Conceptual basis and procedures for the intervention in a multisite HIV prevention trial

Introduction Public health interventions that can be implemented in health service organizations (HSO) are needed as part of the national strategy to reduce HIV infection [1]. This chapter describes a seven-session, small-group intervention aimed at reducing sexual risk acts of clients served in sexually transmitted disease (STD) clinics and HSO. These clinics are potentially important sites for HIV prevention. HIV seroprevalence rates in STD clinics range from 0.1 to 11%, with an overall rate of 2% [2]. Some previous HIV efforts in STD clinics, typically brief programs with individual clients, have shown reductions in sexual risk acts [3–8]. Project Respect, a large-scale trial conducted in STD clinics, compared the effects of a brief risk education session, two 20 min risk-reduction counseling sessions, and a four-session enhanced intervention [4]. Initial 6-month follow-up data indicated that condom use increased with both main and casual partners by about 20% and consistent condom use increased from 15 to 32% in the two-session counseling and the enhanced intervention. These data suggest that such preventive interventions can be successful in STD clinics. Women in HSO represent another priority population for HIV prevention. HIV seroprevalence among women is estimated to be 0.1–0.16%, reflecting 110 000 to 150 000 seropositive women in the United States [9,10]. Approximately 0.6% of non-Hispanic African American women in their thirties are estimated to be living with HIV [9]. In a 1988–1989 survey of reproductive health clinics, rates ranged from 0.0 to 2.28% (median, 0.22%), with rates over 1% primarily occurring on the East Coast and in Puerto Rico [11]. The highest median rate of infection is documented in women aged 25–29 years (0.32%), and the median rates are higher among African American women than among Hispanic (0.11%) or white women (0%). In surveys of primary health-care settings, 0.22–0.5% of women were found to be HIV-positive [12,13]. These data indicate that HSO are an appropriate intervention site to prevent HIV. Even in HSO that serve persons at risk for HIV, not all clients engage in sexual acts that place them at risk. Given the cost of intensive interventions and the fact that brief interventions may be effective for some persons in STD clinics [4], it is critical to target interventions to those at greatest risk of contracting HIV. Therefore, potential participants for this trial were screened to identify those with clear risk factors. The sensitivity and specificity of the screening procedure was high [14] and ensured that intensive interventions were being delivered to those at risk. (See Table 2 in chapter 1 (page S4) for criteria in the screening form.) The intervention was developed to build on earlier work demonstrating that small-group interventions result in significant increases in condom use, in the range of 30% [15–17]. Small groups offer the opportunity for intervention participants to acquire new knowledge and risk-reduction skills, rehearse new behavior patterns, build group norms to support safer sex efforts, and practice new behaviors with a social group of persons with similar life experiences and social demographic backgrounds. Based on previous research and pilot work, seven 90 min sessions were identified as the desirable dose for the intervention program. The small-group, HIV prevention program tested in the NIMH Multisite HIV Prevention Trial was grounded in behavioral theory [18,19] and targeted three primary factors mediating sexual risk acts: (i) outcome expectancies, (ii) skills, and (iii) self-efficacy. Outcome expectancies provide motivation for safer behavior [20]. If high-risk behavior is perceived as generating negative consequences, those unsafe behaviors are likely to be avoided or decrease in frequency, while behaviors with perceived positive consequences, safer practices, are likely to increase in frequency. Based on previous research with adolescents, women [21,22] and homosexual men [23,24], three types of expectations were targeted: (i) personal vulnerability to HIV, (ii) partner reactions to condom use, and (iii) self and social approval towards safer sex acts. Perceived vulnerability to HIV increases with accurate information about disease transmission and accurate evaluations of outcomes of personal risk acts. Partners' reactions to condom use are likely to be more positive when one has the skills to request and encourage condom use, and when one can provide more accurate information regarding the endorsement of condom use. Finally, self and social approval towards safer sex acts result from group interaction and social rewards regarding safer sex. Skills required to implement safer sex include interpersonal negotiation skills and the skills needed to use condoms appropriately. Negotiations concerning male condoms are quite different for men versus women [25,26]. By definition, male condom use requires the cooperation of the male partner who usually holds greater power in the relationship [27,28]. Issues of trust, commitment, and love are often involved in the negotiation of condom use [29,30] and must be addressed if increases in condom use are to be achieved. Therefore, increases in negotiation skills require recognition of gender norms in implementation of safer sex and competence in discussing relationship issues. The second major skill, appropriate condom use, requires practice. Correct condom use can be analyzed in terms of behavioral skill components or steps. Interventions to increase condom use must enhance the participant's ability to correctly implement these steps. Finally, self-efficacy refers to individuals' confidence in their abilities [31], in this case with respect to the implementation of HIV risk-reduction behavior change. Persons lacking self-efficacy are less likely to initiate new behaviors, and may exert less effort and persistence in implementing new skills. Self-efficacy for risk-reduction behavior change has been linked to sexual risk levels of homosexual men [24], heterosexual men [24,32,33], women [33,34], and adolescents [24,35–37]. Self-efficacy is domain-specific; persons can believe that they will be successful in using condoms correctly, but may not feel confident in their ability to negotiate with or influence their partners' attitudes. Self-efficacy can be enhanced by rewarding oneself for using new skills and implementing safer acts, as well as receiving positive feedback from others. Components that are broadly similar across populations must be tailored to meet the different needs of women and men from diverse ethnic, racial, and sociocultural backgrounds. For example, there are substantial gender differences in social cognitive mediators including attributions about sexual experiences [38], sexual coercion [39,40], sexual risk situations encountered [41], self-efficacy to use condoms [42], and sexual self-esteem [43]. In one study, sexually active men's perceived ability to talk with a new sex partner about safer sex was a significant predictor of intent to use condoms [42]. However, among women, intent to use condoms was partially explained by their perceived ability to enjoy sex with a condom. As outcome expectancies, skills, and self-efficacy vary for each gender, interventions must be tailored to these mediators. This is one reason why the NIMH Multisite HIV Prevention Trial intervention was delivered in same-gender groups. Interventions to prevent HIV transmission should also be designed to meet the needs of various ethnic and racial minorities. The majority of persons at high HIV risk within inner-city AIDS epicenters are African American and Hispanic; however, across ethnic-racial groups, there are also differences in cultural norms, values, and attitudes associated with sexual behavior patterns [44–46]. Intervention Following formative, largely qualitative research with each population and setting, piloting of the intervention occurred at each of seven sites with at least 15 participants per site conducted by senior researchers. The intervention was named Project LIGHT, an acronym for ‘living in good health together'. On the basis of the pilot work, a manual was written outlining the objectives, activities, timing, and sample scripts for each of seven 90 min sessions held twice a week. To enhance opportunities for modeling and role-playing interactions between heterosexual partners, all groups included five to 10 participants, and were co-led by male and female facilitators (or two women for female groups). The first session focused on setting the group routine, personalizing participants’ knowledge of HIV, recognizing positive changes in personal HIV prevention strategies, and goal settings. Each of the six sessions included the following: goal review; introduction of new material and related attitudinal and behavioral skills; goal setting; and reinforcing group encouragement. New content was introduced each week, which built on the previous session and shifted from an early focus on motivational enhancement to skills-building [47]. The program covered knowledge, identifying and managing triggers for risk acts, problem-solving in risk situations, condom use, interpersonal assertiveness to negotiate safer sex, and maintenance of new behavioral routines. Each participant practiced skills specific to his or her risk circumstances involving steady partners, casual partners, drug-using partners, and other personally relevant relationships. Each session curriculum contained scripted role plays and activities that structured the interactions among group members to facilitate learning. Scripted examples were provided for each activity; facilitators followed standard protocols but were trained to rephrase and put the intervention in their own words in order to communicate effectively with the participants. Facilitators Implementing prevention activities in small groups requires skill in managing interpersonal interactions and building group cohesiveness. Project LIGHT facilitators were selected on the basis of their previous experience facilitating groups, knowledge of HIV, and positive interpersonal skills. As a part of training, all potential facilitators read materials on behavior change [48] and an HIV manual, observed videotapes of the seven modules, and prepared small cue cards that outlined the key activities and the time allotted to each activity for every module. All facilitators and their supervisors also attended a 4-day central training session. Central training workshops were conducted in small groups with six to eight facilitators, led by teams of senior behavioral researchers who had previously trained HIV facilitators and had experience in behavioral interventions in other health behavior change areas. After presentation of the theoretical background for the intervention, the trainee facilitators role-played both facilitators and participants for each of the seven modules. These facilitator training sessions were videotaped and reviewed by two senior researchers. Trainees were certified as leaders based on skill proficiency demonstrated in the central training and by observational ratings of the first two sessions led with participants. Video- and audiotapes of a minimum of at least 14% of each facilitator's intervention sessions were monitored by site supervisors, with feedback provided biweekly throughout the study. This supervision was supplemented by central quality assurance ratings of the fidelity of the intervention implementation according to the protocol. Session by session curriculum Each session built on material presented in previous sessions and introduced new content (Table 1 summarizes the content introduced in each of the sessions). Session 1 established the program's goals and established the tone, style, and routine for all later sessions. Interpersonal attraction and social support among group members was anticipated to be a key motivator for enhancing participation and implementation of the skills. Therefore, the first session started with introductions, established ground rules for group participation, and encouraged the sharing of important personal HIV-related issues and experiences. As motivation for behavior change requires perception of potential personal risk and accurate knowledge of this risk, in session 1 the facilitators presented information on the HIV seroprevalence in local populations of relevance to the participants. For example, in groups involving clients in Harlem STD clinics, the local statistics for persons with STD in that community were presented. Rather than focusing solely on enhancing fear of disease transmission, the intervention focused on positive values held by the participants that enhanced their desire to stay healthy and to prevent HIV. Facilitators encouraged participants to reflect and build on their past successes at changing behavior. To achieve the transfer of knowledge and skills acquired in the group to the participants' daily routines, group members set goals to accomplish before the next session that furthered their personal risk-reduction plans. If no clear goal had emerged during the session, participants were asked to identify sources of information regarding HIV in their local environment.Table 1: . Objectives of each module of the Project LIGHT intervention.Session 2 and each session thereafter began with goal review and ended with goal setting. Goals were brief, within the capability of the participant, and specific; facilitators helped participants reshape and narrow unrealistic or overly global expectations to ensure success of enactment. Three activities shaped most of the sessions. First, motivation to avoid infection was enhanced by viewing a videotape of HIV-infected persons of ethnicity, age, and risk status similar to that of the participants. Participants identified similarities between themselves and the HIV-infected persons. Second, situational and personal triggers or antecedents of high-risk acts were identified for each participant. These triggers were identified by reviewing personal histories of risky encounters. Third, each participant made a written contract of commitment, agreeing to shift their risk behaviors to reduce HIV transmission. In this context, new goals were set for between-session practice of safer sex. Following identification of personal triggers that stimulate risky HIV-related behavior, session 3 focused on skills to control and modify personal triggers as well as thoughts, feelings, and actions that previously precipitated unsafe acts in different situations. Changing habitual behavioral sequences requires the development of problem-solving skills. Problem solving involves goal setting, generation of alternatives, evaluation of the relative effort and likely success of implementing each alternative, enactment, and evaluation of success [49]. Problem-solving activities helped participants establish personal risk-reduction goals and facilitators helped participants to identify personal reinforcers. Self-reward strategies were modeled by facilitators and then practiced by participants. Group members agreed to achieve personal behavior change goals and then reward themselves. The sharing of positive events built cohesion during the session and facilitated positive expectations for the outcome of the intervention. Session 4 focused on condom use. After a review of goals attained by participants since the previous session, the fourth session directed attention to condom use. Expectations for positive outcomes of condom use were set by examining the advantages and disadvantages of condom use and then identifying expectations of condom use. The relative safety of each type of sexual act and the appropriate and correct use of condoms (e.g., latex condoms with water-based lubricant) was demonstrated, and condom use was practiced by all participants. Both male and female barrier methods were demonstrated with realistic anatomical models. Although only 7% of participants had used injecting drugs in the 90 days prior to the baseline interview, facilitators reviewed methods of cleaning needles and sources of new and clean needles. The goals for the next session focused on condom usage. Both sessions 5 and 6 focused on negotiation of safer sexual behavior. In session 5, a sequence was taught to help participants articulate unwritten nonverbal rules of social behavior that fit the acronym to ‘TALK’ (see Table 1, session 5). The TALK rules helped participants apply problem solving solutions in specific anticipated social encounters with casual and regular partners. The concept of assertiveness when making direct requests and refusals in high-risk situations was introduced in a culturally appropriate way. Methods of TALK that were consistent with the male–female interactions within each ethnic group were encouraged in the group, and each person practiced skills based on her or his experience and comfort level. Role playing was engaging and rewarding; participants enjoyed practicing new behavioral routines. Session 6 further solidified the negotiation skills taught in session 5 by presenting more challenging situations to participants and identifying negotiation messages likely to prevent adverse partner reactions, such as jealousy. One aim of this session was to provide strategies for negotiating with potentially abusive men. ‘Creative negotiation’ enabled women to translate a confrontation into a compliment during sexual negotiation. Participants practiced refusal situations and rewarded themselves for the maintenance of safer sex in various situations. HIV testing prior to pregnancy was described, discussed, and encouraged. Similar to earlier topics such as condom use and HIV awareness, motivation for HIV testing was increased by encouraging participants to examine the benefits and perceived risks of HIV testing, and to gain knowledge, and practice steps needed to seek testing. To complete the training sequence, session 7 focused on the maintenance of safer sex acts by identifying anticipated triggers for future unsafe acts, developing techniques to cope with slips to unsafe behaviors, and initiating self-rewards for continuing safer sex. Ongoing rewards for HIV prevention, such as enjoying safer sex and feeling positive about oneself for being a prevention leader, were identified and implemented in this final session. Graduation from the curriculum was marked with diplomas, a party, and a renewed commitment for safer sex. Case examples The following cases are selected to demonstrate the goals and the types of risk situations encountered by group participants. John was an African American man in his early twenties who had been living with his current partner for 2 years. also to have sexual encounters with his who is the of his as well as with other partners. the of the group sessions, not use condoms with sexual with the of his since had been a at the time they and the that had with three other men since their As the sessions John that should use condoms with then that needed to be tested for HIV, and to use condoms with his current primary partner his his partner to be at the of using However, his request was and found that his partner had to use John was found to be but to using condoms with each was an African American who that condoms had not been used during her with her partner in the Project LIGHT sessions, was that some in same-gender sexual about contracting HIV, her partner in and condom use on their next to communicate with on the and asked about his sexual behavior in to for a agreed to use later and and her partner used condoms on her next to Although not to that be sex with her partner condoms to use in was a African American man who the Project LIGHT sessions in early main for unsafe sex was both and other of use patterns were in his by participants at the of the trial to provide information if they his as across the from into Project LIGHT about issues. not to be at risk of STD or HIV infection from his regular with had sex a condom. to correctly use male was successful in negotiating condom use with his over the of the three sessions of the intervention, and to use condoms throughout the follow-up also to avoid his use triggers by for was a Hispanic who was and an injecting partner was a sex who was also an injecting not to use condoms with his partner used condoms with her attended all sessions, but at the to have unsafe sex with his However, no in most used new needles when The Project LIGHT intervention was a structured of active and activities that participants with new of their HIV risks and helped them gain personal and interpersonal skills needed to reduce their risk behavior. Participants at high risk for HIV established and implemented goals for reducing their risk for contracting HIV. In same-gender groups, men and women to change their behavior to new knowledge and group norms, and social and practice. rates were group members demonstrated skill and participants provided of change in attitudes and behavior. Outcome being conducted will these are in with behavior change outcomes of participants.