Obstetrics & Gynecology:
Preventing Recurrent Sexually Transmitted Diseases in Minority Adolescents: A Randomized Controlled Trial
Thurman, Andrea Ries MD1; Holden, Alan E. C. PhD1; Shain, Rochelle N. PhD1; Perdue, Sondra DrPh1; Piper, Jeanna M. MD2
From the 1Department of Obstetrics and Gynecology, University of Texas Health Sciences Center San Antonio, San Antonio, Texas; and the 2National Institutes of Health, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.
Supported by a grant (U01 AI40029) from the National Institute of Allergy and Infectious Diseases.
Corresponding author: Andrea Ries Thurman, MD, Assistant Professor, Obstetrics and Gynecology, University of Texas Health Sciences Center San Antonio, 7703 Floyd Curl Drive, Mail Code 7836, San Antonio, TX 78229-3900; e-mail: email@example.com.
Financial Disclosure The authors have no potential conflicts of interest to disclose.
OBJECTIVE: To compare the efficacy of a randomized controlled trial of the Sexual Awareness For Everyone (SAFE) behavioral intervention on teenagers (aged 14 to 18 years) compared with adult rates of reinfection with Neiserria gonorrhea or Chlamydia trachomatis cervicitis, and to identify behaviors associated with recurrent infection.
METHODS: Mexican-American and African-American females with a nonviral sexually transmitted disease (STD) were enrolled in SAFE or assigned to the control group. All participants were interviewed and examined at baseline, 6, and 12 months. The primary outcome variable was reinfection with N. gonorrhea or C. trachomatis. Secondary outcomes were changes in risky sexual behavior.
RESULTS: Teens randomized to participation in SAFE had a statistically lower incidence of recurrent N. gonorrhea and C. trachomatis at 0 to 6 months (52%, P=.04) and cumulatively (39%, P=.04) compared with teens in the control group. Cumulatively, teens as a group had higher rates of reinfection (33.1%) than adults (14.4%) (P<.001). Adolescent reinfection was explained by unprotected sex with untreated partners (adjusted odds ratio [OR] 5.58), nonmonogamy (adjusted OR 5.14), and rapid partner turnover (adjusted OR 2.02). In adults, reinfection was predicted by unprotected sex with untreated partners (adjusted OR 4.90), unsafe sex (adjusted OR 2.18), rapid partner turnover (adjusted OR 3.13), and douching after sex (adjusted OR 2.14).
CONCLUSION: Sexual Awareness for Everyone significantly reduced recurrent STDs in teenagers. Adults and teens randomized to the SAFE intervention had significant decreases in high-risk sexual behaviors as compared with those in the control group. Although not specifically designed for teens, the SAFE intervention worked very well in this high-risk population.
CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov, ClinicalTrials.gov, HSC2004415H
LEVEL OF EVIDENCE: I
In a previous randomized controlled trial (RCT), we found that the Sexual Awareness For Everyone (SAFE) behavioral intervention significantly reduced the rate of recurrent Neiserria gonorrhea and Chlamydia trachomatis infections among reproductive-age Mexican-American and African-American women.1 Subsequently, we found that risk reduction was largely explained by five modifiable behaviors: unprotected sex with untreated partners, lack of mutual monogamy, unsafe sex (defined as never using condoms with one or more casual sexual partners or more than five unprotected sex acts in the past 3 months and incorrect or problematic condom use), rapid (less than 3 months) partner turnover, and douching after intercourse.2
Our cohort included minority females at high risk for recurrent sexually transmitted diseases (STDs). All had a current STD, and 70% were under 24 years old.3 Mexican-American and African-American women are disproportionately affected by STDs.3 In the United States in 2005, the incidence of C. trachomatis per 100,000 population was 1,729 in African-American females, 733 in Mexican-American females, and 237 in Caucasian females.3 Adolescents are at the highest risk for STDs, with one in four sexually active teens acquiring an STD each year.4,5
There is much debate on how to alter high-risk sexual behavior in adolescents.6–14 It is assumed that teens and adults have different cognitive processes, life stressors, motivations, and life conditions that may influence behavior change. In this secondary analysis, our goal was to answer two questions: 1) was the SAFE intervention equally effective in preventing recurrent STDs in adolescents and adults, and 2) what modifiable behaviors accounted for differences in reinfection among the two cohorts?
This study was approved by the Institutional Review Boards at the University of Texas Health Science Center at San Antonio and the San Antonio Metropolitan Health District. The methods of this RCT have been published previously.1 Briefly, Mexican-American and African-American females, aged 14 to 45 years, diagnosed with a nonviral STD including Neiserria gonorrhea, Chlamydia trachomatis, syphilis, and Trichomonas vaginalis, were contacted by our research clinic. Participants were randomized to the SAFE intervention or the control group. The randomization scheme is presented in detail in the original publication and was stratified by ethnicity.1 Figure 1 details the enrollment of the original SAFE cohort and the present subset analysis.
In the control group, individual STD risk reduction counseling, lasting approximately 15 minutes, was provided by nurse clinicians according to guidelines issued by the Centers for Disease Control and Prevention.15 Those in the study group received the SAFE intervention, which entailed three, weekly, 3-hour, small group, multicomponent behavioral cognitive interventions.1 The sessions consisted of an average of five or six (range 3–12) participants and a female facilitator, all of the same ethnicity. We adapted the acquired immunodeficiency syndrome (AIDS) Risk Reduction Model to guide intervention development, supplemented with extensive ethnographic data to ensure suitability to our population.16,17 At intervention sessions, we used role-playing, interactive video, handouts, and group discussion to emphasize the preventive strategies of abstinence, periodic abstinence, mutual monogamy, correct and consistent use of condoms, full compliance with treatment protocols, reduction in the number of partners, avoidance of sexual intercourse until the participant and her partner(s) completed treatment, taking time between partners to be selective, avoidance of douching, and seeking medical care whenever a participant suspected infection.1 Overall goals were to have participants recognize their risk for contracting STDs, including human immunodeficiency virus (HIV), commit to behavior change, and acquire the necessary skills to effect change.
All participants were interviewed, examined, screened, and treated for STDs at baseline and at 6 and 12 months of follow-up. Subjects were encouraged to return to our clinic as needed for any symptoms of or concern for reinfection. At each visit a targeted physical examination was performed, with collection of specimens for microbiologic testing, including N. gonorrhea, C. trachomatis, syphilis, and Trichomonas vaginalis. At each visit, participants were offered a test-of-cure after treatments and HIV testing.
The primary outcome of the study was subsequent reinfection with C. trachomatis or N. gonorrhea. Secondary outcomes included the presence or absence of risky sexual behaviors. At baseline and 6 and 12 months, a trained research assistant interviewed each participant regarding sexual risk behaviors, condom use, physical symptoms, partner-specific data, depression and emotional stressors, perception of their risk for STD and HIV acquisition, and other sociodemographic and psychosocial questions. For this analysis, we divided the participants into adolescents (aged 14 to 18 years) and adults (aged 19 years or older). We chose to subdivide the teens at age 18 because we hypothesized that age 18 often marks several transitions, including graduation or leaving school and moving away from home.18
Bivariate relationships between independent variables first were explored using Pearson’s χ2 test. We analyzed behavioral changes from baseline at 0 to 6 months, 6 to 12 months, and cumulative intervals using mutivariate logistic regression analysis and adjusted P values for group differences for baseline behaviors, when these baseline measures were available. In the final analysis, we used multivariate logistic regression to determine the relative effect of each behavior on reinfection compared with “no infection.” In presenting these results, we retained all behavioral risk measures in the analyses to maintain model symmetry.
There were 164 teens and 313 adults in the SAFE study with complete infection and behavioral data at baseline, 6, and 12 months’ follow-up.1 Because the goal of this study was to examine reinfection and high-risk sexual behaviors, we used this subset of the SAFE cohort for our analysis. We excluded sixteen 14- to 15-year-old girls who had a history of sexual abuse (defined as coital debut before age 11 and/or reporting that they had had “bad sexual experiences like rape or sexual abuse in the past,” and/or that their first episode of vaginal or anal sex was involuntary). Secondary analysis of infection data (not shown) found that the SAFE intervention was effective even for females with an abuse history, except for those who were 14 to 15 years old at intake. In addition, this small subset was disproportionately represented in the intervention group (12 of 16) and had high rates of reinfection (9/16, 56.3% cumulatively) and ongoing high-risk behaviors; their inclusion would cloud our understanding of reinfection and behavior patterns. Thus, 148 teens and 313 adults (n=461) remained for analysis. Attrition rates did not differ significantly between groups for any subgroup analysis. Intervention participation rates (before the 6-month visit) were 92% for at least one session, 82% for at least two sessions, and 79% for all three sessions. Among the adolescent and adult study groups, 79.5% and 78.9% attended all three sessions, respectively.
Table 1 shows the baseline characteristics of adolescents versus adults. The groups were not different with respect to the following baseline risky sexual behaviors: multiple sexual partners, recent unsafe sex, recent anal sex, douching after sex, binge drinking (defined as drinking five or more alcoholic beverages at a party), illicit drug use, and being in a nonmonogamous, nonsteady relationship. Significantly more teens lived in impoverished homes, defined by the household income being below the federal poverty threshold for the year the individual enrolled in our study. The teens and adults were similar in their baseline prevalence of N. gonorrhea (10.2% versus 8.5%, P=.83) or C. trachomatis (53.0% versus 54.9%, P=.70); however the adults were significantly more likely to have an index infection of either T. vaginalis or syphilis. When asked the question, “Do you plan to make any changes in your life to lower your chances of catching another STD or the AIDS virus,” 97.0% of teens and 95.5% of adults responded affirmatively (P=.44). In addition, few teens or adults perceived any barriers to making behavioral change, such as upsetting a man they really liked, messing up their relationship, losing their man, fear of being alone, or embarrassment about discussing condom use (data not shown). Most teens (83.5%) and adults (82.3%) (P=.74) reported that they sought medical attention “right away” for “female symptoms.” Only 16.6% of teens and 16.1% of adults (P=.90) reported that being in a relationship with a man was the “most important thing” in life. The teens and adults were similar in their responses to “it is a good idea to have a man on the side” (9.9% versus 12.1% P=.71), “I could support myself financially without a man’s help” (72.2% versus 74.0% P=.67), and “I feel discriminated against based on my ethnicity” (26.5% versus 29.3% P=.53).
Cumulatively, 33.1% of teens (49/148) and 14.4% (45/313) of adults had a recurrent STD (P<.001, relative risk 2.30, 95% confidence interval 1.62–3.28). However, Table 2 shows that teens in the study group responded well to the SAFE intervention; they had significantly lower reinfection rates than teens in the control group at 0 to 6 months and, cumulatively, 0 to 12 months, with a strong trend toward lower reinfection rates at 6 to 12 months (P=.06). None of the participants tested positive for HIV during the study. Of note, among the larger subset of 533 women for whom we have complete infection but not behavioral data,1,2 significant reductions in reinfection rates are evident for teens and adults in the study group versus those in the control group (cumulative re-infection in study versus control teens=24.1% versus 40.2%, P=.02); cumulative re-infection in study versus control adults=10.4% versus 18.6%, P=.03).
Table 3 illustrates how adolescents and adults modified high-risk sexual behaviors at each interval. At baseline, those in the study and control groups were not different in high-risk behaviors, except the teens in the study group were significantly more likely to douche after intercourse than were teens in the control group. Teens in the study group showed significant reductions in several high-risk behaviors, at various time intervals, as compared with teens in the control group. Despite beginning with higher rates of douching, teens randomized to SAFE had significantly lower cumulative douching rates than those in the control group. Teens in the study group did not maintain the safe sex behaviors they achieved at 0 to 6 months and conversely did not attain significant improvements (versus those in the control group) in mutual monogamy and rapid partner turnover until 6 to12 months. Importantly, teens in the study group were not different from teens in the control group in avoiding unprotected sex with untreated partners (P>.05 at each follow-up interval).
Cumulatively, the adults in the study group maintained significant reductions or strong trends (nonmutually monogamous relationships [P=.07]) in all high-risk behaviors compared with adults in the control group, except rapid partner turnover, which took 6 months to reduce significantly.
Contrast Table 3, which shows how the cohorts behaved at each follow-up interval, with Table 4, which demonstrates how each high-risk behavior predicted reinfection. The adjusted (for each behavior in the model) odds ratios (ORs) in Table 4 show the degree to which each behavior predicted reinfection. For teens as a group, unprotected sex with untreated partners was consistently associated with the highest adjusted ORs for reinfection. Table 3 illustrates that the SAFE intervention did not sufficiently influence this behavior in teens in the study group. Cumulatively (0–12 months), reinfection in teens was significantly predicted by unprotected sex with untreated partners, rapid (less than 3 months) partner turnover, and nonmonogamy. Unprotected sex with untreated partners also was associated with the highest risk for reinfection in adults. Cumulative reinfection in adults was significantly associated with unsafe sex, rapid partner turnover, and douching after sex. Analysis of the attributable risk of behaviors (risk of those with behavior minus risk of those without) were consistent with the ranking of behavioral risks based on adjusted OR. Attributable risk was the highest for unprotected sex with untreated partners: .40 for teens and .27 for adults after adjusting for other factors in the model.
Cumulative regression analysis for teens predicted 75.0% of reinfections and correctly classified 74.5% of teens who were not reinfected and 75.9% of teens who experienced recurrent N. gonorrhea or C. trachomatis. In the teen multivariate logistic regression model, we used forward-step multivariate logistic regression analysis to also test the effect of pregnancy, illegal drug use, poverty status, early coital debut, and abuse on reinfection, but only the five behavior variables were independently associated with recurrent infection in teens (data not shown). For adults, the cumulative regression model predicted 70.6% of reinfections and correctly classified 70.1% of adults not reinfected and 73.3% of adults who were reinfected. Similarly, in the adult multivariate logistic regression model, we used forward-step logistic regression to also test the impact of abuse, lives with a sexual partner, and pregnancy on reinfection, but none of these variables was independently associated with recurrent N. gonorrhea or C. trachomatis (data not shown).
Although not specifically designed for adolescents, the SAFE intervention not only significantly decreased recurrent C. trachomatis or N. gonorrhea, the primary biologic outcome, but also reduced risky sexual behaviors among adolescents. However, teens in the study group had higher reinfection rates than corresponding adults because the behavior that was most highly and consistently associated with recurrent infection in teens—unprotected sex with untreated partners—was not sufficiently modified by the SAFE intervention. Additionally, teens in the control arm continued high-risk sexual behavior throughout the study at levels that were higher than adults randomized to the control group.
At baseline, our adolescent participants demonstrated significantly higher rates of poverty, early coital debut, multiple sexual partners, teen pregnancy, and illegal drug use (excluding marijuana), factors associated with risky behavior and recurrent STDs.19 This analysis extends our understanding of which risk-reduction strategies should be emphasized to adolescent girls with an STD, as compared with their adult counterparts, to decrease their risk of reinfection. Unprotected sex with untreated partners was associated with a 6- to 10-fold increased risk of reinfection in teens. This suggests a powerful message: the health care professional who diagnoses an STD in a teen can have a significant impact on reducing reinfection by explaining to the adolescent that she must avoid intercourse until she and her partner(s) are completely treated. Other issues such as rapid partner turnover and mutual monogamy must be stressed, but the adjusted ORs for these behaviors were not as high.
Our findings suggest that some teens either did not understand that they had to avoid intercourse until all infected partners were treated, or they assumed they were protected by antibiotics. Alternatively, the teens may have been more concerned about maintaining the relationship than becoming reinfected. It is possible that the teens’ partners were less likely to be treated than the adults’ partners.20–25 Finally, the partners of teens may have been inherently more risky than the partners of adults in terms of their acquisition of new STDs or other risk factors which we did not measure.26,27
Many of the adults and teens reported abuse at intake. Self-efficacy and relationship power are important components of a woman’s ability to convince her partner(s) to complete treatment and use condoms.10,11,25,28 It has been shown that inconsistent condom use is more common in teens with lower self-efficacy scores.10,12,28 SAFE was designed to empower minority women to make positive changes in their lives. Although the teens had higher rates of illegal drug use, drug use was not independent in predicting reinfection in the multivariate regression analysis. Previous authors found that behavioral intervention, even in adolescent substance abusers, can improve knowledge of STD risk and increase condom use.14
A limitation of our study is that we did not involve the teens’ parents or partners in the intervention, who may be able to support the adolescent in changing high-risk sexual behaviors and reducing recurrent infection.29 However, a third SAFE RCT, currently underway, enrolls the male sexual partners of the index female patients. The major strength of our study was that it was a RCT with a primary biologic outcome. Other RCTs designed to prevent HIV or STDs in adolescents have used self-reported behaviors, such as condom and contraceptive use, alcohol consumption, gang involvement, number of sexual partners, or HIV risk-reduction knowledge as primary outcomes, which may be confounded by reporting or recall bias and are difficult to validate.30–34 It has been shown that adolescent reports of STD status and other high-risk sexual behaviors are subject to bias.33 Our findings suggest that the teens in the study group benefited from their interactions with the adult subjects in the intervention sessions. Maybe the teens learned from the adults’ experiences or otherwise bonded with the young adults in the study. It has been shown that minority populations benefit from ethnically matched group facilitators and that adolescent’s perceptions of group norms are important in determining individual high-risk behaviors.7,12 Our study population was primarily Mexican American, the fastest growing segment of the United States, according to the Census Bureau. Other RCTs designed to prevent high risk sexual behaviors in adolescents, such as the SISTA intervention or the Sister-to-Sister: The Black Women’s Health Project, which included biologic outcomes, have focused primarily on African-American women.31,35–37 The SAFE intervention is also unique because we emphasized seeking medical attention for signs and symptoms of an STD. It is known that a history of an STD is a strong risk factor for recurrent STDs4 and that the sequela of STDs can be prevented by routine screening.38 In a review of behavioral interventions to decrease high risk teen sexual behavior, Kirby found that effective programs focused on reducing specific behaviors and included activities that addressed social pressures that influence sexual behavior, which is part of the SAFE intervention.6
In conclusion, teens randomized to the SAFE intervention had significant decreases in recurrent N. gonorrhea and C. trachomatis. Intervention designed to prevent recurrent STDs in teens needs to emphasize skills to help teens ensure their partners are treated or to otherwise refuse intercourse. Understanding how each age group’s reinfection rates are influenced by specific behaviors will help health professionals communicate age-appropriate STD risk-reduction strategies.
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