PERSONS ATTENDING SEXUALLY transmitted disease (STD) clinics are at risk of acquiring HIV infection.1 HIV counseling and testing have been offered to persons in STD clinics since the HIV test became available in 1985. In 1995, 665,682 HIV tests were done in federally funded STD clinics.2 Many persons currently undergoing HIV testing in STD clinics have been previously counseled and tested for HIV, yet many continue to acquire HIV infection. In Miami, from 1988 through 1992, 3% of persons tested after a previous negative test result had acquired HIV.3
Hundreds of published articles addressing the effectiveness of different types of HIV counseling for preventing HIV infection have been reviewed.4–6 Many early reports described differences in behavior among persons who chose to be tested compared with persons who did not want an HIV test. Investigators of later studies have used more rigorous methods, comparing intervention recipients and equivalent control groups. A critical review of behavioral interventions7 identified five methodologically sound studies demonstrating effective interventions.8–12 These studies measured effects on knowledge, attitudes, and risky behavior, but did not assess health-related outcomes such as the prevention of new STDs or HIV infection. Two later studies compared the incidence of new STDs after two different counseling interventions in STD clinics. In one study, both counseling interventions had similar outcomes.13 In the other study, both of the two different counseling interventions were significantly better than a standard educational approach.14
Early studies suggested that several counseling sessions might result in greater reduction of risk behavior.4 We developed a five-session counseling intervention for persons who were at increased risk for HIV because they had previously acquired an STD, and we tested efficacy by using a randomized controlled trial in which both behavior change and the incidence of new STDs were outcomes.
Our objective was to compare the efficacy of (a) an enhanced counseling prevention program of four group sessions within 2 weeks followed by a booster group session at 2 months and (b) the standard two 20-minute sessions of client-centered HIV prevention counseling. The outcomes of interest were self-reported behavior change and the incidence of new STDs. Persons attending the Medical Center STD Clinic in Houston for the evaluation of a new problem were considered eligible for the study if they reported having received a diagnosis of STD in the past 5 years. They were excluded if they were planning to move away from Houston, if they were not willing to have an HIV test, or if they were HIV-infected. Follow-up visits were scheduled 2, 6, 9, and 12 months after enrollment. At the follow-up visits, participants were asked about their sexual behavior during the past 3 months. Participants were examined for sexually transmitted infections at each follow-up visit and between scheduled visits if they came to the clinic with a complaint. At the completion of the study, records at the other STD clinics in Houston were searched for visits that study participants might have made outside the study site.
Diagnoses of STDs were based on clinical or laboratory findings. Gonorrhea and chlamydia diagnoses required either a positive culture or positive DNA probe of cervical or urethral swabs (Gen-Probe, San Diego, California). Syphilis diagnosis was based on a positive rapid plasma reagin (RPR) with a positive microhemagglutination assay for Treponema pallidum (MHA-TP), a four-fold rise in RPR titer for persons with previous positive RPR, or a positive dark-field examination for a person with a lesion. HIV was diagnosed by enzyme immunoassay (Organon Teknika Corporation, Durham, North Carolina) with a confirmatory Western blot (Cambridge Biotech, Worcester, Massachusetts). A diagnosis of hepatitis B required a positive core-antibody or surface antigen test (Abbott Laboratories, Abbott Park, Illinois). Nongonococcal urethritis required more than 10 white blood cells per high-powered field on examination of a urethral swab of a man with negative test results for gonorrhea and chlamydia. Trichomonas was detected in women by using a wet mount from a vaginal swab. Diagnosis of pelvic inflammatory disease was based on the clinician's impression of adnexal tenderness or cervical motion tenderness. Diagnoses of genital herpes, genital warts, scabies, pediculosis, chancroid, and lymphogranuloma venereum were based on the clinician's impression.
Infections diagnosed after the initial visit were considered new infections if they also met additional criteria. A diagnosis of gonorrhea or chlamydia required that the patient had not had the same infection in the preceding 4 weeks. Syphilis was not considered a new infection unless it was diagnosed 2 or more months after the initial visit. HIV and hepatitis B seroconversion required an additional negative serologic test result after the baseline visit, followed by a positive serologic test result. Genital herpes and genital warts required a negative history of infection. These were considered “possible” new infections because they may have been the reactivation of a previously unrecognized infection.
Development of the intervention used in our study started with a meeting of expert consultants, followed by focus groups and interviews of clinic patients, input from a community advisory panel, and pilot testing. The consultants suggested that the intervention should be designed around the information-motivation-behavioral skills (IMB) Model for AIDS risk reduction.15 According to this model, information, motivation, and behavioral skills are necessary for AIDS prevention behavior. Other aspects thought to be important for a successful intervention were multiple sessions, with a booster after the initial set of sessions; empowerment; skills training; and linking the desirable behaviors to lifestyle, values, and pride. The consultants suggested the inclusion of role play, videos, and games. Group counseling interventions were suggested as preferable to one-on-one counseling because of the potential for peer group rein-forcement.
Focus groups and one-on-one interviews were used to develop and refine the intervention. Pilot testing evaluated some of the approaches suggested by patients and provided an opportunity for the group facilitators to improve their skills. This development phase indicated that group sessions of mixed gender were preferred; four sessions were the maximum that participants would consider; and attendance was better when the four sessions were conducted within 2 weeks (rather than 4 weeks) and when participants received a monetary incentive of $15 for attending sessions.
The four intervention sessions focused on providing the information, motivation, and behavioral skills necessary for persons to change their behavior. The first session took place at the end of the initial clinic visit. In this introduction to the program, role play was used to increase risk perception. The second session focused on responsibility, self-esteem, and values by using videos and group discussions. Session 3 focused on decision making-skills through role play. Session 4 focused on increasing knowledge about HIV and other STD and methods for preventing them. Skills in condom use were addressed in sessions 2 through 4, and needle-cleaning techniques were demonstrated during session 4. The booster session was 2 months later, corresponding to the first follow-up visit. It consisted of a group session in a game format, in which the information, motivation, and skills from the previous sessions were reviewed.
Randomization was by small group. Participants from morning or afternoon clinic sessions were recruited for a group. After the recruitment for that session was complete, a clerk generated a random number from a computer program, which determined the intervention or control status of that group and recorded the link. The clerk then informed the counselor and labeled the participants' records. Participants were scheduled for subsequent counseling sessions with their same group.
Masking participants and counselors to the intervention or the control status was not possible. Baseline interviews were done after randomization but before the first intervention session. Follow-up interviewers were not told the intervention or the control status of the participants, but they could have remembered participants from a counseling session (because the five persons who administered the interviews were also the five persons who facilitated the group intervention). No masking was done during data entry or analysis.
Size of the control group was based on an anticipated 15% return rate with a new STD within 1 year; size of the intervention group was based on an 80% likelihood of detecting (beta = 0.2) a halving of the return rate to 7.5% or less (P = 0.05). Given these conditions, we calculated a need for 278 participants in each group. The number was increased to 500 in each group because of anticipated problems with loss to follow-up.
We used an intention-to-treat analysis, including follow-up information on all participants regardless of the number of group counseling sessions they attended. Persons who were lost to follow-up were compared with persons who attended at least one follow-up session. Separate analyses of changes in behavior over time were done of everyone who returned for any scheduled follow-up visit and of those who returned for all follow-up visits. Although there were quantitative differences in results (persons who attended all follow-up visits were less likely to acquire an STD), the patterns were similar. Thus, we elected to show only the analysis which included persons who attended any follow-up visit.
From March 1992 through June 1993, a total of 1,681 persons were eligible for the study, 996 (59%) of whom agreed to participate. Consent to participate was obtained from more eligible women (65%) than men (56%). Of those who consented, 32 (3.2%) tested HIV-positive and were excluded from follow-up. More men (4.6%) than women (1.4%) were ineligible because of a new HIV-positive test result.
A total of 964 persons were enrolled and followed up: 509 in the intervention group and 455 in the control group. The composition of the two groups was similar: 56% were male, 90% were black, 77% were aged 13 to 34 years, 31% reported more than one sex partner in the past month, 26% had used a condom with their most recent sex partner, 14% had ever used drugs intravenously, and 50% were diagnosed with an STD at the baseline visit (Table 1).
Because the first group counseling session took place during the initial clinic visit, 98% of all participants attended the first counseling session. Attendance at counseling sessions 2, 3, and 4 ranged from 52% to 59%, and 34% attended the booster session. Slightly more women than men attended the counseling sessions. Overall, 47% attended four or more sessions (Table 2).
At least one follow-up evaluation was recorded for 72% of the intervention group and 74% of the control group, but only 22% of both groups attended all four study follow-up visits. The number that attended a particular scheduled follow-up visit ranged from a low of 41% of the intervention group who attended the 6-month follow-up to a high of 55% of the control group who attended the 2-month follow-up (Table 3). Fewer persons thought to be at highest risk for a new STD (because of young age or the presence of an STD at baseline16) attended a follow-up visit, but attendance by persons at high risk was similar for the intervention and control groups (Table 3).
Baseline knowledge about HIV and prevention practices was high. There were no differences by gender or intervention group and no changes over time in the percentage who reported that they could get AIDS if they had sex without a condom (95%); a condom was likely to protect them from AIDS (95%); it was likely they would use a condom next time they had sex (90%); or that they would use a condom every time they had sex (90%). Equal numbers of male and female participants in the intervention and the control groups reported that people who were important to the participant thought the participant should use a condom for every sex act (80% at baseline and 90% at 12 months).
Self-reported risky sexual behavior was significantly reduced, but the reductions were similar both in the intervention and the control group. For example, from baseline to 12 months, the percentage of men who reported more than one sex partner in the past month decreased from 42% to 26% for the intervention group and from 42% to 22% for the control group (Figure 1). The percentage of men that used a condom with their most recent partner increased from baseline to 12 months: 23% to 48% for the intervention group and 30% to 49% for the control group (Figure 2). Similar increases in safer behavior were seen for women; again, there were no differences between the intervention and the comparison group.
The rate of development of a new infection with gonorrhea, chlamydia, syphilis, or HIV was similar for the intervention and control groups (Figure 3). Most final examinations were 12 months after enrollment, but some did not return for their final examination until 15 months. At the end of the study, a new infection with gonorrhea, chlamydia, or syphilis had been diagnosed for 19.0% of the men in the intervention group and 19.3% of men in the control group. Infection with gonorrhea, chlamydia, or syphilis developed in almost as many women: 16.4% in the intervention group and 18.4% in the control group. The numbers of other STDs diagnosed in the two groups were also similar (Table 4). Although trichomonas was more common in the control-group women (23.4%) than in the intervention-group women (17.7%), the difference was not statistically significant (P = 0.15).
Hepatitis B core antibody, indicating past infection with hepatitis B, was detected in 27% of the intervention group and 23% of the control group at baseline. Nine persons (1.3% of 712) who were negative for antigen and antibody at baseline apparently acquired infection, but all may have acquired the infection before the intervention (their first test result after baseline was positive): for 7, the test for core antibody was positive, but the test for surface antigen remained negative; for 2 persons, the tests for core antibody and surface antigen became positive. No one showed evidence of a new infection after two negative serologic test results (350 persons had three or more negative test results).
Similarly, HIV infection was detected in five persons (three intervention, two control), but all five infections could have been present when the persons were enrolled (test results for the first test after baseline were positive). The numbers of months between enrollment and first follow-up for the five HIV seroconverters are 2, 9, 20, 20, and 23. Three of the persons known to have acquired HIV infection had their first follow-up visit after the 15-month cutoff for the efficacy analysis.
Although our primary analysis was intention-to-treat, we also compared persons who attended four or all five intervention sessions with persons who attended three or fewer. The number of persons in whom a new infection developed was similar for these groups (18.0% and 17.8%, respectively). However, persons who attended four or five intervention sessions were less likely to have two or more new infections (3.4%) compared with persons who attended three or fewer intervention sessions (7.4%). Persons who attended the intervention sessions were also more likely to return for study follow-up visits: perfect attendance at all four follow-up visits was achieved by 40% of the persons who attended four or five intervention sessions compared with 7% of persons who attended three or fewer sessions.
The multisession group counseling intervention was no more effective at changing the risk for a new sexually transmitted infection than the standard prevention counseling. Both groups changed considerably from baseline. We cannot tell how much of this change was because of the interventions and how much was regression to the mean17 or changes made by participants because of their concern about having an STD at baseline. Because participants were selected from an STD clinic, we would expect that their behavior just before enrollment was somewhat different from their usual behavior. Another intervention study, in which four individual counseling sessions were compared with two 20-minute standard HIV prevention counseling sessions, also found no benefit for the extra sessions.13 Project RESPECT, a trial of three interventions among STD clinic patients subsequent to our study, also found that four individual counseling sessions were no more effective than two client-centered counseling sessions, but both counseling interventions were more effective than two 5-minute educational messages.14 The standard HIV prevention counseling for the comparison group in our study used an interactive, client-centered approach, but did not use the structured counseling protocol and routine quality assurance procedures that were later developed for Project RESPECT.18 We did not find a benefit from the multiple group sessions compared with standard prevention counseling, but both our intervention arms were more intensive than the 5-minute educational message used in Project RESPECT. We cannot tell whether both interventions worked better than no counseling, because we did not have a no-counseling comparison group.
Another possible reason that the group intervention was no better than the standard prevention counseling sessions is that only half of the persons randomly assigned to the group intervention attended four or five group sessions. We tried several approaches to encourage participation. Pilot testing suggested that the four sessions should be close together and within 2 weeks of the initial clinic visit. Holding the first group session at the time of enrollment increased attendance at that session and also at subsequent sessions; persons who attended the group seemed to like it more than they had thought they would. Incentives also seemed to help. It is possible that attendance would have been higher if we had allowed persons to join other groups that were meeting at different times, but we thought it best to maintain the integrity of the groups for all five sessions. The participation rates might have been higher in group interventions linked to existing groups, such as workplace groups or groups of homosexual men.
The low attendance at the group counseling sessions suggests that this intervention would be difficult to implement successfully. An intervention cannot affect the behavior of persons who do not attend. Restricting the analysis to persons who attended most of the sessions may be deceptive because we had no comparison group. Even our restricted analysis showed no clear benefit from the additional sessions, although the persons who attended all the counseling sessions were also more likely to return for follow-up visits, at which asymptomatic infections could be detected.
Follow-up attendance was also low. At least one follow-up visit was made by 73% of the participants, and 47% were seen at the 12-month visit. Most persons who acquired a symptomatic STD were identified by our study when they returned to the study clinic or one of the nearby public clinics. However, many infections are asymptomatic and would have remained undetected in study participants who did not return for follow-up. Because follow-up rates and the type of person attending follow-up were similar in the intervention and comparison groups, our estimate of the effectiveness is unlikely to be biased, but our missing infections in both groups would limit the power of our study to detect a true difference between the groups.
An outcome measure of the incidence of new sexually transmitted infections avoids some of the potential biases in relying on self-reported behavior change. The use of newer nucleic acid amplification techniques could have improved the detection of STDs in our study. However, the measurement of new infections also has potential for bias.19 Many infections are asymptomatic, so we cannot be sure that persons who did not return to the clinic for follow-up examination did not have an infection. Even when persons are examined, we cannot be sure that all infections will be diagnosed. For example, a trichomonas infection that was missed during the initial exam and diagnosed during a subsequent exam would seem to be a new infection. Some infections may have been present but undetectable during the initial visit. For example, hepatitis B antigen or antibody was newly detected at the first follow-up visit for 9 people. We cannot know whether these were new infections or the detection of an infection that was present when the person was enrolled. Other conditions are difficult to classify as an STD. We chose not to include pelvic inflammatory disease or nongonoccocal urethritis in the absence of gonorrhea or chlamydia. Some of these conditions may have been sexually transmitted.
Assessing behavioral outcomes proved difficult because of the variety of risk behaviors reported-number of partners, number of new partners, percentage of condom use, and condom use with most recent partner. A true reduction in risk might have been missed when a single behavior was used to compare groups, because different behaviors were often changed at the same time. For example, some persons decreased condom use when they entered a monogamous relationship; others increased their number of partners but also used condoms more frequently. We were impressed by the number of ways that the behavioral data could be analyzed. We considered various categories (100% condom use, any condom use), different time intervals (behaviors at each follow-up visit, behaviors at all follow-up visits), and alternative frameworks (behaviors reported at a particular visit, change from baseline for each behavior.) Although we could not detect a difference between the two groups in any analysis we did, we are convinced that masking the intervention status of the groups during analysis would have reduced the likelihood of investigator bias.20,21 Additionally, further analysis relating the behavioral data to the incidence of a new STD may assist future investigators by helping establish the relative contribution of specific behaviors or combinations of behaviors to the risk of acquiring new infections.
Some of the problems we encountered might be avoided by improved study design and more staff. Many problems, however, are inherent to studying a group of persons at high risk of acquiring HIV; for example, they have many competing priorities. Longitudinal studies in STD patient populations have inherent problems with low participation rates and poor follow-up. Effective randomization and incentives for participation in counseling and follow-up probably limited many potential biases in our study but could not eliminate them entirely. Despite the limitations, we are confident that the two sessions of client-centered counseling were as effective as the five sessions of group counseling for these STD clinic patients.
1. Peterman TA, Todd K, Mupanduki I. Opportunities for targeting publicly funded human immunodeficiency virus counseling and testing. J Acquir Immune Defic Syndr Human Retrovirol 1996; 12:69-74.
2. Centers for Disease Control and Prevention. HIV counseling and testing in publicly funded sites: 1995 summary report. Atlanta, GA: U.S. Department of Health and Human Services, 1997.
3. Peterman TA, Zaidi AA, Wroten J. Decreasing prevalence hides a high HIV incidence: Miami. AIDS 1995; 9:965-970.
4. Higgins DL, Galavotti C, O'Reilly KR, et al. Evidence for the effects of HIV antibody counseling and testing on risk behaviors. JAMA 1991; 266:2419-2429.
5. Choi K-H, Coates TJ. Prevention of HIV infection. AIDS 1994; 8:1371-1389.
6. Wolitski RJ, MacGowan RJ, Higgins DL, Jorgensen CM. The effects of HIV counseling and testing on risk-related practices and help-seeking behavior. AIDS Educ Prev 1997; 9(Suppl. B):52-67.
7. Oakley A, Fullerton D, Holland J. Behavioural interventions for HIV/AIDS prevention. AIDS 1995; 9:479-486.
8. DiClemente RJ, Pies CA, Stoller EJ, et al. Evaluation of school-based AIDS education curricula in San Francisco. J Sex Res 1989; 26:188-198.
9. Rotheram-Borus MJ, Koopman C, Haignere C, Davies M. Reducing HIV sexual risk behaviors among runaway adolescents. JAMA 1991; 266:1237-1241.
10. Jemmott JD, Jemmott LS, Fong GT. Reductions in HIV risk-associated sexual behaviors among black male adolescents: effects of an AIDS prevention intervention. Am J Public Health 1992; 82:372-377.
11. Walter HJ, Vaughan RD. AIDS risk reduction among a multiethnic sample of Cuban high school students. JAMA 1993; 270:725-730.
12. Kelly JA, St Lawrence JS, Betts RA, Brasfield TL, Hood HV. A skills training group intervention model to assist persons in reducing risk behaviors for HIV infection. AIDS Educ Prev 1990; 2:24-35.
13. Boyer CB, Barrett DC, Peterman TA, Bolan G. Sexually transmitted disease (STD) and HIV risk in heterosexual adults attending a public STD clinic: evaluation of a randomized controlled behavioral risk-reduction intervention trial. AIDS 1997; 11:359-367.
14. Kamb ML, Rhodes F, Bolan G, et al. Efficacy of risk-reduction counseling to prevent human immunodeficiency virus and sexually transmitted diseases: a randomized controlled trial. JAMA 1998; 280:1161-1167.
15. Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull 1992; 111:455-474.
16. Richert CA, Peterman TA, Zaidi AA, Ransom RL, Wroten JE, Witte JJ. A method for identifying persons at high risk for sexually transmitted infections: opportunity for targeting intervention. Am J Public Health 1993; 83:520-524.
17. Yudkin PL, Stratton IM. How to deal with regression to the mean in intervention studies. Lancet 1996; 347:241-243.
18. Kamb ML, Dillon BA, Fishbien M, Willis KL. Quality assurance of HIV prevention counseling in a multi-center randomized controlled trial. Public Health Rep 1996; 3(Suppl. 1):99-107.
19. Aral SO, Peterman TA. Measuring outcomes of behavioural interventions for STD/HIV prevention. Int J STD AIDS 1996; 7(Suppl. 2):30-38.
20. The Standards of Reporting Trials Group. A proposal for structured reporting of randomized controlled trials. JAMA 1994; 272:1926-1931.
21. Gould SJ. The Mismeasurement of Man. New York: WW Norton, 1981.