Evaluation of a community-based organization's intervention to reduce the incidence of sexually transmitted diseases: a randomized, controlled trial. (Original Article).

Background: The study objectives were to determine whether a community-based organization's intensive counseling intervention would reduce sexually transmitted disease (STD) acquisition among high-risk STD clinic patients and to determine whether a low-cost trial could be conducted in a community-based setting with passive follow-up.

Methods: Participants were randomly assigned to routine counseling or intensive counseling consisting of three 1-hour sessions. We reviewed clinic records to determine 1-year cumulative incidence of STD.

Results: From September 1994 through December 1995, we enrolled 581 high-risk black men. Among the intervention group, 38% did not attend any intervention session; 38% attended all three. The 1-year cumulative incidence of STD did not differ significantly between the intervention (16%) and control groups (12%) (P = 0.20).

Conclusion: Our results suggest that the intensive counseling did not reduce STD acquisition. We encountered problems in conducting this low-cost trial, making results difficult to interpret. Future trials should schedule follow-up STD assessments and will likely need more staff.

Key Words: counseling, human immunodeficiency virus infections, prevention and control, randomized controlled trial, sexually transmitted diseases 

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Counseling patients about risk reduction for acquiring human immunodeficiency virus (HIV) and other sexually transmitted diseases (STDs) can prevent future infections. (1,2) To be effective, HIV counseling should be tailored to the behaviors, circumstances, and special needs of the persons being served. (3) Risk-reduction messages should be culturally relevant, and services should be provided in a style and format sensitive to cultural norms and values and accepted by the target population. During 1987, black male patients aged 15 to 19 years who were attending the STD clinics in Dade County (Miami), Florida, were at high risk for a new STD: 32% returned within i year with a new STD. (4) In addition, the HIV seroconversion rate for persons who returned to the clinics was 3.1 per 100 person-years among patients with repeat HIV tests during December 1987 through December 1990. (5) Our objective was to determine whether an intensive counseling intervention developed by a community-based organization in Dade Coun ty, compared with routine clinic counseling, would reduce the acquisition of new STDs among high-risk STD clinic patients. A secondary objective was to determine whether a low-cost, randomized, controlled trial could be conducted in a community-based setting with passive follow-up.

Methods

Study Design

We conducted a randomized, controlled trial in Dade County to compare intensive counseling with routine counseling. The intensive counseling consisted of three one-on-one sessions by a counselor from the community-based organization. The culturally sensitive counseling was developed and pilot tested by the community-based organization and a consulting behavioral scientist. In developing the intervention, counselors conducted sessions with persons from the target population to obtain their input. The counselors, who were from the community-based organization, were familiar with and sensitive to the cultural norms, values, and traditions of the local population. Each participant was to complete the sessions sequentially, with the same counselor. The first session was scheduled to take place within a few days of random assignment. We attempted to hold the sessions at the most convenient location for each participant, usually in the community where he lived.

In Session 1 (60 minutes), the objectives were to teach condom knowledge and correct use, teach male anatomy, personalize the risk for STDs and HIV, address feelings of invulnerability of youth, encourage screening for STDs, encourage use of condoms, empower the participant with the negotiation skills necessary for consistent condom use, and motivate the participant to return for session 2. In session 2 (45-50 minutes), the objectives were to identify barriers to condom use, teach strategies for overcoming these barriers and identify supports for healthy behaviors, teach female anatomy, discuss alternatives to intercourse by using visual aids, determine attitudes and beliefs about STDs, reinforce positive behavior change, and encourage screening for STDs on the basis of high-risk behaviors rather than just symptoms. In session 3 (40-50 minutes), the objectives were to determine future educational and job plans, guide the participant to educational and job resources, reinforce positive perceptions of supporti ve community norms of condom use, remind the participant of and encourage the practice of alternatives to intercourse (eg, abstinence or outercourse), and encourage screening for STDs.

Sample

The 14th Street STD Clinic and three satellite STD clinics are in Dade County. Since 1986, computerized medical records for these clinics have included a patient number, visit date, reason for visit, laboratory results, diagnoses, treatment, and demographic information. Findings from physical examination appear on the clinic form but are not standardized or computerized.

Persons attending the 14th Street STD Clinic or the 80th Street Terrace Clinic, a satellite public STD clinic, were considered eligible for this study if they were black male patients, 16 to 29 years old, and they had had at least one STD. This group was targeted because young black men with an STD in the past year were at high risk for returning with a new STD. (4)

At registration, computerized and paper clinic records were used to determine eligibility, and study counselors approached eligible patients to participate. A convenience sample was selected for random assignment: eligible patients were approached only if a counselor was available. Participants gave written informed consent before random assignment. Participants in the intervention group received $15 for their time and expenses at each intervention session. Participants in the routine counseling group did not receive monetary compensation. The study protocol was approved by the institutional review boards at the Centers for Disease Control and Prevention and the Florida Department of Health.

Random Assignment

Half of the participants were randomly assigned to intensive counseling and half were randomly assigned to routine counseling. Blocked randomization was used to make the assignments. Numbered, opaque envelopes containing the assignments were created centrally and were distributed in lots of 10 among a total of five counselors during the study period. When a patient agreed to participate, the patient's number was written on the envelope before it was opened to allow auditing of assignment. After the envelope was opened, the intervention assignment was not concealed from participants or clinicians. Investigators performed the primary data analysis while masked to the intervention assignments. No outcome data were analyzed until 18 months after the final participant was enrolled.

Follow-up

No study follow-up visits were scheduled for evaluating participants for STDs. Rather, computerized records were used to determine how many persons returned to one of the four public STD clinics in Dade County with a new STD.

Measures

We reviewed the computerized clinic records to determine the baseline prevalence of STDs and the 1-year cumulative incidence of new STDs for the two groups. STD diagnoses were made on the basis of clinical and laboratory information. Syphilis was defined as a clinician's diagnosis of primary or secondary syphilis. Gonorrhea was defined as a clinician's diagnosis of gonorrhea, a positive smear or culture for gonorrhea, or a positive gonorrhea culture listed as a reason for visit. Chlamydia was defined as a clinician's diagnosis of chlamydia or a positive culture for chlamydia.

Chancroid and lymphogranuloma venereum were defined by a clinician's diagnosis. Nongonococcal urethritis (NGU) was defined as a clinician's diagnosis of NGU without chlamydia or gonorrhea. HIV infection was defined as positive results from two enzyme immunoassays and a confirmatory Western blot analysis.

Gonorrhea, chlamydia, and NGU were considered newly diagnosed if there was no diagnosis of the same infection within the past 2 weeks. Syphilis, chancroid, and lymphogranuloma venereum were considered newly diagnosed if there was no diagnosis of the same infection within the past 4 weeks. An HIV infection was considered new if there had been a negative HIV test on enrollment. "Definite" STD comprised syphilis, gonorrhea, chlamydia, chancroid, lymphogranuloma venereum, and HIV. "Possible" STD added treatment for gonorrhea or chlamydia or a clinician's diagnosis of NGU. We included incident STDs for the year starting 1 month after a participant's date of random assignment and ending 12 months later. Visit records within 1 month of a participant's date of assignment were excluded to allow completion of the intensive counseling intervention.

Analyses

For the primary outcomes, we performed an intent-to-treat, blinded analysis (0.05 level of significance). We tested for the equality of the 1-year cumulative incidence of a new definite STD and of a new possible STD between the two intervention groups by performing Pearson [[chi].sup.2] tests. In calculating the desired sample size, we assumed the 1-year cumulative incidence of a newly diagnosed or treated STD to be 32% for the control group. We needed approximately 330 participants per group for 80% power to detect a reduction in cumulative incidence to 22% (risk ratio [RR], 0.69) in the intervention group (assuming a significance level of 0.05).

Results

From September 1994 through December 1995, 676 patients were asked to participate in the study; 92.8% (n = 627) agreed to participate and were randomly assigned to the counseling groups. However, because 37 participants were later discovered to have been enrolled already and randomly assigned earlier, there were only 590 individual participants. In the analysis, the 37 participants who had been randomly assigned twice were included only in the group to which they were initially assigned. Five persons were ineligible because of age and were excluded from the analysis. Four participants were excluded because they had no clinic records. The final sample comprised 581 participants: 288 in the intervention group and 293 in the control group. We could not find records of a clinic visit within 30 days of assignment for five participants; hence, baseline data were missing for these participants.

At baseline, the intervention and control groups did not differ significantly in mean age or percentage who were single, had a definite STD, had a possible STD, or were HIV-positive (Table 1). Participants' average age was 24 years, almost all were single, approximately one-third had a definite STD and two thirds had a possible STD, and 3 of 368 tested were HIV-positive at baseline.

Intervention attendance was poor. Of the 288 in the intervention group, 38% did not attend any intervention session, 17% attended one, 8% attended two, and 38% attended all three. Those who did attend an intervention session did not differ significantly (P> 0.05) in mean age, percentage who were single at baseline, percentage who had a definite STD at baseline, percentage who had a possible STD at baseline, or cumulative incidence of new definite or possible STD at follow-up from those who did not attend. The cumulative incidence of new definite (or possible) STD at follow-up was 18% (3 0%) among those who did not attend any intervention session, 15% (29%) among those who attended one, 0% (23%) among those who attended two, and 17% (3 5%) among those who attended all three. Of the participants who attended at least one intervention session, 75% completed their last session within 30 days of the randomization date.

The percentage who returned for at least one clinic visit during the 1-year follow-up did not differ significantly between the intervention (43%) group and the control (37%) group (P = 0.13). The 1-year cumulative incidence for those who returned with a new definite STD did not differ significantly between the intervention group (45 of 288 [16%]) and the control group (35 of 293 [12%]) (P = 0.20; RR, 1.3; 95% confidence interval, 0.9-2.0). The time to new definite STD was similar for both groups (Fig. 1). Participants had up to five new definite STDs. In the intervention group, 3% (10 of 288) had more than one STD; in the control group, 4% (12 of 293) had more than one. The 1-year cumulative incidence of returning with a new possible STD was 31% (90 of 288) in the intervention group and 27% (80 of 293) in the control group (P = 0.30; RR, 1.1; 95% confidence interval, 0.9-1.5). The time to new possible STD was similar for both groups (Fig. 2). The number of new specific STDs is similar for each group (Table 2 ). The most common definite STD was gonorrhea (n = 85), followed by chlamydia (n = 25). One person acquired HIV. Treatment for gonorrhea (n = 261) and chlamydia (n = 283) was common.

Discussion

The men in this study were indeed at high risk for infection, but the intensive counseling about STDs and HIV, compared with routine clinic counseling, was not associated with a reduction in the percentage of persons returning with a new STD. However, the results are difficult to interpret because of problems in the design and implementation of this low-cost, randomized, controlled trial in a community-based setting.

Difficulties Encountered in Our Study

Relying on passive follow-up resulted in some data limitations. Without scheduled assessments, we may have missed asymptomatic infections and symptomatic infections. Although other behavioral intervention studies have found significant reductions in STD acquisition using passive followup, (6,7) this lack of STD assessments is a big problem because many infections are asymptomatic. When this study was designed, we anticipated that a small percentage of new infections in men would be asymptomatic (eg, 1--3% for gonorrhea). (8) However, in more recent findings from Project RESPECT, (1) a substantial percentage of new infections in men appeared to be asymptomatic (eg, 28% for gonorrhea) (personal communication, M. Kamb, June 1999). In addition, although the clinics routinely encouraged clients to return for STD screening, an objective of each session of intensive counseling was to encourage STD screening. Therefore, those in the intensive counseling session may seem to have been at higher risk for STDs simply be cause more of them sought treatment. Finally, we were dependent on the accuracy of the existing computerized medical records; the computer occasionally did malfunction during the study, which may have led to the loss of some follow-up records from persons who visited on days when the computer malfunctioned.

We encountered other difficulties. First, 37 patients were unintentionally enrolled and randomly assigned twice, Of these, 51% were randomly assigned first to the control group. This double assignment was attributable, in part, to having two recruiters at each of two sites and lack of sufficient safeguards. Because we conducted intent-to-treat analyses and used the first random assignment for these participants, having these participants in the sample would dilute any treatment effect. Second, not all recorded dates of assignment corresponded clearly to a baseline clinic visit: in fact, baseline STD data are missing for five participants because no clinic visit was recorded within 30 days of the date of assignment. Although clinic computer malfunctions may have contributed to this problem, the reasons for this lack of a correspondence remain unclear. Stricter monitoring during recruitment might have avoided these errors. Third, having a small staff (ie, only two full-time and one half-time persons) responsib le for the day-to-day management of the study, recruiting participants, and serving as study counselors created logistic difficulties that made enrollment of all eligible patients impossible and may have contributed to scheduling problems with the intervention sessions. Furthermore, the small staff size made it difficult to develop and maintain adequate quality assurance measures.

Strengths of this Study

Despite the difficulties, this study had several strengths. The intervention was focused on young black men, who were indeed at high risk for new STDs. The intervention was developed with input from the target population, and the study counselors were from the community. The study did not rely on self-reported risk behavior as an outcome. In addition, the study was managed by a community-based organization and was low cost.

Comparison with Other Studies

Some studies have demonstrated an effect of intervention on reported risky behavior. (9) Few studies, however, have evaluated the intervention's effect on preventing STD, the outcome of interest for a disease prevention program. Five other U.S. randomized, controlled trials have measured the effectiveness of counseling interventions in preventing STD. (1,2,10-12) Like the present study, four of these studies were conducted at STD clinics, (1,10-12) although one also included other community-based clinics, most of which were primary care clinics. (11) The fifth study recruited participants from public health clinics but was conducted at a research clinic. (2) None of these studies was focused specifically on black men. Three of these studies, like ours, found no significant difference in cumulative incidence of STD among the interventions studied. (10-12)

One study that did find a significant difference among interventions, Project RESPECT,(1) had a sample of more than 5,700 men and women from five STD clinics. All three interventions were one-on-one and included HIV testing. The cumulative incidence of new STD over 12 months, by groups, was as follows: (1) 15% for the two brief information sessions (control), (2) 12% for the two client-centered counseling sessions modeled after HIV counseling guidelines from the CDC, and (3) 12% for the four theory-based enhanced counseling sessions (P < 0.05 for either counseling session intervention compared with the brief information sessions).

The other study that found a significant difference among interventions included 617 women with nonviral STD who attended public health clinics in San Antonio, TX. (2) The cumulative incidence of new chlamydial or gonorrheal infection over 12 months, by group, was 27% for one standard 15-minute individual counseling session based on CDC guidelines (control), compared with 17% for the three theory-based, small-group intervention sessions that were culture- and sex-specific (P < 0.05).

Both Project RESPECT (1) and the San Antonio stud? had advantages over our study and the other three studies. (10-12) First, Project RESPECT had the advantage of having a very large sample. Second, a higher percentage of participants in Project RESPECT (79%) (1) and the San Antonio study (75%) (2) completed all noncontrol intervention sessions than in the studies that did not find significant differences (range, 25% to <64%). (10-12) The lower participation rate in our study may be related to working with a higher risk population. Third, although our study and the National Institute of Mental Health study (11) relied primarily on passive follow-up for determining STD incidence, Project RESPECT and the San Antonio study had 6- and 12- month follow-up STD assessments. In addition, a larger proportion of participants in these two studies attended at least one follow-up assessment (81%, (1) 93% (2)) than did participants in the other studies with multiple scheduled follow-up assessments (72%, (10) 73% (12)).

Conclusion

The intensive counseling about STDs and HIV, compared with routine clinic counseling, was not associated with a reduction in the percentage of persons returning with a new STD. The results are difficult to interpret because of problems in the design and implementation of the study. Our study produced some important findings. Future trials should include scheduled follow-up STD assessments to reduce bias from monitoring only symptomatic infection. To be successful, they will likely need more staff to recruit participants, conduct the intervention sessions, and ensure adequate follow-up.

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Table 1

Baseline characteristics, by group (a)

                                    Intervention          Control
Characteristic                        (n = 288)          (n = 293)

Mean age (yr)                     23.6 [+ or -] 3.4  23.6 [+ or -] 3.3
Marital status single (%) (b)            96%                94%
Definite STD (c) at baseline (%)         40%                33%
Possible STD (c) at baseline (%)         69%                63%
HIV-positive (%) (d)                    0.5%               1.2%

(a)STD, sexually transmitted disease; HIV, human immunodeficiency virus.

(b)Data regarding marital status are missing for four participants in
the in tervention group and for six in the control group.

(c)Definite STD comprised syphilis, gonorrhea, chlamydia, chancroid,
lym-phogranuloma venereum, and HIV Possible STD added nongonococcal
urethritis and treatment for gonorrhea or chlamydia. Data regarding
baseline STDs are missing for one participant in the intervention group
and for four participants in the control group.

(d)Data regarding HIV serostatus are missing for 92 participants in the
in tervention group and for 121 participants in the control group.

Table 2

Number of new sexually transmitted diseases, by group (a)

                           Intervention   Control
Disease or treatment type   (n = 288)    (n = 293)

Syphilis                         1            0
Gonorrhea                       45           40
Chlamydia                       14           11
Chancroid                        0            2
Lymphogranuloma venereum         0            0
HIV                              0            1
Nongonococcal urethritis         3            6
Gonorrhea treatment            140          121
Chlamydia treatment            146          137

(a)A participant could have been diagnosed with or treated for multiple
sexually transmitted diseases at one time and could have been diagnosed
with or treated for the same sexually transmitted disease more than
once. HIV, human immunodeficiency virus.

Acknowledgments

We thank H. Virginia McCoy, G. Matthew Seeman, and Gil Silva for their contributions to this work.

Accepted May 24, 2002.

References

(1.) Kamb ML, Fishbein M, Douglas JM Jr, Rhodes F, Rogers J, Bolan G, et al. Efficacy of risk-reduction counseling to prevent human immunodeficiency virus and sexually transmitted diseases: A randomized controlled trial-Project RESPECT Study Group. JAMA 1998;280:1161-1167.

(2.) Shain RN, Piper JM, Newton ER, Perdue ST, Ramos R, Champion JD, et al. A randomized, controlled trial of a behavioral intervention to prevent sexually transmitted disease among minority women. N Engl J Med 1999;340:93-l00.

(3.) Centers for Disease Control and Prevention. HIV Counseling, Testing, and Referral Standards and Guidelines. Atlanta, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, 1994.

(4.) 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.

(5.) Otten MW Jr, Zaidi AA, Peterman TA, Rolfs RT, Witte JJ. High rate of HIV seroconversion among patients attending urban sexually transmitted disease clinics. AIDS 1994;8:549-553.

(6.) Cohen DA, MacKinnon DP, Dent C, Mason HRC, Sullivan E. Group counseling at STD clinics to promote use of condoms. Public Health Rep 1992;107:727-731.

(7.) O'Donnell CR, O'Donnell L, Doval AS, Duran R, Labes K. Reductions in STD infections subsequent to an STD clinic visit: Using video-based patient education to supplement provider interactions. Sex Transm Dis 1998;25:161-168.

(8.) Hook EW III, Handsfield HH. Gonococcal infections in the adult, in Holmes KK, Sparling PF, Mardh PA, Lemon SM, Stamm WE, Piot P, et al (eds): Sexually Transmitted Diseases. New York, McGraw-Hill Health Professions Division, 1999, ed 3, pp 451-466.

(9.) Oakley A, Fullerton D, Holland J. Behavioral interventions for HIV/ AIDS prevention. AIDS 1995;9:479-486.

(10.) 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.

(11.) The National Institute of Mental Health (NIMH) Multisite HIV Prevention Trial Group. The NIMH multisite HIV prevention trial: Reducing HIV sexual risk behavior. Science 1998;280:1889-1894.

(12.) Branson BM, Peterman TA, Cannon RO, Ransom R, Zaidi AA. Group counseling to prevent sexually transmitted disease and HIV: A randomized controlled trial. Sex Transm Dis 1998;25:553-560.

RELATED ARTICLE: Key Points

* Our results suggest that the intensive counseling did not reduce sexually transmitted disease acquisition.

* We encountered problems in conducting this low-cost trial, making results difficult to interpret.

* Future trials should schedule follow-up sexually transmitted disease assessments and will likely need more staff.

From the Epidemic Intelligence Service, Epidemiology Program Office, the Division of HIV/AIDS Prevention-Surveillance and Epidemiology, National Center for HIV, STD, and TB Prevention, and the National Center for Prevention Services, Centers for Disease Control and Prevention, Atlanta, GA; Lock Towns Community Mental Health Center, Inc., Miami, FL. Dr. Maher is currently affiliated with Program Design and Evaluation Services, Multnomah County Health Department and Oregon Department of Human Services, Portland, OR; Dr. Osewe is currently affiliated with the U.S. Agency for International Development in Zimbabwe; and Dr. Scerba is currently affiliated with the Broward County Board of County Commissioners, Ft. Lauderdale, FL.

Reprint requests to the National Center for HIV, STD, and TB Prevention, Office of Communications, Centers for Disease Control and Prevention, Mail Stop E-07, Atlanta, GA 30333. Correspondence to Julie E. Maher, PhD, MS, Program Design and Evaluation Services, 800 N.E. Oregon Street, Suite 550, Portland, OR 97232. Email: [e-mail]

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