SEXUALLY TRANSMITTED DISEASES (STDs) continue to be a major health threat in the United States. The Centers for Disease Control and Prevention (CDC) estimates 19 million STD infections, including HIV, occurring annually in the United States.1,2 Individuals who are infected with STDs are more likely to contract and transmit HIV through sexual contact than individuals who are not infected.3–5 Untreated STDs, including HIV, can cause adverse health consequences such as birth complications, infertility, cancers, and AIDS.6,7 STDs also pose a tremendous economic burden on society. Direct medical costs are estimated at $11.4 billion (in 2000 dollars) in a single year for all age groups, of which approximately $6 billion was used in treating sexually acquired HIV cases (Chesson HW, e-mail communication, October 2004). These figures underscore the importance of identifying interventions successful in reducing STD acquisition and sex behaviors related to HIV and STD transmission.
Ascertaining efficacious HIV/STD interventions for blacks and Hispanics in the United States is particularly pressing because these 2 racial/ethnic minority groups are disproportionally affected by the epidemics. Despite only comprising approximately 25% of the total U.S. population,8,9 blacks and Hispanics constitute an estimated 65% (48% and 17%, respectively) of all persons living with HIV/AIDS at the end of 2004.10 Blacks also account for the largest proportion of chlamydia, gonorrhea, and syphilis cases.1 To reduce such health disparity, it is important to identify and provide prevention to blacks and Hispanics who engage in high-risk sex behaviors for acquiring HIV or other STDs. STD clinics can be an ideal setting for reaching high-risk groups.11 Interventions offered during STD clinic visits for blacks and Hispanics who seek testing or medical treatment provide an important opportunity to modify high-risk sex behaviors, thus preventing HIV and STD transmission.
A few published systematic reviews have evaluated the efficacy of behavioral interventions to prevent HIV risk sex behavior and STD in various risk groups and populations,12–18 and some systematic reviews have specifically focused on clinic-based risk reduction interventions.11,19 However, it is unclear whether the recommendations from these previous reviews are applicable for black and Hispanic STD clinic patients in the United States because the previous reviews were not specifically focused on these 2 racial/ethnic groups. Numerous researchers have recommended the use of culturally tailored interventions for racial/ethnic minority populations to increase the relevance of their content and subsequent efficacy.20–24 Thus, it is important to examine whether intervention effects differ as a function of the degree to which an intervention has relevant cultural components. This systematic review synthesizes available randomized, controlled trials (RCTs) that rigorously evaluated the effects of behavioral interventions in reducing risky sex behavior and incident STD among black and Hispanic STD clinic patients in the United States. In particular, we implemented a meta-analytic approach to assess the overall efficacy of behavioral interventions and to identify factors associated with intervention efficacy, including trial, participant, and other intervention characteristics in addition to cultural appropriateness.
As part of CDC’s HIV/AIDS Prevention Research Synthesis project,25 we developed multiple search strategies to identify relevant published and unpublished reports. First, an automated systematic search was developed using standardized search terms crossreferenced in 3 areas: 1) HIV, AIDS, or STD; 2) intervention evaluation; and 3) behavior or biologic outcomes. This search was performed in multiple electronic bibliographic databases, including AIDSLINE (1988–2000), EMBASE, MEDLINE, PsycINFO, and Sociological Abstracts from 1988 to 2004. For each database, unique index terms supplemented with key words and phrases were searched to build a pool of HIV/AIDS prevention literature. A second automatic search was performed using STD clinics and STD clinic patients as key search terms to capture relevant reports. Additionally, as a result of indexing gaps, a manual search of 35 key journals, which regularly publish HIV or STD prevention research, was performed to locate additional intervention reports for the time period January 2004 to June 2005. Finally, we scanned reference lists of pertinent reports and consulted with experts to obtain recommendations of current and ongoing research.
Trials were included if they met all the following criteria: 1) U.S.-based behavioral intervention that aimed to reduce the risk of HIV or STD transmission; 2) targeting patients attending STD clinics; 3) focusing on blacks or Hispanics or over 50% of the participants identified as black, Hispanic, or a combination of these 2 racial/ethnic groups; 4) evaluating intervention effect with RCT; 5) reporting at least one HIV risk sex behavior (i.e., unprotected vaginal intercourse, unprotected insertive or receptive anal intercourse, condom use) or laboratory and/or clinical diagnosis of new STD acquisition; and 6) providing data necessary for calculation of effect sizes. Authors were contacted to obtain additional information before trials were excluded.
Information from eligible reports was independently abstracted by pairs of trained reviewers. Linkages among reports were identified to ensure that multiple reports describing an intervention were included in the coding and data analyses. Using standardized coding forms, each intervention was coded for trial information (e.g., intervention dates, location), participant characteristics (e.g., age, gender, race/ethnicity, sexual orientation, STD rate at baseline), outcomes (e.g., sex or STD outcome, recall period, follow-up time), and intervention features (e.g., specifically targeting black or Hispanic; based on theory, reporting formative research was conducted to inform development of intervention, content, delivery method, duration, setting). Specific features for culturally tailored interventions were coded as statement of cultural appropriateness and ethnically matched deliverer. We also coded variables related to methodological quality of the trials: description of randomization (generation of randomization sequence, allocation concealment, blinding), type of control group, participation rate, overall and differential retention, and intent-to-treat analysis (i.e., participants analyzed as originally assigned and regardless of exposure to the intervention).26–28 There was a 94% agreement between reviewers across all variables. Coding discrepancies were reconciled through discussion.
Because trials differ in terms of the number of intervention arms, type of outcomes, analyses conducted, and findings reported, we applied the following rules for guiding data abstraction for estimating the overall intervention effect. To meet the independence of effect size assumption, for trials with multiple arms, we selected the contrast between the study arms expected to have the largest effect (e.g., enhanced intervention) and the one expected to have the least effect (e.g., standard of care or waitlist control). Separate analyses were conducted for HIV risk sex behavior and laboratory/clinical diagnosis of new STD. Although the need for statistical adjustment is much less in RCTs than non-RCTs, an adjusted analysis is more conservative, especially when one or more prognostic variables (e.g., baseline risk behavior) may impact outcomes of interest.26,29 Data were used from adjusted models reported by the authors for effect size calculation because baseline differences of potential confounding variables are typically controlled in these models. Otherwise, we calculated effect sizes for the follow-up outcome data by adjusting for baseline sexual behavior differences. For trials that reported multiple follow-up assessments, we selected the longest follow up to assess the sustainability of intervention effect.
Effect sizes were estimated with odds ratios (ORs) because the majority of the trials compared 2 groups on a dichotomous outcome. For trials reporting means and standard deviations on continuous outcomes, standardized mean differences were calculated and then converted into OR values.30 An OR <1 indicates a greater reduction in odds of HIV risk sex behavior or new STD acquisition in the intervention group relative to the comparison group.
Standard meta-analytical methods were used.29–31 We first used the natural logarithm to obtain log OR (lnOR) and calculated its corresponding weight (i.e., inverse variance) for each trial. In estimating the overall effect size, we multiplied each lnOR by its weight, summed the weighted lnOR across trials, and then divided by the sum of the weights. The aggregated lnOR was then converted back to OR by exponential function and a 95% confidence interval (95% CI) was derived. We also examined the magnitude of heterogeneity of effect sizes by using the Q statistic. Both fixed-effects and random-effects models were tested and both models yield similar findings. The final presentation was based on a random-effects model because the random-effects model provides a more conservative estimate of variance and generates more accurate inferences about a population of trials beyond the set of trials included in this review.32
Sensitivity analyses were conducted to determine the robustness of intervention effects by assessing whether the overall results were sensitive to the aforementioned rules used for guiding effect size calculation. We recalculated the overall effect size without adjusting for baseline behavior and with shorter-term follow ups. In addition, the aggregated effect size estimate among all trials was compared with the estimate obtained after excluding a trial (or a set of trials) that might influence the overall estimate. We also conducted a sensitivity analysis, including 9 trials that have both sex and biologic outcomes.
Stratified analyses were conducted to determine whether methodological quality, trial and sample characteristics, or intervention features were associated with effect sizes. We assessed the likelihood of subgroup differences using the between-groups heterogeneity statistic, QB, which has a χ2 distribution and degrees of freedom equal to the number of subgroups minus 1.30,32
Publication bias that may favor trials with significant findings was ascertained by inspection of a funnel plot of standard error estimates versus effect size estimates from individual samples31 and also by a linear regression test.33 For the linear regression test, the standardized effect size estimate (effect size estimate divided by the corresponding standard error estimate) is regressed against the precision (the inverse of the standard error). If the intercept used to measure asymmetry is significantly different from zero, then this indicates evidence of publication bias. We found no evidence of publication bias because the funnel plot (not shown) revealed no asymmetry and the intercept from the linear regression analysis was not significantly different from zero (t = −1.52, P = 0.15, for HIV risk sex behavior; t = 0.002, P = 0.99 for incident STD).
Eighteen RCTs that met the inclusion criteria (Fig. 1) are summarized in Table 1. All trials targeted inner-city urban public health STD clinic patients. Nine trials specifically indicated that their target populations were black or Hispanic.34–42 Blacks were the majority of study participants in 16 trials (range, 51–100%; median, 87.5%). Two trials consisted of majority of Hispanic women (69% and 77%), but also specifically targeted blacks.40,41 Fourteen trials reported 90% to 100% of participants being black or Hispanic. Only 3 trials had more than 10% of participants from other ethnic groups (e.g., white, Asian, Native American, or mixed race), ranging from 22% to 39%.43–45 An additional trial reported 55% of participants being black without providing information on race/ethnicity of the remaining 45% of participants.46 Ten trials recruited both men and women with the majority of study participants being male. Four trials specifically targeted women, 2 of which consisted of a majority of blacks46,47 and the other 2 consisted of a majority of Hispanics.40,41 Four trials specifically targeted adolescent and adult men, all of whom were blacks.35–37,42 The median age across all study samples was 27.5 (range, 17.9–35.3 years). Among 10 trials reporting sexual orientation, the majority of study participants reported being heterosexuals (median percentage, 100%; range, 84–100%). No trial specifically targeted homosexuals or bisexuals. Most trials restricted study entry to those with a recently diagnosed STD or reporting high-risk sex behaviors. The median percentage of participants with a diagnosed STD at study entry was 77% (range, 25–100%).
Most of the trials recruited over 500 participants. Four trials recruited over 3,000 participants. Although all trials were RCTs, a limited number of the trials reported information on generation of randomization sequence (33%), allocation method (39%), and blinding (i.e., treatment allocation masked from outcome assessors, 56%). The median participation rate was 62% of eligible persons (range, 23.6–96.5%). The median retention rate was 73.3% (range, 47–99.3%) at the longest follow-up assessment (median, 6 months for sex behavior outcome; 12 months for STD outcome). All trials used an intent-to-treat approach for data analysis.
Regarding intervention characteristics, the majority of trials were guided by behavioral theories, including AIDS Risk Reduction Model,48 Social Cognitive Theory/Social Learning Theory,49 Information–Motivation–Behavioral Skills Model,50 and Theory of Planned Behavior.51 More than two thirds of the trials reported conducting formative research with the target population to guide the development of interventions. All interventions provided information to increase HIV/STD knowledge. Several interventions also addressed common constructs of behavioral theories such as perceived risk, attitude toward condom, and self-efficacy. All trials except one52 provided skills building, which included technical (e.g., correct use of condoms), personal (e.g., decision-making skills), or interpersonal aspects (e.g., communication about safer sex) through demonstration, practice, or role play.
The interventions were commonly delivered in small groups (56%). Most of the interventions were conducted in STD clinics, 5 were carried out at research clinics,40,41 community service centers,36,42 or a location that was convenient to participants (e.g., community center, home, public area).37 The number of intervention sessions ranged from one to 8, the amount of time to deliver the intervention ranged from 10 minutes to 16 hours, and the total timespan of the intervention ranged from <1 day to 6 months.
Self-Reported HIV Risk Sex Behavior
The aggregated effect size was significant (OR = 0.77; 95% CI = 0.68–0.87; z = −.33; P <0.01; 14 trials; N = 11,590), indicating a 23% decrease in odds of engaging in unprotected sex in the intervention groups relative to the comparison groups at an average of 6 months postintervention assessment. Examination of the forest plot (Fig. 2) and the homogeneity test (Q13 = 19.51, P = 0.11) did not indicate heterogeneity between trials. Additional sensitivity tests did not reveal any single trial that exerted influence on the overall effect size. The overall intervention effect estimate was robust because it did not vary in significance when using data from shorter follow ups (OR = 0.76; 95% CI = 0.67–0.87; z = −4.33; P <0.01), without adjustment for baseline sex behavior (OR = 0.80; 95% CI = 0.72–0.90; z = −3.67; P <0.05), or only from trials that reported both sex and biologic outcomes (OR = 0.78; 95% CI = 0.69–0.87; z = −4.28; P <0.05).
In the stratified analyses shown in Table 2, significantly greater efficacy was found among interventions that used ethnically matched deliverer (vs. not ethnically matched deliverer, QB = 4.20, P <0.05) or facilitator to deliver interventions (vs. healthcare provider or counselor, QB = 5.87, P <0.05).
When comparing intervention groups to comparison groups, the significant intervention effect was seen in trials regardless of participants’ characteristics (i.e., STD date at baseline, specifically targeting black or Hispanic, ≥90% participants being black or Hispanic), methodological quality of trials (i.e., participation rate, retention rate, reporting generation of randomization sequence or allocation concealment), or intervention features (e.g., intervention contents or setting, unit of delivery, total time to deliver intervention).
There were several instances in which effect size was significant in trials with a specific characteristic (e.g., conducting formative research), whereas effect size was not significant in trials without that characteristic (e.g., did not conduct formative research). We explored those differences because they may provide clues about potentially important factors associated with intervention efficacy. Intervention groups were significantly less likely than comparison groups to report unprotected sex in trials that: had a bigger sample size (≥500 participants at baseline), used a nonattention control, reported masking of outcome assessors, conducted formative research, had culturally tailored interventions (i.e., having culturally appropriate content or using ethnically matched deliverer), provided training on correct use of a condom, had more than one intervention session, or delivered interventions longer than 1 hour.
Laboratory Confirmed or Clinically Diagnosed Sexually Transmitted Diseases
For the STD outcome, the aggregated effect size estimate was significant (OR = 0.85; 95% CI = 0.73–0.998; z = −1.98; P = 0.048; 13 trials; N = 16,172) indicating a 15% decrease in odds of acquiring a new STD in the intervention groups relative to the comparison groups at an average of 12 months postintervention assessment. Figure 3 showed the heterogeneity of trials (Q12 = 24.37, P = 0.02), however, excluding any of the trials did not affect the significance of heterogeneity. Additional sensitivity analyses indicated that the magnitude of the overall effect lessened very slightly when data from shorter follow ups (OR = 0.85; 95% CI = 0.72–1.00; z = −1.93; P = 0.053) or data from trials that had both sex and biologic outcomes (OR = 0.82; 95% CI = 0.67–1.00; z = −1.94; P = 0.051) were used. None of the trials provided data adjusted for baseline STD status and thus sensitivity analyses could not be conducted for this variable.
Similar to the findings for the unprotected sex outcome, the stratified analyses (Table 2) showed that significantly greater efficacy was found among interventions that used ethnically matched deliverer (vs. not ethnically matched deliverer, QB = 7.64, P <0.05). Additionally, interventions were more successful in reducing incident STD if they were theory-based versus interventions that did not report theoretical ground (QB = 6.77, P <0.05).
When exploring the pattern (i.e., significant effect size in trials with a specific characteristic, but nonsignificant effect size in trials without that characteristic), we found intervention groups were significantly less likely than comparison groups to report new STD acquisition in trials that: had ≥90% of participants being black or Hispanic, had <70% participation rate, had ≥70% retention rate, had ≥500 participants at baseline, used a nonattention control, reported formative research was conducted, had culturally tailored interventions, delivered by facilitator, addressed self-efficacy, or provided training on correct use of a condom.
It is very encouraging that behavioral interventions are efficacious not only in reducing self-reported unprotected sex, but also in reducing laboratory or clinical diagnosis of new STD acquisition in black and Hispanic patients who attended STD clinics. These significant intervention effects were sustainable over an average period of 6 months for the sex behavior outcome and 12 months for the biologic outcome.
Aside from overall efficacy, this meta-analysis also suggests several intervention features associated with reduction of unprotected sex and new STD acquisition. Consistent with the recommendations of previous reviews,11,16 interventions that are theory-based or conduct formative ethnographic research to inform intervention development are likely to be efficacious. Additionally, culturally tailored interventions showed success in reducing unprotected sex and incident STD among black and Hispanic STD clinic patients. These findings support the notion that researchers should conduct ethnographic research and use ethnically matched deliverers to strengthen the cultural sensitivity and ecologic validity of HIV prevention interventions.22 Although we could not distinguish the successful interventions from the others on the basis of intervention level (group vs. individual) or intervention settings (STD clinics vs. non-STD clinics), efficacious interventions may be more likely to be skills-based interventions that provide training on condom use by demonstrating correct use of a condom or giving participants the opportunity to practice. However, as a result of a small number of trials that did not provide training on condom use, this finding needs to be reassessed when additional trials become available.
Some inconsistent findings were observed in factors associated with intervention efficacy of reducing unprotected sex and new STD acquisition. For example, the intervention groups were significantly less likely than the comparison groups to report unprotected sex in trials that had more than one session or were longer than 1 hour or reported masking of outcome assessors. However, these factors were not associated with intervention efficacy in reducing new STD acquisition. Although intervention effects in reducing unprotected sex were, in general, not affected by methodological quality of trials, the findings of our stratified analyses indicate that higher-quality trials (e.g., larger sample size or higher retention rate) may be more likely than lower-quality trials to show reduction in new STD acquisition. These inconsistent findings are not surprising because the complex nature of the relationship between behavior and infection presents a major challenge to the design and evaluation of interventions.7,16 Further research is needed to explore the relationship among behavioral risk reduction strategies, changes in behaviors, and reductions in STD rates.53,54
It is important to note that all trials used multiple intervention components and sometimes the same set of components, thus making it difficult to unravel the independent effects or interactions among study characteristics. To help identify important intervention features necessary for efficacy, future research should consider using factorial designs to appropriately test the independent contributions of individual intervention component.
The generalizability of the meta-analytic findings warrants comment. Although most trials have more than 90% of participants being black or Hispanic, there is a slight chance that the findings might be influenced by the small proportion of participants from other racial/ethnic groups. Additionally, all 18 RCTs evaluated in this review targeted inner-city urban public health STD clinic patients. The study participants were primarily heterosexuals. Although black men who have sex with men (MSM) are more likely than white MSM to have an STD,55 which contributes to the racial differences in HIV disease burden, no intervention identified in this review specifically targeted black or Hispanic MSM. Thus, it is unclear whether and to what extent the findings of this review generalize to those men or to other subpopulations such as those who reside in rural areas or who did not seek care in public health STD clinics. It is possible that the efficacious interventions identified in this review can be applicable to different settings and subpopulations of blacks and Hispanics if interventions are appropriately adapted to the needs and characteristics of populations of interest. However, questions remain about whether and how interventions can be adapted to different settings and contexts. Translation and evaluation of interventions with evidence of efficacy that have been adapted for use in populations that did not host the original intervention trial would be a valuable line of inquiry.
In conclusion, this review shows that behavioral interventions result in significant reductions in unprotected sex and new STD acquisition among black and Hispanic STD clinic patients. When developing intervention programs for these 2 groups, prevention providers should consider adopting the following efficacious strategies identified in this review: a basis of behavioral theory, formative ethnographic research to inform intervention development, culturally appropriate contents, ethnically matched deliverers, and skills training on correct use of a condom. The extent to which these prevention strategies are applicable to subgroups of blacks or Hispanics (e.g., those residing in rural areas, seeking care outside STD clinic settings, MSM) and whether these intervention strategies are cost-effective require further research. Translating evidence-based research into practice is not without challenges. Evaluating the effectiveness of proven prevention strategies once they have been applied in real-world settings, particularly when they have been adapted or tailored, should be accorded a high priority in HIV/STD prevention research.
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