Sondra T. Perdue

A Randomized, Controlled Trial of a Behavioral Intervention to Prevent Sexually Transmitted Disease among Minority Women

BACKGROUND African-American and Hispanic women are disproportionately affected by sexually transmitted diseases, including the acquired immunodeficiency syndrome (AIDS). In the effort to reduce infection rates, it is important to create and evaluate behavioral interventions that are specific to the target populations. METHODS We enrolled women with nonviral sexually transmitted diseases in a randomized trial of a sex- and culture-specific behavioral intervention. The intervention consisted of three small-group sessions of three to four hours each designed to help women recognize personal susceptibility, commit to changing their behavior, and acquire necessary skills. The control group received standard counseling about sexually transmitted diseases. The design of the intervention was based on the AIDS Risk Reduction Model and ethnographic data on the study populations. Participants in both groups underwent screening, counseling, and an interview before randomization and at the 6- and 12-month follow-up visits. The principal outcome variable was subsequent chlamydial or gonorrheal infection, which was evaluated on an intention-to-treat basis by logistic-regression analysis. RESULTS A total of 424 Mexican-Americans and 193 African-American women were enrolled; 313 were assigned to the intervention group and 304 to the control group. The rate of participation in the intervention was 90 percent. The rates of retention in the sample were 82 and 89 percent at the 6- and 12-month visits, respectively. Rates of subsequent infection were significantly lower in the intervention group than in the control group during the first 6 months (11.3 vs. 17.2 percent, P=0.05), during the second 6 months (9.1 vs. 17.7 percent, P=0.008), and over the entire 12-month study period (16.8 vs. 26.9 percent, P=0.004). CONCLUSIONS A risk-reduction intervention consisting of three small-group sessions significantly decreased the rates of chlamydial and gonorrheal infection among Mexican-American and African-American women at high risk for sexually transmitted disease.

Prevention of gonorrhea and chlamydia through behavioral intervention: Results of a two-year controlled randomized trial in minority women

Background: Sexually transmitted disease (STD), including AIDS, disproportionately affects African-American and Hispanic women. Goal: To evaluate efficacy of standard and enhanced (addition of optional support groups) gender- and culture-specific, small-group behavioral interventions, compared to interactive STD counseling, in high risk minority women for two years. Methods: Women with a non-viral STD were treated and enrolled in a randomized trial. Follow-up screens and interviews occurred at 6 months, 1 year, 18 months (short interview, optional exam) and 2 years. The primary outcome was subsequent infection with chlamydia and/or gonorrhea. Secondary outcomes included risky sexual behaviors. We employed logistic regression based on intention-to-treat. Results: Data from 775 women were included; the retention rate was 91%. Adjusted infection rates were higher in the controls in Year 1 (26.8%), Year 2 (23.1%), and cumulatively (39.8%) than in the enhanced (15.4%, P = 0.004; 14.8%, P < 0.03; 23.7%, P < 0.001, respectively) and standard (15.7%, P = 0.006; 14.7%, P = 0.03; 26.2%, P < 0.008, respectively) intervention arms at these time points. Enhanced-intervention women who opted to attend support groups (attendees) had the lowest adjusted infection rates in Year 1 (12.0%) and cumulatively (21.8%). Intervention women in general, but particularly attendees, were significantly less likely than controls to have repeat infections. Multiple partners and unprotected sex with an untreated or incompletely treated partner helped explain group differences in infection. Conclusions: Risk-reduction interventions significantly decreased both single and multiple infective episodes with chlamydia and/or gonorrhea and risky sexual behaviors in the two-year study period. Support-group attendance appeared to contribute additional risk reduction in Year 1.

Behaviors changed by intervention are associated with reduced STD recurrence: the importance of context in measurement.

Background Evaluations of STD/HIV interventions incorporating behavioral and biologic outcomes have not reported strong correspondence. Goal The goal of the study was to demonstrate that behaviors, measured comprehensively, are associated with infection and to delineate the behaviors responsible for reduced infection rates in Project SAFE (Sexual Awareness For Everyone). Study Design Follow-up data from an intervention trial were analyzed to determine: (1) study versus control differences in complex risk behaviors and (2) the overall relationship between these behaviors and infection status (chlamydia and/or gonorrhea), with use of multiple logistic regression. Results Lower infection rates among 249 women who received intervention (compared with 228 controls) were explained by reduced-risk status in 5 modifiable behaviors. The 0 to 12–month logistic regression model (including sex with untreated partner [OR = 5.6], lack of mutual monogamy [OR = 2.4], unsafe sex [OR = 1.9], rapid partner turnover [OR = 2.7], and douching after sex [OR = 1.9]) correctly predicted infection status for 75.3% of participants (71.8% of infected, 76.2% of uninfected). Women in nonmutually monogamous unions who had sex with partners who were untreated or incompletely treated were 13 times more likely to be infected than those who were monogamous and avoided sex with an untreated/incompletely treated partner. Conclusion This intervention reduced infection rates by maintaining low-risk behaviors and changing high-risk behaviors. We elucidated the complex relationship between behavior and infection by incorporating context into variable conceptualization and considering several behaviors simultaneously.

A chlamydial type III-secreted effector protein (Tarp) is predominantly recognized by antibodies from humans infected with Chlamydia trachomatis and induces protective immunity against upper genital tract pathologies in mice.

Chlamydia trachomatis genome is predicted to encode a type III secretion system consisting of more than 40 open reading frames (ORFs). To test whether these ORFs are expressed and immunogenic during chlamydial infection in humans, we expressed 55 chlamydial ORFs covering all putative type III secretion components plus control molecules as fusion proteins and measured the reactivity of these fusion proteins with antibodies from patients infected with C. trachomatis in the urogenital tract (24 antisera) or in the ocular tissue (8 antisera). Forty-five of the 55 proteins were recognized by at least 1 of the 32 human antisera, suggesting that these proteins are both expressed and immunogenic during chlamydial infection in humans. Tarp, a putative type III secretion effector protein, was identified as a novel immunodominant antigen due to its reactivity with the human antisera at high frequency and titer. The expression and immunogenicity of Tarp were confirmed in cell culture and mouse systems. Tarp was mainly associated with the infectious form of chlamydial organisms and became undetectable between 13 and 24 h during the infection cycle in cell culture. Mice intravaginally infected with C. muridarum developed Tarp-specific humoral and cellular immune responses. More importantly, immunization of mice with Tarp induced Th1-dominant immunity that significantly reduced the shedding of live organisms from the lower genital tract and attenuated inflammatory pathologies in the fallopian tube tissues. These observations have demonstrated that Tarp, an immunodominant antigen identified by human antisera, can induce protective immunity against chlamydial infection and pathology in mice.

Cervicitis and genitourinary symptoms in women culture positive for Mycoplasma genitalium.

Problem  Mycoplasma genitalium has been associated with male urethritis. We sought to relate M. genitalium to genitourinary signs and symptoms in women.

Sexual abuse and sexual risk behaviors of minority women with sexually transmitted diseases

The relationship between sexual abuse and sexually transmitted disease (STD) represents an important and underinvestigated context of domestic violence. This study examined the association between sexual abuse, sexual risk behaviors, and risk for reinfection and HIV among minority women with STD. Mexican American and African American women (n = 617) with active STD entered a randomized study of behavioral intervention to reduce STD recurrence. Each underwent questioning at entry regarding sexual abuse and sexual risk behaviors. Comparisons of these behaviors using chi-square, t tests, and logistic regression were made by history of sexual abuse. Sexually abused women were more likely to have lower incomes, earlier coitus, STD history, currently abusive partners, new sex partners, anal sex, and bleeding with sex, placing them at increased risk for STD reinfection and HIV. Due to this association with sexual risk behavior, assessment for sexual abuse is essential in programs focusing on STD/HIV prevention.

Mycoplasma genitalium symptoms, concordance and treatment in high-risk sexual dyads.

The objective of this study was to determine the prevalence and concordance of Mycoplasma genitalium (MG) among Mexican American and African American women and their male sexual partners. Secondary objectives were to determine symptoms of MG infection and persistence of MG after antibiotic therapy. Heterosexual couples were tested for MG and interviewed separately regarding symptoms and behavioural/epidemiologic variables at baseline, six and 12 months. The overall prevalence of MG among women and men was 9.5% and 10.6%, respectively. Subjects were five times more likely to be infected with MG if their sexual partner was MG positive. Among men and women, MG prevalence and mean bacterial loads were similar after receiving single-dose azithromycin, doxycycline or no antibiotics. MG was associated with current urethral discharge in men. No clinical symptoms were specifically diagnostic of MG infection in women.

Preventing recurrent sexually transmitted diseases in minority adolescents: a randomized controlled trial.

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

Relationship of abuse and pelvic inflammatory disease risk behavior in minority adolescents

Purpose Little is known about the relationship between minority adolescents experiences of sexual or physical abuse and the pathology of gynecological symptoms that might have an impact on the diagnosis of sexually transmitted disease (STD) or risk for pelvic inflammatory disease (PID). The objective of this study was to determine the relationship of sexual or physical abuse to the pathology of genitourinary symptoms that impact diagnoses of STD and risk for PID among Mexican American and African American adolescent women with a current STD. Methods Mexican American and African American adolescent women (n = 373) with an STD underwent a targeted physical exam and questioning regarding sexual or physical abuse, current genitourinary symptomatology, and risk behaviors known to be associated with PID to determine the relationship of sexual or physical abuse to the pathology of genitourinary symptoms that impact diagnoses of STD and risk for PID. Results Bivariate comparisons found that abused adolescents (n = 232) reported more behaviors associated with increased risk for PID, including earlier coitus, more sex partners, higher STD recurrence, and delayed health‐seeking behavior. Multivariate comparisons found that abused adolescents were more likely to report pathologic genitourinary symptomatology than those who were not abused. Clinicians reported more abnormal physical exams but did not make any more presumptive diagnoses of PID for abused than nonabused adolescents. Conclusions Delayed treatment for PID dramatically worsens future fertility and chronic pelvic pain. These findings demonstrate that abused adolescent women are at high risk for PID. Because of its considerable impact on risk for PID, an assessment for abuse is essential in clinical management of adolescent women with STD and diagnosis of PID.

Minority women with sexually transmitted diseases: Sexual abuse and risk for pelvic inflammatory disease

Mexican American and African American women (N = 617) with a sexually transmitted disease (STD) underwent a targeted physical exam and questioning regarding sexual abuse, current genitourinary symptomatology, and pelvic inflammatory disease (PID) risk behaviors to determine the relationship between sexual abuse and risk for PID. Sexually abused women (n = 194) reported higher PID risk behaviors, including earlier coitus, more sex partners, higher STD recurrence, and a tendency toward delayed health-seeking behavior. They also reported more severe genitourinary symptomatology, confirmed by physical exam, and presumptive diagnoses of PID. These characteristics identify sexually abused women at high risk for PID. Because of its considerable impact on risk for PID, assessment for sexual abuse is essential in clinical management of women with STD and for diagnosis of PID.