculated overall and not by study arm.
The proportion who received monthly directly observed therapy within 2 weeks of the scheduled follow-up visit; the adherence rate was calculated overall and not by study arm.
The proportion who received monthly directly observed therapy within 2 weeks of the scheduled follow-up visit.
The proportion who reported taking at least 95% of the prescribed doses, calculated overall and not by study arm.