Institutional review boards (IRB) at the University of Pennsylvania and Temple University approved this study. Because the Centers for Disease Control and Prevention (CDC) co-author was not engaged in direct contact with the participants, the CDC deferred approval to the IRB at the University of Pennsylvania. The study included African American MSM irrespective of their HIV status and sexual orientation self-identification. Potential participants were screened for eligibility. Men were eligible to participate if they were at least 18 years of age, self-identified as black or African American, were born a male, and reported having anal intercourse with a man in the previous 90 days.
Men were excluded if they reported having anal intercourse with only one main male partner in the past 90 days or had participated in an HIV/STI risk-reduction intervention in the past 12 months. Those eligible were invited to participate in Project Being Responsible for Ourselves (BRO) designed to reduce the chances that men develop devastating health problems, including cardiovascular diseases, cancers, and STIs, including HIV. Informed consent while blind to group assignment was required for participation. Participants were recruited in the Philadelphia area (a) through advertising in local newspapers read by African American MSM, (b) through community-based organizations (CBOs) serving African American MSM, (c) through recruitment flyers posted at colleges, universities, parks, bars, and adult bookstores, (d) through face-to-face recruitment at social events, activities, and parties where a large turnout of African American MSM was expected, and (e) through the referrals of participants (i.e., snowballing).
In a RCT design, computer-generated random number sequences were used to randomly assign participants to the BRO HIV/STI risk-reduction intervention or the attention-matched health-promotion intervention that served as the control condition using concealment of allocation techniques designed to minimize bias in assignment. The biostatistician generated the random assignments; the project director implemented the assignments. Participants were enrolled between April 2008 and March 2011, with all data collection completed by May 2012.
Participants who completed the pre-intervention questionnaire and attended Intervention Session 1, which occurred at the same visit, were enrolled in the trial. After enrollment, data collectors, but not intervention facilitators or participants, were blind to group assignments. We held the intervention and data-collection sessions at a university research center. Participants were compensated with $25 for the pre-intervention assessment, $25 for each of the three intervention sessions, $25 for the immediate post-intervention assessment, and $50 for each of the two follow-up assessments.
Interventions
The HIV/STI risk-reduction and health-promotion interventions were developed based on social cognitive theory [
14] and the reasoned action approach [
15,
16], integrated with extensive formative research [
17], including focus groups and pilot testing. Social cognitive theory has been used to develop interventions to change sexual-risk behaviors [
20,
23‐
26] and a host of other health behaviors [
27‐
31]. Most relevant here are the social-cognitive-theory constructs of “outcome expectancy,” beliefs about the consequences of a specific behavior, and “self-efficacy,” people’s confidence that they can execute a specific behavior; its emphasis on behavioral skills; and its methods for increasing skills, particularly practice with performance feedback (e.g., role-playing). The reasoned action approach is an extension of the theory of planned behavior [
32], which itself is an extension of the theory of reasoned action [
33]. Most relevant here are the reasoned action approach’s emphasis on the importance of salient beliefs, its notion that such beliefs may vary from population to population and from behavior to behavior, and its methods to identify such population-specific beliefs: namely, the use of qualitative research, including focus groups. Identifying the salient beliefs in the population and then employing intervention activities designed to influence those population-specific beliefs can result in an intervention that is both theoretically grounded and tailored to the population.
Consistent with the reasoned action approach, we conducted qualitative research, seven focus groups with African American MSM and one with representatives of CBOs that serve African American MSM, to ensure the intervention was tailored to the population. In addition, we conducted three pilot tests of the interventions. Each intervention consisted of three 90-min one-on-one individual sessions implemented during 3 consecutive weeks by specially trained facilitators using standardized intervention manuals. We utilized one-on-one interventions to allay concerns some African American MSM might have about revealing their sexual behavior with other men by virtue of participating in a group-based intervention [
18,
19], a concern expressed in the focus groups with African American MSM and with representatives of CBOs serving African American MSM. Sessions 1 and 2 in each intervention included take-home assignments that the participants reviewed at the subsequent session. The delivery of each intervention was tailored to the information that the participants provided during the sessions, including information about behaviors relevant to the particular intervention, the context in which the behaviors occurred, and participants’ motivation for the behaviors.
The BRO HIV/STI risk-reduction intervention was designed to strengthen outcome expectancies expressed in focus groups with African American MSM, outcome expectancies that have been observed in other populuations, including the hedonistic outcome expectancy that using condoms would not interfere with sexual enjoyment [
9,
11,
23,
24,
34‐
37], the prevention outcome expectancy that using condoms prevents STIs, including HIV [
24,
38], and the self-evaluative outcome expectancy that using condoms would make the man feel good about himself [
9,
23,
35]. The intervention was designed to address aspects of self-efficacy identified in the focus groups, including technical-skill self-efficacy to use condoms correctly without interfering with sexual enjoyment [
8,
36,
37], impulse-control self-efficacy to exercise the necessary control to use condoms even when sexually excited, under the influence of alcohol or drugs, or in the presence of other triggers for unsafe sex [
11,
24,
37], and skills and self-efficacy to negotiate condom use with sexual partners [
8,
36,
37]. In addition, it was designed to increase knowledge regarding the risk of acquiring or transmitting HIV and other STIs, and perceived vulnerability to HIV infection or re-infection with a different strain of HIV.
In Session 1, a general introduction was designed to provide an overview, create enthusiasm, build trust, and help the facilitator learn about the participant as an individual, including his goals, reasons for participating, and sexual orientation self-identification. In the “Where Do You Draw the Line” activity, participants discussed their sexual-risk behavior, including when and where they had sex, the types of sex in which they engaged, and when they used and did not use condoms, information used later to tailor activities (e.g., role-plays) to the participants. Participants completed a risk-assessment activity on risky sexual practices, an activity that focus groups said would help men to recognize their personal risk of HIV, an activity also designed to identify factors that trigger participants’ sexual-risk behaviors. This activity also provided information that allowed the facilitator to tailor the intervention to the unique risk and other characteristics (e.g., triggers) of each man by focusing on the particular risk behaviors and contexts most relevant to him. The intervention then focused on HIV/STI risk-reduction knowledge and perceived risk of HIV/STIs. A mini lecture covered HIV/STI symptoms, transmission, and prevention. A discussion of the participant’s goals and dreams and how his sexual-risk behaviors might affect his goals for himself, partners, and community introduced the take-home assignment, “Moving Towards My Goals,” which asked the participant to identify a behavioral goal based on his sexual risk identified earlier and to create a personal HIV sexual-risk-reduction plan he could employ to attain that goal.
In Session 2, activities addressed participants’ outcome expectancies regarding condom use and the correct and consistent use of condoms. It began with a review of the Session 1 take-home assignment, including participants’ barriers to achieving their personal behavioral goals and strategies to surmount the barriers, with facilitators following a different protocol depending on whether the participant had completed the assignment. A “Forced Choice” activity examined the participants’ beliefs about circumstances under which they should use condoms and the type of person who is vulnerable to HIV/STI. The facilitator demonstrated on an anatomical model correct condom use and then the participant practiced the correct steps for condom use on an anatomical model. The participants considered ways to make condom use fun and pleasurable and how alcohol and drug use might affect condom use. The facilitator also asked the participant to list excuses that he and his partners give for not wanting to use condoms and to think of responses to neutralize the excuses. A take-home assignment, “Creating a Relapse Prevention Plan,” asked the participant to imagine that he had been practicing safer sex and that he was suddenly faced with the triggers to have unsafe sex he had enumerated earlier. The facilitator asked the participant to identify ways he might avoid such triggers and to suggest discreet ways to have condoms available when needed.
In Session 3, the focus was on building knowledge, self-efficacy, and skills regarding negotiating condom use. A discussion centered on the Session 2 take-home assignment. The facilitator and participants enacted role-play scenarios about African American MSM negotiating condom use in an insertive or receptive role, with steady, casual, paying, or female partners, and under circumstances when they had slipped and had unsafe sex. Focus-group participants had liked the scenarios, saying they were realistic and employed relevant locations, including “Gay Acres,” where some men in the Philadelphia area meet other men for sex. The facilitator could adapt each role-play scenario to suit the information the participant previously provided to ensure that the scenarios was as authentic as possible. Participants learned and practiced negotiation and communication skills using “Say No, Explain Why, Provide Alternatives and Talk it Out (SWAT),” a four-step strategy to communicate effectively their decision to use condoms and abstain from unprotected intercourse. A “Virtual Sex Project” interactive video allowed participants to select personally relevant risk situations for actors in “hook-up” scenarios, scenarios that focus group participants said were realistic. The participants reviewed their personal HIV sexual-risk-reduction plan developed in Session 1 and explored ways to overcome potential obstacles and to sustain behavior change. In the “Commitment to Safety” activity, the participants wrote a safer-sex promise letter to self, partners, and community that was mailed to them 6 weeks after the intervention to remind them of their commitment to be safe sexually.
The time- and dosage-matched health-promotion intervention provided a control for “Hawthorne effects,” reducing the likelihood that the HIV/STI risk-reduction intervention’s effects could be attributed to non-specific features, including special attention [
39]. Its activities, while similar to those in the HIV/STI risk-reduction intervention, focused on increasing physical activity and fruit-and-vegetable consumption and decreasing fat consumption to reduce the risk of chronic diseases, including heart disease, hypertension, stroke, diabetes, and certain cancers—leading causes of morbidity and mortality among African Americans [
40].
We considered employing African American MSM as facilitators, but the focus groups with representatives of CBOs revealed that CBO staff who worked with African American MSM were mainly African American or Latino women of no particular sexual orientation self-identification and the African American MSM focus groups revealed no consensus on the desirable gender or sexual orientation of facilitators. Accordingly, we employed facilitators irrespective of gender and sexual orientation. The facilitators were 23 adults (17 women and 6 men) 28–64 years of age (mean age = 44.2). Twenty were African American, two were Latino, and one was white. About 56.5 % had a Master’s degree, which was the modal and median education; 79.1 % had previously facilitated HIV/STI risk-reduction interventions, 50.0 % had previously facilitated health-promotion interventions, and 65.2 % had previously worked with African American MSM. We hired individuals who had the basic skills to implement either of the two interventions. After stratifying them by gender and age, we randomly assigned them to be trained to implement one of the two interventions. In this way, we randomized facilitators’ characteristics across interventions; hence, reducing the plausibility of attributing any effects of the interventions to the facilitators’ pre-existing characteristics [
24].
The facilitators received three 8-hour days of training in their assigned intervention, training that included a project overview, the theoretical framework, background information relevant to the assigned intervention, and effective facilitation techniques, including presentation style, time management, and nonverbal and verbal communication, and stressed the importance of implementation fidelity. The HIV/STI-risk-reduction-intervention training also covered transgender issues, sexual identity development, and “tops” versus “bottoms” (sexual positions). During the training, the trainers modeled the intervention activities, the facilitators learned their assigned intervention, practiced implementing it, received feedback from each other, the trainers, and investigators, and created common responses to potential issues that might arise during implementation. Besides the facilitator training, we provided facilitators and all staff who might have even incidental contact with the participants two 8-hour days of sensitivity training on the knowledge, skills, and perspectives necessary to work effectively with African American MSM.
We employed several quality assurance procedures. A facilitator supervisor met with the facilitator before each session, reviewing the materials, answering any questions, reviewing the session’s purpose, and reiterating any specific points that the facilitator should emphasize in the session. When the session ended, the supervisor reviewed the facilitator’s log sheets indicating the extent to which the facilitator completed the activities and debriefed him or her, addressing concerns and providing suggestions to address implementation issues. The supervisor also reviewed the digital tape recordings of the sessions and subsequently provided performance feedback to the facilitators and retraining if necessary. Periodically, the supervisor held group meetings with all the facilitators to discuss implementation issues and to fashion common responses.
Sample size and Statistical Analysis
A statistical power analysis was performed to calculate the sample size required to detect a clinically significant effect of the HIV/STI risk-reduction intervention on the primary outcome, consistent condom use, compared with the attention-control group. In the pilot survey, we found that 42 % of the African American MSM reported consistent condom use over all of their anal and vaginal intercourse acts in the past 90 days. We selected an absolute increase of 14 % points in consistent condom use as a clinically and substantively important effect size. Assuming a two-tailed test, α = 0.05, 20 % attrition, and a 14 % increase in consistent condom use from 42 % in the control group to 56 % in the HIV/STI intervention group, with N = 594 men enrolled in the trial, the estimated statistical power was 84 % [
58].
We used descriptive statistics to summarize the participants at baseline on socio-demographic variables and χ
2 test and logistic regression to analyze attrition. The efficacy of the HIV/STI risk-reduction intervention averaged over the 6- and 12-month follow-ups compared with the health-promotion intervention was tested using logistic generalized-estimating-equations (GEE), adjusting for the longitudinal repeated measurements on participants [
59,
60] and controlling for baseline measure of the outcome. The models were fit and contrast statements specified to obtain estimated odds ratios and their corresponding 95 % confidence intervals (CI). Robust standard errors were used and an independent working correlation matrix was specified.
The models included time-independent covariates, baseline measure of the outcome, intervention condition, and time (two categories representing 6- and 12-month follow-up). In addition, we included as covariates sexual orientation self-identification, self-reported HIV status, and age group in analyses in which they were statistically significant. We report estimated intervention standardized effect sizes (ds) averaged over the two follow-up assessments, calculated by transforming the odds ratios using the Cox transformation [
61]. Models assessing whether the efficacy of the intervention differed between the two follow-ups included the baseline measure of the criterion, intervention condition, time, and the Intervention-Condition × Time interaction. The analyses were performed using an intent-to-treat model with participants analyzed based on their intervention assignment, regardless of the number of intervention or data-collection sessions they attended. Analyses were completed using SAS V9.
We assessed mediation using a product-of-coefficients approach [
7,
62], where the α path denotes the effect of the intervention on a potential mediator at the immediate post-intervention assessment, the β path denotes the effect of the potential mediator on consistent condom use averaged over the 6- and 12-month post-intervention assessments, and the product of α and β (αβ) quantifies the mediated effect of the intervention. Mediation is determined by testing whether the αβ product differs significantly from ‘0’. Each theoretical construct was evaluated separately for mediation of effects of the intervention on the primary outcome, consistent condom use. We estimated the α paths using linear regression models on theoretical constructs at the immediate post-intervention assessment, adjusting for baseline of the theoretical construct and consistent condom use. We estimated the β paths using GEE logistic regression models with time, intervention condition, and baseline of the theoretical construct and consistent condom use as covariates. Estimated mean differences and 95 % CI are reported for the α paths. Estimated odds ratios and 95 % CI are reported for the β paths. Estimated αβ products and, because the distribution of a product is non-normal, asymmetric 95 % confidence intervals (ACI) calculated using the bootstrap quantile method [
62] with 2,000 replicates are reported. The p < 0.05, two-tailed statistical significance criterion was used. Mediation analyses were conducted in R version 2.15.1 [
63].